EMBASE Cardiac Update AutoAlert: EPICORE Cardiac Surgery Blogger2

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<1>
Accession Number
20160579642
Author
Yang Y.; Lei J.; Huang W.; Lei H.
Institution
(Yang, Lei, Huang, Lei) Department of Cardiology, The First Affiliated
Hospital of Chongqing Medical University, Chongqing, China
Title
Efficacy and safety of biodegradable polymer sirolimus-eluting stents
versus durable polymer drug-eluting stents: A meta-analysis of randomized
trials.
Source
International Journal of Cardiology. 222 (pp 486-493), 2016. Date of
Publication: 01 Nov 2016.
Publisher
Elsevier Ireland Ltd
Abstract
Background A meta-analysis was performed to investigate the safety and
efficacy of biodegradable polymer sirolimus-eluting stents (BP-SESs)
compared with durable polymer drug-eluting stents (DP-DESs). Methods
Online databases, including PubMed, EMBASE and the Cochrane Library, were
searched for randomized controlled trials that compared BP-SESs and
DP-DESs and reported rates of overall and cardiac mortality, myocardial
infarction (MI), stent thrombosis (ST), target lesion revascularization
(TLR), target vessel revascularization (TVR) and late lumen loss (LLL).
Results A total of 15 studies investigating 14,187 patients were included
in the meta-analysis. The BP-SESs significantly reduced the risk of late
ST (OR: 0.57; 95% CI: 0.33-0.98; p = 0.04), very late ST (OR: 0.53; 95%
CI: 0.29-0.97; p = 0.04) and in-stent LLL (MD: - 0.06, 95% CI: - 0.11 to -
0.01; p = 0.01) compared with the DP-DESs but did not improve mortality
(OR: 0.95; 95% CI: 0.81-1.11; p = 0.52), cardiac mortality (OR: 0.89; 95%
CI: 0.72-1.10; p = 0.27), MI (OR: 0.90; 95% CI: 0.76-1.08; p = 0.27), TLR
(OR: 0.95; 95% CI: 0.81-1.11; p = 0.51), TVR (OR: 0.96; 95% CI: 0.81-1.13;
p = 0.62) or in-segment LLL (MD: - 0.03, 95% CI: - 0.06-0.01; p = 0.10).
Conclusions In this meta-analysis of randomized controlled trials, the
BP-SESs were superior to the DP-DESs in terms of late ST, very late ST and
in-stent LLL. Further large randomized controlled trials with long-term
follow-up are required to validate the benefits of BP-SESs.

<2>
Accession Number
20160261115
Author
Weng W.; Zhang F.; Lineaweaver W.C.; Gao W.; Yan H.
Institution
(Weng, Gao, Yan) Division of Plastic and Hand Surgery, Department of
Orthopaedics, Second Affiliated Hospital of Wenzhou Medical University,
109 West Xueyuan Road, Lucheng District, Wenzhou 325027, China
(Zhang, Lineaweaver) Joseph M. Still Burn and Reconstructive Center,
Jackson, MS, United States
Title
The Value of Postconditioning in Plastic and Reconstructive Surgery: A
Systematic Review.
Source
Journal of Reconstructive Microsurgery. 32 (4) (pp 285-293), 2016. Date of
Publication: 28 Mar 2016.
Publisher
Thieme Medical Publishers, Inc.
Abstract
Background Ischemia-reperfusion (I/R) injury by abrupt restoration of
circulation after prolonged ischemia has still been an unsolved problem in
plastic and reconstructive surgery. The concept of postconditioning
(post-con), which has been well described in cardiovascular surgery, has
been recently introduced in plastic and reconstructive surgery. As an
"after-injury strategy," post-con may be a promising approach to reduce
I/R injury and improve flap survival after ischemia. Methods A systematic
review was performed by searching electronic databases of PubMed and web
of science to identify all the studies regarding the application of the
post-con technique in plastic and reconstructive surgery between 1950 and
2015. Inclusion criteria were English articles with clear reporting the
post-con techniques and detailed outcomes. Results In total, 476 articles
were identified and 18 studies reporting post-con in plastic and
reconstructive surgery met the inclusion criteria in this review,
including 11 studies of mechanical post-con, 3 studies of pharmacological
post-con, 1 study of both mechanical and pharmacological post-con, and 3
studies of remote post-con. All these studies reported protective effects
of any kind of post-con techniques in I/R injuries and could improve flap
survivals. Conclusion In general, the strategy of post-con may effectively
reduce I/R injury and improve the survival of flaps after ischemia in
animal studies, yet no consensus regarding the exact technical details
(intervention timing, cycles, intermittent duration, etc.) has been
reached. Further studies aiming to explore its mechanisms as well as
specific methodology are required before clinical application in plastic
and reconstructive surgery.

<3>
Accession Number
27468580
Author
Straub N.; Bauer E.; Agarwal S.; Meybohm P.; Zacharowski K.; Hanke A.A.;
Weber C.F.
Title
Cost-Effectiveness of POC Coagulation Testing Using Multiple Electrode
Aggregometry.
Source
Clinical laboratory. 62 (6) (pp 1167-1178), 2016. Date of Publication:
2016.
Abstract
BACKGROUND: The economic effects of Point-of-Care (POC) coagulation
testing including Multiple Electrode Aggregometry (MEA) with the
Multiplate device have not been examined.
METHODS: A health economic model with associated clinical endpoints was
developed to calculate the effectiveness and estimated costs of
coagulation analyses based on standard laboratory testing (SLT) or POC
testing offering the possibility to assess platelet dysfunction using
aggregometric measures. Cost estimates included pre- and perioperative
costs of hemotherapy, intra- and post-operative coagulation testing costs,
and hospitalization costs, including the costs of transfusion-related
complications.
RESULTS: Our model calculation using a simulated true-to-life cohort of
10,000 cardiac surgery patients assigned to each testing alternative
demonstrated that there were 950 fewer patients in the POC branch who
required any transfusion of red blood cells. The subsequent numbers of
massive transfusions and patients with transfusion-related complications
were reduced with the POC testing by 284 and 126, respectively. The
average expected total cost in the POC branch was 288 Euro lower for every
treated patient than that in the SLT branch.
CONCLUSIONS: Incorporating aggregometric analyses using MEA into
hemotherapy algorithms improved medical outcomes in cardiac surgery
patients in the presented health economic model. There was an overall
better economic outcome associated with POC testing compared with SLT
testing despite the higher costs of testing.

<4>
Accession Number
27532914
Author
Haussig S.; Mangner N.; Dwyer M.G.; Lehmkuhl L.; Lucke C.; Woitek F.;
Holzhey D.M.; Mohr F.W.; Gutberlet M.; Zivadinov R.; Schuler G.; Linke A.
Institution
(Haussig) University of Leipzig, Heart Center, Leipzig, Germany
(Mangner) University of Leipzig, Heart Center, Leipzig, Germany
(Dwyer) Buffalo Neuroimaging Analysis Center, Department of Neurology,
University of Buffalo, Buffalo, New York
(Lehmkuhl) University of Leipzig, Heart Center, Leipzig, Germany
(Lucke) University of Leipzig, Heart Center, Leipzig, Germany
(Woitek) University of Leipzig, Heart Center, Leipzig, Germany
(Holzhey) University of Leipzig, Heart Center, Leipzig, Germany
(Mohr) University of Leipzig, Heart Center, Leipzig, Germany3Leipzig Heart
Institute, Leipzig, Germany
(Gutberlet) University of Leipzig, Heart Center, Leipzig, Germany
(Zivadinov) Buffalo Neuroimaging Analysis Center, Department of Neurology,
University of Buffalo, Buffalo, New York
(Schuler) University of Leipzig, Heart Center, Leipzig, Germany
(Linke) University of Leipzig, Heart Center, Leipzig, Germany3Leipzig
Heart Institute, Leipzig, Germany
Title
Effect of a Cerebral Protection Device on Brain Lesions Following
Transcatheter Aortic Valve Implantation in Patients With Severe Aortic
Stenosis: The CLEAN-TAVI Randomized Clinical Trial.
Source
JAMA. 316 (6) (pp 592-601), 2016. Date of Publication: 09 Aug 2016.
Abstract
IMPORTANCE: Stroke remains a major predictor of mortality after
transcatheter aortic valve implantation (TAVI). Cerebral protection
devices might reduce brain injury as determined by diffusion-weighted
magnetic resonance imaging (DWMRI).
OBJECTIVE: To determine the effect of a cerebral protection device on the
number and volume of cerebral lesions in patients undergoing TAVI.
DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, single center,
blinded, randomized clinical trial in higher-risk patients with severe
aortic stenosis undergoing TAVI at the University of Leipzig Heart Center.
Brain MRI was performed at baseline, 2 days, and 7 days after TAVI.
Between April 2013 and June 2014, patients were randomly assigned to
undergo TAVI with a cerebral protection device (filter group) or without a
cerebral protection device (control group). The last 1-month follow-up
occurred in July 2014.
INTERVENTIONS: TAVI with or without a cerebral protection device (filter
system).
MAIN OUTCOMES AND MEASURES: The primary end point was the numerical
difference in new positive postprocedure DWMRI brain lesions at 2 days
after TAVI in potentially protected territories. The first hierarchical
secondary outcome was the difference in volume of new lesions after TAVI
in potentially protected territories.
RESULTS: Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1)
years in the filter group (n=50) and 79.1 (4.1) years in the control group
(n=50), and the mean (SD) procedural risk scores (logistic EuroScores)
were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control
group. For the primary end point, the number of new lesions was lower in
the filter group, 4.00 (interquartile range [IQR], 3.00-7.25) vs 10.00
(IQR, 6.75-17.00) in the control group (difference, 5.00 [IQR, 2.00-8.00];
P<.001). For the first hierarchical secondary end point, new lesion volume
after TAVI was lower in the filter group (242 mm3 [95% CI, 159-353]) vs in
the control group (527 mm3 [95% CI, 364-830]) (difference, 234 mm3 [95%
CI, 91-406]; P=.001). Considering adverse events, 1 patient in the control
group died prior to the 30-day visit. Life-threatening hemorrhages
occurred in 1 patient in the filter group and 1 in the control group.
Major vascular complications occurred in 5 patients in the filter group
and 6 patients in the control group. One patient in the filter group and 5
in the control group had acute kidney injury, and 3 patients in the filter
group had a thoracotomy.
CONCLUSIONS AND RELEVANCE: Among patients with severe aortic stenosis
undergoing TAVI, the use of a cerebral protection device reduced the
frequency of ischemic cerebral lesions in potentially protected regions.
Larger studies are needed to assess the effect of cerebral protection
device use on neurological and cognitive function after TAVI and to devise
methods that will provide more complete coverage of the brain to prevent
new lesions.
TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01833052.

<5>
Accession Number
25254357
Author
Ducrocq G.; Schulte P.J.; Becker R.C.; Cannon C.P.; Harrington R.A.; Held
C.; Himmelmann A.; Lassila R.; Storey R.F.; Sorbets E.; Wallentin L.; Steg
P.G.
Institution
(Ducrocq, Schulte, Becker, Cannon, Harrington, Held, Himmelmann, Lassila,
Storey, Sorbets, Wallentin, Steg) Departement Hospitalo-Universitaire
FIRE, AP-HP, Hopital Bichat, Paris, France
Title
Association of spontaneous and procedure-related bleeds with short- and
long-term mortality after acute coronary syndromes: an analysis from the
PLATO trial.
Source
EuroIntervention : journal of EuroPCR in collaboration with the Working
Group on Interventional Cardiology of the European Society of Cardiology.
11 (7) (pp 737-745), 2015. Date of Publication: 01 Nov 2015.
Abstract
AIMS: We sought to describe the differential effect of bleeding events in
acute coronary syndromes (ACS) on short- and long-term mortality according
to their type and severity.
CONCLUSIONS: Major bleeding is associated with high subsequent mortality
in ACS. However, this association is much stronger in the first 30 days
and is strongest for spontaneous (vs. procedure-related) bleeding.
METHODS AND RESULTS: The PLATO trial randomised 18,624 ACS patients to
clopidogrel or ticagrelor. Post-randomisation bleeding events were
captured according to bleeding type (spontaneous or procedure-related),
with PLATO, TIMI, and GUSTO definitions. The association of bleeding
events with subsequent short-term (<30 days) and long-term (>30 days)
all-cause mortality was assessed using time-dependent Cox proportional
hazard models. A model was fitted to compare major and minor bleeding for
mortality prediction. Of 18,624 patients, 2,189 (11.8%) had at least one
PLATO major bleed (mean follow-up 272.2+/-123.5 days). Major bleeding was
associated with higher short-term mortality (adjusted hazard ratio [HR]
9.28; 95% confidence interval [CI]: 7.50-11.48) but not with long-term
mortality (adjusted HR 1.28; 95% CI: 0.93-1.75). Spontaneous bleeding was
associated with short-term (adjusted HR 14.59; 95% CI: 11.14-19.11) and
long-term (adjusted HR 3.38; 95% CI: 2.26-5.05) mortality.
Procedure-related bleeding was associated with short-term mortality
(adjusted HR 5.29; 95% CI: 4.06-6.87): CABG-related and
non-coronary-procedure-related bleeding were associated with a higher
short-term mortality, whereas PCI or angiography-related bleeding was not
associated with either short- or long-term mortality. Similar results were
obtained using the GUSTO and TIMI bleeding definitions.

<6>
[Use Link to view the full text]
Accession Number
26418303
Author
Garg P.; Malhotra A.; Desai M.; Sharma P.; Bishnoi A.K.; Tripathi P.;
Rodricks D.; Pandya H.
Institution
(Garg, Malhotra, Desai, Sharma, Bishnoi, Tripathi, Rodricks, Pandya) From
the Departments of *Cardiovascular and Thoracic Surgery, +Pathology,
++Perfusion, and Medical Research, U. N. Mehta Institute of Cardiology and
Research Center (Affiliated to B. J. Medical College), Civil Hospital
Campus, Asarwa, Ahmedabad, India
Title
Pretransfusion Comparison of Dialyser-Based Hemoconcentrator With Cell
Saver System for Perioperative Cell Salvage.
Source
Innovations (Philadelphia, Pa.). 10 (5) (pp 334-341), 2015. Date of
Publication: 01 Sep 2015.
Abstract
OBJECTIVE: Cell Saver system is the method of choice for red blood cell
salvage from the surgical field; however, cost is a limiting factor. We at
our institute have devised a cost-effective version of dialyser-based
autotransfusion system. We performed pretransfusion comparison of our
autotransfusion system with conventional cell saver system.
METHODS: A prospective randomized observational study was performed in 104
consecutive patients with coronary artery disease undergoing by off-pump
coronary artery bypass grafting. Patients were divided into two groups. In
the dialyser group (53 patients), blood from surgical field was salvaged
by our dialyser-based system. In the cell saver group (51 patients), blood
was salvaged by cell saver. In both groups, 20-mL sample from the salvaged
blood was analyzed for hemoglobin, platelets, protein, albumin, free
hemoglobin, osmotic fragility, and peripheral blood smear examination.
RESULTS: Total hemoglobin salvaged was comparable in both groups (85% vs
76%). On peripheral smear, red blood cells were swollen, but morphology
was preserved. Moreover, normal osmotic fragility suggested absence of any
lethal damage to red blood cells in either group. Dialyser-based system
was more efficient in salvaging platelets (42.9% vs 6%), proteins (79.2%
vs 0%), and albumin (65% vs 0%). Total free hemoglobin was three times
more in dialyser group but was well below recommended limits.
CONCLUSIONS: Dialyser-based system is economical, is equally efficacious
in salvaging red blood cells, is more effective in salvaging platelets and
proteins, and does not contain significant amount of free hemoglobin.
Therefore, this salvaged blood can be safely transfused.

<7>
Accession Number
25037617
Author
Nathan M.; Sleeper L.A.; Ohye R.G.; Frommelt P.C.; Caldarone C.A.;
Tweddell J.S.; Lu M.; Pearson G.D.; Gaynor J.W.; Pizarro C.; Williams
I.A.; Colan S.D.; Dunbar-Masterson C.; Gruber P.J.; Hill K.; Hirsch-Romano
J.; Jacobs J.P.; Kaltman J.R.; Kumar S.R.; Morales D.; Bradley S.M.;
Kanter K.; Newburger J.W.
Institution
(Nathan) Children's Hospital Boston and Harvard Medical School, Boston,
Mass. Electronic address:
(Sleeper) Cytel Inc, Cambridge, Mass
(Ohye) University of Michigan Medical School, Ann Arbor, Mich
(Frommelt) Children's Hospital of Wisconsin and Medical College of
Wisconsin, Milwaukee, Wis
(Caldarone) Hospital for Sick Children, Toronto, Ontario, Canada
(Tweddell) Children's Hospital of Wisconsin and Medical College of
Wisconsin, Milwaukee, Wis
(Lu) New England Research Institutes, Watertown, Mass
(Pearson) National Heart, Lung, and Blood Institute, National Institutes
of Health, Bethesda, Md
(Gaynor) Children's Hospital of Philadelphia and University of
Pennsylvania Medical School, Philadelphia, Pa
(Pizarro) Nemours Cardiac Center, Wilmington, Del
(Williams) Morgan Stanley Children's Hospital of NewYork-Presbyterian, New
York, NY
(Colan) Children's Hospital Boston and Harvard Medical School, Boston,
Mass; New England Research Institutes, Watertown, Mass
(Dunbar-Masterson) Children's Hospital Boston and Harvard Medical School,
Boston, Mass
(Gruber) University of Iowa Carver College of Medicine, Iowa City, Iowa
(Hill) Duke University, Chapel Hill, NC
(Hirsch-Romano) University of Michigan Medical School, Ann Arbor, Mich
(Jacobs) Johns Hopkins All Children's Heart Institute, St Petersburg, Fla
(Kaltman) National Heart, Lung, and Blood Institute, National Institutes
of Health, Bethesda, Md
(Kumar) Children's Hospital Los Angeles, Los Angeles, Calif
(Morales) Cincinnati Children's Medical Center, Cincinnati, Ohio
(Bradley) Medical University of South Carolina, Charleston, SC
(Kanter) Emory University, Atlanta, Ga
(Newburger) Children's Hospital Boston and Harvard Medical School, Boston,
Mass
Title
Technical performance score is associated with outcomes after the Norwood
procedure.
Source
The Journal of thoracic and cardiovascular surgery. 148 (5) (pp
2208-2213), 2014. Date of Publication: 01 Nov 2014.
Abstract
OBJECTIVES: The technical performance score (TPS) has been reported in a
single center study to predict the outcomes after congenital cardiac
surgery. We sought to determine the association of the TPS with outcomes
in patients undergoing the Norwood procedure in the Single Ventricle
Reconstruction trial.
METHODS: We calculated the TPS (class 1, optimal; class 2, adequate; class
3, inadequate) according to the predischarge echocardiograms analyzed in a
core laboratory and unplanned reinterventions that occurred before
discharge from the Norwood hospitalization. Multivariable regression
examined the association of the TPS with interval to first extubation,
Norwood length of stay, death or transplantation, unplanned postdischarge
reinterventions, and neurodevelopment at 14 months old.
RESULTS: Of 549 patients undergoing a Norwood procedure, 356 (65%) had an
echocardiogram adequate to assess atrial septal restriction or arch
obstruction or an unplanned reintervention, enabling calculation of the
TPS. On multivariable regression, adjusting for preoperative variables, a
better TPS was an independent predictor of a shorter interval to first
extubation (P=.019), better transplant-free survival before Norwood
discharge (P<.001; odds ratio, 9.1 for inadequate vs optimal), shorter
hospital length of stay (P<.001), fewer unplanned reinterventions between
Norwood discharge and stage II (P=.004), and a higher Bayley II
psychomotor development index at 14 months (P=.031). The TPS was not
associated with transplant-free survival after Norwood discharge,
unplanned reinterventions after stage II, or the Bayley II mental
development index at 14 months.
CONCLUSIONS: TPS is an independent predictor of important outcomes after
Norwood and could serve as a tool for quality improvement.

<8>
Accession Number
25753362
Author
Stammers A.N.; Kehler D.S.; Afilalo J.; Avery L.J.; Bagshaw S.M.; Grocott
H.P.; Legare J.-F.; Logsetty S.; Metge C.; Nguyen T.; Rockwood K.; Sareen
J.; Sawatzky J.-A.; Tangri N.; Giacomantonio N.; Hassan A.; Duhamel T.A.;
Arora R.C.
Institution
(Stammers) Faculty of Kinesiology & Recreation Management, Health, Leisure
& Human Performance Research Institute, University of Manitoba, Winnipeg,
Manitoba, Canada Institute of Cardiovascular Sciences, St. Boniface
Hospital Research Centre, Winnipeg, Manitoba, Canada
(Kehler) Faculty of Kinesiology & Recreation Management, Health, Leisure &
Human Performance Research Institute, University of Manitoba, Winnipeg,
Manitoba, Canada Institute of Cardiovascular Sciences, St. Boniface
Hospital Research Centre, Winnipeg, Manitoba, Canada
(Afilalo) Divisions of Cardiology and Clinical Epidemiology, Department of
Medicine, Jewish General Hospital, McGill University, Montreal, Quebec,
Canada
(Avery) Winnipeg Regional Health Authority Cardiac Sciences Program,
Winnipeg, Manitoba, Canada
(Bagshaw) Division of Critical Care Medicine, Faculty of Medicine and
Dentistry, University of Alberta, Edmonton, Alberta, Canada
(Grocott) Department of Surgery, Faculty of Medicine, University of
Manitoba, Winnipeg, Manitoba, Canada Department of Anesthesia &
Perioperative Medicine, Faculty of Medicine, University of Manitoba,
Winnipeg, Manitoba, Canada
(Legare) Division of Cardiac Surgery, Department of Surgery, Dalhousie
University, Halifax, Nova Scotia, Canada
(Logsetty) Department of Surgery, Faculty of Medicine, University of
Manitoba, Winnipeg, Manitoba, Canada
(Metge) Winnipeg Regional Health Authority Cardiac Sciences Program,
Winnipeg, Manitoba, Canada Department of Community Health Sciences,
Faculty of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
(Nguyen) Section of Cardiology, Faculty of Medicine, University of
Manitoba, Winnipeg, Manitoba, Canada
(Rockwood) Division of Geriatric Medicine, Department of Medicine,
Dalhousie University, Halifax, Nova Scotia, Canada
(Sareen) Department of Community Health Sciences, Faculty of Medicine,
University of Manitoba, Winnipeg, Manitoba, Canada Department of
Psychiatry, Faculty of Medicine, University of Manitoba, Winnipeg,
Manitoba, Canada
(Sawatzky) Institute of Cardiovascular Sciences, St. Boniface Hospital
Research Centre, Winnipeg, Manitoba, Canada Faculty of Health Sciences,
College of Nursing, University of Manitoba, Winnipeg, Manitoba, Canada
(Tangri) Section of Nephrology, Faculty of Medicine, University of
Manitoba, Winnipeg, Manitoba, Canada
(Giacomantonio) Division of Cardiology, Department of Medicine, Dalhousie
University, Halifax, Nova Scotia, Canada
(Hassan) Department of Cardiac Surgery, New Brunswick Heart Centre, Saint
John Regional Hospital, Saint John, New Brunswick, Canada
(Duhamel) Faculty of Kinesiology & Recreation Management, Health, Leisure
& Human Performance Research Institute, University of Manitoba, Winnipeg,
Manitoba, Canada Institute of Cardiovascular Sciences, St. Boniface
Hospital Research Centre, Winnipeg, Manitoba, Canada Department of
Physiology, University of Manitoba, Winnipeg, Manitoba, Canada
(Arora) Institute of Cardiovascular Sciences, St. Boniface Hospital
Research Centre, Winnipeg, Manitoba, Canada Department of Surgery, Faculty
of Medicine, University of Manitoba, Winnipeg, Manitoba, Canada
Title
Protocol for the PREHAB study-Pre-operative Rehabilitation for reduction
of Hospitalization After coronary Bypass and valvular surgery: a
randomised controlled trial.
Source
BMJ open. 5 (3) (pp e007250), 2015. Date of Publication: 2015.
Abstract
INTRODUCTION: Frailty is a geriatric syndrome characterised by reductions
in muscle mass, strength, endurance and activity level. The frailty
syndrome, prevalent in 25-50% of patients undergoing cardiac surgery, is
associated with increased rates of mortality and major morbidity as well
as function decline postoperatively. This trial will compare a
preoperative, interdisciplinary exercise and health promotion intervention
to current standard of care (StanC) for elective coronary artery bypass
and valvular surgery patients for the purpose of determining if the
intervention improves 3-month and 12-month clinical outcomes among a
population of frail patients waiting for elective cardiac surgery.
METHODS AND ANALYSIS: This is a multicentre, randomised, open end point,
controlled trial using assessor blinding and intent-to-treat analysis.
Two-hundred and forty-four elective cardiac surgical patients will be
recruited and randomised to receive either StanC or StanC plus an 8-week
exercise and education intervention at a certified medical fitness
facility. Patients will attend two weekly sessions and aerobic exercise
will be prescribed at 40-60% of heart rate reserve. Data collection will
occur at baseline, 1-2 weeks preoperatively, and at 3 and 12 months
postoperatively. The primary outcome of the trial will be the proportion
of patients requiring a hospital length of stay greater than 7 days.
POTENTIAL IMPACT OF STUDY: The healthcare team is faced with an
increasingly complex older adult patient population. As such, this trial
aims to provide novel evidence supporting a health intervention to ensure
that frail, older adult patients thrive after undergoing cardiac surgery.
ETHICS AND DISSEMINATION: Trial results will be published in peer-reviewed
journals, and presented at national and international scientific meetings.
The University of Manitoba Health Research Ethics Board has approved the
study protocol V.1.3, dated 11 August 2014 (H2014:208).
TRIAL REGISTRATION NUMBER: The trial has been registered on
ClinicalTrials.gov, a registry and results database of privately and
publicly funded clinical studies (NCT02219815).

<9>
Accession Number
25712464
Author
Luo X.; Zhao Z.; Chai H.; Zhang C.; Liao Y.; Li Q.; Peng Y.; Liu W.; Ren
X.; Meng Q.; Chen C.; Chen M.; Feng Y.; Huang D.
Institution
(Luo, Zhao, Chai, Zhang, Liao, Li, Peng, Liu, Ren, Meng, Chen, Chen, Feng,
Huang) Department of Cardiology, West China Hospital of Sichuan
University, No.37 Guo Xue Xiang of Wuhou District, 610041, Chengdu,
Sichuan, P.R. China
Title
Efficacy of transcatheter aortic valve implantation in patients with
aortic stenosis and reduced LVEF. A systematic review.
Source
Herz. 40 (pp 168-180), 2015. Date of Publication: 01 Apr 2015.
Abstract
BACKGROUND: Transcatheter aortic valve implantation (TAVI) is safe and
effective for patients with aortic stenosis (AS) who have a high operative
risk. However, there is still debate on the effect of TAVI in AS patients
with reduced left ventricular ejection fraction (REF). The objective of
the review is to clarify the efficacy of TAVI and the impact of REF on the
30-day and midterm mortality in these patients.
METHODS: Studies on TAVI were searched in PubMed, Embase, and the Cochrane
Library databases and were included in this review following predefined
criteria. Data were extracted and pooled risk ratios (RR) were synthesized
to explore the relationship between REF and 30-day plus midterm mortality.
RESULTS: Twenty-eight studies comprising 14,099 patients were included in
the analysis of the association of REF with the prognosis of patients
after TAVI. An average increase in left ventricular ejection fraction of
8-10% was observed among these patients after TAVI. REF was not related to
the 30-day mortality [RR =1.90, 95% confidence interval (CI) =0.80-4.47];
however, it was related to the midterm mortality (RR =1.49, 95%CI
=1.14-1.93) of patients undergoing TAVI. Patients with low-flow and
low-gradient AS had a higher 30-day mortality (RR =1.54, 95%CI =1.11-2.13)
and midterm mortality rate (RR =1.69, 95%CI =1.33-2.14) compared with AS
patients without these characteristics. The mortality of TAVI patients was
significantly lower than that of those undergoing conservative therapy,
and was similar to that of patients undergoing surgical aortic valve
replacement.
CONCLUSION: REF was not associated with 30-day mortality, but it was
associated with the midterm mortality of TAVI patients. Patients with REF
could benefit from TAVI compared with conservative therapy.

<10>
Accession Number
20160642250
Author
Chakravarty T.; Van Belle E.; Jilaihawi H.; Noheria A.; Testa L.; Bedogni
F.; Ruck A.; Barbanti M.; Toggweiler S.; Thomas M.; Khawaja M.Z.; Hutter
A.; Abramowitz Y.; Siegel R.J.; Cheng W.; Webb J.; Leon M.B.; Makkar R.R.
Institution
(Chakravarty, Jilaihawi, Abramowitz, Siegel, Cheng, Makkar) Cedars-Sinai
Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California,
United States
(Van Belle) Department of Cardiology, University Hospital, Lille, France
(Noheria) Department of Cardiology, Mayo Clinic, Rochester, Minnesota,
United States
(Testa, Bedogni) Department of Cardiology, Clinical Institute S. Ambrogio,
Milan, Italy
(Ruck) Department of Cardiology, Karolinska University Hospital,
Stockholm, Sweden
(Barbanti) Department of Cardiology, University of Catania, Catania, Italy
(Barbanti, Webb) St. Paul's Hospital, Vancouver, Canada
(Toggweiler) Luzerner Kantonsspital, Lucerne, Switzerland
(Thomas, Khawaja) Guys and St. Thomas' Hospital, London, United Kingdom
(Hutter) German Heart Center, Munich, Germany
(Leon) Columbia University Medical Center, New York-Presbyterian Hospital,
New York, New York, United States
Title
Meta-Analysis of the Impact of Mitral Regurgitation on Outcomes After
Transcatheter Aortic Valve Implantation.
Source
American Journal of Cardiology. 115 (7) (pp 942-949), 2015. Date of
Publication: 01 Apr 2015.
Publisher
Elsevier Inc.
Abstract
Significant mitral regurgitation (MR) constitutes an important co-existing
valvular heart disease burden in the setting of aortic valve stenosis.
There are conflicting reports on the impact of significant MR on outcomes
after transcatheter aortic valve implantation (TAVI). We evaluated the
impact of MR on outcomes after TAVI by performing a meta-analysis of 8
studies involving 8,927 patients reporting TAVI outcomes based on the
presence or absence of moderate-severe MR. Risk ratios (RRs) were
calculated using the inverse variance random-effects model. None-mild MR
was present in 77.8% and moderate-severe MR in 22.2% of the patients. The
presence of moderate-severe MR at baseline was associated with increased
mortality at 30 days (RR 1.35, 95% confidence interval [CI] 1.14 to 1.59,
p = 0.003) and 1 year (RR 1.24, 95% CI 1.13 to 1.37, p <0.0001). The
increased mortality associated with moderate-severe MR was not influenced
by the cause of MR (functional or degenerative MR; RR 0.90, 95% CI 0.62 to
1.30, p = 0.56). The severity of MR improved in 61 +/- 6.0% of patients
after TAVI. Moderate-severe residual MR, compared with none-mild residual
MR after TAVI, was associated with significantly increased 1-year
mortality (RR 1.48, 95% CI 1.31 to 1.68, p <0.00001). In conclusion,
baseline moderate-severe MR and significant residual MR after TAVI are
associated with an increase in mortality after TAVI and represent an
important group to target with medical or transcatheter therapies in the
future.

<11>
Accession Number
20160553522
Author
Koster G.; Bekema H.J.; Wetterslev J.; Gluud C.; Keus F.; van der Horst
I.C.C.
Institution
(Koster, Keus, van der Horst) Department of Critical Care, University of
Groningen, University Medical Centre Groningen, P.O. Box 30.001, Groningen
9700 RB, Netherlands
(Bekema) Department of Anaesthesiology, University of Groningen,
University Medical Centre Groningen, Groningen, Netherlands
(Wetterslev, Gluud) The Copenhagen Trial Unit, Centre for Clinical
Intervention Research, Department 7812, Rigshospitalet, Copenhagen
University Hospital, Copenhagen 2100, Denmark
Title
Milrinone for cardiac dysfunction in critically ill adult patients: a
systematic review of randomised clinical trials with meta-analysis and
trial sequential analysis.
Source
Intensive Care Medicine. 42 (9) (pp 1322-1335), 2016. Date of Publication:
01 Sep 2016.
Publisher
Springer Verlag
Abstract
Introduction: Milrinone is an inotrope widely used for treatment of
cardiac failure. Because previous meta-analyses had methodological flaws,
we decided to conduct a systematic review of the effect of milrinone in
critically ill adult patients with cardiac dysfunction. Methods: This
systematic review was performed according to The Cochrane Handbook for
Systematic Reviews of Interventions. Searches were conducted until
November 2015. Patients with cardiac dysfunction were included. The
primary outcome was serious adverse events (SAE) including mortality at
maximum follow-up. The risk of bias was evaluated and trial sequential
analyses were conducted. The quality of evidence was assessed by the
Grading of Recommendations Assessment, Development and Evaluation
criteria. Results: A total of 31 randomised clinical trials fulfilled the
inclusion criteria, of which 16 provided data for our analyses. All trials
were at high risk of bias, and none reported the primary composite outcome
SAE. Fourteen trials with 1611 randomised patients reported mortality data
at maximum follow-up (RR 0.96; 95% confidence interval 0.76-1.21).
Milrinone did not significantly affect other patient-centred outcomes. All
analyses displayed statistical and/or clinical heterogeneity of patients,
interventions, comparators, outcomes, and/or settings and all featured
missing data. Discussion: The current evidence on the use of milrinone in
critically ill adult patients with cardiac dysfunction suffers from
considerable risks of both bias and random error and demonstrates no
benefits. The use of milrinone for the treatment of critically ill
patients with cardiac dysfunction can be neither recommended nor refuted.
Future randomised clinical trials need to be sufficiently large and
designed to have low risk of bias.

<12>
Accession Number
20160466934
Author
van Diepen S.; Alemayehu W.G.; Zheng Y.; Theroux P.; Newby L.K.; Mahaffey
K.W.; Granger C.B.; Armstrong P.W.
Institution
(van Diepen) Divisions of Critical Care and Cardiology, University of
Alberta, Edmonton, AB, Canada
(van Diepen, Alemayehu, Zheng, Armstrong) Canadian VIGOUR Centre,
University of Alberta, Edmonton, AB, Canada
(Theroux, Granger) Institut de Cardiologie de Montreal, Universite de
Montreal, Quebec, Canada
(Newby) Duke Clinical Research Institute, Duke University Medical Center,
Durham, NC, United States
(Armstrong) Division of Cardiology, University of Alberta, Edmonton, AB,
Canada
(Mahaffey) Stanford University Medical Center, Stanford University School
of Medicine, Stanford, CA, United States
(van Diepen) 2C2 Cardiology Walter MacKenzie Center, University of Alberta
Hospital, 8440-11 St., Edmonton, AB T6G 2B7, Canada
Title
Temporal changes in biomarkers and their relationships to reperfusion and
to clinical outcomes among patients with ST segment elevation myocardial
infarction.
Source
Journal of Thrombosis and Thrombolysis. 42 (3) (pp 376-385), 2016. Date of
Publication: 01 Oct 2016.
Publisher
Springer New York LLC
Abstract
Coronary plaque rupture mediating acute ST segment elevation myocardial
infarction (STEMI) is associated with a systemic inflammatory response.
Whether early temporal changes in inflammatory biomarkers are associated
with angiographic and electrocardiographic markers of reperfusion and
subsequent clinical outcomes is unclear. In the APEX-AMI biomarker
substudy, 376 patients with STEMI had inflammatory biomarkers measured at
the time of hospital presentation and 24 h later. The primary outcome was
the 90-day composite of death, shock, or heart failure. Secondary
reperfusion outcomes were (1) worst least residual ST segment elevation
(ST-E: <1 mm, 1 to <2 mm, >2 mm) and (2) post-percutaneous coronary
intervention (PCI) TIMI flow grade (0/1/2 vs 3) and TIMI myocardial
perfusion grade (TMPG 0/1 vs 2/3). The 90-day incidence of death, shock or
heart failure was 21.3 % in this cohort. Electrocardiographic reperfusion
(worst residual ST-E <1 mm, 1 to <2 mm, >2 mm) was associated with
differences in 24 h change in N-terminal proB-type natriuretic peptide
(NT-proBNP) (1192.8, 1332.5, 1859.0 ng/mL; p = 0.043) and the
pro-inflammatory cytokines Interleukin (IL)-6 (14.0, 13.6, 22.1 pg/mL; p =
0.016), IL-12 (-0.5, -0.9, -0.1 pg/mL; p = 0.013), and tumor necrosis
factor alpha (TNFalpha) (1.0, 0.6, 3.6 pg/mL; p = 0.023). Angiographic
reperfusion (TMPG 0/1 vs 2/3) was associated with changes in median
NT-proBNP (2649.3, 1382.7 ng/mL; p = 0.002) and IL-6 (28.7, 15.1; p =
0.040). After adjustment for baseline covariates, the 24 h change in the
pro-inflammatory cytokine TNFalpha [hazard ratio (HR) 0.49; 95 % CI
0.26-0.95; p = 0.035] and the anti-inflammatory cytokine IL 10 (HR 1.41;
95 % CI 1.06-1.87; p = 0.018) were independently associated with the
primary composite outcome. Successful coronary reperfusion was associated
with less systemic inflammatory response and greater temporal inflammatory
changes were independently associated with higher 90-day composite of
death, shock, or heart failure. These findings provide support for an
association between success of reperfusion, an acute STEMI inflammatory
response and subsequent clinical outcomes.

<13>
Accession Number
20160638556
Author
Coca S.G.; Nadkarni G.N.; Garg A.X.; Koyner J.; Thiessen-Philbrook H.;
McArthur E.; Shlipak M.G.; Parikh C.R.; Raman J.; Jeevanandam V.; Akhter
S.; Edelstein C.; Passik C.; Nagy J.; Swaminathan M.; Chu M.; Goldbach M.;
Guo L.R.; McKenzie N.; Myers M.L.; Novick R.; Quantz M.; Zappitelli M.;
Palijan A.; Dewar M.; Darr U.; Hashim S.; Elefteriades J.; Geirsson A.;
Garwood S.; Butrymowicz I.; Krumholz H.
Institution
(Coca, Nadkarni) Division of Nephrology, Department of Medicine, Icahn
School of Medicine at Mount Sinai, New York, NY, United States
(Garg, Thiessen-Philbrook, McArthur, Chu, Goldbach, Guo, McKenzie, Myers,
Novick, Quantz) Division of Nephrology, Department of Medicine, Western
University, London, ON, Canada
(Koyner, Raman, Jeevanandam, Akhter) Section of Nephrology, Department of
Medicine, University of Chicago, Pritzker School of Medicine, Chicago, IL,
United States
(Shlipak) Division of General Internal Medicine, San Francisco VA Medical
Center, University of California, San Francisco, CA, United States
(Parikh) Program of Applied Translational Research, Department of Internal
Medicine, Yale University School of Medicine, New Haven, CT, United States
(Parikh) Section of Nephrology, Department of Medicine, Yale University
School of Medicine, VA CT Healthcare System, Program of Applied
Translational Research, New Haven, CT, United States
(Edelstein) U of Colorado, United States
(Passik, Nagy) Danbury Hospital, United States
(Swaminathan) Duke University, United States
(Zappitelli, Palijan) Montreal Children's, United States
(Dewar, Darr, Hashim, Elefteriades, Geirsson, Garwood, Butrymowicz,
Krumholz) Yale-New Haven, United States
Title
First post-operative urinary kidney injury biomarkers and association with
the duration of AKI in the TRIBE-AKI cohort.
Source
PLoS ONE. 11 (8) (no pagination), 2016. Article Number: e0161098. Date of
Publication: August 2016.
Publisher
Public Library of Science
Abstract
Background: We previously demonstrated that assessment of the duration of
AKI, in addition to magnitude of rise in creatinine alone, adds prognostic
information for long-term survival. We evaluated whether post-operative
kidney injury biomarkers in urine collected immediately after cardiac
surgery associate with duration of serum creatinine elevation. Methods: We
studied 1199 adults undergoing cardiac surgery in a prospective cohort
study (TRIBEAKI) and examined the association between the levels of five
urinary biomarkers individually at 0-6 hours after surgery: interleukin-18
(IL-18), neutrophil gelatinase-associated lipocalin (NGAL), kidney injury
molecule-1 (KIM-1), liver fatty acid binding protein (L-FABP) and albumin
with duration of serum creatinine-based AKIN criteria for AKI (0 (no AKI),
1-2, 3-6, >7 days). Results: Overall, 407 (34%) patients had at least
stage 1 AKI, of whom 251 (61.7%) had duration of 1-2 days, 118 (28.9%) had
duration 3-6 days, and 38 (9.3%) had duration of >7 days. Higher
concentrations of all biomarkers (per log increase) were independently
associated with a greater odds of a longer duration of AKI; odds ratios
and 95%confidence intervals using ordinal logistic regression were the
following: IL-18: 1.22, 1.13-1.32; KIM-1: 1.36, 1.21-1.52; albumin 1.20,
1.09-1.32; L-FABP 1.11, 1.04-1.19; NGAL 1.06, 1.00-1.14). AKI duration of
7 days or longer was associated with a 5-fold adjusted risk of mortality
at 3 years. Conclusions: There was an independent dose-response
association between urinary levels of injury biomarkers immediately after
cardiac surgery and longer duration of AKI. Duration of AKI was also
associated with long term mortality. Future studies should explore the
potential utility of these urinary kidney injury biomarkers to enrich
enrollment of patients at risk for longer duration of AKI into trials of
interventions to prevent or treat post-operative AKI.

<14>
Accession Number
20160640685
Author
Min J.J.; Lee J.-H.; Kang S.H.; Kim E.; Lee S.M.; Cho J.H.; Kim H.K.
Institution
(Min, Lee, Kang, Kim, Lee) Department of Anesthesiology and Pain Medicine,
Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul,
South Korea
(Cho, Kim) Department of Thoracic and Cardiovascular Surgery, Samsung
Medical Center, Sungkyunkwan University School of Medicine, Seoul, South
Korea
Title
The Fast and Easy Way for Double-Lumen Tube Intubation: Individual Angle-
Modification.
Source
PLoS ONE. 11 (8) (no pagination), 2016. Article Number: e0161434. Date of
Publication: August 2016.
Publisher
Public Library of Science
Abstract
To find the faster and easier way than the existing intubating technique
for double-lumen tube, we modified the angle of double-lumen tube
according to an individual's upper airway anatomy and compared the time
needed and the number of attempts for successful intubation between
individually angle-modified and non-modified double-lumen tubes. Adult
patients undergoing elective thoracic surgery were randomly allocated in
either non-anglemodified (Group N, n = 54) or angle-modified (Group M, n =
54) groups. During mask ventilation in the sniffing position,
angle-modification was performed in Group M as follows: The distal tip of
the tube was placed at the level of the cricoid cartilage and the shaft
was bent at the intersection of the oral and pharyngeal axes estimated
from the patient's surface anatomy. The time needed and the number of
attempts for successful intubation and Cormack and Lehane (C-L) grade were
recorded. Overall median intubation time (sec) was significantly shorter
in Group M than in Group N [10.2 vs. 15.1, P<0.001]. In addition, Group M
showed the shorter median intubation time (sec) in C-L grades I-III [8.2
vs. 11.1 in C-L grade I, (P = 0.003), 10.3 vs. 15.3 in II, (P = 0.001),
and 11.8 vs. 27.9 in III, (P<0.001), respectively]. Moreover, all
intubation was successfully performed at the first attempt in patients
with C-L grades I-III in Group M (P = 0.027). Our study showed an
individual angle-modification would be useful for the fast and easy
intubation of double-lumen tube in patients with C-L grades I-III.

<15>
Accession Number
20160643134
Author
Tempe D.K.; Kiro K.L.; Satyarthy S.; Virmani S.; Kumar P.; Betigiri V.M.;
Minhas H.S.
Institution
(Tempe, Kiro, Virmani, Kumar) Departments of Anaesthesiology and Intensive
Care, G B Pant Hospital, New Delhi 110002, India
(Satyarthy, Betigiri, Minhas) Cardiothoracic and Vascular Surgery, G B
Pant Hospital, New Delhi, India
Title
Evaluation of different types of inferior vena cava cannulae placement by
transesophageal echocardiography and its impact on hepatic dysfunction.
Source
Perfusion (United Kingdom). 31 (6) (pp 482-488), 2016. Date of
Publication: 01 Sep 2016.
Publisher
SAGE Publications Ltd
Abstract
Background: Postoperative hepatic dysfunction may occur in an otherwise
uncomplicated open heart surgery. One of the reasons is malpositioning of
the inferior vena cava (IVC) cannula in the hepatic vein (HV) or beyond. A
straight cannula is considered more likely to be malpositioned compared to
the angled cannula and a malpositioned cannula can lead to hepatic
dysfunction. Methods: In this prospective study, forty adult patients
undergoing atrial septal defect repair were randomized into two groups as:
straight cannula group (n=20) and angled cannula group (n=20). The cannula
position was assessed by transesophageal echocardiography (TEE) (hepatic
vein view). Alanine aminotransferase levels (ALT) and bilirubin levels
were measured immediately, at 6 hours and on day 1, day 2 and day 7 after
surgery as a marker of hepatic injury. Results: TEE localization of the
IVC cannula was achieved in all patients except one. Visualization was
good in 85% of patients. A cannula in the HV or beyond the HV in the IVC
was considered malpositioned. The number of cases of cannula malposition
was 10 (50%) and 4 (20%) in the straight and angled cannula groups,
respectively. The pattern of change in serum bilirubin and liver enzymes
levels in the postoperative period was similar in both the groups
(p>0.05). The mean distance between the right atrium (RA) - inferior vena
cava (IVC) junction to the hepatic vein was 1.94+/-0.56 cm and the mean
diameters of the IVC and HV were 1.95+/-0.5 and 1.31+/-0.33 cm,
respectively. Conclusion: TEE can be used to monitor IVC cannula position.
A higher frequency of cannula malposition was observed with the straight
cannula compared to the angled cannula, but was not found to be associated
with hepatic dysfunction.

<16>
[Use Link to view the full text]
Accession Number
20160638394
Author
Firat A.C.; Zeyneloglu P.; Ozkan M.; Pirat A.
Institution
(Firat, Zeyneloglu, Pirat) Department of Anesthesiology, Baskent
University Faculty of Medicine, Ankara, Turkey
(Ozkan) Department of Cardiovascular Surgery, Baskent University Faculty
of Medicine, Ankara, Turkey
Title
A Randomized Controlled Comparison of the Internal Jugular Vein and the
Subclavian Vein as Access Sites for Central Venous Catheterization in
Pediatric Cardiac Surgery.
Source
Pediatric Critical Care Medicine. 17 (9) (pp e413-e419), 2016. Date of
Publication: 01 Sep 2016.
Publisher
Lippincott Williams and Wilkins
Abstract
Objectives: To compare internal jugular vein and subclavian vein access
for central venous catheterization in terms of success rate and
complications. Design: A 1:1 randomized controlled trial. Setting: Baskent
University Medical Center. Patients: Pediatric patients scheduled for
cardiac surgery. Interventions: Two hundred and eighty children undergoing
central venous catheterization were randomly allocated to the internal
jugular vein or subclavian vein group during a period of 18 months.
Measurements and Main Results: The primary outcome was the first-attempt
success rate of central venous catheterization through either approach.
The secondary outcomes were the rates of infectious and mechanical
complications. The central venous catheterization success rate at the
first attempt was not significantly different between the subclavian vein
(69%) and internal jugular vein (64%) groups (p = 0.448). However, the
overall success rate was significantly higher through the subclavian vein
(91%) than the internal jugular vein (82%) (p = 0.037). The overall
frequency of mechanical complications was not significantly different
between the internal jugular vein (25%) and subclavian vein (31%) (p =
0.456). However, the rate of arterial puncture was significantly higher
with internal jugular vein (8% vs 2%; p = 0.03) and that of catheter
malposition was significantly higher with subclavian vein (17% vs 1%; p <
0.001). The rates per 1,000 catheter days for both positive catheter-tip
cultures (26.1% vs 3.6%; p < 0.001) and central-line bloodstream infection
(6.9 vs 0; p < 0.001) were significantly higher with internal jugular
vein. There were no significant differences between the groups in the
length of ICU and hospital stays or in-hospital mortality rates (p > 0.05
for all). Conclusions: Central venous catheterization through the internal
jugular vein and subclavian vein was not significantly different in terms
of success at the first attempt. Although the types of mechanical
complications were different, the overall rate was similar between
internal jugular vein and subclavian vein access. The risk of infectious
complications was significantly higher with internal jugular vein access.

<17>
[Use Link to view the full text]
Accession Number
20160638375
Author
Klee P.; Arni D.; Saudan S.; Schwitzgebel V.M.; Sharma R.; Karam O.;
Rimensberger P.C.
Institution
(Klee, Schwitzgebel) Paediatric Endocrine and Diabetes Unit, Service of
Development and Growth, Department of Pediatrics, University Hospital of
Geneva, 6, rue Willy-Donze, Geneva 1211, Switzerland
(Arni, Karam, Rimensberger) Service of Neonatology and Pediatric Intensive
Care, Department of Pediatrics, University Hospital of Geneva, Geneva,
Switzerland
(Saudan, Sharma) Pediatric Anesthesia Unit, Department of Anesthesiology,
University Hospital of Geneva, Geneva, Switzerland
Title
Ketosis after Cardiopulmonary Bypass in Children Is Associated with an
Inadequate Balance between Oxygen Transport and Consumption.
Source
Pediatric Critical Care Medicine. 17 (9) (pp 852-859), 2016. Date of
Publication: 01 Sep 2016.
Publisher
Lippincott Williams and Wilkins
Abstract
Objectives: Hyperglycemia after cardiac surgery and cardiopulmonary bypass
in children has been associated with worse outcome; however, causality has
never been proven. Furthermore, the benefit of tight glycemic control is
inconsistent. The purpose of this study was to describe the metabolic
constellation of children before, during, and after cardiopulmonary
bypass, in order to identify a subset of patients that might benefit from
insulin treatment. Design: Prospective observational study, in which
insulin treatment was initiated when postoperative blood glucose levels
were more than 12 mmol/L (216 mg/dL). Setting: Tertiary PICU. Patients:
Ninety-six patients 6 months to 16 years old undergoing cardiac surgery
with cardiopulmonary bypass. Interventions: None. Measurements and Main
Results: Metabolic tests were performed before anesthesia, at the end of
cardiopulmonary bypass, at PICU admission, and 4 and 12 hours after PICU
admission, as well as 4 hours after initiation of insulin treatment.
Ketosis was present in 17.9% patients at the end of cardiopulmonary bypass
and in 31.2% at PICU admission. Young age was an independent risk factor
for this condition. Ketosis at PICU admission was an independent risk
factor for an increased difference between arterial and venous oxygen
saturation. Four hours after admission (p = 0.05). Insulin corrected
ketosis within 4 hours. Conclusions: In this study, we found a high
prevalence of ketosis at PICU admission, especially in young children.
This was independently associated with an imbalance between oxygen
transport and consumption and was corrected by insulin. These results set
the basis for future randomized controlled trials, to test whether this
subgroup of patients might benefit from increased glucose intake and
insulin during surgery to avoid ketosis, as improving oxygen transport and
consumption might improve patient outcome.

<18>
Accession Number
20160639398
Author
Furqan A.; Ahmad S.; Ali L.; Akhtar R.; Raza Baig M.A.; Altaf R.
Institution
(Furqan) Department of Anesthesia, Multan Institute of Kidney Diseases,
Multan, Pakistan
(Ahmad, Altaf) Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakistan
(Ali) Multan Medical and Dental College, Multan, Pakistan
(Akhtar) Nishter Hospital Multan, Pakistan
Title
Comparison of effects of propofol and isosorbide dinitrate during
rewarming on cardiopulmonary bypass.
Source
Pakistan Journal of Medical Sciences. 32 (4) (pp 806-810), 2016. Date of
Publication: July-August 2016.
Publisher
Professional Medical Publications (Raja Ghazanfar Ali Road, Saddar,
Karachi, Pakistan)
Abstract
Objectives: Comparison of effects of propofol and isosorbide dinitrate
during rewarming on cardiopulmonary bypass in patients undergoing coronary
artery bypasses grafting. Methods: It was randomized prospective clinical
trial. One hundred and twenty patient (120) undergoing CABG surgery were
included in this study. Group-I (Study group, n=60): in which only
propofol infusion used during rewarming and Group-II (control Group, n=60)
in which isosorbide dinitrate and propofol infusion combination was used
during rewarming. The data was entered and analyzed through SPSS Version
19. Independent sample T-test and chi-square test were used for data
analysis. P value of < 0.05 was taken as significant. Results: Mean
arterial pressures during rewarming were 63.41+/-3.61 mmHg in propofol
group versus 60.80+/-4.86 mmHg in control group (p-value 0.001). Core
temperature on weaning from cardiopulmonary bypass was 37.11+/-0.49 C in
propofol group and 37.00+/-0.18 C in control group. After drop in core
temperature was little more in propofol group (1.02+/-0.36 oC) versus
0.96+/-0.37 C in control group but this difference was not statistically
significant (p-value 0.41). Mean Ventilation time after surgery in
propofol group was 4.65+/-0.65 hours versus 5.03+/-0.81 hours in control
group (p-value 0.006). Conclusion: Propofol alone is capable of fulfilling
the requirements of adequate rewarming during Cardiopulmonary bypass and
can produce more hemodynamic stability and early post-operative recovery.

<19>
Accession Number
20160639357
Author
Smit B.; Smulders Y.M.; de Waard M.C.; Boer C.; Vonk A.B.A.; Veerhoek D.;
Kamminga S.; de Grooth H.J.S.; Garcia-Vallejo J.J.; Musters R.J.P.; Girbes
A.R.J.; Oudemans-van Straaten H.M.; Spoelstra-de Man A.M.E.
Institution
(Smit, de Waard, de Grooth, Girbes, Oudemans-van Straaten, Spoelstra-de
Man) VU University Medical Center, ICaR-VU, Intensive Care, Amsterdam,
Netherlands
(Smulders) VU University Medical Center, ICaR-VU, Internal Medicine,
Amsterdam, Netherlands
(Boer, Kamminga) VU University Medical Center, ICaR-VU, Anesthesiology,
Amsterdam, Netherlands
(Vonk) VU University Medical Center, ICaR-VU, Cardiothoracal Surgery,
Amsterdam, Netherlands
(Veerhoek) VU University Medical Center, ICaR-VU, Clinical Perfusion,
Amsterdam, Netherlands
(Garcia-Vallejo) VU University Medical Center, ICaR-VU, Molecular Cell
Biology and Immunology, Amsterdam, Netherlands
(Musters) VU University Medical Center, ICaR-VU, Physiology, Amsterdam,
Netherlands
Title
The cardiovascular effects of hyperoxia during and after cabg surgery.
Source
Intensive Care Medicine Experimental. 3 (no pagination), 2015. Article
Number: A949. Date of Publication: 2015.
Publisher
SpringerOpen

<20>
Accession Number
20160622154
Author
Moscarelli M.; Emmanuel S.; Athanasiou T.; Speziale G.; Fattouch K.;
Casula R.
Institution
(Moscarelli) Honorary Research Fellow, NHLI, Imperial College London,
United Kingdom
(Moscarelli, Speziale) GVM Care and Research, Anthea Hospital, Bari, Italy
(Emmanuel) St Vincent's Hospital, Sydney, Australia
(Athanasiou, Casula) Department of Surgery and Cancer, Imperial College,
Paddington, London, United Kingdom
(Fattouch) GVM Care & Research, Maria Eleonora, Palermo, Italy
Title
The role of minimal access valve surgery in the elderly. A meta-analysis
of observational studies.
Source
International Journal of Surgery. Part A. 33 (pp 164-171), 2016. Date of
Publication: 01 Sep 2016.
Publisher
Elsevier Ltd
Abstract
Background Minimal access valve surgery, both mitral and aortic, may be
related to improvement in specific post-operative outcomes, therefore may
be beneficial for the subgroup of the elderly referred for valve surgery.
Methods A systematic literature review identified several different
studies, of which 6 fulfilled criteria for meta-analysis. Outcomes for a
total of 1347 patients (675 conventional standard sternotomy and 672
minimally invasive valve surgery) were assessed with a meta-analysis using
random effects modeling. Heterogeneity, subgroup analysis with quality
scoring were also assessed. The primary endpoint was early mortality.
Secondary endpoints included intra and post-operative outcomes. Results In
the context of elderly patients, minimal access valve surgery conferred
comparable early mortality to standard sternotomy (odd ratio (OR) 0.79, CI
[0.40,1.56], p = 0.50) with no heterogeneity (p = 0.13); it was also
associated with reduced mechanical intubation time (OR 0.48, CI
[0.30,0.78], p = 0.003) and reduced post-operative length of stay
(weighted mean difference (WMD) -2.91, CI [-3.09, -2.74] p < 0.00001),
however both cardio-pulmonary bypass time and cross clamp time were longer
(WMD 24.29, CI [22.97, 25.61] p < 0.00001 and WMD 8.61, CI [7.61, 9.61], p
< 0.00001, respectively); subgroup analysis demonstrated statistically
significant reduced post-operative length of stay for both minimally
invasive aortic and mitral surgery (WMD -2.84, CI [-3.07, -2.60] p <
0.00001 and WMD -2.98, CI [-3.25, -2.71] p < 0.00001 respectively).
Conclusions Despite a prolonged cardiopulmonary bypass and cross clamp
time, minimally invasive valve surgery is a safe alternative to standard
sternotomy in the elderly, with similar early mortality, and improvements
in intubation time as well as length of stay.

<21>
Accession Number
20160621403
Author
Park J.H.; Shim J.-K.; Song J.-W.; Soh S.; Kwak Y.-L.
Institution
(Park, Shim, Song, Soh, Kwak) Department of Anesthesiology and Pain
Medicine, Yonsei University College of Medicine, 50 Yonsei-ro,
Seodaemun-gu, Seoul 03722, South Korea
(Shim, Song, Kwak) Anesthesia and Pain Research Institute, Yonsei
Cardiovascular Research Institute, Yonsei University College of Medicine,
50 Yonsei-ro, Seodaemungu, Seoul 03722, South Korea
Title
Effect of atorvastatin on the incidence of acute kidney injury following
valvular heart surgery: a randomized, placebo-controlled trial.
Source
Intensive Care Medicine. 42 (9) (pp 1398-1407), 2016. Date of Publication:
01 Sep 2016.
Publisher
Springer Verlag
Abstract
Purpose: Statins, 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA)
reductase inhibitors have the potential to reduce acute kidney injury
(AKI) after cardiac surgery through their pleiotropic properties. Here we
studied the preventive effect of atorvastatin on AKI after valvular heart
surgery. Methods: Two-hundred statin-naive patients were randomly
allocated to receive either statin or placebo. Atorvastatin was
administered orally to the statin group according to a dosage schedule (80
mg single dose on the evening prior to surgery; 40 mg on the morning of
surgery; three further doses of 40 mg on the evenings of postoperative
days 0, 1, and 2). AKI incidence was assessed during the first 48
postoperative hours on the basis of Acute Kidney Injury Network criteria.
Results: The incidence of AKI was similar in the statin and control groups
(21 vs. 26 %, respectively, p = 0.404). Biomarkers of renal injury
including plasma neutrophil gelatinase-associated lipocalin and
interleukin-18 were also similar between the groups. The statin group
required significantly less norepinephrine and vasopressin during surgery,
and fewer patients in the statin group required vasopressin. There were no
significant differences in postoperative outcomes. Conclusions: Acute
perioperative statin treatment was not associated with a lower incidence
of AKI or improved clinical outcome in patients undergoing valvular heart
surgery. (ClinicalTrials.gov NCT01909739).

<22>
Accession Number
20160639681
Author
Fischer A.; Winkler A.; Spiegl M.; Salamon A.; Altmann K.; Themessl-Huber
M.; Mouhieddine M.; Schiferer A.; Strasser E.-M.; Paternostro-Sluga T.;
Hiesmayr M.
Institution
(Fischer, Winkler, Spiegl, Salamon, Altmann, Themessl-Huber, Mouhieddine,
Schiferer, Hiesmayr) Medical University of Vienna, Vienna, Austria
(Strasser) Kaiser Franz Josef Hospital, Vienna, Austria
(Paternostro-Sluga) Donauspital, Vienna, Austria
Title
Effects of neuromuscular electrical stimulation on muscle mass and
strength in critically ill patients after cardiothoracic surgery (Catastim
2).
Source
Intensive Care Medicine Experimental. 3 (no pagination), 2015. Article
Number: A818. Date of Publication: 2015.
Publisher
SpringerOpen

<23>
Accession Number
20160639780
Author
Zarbock A.; Kellum J.; Van Aken H.; Schmidt C.; Martens S.; Gorlich D.;
Meersch M.
Institution
(Zarbock, Van Aken, Schmidt, Martens, Gorlich, Meersch) University
Hospital Munster, Munster, Germany
(Kellum) University of Pittsburgh, Pittsburgh, PA, United States
Title
Long-term effects of remote ischaemic preconditioning in high risk
patients undergoing cardiac surgery: Follow-up of a randomised clinical
trial.
Source
Intensive Care Medicine Experimental. 3 (no pagination), 2015. Article
Number: A411. Date of Publication: 2015.
Publisher
SpringerOpen

<24>
Accession Number
20160633871
Author
Rafiq S.; Johansson P.I.; Kofoed K.F.; Olsen P.S.; Steinbruchel D.A.
Institution
(Rafiq, Olsen, Steinbruchel) Department of Cardiothoracic Surgery, the
Heart Centre, Rigshospitalet, Copenhagen University Hospital, Copenhagen,
Denmark
(Johansson) Capital Region Blood Bank, Section for Transfusion Medicine,
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
(Kofoed) Department of Cardiology, the Heart Centre, Rigshospitalet,
Copenhagen University Hospital, Copenhagen, Denmark
Title
Preoperative hemostatic testing and the risk of postoperative bleeding in
coronary artery bypass surgery patients.
Source
Journal of Cardiac Surgery. 31 (9) (pp 565-571), 2016. Date of
Publication: 01 Sep 2016.
Publisher
Blackwell Publishing Inc.
Abstract
BACKGROUND: We sought to assess predictability of excessive bleeding using
thrombelastography (TEG), multiplate impedance aggregometry, and
conventional coagulation tests including fibrinogen in patients undergoing
coronary artery bypass graft (CABG) surgery. METHODS: A total of 170
patients were enrolled in this prospective observational study. TEG,
Multiplate aggregometry, and coagulation tests were sampled on the day
before surgery. Excessive bleeding was defined as >1000 mL over 18 hours.
RESULTS: Multiplate-adenosine diphosphate (ADP) measurements were
significantly lower in patients with excessive bleeding, 85.5AU +/- 32.8
versus 108.5AU +/- 30.0, p = 0.012. Bivariate analysis revealed body mass
index, myocardial infarction, and multiplate-ADP as predictors of
bleeding. In multivariable linear regression analysis, multiplate-ADP
remained a significant predictor of bleeding (beta: -6.2 [confidence
interval: -12.0 to -0.3], p = 0.035). The lowest interval of
multiplate-ADP (<50 AUC) was associated with significantly more bleeding
and need for platelet concentrate transfusion. Fibrinogen levels <2.5 g/L
were also found to be associated with excess bleeding (p = 0.020).
CONCLUSIONS: Multiplate impedance aggregometry identified patients at risk
for excessive bleeding after CABG. Low fibrinogen levels were associated
with increased bleeding. Neither routine TEG parameters nor conventional
coagulation tests were correlated with bleeding.

<25>
Accession Number
20160637963
Author
Castrodeza J.; Amat-Santos I.J.; Serra V.; Nombela-Franco L.; Brinster
D.R.; Gutierrez-Ibanes E.; Rojas P.; Tornos P.; Carnero M.; Cortes C.;
Tobar J.; Di Stefano S.; Gomez I.; San Roman J.A.
Institution
(Castrodeza, Amat-Santos, Rojas, Cortes, Tobar, Di Stefano, Gomez, San
Roman) Institute of Heart Sciences (ICICOR), Hospital Clinico
Universitario, Valladolid, Spain
(Serra, Tornos) Cardiology Department, Hospital Vall d'Hebron, Barcelona,
Spain
(Nombela-Franco) Cardiology Department, Hospital Clinico Universitario San
Carlos, Madrid, Spain
(Brinster) Cardiac Surgery Department, Lenox Hill Hospital Northwell
Health, NY, United States
(Gutierrez-Ibanes) Cardiology Department, Hospital General Universitario
Gregorio Maranon, Madrid, Spain
(Carnero) Cardiac Surgery Department, Hospital Clinico Universitario San
Carlos, Madrid, Spain
Title
Therapeutic alternatives after aborted sternotomy at the time of surgical
aortic valve replacement in the TAVI Era-Five centre experience and
systematic review.
Source
International Journal of Cardiology. 223 (pp 1019-1024), 2016. Date of
Publication: 15 Nov 2016.
Publisher
Elsevier Ireland Ltd
Abstract
Background We aimed to analyze causes, management, and outcomes of the
unexpected need to abort sternotomy in aortic stenosis (AS) patients
accepted for surgical aortic valve replacement (SAVR) in the transcatheter
aortic valve implantation (TAVI) era. Methods Cases of aborted sternotomy
(AbS) were gathered from 5 centers between 2009 and 2014. A systematic
review of all published cases in the same period was performed. Results A
total of 31 patients (71% males, 74 +/- 8 years, LogEuroSCORE 11.9 +/-
7.4%) suffered an AbS (0.19% of all sternotomies). Main reasons for Abs
included previously unknown porcelain aorta (PAo) in 83.9%, mediastinal
fibrosis due to radiotherapy in 12.9%, and chronic mediastinitis in 3.2%.
Median time between AbS and next intervention was 2.3 months (IQR:
0.7-5.8) with no mortality within this period. Only a case was managed
with open surgery. In 30 patients (96.8%) TAVI was performed with a rate
of success of 86.7%. Three patients (9.7%) presented in-hospital death and
17 (54.8%) had in-hospital complications including heart failure (9.6%),
major bleeding (6.9%), and acute kidney injury (9.6%). Older patients (76
+/- 8 vs. 70 +/- 8 years, p = 0.045), previous cardiac surgery (60% vs.
15.4%, p = 0.029), and shorter time from AbS to next intervention (5.1 +/-
5 vs. 1 +/- 0.7 months, p = 0.001) were related to higher six-month
mortality (22.6%). Conclusions The main reason for AbS was PAo. This
entity was associated to a higher rate of complications and mortality,
especially in older patients and with prior cardiac surgery. A preventive
strategy in these subgroups might be based on imaging evaluation. TAVI was
the most extended therapy.

<26>
Accession Number
2015348276
Author
Fujihara M.; Higashimori A.; Kato Y.; Taniguchi H.; Iwasaki Y.; Amano T.;
Sumiyoshi A.; Nishiya D.; Yokoi Y.
Institution
(Fujihara, Higashimori, Yokoi) Department of Cardiology, Kishiwada
Tokushukai Hospital, 4-27-1 Kamori-cho, Kishiwada, Osaka 596-8522, Japan
(Kato, Taniguchi) Department of Cardiology, Saiseikai Noe Hospital, Osaka,
Japan
(Iwasaki) Department of Cardiology, Osaka General Medical Center, Osaka,
Japan
(Amano) Department of Cardiology, Uji Tokushukai Hospital, Kyoto, Japan
(Sumiyoshi) Department of Cardiology, Sakurabashi Watanabe Hospital,
Osaka, Japan
(Nishiya) Department of Cardiology, Higashi Sumiyoshi Morimoto Hospital,
Osaka, Japan
Title
Nitinol stent implantation for femoropopliteal disease in patients on
hemodialysis: results of the 3-year retrospective multicenter APOLLON
study.
Source
Heart and Vessels. 31 (9) (pp 1476-1483), 2016. Date of Publication: 01
Sep 2016.
Publisher
Springer-Verlag Tokyo
Abstract
The clinical outcomes of nitinol stents for femoropopliteal arterial (FP)
disease in patients on hemodialysis were assessed. Endovascular therapy
(EVT) is accepted for symptomatic FP disease. However, the clinical
outcomes of patients on dialysis are not well known. A multicenter
retrospective study was conducted with data between November 2010 and
August 2013. A total of 484 consecutive patients who successfully
underwent EVT for FP disease with nitinol stents were recruited and
analyzed. Patients were categorized into the hemodialysis group (N = 161)
and non-hemodialysis group (N = 323). The primary measure was primary
patency verified by duplex ultrasound at a rest peak systolic velocity
(PSVR) of >2.5, and secondary measures were freedom from target lesion
revascularization (TLR) and major amputation-free survival (AFS). Average
follow-up duration was 19.5 +/- 13.5 months. The primary patency rate at 3
years was significantly lower in the hemodialysis group than the
non-hemodialysis group (33.8 vs. 43.7 %; p = 0.036). Freedom from TLR at 3
years was 55.0 % in the hemodialysis group and 66.1 % in the
non-hemodialysis group (p = 0.032). The hemodialysis group showed a
significantly lower AFS rate at 3 years than the non-hemodialysis group
(86.4 vs. 58.2 %; p < 0.001). In hemodialysis patients, nitinol stent use
resulted in a lower patency rate, higher TLR rate, and lower AFS rate
compared to non-hemodialysis patients. These data suggest that nitinol
stent implantation for FP arteries in hemodialysis patient needs to be
reconsidered.

<27>
Accession Number
20160634586
Author
Bundhun P.K.; Yanamala C.M.; Huang F.
Institution
(Bundhun, Huang) Institute of Cardiovascular Diseases, First Affiliated
Hospital of Guangxi Medical University, Nanning, Guangxi 530021, China
(Yanamala) EALING Hospital, University of Buckingham, Department of
Internal Medicine, Uxbridge road, Southall, London UB1 3HW, United Kingdom
Title
Should a prolonged duration of dual anti-platelet therapy be recommended
to patients with diabetes mellitus following percutaneous coronary
intervention? A systematic review and meta-analysis of 15 studies.
Source
BMC Cardiovascular Disorders. 16 (1) (no pagination), 2016. Article
Number: 161. Date of Publication: 30 Aug 2016.
Publisher
BioMed Central Ltd.
Abstract
Background: This study aimed to compare the adverse clinical outcomes
associated with a short and a prolonged duration of Dual Anti-Platelet
Therapy (DAPT) in patients with Diabetes Mellitus (DM) after undergoing
Percutaneous Coronary Intervention (PCI). Methods: Medline/PubMed, EMBASE
and the Cochrane library were searched for studies comparing the short and
prolonged DAPT use in patients with DM. Adverse outcomes were considered
as the clinical endpoints in this analysis. Odds Ratios (OR) with 95 %
Confidence Intervals (CI) were used to express the pooled effect on
discontinuous variables and the pooled analyses were performed with RevMan
5.3. Results: Fifteen studies with a total number of 25,742 patients with
DM were included in this current analysis which showed no significant
differences in primary endpoints, net clinical outcomes, myocardial
infarction and stroke with OR: 1.03, 95 % CI: 0.65-1.64; P = 0.90, OR:
0.96, 95 % CI: 0.69-1.34; P = 0.81, OR: 0.85, 95 % CI: 0.70-1.04; P = 0.12
and OR: 0.94, 95 % CI: 0.65-1.36; P = 0.75 respectively. Revascularization
was also similar between these 2 groups of patients with DM. However, even
if mortality favored prolonged DAPT use, with OR: 0.87, 95 % CI:
0.76-1.00; P = 0.05, the result only approached significance. Also, stent
thrombosis insignificantly favored a prolonged DAPT duration with OR:
0.56, 95 % CI: 0.27-1.17; P = 0.12. Thrombolysis In Myocardial Infarction
(TIMI) defined major and minor bleeding were not significantly different
in these diabetic patients with OR: 0.91, 95 % CI: 0.60-1.37; P = 0.65 and
OR: 1.08, 95 % CI: 0.62-1.91; P = 0.78 respectively. However, bleeding
defined by the Bleeding Academic Research Consortium (BARC) classification
was significantly higher with a prolonged DAPT use in these diabetic
patients with OR: 1.92, 95 % CI: 1.58-2.34; P < 0.00001. Conclusion:
Following PCI, a prolonged DAPT use was associated with similar adverse
clinical outcomes but with a significantly increased BARC defined bleeding
compared to a short term DAPT use in these patients with DM. However, even
if mortality and stent thrombosis favored a prolonged DAPT use, these
outcomes only either reached statistical significance or were
insignificant respectively, showing that a clear decision about
recommending a prolonged duration of DAPT to patients with DM might not be
possible at this moment, warranting further research in this particular
subgroup.

<28>
Accession Number
20160629140
Author
Stefan V.; Ahmed A.K.; Didier C.; Pieter S.; Ton S.; Jozef B.; Yoshinobu
O.; Patrick W.S.
Institution
(Stefan, Patrick) Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp,
Belgium
(Ahmed) Department of Cardiology, Bern University Hospital, Bern,
Switzerland
(Didier) Service de Cardiologie, Centre Hospitalier Universitaire
Rangueil, Toulouse, France
(Pieter) Department of Cardiology, University Medical Center Utrecht,
Utrecht, Netherlands
(Ton) OLVG Amsterdam, Amsterdam, Netherlands
(Jozef) Cardiovascular Center, OLV Ziekenhuis Aalst, Aalst, Belgium
(Yoshinobu, Patrick) Erasmus Medical Center, Rotterdam, Netherlands
(Patrick) International Centre for Circulatory Health, NHLI, Imperial
College London, London, United Kingdom
Title
Direct implantation of rapamycin-eluting stents with bioresorbable drug
carrier technology utilising the svelte coronary stent-on-a-wire: The
direct II study.
Source
EuroIntervention. 12 (5) (pp e615-e622), 2016. Date of Publication: August
2016.
Publisher
EuroPCR
Abstract
Aims: Our aim was to demonstrate the safety and efficacy of the Svelte
sirolimus-eluting coronary stenton-a-wire Integrated Delivery System (IDS)
with bioresorbable drug coating compared to the Resolute Integrity
zotarolimus-eluting stent with durable polymer in patients with de novo
coronary artery lesions. Methods and results: Direct stenting,
particularly in conjunction with transradial intervention (TRI), has been
associated with reduced bleeding complications, procedure time, radiation
exposure and contrast administration compared to conventional stenting
with wiring and predilatation. The low-profile Svelte IDS is designed to
facilitate TRI and direct stenting, reducing the number of procedural
steps, time and cost associated with coronary stenting. DIRECT II was a
prospective, multicentre trial which enrolled 159 patients to establish
non-inferiority of the Svelte IDS versus Resolute Integrity using a 2:1
randomisation. The primary endpoint was angiographic in-stent late lumen
loss (LLL) at six months. Target vessel failure (TVF), as well as
secondary clinical endpoints, will be assessed annually up to five years.
At six months, in-stent LLL was 0.09+/-0.31 mm in the Svelte IDS group
compared to 0.13+/-0.27 mm in the Resolute Integrity group (p<0.001 for
non-inferiority). TVF at one year was similar across the Svelte IDS and
Resolute Integrity groups (6.5% vs. 9.8%, respectively). Conclusions:
DIRECT II demonstrated the non-inferiority of the Svelte IDS to Resolute
Integrity with respect to in-stent LLL at six months. Clinical outcomes at
one year were comparable between the two groups. ClinicalTrials.gov
Identifier: NCT01788150

<29>
Accession Number
612039942
Author
Shaddy R.; Chen F.; Canter C.; Halnon N.; Kochilas L.; Jefferies J.;
Rossano J.; Bonnet D.; Kantor P.; Burch M.
Institution
(Shaddy, Rossano) Children's Hospital of Philadelphia, Philadelphia, PA,
United States
(Chen) Novartis Pharmaceuticals Corporation, East Hanover, NJ, United
States
(Canter) Washington University, St. Louis, MO, United States
(Halnon) UCLA, Los Angeles, CA, United States
(Kochilas) Children's Health Care of Atlanta, Atlanta, GA, United States
(Jefferies) Cincinnati Children's Hospital Medical Center, Cincinnati, OH,
United States
(Bonnet) Necker Hospital-Universite, Paris, France
(Kantor) University of Alberta, Edmonton, AB, Canada
(Burch) Great Ormond Street Hospital for Children, London, United Kingdom
Title
Pharmacokinetics/pharmacodynamics, efficacy and safety of
sacubitril/valsartan versus enalapril in pediatric patients with heart
failure due to systemic left ventricle systolic dysfunction: Study design
and rationale.
Source
Journal of Cardiac Failure. Conference: 20th Annual Scientific Meeting of
the Heart Failure Society of America United States. Conference Start:
20160917 Conference End: 20160920. 22 (pp S36-S37), 2016. Date of
Publication: August 2016.
Publisher
Churchill Livingstone Inc.
Abstract
Background: Pediatric HF is characterized by significant morbidity and
mortality and the rationale for medical therapy primarily comes from adult
studies. Sacubitril/ valsartan (LCZ696) reduced mortality and delayed HF
progression vs. enalapril and was generally well tolerated in PARADIGM-HF
trial in adults with HFrEF; however, benefit in pediatric patients is
unknown. Study Design: This multicenter study will use an adaptive,
seamless, 2-stage design (Figure). Part 1, open-label study will determine
the PK/PD of single-dose LCZ696 in 36 pediatric HF patients (1 month to
<18 years) stratified into 3 age groups (Group 1:6 to <18 years; Group 2:1
to <6 years; Group 3:1 month to <1 year) in a sequential overlapping
fashion and in descending age-group order. The dose for Group 1 (3.1
mg/kg) corresponds to ~200 mg LCZ696 dose in an adult with 65 kg
bodyweight. The dose for subsequent Groups will be adjusted based on
safety information from previous group(s). Part 2 is a 52-week randomized,
double-blind, parallel-group, active-controlled study. The duration will
provide 1-year growth and safety data in growing children. Eligible
patients (N = 360) stratified by age and NYHA/Ross classification will be
randomized to LCZ696 or enalapril (target dose: 0.2 mg/kg bid; maximum 10
mg bid). A lack of validated efficacy endpoints for these patients led to
the development of a novel Global Rank primary endpoint derived by ranking
patients (worst to best outcome) based on clinical events, such as death
and listing for urgent heart transplant/mechanical life support; worsening
HF; and measures of functional assessment (NYHA/Ross) and patient-reported
QoL outcomes. Safety areas of interest include known risks for LCZ696 and
enalapril, such as hypotension, hyperkalemia, worsening renal function,
and angioedema. Conclusion: This ambitious study will be the largest
prospective pediatric HF trial attempted to date, and first to use a
Global Rank endpoint; experience of the latter will enable more future
research in this challenging area. (Figure Presented).

<30>
Accession Number
612039941
Author
Park M.; Ewald G.; Franco V.; Garcia-Ferrer J.; Hage A.; Horn E.; Mandras
S.; Mathier M.; Rame E.; Selej M.; Wang I.-W.; Frantz R.
Institution
(Park) Houston Methodist Research Institute, Houston, TX, United States
(Ewald) Washington University, St Louis, MO, United States
(Franco) Ohio State University, Columbus, OH, United States
(Garcia-Ferrer, Selej) Actelion Pharmaceuticals, South San Francisco, CA,
United States
(Hage) Cedars-Sinai Medical Center, Los Angeles, CA, United States
(Horn) Weill Cornell Medical College, New York, NY, United States
(Mandras) Ochsner Medical Center, New Orleans, LA, United States
(Mathier) University of Pittsburgh, Pittsburgh, PA, United States
(Rame) University of Pennsylvania, Philadelphia, PA, United States
(Wang) Indiana University Health, Indianapolis, IN, United States
(Frantz) Mayo Clinic, Rochester, MN, United States
Title
Soprano: Study of macitentan in patients with pulmonary hypertension (PH)
post-left ventricular assist device (LVAD) implantation.
Source
Journal of Cardiac Failure. Conference: 20th Annual Scientific Meeting of
the Heart Failure Society of America United States. Conference Start:
20160917 Conference End: 20160920. 22 (pp S14), 2016. Date of Publication:
August 2016.
Publisher
Churchill Livingstone Inc.
Abstract
Introduction: In the US, 5.8 million individuals have heart failure (HF).
LVADs are increasingly being used in patients with Stage D HF and reduced
ejection fraction. LVADs are used as a bridge-to-transplant (BTT) or as
destination therapy. Persistent PH post- LVAD implantation is associated
with right ventricular (RV) failure and substantial morbidity and
mortality. Pre-capillary PH post-LVAD in BTT patients is associated with
decreased transplant eligibility and post-heart transplant survival. Most
data on the use of pulmonary vasodilators in LVAD patients are derived
from single-center, open-label experiences. No targeted pulmonary arterial
hypertension (PAH) therapy has been studied in a randomized,
placebo-controlled trial to benefit patients with PH post-LVAD
implantation. Hypothesis: Once-daily macitentan is a new, dual endothelin
receptor antagonist (ERA) with a favorable safety profile approved for
PAH. In the phase 3 SERAPHIN study, macitentan improved long-term clinical
outcomes, functional status, exercise capacity, and cardiopulmonary
hemodynamics in PAH patients. The phase 2 SOPRANO study (NCT02554903) will
evaluate macitentan in patients with PH post-LVAD implantation. Methods:
Patients will be randomized (1:1) to placebo or macitentan 10 mg once
daily. The study will consist of a 12-week double-blind treatment phase
and a 30-day follow-up period. Patients will be >18 years; have mean
pulmonary arterial pressure >25 mmHg, pulmonary artery wedge pressure <18
mmHg, and pulmonary vascular resistance >3 woods units; and have had an
LVAD implanted within 45 days pre-randomization. Results: SOPRANO will
enroll 64 patients from approximately 30 US sites. The primary endpoint
will be the change in pulmonary vascular resistance at week 12 vs
baseline. Secondary endpoints include safety and changes in
cardiopulmonary hemodynamics, functional class, and NT-proBNP from
baseline to week 12. The effects of macitentan on echocardiographic RV
parameters, selected clinical events (eg, hospitalization days), and renal
function as estimated by GFR will be explored. Recruitment is ongoing.
Conclusions: SOPRANO is the first randomized, placebo-controlled study of
ERAs and pulmonary vasodilators in patients with PH post-LVAD
implantation. SOPRANO will provide insights into the effects of ERAs on
cardiopulmonary hemodynamics, RV function, and cardiac and renal
biomarkers in this growing population.

<31>
Accession Number
612039633
Author
Gass A.; Lovett E.; Georgakopoulos D.; Antretter H.; Ince H.; Schlensak
C.; Weyand M.; Bujnoch D.; Hotz H.; Rame J.E.; Miller L.W.
Institution
(Gass) Westchester Medical Center, Valhalla, NY, United States
(Lovett, Georgakopoulos) Sunshine Heart Inc, Eden Prairie, MN, United
States
(Antretter) Medizinische Universitat Innsbruck, Innsbruck, Austria
(Ince) Vivantes Klinikum am Friedrichshain, Berlin, Germany
(Schlensak) Eberhard Karls Universitat Tubingen, Tubingen, Germany
(Weyand, Bujnoch) Universitatsklinikum Erlangen Krankenhausstrasse,
Erlangen, Germany
(Hotz) UK Cardio-Centrum Berlin GmbH, Berlin, Germany
(Rame) Hospital University of Pennsylvania, Philadelphia, PA, United
States
(Miller) Morgan Heart Institute, Tampa, FL, United States
Title
Clinical experience in advanced HF patients implanted with an extra-aortic
counterpulsation device (EACD).
Source
Journal of Cardiac Failure. Conference: 20th Annual Scientific Meeting of
the Heart Failure Society of America United States. Conference Start:
20160917 Conference End: 20160920. 22 (pp S108), 2016. Date of
Publication: August 2016.
Publisher
Churchill Livingstone Inc.
Abstract
Background: Despite optimal medical and device therapy, patients with NYHA
Class III/ambulatory IV HF experience high rates of morbidity and
mortality. Due to the progressive nature of the disease, some patients
remain symptomatic requiring hospitalizations, transplantation or a Left
Ventricular Assist Device (LVAD), exposing them to potential
complications, side effects and limiting their overall survival. An
Extra-aortic counterpulsation device (EACD) is a novel therapy, consisting
of an extravascular cuff implanted on the ascending aorta. EACD operates
on the principle of counterpulsation to enhance myocardial perfusion and
reduce cardiac afterload. Previous results demonstrate these benefits may
be mediated through neuro-modulatory mechanisms. Methods: Data were
collected from a European multi-center, postmarket study designed to
observe the clinical outcomes of advanced heart failure patients not yet
on inotropic support treated with EACD. Results: EACD system implant
occurred in 15 patients. EACD significantly improved QOL, 6MHWd and LV
ejection fraction (Table 1). A non-significant trend was observed in pulse
pressure and enddiastolic volume. No patients experienced stroke or
sepsis. Drive line infection rate was 13.3% (2/15) for the entire cohort.
Treatment effects were measured by paired statistical analysis.
Conclusions: In this cohort of patients with advanced HF, EACD
demonstrated improvements in quality of life, functional capacity and
cardiac remodeling with a favorable safety profile. Changes observed in
the end-systolic volume have been shown to correlate with improved
outcomes from several large trials. The modular design and non-obligatory
features of the device will facilitate future trials to assess the
potential for weaning from therapy, delaying or avoiding cardiac
transplant or as bridge to transplant. (Table Presented).

<32>
Accession Number
611935434
Author
Schofer J.; Colombo A.; Lefevre T.; Latib A.; Bruschi G.; Fajadet J.;
Nickenig G.; Redwood S.; Mullen M.; Maisano F.; Weissman N.; Thomas M.;
Young C.; Yap J.; Grube E.; Sinning J.-M.; Hauptmann K.E.; Friedrich I.;
Lauterbach M.; Schmoeckel M.; Klugmann S.; Bijuklic K.; Tchetche D.; De
Marco F.
Institution
(Schofer) Medical Care Center Hamburg, University Cardiovascular Center,
Hamburg, Germany
(Colombo, Latib, Maisano) San Raffaele Hospital, Milano, Italy
(Lefevre) Institut Cardiovasculair Paris Sud, Hopital Prive Jacques
Cartier, Massy, France
(Bruschi, Klugmann, De Marco) Azienda Ospedaliera Niguarda Ca Granda,
Milano, Italy
(Fajadet, Tchetche) Clinique Pasteur, Toulouse, France
(Nickenig, Grube, Sinning) University Hospital Bonn, Bonn, Germany
(Redwood, Thomas, Young) St. thomas Hospital, London, United Kingdom
(Mullen, Yap) The heart Hospital, London, United Kingdom
(Weissman) Medstar Health Research Institute, Georgetown University,
Washington DC, United States
(Hauptmann, Friedrich, Lauterbach) Krankenhaus Der Baumherzigen Bruder,
Trier, Germany
(Schmoeckel, Bijuklic) Asklepios Klinik St. Georg, Hamburg, Germany
Title
The DISCOVER trial: Three-year outcomes of a fully repositionable and
retrievable non-metallic transcatheter aortic valve.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 353), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The DISCOVER trial is a prospective, multicentre evaluation of the
safety and efficacy of the Direct Flow Medical Percutaneous Aortic Valve
System for the treatment of severe symptomatic aortic stenosis extreme
risk patients. Methods and results: One hundred extreme risk patients with
a logistic EuroSCORE > 20 or other high surgical risk comorbidities were
enrolled at 9 centres in Europe. Clinical and haemodynamic outcomes were
assessed. All echocardiographic and angiographic data were evaluated by an
independent core laboratory (MedStar) and adverse events adjudicated by an
independent clinical event committee using VARC definitions. Patients were
83.1+/-5.9 years, logistic EuroSCORE 22.5+/-11.3% and STS scores
9.7+/-8.7%. Other comorbidities included coronary artery disease in 58%,
prior CABG 23%, chronic kidney disease 26%, and severe chronic obstructive
pulmonary disease in 13%. A 25mm valve was implanted in 58 patients and a
27mm valve in 40 patients. Two patients did not receive a study valve. At
2 years, overall survival was 81% and freedom from death and stroke was
77%. Freedom from cardiovascular mortality was 88%. Paravalvular
regurgitation was none or trace in 85% of patients, with total aortic
regurgitation graded as none or trace in 77% of patients. There were no
cases of moderate or severe aortic regurgitation. Mean pressure gradient
and effective orifice area remained stable at 2 years 12.6+/-6.1mmHg and
1.4+/-0.42cm2 compared to 12.2+/-6.6 mmHg and 1.6+/-0.42cm2 at 1 year and
12.6+/-5.8 mmHg and 1.5+/-0.48 cm2 at 30 days. New York Heart Association
functional class was I or II in 92% of patients at the 2-year follow-up.
Three-year outcomes and echocardiographic data are being evaluated and
will be presented. Conclusions: The Direct Flow Medical Transcatheter
Aortic Valve System demonstrates excellent 2-year clinical and
haemodynamic outcomes in extreme surgical risk patients with severe aortic
stenosis. Three-year outcomes will be available at the time of the meeting
for the first time.

<33>
Accession Number
611935431
Author
Chandrasekhar J.; Asgar A.; Lefevre T.; Kupatt C.; Dumonteil N.; Webb J.;
Colombo A.; Windecker S.; Ten Berg J.; Hildick-Smith D.; Mehran R.;
Boekstegers P.; Linke A.; Tron C.; Van Belle E.; Fach A.; Jeger R.;
Sardella G.; Hink H.U.; Husser O.; Grube E.; Deliargyris E.; Bernstein D.;
Lechthaler L.; Anthopoulos P.; Hengstenberg C.; Dangas G.
Institution
(Chandrasekhar, Mehran, Dangas) Icahn School of Medicine at Mount Sinai,
New York, United States
(Asgar) Montreal Heart Institute, Montreal, Canada
(Lefevre) Institut Cardio Vasculaire Paris Sud, Hopital Prive Jacques
Cartier, Massy, France
(Kupatt) LMU Munich, Munich, Germany
(Dumonteil) CHU Rangueil, Toulouse, France
(Webb) St. Paul's Hospital, Vancouver, BC, Canada
(Colombo) San Raffaele Hospital, Milan, Italy
(Windecker) Department of Cardiology, Bern University Hospital, Bern,
Switzerland
(Ten Berg) St. Antonius Ziekenhuis, Nieuwegein, Netherlands
(Hildick-Smith) Sussex Cardiac Centre, Brighton and Sussex University
Hospitals NHS Trust, Brighton,East Sussex, United Kingdom
(Boekstegers) Helios Heart Center Siegburg, Siegburg, Germany
(Linke) Universitat Leipzig, Herzzentrum, Leipzig, Germany
(Tron) CHU De Rouen, Rouen, France
(Van Belle) Department of Cardiology, Inserm UMR 1011, University
Hospital,and CHRU Lille, Lille, France
(Fach) Klinikum Links Der Weser Bremen, Bremen, Germany
(Jeger) Cardiology University Hospital Basel, Basel, Switzerland
(Sardella) Policlinico Umberto I, Rome, Italy
(Hink) Universitatsmedizin Mainz, Mainz, Germany
(Husser) Deutsches Herzzentrum Munchen, Technische Universitat Munchen,
Munchen, Germany
(Grube) Universitaetsklinikum Bonn, Bonn, Germany
(Deliargyris, Bernstein, Anthopoulos) Medicines Company, Parsippany, NJ,
United States
(Lechthaler) Medicines Company, Zurich, Switzerland
(Hengstenberg) DZHK (German Centre for Cardiovascular Research), Partner
Site Munich Heart Alliance,and Deutsches Herzzentrum Munchen, Technische
Universitat Munchen, Munich, Germany
Title
Gender-based differences in 30-day outcomes with contemporary
transcatheter aortic valve replacement: Results from the BRAVO 3
randomised trial.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 428), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: In those undergoing transcatheter aortic valve replacement (TAVR),
women experience more procedural complications but better survival than
men. We sought to compare the 30-day outcomes by gender in a contemporary
TAVR cohort from the BRAVO 3 trial. Methods and results: BRAVO 3 was a
randomised multicentre trial comparing transfemoral TAVR with bivalirudin
vs. unfractionated heparin (n=802). The primary safety endpoint was
Bleeding Academic Research Consortium (BARC) type >3b bleeding. Major
adverse cardiovascular events (MACE) were a composite of 30-day death, MI
or stroke. Net adverse cardiovascular events (NACE) were a composite of
30-day MACE or BARC >3b bleeding. Of the total cohort, 391 were female
(49%). Women were older and 76% (vs. 58% in men) were >80 years old. Women
had lower body weight, less prior myocardial infarction, coronary artery
bypass surgery, diabetes, atrial fibrillation, lung disease but similar
EuroSCORE and higher left ventricular ejection fraction compared with men.
Use of general anaesthesia was similar and two thirds underwent Edward
SAPIEN (ES) TAVR. Women received smaller valves (23 mm ES or 26 mm
CoreValve) than men and were less likely to need an additional TAVR
device. The use of closure devices was similar in both groups. Post
procedure, more than two thirds of the cohort received dual antiplatelet
therapy. At 30 days, the incidence of BARC >3b bleeding was similar in men
and women (10.5% vs. 9%, p 0.48). There were no differences in the
incidence of 30-day death (4.6% vs. 4.9%, p 0.87), MACE (8.3% vs. 7.4%, p
0.65), NACE (14.8% vs. 15.6%, p 0.76) or major vascular complications
(7.8% vs. 11.0%, p 0.11) in men versus women. Women experienced greater
30-day GUSTO moderate/severe (12.2% vs. 18.9%, p 0.008) and ACUITY major
bleeding (27.3% vs. 36.1%, p 0.007) than men. Conclusions: Women
demonstrated similar survival, MACE and vascular complications at 30 days
compared with men in this contemporary TAVR population but a trend for
more bleeding depending on the definition used.

<34>
Accession Number
611935404
Author
Erglis A.
Institution
(Erglis) Latvian Centre of Cardiology, Riga, Latvia
Title
Results of the multicentre (PHASE II) mitral valve repair clinical trial
(MAVERIC trial) for the treatment of secondary mitral regurgitation in
chronic heart failure.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 377), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The MAVERIC trial is a prospective, non-randomised study of the ARTO
System, a novel transcatheter device that can be used in the treatment of
functional mitral regurgitation. Methods and results: The ARTO System
percutaneously modifies the mitral annulus to improve leaflet coaptation
in patients with functional mitral regurgitation (FMR) and systolic heart
failure (HF). The procedure is carried out under general anaesthesia with
transoesophageal echocardiographic (TEE) guidance. Briefly, a magnetic
catheter (MagneCath) is placed in the coronary sinus (CS) from the right
internal jugular vein (RIJV). A second MagneCath is placed in the left
atrium (LA). The two MagneCaths are manipulated and linked magnetically
posteriorly in the left atrium behind the posterior mitral leaflet. A
small puncturing wire is then advanced from the CS into the LA MagneCath
and externalised to create a continuous loop wire from the RIJV to the
right femoral vein (RFV). Through a series of wire and catheter exchanges,
a CS anchor is then placed in the coronary sinus and connected to an
atrial septal anchor by a suture of adjustable length. This suture is then
adjusted in length in order to shorten the anteroposterior (AP) diameter
of the mitral annulus until significant reduction is seen in the mitral
regurgitation. One-year results for Phase I (single centre) of the MAVERIC
trial have previously been reported. There were no new adverse events
between the 6-month and 1-year follow-up. From baseline to 12 months,
there were stable and meaningful improvements. Effective regurgitant
orifice area decreased from 30.3+/-11.1 to 15.9+/-8.6 mm² and
regurgitant volumes from 45.4+/-15.0 to 24.0+/-11.4 ml. LV end-diastolic
volume index improved from 118.7+/-28.6 to 97.8+/-26.4 ml/m².
Mitral annular anteroposterior diameter decreased from 45.0+/-3.3 to
39.1+/-3.6 mm. Functional status was 81.8% NYHA functional Class III/IV
improving to 60% functional Class I/II. Conclusions: The percutaneous ARTO
system is a novel transcatheter device that can be used in the treatment
of FMR. Latest enrolment and safety and efficacy data will be presented.

<35>
Accession Number
611935398
Author
Kornowski R.; Rougin A.; Daneneberg H.; Assa H.V.; Rozenbaum E.; Guetta
V.; Merdler A.; Assali A.
Institution
(Kornowski, Assa, Assali) Rabin Medical Center, Petach Tikva, Israel
(Rougin) Rambam Health Corporation, Haifa, Israel
(Daneneberg) Hadasit Medical Research Service and Development Ltd,
Jerusalem, Israel
(Rozenbaum) Clalit Health Services, Meir Medical Center, Kfar Sava, Israel
(Guetta) Medical Research Infrastructure Development and Health Services,
Sheba Medical Center, Tel Hashomer, Israel
(Merdler) Clalit Health Services, Through Lady Davis Carmel Medical
Center, Haifa, Israel
Title
BIOFLOW-III satellite Israeli diabetic prospective registry with the
ORSIRO sirolimus-eluting stent and comprehensive diabetic care: One-year
clinical outcomes.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 52), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: A prospective registry to evaluate the clinical performance of the
new generation ORSIRO drug eluting stent in diabetic coronary patients
while taking a comprehensive approach in treating the diabetic disease
following coronary interventions. Methods and results: Between July 2013
and May 2014, 120 diabetic patients (type 1 or 2) were enrolled
consecutively in this national, multicentre BIOFLOW-III Satellite Israel
Registry using the ORSIRO Sirolimus eluting stent coated with unique
passive and active biocompatible and biodegradable components. Subjects
were required to undergo a dedicated diabetic consultancy at 1 and 6 month
follow-up in order to optimise the diabetic and lipid metabolic control.
Primary endpoint was target lesion failure (TLF) at 12 months follow-up
(composite of cardiac death, any target myocardial infarction, coronary
artery bypass graft and clinically driven target lesion
revascularisation). Ninety-five percent (113/120) follow-up compliance at
twelve-month was achieved. One hundred men (83.3%) and 20 women were
enrolled at 6 sites in Israel. The mean age was 63.9 +/- 9.2, 81.7% of the
subjects suffered from hypertension, 93.3% suffered from dyslipidaemia,
62.5% were present or past smokers and 25.8% were insulin treated
diabetics. Reference vessel diameter was 2.98 +/- 0.46mm, 51% of the
lesions were complex (B2 and C) and moderate to severe calcification was
observed in 18.9%. Among patients, 42.5% experienced stable angina at
baseline, 28.3% unstable angina and 25.8% non-STEMI. The primary endpoint
(TLF) at 12-month follow-up was 6.9% (95% CI 3.5-13.3), including cardiac
death 0.9%, target vessel MI 1.0%, target lesion revascularisation 2.7%
and need for CABG in 1.0%. Definite and probable stent thrombosis was 0.8
(95% CI 0.1-5.8). At one year, 87% of patients were free of angina
symptoms. Conclusions: The treatment of diabetic coronary patients using
the ORSIRO drug eluting stent followed by comprehensive diabetic care was
associated with excellent one-year clinical outcomes.

<36>
Accession Number
611935397
Author
Yano H.; Horinaka S.; Ishimitsu T.
Institution
(Yano) Nasu Red Cross Hospital, Tochigi, Japan
(Horinaka, Ishimitsu) Dokkyo Medical University Hospital, Tochigi, Japan
Title
Comparison of predilation with scoring balloons vs. conventional balloons
(or direct stenting) for coronary stenting analysed with OCT.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 227), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: This study was conducted to determine the influence of lesion
preparation using the Scoreflex balloon on final stent expansion. In these
patients where DES are used, the role of different predilation strategies
has yet to be established. Methods and results: Eighty consecutive de novo
non or mild calcified lesions (calcification <25% of circumference)
treated with a single 2.5-3.5 mm cobalt-chromium everolimus-eluting stent
under OCT without post-dilatation, using 3 implantation strategies, were
studied: (1) direct stenting without predilatation (DS; n=25), (2)
predilatation with the Scoreflex balloon (SF; n=30), and (3) predilatation
with the conventional semi-compliant balloon (SB; n=25). Stent expansion
was defined as the ratio of OCT-measured minimum stent area to the
manufacturer's predicted stent area. Although the balloon size and the
maximal dilatation pressure for predilatation was larger (2.90+/-0.31 vs.
2.68+/-0.24 mm, p=0.012) and higher (10.4+/-3.7 vs. 8.6+/-3.7 atm,
p=0.013) in the SB group than in the SF group, lumen gain was 2.03+/-0.12
mm in the SF, 1.84+/-0.20 mm in the SB, and 1.81+/-0.12 mm in the DS group
(SF vs. SB or DS, p=0.015), respectively. OCT data showed numerically
greater lumen area gain of 3.04+/-0.27 mm 2 in the SF group compared to
2.53+/-0.68 mm² with the SB group, and 2.60+/-0.50
mm² with the DS group (SF vs. SB or DS, p=0.005). Additionally,
malapposition at post-PCI was significantly lower in the SF than in the SB
or DS group (4.0+/-1.8 vs 5.8+/-2.0 or 6.0+/-2.3%, p=0.030). Conclusions:
In this observational, non-randomised study, lesion preparation with the
Scoreflex balloon led to a numerically larger lumen gain, lower
malapposition, and minimised the difference between predicted and achieved
stent dimensions even though the lesion was mildly calcified.

<37>
Accession Number
611935377
Author
Yamaji K.; Shiomi H.; Morimoto T.; Nakatsuma K.; Toyota T.; Kimura T.
Institution
(Yamaji) Kokura Memorial Hospital, Kitakyushu, Japan
(Shiomi, Nakatsuma, Toyota, Kimura) Kyoto University, Graduate School of
Medicine, Kyoto, Japan
(Morimoto) Hyogo College of Medicine, Nishinomiya, Japan
Title
Effects of age and sex on clinical outcomes after PCI relative to CABG in
patients with triple vessel coronary artery disease.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 75), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: Age and sex were important considerations on the choice between PCI
and CABG in daily clinical practice. We sought to evaluate the effects of
the age and sex on clinical outcomes after PCI relative to CABG in the 2
large-scale all-comer registries. Methods and results: In 25,816 patients
enrolled in the multicentre CREDO-Kyoto registry (Cohort-1: N=9,877, and
Cohort-2: N=15,939), the current study population consisted of 5,651
patients (men: N=3,998, and women: N=1,653) with triple vessel coronary
artery disease who were considered to be pertinent in comparing PCI with
CABG (PCI: N=3,165, and CABG: N=2,486). Patients were divided into 3
groups according to the tertiles of age: <65 years (N=1,972), 66-73 years
(N=1,820), and >74 years (N=1,859). Clinical follow-up durations for the
survivors were different between Cohort-1 and -2 and were similar between
the PCI and CABG groups (Cohort-1: 9.9+/-3.4 years versus 10.1+/-3.4
years, P=0.48, and Cohort-2: 5.3+/-1.2 years versus 5.3+/-1.4 years,
P=0.91). CABG as compared with PCI was associated with lower long-term
adjusted risk for mortality (HR 1.25 [95%CI 1.07-1.47], P=0.006),
myocardial infarction (HR 2.20 [95%CI 1.52-3.17], P<0.001), heart failure
hospitalisation (HR 1.73 [95%CI 1.38-2.30], P<0.001), and any coronary
revascularisation (HR 4.53 [95%CI 3.78-5.44], P<0.001) but with higher
adjusted risk for stroke (HR 0.75 [95%CI 0.57-0.98], P=0.04). The excess
adjusted mortality risk of PCI relative to CABG was significant in
patients >74 years of age (HR 1.41 [95% CI 1.11-1.79], P=0.005), while the
risks were neutral in patients <65 years of age (HR 1.04 [95% CI
0.72-1.50], P=0.84) and in patients 66-73 years of age (HR 1.02 [95%CI
0.77-1.35], P=0.91) (P interaction =0.003). The excess mortality risk of
PCI relative to CABG was significant in men (HR 1.24 [95% CI 1.03-1.50],
P=0.02), and trended to be significant in women (HR 1.34 [95% CI
0.98-1.84], P=0.07), without significant interaction between sex and the
mortality risk of PCI relative to CABG (Pinteraction=0.56). Conclusions:
There was a significant association between age and the mortality risk of
PCI relative to CABG with excess risk in patients >74 years of age and
neutral risk in younger patients. There was no significant sex-related
difference in the mortality risk of PCI relative to CABG.

<38>
Accession Number
611935316
Author
Barbanti M.; Webb J.; Van Mieghem N.; Makkar R.; Piazza N.; Latib A.;
Sinning J.-M.; Won-Keun K.; Bleiziffer S.; Bedogni F.; Kapadia S.;
Tchetche D.; Rodes-Cabau J.; Fiorina C.; Nombela-Franco L.; De Marco F.;
De Jaegere P.; Chakravarty T.; Vaquerizo B.; Colombo A.; Grube E.;
Svensson L.; Nickenig G.; Mollmann H.; Dellarosa F.; Elhmidi Y.; Dvir D.;
Imme S.; Gulino S.; Patane M.; Sicuso R.; Petronio A.S.; Tamburino C.
Institution
(Barbanti, Tamburino, Imme, Gulino, Patane, Sicuso, Tamburino) Ferrarotto
Hospital, University of Catania, Catania, Italy
(Webb, Dvir) St Paul's Hospital, Vancouver, Canada
(Van Mieghem, De Jaegere) Thoraxcenter, Erasmus Medical Center, Rotterdam,
Netherlands
(Makkar, Chakravarty) Cedars-Sinai Heart Institute, Los angeles, United
States
(Piazza) Mcgill University Health Center, Montreal, Canada
(Latib, Colombo) San Raffaele Scientific Institute, Milan, Italy
(Sinning, Grube, Nickenig) Heart Centre Bonn, Department of Medicine II,
University Hospital, Bonn, Germany
(Won-Keun, Mollmann) Kerckhoff Heart and Thorax Center, Bad Nauheim,
Germany
(Bleiziffer, Vaquerizo, Elhmidi) German Heart Center Munich, Technical
University Munich, Munich, Germany
(Bedogni, De Marco) IRCCS Policlinico San Donato, San Donato Milanese,
Italy
(Kapadia, Svensson) Cleveland Clinic Foundation, Cleveland, United States
(Tchetche, Dellarosa) Clinique Pasteur, Toulouse, France
(Rodes-Cabau) Quebec Heart and Lung Institute, Laval University, Quebec
City, Canada
(Fiorina) Spedali Civili, Brescia, Italy
(Nombela-Franco) Hospital Clinico Universitario San Carlos, Madrid, Spain
(Petronio) Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy
Title
Outcomes of re-do transcatheter aortic valve replacement for the treatment
of post-procedural and late transcatheter valve failure.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 327), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The aim of this multicentre international collaboration was to
examine the safety and midterm efficacy of re-do transcatheter aortic
valve replacement (TAVR) to treat post-procedural and late transcatheter
valve failure. Methods and results: Clinical and echocardiographic
outcomes of 46 consecutive patients who underwent re-do TAVR procedures
more than 2 weeks post-procedure were collected from 14 centres across
Italy, Germany, Canada, Spain, France, the Netherlands and the United
States. Indications for re-do TAVR were moderate-severe prosthetic aortic
valve stenosis (n=10, 21.7%), moderate-severe central prosthetic aortic
valve regurgitation (n=13, 28.3%), and moderate-severe paraprosthetic
aortic valve regurgitation (n=23, 50.0%). The index TAVR was most commonly
a Medtronic CoreValve (N=36, 78.3%), followed by Edwards SAPIEN type
valves (n=10, 21.8%). The re-do TAVR device was most commonly a CoreValve
(n=28, 60.9%), followed by a SAPIEN type valve (n=17, 37.1%), or a Boston
Lotus valve (n=1, 2.2%). In 37 patients (80.4%), re-do TAVR was performed
using the identical device type or that of the succeeding generation.
Valve performance was uniformly good following re-do TAVR (mean
transvalvular gradient post re-do TAVR: 12.5+/-6.1 mmHg). At hospital
discharge all patients remained alive, with one non-disabling stroke
(2.2%) and one life-threatening bleed (2.2%). Permanent pacemaker
implantation was required in 3 out of 31 patients without a prior
pacemaker (9.7%). Late survival was 84.2% at a median follow-up of 1,589
days (range: 31 to 3,775) after index TAVR and 635 days (range: 8 to
2,460) after re-do TAVR. Conclusions: Re-do TAVR for the treatment of
post-procedural and late transcatheter aortic valve prosthesis failure is
safe and associated with favorable acute and midterm clinical and
echocardiographic outcomes.

<39>
Accession Number
611935303
Author
Rodriguez V.; Esteban M.I.; Rodriguez R.
Institution
(Rodriguez, Esteban, Rodriguez) Hospital Clinico San Carlos, Madrid, Spain
Title
Prospective study of peripheral vascular events and one-month follow-up in
patients who have undergone transfemoral aortic valve replacement.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 327), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We present the first anatomophysiological study that observe
transaortic valve implantation (TAVI) patients before, during and one
month after TAVI. Methods and results: This was a prospective,
observational monocentric, cohorts, single-blind study of 106 consecutive
patients between September 2010 and December 2012. Seventy-nine (79) met
the inclusion criteria but only 49 completed the study. TAVI was performed
entirely by the percutaneous approach in all cases: 12 patients (25%) had
vascular complications, 7 patients (14%) needed a vascular graft stent and
no patient underwent surgery after TAVI. The minimal luminal diameter
(MLD) decreased from 6.43+1.2mm (preprocedure) to 5.82+1.4mm
(post-procedure) and the minimal luminal area (MLA) decreased from 34+13
mm² (pre- procedure) to 28+14 mm 2 (post-procedure). There were
no significative statistical differences in the noninvasive inferior limb
physiological study performed before and 1 month after TAVI. Conclusions:
Patients undergoing TAVI have an average decrease of 1mm at the MLD and
6mm² at the MLA in the artery where the large diameter sheath
is placed. However, this luminal loss does not imply peripheric arterial
flow compromise.

<40>
Accession Number
611935281
Author
Testa L.; De Backer O.; Raban J.; Van Boven A.; Jimenez J.; De Jaegere P.;
Brambilla N.; Bedogni F.
Institution
(Testa, Brambilla, Bedogni) Irccs Pol. S. Donato, Milan, Italy
(De Backer) Rigshospitalet, Copenhagen, Denmark
(Raban) Universitatsspital Basel, Basel, Switzerland
(Van Boven) Medisch Centrum Leeuwarden, Leeuwarden, Netherlands
(Jimenez) Hjrj, Huelva, Spain
(De Jaegere) Erasmus mc, Rotterdam, Netherlands
Title
Transcatheter valve-in-valve implantation using the Portico system: A
multicentre registry.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 373), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We sought to evaluate the safety/efficacy profile of the Portico
system in patients undergoing TAVI for failed aortic bioprostheses.
Methods and results: Portico system implantation was performed in 24
high-risk patients with a failed bioprosthesis. General anesthaesia was
chosen in 5 cases (21%). Mean age was 83.14+/-4.86. NYHA Class III/IV was
present in 16 pts (66%). Logistic EuroSCORE was 31.1+/-16.46%. Ejection
fraction was 57.64+/-11.65. Fourteen degenerated bioprostheses were
"stented". Patients/prostheses were divided into type A (mainly stenotic,
10 pts), and type B (mainly regurgitant, 14 pts). Implantation success
rate was 100%. Mean aortic gradient in group A decreased from 47.5+/-10
mmHg to 12+/-4 mmHg. In all but one patient in group B, PVL was >1. NYHA
class improved in all patients. No patients died during the procedure. Two
patients died in hospital (8%). Two myocardial infarction (8%), and 2 (8%)
complete AV blocks requiring a pacemaker implantation were observed in
hospital. No major bleedings or coronary obstruction occurred.
Conclusions: Portico system implantation was feasible, with excellent
procedural success and a considerable survival rate. These findings
support the use of this second-generation retrievable and repositionable
transcatheter bioprosthesis in patients with a failed surgical
bioprosthesis deemed at a prohibitive risk for surgical re-do.

<41>
Accession Number
611935277
Author
Kinnaird T.; Kwok C.S.; Narain A.; Butler R.; Ossei-Gerning N.; Ludman P.;
Moat N.; Anderson R.; Mamas M.
Institution
(Kinnaird, Ossei-Gerning, Anderson) University Hospital of wales, Cardiff,
United Kingdom
(Kwok, Butler, Mamas) University Hospital of North Midlands,
Stoke-on-trent, United Kingdom
(Narain) Cardiovascular Research Group, Keele University, Stoke-on-trent,
United Kingdom
(Ludman) Queen Elizabeth Hospital, Birmingham, United Kingdom
(Moat) Royal Brompton Hospital, London, United Kingdom
Title
PCI with DES versus CABG for isolated proximal left anterior descending
coronary disease: A systematic review and meta-analysis.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 223), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The optimal revascularisation strategy for patients with isolated
LAD disease remains uncertain. We performed a meta-analysis of the data
comparing the efficacy and safety of CABG against PCI-DES among patients
with isolated proximal LAD disease. Methods and results: We searched
MEDLINE and EMBASE using the search terms: (drug eluting stent or DES or
percutaneous coronary intervention or PCI) AND (bypass or coronary artery
bypass graft or CABG or left internal mammary artery or LIMA) AND (left
anterior descending or LAD). We excluded studies that had multivessel
disease or where PCI was undertaken using bare metal stents. Data analysis
was performed using Review Manager (Version 5.3.3; Nordic Cochrane Centre,
Copenhagen, Denmark 2014) to perform random effects meta-analysis using a
generic inverse variance method. Analysis was stratified by whether the
analysis used adjustment for potential confounders or propensity score
matching or the studies were unadjusted. Our search yielded 1,617 relevant
articles with 13 articles meeting the inclusion criteria (4 randomised
trials and 9 cohort studies) with the largest RRCT enrolling a total of
189 patients. There was a total of 5,565 participants (range 80 to 1,430)
with an average age of 63 years and 72% were male. There was a total of
120 deaths among 2,416 participants (5.0%) who received PCI with DES and
127 deaths among 2,721 participants (4.7%) who received CABG from 10
studies. The pooled results suggest no significant difference in mortality
comparing DES to CABG for both adjusted and unadjusted results. For MACE,
DES was associated with significant increase in adverse events after
adjustments (RR 1.70, 95% CI: 1.10-2.61, 5 studies, 2,956 participants)
and overall (RR 1.49, 95% CI: 1.12-1.97, 10 studies, 4,751 participants).
For myocardial infarction, treatment with PCI and DES had 23 events among
1,047 participants (2.2%) while patients who received CABG had 29 events
in 869 participants (3.3%). The pooled results suggested no significant
difference with adjustments (RR 3.97, 95% CI: 0.43-37.95, 1 study, 350
participants) and without adjustments (RR 0.82, 95% CI: 0.55-1.21, 6
studies, 1,566 participants) and overall (RR 0.86, 95% CI: 0.58-1.26, 7
studies, 1,916 participants). There was a total of 290 TVR events among
2,531 participants in the PCI with DES group (11%), and a total of 147 TVR
events among 2,940 participants in the CABG group (3.9%). The pooled
results of PCI with DES were associated with significant increases in TVR
for both adjusted (RR 3.70, 95% CI: 1.74-7.83, 2,531 participants),
unadjusted (RR 2.44, 95% CI: 1.21-4.89, 2,940 participants) and overall
results (RR 2.85, 95% CI: 1.85-4.40, 5,471 participants) compared to CABG.
For stroke events, there were 2 studies with 9 events in 225 participants
in the PCI with DES group (4%) and 6 events in 329 participants in the
CABG group (2%). The pooled results suggest no significant difference for
adjusted, unadjusted and overall results. Conclusions: For patients with
isolated disease of the LAD, meta-analysis of the available data suggests
revascularisation with a PCI-DES strategy offers similar mortality, MI and
stroke rates to CABG at the expense of increased TVR. More randomised
trials are needed.

<42>
Accession Number
611935269
Author
Jensen C.; Wolf A.; Schmitz T.; Schmidt T.; Frerker C.; Thielsen T.;
Schafer U.; Schofer N.; Deuschl F.; Frambach P.; Wagner D.; Kaiser C.;
Jeger R.; Paker E.; Romero M.; Ladich E.; Virmani R.; Naber C.
Institution
(Jensen, Wolf, Schmitz, Naber) Contilia Heart and Vascular Center,
Elisabeth Hospital, Essen, Germany
(Schmidt, Frerker, Thielsen) Department of Cardiology, AK St. Georg
Hospital, Hamburg, Germany
(Schafer, Schofer, Deuschl) Division of Cardiology, University Heart
Center Eppendorf, Hamburg, Germany
(Frambach, Wagner) Institut National De Chirurgie Cardiaque Et De
Cardiologie Interventionnelle, Luxembourg, Luxembourg
(Kaiser, Jeger) Division of Cardiology, University of Basel, Basel,
Switzerland
(Paker) Haukeland Clinic, Bergen, Norway
(Romero, Ladich, Virmani) CV Path Institute,Inc., Gaithersburg, United
States
Title
Prevalance and etiopathology of thromboembolic debris during transcather
interventional aortic valve replacement: Preliminary results of the
SENTINEL H-study.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 348), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Aim of this study was to analyse the prevalence and etiopathology of
captured debris using a dual-filter cerebral protection system in clinical
real-life patients undergoing transcatheter aortic valve replacement
(TAVR). Methods and results: This is a prospective, multicentre, all-comer
study including patients with severe symptomatic aortic stenosis
undergoing TAVR with the use of a dual filter-based cerebral protection
system (Sentinel Cerebral Protection System, Claret Medical, Inc., Santa
Rosa, CA, USA). In all, 225 patients (mean 83.7 years) from 6 European
sites were included. Main vascular access site for TAVR was femoral (98%).
In 214 patients (95%), the dual-filter device was successfully delivered,
with additional 4 patients in whom devices were delivered partially. In
one patient radial artery dissection (0.4%) occurred during device
introduction. No serious adverse events occurred due to device delivery.
In this abstract the contents of 219 different filters (111 proximal and
108 distal) from 111 of the early patients were analyzed by CVPath
Institute. 99% of patients showed embolic debris, which was equally
distributed over the proximal (93%) and distal (93%) filters. Acute
thrombus was the most commonly captured tissue (in 95% of patients),
though it was most commonly found in combination with tissue or foreign
material (in 83% of patients), including arterial wall fragments (59%),
valve tissue (57%), foreign material (43%), calcifications (42%), and
organising thrombi (40%). Myocardium fibers, tissue of unknown origin, and
necrotic core were observed in the filters of a minority of patients (8%,
7% and 5 %, respectively). Conclusions: In clinical real-life a
dual-filter cerebral protection system can be successfully and safely
deployed in the vast majority of patients undergoing TAVR. In almost all
analysed patients cerebral embolic debris was captured by these filters.
The relatively high prevalence of periprocedural captured foreign bodies
is surprising and might indicate the need for improvement of the material
involved during TAVR.

<43>
Accession Number
611935268
Author
Kalra S.S.; Firoozi S.; Blackman D.; Rashid S.; Davies S.; Moat N.; Yeh
J.; Dalby M.; Kabir T.; Khogali S.S.; Anderson R.A.; Groves P.H.; Mylotte
D.; Hildick-Smith D.; Rampat R.; Kovac J.; Gunarathne A.; Laborde J.-C.;
Brecker S.J.
Institution
(Kalra, Firoozi, Laborde, Brecker) St. George's Hospital, London, United
Kingdom
(Blackman, Rashid) Leeds General Infirmary, Leeds, United Kingdom
(Davies, Moat, Yeh) Royal Brompton Hospital, London, United Kingdom
(Dalby, Kabir) Harefield Hospital, London, United Kingdom
(Khogali) New cross Hospital, Wolverhamptom, United Kingdom
(Anderson, Groves) University Hospital Wales, Cardiff, United Kingdom
(Mylotte) University Hospital Galway, Galway, Ireland
(Hildick-Smith, Rampat) Royal Sussex County Hospital, Brighton, United
Kingdom
(Kovac, Gunarathne) Glenfield Hospital, Leicester, United Kingdom
Title
Initial experience of a second-generation self-expanding transcatheter
aortic valve: The United Kingdom and Ireland IMPLANTERS registry.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 326), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The Medtronic CoreValve Evolut TM R (Medtronic, Minnesota,USA) is a
self-expanding, recapturable and repositionable second generation
transcatheter aortic valve prosthesis. We report initial results of the UK
& Ireland EvolutTM R Implanters" Registry. Methods and results:
Prospective clinical, procedural and outcome data were collected for 240
patients across 9 implantation centres in the UK and Ireland. This
represented the initial and learning curve experience with this novel
device. Clinical characteristics: Mean age was 81.0 +/- 8.7 years, 37.7%
male. Mean logistic EuroSCOREe was 19.6 +/- 13.5% and mean Society of
Thoracic Surgeons Score was 5.9 +/- 5.6%. The indications for TAVI
included aortic stenosis (n=170, 70.8%), mixed aortic valve disease (n=44,
18.4%) and failing bioprosthesis (n=26, 10.8%). 84.1% of the cases were
performed electively. Pre-procedural computed tomography was performed in
92.9% of patients. Procedural Characteristics: 42.5% of implants were
undertaken using conscious sedation with transfemoral access in 94.2% (219
percutaneous, 7 surgical cut-down) and subclavian access in 5.8%. In the
226 transfemoral cases, the 14F InLineTM Sheath only was used in 64.5% and
in 35.5% of cases an 18F Sheath was used as well. In the 219 percutaneous
transfemoral cases, dedicated femoral closure devices (ProGlide [Abbott
Vascular, Abbott Park, Il, USA] or Prostar [Abbott Vascular]) were used
for haemostasis 94.1% of the time. Initial balloon aortic valvuloplasty
was performed in 27.9% of cases. All 3 device sizes were used: 23mm (n=47,
19.6%), 26mm (n=70, 29.2%) and 29mm (n=123, 51.2%). The valve was
successfully deployed in 98.8% of cases based on VARC-2 (Valve Academic
Research Consortium 2) criteria. Valve repositioning was undertaken in
22.8% and valve retrieval (full recapture) in 16.3% of patients.
Post-deployment balloon dilatation was required in 20.8% of patients. Mean
procedural time was 135.3 +/- 60.0 minutes. Outcome: 30-day survival of
this cohort was 97.9% and 30-day stroke rate (both major and minor) was
3.5%. Paravalvular leak (PVL) at the end of the procedure was mild or less
in 91.3% of cases. 30 day PVL rates will be presented. Major vascular
complications occurred in 7.1%. Permanent pacemaker implantation was
required in 12.1% at a mean 3.7 +/- 3.1 days post-procedure. Acute kidney
injury occurred in 10 (4.2%) patients with 2 (0.8%) of these patients
requiring new renal replacement therapy. Conclusions: The Medtronic
CoreValve EvolutTM R provides several technical advantages on first
generation transcatheter aortic valve prostheses. We report the largest
real-world registry to date, of this device. The low rates of mortality,
stroke, PVL and permanent pacemaker rates observed in the CE Mark Trial
appear reproducible in real-world practice.

<44>
Accession Number
611935264
Author
Sotomi Y.; Cavalcante R.; Ahn J.-M.; Lee C.W.; Winter R.J.D.; Wykrzykowska
J.J.; Onuma Y.; Park S.-J.; Serruys P.W.
Institution
(Sotomi, Winter, Wykrzykowska) Academic Medical Center, University of
Amsterdam, Amsterdam, Netherlands
(Cavalcante, Onuma) Thoraxcenter, Erasmus Medical Center, Rotterdam,
Netherlands
(Ahn, Lee, Park) Heart Institute, University of Ulsan, Asan Medical
Center, Seoul, South Korea
(Serruys) International Centre for Circulatory Health, NHLI, Imperial
College London, London, United Kingdom
Title
Gender difference of five-year clinical outcomes following coronary artery
bypass surgery vs. DES implantation: Analysis of pooled data from SYNTAX,
BEST, and PRECOMBAT randomised controlled trials.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 249), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: This study assessed gender differences in 5-year outcomes between
coronary artery bypass grafting (CABG) and percutaneous coronary
intervention (PCI) in pooled data from the SYNTAX, BEST, and PRECOMBAT
randomised controlled trials. Methods and results: SYNTAX, BEST, and
PRECOMBAT trials are prospective, multinational randomised controlled
trials. Patients amenable for equivalent revascularisation using either
treatment option were randomised 1:1 to PCI with drug-eluting stents
(paclitaxel-, sirolimus-, or everolimus-eluting stents) or CABG. The
primary endpoint of this study was the 5-year occurrence of MACCE, a
composite of all-cause death, myocardial infarction, stroke or repeat
revascularisation. A total of 3,280 patients were randomised, of whom 794
(24.2%) were female. Median follow-up duration was 1,800 days. Although
the baseline characteristics were well matched between the treatment
groups, females were older, had higher EuroSCORE, lower creatinine
clearance, and higher prevalence of hypertension and diabetes than males.
Similar to males, the 5-year MACCE rate in females was significantly
higher in the PCI arm than in the CABG arm (female, 31.2% vs. 21.6%,
hazard ratio [HR] [95% confidence interval (CI)] 1.43 [1.16-2.05],
p=0.003; male, 28.9% vs. 21.5%, HR [95% CI] 1.41 [1.20-1.65], p<0.001),
which was mainly driven by higher rates of myocardial infarction and
repeat revascularisation. In the CABG arm, compared with males, females
had similar MACCE (log-rank test, p=0.98), similar all-cause mortality
(p=0.72) and a worse stroke rate (p=0.04), while in the PCI arm, females
had similar MACCE (p=0.36), worse all-cause mortality (p=0.06), and a
similar stroke rate (p=0.50). The risk of repeat revascularisation for PCI
compared with CABG was higher in females than in males (female, HR [95%
CI] 2.73 [1.78-4.19], p<0.001; male, HR [95% CI] 1.86 [1.49-2.31],
p<0.001). Conclusions: In the most challenging group of patients with
multivessel and/or left main disease in the pooled data, relative
differences in MACCE between CABG and PCI at 5 years were similar for male
and female patients despite gender-related differences in baseline
comorbidity. However, female gender negatively affected all-cause
mortality in PCI and stroke in CABG.

<45>
Accession Number
611935259
Author
Hiltrop N.; Bennett J.; Adriaenssens T.; Herijgers P.; Desmet W.
Institution
(Hiltrop, Bennett, Adriaenssens, Herijgers, Desmet) University Hospitals
Leuven, Leuven, Belgium
Title
Circumflex coronary artery injury after mitral valve surgery: A
comprehensive review of the literature.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 400), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Since the left circumflex coronary artery (LCx) is closely related
to the mitral valve annulus, it is susceptible to perioperative injury.
Disagreement exists regarding underlying mechanisms, predisposing factors
and therapeutic strategies. Methods and results: Using a MeSH terms-based
PubMed search, 44 cases of mitral valve surgery related to LCx injury were
detected. We performed a comprehensive analysis of available literature,
investigating mitral valve surgery related to LCx injury. Mitral valve
surgery related to coronary artery injury has a reported frequency of 0.5%
to 1.8%, occurring after mitral valve replacement as well as mitral valve
annuloplasty. In 70% (n=31) of cases providing details on gender, 68% were
male (n=21). Findings from preoperative coronary angiography were reported
in 55% (n=24) of all published cases, of which 79% (n=19) had normal
preoperative coronary angiograms. Coronary abnormalities were present in
11% (n=5), with all 5 patients having an anomalous LCx originating from
the right coronary cusp, compared to a reported incidence of 0.67% in
diagnostic coronary angiographies. Coronary dominance was reported in 73%
(n=32), predominantly showing left (69%, n=22) or balanced (19%, n=6)
circulations. Right coronary dominance was present in 12% (n=4).
Information regarding time of onset of ischaemia and diagnosis was
available in 80% of patients (n=35). Myocardial compromise was diagnosed
early in 86% (n=30), either perioperatively in 37% (n=11) or during the
very first hours of the postoperative phase in 63% (n=19), most frequently
during cardiopulmonary bypass weaning. Delayed symptoms were present in
14% (n=5). Echocardiography demonstrated new regional wall motion
abnormalities in 80% (n=24), but was negative in 20% (n=6) despite
coronary compromise. Use of echocardiography and its potential findings
was not reported in 32% of patients (n=14), leaving an opportunity for
improving perioperative care in mitral valve surgery patients.
Electrocardiography showed myocardial ischaemia in 97% (n=34), including
regional ST-segment elevations in 68% (n=23). Alongside myocardial
ischaemia, a variety of arrhythmias have also been reported in association
with mitral valve surgery related to LCx injury. Various mechanisms
explaining coronary injury have been postulated, including arterial
entrapment with a fixation suture, obliteration of the artery caused by a
suture passing through, coronary perforation, thrombotic occlusion and
vascular distortion caused by tissue retraction. Therapeutic options after
prompt diagnosis consist of surgical or percutaneous treatment, depending
on patient and lesion specific characteristics. Primary treatment was
surgical in 42% (n=15) and percutaneous in 58% (n=21), reporting success
rates of 87% (n=13) and 81% (n=17), respectively. These favourable results
should however be interpreted with care since this could represent
publication bias. Conclusions: We confirm an augmented risk of mitral
valve surgery related to LCx injury in balanced or left-dominant coronary
circulations. Preoperative knowledge of coronary anatomy is useful as a
preventive measure to identify true high-risk patients, although right
coronary dominance does not preclude LCx injury. An anomalous LCx arising
from the right coronary cusp was identified as a possible specific
high-risk entity. Electrocardiographic monitoring and intraoperative
echocardiography remain paramount to ensure timely diagnosis and
treatment.

<46>
Accession Number
611935257
Author
Worthley S.; Walther T.; Mollmann H.; Linke A.; Holzhey D.; Manoharan G.
Institution
(Worthley) Royal Adelaide Hospital, Adelaide, Australia
(Walther, Mollmann) Kerckhoff-Klinik, Bad Nauheim, Germany
(Linke, Holzhey) Herzzentrum Leipzig, Leipzig, Germany
(Manoharan) Royal Victoria Hospital, Belfast, United Kingdom
Title
Multicentre clinical study evaluating a novel self-expanding and
resheathable transcatheter aortic valve system six-month results.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 347), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Limitations due to the lack of repositioning are still obvious for
first generation TAVI systems. We evaluated the multicentre outcomes of
the self-expanding, resheathable PorticoTM (St. Jude Medical) TAVI system.
Methods and results: Between March 2012 and September 2015, 222 TAVI
patients were enrolled and 220 implanted at 12 sites in the UK, Germany,
Netherlands, Denmark and Australia using the 18 Fr and 19 Fr Portico
systems (23mm, 25mm, 27mm or 29mm valves). Two patients are considered
procedurally excluded because they did not receive a Portico valve and per
protocol were followed for 30 days. The remaining patients will be
followed for 12 months. Adverse events were categorised by VARC I
definitions and adjudicated by an independent events committee.
Echocardiography was evaluated by an independent laboratory. The Portico
TAVI system was successfully implanted in 220 patients (74.0% Female; Mean
age=83+/-4.6; STS Score=5.8+/-3.3, Aortic valve area 0.7+/-0.2cm 2 ).
Resheathing and repositioning was performed in 33% of the procedures and
was successful in all instances. Average depth of implant into LVOT was
6.1+/-2.2mm. The collective 6-month results are presented for the first
time in this abstract. At 6 months haemodynamic function maintained
improvement from pre-procedure baseline values. Mean Aortic Valve Area
increased from 0.7+/-0.2 to 1.7+/-0.4 cm2 and mean gradient improved from
43.4+/-14.6 to 8.2+/-3.3 mmHg. Paravalvular leak at 6-months was
absent/trace in 41%, mild in 56.8%, moderate in 2.2% and severe in 0%,
respectively. There was a significant improvement (p<.0001) from baseline
to 6-months in NYHA functional status. The majority of VARC I defined
event rates observed in the trial occurred within the first 30 days of
implant and were generally low. Mortality was 3.6 % and 8.6% at 30 days
and 6 months, respectively. Disabling stroke was observed in 3.2% and 4.1%
of patients at 30 days and 6 months. Thirty patients (13.5%) required new
onset pacemaker implantation at 30 days with one additional patient
receiving a pacemaker through 6 months (14%). There was no significant
difference in the safety profile of those patients who had a
resheath/repositioning of the device. Conclusions: The self-expanding
PorticoTM TAVI system allows for safe resheathing, repositioning and
optimisation of the device position in elderly and high risk patients. The
functional and symptomatic outcomes appear to support the efficacy and
safety of the device through 6 months.

<47>
Accession Number
611935256
Author
Fiorina C.; Bruschi G.; De Carlo M.; De Marco F.; Coletti G.; Bonardelli
S.; Adamo M.; Curello S.; Scioti G.; Panisi P.; Bedogni F.; Petronio A.S.;
Ettori F.
Institution
(Fiorina, Coletti, Bonardelli, Adamo, Curello, Ettori) Spedali Civili,
Brescia, Italy
(Bruschi) Niguarda CA' Granda Hospital, Milan, Italy
(De Carlo, Scioti, Petronio) Azienda Ospedaliera Universitaria Pisana,
Pisa, Italy
(De Marco, Panisi, Bedogni) Irccs Policlinico San Donato, Milan, Italy
Title
Transaxillary vs. transaortic approach for TAVI with the corevalve
revalving system: Insights from a multicentre experience.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 421), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To evaluate the impact on procedural and clinical outcomes of
transaxillary (TAx) compared to transaortic (TAo) access for transcatheter
aortic valve implantation (TAVI) with the Medtronic CoreValve Revalving
System (CRS). Methods and results: All consecutive patients who underwent
TAVI with CRS treated in 4 high-volume Italian centres were analysed.
Device success, and safety and efficacy endpoints according to VARC-2
criteria were evaluated. Among 1,049 patients undergoing CRS implantation
between September 2007 and February 2014, 242 (23%) were treated through
the TAx (61%) and TAo (39%) routes because of peripheral artery disease.
Demographic features were similar, except for a higher clinical risk
profile (STS-PROM: 10% vs. 6%, p=0.005) and previous CABG (20% vs. 9%,
p=0.011) in the TAo group. Device success was similar (p=0.16) with a
trend towards a lower incidence of significant paravalvular leak (6% vs.
14%, p=0.07) and a significant reduction of permanent pacemaker (PPM)
implantation (13% vs. 34%, p=0.017) in the TAo group. The 30-day all-cause
mortality rate was similar in both (p=0.2), as well as the survival rate
at 1 year of follow-up (83% vs. 85.3% for TAx vs. TAo; p=0.7). Conversely,
the TAo group showed a higher incidence of acute kidney injury (p=0.016)
and a longer hospital stay after the index procedure (10 days [8-14] vs. 8
[7-12], p=0.001), mostly due to sternal complications or specific thoracic
complications (pneumonia, pleural effusion) requiring specialised
postoperative care. By multivariate analysis the vascular access was not
an independent predictor for 30-day mortality (OR 1.5, 95% CI: 0.3-7;
p=0.7); it is an independent predictor for a longer hospital stay (TAo
route; OR 0.37, 95% CI: 0.18-0.75; p=0.006) and for PPM implantation after
the procedure (TAx route; OR 3.7, 95% CI: 1.2-10.8; p=0.017). Conclusions:
Although there was a higher clinical risk profile in the transaortic
population, the TAo approach showed an equally high device success with
similar safety and efficacy, compared to the TAx route. However, due to
non-procedure-specific complications requiring specialised postoperative
care, the TAo route should be considered as a third choice for vascular
access, after ruling out the feasibility of both the transfemoral and
transaxillary approaches.

<48>
Accession Number
611935236
Author
Moura-Ferreira S.; Silva M.; Dias T.; Guerreiro C.; Caeiro D.; Dias A.;
Ponte M.; Braga P.; Rodrigues A.; Pelicano N.; Vouga L.; Gama V.
Institution
(Moura-Ferreira, Pelicano) Hospital Do Divino Espirito Santo De Ponta
Delgada, Ponta Delgada, Portugal
(Silva, Dias, Guerreiro, Caeiro, Dias, Ponte, Braga, Rodrigues, Vouga,
Gama) Centro Hospitalar De Vila Nova De Gaia Espinho, Vila Nova De Gaia
Espinho, Portugal
Title
Predictors of all-cause mortality during follow-up after non-emergent CABG
surgery or PCI due to left main coronary artery disease.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 47), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: The aim of this study was to report long-term all-cause mortality
after non-emergent coronary artery bypass Ggraft (CABG) surgery or
percutaneous coronary intervention (PCI) due to left main coronary artery
(LMCA) disease. Methods and results: Retrospective, observational study
including all patients submitted to non-emergent CABG surgery or PCI in
our centre, due to significant unprotected LMCA disease detected
angiographically, between January 2008 and September 2015. Information
regarding baseline characteristics, past and present medical history,
motive for CABG or PCI, type of procedure performed and localisation of
the lesion in LMCA (distal vs. non-distal lesion) was retrospectively
collected. All patients were followed-up and all-cause mortality was
assessed. Of these, 289 patients (81.7% male; mean age 65.6+/-11.2 years
old; mean EuroSCORE II [ESII] 3.6+/-5.8), including those with stable
angina (22.8%), unstable angina (43.8%), acute non-ST-segment elevation
myocardial infarction (33%) were analysed. Of these, 226 (78.2%) patients
were submitted to CABG surgery and 204 patients (70.6%) had significant
distal LMCA disease. At a median follow-up period of 1095 days, follow-up
all-cause mortality rate was 11.8%. The prevalence of most cardiovascular
risk factors was not statistically different between the group of patients
that died and the group of patients that survived during the follow-up
period. However, PCI procedure, non-distal LMCA and ESII was significantly
associated with the primary endpoint (p<0.01). However, after preforming a
multivariate regression analysis, only ESII remained associated with the
primary endpoint (95% CI 0.80-0.94 p<0.01). After preforming a receiver
operating characteristics (ROC) curve, we found that AUC for ESII was
0.823 (95% CI 0.73-0.92 p<0.01), which yield a good discriminate power.
The best cut-off point for ESII was 5.97 (sensitivity 86.4% and
specificity 76.9%). In a binary logistic regression model, an ESII equal
or above 5.97 was associated with 18 times increase in the probability of
dying during follow-up. Conclusions: Our study demonstrated that, in this
population, ESII is a strong and independent predictor of all-cause
mortality during follow-up after non-emergent CABG surgery or PCI due to
unprotected LMCA disease. Randomised controlled clinical trials including
a larger number of patients are needed to validate ESII as a predictor of
all-cause mortality in these patients.

<49>
Accession Number
611935235
Author
Codner P.; Levi A.; Gargiulo G.; Praz F.; Hayashida K.; Masalha A.;
Watanabe Y.; Mylotte D.; Debry N.; Barbanti M.; Lefevre T.; Modine T.;
Bosmans J.; Windecker S.; Barbash I.; Sinning J.-M.; Nickenig G.;
Barsheshet A.; Kornowski R.
Institution
(Codner, Levi, Masalha, Barsheshet, Kornowski) Rabin Medical Center, Petah
Tikva, Israel
(Gargiulo) Federico II University of Naples, Naples, Italy
(Praz, Windecker) Inselspital University Hospital, Bern, Switzerland
(Hayashida) Keio University Hospital, Keio, Japan
(Watanabe, Lefevre) Institute Cardiovasculaire Paris Sud, Paris, France
(Mylotte) Galway University Hospital, Galway, Ireland
(Debry, Modine) Cardiology Department, Chru, Lille, France
(Barbanti) Ferrarotto Hospital, Catania, Italy
(Bosmans) University Hospital, Antwerp, Belgium
(Barbash) Sheba Medical Center, Ramat Gan, Israel
(Sinning, Nickenig) Bonn University Hospital, Bonn, Germany
Title
Impact of renal dysfunction on transcatheter aortic valve replacement
outcome in a large multicentre cohort.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 347), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We evaluated outcomes within a large cohort of patients undergoing
TAVR distinguished by renal function.The potential impact of chronic renal
disease on TAVR prognosis is not fully understood and these patients were
excluded from randomised trials. Methods and results: Baseline
characteristics, procedural data and clinical follow-up findings were
collected from 10 high-volume TAVR centres in Europe, Israel and Japan.
Data was analysed according to renal function. Patients (n=1204) were
divided into 4 groups according to pre-TAVR estimated glomerular
filtration rate (eGFR): group I (eGFR >60) n=288 (female 45%), group II
(eGFR 31-60) n=452 (female 61%), group III (eGFR <30) n=398 (female 61%)
and group IV (dialysis) n=66 (female 31%). Mean age was 78+/-7, 82+/-5,
84+/-5 and 76+/-7 years old for patients in group I, II, III and IV;
respectively (p<0.001). Mean Society of Thoracic Surgeons (STS) score was
higher in patients with lower pre-procedural eGFR: 5.4% (3.7-7.1) in group
I; 6.0% (4.3-9.0) in group II; 8.8% (6.0-12.6) in group III; and 10.1%
(7.7-16.0) in group IV; (p <0.001). All-cause mortality at 1-year was
higher in patients with lower eGFR (9.0%, 12.1%, 24.3%, 24.2% for group I,
II, III and IV; respectively, p <0.001). Multivariate analysis
demonstrated that eGFR <30, but not eGFR 31-60, was associated with
increased risk of death (OR 3), bleeding (OR 5.2) and device implantation
failure (HR 2.28). For each 10-mL/min decrease in eGFR, there was an
associated relative increase in the risk of death (35%; p<0.001),
cardiovascular death (14%;p=0.018), major bleeding 35% (p<0.001), and
transcatheter valve failure (16%;p=0.007). Renal dysfunction was not
associated with stroke or requirement for pacemaker implantation
Conclusions: Among patients undergoing TAVR, baseline renal dysfunction is
an important independent predictor of morbidity and mortality.

<50>
Accession Number
611935229
Author
Brecker S.; Bleiziffer S.; Bosmans J.; Gerckens U.; Wenaweser P.;
Tamburino C.; Linke A.
Institution
(Brecker) St. George's Hospital, London, United Kingdom
(Bleiziffer) German Heart Center, Munich, Germany
(Bosmans) University Hospital Antwerp, Antwerp, Belgium
(Gerckens) Gemeinschaftskrankenhaus Bonn, Bonn, Germany
(Wenaweser) University Hospital Bern, Bern, Switzerland
(Tamburino) Ferrarotto Hospital, University Of Catania, Catania, Italy
(Linke) University of Leipzig Heart Center, Leipzig, Germany
Title
Four-year clinical and echocardiographic follow-up of aortic stenosis
patients implanted with a self-expanding bioprosthesis.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 421), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Longer-term durability data of TAVI in large cohorts are required
before expanding this therapy to lower-risk cohorts. ADVANCE is a
multicentre real-world study which evaluated outcomes after self-expanding
TAVI. Four-year data are now presented. Methods and results: The ADVANCE
study is a fully monitored, multicentre "real-world" study conducted in
highly experienced centres, which evaluated outcomes following
implantation of a self-expanding transcatheter aortic valve system. The
study enrolled 1,015 "real-world" patients with severe aortic stenosis who
underwent femoral, subclavian or direct aortic implantation of the
CoreValve device at 44 centres in Western Europe, Asia and South America.
Baseline characteristics include mean age 81.1+/-6.4 years, 51% female,
and log EuroSCORE 19.4+/-12.3%. The primary endpoint was a composite of
major adverse cardiac and cerebrovascular events (MACCE). Patients were
followed by annual visits and echocardiographic investigations.
Endpoint-related events were adjudicated according to VARC-1 definitions
by an independent clinical events committee. All-cause mortality at 4
years was 41.5%, cardiovascular mortality was 27.3%, and the stroke rate
was 8.5%. All-cause mortality was 31.7%, 41.6%, and 47.6% in patients with
a EuroSCORE <10%, >10-20%, and >20%, respectively, and hence associated
with the preoperative risk profile of the patients (p<0.01). Although
26.5% of the patients received a new pacemaker up to 30 days after TAVI,
this had no impact on 4-year mortality (39.2% with pacemaker vs. 42.3%
without pacemaker, p=0.45). There was a significant improvement in New
York Heart Association (NYHA) symptom status early after implantation of
the valve, which was persistently evident at 4 years after the procedure.
Implantation of the CoreValve led to a significant improvement in valve
haemodynamics. Haemodynamics remained consistent to 4 years, including the
effective aortic valve orifice area (1.8+/-0.5 cm2) and mean aortic
gradient (8.3+/-4.0 mmHg). Aortic regurgitation grade remained relatively
unchanged over time (30 days none/trace, mild, moderate/severe:
21.5%/64.1%/14.3% and at 4 years none/trace, mild, moderate/severe:
39.0%/48.2%/12.8%). Conclusions: ADVANCE, which was conducted on a
"real-world" TAVI population, is the largest study to demonstrate
sustained valve haemodynamics at 4 years after the procedure. Especially
patients with an extreme preoperative risk profile (ES >20) showed a
remarkably high survival rate at 4 years, as the other cohorts did in the
presence of low stroke and complication rates. These longer-term results -
especially regarding valve durability - are consistent with the notion
that TAVI is a safe, durable therapy.

<51>
Accession Number
611935223
Author
Talamali A.; Feliachi S.; Makhdoul I.
Institution
(Talamali, Feliachi, Makhdoul) Hopital Central De l'armee, Algers, Algeria
Title
Stress hyperglycaemia in the acute phase of a STEMI: A residual risk in
the era of primary angioplasty?.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 222), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To compare the impact of admission hyperglycaemia in STEMI on
in-hospital mortality in patients undergoing primary angioplasty to those
with no reperfusion therapy. Methods and results: A prospective,
multicentre study with a recruitment of 1,222 consecutive patients without
a prior history of diabetes and HbA1c <6.5% in the first 24 hours of
STEMI. The average age of the population was 60.28+/-13 yrs, the mean
glycaemia on admission was 1.39+/-0.333 g/l, 56.2% of the patients
benefited from early coronary reperfusion, and the in-hospital mortality
was 7.2%. The results showed a linear correlation between the level of
glycaemia on admission and in-hospital mortality: an increase of 10 mg/l
of serum glucose was associated with an increased mortality of 2.6%
(2.0-3.3), p<0.001. The mortality was higher in the population of patients
who did not receive any reperfusion therapy, 12.2% versus 3.3% (p<0.001).
However, the impact of glycaemia on admission seems more important in the
population of reperfused patients (adjusted OR 5.2 [1.5-17.5], p=0.008,
versus adjusted OR 2.7 [1.3-5.38], p=0.005). Conclusions: Hyperglycaemia
on admission is an independent predictive factor of short-term mortality
in non-diabetic patients during the acute phase of STEMI. Its impact is
more important in patients who benefit from a revascularisation therapy at
an early stage.

<52>
Accession Number
611935210
Author
Jimenez Mazuecos J.; Cordoba Soriano J.G.; Diaz Fernandez J.F.; Perez
Santigosa P.; Botas J.; Herrero Garibi J.; Lazaro Garcia R.; Roa Garrido
J.; Sanchez Burguillos F.J.; Hernando L.; Robles J.; Valencia Serrano F.;
Gallardo Lopez A.
Institution
(Jimenez Mazuecos, Cordoba Soriano, Gallardo Lopez) Complejo Hospitalario
Universitario De Albacete, Albacete, Spain
(Diaz Fernandez, Roa Garrido) Hospital Universitario Juan Ramon Jimenez,
Huelva, Spain
(Perez Santigosa, Sanchez Burguillos) Hospital Universitario Nuestra
Senora De Valme, Sevilla, Spain
(Botas, Hernando) Hospital Universitario Fundacion Alcorcon, Madrid, Spain
(Herrero Garibi, Robles) Hospital Universitario De Burgos, Burgos, Spain
(Lazaro Garcia, Valencia Serrano) Hospital Universitario Torrecardenas,
Almeria, Spain
Title
Self-expanding transcatheter aortic valve programmes in centres without
on-site cardiac surgery: Has the time for these centres come?.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 399), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Current European guidelines restrict TAVI procedures to centres with
on-site cardiac surgery (CS) due to the possibility of the need for
emergent open-surgery conversion. Methods and results: We evaluated the
features and the course of patients undergoing TAVI in six centres without
on-site CS but with the possibility for transfer to a reference centre for
urgent CS. All procedures were accepted by each Heart Team with
participation of each referring cardiac surgeon. A total of 200 patients
(81.5+/-5 years; 49% male; mean STS score 5+/-3%; mean EuroSCORE 18+/-10%)
were included. The mean distance from the CS centre of reference was 66 km
(0.2-154 km). Twenty-six percent of the procedures were performed under
general anaesthesia with fully percutaneous procedure in 90%. Device
success was achieved in 97%. Regarding the course, the incidence of major
bleeding and major vascular complications was 8% and 4%, respectively;
mortality at 72 hours, in-hospital and at 30 days was 2%, 5% and 6%,
respectively (3% cardiovascular and 3% non-cardiovascular death). No
annular ruptures or aortic dissection were described. There were 4 cardiac
perforations and 3 coronary occlusions (1 death) which were managed
percutaneously. No transfers to urgent or elective surgery occurred.
Conclusions: In this multicentre registry, survival at discharge and at 30
days is similar to that published in centres with on-site cardiac surgery.
Nowadays, with the improvements of self-expanding devices and greater
experience in the selection of patients, the restriction of TAVI
interventions to centres without on-site cardiac surgery does not seem
reasonable.

<53>
Accession Number
611935176
Author
Nickenig G.; Hammerstingl C.; Vahanian A.; Messika-Zeitoun D.; Kuck K.-H.;
Frerker C.; Alfieri O.; Colombo A.; Latib A.; Baldus S.; Volker R.;
Topilsky Y.; Grayburn P.; Maisano F.
Institution
(Nickenig, Hammerstingl) University of Bonn, Bonn, Germany
(Vahanian, Messika-Zeitoun) Hospital Bichat, Paris, France
(Kuck, Frerker) Askelopios - St Georg, Hamburg, Germany
(Alfieri, Colombo, Latib) Ospedale San Raffaele, Milano, Italy
(Baldus, Volker) Universitat ZU Koln, Koln, Germany
(Topilsky) Sourasky Medical Center, Tel-Aviv, Israel
(Grayburn) Baylor Heart and Vascular Hospital, Dallas, TX, United States
(Maisano) University Hospital, Zurich, Switzerland
Title
One-year follow-up results of mitral valve reconstruction system
multicentre trial.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 323), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The aim of this multicentre study was to evaluate the feasibility,
safety and up to 12 month outcome of Cardioband in patients with secondary
mitral regurgitation (MR). Methods and results: Cardioband system enables
percutaneous implantation of an adjustable "surgical-like" device for
mitral reconstruction and mitral regurgitation reduction using a
transseptal approach. Between February 2013 and October 2015, 49 high-risk
patients with significant secondary MR were enrolled at 7 sites in Europe.
All patients were screened by echocardiography and cardiac CT to assess
feasibility. Mean age was 71 years (range 48-81), thirty eight patients
were males (78%). Mean EuroSCORE II was 7.3%+/-6.5%. At baseline 82% of
patients were in NYHA class III-IV with mean left ventricular ejection
fraction of 33+/-12% (15%-69%). Device implantation was feasible in 100%
patients. Procedural success (device successfully implanted with reduction
of MR <2+ at discharge) was achieved in 87% of patients (41/47). After
device cinching, an average ~30% reduction of the septo-lateral diameter
was observed (from 37+/-4 mm to 26+/-4 mm; p<0.01). Thirty-day mortality
was 4.1% (adjudicated as unrelated to the device). At 12 months follow up
(N=22) 89% of patients had MR<2+, 68% of patients presented with NYHA
class I-II and with significant improvement in quality of life (MLWHFQ)
from 39 to 19 (p<0.01) and exercise tolerance (6MWT) from 272 to 343
meters (p<0.01). Conclusions: Transseptal mitral repair with the
Cardioband device resulted in MR reduction by reconstruction of the mitral
annulus. Safety profile is comparable to other transcatheter mitral
procedures. MR severity reduction and clinical benefit are stable up to 12
months.

<54>
Accession Number
611935172
Author
Ansari M.; Garcia D.; Piazza N.
Institution
(Ansari) Metro Heart and Vascular Institute, Metro Health Hospital-Msu,
Wyoming, United States
(Garcia) Ochsner Heart and Vascular Institute, New Orleans, United States
(Piazza) Mcgill University, Montreal, Canada
Title
Transcatheter tricuspid valve replacement: Analysis of outcomes from all
reported cases.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 419), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We aimed to evaluate the clinical outcomes of all tricuspid valve
replacement cases described in the literature. Methods and results:
PubMed, Cochrane and Embase were systematically reviewed for all cases
describing TVR for patients with severe symptomatic TS and TR in patients
who had previous tricuspid valve repair and were deemed poor surgical
candidates. We described pre-TVR characteristics as such as the main risk
factors for tricuspid valve repair, type of valve used and post-TVR as
such as clinical presentation, type of new valve implanted and its size,
access used, presence of regurgitation, mean gradient and death. A total
of 53 reports of single or case series provided a total of 103 patients.
The mean age was 43.2+/-22.42 years, the majority were female (62%).
Baseline tricuspid pathology was associated with rheumatic heart disease
(18%) and Ebstein anomaly (17%). Carpentier ES valvular ring was the most
commonly used (35%) for initial surgical repair. The most common clinical
presentation was severe TR (43%). The Melody valve was the most commonly
used valve for TVR (54%) through transfemoral access (42%). After TVR, the
majority of patients did not develop any TR (>50%), and presented a mean
gradient 3.44+/-2.3 mmHg. There was only one death reported. Conclusions:
Our analysis suggests that TVR is a safe and feasible option for patients
with failing previous surgical repair. Further randomised clinical studies
comparing TVR to medical therapy should be pursued.

<55>
Accession Number
611935122
Author
Stella P.; Abawi M.; Voskuil M.; Bijuklic K.; Riess F.C.; Hansen L.;
Schofer J.
Institution
(Stella, Abawi, Voskuil) Department of Interventional Cardiology,
University Medical Center Utrecht, Utrecht, Netherlands
(Bijuklic, Schofer) Medical Care Center, Department for Percutaneous
Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg,
Germany
(Riess, Hansen) Department of Cardiac Surgery, Albertinen Heart Center,
Hamburg, Germany
Title
First clinical experience with the third generation cerebral embolic
protection device during TAVI.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 321), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The TriGuard cerebral embolic protection system is a nitinol frame
and mesh that is positioned in the aortic arch to prevent cerebral
embolisation. We evaluated the clinical performance of the third
generation TriGuard device in 2 European centres. Methods and results: The
device was used in 31 patients (78.8+/- 8.7 yrs, 45.2% male) with
symptomatic aortic valve stenosis, who underwent transfemoral TAVI because
of high risk for open heart surgery (EuroSCORE II 7.6+/-6.3, STS Score
2.4+/-0.9). The TriGuard covered all 3 vessels with no device interference
in all patients. Pre-TAVI balloon dilatation was performed in 67.7%,
post-dilatation in 22.6%, valve in valve implantation in 9.7% of patients.
In 29%, the Medtronic Core Valve/Evolute R, in 67.7%, the Edwards SAPIEN
and in 3.2%, the Boston Scientific Lotus valve was used. Results show
MACCE 9.7% (3/31). Mortality, 0.0% (0/31): all stroke, 0.0% (0/31);
disabling stroke, 0.0% (0/31); non-disabling stroke, 0.0% (0/31).
Life-threatening or disabling bleeding, 9.7% (3/31) and device related
bleeding, 0.0% (0/31). TriGuard related, 0.0% (0/31). AKI Stage 2/3, 0.0%
(0/31). Major Vascular Complication, 0.0% (0/31). This study is currently
ongoing and at least 50 patients will be presented at EuroPCR.
Conclusions: The third generation TriGuard device is safe with improved
performance and ease of use, 100% of the cases had 3 vessel coverage and
no strokes.

<56>
Accession Number
611935033
Author
Montone R.A.; Castriota F.; Montorfano M.; Agnifili M.; Brambilla N.;
Regazzoli D.; Nerla R.; Angelillis M.; Fraccaro C.; Tarantini G.; Petronio
A.S.; Bedogni F.
Institution
(Montone, Agnifili, Brambilla, Bedogni) IRCCS Policlinico San Donato, San
Donato Milanese, Italy
(Castriota, Nerla) Maria Cecilia Hospital GVM Research and Care,
Cotignola, Italy
(Montorfano, Regazzoli) Ospedale San Raffaele, Milan, Italy
(Angelillis, Petronio) University of Pisa, Pisa, Italy
(Fraccaro, Tarantini) Padova University Hospital, Padova, Italy
Title
Procedural and 30-day clinical outcomes following TAVI with the Lotus
valve: Results of the RELEVANT study.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 367), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We report periprocedural and 30-day clinical outcomes following
transcatheter aortic valve implantation (TAVI) using the Lotus Valve
System, a second-generation fully repositionable and retrievable device.
Methods and results: Five major Italian centres performing TAVI using the
Lotus valve participated in the RELEVANT (REgistry of Lotus valvE for
treatment of aortic VAlve steNosis with Tavi) study, an Italian national
prospective non-randomised multicentre registry. All consecutive high-risk
symptomatic patients with severe aortic stenosis were evaluated by a Heart
Team and screened for eligibility for TAVI. The primary endpoint was
periprocedural and 30-day mortality. Secondary endpoints included
periprocedural and 30-day safety/effectiveness metrics according to Valve
Academic Research Consortium (VARC)-2 criteria. One hundred and ninety-two
patients undergoing TAVI with the Lotus valve up to December 2015 were
enrolled. Mean age was 83.7 years, 52% were females. The procedure was
performed through femoral artery access in 187 patients (97.4%) and
subclavian artery access in 5 patients (2.6%). Procedural success was
achieved in all patients. The survival rate was 97.4% at discharge and at
30 days. Four patients required urgent cardiac surgery for cardiac
tamponade. The stroke rate was 1.6% at discharge and at 30 days. Three
major and seven minor VARC-2 defined periprocedural vascular complications
occurred. Patients requiring a permanent pacemaker implantation were 26.6%
at discharge and 27.6% at 30 days. Paravalvular regurgitation (PVR) was
trace/mild in all patients at discharge. Only one patient had moderate PVR
at 30 days, whereas none had severe PVR. Conclusions: The RELEVANT study
showed that TAVI using the Lotus valve was safe and effective in a
real-world population of patients with severe aortic stenosis at high risk
for cardiac surgery, with excellent periprocedural and 30-day clinical
outcomes.

<57>
Accession Number
611935018
Author
Abdul-Jawad Altisent O.; Durand E.; Munoz-Garcia A.J.; Nombela-Franco L.;
Cheema A.; Kefer J.; Gutierrez E.; Benitez L.M.; Amat-Santos I.J.; Serra
V.; Puri R.; Eltchaninoff H.; Angulo Llanos R.; Cortes C.; Garcia Del
Blanco B.; Elizaga J.; Del Trigo M.; Campelo-Parada F.; Regueiro A.;
Rodes-Cabau J.
Institution
(Abdul-Jawad Altisent, Puri, Del Trigo, Campelo-Parada, Regueiro,
Rodes-Cabau) Quebec Heart and Lung Institut, Quebec City, Canada
(Durand, Eltchaninoff) University Hospital Of Rouen, Hospital Charles
Nicolle, Rouen, France
(Munoz-Garcia) Hospital Universitario Virgen De La Victoria, Universidad
De Malaga, Malaga, Spain
(Nombela-Franco) Hospital Universitario Clinico San Carlos, Madrid, Spain
(Cheema) St. Michael's Hospital, Toronto University, Toronto, Canada
(Kefer) Saint Luc University Hospital, Brussels, Belgium
(Gutierrez, Angulo Llanos, Elizaga) Instituto De Investigacion Sanitaria
Gregorio Maranon, Madrid, Spain
(Benitez) Clinica De Occidente De Cali, Valle Del Cauca, Colombia
(Amat-Santos, Cortes) Hospital Clinico Universitario De Valladolid,
Valladolid, Spain
(Serra, Garcia Del Blanco) Hospital Universitari Vall D'Hebron, Barcelona,
Spain
Title
Atrial fibrillation, transcatheter aortic valve replacement and
antithrombotic therapy.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 416), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To examine the risk of ischaemic events and bleeding episodes
associated with differing antithrombotic strategies in patients undergoing
TAVR with concomitant AF. Methods and results: A multicentre evaluation
comprising 2,186 patients undergoing TAVR was undertaken. Post-TAVR
prescriptions were used to determine the antithrombotic regimen employed
according to the following 2 groups: monotherapy (MT) with VKA (n=101); or
double therapy (DT) comprised of a single antiplatelet agent (aspirin or
clopidogrel) plus VKA (n=463). Endpoint definitions were in accordance
with Valve Academic Research Consortium-2 (VARC-2) criteria. The rate of
stroke, major cardiovascular events (stroke, myocardial infarction or
cardiovascular death), major/life-threatening bleeding events and death
were assessed by a Cox multivariate model regression survival analysis
according to the antithrombotic regimen used. During a median follow-up of
13 (IQR: 3-31) months there were no differences between groups in the rate
of stroke (MT: 5%, DT: 5%, adjusted HR [95% CI]: 1.05 [0.39-2.83],
p=0.93), major cardiovascular events (MT: 13.9%, DT: 16.4%, adjusted HR
[95% CI]: 1.28 [0.72-2.29], p=0.41) and death (MT: 22.8%, DT: 19.2%,
adjusted HR [95% CI]: 0.93 [0.58-1.50], p=0.77). A higher risk of major or
life-threatening bleeding was found in the DT group (adjusted HR [95% CI]:
1.91 [1.11-3.31], p=0.02). Conclusions: In TAVR recipients prescribed VKA
therapy for AF, concomitant antiplatelet therapy use does not reduce the
incidence of stroke, major cardiovascular events or death, whilst
increasing the risk of major/life-threatening bleeding.

<58>
Accession Number
611935004
Author
Panoulas V.; Thyregod H.G.; Nihoyannopoulos P.; Sen S.; Franks R.; Ariff
B.; Deepa G.; Fertleman M.; Cousins J.; Sutaria N.; Anderson J.;
Chukwuemeka A.; Bicknell C.; Ruparelia N.; Malik I.; Francis D.; Mikhail
G.
Institution
(Panoulas, Nihoyannopoulos, Sen, Franks, Ariff, Deepa, Fertleman, Cousins,
Sutaria, Anderson, Chukwuemeka, Bicknell, Ruparelia, Malik, Francis,
Mikhail) Hammersmith Hospital, Imperial College Healthcare NHS Trust,
London, United Kingdom
(Thyregod) Department of Cardiothoracic Surgery, Heart Centre,
Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
Title
Survival of female patients with severe aortic stenosis after TAVI vs.
surgical aortic valve replacement: A meta-analysis of randomised
controlled trials.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 393), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The aim of the current meta-analysis of randomised controlled trials
was to evaluate the midterm (up to 2-year) survival in females with aortic
stenosis undergoing TAVI versus surgical aortic valve replacement. Methods
and results: Randomised controlled trials reporting midterm survival of
patients with severe aortic stenosis treated with TAVI versus surgical
aortic valve replacement were searched through MEDLINE, EMBASE and
COCHRANE databases and proceedings of international meetings. The results
of all studies were combined using a random-effects model. A 2-tailed
alpha of 5% was used for hypothesis testing. Four randomised controlled
trials (reported by different authors at different time points) including
a total of N=1,844 patients were analysed (PARTNER 1, NOTION, CoreValve US
Pivotal Trial, STACCATO). In these studies, a total of 831 females were
treated with either TAVI (N=422) or surgical aortic valve replacement
(N=409). An increased survival was demonstrated in female patients treated
with TAVI versus surgical aortic valve replacement, both at 1 year (hazard
ratio 0.60, 95% confidence interval: 0.37 to 0.97) and 2 years (hazard
ratio 0.65, 95% confidence interval: 0.47 to 0.91). A similar trend was
not observed in the male subgroup, either in the 1-year (hazard ratio
1.09, 95% confidence interval: 0.78 to 1.51), or in the 2-year (hazard
ratio 1.02, 95% confidence interval: 0.74 to 1.41) follow-up. This
beneficial effect could be attributed to the reduced periprocedural
mortality and bleeding complications in the TAVI group alongside the
increased post-procedural aortic valve area, which could expedite
favourable left ventricular remodelling. Conclusions: The current
meta-analysis suggests an increased midterm survival in female patients
undergoing TAVI versus surgical aortic valve replacement for severe aortic
stenosis. The lower periprocedural mortality alongside the larger aortic
valve area increase in TAVI compared to surgical aortic valve replacement
with stented prostheses may explain the improved survival of female
patients with severe aortic stenosis treated with TAVI as compared to
surgical aortic valve replacement.

<59>
Accession Number
611934976
Author
Muller D.; Sorajja P.; Walters D.; Grayburn P.; Dahle G.; Blanke P.; Jansz
P.; Farivar R.; Clarke A.; Stoler R.; Rein K.; Popma J.; Shaw M.; Scalia
G.; Hebeler R.; Pedersen W.; Leipsic J.
Institution
(Muller, Jansz, Shaw) St Vincent's Hospital, Darlinghurst, Australia
(Sorajja, Farivar, Pedersen) Minneapolis Heart Institute, Minneapolis,
United States
(Walters, Clarke, Scalia) Prince Charles Hospital, Brisbane, Australia
(Grayburn, Stoler, Hebeler) Baylor Heart and Vascular Hospital, Dallas,
United States
(Dahle, Rein) Oslo University Hospital, Oslo, Norway
(Blanke, Leipsic) St Paul's Hospital, Vancouver, Canada
(Popma) Beth Israel Deaconness Medical Center, Boston, United States
Title
Transcatheter mitral valve replacement for severe mitral regurgitation:
The TENDYNE early feasibility trial.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 365), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To evaluate transcatheter mitral valve replacement in patients with
severe, symptomatic mitral regurgitation (MR) at high risk for surgical
repair or replacement. Methods and results: The Tendyne Early Feasibility
study is a prospective, non-randomised registry evaluating a novel
transcatheter mitral valve prosthesis. The device consists of a D-shaped
outer frame, a circular inner frame, and a porcine pericardial trileaflet
valve. It is deployed from a transapical approach within the mitral
annulus and is secured using a tether affixed to the apex of the left
ventricle. The valve is recapturable, repositionable, and fully
retrievable. Eligibility criteria for the study included symptomatic grade
3 or 4 mitral regurgitation, left ventricular ejection fraction (LVEF) >
30%, LV end-diastolic dimension < 7.0cm, and high or prohibitive surgical
risk. Exclusions included prior mitral or aortic valve surgery, severe
coronary disease, heart failure requiring inotropic support, and severe
tricuspid regurgitation or right ventricular dysfunction. To date, 21
patients (20 male; age 77.1yrs (range 55.1-91.4)) have been treated at 5
study sites. All had symptomatic grade 3 or 4 MR that was secondary
(n=18), primary (n=1), or of mixed pathology (n=2). The LVEF was
43.2+/-12.4% and the STS score was 10.0+/-13.4%. In 19 patients (90.5%),
the device was deployed with no residual MR. Device deployment was not
stable in one patient, and resulted in LV outflow obstruction in another.
In both cases, the device was removed without adverse sequelae. Three
patients (14.3%) required periprocedural transfusion. There was one death
at post-operative day 13 due to sepsis. The other 20 patients were
discharged after a length of stay between 5 and 12 days. At 30 day review,
there were no further deaths, no strokes, no paravalvular leak or
haemolysis, and no need for MV surgery. Detailed 30day echo core
laboratory and adjudicated clinical event data will be reported.
Conclusions: These early results from the feasibility trial suggest that
the Tendyne transcather mitral valve system can be used to safely and
effectively treat symptomatic mitral regurgitation in a high-risk
population.

<60>
Accession Number
611934975
Author
Pagnesi M.; Jabbour R.J.; Latib A.; Kawamoto H.; Regazzoli D.; Mangieri
A.; Montalto C.; Ancona M.; Giannini F.; Chieffo A.; Montorfano M.; Monaco
F.; Castiglioni A.; Alfieri O.; Colombo A.
Institution
(Pagnesi, Jabbour, Latib, Kawamoto, Regazzoli, Mangieri, Montalto, Ancona,
Giannini, Chieffo, Montorfano, Monaco, Castiglioni, Alfieri, Colombo) San
Raffaele Scientific Institute, Milan, Italy
Title
Predilatation prior to TAVI: Is it still a prerequisite?.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 318), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We aimed to compare the periprocedural and 1-year outcomes of
patients who underwent transcatheter aortic valve implantation (TAVI) with
or without prior balloon valvuloplasty using either self-expanding or
balloon-expandable valves. Methods and results: A retrospective analysis
was performed on 517 patients undergoing TAVI with (n=326) or without
predilatation (n=191). The devices implanted included the self-expanding
Medtronic CoreValve (n=216) or Evolut R (n=30), and the balloon-expandable
Edward SAPIEN XT (n=210) or SAPIEN 3 (n=61) valves. The primary endpoints
were 1-year major adverse cardiac and cerebrovascular events (MACCE) and
mortality in patients with versus without predilatation. Secondary
objectives included the evaluation of periprocedural results and 30-day
outcomes. In the no predilatation group, the total contrast volume was
lower and the postdilatation rate was higher (35.6% versus 21.5%, p <
0.001). Patients without prior valvuloplasty had a significantly higher
30-day MACCE rate, driven by a higher incidence of stroke (0.3%
predilatation versus 3.7% no predilatation; p < 0.01). MACCE and mortality
at one year were similar in both groups (log-rank test p values 0.20 and
0.15, respectively). The 1-year outcomes were similar also in the
self-expanding (log-rank test p values 0.10 and 0.21) and
balloon-expandable sub-groups (log-rank test p values 0.35 and 0.58).
Independent predictors of MACCE at 1 year were serum creatinine (HR, 1.27;
95% CI, 1.11-1.44; p < 0.001), NYHA class 3-4 (HR, 2.21; 95% CI,
1.07-4.60; p = 0.03), logistic EuroSCORE (HR, 1.02; 95% CI, 1.01-1.04; p <
0.01), and postdilatation (HR, 2.50; 95% CI 1.42-4.39; p < 0.01). Of note,
1-year MACCE and mortality were higher in the postdilatation (n=138)
versus no postdilatation group (n=379). After propensity score-matching
(n=113 pairs), there were no differences in 1-year MACCE or mortality
between patients undergoing TAVI with versus without predilatation.
Conclusions: Our single-centre experience indicated that in selected
patients and with specific transcatheter heart valves, TAVI without
predilatation was not associated with a higher incidence of midterm MACCE
and mortality. However, the exclusion of prior valvuloplasty increases the
need for postdilatation. Results of ongoing randomised trials are needed
before making a definite statement.

<61>
Accession Number
611934973
Author
Ozel E.; Tastan A.; Ozturk A.; Ozcan E.E.; Kilicaslan B.; Ekinci S.;
Ozdogan O.
Institution
(Ozel, Kilicaslan, Ekinci, Ozdogan) Tepecik Training and Research
Hospital, Izmir, Turkey
(Tastan, Ozturk, Ozcan) Sifa University, Izmir, Turkey
Title
Procedural and one-year clinical outcomes of BRS for the treatment of CTO:
A single-centre experience.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 214), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: We aimed to report our bioresorbable vascular scaffold system
experience for the treatment of chronic total occlusions (CTOs) in terms
of procedural features and 1-year clinical follow-up results. Methods and
results: Forty-one consecutive patients with CTO lesions who were referred
to our clinic between January 2013 and December 2014 were analysed. A
total number of 52 bioresorbable vascular scaffolds were implanted.
Patient characteristics, procedural features (target vessel, J-CTO score,
bioresorbable vascular scaffold diameter, bioresorbable vascular scaffold
length, post-dilatation rate, type of post-dilatation balloon, procedure
time, fluoroscopy time, contrast volume, post-procedure reference vessel
diameter, post-procedure minimal lesion diameter, type of CTO technique
and rate of microcatheter use) and 1-year clinical follow-up results
(death, myocardial infarction, angina, coronary artery bypass graft
[CABG], target lesion revascularisation and target vessel
revascularisation) were analysed. Descriptive and frequency statistics
were used for statistical analysis. Among patients, mean age was
61.9+/-9.7 years, 85.4% were male and 51.2% had diabetes. Prior myocardial
infarction incidence was 65.9%; 56.1% of the patients had percutaneous
coronary intervention and 17.1% had CABG before. The procedure was
performed via the radial route in 24.3% of the patients. The target vessel
was the right coronary artery in 48.7% of the patients. Fifty-six percent
of the lesions had intermediate, 19.5% of the lesions had difficult and
9.7% of the lesions had very difficult lesion complexity according to the
J-CTO score. Procedural success was 100%. Post-dilatation was performed on
the implanted bioresorbable vascular scaffolds in 97.5% of cases, mainly
by non-compliant balloon. Most (87.8%) of the bioresorbable vascular
scaffolds were implanted by the antegrade CTO technique. We used a
microcatheter in 13 patients. Six patients had side branch occlusion and 4
patients had side branch narrowing: these were treated successfully by
bifurcation techniques. Mean procedure time was 92+/-35.6 minutes. Mean
contrast volume was 146.6+/-26.7 ml. At 1 year, there was no death. One
patient had lesion-related myocardial infarction and needed
revascularisation becuse of early cessation of dual antiplatelet therapy.
Eleven patients had angina and 5 of them needed target vessel
revascularisation. Conclusions: Bioresorbable vascular scaffold
implantation appeared to be effective and safe in CTO lesions according to
our results but randomised studies with a higher number of patients with
longer follow-up are needed.

<62>
Accession Number
611934959
Author
Cavalcante R.; Mancone M.; Sotomi Y.; Falcone M.; Abdelghani M.;
Suwannasom P.; Zeng Y.; Tenekecioglu E.; Tateishi H.; Collet C.; Diletti
R.; Onuma Y.; Serruys P.
Institution
(Cavalcante, Sotomi, Abdelghani, Suwannasom, Zeng, Tenekecioglu, Tateishi,
Collet, Diletti) Erasmus Medical Center, Rotterdam, Netherlands
(Mancone, Falcone) Umberto I Hospital, Sapienza University of Rome, Rome,
Italy
(Onuma) Cardialysis Bv, Rotterdam, Netherlands
(Serruys) Imperial College London, London, United Kingdom
Title
Major infection after coronary bypass surgery and stenting in the
randomised SYNTAX trial: Incidence, predictors and impact on five-year
mortality.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 64), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: To assess incidence, predictors and impact on 5 years mortality of
infection events after CABG and PCI in patients with three-vessel and/or
left main coronary disease randomised in the landmark SYNTAX trial.
Methods and results: The SYNTAX trial was a multicenter randomized
controlled trial that enrolled 1,800 patients with multivessel and/or left
main coronary artery disease to undergo either CABG surgery or PCI.
Patients were followed up to 5 years. An experienced cardiologist and an
infectious diseases specialist, blinded for study arm and outcomes,
assessed all infection events. Major infection was defined as the
occurrence of deep incisional surgical site infections and skin and soft
tissue infections, mediastinitis or blood stream infections. Of these, 897
patients were randomised to CABG and 903 to PCI. Baseline characteristics
were well balanced between the two groups. Approximately 25% of patients
had diabetes. CABG surgery was associated with a more than 2-fold increase
in the rate of any infection as compared to PCI during the 5 years
follow-up (28.9% vs. 14.7%, respectively; HR 2.2, 95%CI 1.8 to 2.8;
p<0.000001) and a more than 6-fold increase in the rate of major infection
(11.1% vs. 1.9%, respectively; HR 6.3, 95%CI 3.8 to 10.6, p<0.000001). The
most incident infections were wound infection (9.5%), pneumonia (7.0%),
urinary tract infection (2.8%) and sepsis (1.6%) in the CABG group; and
pneumonia (4.8%), urinary tract infection (2.1%),
abdominal/gastrointestinal (2.1%) and sepsis (1.0%) in the PCI arm. CABG
was associated with higher incidences of wound infection (p<0.001) and
pneumonia (p=0.042) than PCI. Major infection was independently associated
with a higher incidence of all-cause mortality at 5 years in the CABG arm
(HR 1.8, 95%CI 1.1 to 3.1, p=0.032) but not in the PCI arm (HR 1.2, 95%CI
0.4 to 3.9, p=0.73) after adjusting for age, gender, body mass index,
ejection fraction, presence of diabetes, peripheral vascular disease,
chronic obstructive pulmonary disease and creatinine clearance less than
60 ml/min. Body mass index was the only independent predictor of major
infection in the CABG group while body mass index and renal failure were
independently associated with major infection in the PCI group.
Conclusions: In the final 5-years follow-up of the landmark SYNTAX trial,
CABG surgery was associated with a higher incidence of overall and major
infection when compared to PCI. Major infection was independently
associated with increased all-cause mortality in the CABG arm but not in
the PCI arm. Independent predictors of major infection included body mass
index in the CABG arm and body mass index and renal failure in the PCI
arm. Due to its independent association with all-cause mortality, this
important outcome should be considered as a major endpoint in future
randomised trials.

<63>
Accession Number
611934949
Author
Moreno R.; Steinwender C.; Dirkali A.; Polad J.; Fajadet J.; Musumeci G.;
Eber B.; Christen T.; Dawkins K.D.
Institution
(Moreno) Hospital La Paz, Madrid, Spain
(Steinwender) Kepler University Hospital, Linz, Austria
(Dirkali) Albert Schweitzer Ziekenhuis, Dordrecht, Netherlands
(Polad) Jeroen Bosch Ziekenhuis, Netherlands
(Fajadet, Musumeci) Clinique Pasteur, Tououse, France
(Eber) Klinikum Kreuzschwestern, Wels, Austria
(Christen, Dawkins) Boston Scientific Corp, Marlborough, United States
Title
Four-year results from the multicentre PROMUS Element European
Post-Approval (PE-Prove) registry: Outcomes in 1,010 unselected patients
treated with a platinum-chromium everolimus-eluting stent.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 88), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: The objective of the PROMUS ElementTM European Post-Approval
(PE-Prove) Registry is to collect outcomes from an unselected patient
population treated with the platinum-chromium, everolimus-eluting PROMUS
Element stent. Methods and results: PE-PROVE is a prospective, open-label,
multicentre observational study that enrolled 1010 patients at 40 European
sites who were candidates for coronary artery stenting with the PROMUS
Element stent and who provided informed consent. At baseline, 75% of
patients were male, 25% had medically treated diabetes, 18% had a
myocardial infarction within 24 hours prior to the index procedure, and
20.1% had unstable angina. Half of the patients had AHA/ACC Type B2 or C
lesions, 7% had chronic total occlusions, and 15% required overlapping
stents. We have previously reported that the 1-year primary endpoint of
overall and PROMUS Element-stent-related target vessel failure rates
(defined as death related to the target vessel, myocardial infarction
related to the target vessel, and target vessel revascularisation) were
6.2% (60/975) and 3.4% (33/976), respectively. At 4 years, 937 patients
were eligible for clinical follow-up, and data were available on 915
(97.7%).By Kaplan-Meier analysis (N=1010), the overall 4-year rate of
target vessel failure was 12.2% (n=118) and study stent-related target
vessel failure was 5.7% (n=55). Four-year cardiac and overall death rates
were 4.0% (n=38) and 7.6% (n=73), respectively. Myocardial infarction was
defined according to the definition used in the Platinum trial based on
CK>2x URL for periprocedural MI and CK> URL for spontaneous MI), and
occurred in 5.5% (n=53) of patients; 2.9% (n=28) were considered related
to the study stent. A total of 8.0% (n=76) patients underwent target
vessel revascularisation, and 4.5% (n=43) were related to the study stent.
ARC definite/probable stent thrombosis was reported for 0.9% (n=9)
patients at 4 years, all of which were considered related to the PROMUS
Element stent. This is the first report of 4-year outcomes with this stent
in unselected patients. Additional results in high-risk subgroups (e.g.,
diabetes, small vessels, long lesions) will be available at the time of
the meeting. Conclusions: In this large, multicentre registry of
unselected patients, the PROMUS Element everolimus-eluting stent continues
to provide favourable outcomes with extended clinical follow-up,
demonstrating low rates of adverse events at 4 years in routine clinical
practice. Patients will continue to be followed annually for 5 years.

<64>
Accession Number
611934894
Author
Abdel-Wahab M.; El-Mawardy M.; Schwarz B.; Sato T.; Allali A.; Richardt G.
Institution
(Abdel-Wahab, El-Mawardy, Schwarz, Sato, Allali, Richardt) Segeberger
Kliniken, Bad Segeberg, Germany
Title
Comparison of balloon-expandable and mechanically expanded transcatheter
aortic valves: Matched comparison from a single-centre experience.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 363), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To assess the haemodynamic performance and intermediate-term
clinical outcome after transcatheter aortic valve implantation (TAVI)
using the balloon-expandable SAPIEN 3 valve and the mechanically expanded
Lotus valve. Methods and results: A total of 120 patients (81.0+/-5.1
years of age, 43.3% males, Logistic EuroSCORE 17.5+/-10.6%) were assessed.
Sixty consecutive patients undergoing a Lotus TAVI were compared with 60
matched patients treated with a SAPIEN 3 valve. Patients were matched for
age, sex, left ventricular ejection fraction (LVEF), logistic EuroSCORE
and mean aortic annulus diameter as measured by computed tomography (CT).
All endpoints were assessed in accordance with the Valve Academic Research
Consortium (VARC)-2 criteria for event definition. The SAPIEN 3 and Lotus
cohorts were well matched (age 82.1+/-5.1 vs. 80.7+/-5.2 years, p=0.57;
female gender 56.7 vs. 56.7%, p=1.0; LVEF 57.1 vs. 58.9%, p=0.28; logistic
EuroSCORE 17.5+/-10.8 vs. 17.5+/-10.4%, p=0.98; mean annulus diameter
25.0+/-2.0 vs. 24.7+/-2.2 mm, p=0.40). Other baseline characteristics were
not significantly different between both groups, except for previous
bypass surgery (3.3% for SAPIEN 3 vs. 16.7% for Lotus, p=0.02). All
procedures were performed transfemorally under conscious sedation. Balloon
pre-dilatation was performed in 30.0% and 33.3% of SAPIEN 3 and Lotus
implantations, respectively (p=0.69). Post-dilatation was rarely performed
(8.3% with SAPIEN 3 vs. 0% with Lotus, p=0.05). Post-procedural aortic
regurgitation as assessed by echocardiography was non/trace in 68.3% vs.
80% and mild in 31.7% vs. 20% of SAPIEN 3 and Lotus patients respectively
(p=0.14). No patients had more-than-mild AR. Post-procedural mean
gradients were not significantly different (11.3+/-3.6 vs. 12.7+/-4.2
mmHg, p=0.06). Significant patient prosthesis mismatch was observed in
five SAPIEN 3 and three Lotus patients. Consequently, the VARC-2 defined
device success rate was 91.7% vs. 93.3% in the SAPIEN 3 and Lotus cohorts,
respectively (p=1.0). All-cause mortality (1.7% in each group, p=1.0),
stroke (0% vs. 3.3%, p=0.49) and major vascular complications (3.3% vs.
0%, p=0.49) were not different at 30 days in the SAPIEN 3 and Lotus
cohorts, respectively. Permanent pacemaker (PPM) insertion rate was
significantly higher in the Lotus group at 30 days (51.7% vs. 18.3%,
p<0.001), with a trend towards reduced PPM rates in the Lotus group with
increased experience (60% in the first 30 patients vs. 39% in the last 30
patients). Mortality rates at 6 and 12 months were low and not
significantly different between both groups (4% vs. 6.5% at 6 months,
p=0.66, and 7.4% vs. 13.3% at 12 months, p=0.67). Conclusions: In this
matched comparison of high surgical risk patients undergoing TAVI with the
balloon-expandable SAPIEN 3 valve and the mechanically expanded Lotus
valve, haemodynamic and clinical outcomes at 30 days, 6 months and 1 year
were excellent and not significantly different between both devices. While
mild residual AR tended to be less common with the mechanically expanded
device, rates of new PPM were significantly higher. The clinical
significance of these differences may need to be tested in a randomised
controlled trial.

<65>
Accession Number
611934863
Author
Shlofmitz E.; Doshi R.; Shlofmitz R.; Jauhar R.; Meraj P.
Institution
(Shlofmitz, Doshi, Jauhar, Meraj) North Shore Lij Health System, New York,
United States
(Shlofmitz) St. Francis Hospital, Roslyn, United States
Title
Outcomes of orbital atherectomy in patients with severe left ventricular
systolic dysfunction.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 134), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To assess the efficacy and safety of orbital atherectomy in vessel
preparation treatment for severely calcified coronary lesions in patients
with severe left ventricular systolic dysfunction. Methods and results:
Multicentre retrospective analysis was performed on all patients who
underwent orbital atherectomy at clinical sites from January 2012 to
August 2015 (n=318). Cases with left ventricular ejection fraction <35%
were included (n=29). Ejection fraction was determined by left
ventriculography at the time of catheterisation, or by echocardiogram
post-catheterisation when no ventriculogram was performed. The average age
in the cohort with ejection fraction <35% was 74 years, and 73.8 years in
those with ejection fraction >35%. There were no differences between the
groups in any baseline characteristic (hypertension, hyperlipidaemia,
prior CABG or PCI) except for a higher incidence of diabetes and active
smokers in the group with ejection fraction <35%. There were no procedural
complications of dissection, perforation or no-reflow phenomenon with any
of the interventions. No cases of 30-day myocardial infarction, stroke,
stent thrombosis, restenosis, target vessel revascularisation, or emergent
bypass occurred. One patient died within 30 days from non-cardiac causes
after postoperative complications from non-cardiac surgery. Sixty-two
percent (n=18) of patients underwent orbital atherectomy with no
mechanical circulatory support, while 24% (n=7) had placement of an
intra-aortic balloon pump, and 14% (n=4) had a temporary percutaneous left
ventricular assist device placed. There was no haemodynamic compromise
seen in the patients who underwent atherectomy without mechanical support.
Conclusions: This patient cohort represents a high-risk patient population
that is often encountered in clinical practice but rarely studied in
clinical trials. With the ageing of the population, the number of patients
who fit into this category has been increasing. These patients are often
not surgical candidates owing to their extreme surgical risk. Severe
systolic dysfunction is a relative contraindication for rotational
atherectomy. Orbital atherectomy is a novel percutaneous device that
allows debulking of severely calcified lesions to assist in optimal stent
deployment. Orbital atherectomy has not been well evaluated in patients
with severely reduced left ventricular systolic function. We have
demonstrated orbital atherectomy to be feasible and safe in patients with
severely calcified coronary lesions with severely reduced left ventricular
systolic function.

<66>
Accession Number
611934823
Author
Sang-Hoon S.; Pil-Sang S.; Guang-Won S.; Dong-Kie K.; Doo-Il K.; Young Bin
S.; Joo-Yong H.; Seung-Hyuk C.; Hyeon-Cheol G.
Institution
(Sang-Hoon, Pil-Sang, Guang-Won, Dong-Kie, Doo-Il) Haeundae Paik Hospital,
Busan, South Korea
(Young Bin, Joo-Yong, Seung-Hyuk, Hyeon-Cheol) Samsung Medical Center,
Sungkyunkwan University, School of Medicine, Seoul, South Korea
Title
Major predictors of long-term clinical outcomes after PCI for coronary
bifurcation lesions with a 2-stent strategy.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 210), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Although the current guidelines recommend the provisional 1-stent
strategy as the preferred approach, the 2-stent strategy is still a viable
option for some patients who have complex coronary artery bifurcation
lesions. Methods and results: We retrospectively evaluated all patients
who underwent a 2-stent strategy with drug-eluting stents (DES) between
January 2003 and December 2009 from 18 centres in Korea. The primary
outcome was the target vessel failure (TVF) rate, a composite of cardiac
death, myocardial infarction (MI), or target vessel revascularisation
(TVR). Among 2,897 enrolled patients in the Coronary Bifurcation Stent
(COBIS) II registry database, a total of 610 patients (69.7% men) with a
median age of 63 years underwent a 2-stent strategy. Diabetes was noted in
30.5% of patients. Patients underwent PCI because of acute coronary
syndrome in 68.9% of cases. The target lesion was the left main
bifurcation in 44.3% of patients and the left anterior descending/diagonal
branch in 47.0% of patients. Defined according to the Medina
classicification, true bifurcation was observed in 73.8% of patients. The
median SYNTAX (Synergy Between Percutaneous Coronary Intervention With
Taxus and Cardiac Surgery) score was 19 (interquartile range 13-26).
First-generation DES were used in 86.7% of patients. There was a 25.6%
crossover rate from a provisonal 1-stent to a 2-stent strategy on the side
branch. The crush technique was used most frequently (54.3%) followed by
the T-stenting technique (28.9%), V-stenting (13.0%) and culotte stenting
(3.1%). Final kissing ballooning (FKB) was performed in 83.0% of patients.
Angiographic success was achieved in 99.5% in the main vessel and 98.5% in
the side branch. During median follow-up of 3 years, the cumulative
incidence of TVF, cardiac death, MI, TVR, and target lesion
revascularisation was 20.5%, 2.3%, 3.4%, 17.2%, and 13.0%, respectively.
Definite or probable stent thrombosis was noted in 13 patients (2.1%)
during the follow-up period: early stent thrombosis in 4 patients (0.7%),
late in 3 patients (0.5%), and very late in 6 patients (1.0%).
Interestingly, every patient with early stent thrombosis was not taking
dual antiplatelet agents at the time of presentation. By Cox propotional
regression analysis, the predictors for long-time TVF were left main
bifurcation (adjusted hazard ratio [HR] 2.39, 95% confidence interval
[CI]: 1.63-3.52; p<0.001), high SYNTAX score >32 ( adjusted HR 2.16, 95%
Cl: 1.003-4.65; p=0.049), whereas each stenting technique was not. The
second-generation DES (adjusted HR 0.32, 95% Cl: 0.13-0.80; p=0.014), FKB
(adjusted HR 0.53, 95% Cl: 0.35-0.81; p=0.003), and the use of
non-compliant balloons (adjusted HR 0.57, 95% Cl: 0.38-0.86; p=0.007) had
a protective effect on the occurrence of TVR in the 2-stent strategy of
bifurcation PCI. Conclusions: These results demonstrate that the 2-stent
strategy is associated with feasible procedural and acceptable clinical
outcomes. Several clinical characteristics were identified as important
periprocedural predictors of long-term adverse outcomes in patients with
bifurcation lesions with a 2-stent strategy PCI.

<67>
Accession Number
611934819
Author
Amat-Santos I.J.; Cortes C.; Nombela-Franco L.; Munoz-Garcia A.J.;
Gutierrez-Ibanes E.; De La Torre J.M.; Cordoba-Soriano J.G.; Castrodeza
J.; Tobar J.; Puerto A.; San Roman J.A.
Institution
(Amat-Santos, Cortes, Castrodeza, Tobar, Puerto, San Roman) Instituto De
Ciencias Del Corazon (icicor), Hospital Clinico Universitario De
Valladolid, Valladolid, Spain
(Nombela-Franco) Hospital Clinico Universitario San Carlos, Madrid, Spain
(Munoz-Garcia) Hospital Clinico Virgen De La Victoria, Malaga, Spain
(Gutierrez-Ibanes) Hospital General Universitario Gregorio Maranon,
Madrid, Spain
(De La Torre) Hospital Universitario Marques De Valdecilla, Santander,
Spain
(Cordoba-Soriano) Hospital General Universitario De Albacete, Albacete,
Spain
Title
Prognostic impact, imaging predictors of improvement, and potential
percutaneous management of mitral regurgitation after transcatheter aortic
valve replacement: A multicentre study.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 362), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Our aim was to: 1, analyse the impact of the degree and improvement
of mitral regurgitation (MR) in TAVI patients; 2/ validate the main
imaging determinants of improvement; 3/ determine the potential candidates
for double-valve percutaneous repair. Methods and results: A total of 1110
patients with severe AS from 6 centres who underwent TAVI were included.
In-hospital to 6-month follow up outcomes according to the degree of MR
were evaluated. Off-line central analysis of echocardiographic and
multidetector computed tomography (MDCT) images were performed to
determine predictors of improvement, follow up outcomes, and potential
percutaneous alternatives to treat persistent MR. In all, 16% (177
patient) of the global study population (1110 patients) presented
significant MR before TAVI and experienced a 3-fold increase in 6-month
mortality (35 vs. 10.2%, p<0.001). MR degree improved in 60% of the
patients. Mitral annulus diameter <35.5-mm (OR=9 (3.20 - 25.28), p<0.001)
and calcification of the mitral apparatus by MDCT (OR=11.23 (4.03-31.30),
p<0.001) were independent predictors of persistent MR. At least 14
patients (1.3% of the entire cohort, 13.1% of patients with persistent MR)
met criteria for percutaneous mitral repair through MitraClip (9.3%) or
balloon-expandable valve implantation (3.7%). Conclusions: MR is not
uncommon in TAVI subjects (16%) and conditions a higher mortality. In more
than half of patients, the MR degree improves after the procedure, which
can be predicted by characterisation of the mitral apparatus through MDCT.
According to standardised imaging criteria, about 1 in 10 patients whose
MR persists may benefit from subsequent mitral percutaneous procedures.

<68>
Accession Number
611934807
Author
Webb J.G.
Institution
(Webb) St. Paul's Hospital, University of British Columbia, Vancouver,
Canada
Title
A third-generation balloon expandable transcatheter heart valve: European
one-year clinical follow-up of transfemoral intermediate and high surgical
risk patients.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 361), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: TAVI outcomes in 250 (transfemoral=191, transapical=59) patients are
being studied in a SAPIEN 3 valve European investigational trial. 1-year
results from transfemoral (intermediate surgical risk=101, high surgical
risk=90) cohorts are reported here. Methods and results: Patients with
severe aortic stenosis were screened and selected per Heart Team and
intermediate (logistic EuroSCORE >10-14, Society Thoracic Surgery Score >
4-7) or higher surgical risk patients enrolled in a prospective,
multicenter, non-randomized clinical investigation of the Edwards SAPIEN 3
transcatheter heart valve for commercial approval. Enrollment took place
in Europe and Canada between January 2013 and November 2014. Baseline mean
patient age for transfemoral intermediate and high risk patients was
84.4+/-3.8 and 84.7+/-5.1 years, respectively. Female patients represented
54.5% and 60.0% of each cohort. Mean logistic EuroSCOREs were 13.2+/-5.1
and 21.4+/-10.9 and Society of Thoracic Surgery Scores 5.2+/-1.7% and
8.1+/-4.2% for the two groups of transfemoral patients. Patient
characteristics included: New York Heart Association Class III/IV in 64.4%
of intermediate risk and in 85.6% of high risk patients, severe pulmonary
hypertension 1.0% and 7.8%, carotid disease 14.9% and 22.5%, diabetes
26.7% and 32.2%, previous myocardial infarction 10.9% and 15.6%, renal
insufficiency 33.7% and 43.3% and atrial fibrillation 16.8% and 27.8%. At
1 year, the cumulative Kaplan Meier freedom from all-cause and
cardiovascular mortality for transfemoral intermediate surgical risk
patients was 91.9% and 95.9%, for high surgical risk 89.8% and 97.8%. The
Kaplan Meier estimate for adjudicated disabling stroke was 4.1% and 1.2%
respectively, new onset atrial fibrillation 8.0% and 6.8% and myocardial
infarction 4.2% and 2.2%. The event rate for new pacemaker implantation at
1 year was 4.0% in intermediate risk and 12.4% in high risk patients.
There were no reports of prosthetic valve thrombosis or endocarditis in
either cohort. Improvements in quality of life assessments and 6 minute
walk tests were reported over baseline at 1 year with significant
improvements in New York Heart Association classification (p<0.0001) in
each risk group. Core lab echocardiographic evaluations at 1 year showed
similar valve performance; mean gradients of 13.0+/-5.3 and 11.1+/-4.7mmHg
in each risk group and effective orifice areas of 1.4+/-0.4 and
1.5+/-0.4cm², respectively. Paravalvular regurgitation was low
in the majority of patients with none/trace reported in 73.5% of those
with intermediate and 79.1% with high surgical risk. Mild/mild-moderate
paravalvular regurgitation was seen in 24.5% and 17.9% and
moderate/moderate-severe in 1.9% and 3.0%. No severe paravalvular
regurgitation was seen in either cohort. Conclusions: Aortic stenosis TAVI
patients with intermediate and high surgical risk treated via transfemoral
access with the SAPIEN 3 transcatheter heart valve had particularly low
mortality at 1 year and low rates of other major complications as well as
functional improvements and sustained haemodynamic valve performance.
These results suggest that SAPIEN 3 design improvements clinically benefit
patients with intermediate and high surgical risk.

<69>
Accession Number
611934791
Author
Spaziano M.; Mylotte D.; Barbanti M.; Bleiziffer S.; Bosmans J.; De Backer
O.; Debry N.; Grube E.; Lange R.; Martucci G.; Modine T.; Sinning J.M.;
Sondergaard L.; Tamburino C.; Piazza N.
Institution
(Spaziano) Institut Cardiovasculaire Paris Sud, Massy, France
(Mylotte) Galway University Hospitals, Galway, Ireland
(Barbanti, Tamburino) Ferrarotto Hospital, Catania, Italy
(Bleiziffer, Lange) German Heart Center, Munich, Germany
(Bosmans) University Hospital Antwerp, Antwerp, Belgium
(De Backer, Sondergaard) Rigshospitalet, Copenhagen, Denmark
(Debry, Modine) Centre Hospitalier Regional Universitaire De Lille, Lille,
France
(Grube, Sinning) University Hospital Bonn, Bonn, Germany
(Martucci, Piazza) Mcgill University Health Center, Montreal, Canada
Title
TAVI vs. Re-do surgery for failing surgical aortic bioprostheses: A
multicentre comparison of post-procedural gradients.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 437), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: This study aimed to compare post-procedural aortic gradients of
patients undergoing TAV-in-SAV with the Edwards devices, CoreValve or
re-do SAVR after accounting for baseline differences by propensity score
matching. Methods and results: Patients from 7 centres in Europe and
Canada who had undergone either TAV-in-SAV (n=79) or re-do SAVR (n=126)
were identified. Significant independent predictors used for propensity
scoring were age, NYHA functional class, number of prior cardiac
surgeries, urgent procedure, pulmonary hypertension, and COPD grade. Using
a caliper range of +/-0.05, a total of 78 well-matched patient pairs were
found. Patients were subdivided into quartiles according to failing
bioprosthesis true inner diameter (Q1: <18.5 mm; Q2: 19-20 mm; Q3: 20.5-21
mm; Q4: >22 mm). Within each quartile, post-procedural echocardiographic
mean aortic gradients were compared between re-do SAVR, CoreValve and the
Edwards devices (SAPIEN, XT or S3). Mean difference between labelled valve
size and true inner diameter was 2.5+/-1.6 mm (range: 0 mm-4.5 mm). In the
TAV-in-SAV group, the Edwards devices were used in 41% of patients (n=32)
and the CoreValve was used in the remaining 46 patients (59%). Mean
post-procedural aortic gradient was 21.3+/-7.2 mmHg in the Edwards group,
15.4+/-6.7 mmHg in the CoreValve group, and 14.3+/-6.2 mmHg in the re-do
SAVR group (p=0.0002). Mean gradient in Q1 was 25.0 mmHg in the Edwards
group (n=1), 15.6+/-3.2 mmHg in the CoreValve group, and 18.9+/-8.2 mmHg
in the re-do SAVR group (p=NS). In Q2, mean gradients were significantly
higher in the Edwards group (22.0+/-9.6 mmHg) compared to the CoreValve
(18.5+/-7.1 mmHg) and re-do SAVR groups (11.3+/-4.2 mmHg) (p=0.03). The
same results were found in Q3 (Edwards: 22.3+/-6.0 mmHg; CoreValve:
16.0+/-7.0 mmHg; re-do SAVR: 12.9+/-5.4 mmHg; p=0.01) and Q4 (Edwards:
19.5+/-6.4 mmHg; CoreValve: 13.0+/-8.4 mmHg; re-do SAVR: 11.9+/-3.5 mmHg;
p=0.02). Conclusions: Patients with aortic bioprosthesis failure treated
with either re-do SAVR or CoreValve have significantly lower
post-procedural gradients than those treated with the Edwards valves. This
was true for all failing valve sizes except the smallest, in which the
Edwards devices were used infrequently.

<70>
Accession Number
611934743
Author
Sadamatsu K.; Matoba T.; Nakashiro S.; Takase S.; Suematsu N.; Koga Y.;
Eshima K.; Yamamoto M.; Takemoto M.; Hironaga K.; Mukai Y.; Inoue S.; Oi
K.; Higo T.; Egashira K.; Sunagawa K.
Institution
(Sadamatsu, Eshima) St. Mary's Hospital, Kurume, Japan
(Matoba, Nakashiro, Takase, Egashira, Sunagawa) Kyushu University,
Graduate School of Medical Sciences, Fukuoka, Japan
(Suematsu) Japanese Red Cross Fukuoka Hospital, Fukuoka, Japan
(Koga) Saga-Ken Medical Centre Koseikan, Saga, Japan
(Yamamoto) Harasanshin Hospital, Fukuoka, Japan
(Takemoto) Munakata Suikokai General Hospital, Fukutsu, Japan
(Hironaga) Saiseikai Fukuoka General Hospital, Fukuoka, Japan
(Mukai, Inoue, Oi, Higo) Kyushu University Hospital, Fukuoka, Japan
Title
Effect of ezetimibe in combination with statins on coronary plaque
regression in patients after coronary stenting.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 34), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: In this study, we evaluated the additional effect of ezetimibe to
statins on coronary plaque regression with intravascular ultrasound in
patients after successful coronary stent implantation. Methods and
results: The CuVIC Trial (Clinical trials registry: UMIN000005597) was a
prospective, randomised, open, blinded-endpoint trial, in which 260
patients after successful coronary stent implantation were randomly
assigned into two arms (statin monotherapy [S], and ezetimibe + statin
combination therapy [ES]). Among them, we recruited 79 patients (39 in S
and 40 in ES) for this substudy, in whom serial intravascular ultrasound
images of non-culprit lesions were examined. After 7+/-1 months follow-up
periods, low-density lipoprotein levels were lower in ES than S (68+/-24
vs. 80+/-24 mg/dL, p=0.02), although the prescription of high intensity
statins was frequent for S. Campesterol levels, which is a cholestrol
absoption marker, were significantly reduced in ES (from 3.7+/-1.4 to
2.2+/-0.9 mug/mL, p<0.01), while the levels in S were increased (from
4.1+/-2.1 to 5.1+/-2.1 mug/mL, p<0.01) during the follow-up period. The
percent change in percent atheroma volume was significantly larger in ES
than S (-6.1+/-1.5 vs -1.2+/-1.8%, p=0.04), although the absolute change
in percent atheroma volume did not reach statistical significance
(-2.7+/-0.6 vs -0.7+/-0.8%, p=0.06). The percent change in percent
atheroma volume was significantly associated with the campesterol levels
at the follow-up (R 2 =0.11, p<0.01), but not with the percent change of
low-density lipoprotein levels. Conclusions: The combination therapy with
ezetimibe and statins achieved further decrease of low density lipoprotein
levels with the inhibition of cholesterol absorption, and then resulted in
prominent regression in coronary plaque compared to the statin
monotherapy. Therefore, the combination of ezetimibe and statins might be
a promising option for high-risk patients after PCI.

<71>
Accession Number
611934736
Author
Zilio F.; Al mamary A.; Cabianca E.; Pedemonte E.; Ronco F.; Ugo F.;
Cerrato E.; Cernetti C.; Coccato M.; De Iaco G.; Fineschi M.; Granata F.;
Bossone E.; La Manna A.; Lettieri C.; Marchese A.; Mauro C.; Musumeci G.;
Parodi G.; Saia F.; Tarantini G.; Napodano M.
Institution
(Zilio, Al mamary, Tarantini, Napodano) Department of Cardiac, Thoracic
and Vascular Sciences, University of Padova, Padova, Italy
(Cabianca) Uoc Cardiologia, Ospedale San Bortolo, Vicenza, Italy
(Pedemonte) Uo Diagnostica Ed Interventistica Cardiovascolare Asl 3,
Pistoia, Italy
(Ronco) Emodinamica Ulss 12 Veneziana, Venezia, Italy
(Ugo) S.c. Cardiologia, Ospedale S. Giovanni Bosco, Torino, Italy
(Cerrato) Infermi Hospital, Rivoli (TO), Italy
(Cernetti) San Giacomo Hospital, Castelfranco Veneto (TV), Italy
(Coccato) Ospedale Santa Maria Dei Battuti, Conegliano (TV), Italy
(De Iaco) Sc Cardiologia Interventistica, Irccs Asmn, Reggio Emilia, Italy
(Fineschi) U.o. Emodinamica, Azienda Ospedaliera Universitaria Senese,
Siena, Italy
(Granata) Laboratory of Interventional Cardiology, Department of
Cardiology Santa Maria Della Pieta Hospital, Nola (NA), Italy
(Bossone) Heart Department, University Hospital, Salerno, Italy
(La Manna) Division of Cardiology, Ferrarotto University Hospital,
Catania, Italy
(Lettieri) Dipartimento Cardio-Toraco-Vascolare, Asst Carlo Poma, Mantova,
Italy
(Marchese) Anthea Hospital GVM Care and Research, Bari, Italy
(Mauro) Uosc Cardiologia-Utic, Aorn a. Cardarelli, Napoli, Italy
(Musumeci) Dipartimento Cardiovascolare, Asst Papa Giovanni XXIII,
Bergamo, Italy
(Parodi) Department of Heart and Vessels, Careggi Hospital, Florence,
Italy
(Saia) Cardio-Thoraco-Vascular Department, University Hospital Policlinico
S. Orsola-Malpighi, Bologna, Italy
Title
Plastic healing of spontaneous coronary artery dissection using BRS: A
multicentre registry.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 132), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The aim of this study was to investigate feasibility and safety of
BRS implantation in spontaneous coronary artery dissections needing vessel
wall restoration due to flow-limiting lesions or persistent/relapsing
ischaemia. Methods and results: In a multicentre registry, 26 patients
affected by spontaneous coronary artery dissections presenting with acute
coronary syndrome and treated by BRS implantation between 2013 and 2015
were assessed. Indications for treatment were flow-limiting lesions and/or
persisting/relapsing ischaemia. Device success was defined as successful
delivery of scaffold at intended target lesion with full device expansion;
procedural success was defined as device success with normal antegrade
flow and residual stenosis <30%. MACE (including death, myocardial
infarction, heart failure, stroke, life-threatening bleeding, left
ventricular assist device implantation and cardiac transplantation) and
target vessel failure (including target vessel myocardial infarction and
clinically indicated target vessel revascularisation) were assessed at 6
and 12 months; CT scan or coronary angiography was planned at 6 to
12-month follow-up. All but one patient were female, mean age 47.8+/-6.2
years; risk factors for spontaneous coronary artery dissection were
identified in 13 patients. Clinical presentation was STEMI (46%), NSTE-ACS
(39%), or life-threatening arrhythmias (15%). Left anterior descending
artery was the most common culprit vessel (68%); 2-vessel dissection was
found in 5 patients, 2 of whom underwent BRS deployment on 2 vessels.
Thus, 28 coronary arteries were treated. As regards angiographic features,
26 of 28 lesions were longer than 20 mm, bifurcation treatment was
required in 5 cases (mostly as provisional stenting). Revascularisation
was accomplished with 1 to 5 BRS per patient (mean total scaffold length
57.7+/-21.0 mm, range 12-130 mm), using different overlapping techniques,
with distal-to-proximal implantation sequence in 87% of cases. IVUS
guidance was used in 11 cases (42%). Post-dilatation was accomplished in
71%. Hybrid procedures with one or more metallic DES implantation were 5.
Device success was achieved in 27 of 28 (96%) lesions; full coverage was
achieved in 25 of 28 (89%) lesions, lesion extension occurred in 1 of 28
vessels. Procedural success was achieved in 25 of 26 (96%) patients. No
in-hospital deaths and 1 non-fatal myocardial reinfarction were observed;
4 patients complained of angina relapse, leading to 1 target lesion
revascularisation with additional (distal) DES deployment; in the
remaining cases, side branches were deemed responsible for the symptoms.
At 6-month follow-up, available for 21 patients, 1 non-fatal myocardial
infarction leading to target vessel revascularisation was observed. CT
scan or angiographic evaluation, available for 7 patients, showed BRS
patency in all cases, while persistence of vessel haematoma/dissection was
depicted in 1 patient. Complete follow-up will be provided at the meeting.
Conclusions: BRS implantation seems feasible and safe in spontaneous
coronary artery dissection, with high rates of device and procedural
success. The potential application of BRS in this setting to promote
vessel healing needs further evaluation in larger studies.

<72>
Accession Number
611934733
Author
Haude M.; Siminiak T.; Lipiecki J.; Sadowski J.; Hoppe U.; Sievert H.;
Muller-Ehmsen J.; Fajadet J.; Fichtlscherer S.; Goldberg S.L.
Institution
(Haude) Lukaskrankenhaus Neuss, Neuss, Germany
(Siminiak) Cardiology and Rehabilitation Hospital, Kowanowku, Poland
(Lipiecki) Centre Hospitalier Universitaire, Clermont Ferrand, France
(Sadowski) Pope John Paull II, Krakow, Poland
(Hoppe) Salk-Paracelsus Universitat Salzburg, Salzburg, Austria
(Sievert) Cardiovascular Centre, St. katharinen Hospital, Frankfurt,
Germany
(Muller-Ehmsen) Asklepios Klinik Altona, Hamburg, Germany
(Fajadet) La clinique Pasteur, Toulouse, France
(Fichtlscherer) Klinikum Der Johann Wolfgang Goethe Universitat, Frankfurt
am Main, Germany
(Goldberg) Kalispell Regional Medical Center, Kalispell, United States
Title
Combined results on safety and efficacy of two prospective, multicentre
trials for the treatment of functional mitral regurgitation by
percutaneous annuloplasty.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 360), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To assess whether the reduction of FMR associated with PMA is safe,
measured by 30-day major adverse event (MAE) rate, and results in clinical
benefit measured by haemodynamic and functional changes. Methods and
results: Combined data from patients enrolled in two safety trials of the
Carillon device: the TITAN and TITAN II trials are presented. The
inclusion criteria for both trials were: New York Heart Association (NYHA)
Class II-IV heart failure and stable medical therapy; moderate to severe
FMR, and left ventricular ejection fraction (LVEF) <40%. In addition to
corelab analysed regurgitant volume, clinical measures of efficacy,
including NYHA Class and six-minute walk distance (6MWD), were collected
through 12 months. A combined total of 66 patients were implanted. At
baseline, dilated cardiomyopathy was of ischaemic origin in 62% of
patients, mean ejection fraction (EF) was 29%, and mean left ventricular
end diastolic diameter (LVEDD) was 6.5 cm. The MAE rate through 30-days
for all 66 patients was 1.5% with one death unrelated to the procedure or
the device. No patients experienced myocardial infarction through 30 days.
There were no device related MAE through 12 months. The mean changes (+/-
standard deviation) in regurgitant volume (millilitre) at baseline, one
month, six months and 12 months were 34.5 +/-12 (n=60), 26.5 +/-15 (n=56),
21.6 +/-13 (n=49), 19.3 +/-13 (n=39) respectively (analysis of variance,
P<0.001). In similar intervals, the mean changes in 6MWD (metres) were 299
+/-77 (n=65), 387 +/-132 (n=57), 418 +/-175 (n=45), 395 +/-158 (n=42)
(P<0.01); and in NYHA classification 3.0 +/-0.3 (n=66), 2.1 +/-0.6 (n=61),
2.1 +/-0.7 (n=52), 2.1 +/-0.7 (n=47) (P<0.001). Conclusions: Implantation
of the Carillon device was safe, resulted in clinical significant
reductions in FMR which was associated with marked symptomatic and
functional improvement.

<73>
Accession Number
611934724
Author
Kedev S.; Neskovic C.; Moris De La Tassa C.; Zivkovic M.; Trillo Nouche
N.; Valdes Chavarri M.; Vazquez Gonzalez N.; Bartorelli A.; Antoniucci D.;
Tamburino C.; Colombo A.; Abizaid A.; Stankovic G.
Institution
(Kedev) PHE University, Cardiology Clinic, Skopje, Macedonia
(Neskovic) Clinical Hospital Center Zemun, Belgrade, Serbia
(Moris De La Tassa) Hospital Universitario Central Asturias-Oviedo,
Oviedo, Spain
(Zivkovic) Clinical Center Nis, Nis, Serbia
(Trillo Nouche) Complejo Hospitalario Universitario Santiago De
Compostela, Santiago de Compostela, Spain
(Valdes Chavarri) Hu Virgen Arrixaca-Murcia, Murcia, Spain
(Vazquez Gonzalez) Complejo Hospitalario Universitario A Coruna, A Coruna,
Spain
(Bartorelli) Cardiologico Monzino, Milan, Italy
(Antoniucci) Azienda Ospedaliero Universitaria Careggi, Florence, Italy
(Tamburino) Azienda Ospedaliero Universitaria, Policlinico vittorio
Emanuele - Ospedale Ferrarotto, Catania, Jamaica
(Colombo) San Raffaele Hospital, Milan, Italy
(Abizaid) Instituto Dante Pazzanese De Cardiologia, Sao Paolo, Brazil
(Stankovic) Clinical Center of Serbia, Belgrade, Serbia
Title
Safety and efficacy of biodegradable polymer DES in management of patients
with acute STEMI: MASTER study-one-year clinical outcomes.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 108), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: To test hypothesis whether the use of DES with bioresorbable polymer
is related with favourable outcomes in patients with acute STEMI as
compared to its bare metal stent platform. Methods and results: The MASTER
study is a prospective, single-blind, 3:1 randomised study that enrolled
500 patients with acute STEMI in 14 centres, designed to demonstrate
safety and efficacy of primary PCI with bioresorbable polymer
sirolimus-eluting stent Ultimaster (BP-SES) versus the bare metal stent
(BMS) platform. The primary endpoints of the study are: safety at 1 month
(composite of all-cause death, recurrent MI, unplanned infarct related
artery revascularisation, stroke, definite stent thrombosis or major
bleeding), efficacy at 6 months (in-stent late loss in angiographic
subset) and safety and efficacy at 1 year (target vessel failure, TVF).
The mean age (60.2 vs. 61.5y), gender (81.0% vs. 80.0% male) rate of
diabetes (15.2% vs. 12.8%), hypertension (53.3% vs. 51.2%), smoking (50.7%
vs. 48%) and family history of CAD (33.9% vs .32.8%) did not differ
between two groups. The culprit lesion was most often located in RCA
(47%). Diameter stenosis pre-procedure was 96.5% and 97.1% in BP-SES and
BMS groups, while post-procedure was 1.1% and 1.0% respectively. 51% of
patients had direct stenting. The pain-to-balloon time (294 mins vs. 263
mins, P=0.20) and door-to-balloon time (74 mins vs 70 mins, P=0.76) were
also similar. Thrombus aspiration was performed in more than one third of
patients. More than 70% of the patients had TIMI 0 or 1 before procedure
in both groups, and after procedure 96% of patients in BP-SES and 95% in
BMS arm had TIMI 3. At baseline BP-SES patients had more frequently staged
procedure planned (24% vs 12%, p<0.01), higher number of stents implanted
per lesion (1.5+/-0.9 vs 1.3+/-0.6, p<0.01) and longer total stent length
per patient (29.8 +/-17.3 mm vs. 26.0+/-12.1 mm, p<0.01). The primary
safety endpoint occurred in 3.5% vs 7.2% of patients at 1 month (p=0.13).
At 6 months, in the angiographic subset (141 lesions) late loss in BP-SES
was 0.10+/-0.43mm vs 0.87+/-0.61mm with BMS (p for superiority <0.01). At
6 months, in Ultimaster and in BMS group the rate of cardiac death was
2.7% vs 4.0% (p=0.54), clinically driven (CD) TLR was 1.9% vs 5.6%
(p=0.05), and CD-TVR was 2.4 vs 5.6 (p=0.09) respectively. The TLF rate
was 4.3 vs. 8.8 % (p=0.07), while the TVF was 4.8% vs. 8.8% (p=0.12).
Major bleeding rate was 0.8% vs 2.4% (p=0.17). Occurrence of patient
oriented composite endpoint (composite of all deaths, all MIs and all
coronary revascularisations) was 7.7% vs 14.4% (p=0.03) in BP-SES and BMS
groups, and the rate of definite or probable stent thrombosis was
significantly lower in BP-SES group when compared with BMS (1.3% vs. 4.8%,
p=0.03). Conclusions: In a population representative of daily practice,
superior efficacy and favourable short-term safety of BP-SES vs. BMS were
shown. According to the currently available MASTER trial data, the
Ultimaster DES with bioresorbable polymer coated abluminally on thin
struts are valuable features in the STEMI setting. The primary endpoint of
TVF at 1 year will be available at the time of presentation and is
expected to confirm superiority of Ultimaster over BMS.

<74>
Accession Number
611934723
Author
Praz F.; Windecker S.; Testa L.; Simonato M.; George I.; Nickenig G.;
Casselman F.; Bleiziffer S.; Ferrari E.; Yao R.; Chodor P.; Campante Teles
R.; Weisz G.; Landes U.; Elhmidi Y.; Welsh R.; Petursson P.; Barbanti M.;
De Backer O.; Rana R.; Bunc M.; Walton A.; Kornowski R.; Dvir D.
Institution
(Praz, Windecker) Universitatsspital Bern, Bern, Switzerland
(Testa) Irccs Pol. San Donato, Milan, Italy
(Simonato) Escola Paulista De Medicina-Unifesp, Sao Paulo, Brazil
(George) Columbia University, Medical Center, New York, United States
(Nickenig) Universitatsklinikum Bonn, Bonn, Germany
(Casselman) OLV Clinic, Aalst, Belgium
(Bleiziffer, Elhmidi) German Heart Center, Munich, Germany
(Ferrari) University Hospital Of Lausanne, Lausanne, Switzerland
(Yao) University Of British Columbia, Vancouver, Canada
(Chodor) Silesian Center For Heart Diseases, Zabrze, Poland
(Campante Teles) Hospital De Santa Cruz, Lisbon, Portugal
(Weisz) Shaare Zedek Medical Center, Jerusalem, Israel
(Landes, Kornowski) Rabin Medical Center, Petah Tivka, Israel
(Welsh) Mazankowski Heart Institute, Edmonton, Canada
(Petursson) University of Gothenburg, Gothenburg, Sweden
(Barbanti) Ferraroto Hospital, Catania, Italy
(De Backer) Rigshospitalet, Copenhagen, Denmark
(Rana, Dvir) St. Paul's Hospital, Vancouver, Canada
(Bunc) Ukc Ljubljana, Ljubljana, Slovenia
(Walton) Alfred Hospital, Melbourne, Australia
Title
Impact of impaired renal function on survival following transcatheter
aortic valve-in-valve implantation: Insights from the Valve-in-Valve
International Data registry (VIVID).
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 408), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: Chronic renal failure is a predictor of adverse outcomes after both
surgical and conventional transcatheter aortic valve replacement. The
impact of baseline renal failure on short-term outcomes following aortic
valve-in-valve has not been explored. Methods and results: A total of
1,453 patients from the Valve-in-Valve International Data (VIVID) registry
were included in the present analysis. Patients were divided into two
groups according to their baseline renal function. Impaired baseline
kidney function was defined as a glomerular filtration rate <60 ml/min.
Clinical endpoints were assessed according to the Valve Academic Research
Consortium-2 criteria. Primary endpoints were defined as all-cause or
cardiovascular mortality within 30 days. Impaired renal function was
recorded in 744/1,453 patients (51%). At baseline, patients with impaired
renal function had more advanced symptoms (30.3% vs. 22.6% in NYHA Class
IV; p<0.001) and lower left ventricular ejection fraction (51% vs. 53%;
p<0.001). Furthermore, impaired renal function patients were older (79.2
years vs. 76.8 years; p<0.001) and at higher surgical risk (mean STS score
12.1+/-9.5% vs. 8.2+/-7.8%; p<0.001). Patients with impaired renal
function experienced more post-procedural major or life-threatening
bleeding complications (8.4% vs. 4.6%; p=0.005). However, no difference
was detected in the incidence of major stroke (1.4% vs. 1.7%; p=0.67).
Patients in the impaired renal function group experienced acute kidney
injury (RIFLE >2) more frequently following the procedure (11.5% vs. 2%;
p<0.001). At 30-day follow-up, overall mortality was significantly higher
in the patients with impaired renal function at baseline in comparison to
those without (7.6% vs. 2.5%, p<0.001). Multivariable analysis confirmed
impaired renal function as a strong independent predictor of mortality in
patients undergoing aortic valve-in-valve (OR 3.7; 1.7-8.5; p=0.001), as
well as having a small surgical valve and undergoing non-transfemoral
access. Conclusions: The present large multicentre analysis establishes
that impaired renal function at baseline is a strong independent predictor
of mortality in patients undergoing aortic valve-in-valve. Moreover, renal
impairment significantly increases the risk of acute kidney injury and
major bleeding. Optimal patient screening and assessment is critical in
order to achieve best results with valve-in-valve procedures.

<75>
Accession Number
611934701
Author
Abawi M.; Agostoni P.; Stella P.
Institution
(Abawi, Stella) UMC-Utrecht, Utrecht, Netherlands
(Agostoni) St. Antonius Hospital, Nieuwgein, Netherlands
Title
Rationale and design of the Edwards SAPIEN 3 periprosthetic leakage
evaluation vs. Medtronic CoreValve in transfemoral aortic valve
implantation (ELECT) trial: A randomised comparison of balloon-expandable
vs. self-expanding transcatheter aortic valve prostheses.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 383), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The current randomised study aims to evaluate potential differences
between the balloon-expandable Edwards SAPIEN 3TM and the self-expanding
Medtronic CoreValve system with main focus on post-TAVI periprosthetic
aortic regurgitation. Methods and results: The ELECT study is a
single-centre, prospective, two-arm randomised controlled trial. For the
purposes of this study, 108 consecutive adult patients will be randomly
allocated to receive the SAPIEN 3 (n=54) or the CoreValve system (n=54).
Randomisation will be performed using sealed envelopes. Only patients with
aortic annulus diameter between >18 and <29 mm and anatomy suitable for
transfemoral TAVI will be included. Conclusions: The ELECT trial is the
first randomised controlled trial to compare quantitatively the extent of
post-TAVI PPR between SAPIEN 3 and CoreValve. Furthermore, it will
evaluate potential differences between the two prostheses with regard to
midterm clinical outcome and quality of life.

<76>
Accession Number
611934658
Author
Perrin N.; Roffi M.; Frei A.; Ellenberger C.; Licker M.; Noble S.
Institution
(Perrin, Roffi, Frei, Ellenberger, Licker, Noble) University Hospital Of
Geneva, Geneva, Switzerland
Title
Treatment of severe aortic stenosis with a new-generation recapturable and
repositionable self-expanding transcatheter aortic valve system: A
single-centre experience of consecutive patients.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 382), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The purpose of the present study is to report prospectively
collected safety data and clinical outcomes of the new-generation
recapturable and repositionable CoreValve Evolut R System (Medtronic,
Inc., Minneapolis, MN, USA). Methods and results: Between February and
December 2015, 51 consecutive patients underwent TAVI at a tertiary
centre. All were treated with the 14 Fr CoreValve Evolut R System for
symptomatic severe aortic stenosis. Clinical endpoints were independently
adjudicated according to the Valve Academic Research Consortium (VARC)-2
criteria. Primary outcomes consisted of the VARC-2 early safety composite
endpoints at 30 days and device success. Device success was defined as the
absence of procedural mortality, correct positioning of a single
prosthetic heart valve into the proper anatomical location and intended
performance (no prosthesis patient mismatch and mean aortic valve gradient
<20 mmHg or peak velocity <3 m/s, and no moderate or severe prosthetic
valve regurgitation). The incidence of new pacemaker implantation was also
reported. The median population age was 82 [IQR: 78.5-86] years and 42.2%
were females with a median EuroSCORE II (European System for Cardiac
Operative Risk Evaluation) and Society of Thoracic Surgeons score of 3.6%
[IQR: 2.1-4.8] and 3.4% [IQR: 2.4-5.0], respectively. A previous pacemaker
was present in 11.8% of patients. A fully percutaneous vascular approach
was preferred in 90.2% of patients and the EnVeo R delivery catheter was
advanced sheathless in 88.2% of patients. All attempts (11/51) at valve
repositioning were successful. At 30 days, 2 patients (4.7%) died and 4
patients (8.7%) presented a stroke including one disabling stroke (Rankin
score of 4). Two patients (3.9%) experienced major vascular complications
and 3 (5.9%) had life-threatening bleedings. Overall device success was
reported in 88.2% of patients. Paravalvular leakage at 30 days was less
than moderate and moderate in 97.4% and 2.6% of patients, respectively. No
severe paravalvular leakage was reported. The CoreValve Evolut R System
was effective in reducing mean transvalvular aortic gradient from
43.7+/-14.3 at baseline to 7.8+/-3.7 at discharge (p<0.0001 vs. baseline)
and 7.8+/-4.1 at 30 days. New permanent pacemaker implantation was
required in 21.6%. Conclusions: The first experience with the
new-generation CoreValve Evolut R System shows high device success and
acceptable morbidity and mortality. The reduced sheath size and recapture
properties have the potential to improve clinical outcomes, though this
will have to be demonstrated in larger multicentre studies.

<77>
Accession Number
611934631
Author
Gotberg M.; Koul S.; Nozohoor S.; Olivecrona G.; Harnek J.; Bjursten H.
Institution
(Gotberg, Koul, Nozohoor, Olivecrona, Harnek, Bjursten) Skane University
Hospital, Lund University, Lund, Sweden
Title
Single-centre evaluation of a next-generation fully repositionable and
retrievable transcatheter aortic valve.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 356), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: The purpose of this study was to evaluate the safety and efficacy of
the new fully repositionable and retrievable TAVR valve, the Lotus Valve
System in a high-risk all-comers TAVR population. Methods and results: We
performed a prospective single-centre, non-randomised evaluation of the
Lotus Valve System at Skane University Hospital, Sweden. The first 100
consecutive Lotus valve implantations were included in the analysis.
Outcome was assesed according to VARC2 criteria. Paravalvular leak (PVL)
was assessed by an independent experienced observer. Post-operative
pacemaker rates were assessed using the Swedish Pacemaker Registry with
100% coverage. Mean age of the patient population was 82.8 years. Mean
STS-score was 6.7. Mean aortic valve area was 0.6+/-0.2cm2. The valve was
successfully implanted in 100/101 patients, with no cases of valve
embolisation, ectopic valve deployment or addititional valve implantation.
In one patient, the procedure was aborted due to device failure, the
patient was successfully treated with a Lotus valve one month later. In
one other patient, the procedure was aborted due to inability to cross a
severely tortuous aorta with the delivery system. Mean transvalvular
gradient improved from 48.1+/-11.9mmHg to 9.9+/-3.5mmHg. At 30 days, the
mortality rate was 3%. Two deaths were due to stroke and one death was due
to a ventricular rupture. Major stroke rate was 2% and major vascular
complications rate was 2%. A total of 86% of patients had no/trace PVL,
12% had mild PVL and one patient had a moderate PVL due to a large
calcified annular nodule. A low rate of pacemaker implantation was noted
with 13% having received a permanent pacemaker post-TAVR. This number was
only 8% in the last 50% due to improvement in the implantation technique.
Conclusions: This single-centre evaluation of the Lotus Valve system
demonstrated a favorable clinical outcome in a high-risk TAVR-population
with observed minimal paravalvular leak and lower pacemaker rates than
observed in previous trials.

<78>
Accession Number
611934586
Author
Boukhris M.; Tomasello S.D.; Marza F.; Ibn Elhadj Z.; Azzarelli S.;
Galassi A.R.
Institution
(Boukhris, Marza, Galassi) Department of Experimental and Clinical
Medicine, University of Catania, Catania, Italy
(Tomasello, Azzarelli) Cannizzaro Hospital, Catania, Italy
(Ibn Elhadj) Cardiology Department, Abderrahmen Mami Hospital, Ariana,
Tunisia
Title
Percutaneous coronary revascularisation for CTO: A novel predictive score
of technical failure.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 29), 2016. Date of Publication: May
2016.
Publisher
EuroPCR
Abstract
Aims: This study sought to describe the 10-year experience of a chronic
total occlusion (CTO) dedicated operator, and to establish a model for
predicting technical failure. Methods and results: From January 2005 to
December 2014, 1019 patients (aged 61.1+/-9.7 years, 91.3% males)
underwent 1073 CTO procedures performed by a single CTO dedicated
operator. The study population was subdivided into two time period groups:
period 1 (from January 2005 to December 2009, n=378) and period 2 (from
January 2010 to December 2014, n=641). J-CTO score was used to assess CTO
lesions' difficulty. Lesions attempted in period 2 were more complex in
comparison with those in period 1 (J-CTO score >3: 56.6% vs. 29.4%;
p<0.001, respectively). As compared to period 1, both technical and
clinical success rates has significantly improved (from 87.8% to 94.4%
[p=0.001], and from 77.6% to 89.9% [p<0.001], respectively).
Hosmer-Lemeshow test revealed lack of fit between J-CTO score and
technical failure (chi 2 =7.817; p=0.05), and receiver operating
characteristic curve demonstrated low descrimination (area under the
curve=0.556). Notably, an increase in J-CTO score was associated with
greater use of antegrade dissection re-entry techniques and retrograde
approach. Observations were randomly assigned to a derivation set and a
validation set (at a 2:1 ratio). A prediction score for technical failure
including age >75 years (1point), ostial location (1point) and collateral
filling Rentrop <2 (2points) was established by assigning points for each
independent predictor in the derivation set according to the beta
coefficient and summing all points accrued. This latter score stratified
procedures into 4 difficulty groups: easy (0), intermediate (1), difficult
(2), and very difficult (3-4) with decreasing technical success rates. In
derivation and validation sets, areas under the curves were comparable
(0.728 and 0.772, respectively). Conclusions: With growing expertise,
success rate has increased despite an increasing complexity of attempted
lesions. Conversely to J-CTO score, the established ORA score (O:ostial;
R:Rentrop<2; A: age>75 years) was able to predict the probability of
technical failure, thus might be applied for difficulty grading of CTO PCI
procedures and for rationalising their indications.

<79>
Accession Number
611934568
Author
Moura-Ferreira S.; Silva M.; Dias T.; Guerreiro C.; Caeiro D.; Dias A.;
Ponte M.; Braga P.; Rodrigues A.; Pelicano N.; Gama V.
Institution
(Moura-Ferreira, Pelicano) Hospital Do Divino Espirito Santo De Ponta
Delgada, Ponta Delgada, Portugal
(Silva, Dias, Guerreiro, Caeiro, Dias, Ponte, Braga, Rodrigues, Gama)
Centro Hospitalar De Vila Nova De Gaia Espinho, Vila Nova De Gaia Espinho,
Portugal
Title
In-hospital adverse outcome predictors of coronary stenting in unprotected
left main coronary artery PCI: A single-centre experience.
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 204), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: This study aimed to evaluate the feasibility and the predictors of
in-hospital adverse outcomes in patients undergoing unprotected left main
coronary artery (ULMCA) percutaneous coronary intervention (PCI). Methods
and results: Retrospective, observational study, including all patients
undergoing ULMCA stenting due to significant ULMCA disease detected
angiographically between January 2008 and September 2015. Eighty-four
patients, including those with stable angina (22.6%), unstable angina
(15.5%), acute non-ST-segment elevation myocardial infarction (35.7%) and
acute ST-segment elevation myocardial infarction (26.2%) with significant
ULMCA disease (57.1% distal lesions) undergoing ULMCA stenting, were
consecutively enrolled. The patients" mean age was 70.7+/-12.3 years old
and mean EuroSCORE II was 9.6+/-11.6 points. Mechanical support, including
extracorporeal membrane oxygenation, mechanical ventilation and/or
intra-aortic balloon pump, was used in 1.2% (1/84), 16.7% (14/84) and
35.7% (30/84) patients, respectively. Stent implantation was successfully
performed in all patients. In-hospital major adverse cardiac and
cerebrovascular event (MACCE) and in-hospital all-cause mortality rates
were 7.1% (6/84) and 9.5% (8/84), respectively. Acute myocardial
infarction, cardiogenic shock, usage of mechanical ventilation or
intra-aortic balloon pump were all associated with in-hospital adverse
outcomes (MACCE and in-hospital all-cause mortality [p<0.001]).
Conclusions: Our study demonstrated that catheter-based ULMCA stenting has
high rates of procedural success and is a feasible treatment option. We
also concluded that adverse clinical setting (acute myocardial infarction,
cardiogenic shock, usage of mechanical ventilation or intra-aortic balloon
pump) in patients undergoing ULMCA stenting is associated with poor
in-hospital outcome. Data from randomised controlled clinical trials
including a larger number of patients are needed to assess further the
predictors of in-hospital adverse outcomes in patients undergoing ULMCA
PCI.

<80>
Accession Number
611934557
Author
Aziz M.; Webb J.; Abdel-Wahab M.; Mcelhinney D.; Duncan A.; Tchetche D.;
Simonato M.; Barbanti M.; Petronio A.S.; Maisano F.; Gama V.; Gaia D.;
Hilker M.; Kocka V.; Wijeysundera H.; Hellig F.; Nissen H.; Bekeredjian
R.; Vahanian A.; Himbert D.; Rihal C.; Duffy S.; Dvir D.
Institution
(Aziz, Webb, Dvir) St. Paul's Hospital, Vancouver, Canada
(Abdel-Wahab) Segeberger Kliniken, Bad Segeberg, Germany
(Mcelhinney) Stanford University, Stanford, United States
(Duncan) Royal Brompton Hospital, London, United Kingdom
(Tchetche) Clinique Pasteur, Toulouse, France
(Simonato, Gaia) Escola Paulista De Medicina - UNIFESP, Sao Paulo, Brazil
(Barbanti) Ferraroto Hospital, Catania, Italy
(Petronio) University of Pisa, Pisa, Italy
(Maisano) Universitatsspital Zurich, Zurich, Switzerland
(Gama) Centro Hospitalar De Vila Nova De Gaia, Vila Nova de Gaia, Portugal
(Hilker) Universitatsklinikum Regensburg, Regensburg, Germany
(Kocka) Cardiocentre Praha, Prague, Czech Republic
(Wijeysundera) Sunnybrook Hospital, Toronto, Canada
(Hellig) Sunninghill Hospital, Johannesburg, South Africa
(Nissen) Odense University Hospital, Odense, Denmark
(Bekeredjian) University of Heidelberg, Heidelberg, Germany
(Vahanian, Himbert) Hopital Bichat, Paris, France
(Rihal) Mayo Clinic, Rochester, United States
(Duffy) Alfred Hospital, Melbourne, Australia
Title
Mortality prediction after transcatheter treatment of failed bioprosthetic
valves: Insights from the valve-in-valve international data registry
(VIVID).
Source
EuroIntervention. Conference: EuroPCR 2016 France. Conference Start:
20160517 Conference End: 20160520. (pp 430), 2016. Date of Publication:
May 2016.
Publisher
EuroPCR
Abstract
Aims: There is no scoring system yet validated to predict mortality after
aortic valve-in-valve. Commonly used scoring systems were assessed
regarding their performance based on accuracy and generalisability to
estimate aortic valve-in-valve mortality. Methods and results: A total of
1,485 patients, included in the Valve-In-Valve International Data (VIVID)
registry undergoing aortic ViV procedures, were evaluated (57.2% male,
77.9+/-9.1 years). STS, logistic EuroSCORE I, and EuroSCORE II were
calculated by 2 separate researchers. The accuracy of these scores was
evaluated based on calibration and discrimination. Thirty-day all-cause
mortality was 74 of 1,426 patients (5.19%). Observed mortality within 30
days differed in each quartile (Q1/Q2/Q3/Q4): logistic EuroSCORE I,
2.8%/3.2%/3.7%/10.5% (p<0.001), EuroSCORE II, 0.6%/4.5%/4.5%/10.2%
(p<0.001), and STS, 2.3%/2.9%/5.6%/10% (p<0.001). Observed: expected
mortality ratios (O:E) were all <1: STS, 0.59 (95% CI: 0.457-0.677);
logistic EuroSCORE I, 0.17 (95% CI: 0.135-0.205); EuroSCORE II, 0.36 (95%
CI: 0.287-0.433). O:E mortality ratios by score quartiles showed higher
results for STS in comparison to other groups evaluated: Q1 (STS 0.74,
logistic EuroSCORE I 0.24, EuroSCORE II 0.1, p=0.03), Q2 (STS 0.52,
logistic EuroSCORE I 0.14, EuroSCORE II 0.42, p=0.01), Q3 (STS 0.65,
logistic EuroSCORE I 0.11, EuroSCORE II 0.3, p<0.001), Q4 (STS 0.54,
logistic EuroSCORE I 0.2, EuroSCORE II 0.39, p<0.001). Calculated
discriminative power (C-index per AUC): STS 0.729 (95% CI: 0.659-0.799),
logistic EuroSCORE 0.684 (95% CI: 0.606-0.763) and EuroSCORE II 0.719 (95%
CI: 0.646-0.792). Conclusions: The current, large, multicentre study
demonstrates that, in patients undergoing valve-in-valve procedures, STS
is the least erroneous score in low, intermediate and high-risk patients,
with the highest discriminatory power among studied scores. Nevertheless,
all studied risk scores significantly overestimate early mortality after
valve-in-valve procedures. There is a need to create a novel predictive
scoring system specific to patients undergoing transcatheter aortic
valve-in-valve implantation with high accuracy and generalisability.

<81>
Accession Number
611869509
Author
Narula J.; Kiran U.; Kapoor P.; Choudhury M.; Rajashekar P.; Chowdhary
U.K.
Institution
(Narula, Kiran, Kapoor, Choudhury, Rajashekar, Chowdhary) All India
Institute of Medical Sciences, Delhi, India
Title
Electrically cardio-metering intraoperative autologous donation.
Source
Vox Sanguinis. Conference: 34th International Congress of the
International Society of Blood Transfusion United Arab Emirates.
Conference Start: 20160903 Conference End: 20160908. 111 (pp 20), 2016.
Date of Publication: September 2016.
Publisher
Blackwell Publishing Ltd
Abstract
Background: Intra-operative autologous donation (IAD) besides its proven
role in blood conservation, decreases the circulatory overload being
handled by the ventricles in volume loaded patients with pulmonary
hypertension (PH) secondary to left heart disease (LHD). Bioimpedance
based electrical cardiometry (EC) has recently shown to provide accurate
measurements of cardiac output (CO), thoracic fluid content (TFC) and
volume shifts, estimation of which is of prime importance in patients with
critical pre-operative state. Aim: To evaluate the effect of IAD induced
volume shifts on hemodynamics and lung gaseous exchange using EC in
patients with pulmonary artery hypertension secondary to left heart
disease. Methods: Prospective randomized controlled trial conducted in 50
patients scheduled to undergo heart valve replacement. IAD performed in
the test group was simultaneously replaced with 1:1 colloid. TFC,
hemodynamic and EC data were recorded at T1-baseline (post induction) and
T2-20 min post-IAD. Results: Withdrawal of 15% of blood volume in the IAD
group caused a significant reduction in TFC -10.1% (-15.0 to -6.1), right
atrial pressure -23% (-26.6 to -17.6), mean arterial pressure -12.6%
(-22.2 to -3.8), airway pressures; [peak -6.2% (-11.7 to -2.8) and mean
-15.4% (-25.0 to -8.3)] and oxygenation index (OI) -10.34%(-16.4 to -4.8).
Linear regression analysis showed good correlation between the amount of
autologous blood removed and percentage change in TFC, RAP, peak and mean
airway pressures and OI. Conclusions: Our study shows that therapeutic
benefits derived from IAD include decongestion of volume loaded patients,
decrease in intrathoracic fluid and improvement in gas exchange. EC tracks
beat-to-beat fluid and hemodynamic fluctuations during IAD and can help to
execute an early patient specific goal directed therapy allowing for its
safe implementation in high risk patients with PH-LHD.

<82>
Accession Number
611869458
Author
Crighton G.
Institution
(Crighton) Haematology Society of Australia and New Zealand, Sydney, NSW,
Australia
Title
Evidence-based patient bood management guidelines for neonatal and
paediatric patients.
Source
Vox Sanguinis. Conference: 34th International Congress of the
International Society of Blood Transfusion United Arab Emirates.
Conference Start: 20160903 Conference End: 20160908. 111 (pp 18-19), 2016.
Date of Publication: September 2016.
Publisher
Blackwell Publishing Ltd
Abstract
Introduction/Aims: The National Blood Authority (NBA), Australia has
funded and managed the development of evidence-based Patient Blood
Management (PBM) Guidelines, comprising six modules: Critical
Bleeding/Massive Transfusion (2011), Perioperative (2012), Medical (2012),
Critical Care (2012), Obstetric/Maternity (2015) and Neonatal/Paediatrics
(2016). A national strategy for implementation has been developed by the
NBA with a series of tools and activities to support health departments
and health providers in their uptake of these guidelines. Module 6 -
Neonatal and Paediatrics aimed to systematically review and critically
appraise the literature with respect to PBM in neonatal and paediatric
patients. Methods: The module was developed by collaboration between
professional partners in systematic review and guideline authorship and a
Clinical/Consumer Reference Group (CRG) comprising experts from clinical
colleges and societies; in the areas of fetal-maternal medicine,
neonatology, paediatric haematology, paediatric anaesthesia, intensive
care, cardiac surgery, oncology, haemoglobinopathies, nursing and PBM, in
addition to consumer and indigenous representatives. Systematic review
questions were formulated for the target population 'neonatal and
paediatric patients' and included: the effect of red blood cell (RBC) and
other blood component transfusion on patient outcomes, the effect of
non-transfusion measures to increase haemoglobin on patient outcomes and
the effect of strategies to minimize blood loss and/or reduce RBC
transfusion. A comprehensive search of electronic databases and clinical
trials registries was conducted for the years 1995 to 2014 (inclusive).
Three types of guidance were developed; Recommendations were developed
where a question had been critically appraised and evidence was found to
guide practice, and Practice Points were developed by CRG consensus where
insufficient evidence was found. Expert Opinion Points were formulated
based on CRG consensus for other areas that were considered important in
neonatal and paediatric PBM but outside the scope of the systematic
review. Module 6 has been peer reviewed, and independently assessed
according to the Appraisal of Guidelines for Research & Evaluation II. The
Module's recommendations were approved by the National Health and Medical
Research Council on 21 March 2016. Results: Twelve Recommendations for or
against the use of a number of interventions in neonatal and, or,
paediatric patients were developed. These included RBC transfusion in
critically ill patients and sickle cell disease (SCD),
erythropoiesis-stimulating agents in preterm infants, hydroxyurea in SCD,
fresh frozen plasma based primes and recombinant factor VIIa in cardiac
surgery, intravenous immunoglobulin for rhesus disease of the newborn,
prevention of hypothermia and anti-fibrinolytics in surgical patients. In
addition 40 Practice Points and 37 Expert Opinion Points provide further
guidance. Conclusions: These guidelines will aid decisions on whether to
transfuse a neonate or child in the context of specific patient
circumstances, and the full range of other available treatments, balancing
the evidence for efficacy and improved clinical outcome against the
potential risk. Many areas were identified with insufficient evidence to
make recommendations. Furthermore, despite the potential for long-term
consequences of neonatal and paediatric interventions, most studies only
addressed short-term outcomes, which were often insufficient to determine
overall risks and benefits. The evidence gaps identified provide a focus
for future research.