Results Generated From:
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Embase <1980 to 2015 Week 28>
Embase (updates since 2015-07-03)
<1>
Accession Number
2015159474
Authors
Jang J.-S. Jin H.-Y. Seo J.-S. Yang T.-H. Kim D.-K. Kim D.-S. Cho K.-I.
Kim B.-H. Park Y.H. Je H.-G.
Institution
(Jang, Jin, Seo, Yang, Kim, Kim) Department of Cardiology, Busan Paik
Hospital, University of Inje College of Medicine, Busan, South Korea
(Cho) Department of Cardiology, Kosin University, Medical Center, Busan,
South Korea
(Kim) Department of Internal Medicine, Pusan National University Hospital,
Busan, South Korea
(Park, Je) Department of Cardiovascular and Thoracic Surgery, Research
Institute for Convergence of Biomedical Science and Technology, Pusan
National University, Yangsan, South Korea
Title
Meta-analysis of multivessel versus culprit-only percutaneous coronary
intervention in patients with non-ST-segment elevation acute coronary
syndrome and multivessel coronary disease.
Source
American Journal of Cardiology. 115 (8) (pp 1027-1032), 2015. Date of
Publication: 2015.
Publisher
Elsevier Inc.
Abstract
Even in the era of contemporary drug-eluting stents, it is not clear
whether percutaneous coronary intervention (PCI) for nonculprit lesions
can improve long-term outcomes in patients with noneST-segment elevation
acute coronary syndrome (NSTE-ACS) with multivessel coronary disease.
Relevant studies published through August 2014 were searched and
identified in the electronic databases. Summary estimates were obtained
using a randomeffects model. From 368 initial citations, 8 observational
studies with 8,425 patients (3,227 multivessel and 5,198 culprit-only PCI)
were included. Mean follow-up duration was 18 months. There were no
significant differences in all-cause mortality (odds ratios [ORs] 0.85,
95% confidence interval [CI] 0.70 to 1.04) and myocardial infarction (OR
0.86, 95% CI 0.55 to 1.35). However, multivessel PCI was associated with a
significantly lower rate of repeat revascularization (OR 0.75, 95% CI 0.56
to 1.00). Comparison of multivessel versus culprit-only PCI disclosed OR
for major adverse cardiac events of 0.74 (95% CI 0.57 to 0.97). In
conclusion, multivessel PCI reduced repeat revascularization without
significant benefits in terms of mortality or myocardial infarction at the
long-term follow-up in patients with NSTE-ACS and multivessel coronary
disease. Future randomized studies that examine the safety and efficacy of
multivessel PCI in NSTE-ACS are warranted.
<2>
Accession Number
2015075999
Authors
Schoenrath F. Markendorf S. Brauchlin A.E. Seifert B. Wilhelm M.J. Czerny
M. Riener R. Falk V. Schmied C.M.
Institution
(Schoenrath, Falk) Department of Cardiothoracic and Vascular Surgery,
Deutsches Herzzentrum Berlin, Augustenburger Platz 1, Berlin 13353,
Germany
(Markendorf, Wilhelm) Clinic for Cardiovascular Surgery, University Heart
Center, Zurich, Switzerland
(Brauchlin, Schmied) Clinic for Cardiology, University Heart Center,
Zurich, Switzerland
(Seifert) Epidemiology Biostatistics and Prevention Institute, Department
of Biostatistics, University of Zurich, Zurich, Switzerland
(Czerny) Department of Cardiovascular Surgery, University Heart Center
Freiburg-Bad Krozingen, Freiburg, Germany
(Riener) Sensory-Motor Systems Lab, ETH, Zurich, Switzerland
(Falk) University Hospital Balgrist, University of Zurich, Zurich,
Switzerland
Title
Robot-Assisted Training Early after Cardiac Surgery.
Source
Journal of Cardiac Surgery. 30 (7) (pp 574-580), 2015. Date of
Publication: 01 Jul 2015.
Publisher
Blackwell Publishing Inc.
Abstract
Background To assess feasibility and safety of a robot-assisted gait
therapy with the Lokomat system in patients early after open heart
surgery. Methods Within days after open heart surgery 10 patients were
subjected to postoperative Lokomat training (Intervention group, IG)
whereas 20 patients served as controls undergoing standard postoperative
physiotherapy (Control group, CG). All patients underwent six-minute walk
test and evaluation of the muscular strength of the lower limbs by
measuring quadriceps peak force. The primary safety end-point was freedom
from any device-related wound healing disturbance. Patients underwent
clinical follow-up after one month. Results Both training methods resulted
in an improvement of walking distance (IG [median, interquartile range,
p-value]: +119 m, 70-201 m, p = 0.005; CG: 105 m, 57-152.5m, p < 0.001)
and quadriceps peak force (IG left: +5 N, 3.8 7 N, p = 0.005; IG right:
+3.5 N, 1.5-8.8 N, p = 0.011; CG left: +5.5 N, 4-9 N, p < 0.001; CG right:
+6 N, 4.3-9.8 N, p < 0.001) in all participants. Results with
robot-assisted training were comparable to early postoperative standard in
hospital training (median changes in walking distance in percent, p =
0.81; median changes in quadriceps peak force in percent, left: p = 0.97,
right p = 0.61). No deep sternal wound infection or any adverse event
occurred in the robot-assisted training group. Conclusions Robot-assisted
gait therapy with the Lokomat system is feasible and safe in patients
early after median sternotomy. Results with robot-assisted training were
comparable to standard in hospital training. An adapted and combined
aerobic and resistance training intervention with augmented feedback may
result in benefits in walking distance and lower limb muscle strength
(ClinicalTrials.gov number, NCT 02146196). doi: 10.1111/jocs.12576 (J Card
Surg 2015;30:574-580)
<3>
Accession Number
2015071286
Authors
Lim J.Y. Deo S.V. Rababa'H A. Altarabsheh S.E. Cho Y.H. Hang D. McGraw M.
Avery E.G. Markowitz A.H. Park S.J.
Institution
(Lim, Markowitz, Park) Asan Medical Center, Ulsan School of Medicine,
Seoul, South Korea
(Deo) Division of Cardiovascular Surgery, Case Medical Center, Case
Western Reserve University, Cleveland, Ohio, United States
(Rababa'H) Department of Clinical Pharmacy, Jordan University of Science
and Technology, Irbid, Jordan
(Altarabsheh) Department of Cardiac Surgery, Queen Alia Heart Institute,
Amman, Jordan
(Cho) Samsung Hospital, Sungkyunkwan School of Medicine, Seoul, South
Korea
(Hang) School of Medicine, Case Western Reserve University, Cleveland, OH,
United States
(McGraw) Health Sciences Library, Case Western Reserve University,
Cleveland, OH, United States
(Avery) Department of Anesthesia and Peri-operative Medicine, Case Medical
Center, Case Western Reserve University, Cleveland, OH, United States
Title
Levosimendan Reduces Mortality in Adults with Left Ventricular Dysfunction
Undergoing Cardiac Surgery: A Systematic Review and Meta-analysis.
Source
Journal of Cardiac Surgery. 30 (7) (pp 547-554), 2015. Date of
Publication: 01 Jul 2015.
Publisher
Blackwell Publishing Inc.
Abstract
Introduction Levosimendan is implemented in patients with low cardiac
output after cardiac surgery. However, the strength of evidence is limited
by randomized controlled trials enrolling a small number of patients.
Hence we have conducted a systematic review to determine the role of
levosimendan in adult cardiac surgery. Methods PUBMED, WoS, Cochrane
database, and SCOPUS were systematically queried to identify original
English language peer-reviewed literature (inception-October 2014)
comparing clinical results of adult cardiac surgery between levosimendan
and control. Pooled odds ratio (OR) was calculated using the Peto method;
p < 0.05 is significant; results are presented within 95% confidence
intervals. Continuous data was compared using standardized mean
difference/mean difference. Results Fourteen studies were included in the
analysis. Levosimendan reduced early mortality in patients with reduced
ejection fraction (5.5% vs. 9.1%) (OR 0.48 [0.23-0.76]; p = 0.004). This
result was confirmed using sensitivity analysis. Postoperative acute renal
failure was lower with levosimendan therapy (7.4% vs. 11.5%). Intensive
care unit stay was shorter in the levosimendan cohort comparable in both
groups (standardized mean difference -0.31 [-0.53, -0.09]; p = 0.006;
I<sup>2</sup> = 33.6%). Levosimendan-treated patients stayed 1.01
(1.61-0.42) days shorter when compared to control (p = 0.001). Conclusion
Our meta-analysis demonstrates that Levosimendan improves clinical
outcomes in patients with left ventricular dysfunction undergoing cardiac
surgery. Results of the ongoing multicenter randomized controlled trial
are awaited to provide more conclusive evidence regarding the benefit of
this drug. doi: 10.1111/jocs.12562 (J Card Surg 2015;30:547-554)
<4>
Accession Number
2015176171
Authors
Buggeskov K.B. Jakobsen J.C. Secher N.H. Jonassen T. Andersen L.W.
Steinbruchel D.A. Wetterslev J.
Institution
(Buggeskov, Andersen) The Heart Centre, Rigshospitalet, Department of
Cardiothoracic Anaesthesiology, 4142, Blegdamsvej 9, Copenhagen DK-2100,
Denmark
(Jakobsen, Wetterslev) Centre for Clinical Intervention Research,
Rigshospitalet, The Copenhagen Trial Unit, 7812, Blegdamsvej 9, Copenhagen
DK-2100, Denmark
(Secher) Rigshospitalet, Department of Anaesthesiology, 2041, Blegdamsvej
9, Copenhagen DK-2100, Denmark
(Jonassen) University of Copenhagen, Department of Biomedical Sciences,
The Panum Institute, Blegdamsvej 3, Copenhagen DK-2200, Denmark
(Steinbruchel) The Heart Centre, Rigshospitalet, Department of
Cardiothoracic Surgery, 2152, Blegdamsvej 9, Copenhagen DK-2100, Denmark
Title
Detailed statistical analysis plan for the pulmonary protection trial.
Source
Trials. 15 (1) , 2014. Article Number: 510. Date of Publication: December
23, 2014.
Publisher
BioMed Central Ltd.
Abstract
Background: Pulmonary dysfunction complicates cardiac surgery that
includes cardiopulmonary bypass. The pulmonary protection trial evaluates
effect of pulmonary perfusion on pulmonary function in patients suffering
from chronic obstructive pulmonary disease. This paper presents the
statistical plan for the main publication to avoid risk of outcome
reporting bias, selective reporting, and data-driven results as an update
to the published design and method for the trial. Results: The pulmonary
protection trial is a randomized, parallel group clinical trial that
assesses the effect of pulmonary perfusion with oxygenated blood or
CustodiolTM HTK (histidine-tryptophan-ketoglutarate) solution versus no
pulmonary perfusion in 90 chronic obstructive pulmonary disease patients.
Patients, the statistician, and the conclusion drawers are blinded to
intervention allocation. The primary outcome is the oxygenation index from
10 to 15minutes after the end of cardiopulmonary bypass until 24hours
thereafter. Secondary outcome measures are oral tracheal intubation time,
days alive outside the intensive care unit, days alive outside the
hospital, and 30- and 90-day mortality, and one or more of the following
selected serious adverse events: pneumothorax or pleural effusion
requiring drainage, major bleeding, reoperation, severe infection,
cerebral event, hyperkaliemia, acute myocardial infarction, cardiac
arrhythmia, renal replacement therapy, and readmission for a
respiratory-related problem. Conclusions: The pulmonary protection trial
investigates the effect of pulmonary perfusion during cardiopulmonary
bypass in chronic obstructive pulmonary disease patients. A preserved
oxygenation index following pulmonary perfusion may indicate an effect and
inspire to a multicenter confirmatory trial to assess a more clinically
relevant outcome. Trial registration: ClinicalTrials.gov identifier:
NCT01614951, registered on 6 June 2012
<5>
Accession Number
2015157228
Authors
Ilic M.K. Madzarac G. Kogler J. Stancic-Rokotov D. Hodoba N.
Institution
(Ilic, Kogler, Hodoba) Department of Anesthesiology, University Hospital
Centre Zagreb, Zagreb, Croatia
(Madzarac, Stancic-Rokotov) Department of Thoracic Surgery 'Jordanovac,',
University Hospital Centre Zagreb, Zagreb, Croatia
Title
Intraoperative volume restriction in esophageal cancer surgery: An
exploratory randomized clinical trial.
Source
Croatian Medical Journal. 56 (3) (pp 290-296), 2015. Date of Publication:
2015.
Publisher
Medicinska Naklada Zagreb
Abstract
Aim To investigate whether the fluid volume administered during esophageal
cancer surgery affects pulmonary gas exchange and tissue perfusion.
Methods An exploratory single-center randomized clinical trial was
performed. Patients with esophageal cancer who underwent Lewis-Tanner
procedure between June 2011 and August 2012 at the Department of Thoracic
surgery "Jordanovac", Zagreb were analyzed. Patients were randomized (1:1)
to receive a restrictive volume of intraoperative fluid (<8 mL/kg/h) or a
liberal volume ( > 8 mL/kg/h). Changes in oxygen partial pressure
(Pao<inf>2</inf>), inspired oxygen fraction (FiO<inf>2</inf>), creatinine,
and lactate were measured during and after surgery. Results Overall 16
patients were randomized and they all were analyzed (restrictive group n =
8, liberal group n = 8). The baseline value
Pao<inf>2</inf>/FiO<inf>2</inf> ratio (restrictive) was 345.01 +/- 35.31
and the value six hours after extubation was 315.51 +/- 32.91; the
baseline Pao<inf>2</inf>/FiO<inf>2</inf> ratio (liberal) was 330.11 +/-
34.71 and the value six hours after extubation was 307.11 +/- 30.31. The
baseline creatinine value (restrictive) was 91.91 +/- 12.67 and the value
six hours after extubation was 100.88 +/- 18.33; the baseline creatinine
value (liberal) was 90.88 +/- 14.99 and the value six hours after
extubation was 93.51 +/- 16.37. The baseline lactate value (restrictive)
was 3.93 +/- 1.33 and the value six hours after extubation was 2.69 +/-
0.91. The baseline lactate value (liberal) was 3.26 +/- 1.25 and the value
six hours after extubation was 2.40 +/- 1.08. The two groups showed no
significant differences in Pao<inf>2</inf>/FiO<inf>2</inf> ratio (P =
0.410), creatinine (P = 0.410), or lactate (P = 0.574). Conclusions
Restriction of intraoperative applied volume does not significantly affect
pulmonary exchange function or tissue perfusion in patients undergoing
surgical treatment for esophageal cancer.
<6>
Accession Number
2015173423
Authors
de Hoogd S. Ahlers S.J.G.M. van Dongen E.P.A. Tibboel D. Dahan A. Knibbe
C.A.J.
Institution
(de Hoogd, Ahlers, Knibbe) St Antonius Hospital, Department of Clinical
Pharmacy, Koekoeklaan 1, Nieuwegein 3435 CM, Netherlands
(van Dongen) St Antonius Hospital, Department of Anesthesiology and
Intensive Care, Koekoeklaan 1, Nieuwegein 3435 CM, Netherlands
(Tibboel, Knibbe) Erasmus MC - Sophia Children's Hospital, Intensive Care
and Department of Pediatric surgery, Wytemaweg 80, Rotterdam 3015 CN,
Netherlands
(Dahan) Leiden University Medical Center, Department of Anesthesiology,
Albinusdreef 2, Leiden 2333 ZA, Netherlands
(Knibbe) Leiden University, Division of Pharmacology, Leiden Academic
Center for Drug Research, Einsteinweg 55, Leiden, Netherlands
Title
Remifentanil versus fentanyl during cardiac surgery on the incidence of
chronic thoracic pain (REFLECT): Study protocol for a randomized
controlled trial.
Source
Trials. 15 (1) , 2014. Article Number: 466. Date of Publication: November
27, 2014.
Publisher
BioMed Central Ltd.
Abstract
Background: Chronic thoracic pain after cardiac surgery is prevalent (11
to 56%) and may affect patients' physical and mental health status.
Despite its favorable pharmacokinetic and pharmacodynamic properties, high
doses of remifentanil administered during surgery are reported to cause
acute postoperative pain and increased requirements for analgesics.
Recently, an association between remifentanil use and the incidence of
chronic thoracic pain in the long term was also reported. Our objective is
to investigate the influence of the intraoperative remifentanil on chronic
postoperative pain in a prospective randomized controlled trial.
Methods/design: In this prospective, randomized, single-blind clinical
trial, all patients (N =126) between 18 and 85 years undergoing cardiac
surgery via sternotomy receive a continuous infusion of propofol together
with intermittent intravenous fentanyl at predetermined times
perioperatively. Patients are randomized to receive either an additional
continuous infusion of remifentanil (0.15
mug<sup>-1</sup>kgIBW<sup>-1</sup> min<sup>-1</sup>) or additional
fentanyl (200 to 500 mug) as needed during surgery. The primary end point
is the prevalence of chronic thoracic pain 12 months after surgery.
Secondary end points include acute postoperative pain; postoperative
analgesic use; chronic thoracic pain 3 and 6 months after surgery; quality
of life (SF-12) at 3, 6 and 12 months after surgery; work productivity;
and use of health care. In addition, thermal detection and pain thresholds
are measured preoperatively, 3 days after surgery and 12 months after
surgery using quantitative sensory testing (QST). Finally, the influence
of several genetic variances on the different outcomes will be measured.
Discussion: Chronic thoracic pain is prevalent after cardiac surgery, and
research is needed to minimize the risk of chronic persistent
postoperative pain, which is an invalidating, long-term complication of
surgery. The objective of this trial is to determine the influence of
perioperative remifentanil on long-term pain outcomes for cardiac patients
in a prospective randomized trial. The results may be used to optimize
perioperative analgesia techniques and, thereby, improve quality of life
after cardiac surgery. Trial registration: Clinicaltrials.gov NCT02031016
on 13 December 2013.
<7>
Accession Number
2015169871
Authors
Higgs M. Fernandez R.
Institution
(Higgs, Fernandez) St George Hospital, Sydney, NSW, Australia
(Fernandez) University of Wollongong, Wollongong, NSW, Australia
(Higgs, Fernandez) Center for Evidence Based Initiatives in Health Care,
Sydney, NSW, Australia
Title
The effect of insulin therapy algorithms on blood glucose levels in
patients following cardiac surgery: A systematic review.
Source
JBI Database of Systematic Reviews and Implementation Reports. 13 (5) (pp
205-243), 2015. Date of Publication: 30 Jun 2015.
Publisher
Joanna Briggs Institute
Abstract
Background: A number of insulin infusion algorithms, with varying methods
and effects, have been developed to guide the management of postoperative
hyperglycemia in critically ill patients. Objectives: The objective of
this study was to investigate the effect of insulin therapy algorithms on
blood glucose levels in patients in critical care environments following
cardiac surgery. Inclusion Criteria: Types of participants: Adult patients
aged 18 or older who were admitted to a critical care environment after
cardiac surgery and who received insulin therapy for glycemic control
during the acute postoperative phase of their admission. Types of
intervention: The intervention of interest was continuous intravenous
insulin therapy. Types of studies: Experimental study designs including
randomized controlled trials, non-randomized controlled trials and
controlled before and after studies published in the English language were
included in this review. Types of outcomes: Primary outcomes of interest
included objective measures of glycemic control and secondary outcomes of
interest included the incidence of adverse events. Search Strategy: The
search aimed to find both published and unpublished studies through
electronic databases, reference lists, key reports and the World Wide Web.
An extensive search was undertaken for the following databases: Medline,
CINAHL, PubMed, Embase, Scopus, the Cochrane Library, Dare, Social Science
Index, ProQuest, and MedNar. Databases were searched up to March 2014.
Methodological Quality: All studies selected were assessed by two
reviewers independently for methodological quality prior to inclusion in
the review using the standardized Joanna Briggs Institute Meta-Analysis of
Statistics Assessment and Review Instrument critical appraisal tool. Any
disagreements that arose between the reviewers were resolved through
discussion. Data Collection: Quantitative data was extracted from papers
included in the review using the standardized data extraction tool from
Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review
Instrument. All results were subject to double data entry. Data Synthesis:
Statistical pooling of the data in meta-analysis was carried out using
Review Manager meta-analysis software where possible. Odds Ratios,
Relative Risks, Weighted Means Differences and their 95% Confidence
Interval were calculated where appropriate. Where statistical pooling was
not possible due to the heterogeneity of the studies the findings are
presented in narrative form including tables and figures. Results:
Thirteen studies were included in the final review. Pooled data
demonstrated significantly improved mean blood glucose levels (Weighted
Means Differences -27.24, 95% Confidence Interval: -27.77 - -26.72), p <
0.00001 and achievement of target blood glucose levels range (Relative
Risks 1.43, 95% Confidence Interval: 1.18 - 1.72), p = 0.0002, among
participants who received the paper nomogram continuous intravenous
insulin method of glucose control compared to the bolus regime group.
Studies that investigated paper nomogram directed continuous intravenous
insulin compared to computer calculator directed continuous intravenous
insulin demonstrated a statistically significant improved mean blood
glucose levels (Weighted Means Differences -23.74, 95% Confidence
Interval: -24.45 - -23.02), p <0.00001 and higher percentage of time in
which glucose levels were within the target range in the computer
calculator group. A significantly lower incidence (p < 0.05) of
hyperglycemia was observed in the computerized calculator directed
continuous TRUNCATED AT 500 WORDS.
<8>
Accession Number
2015167172
Authors
Bona V. Khawaja M.Z. Bapat V. Young C. Hancock J. Redwood S. Fusari M.
Thomas M.
Institution
(Bona, Khawaja, Bapat, Young, Hancock, Redwood, Thomas) Department of
Cardiology, Guy's and St. Thomas' NHS Foundation Trust, St. Thomas'
Hospital, Westminster Bridge Road, London SE1 7EH, United Kingdom
(Khawaja, Redwood) BHF Centre of Excellence, Rayne Institute, King's
College London, London, United Kingdom
(Fusari) Cardiologico Monzino Hospital, Milan, Italy
Title
Early and late changes in quality of life following transcatheter aortic
valve implantation using the transfemoral and transapical approaches.
Source
EuroIntervention. 11 (2) (pp 221-229), 2015. Date of Publication: 01 Jun
2015.
Publisher
EuroPCR
Abstract
Aims: To evaluate the effects of access route upon clinical results and
quality of life (QoL) in patients under-going either transfemoral
(TF-TAVI) or transapical balloon-expandable transcatheter aortic valve
implanta-tion (TA-TAVI) in the real world. Methods and results: A
prospective analysis was performed upon 264 consecutive patients receiving
TF-TAVI or TA-TAVI. QoL was assessed using the EQ-5D questionnaire. At
baseline, TA-TAVI patients reported significantly more problems in
mobility, self-care, usual activities and lower overall health sta-tus
domains (p<0.01 for all). At 30 days, the TF-TAVI group reported fewer
problems with usual activity (p=0.01) and pain/discomfort (p<0.01), and
higher EQ-5D index and visual analogue scale (VAS) (p=0.01 and p<0.01,
respectively) than the TA-TAVI group. Nevertheless, the absolute
improvements (!EQ-5D index and !EQ-5D VAS) were larger in the TA-TAVI
group, with most dramatically marked QoL absolute improve-ments (p<0.01
and p=0.02, respectively). By one year, notwithstanding higher all-cause
mortality in the sicker TA-TAVI group, there were no differences between
groups in any EQ-5D domain. Indeed, surviving TA-TAVI group's greater
absolute improvements remained (p<0.01). Conclusions: QoL is greater at
the earlier time point of 30 days in the TF-TAVI cohort but equatable by
one year. However, the magnitude of improvement in QoL is greater in the
TA-TAVI patients at both 30 days and one year.
<9>
Accession Number
2015167165
Authors
Cassese S. Byrne R.A. Laugwitz K.-L. Schunkert H. Berger P.B. Kastrati A.
Institution
(Cassese, Byrne, Schunkert, Kastrati) Deutsches Herzzentrum, Technische
Universitat Munchen, Lazarettstrasse 36, Munich D-80636, Germany
(Laugwitz, Kastrati) Medizinische Klinik, Klinikum Rechts der Isar,
Technische Universitat Munchen, Munich, Germany
(Laugwitz, Schunkert, Kastrati) DZHK (German Centre for Cardiovascular
Research), Partner Site Munich Heart Alliance, Munich, Germany
(Berger) Geisinger Medical Center, Danville, PA, United States
Title
Bivalirudin versus heparin in patients treated with percutaneous coronary
intervention: A meta-analysis of randomised trials.
Source
EuroIntervention. 11 (2) (pp 196-203), 2015. Date of Publication: 01 Jun
2015.
Publisher
EuroPCR
Abstract
Aims: Current recommendations on the use of bivalirudin in patients
treated with percutaneous coronary intervention (PCI) are mostly based on
trials comparing bivalirudin versus heparin plus planned glycoprotein
IIb/IIIa inhibitor (GPI). Whether bivalirudin is also superior to heparin
alone is still not well established. This meta-analysis investigates the
efficacy and safety of bivalirudin versus heparin in patients treated with
PCI without planned use of GPI. Methods and results: Scientific databases
and websites were searched for randomised controlled trials. The primary
efficacy and safety outcomes were the 30-day incidence of death and major
bleeding, respectively. The secondary outcomes were the 30-day incidence
of myocardial infarction (MI), definite stent thrombo-sis (ST), urgent
target vessel revascularisation (TVR), and overall death at the longest
available follow-up. Odds ratio (OR) and 95% confidence interval (95% CI)
served as summary statistics. Ten trials were identi-fied including a
total of 18,065 PCI patients randomised to bivalirudin (n=9,033) versus
heparin (n=9,032). At 30 days, bivalirudin versus heparin showed a
comparable risk of death (1.09 [0.83-1.41], p=0.54), and MI (1.10
[0.83-1.46], p=0.50) with a trend towards a higher risk of urgent TVR
(1.37 [0.96-1.96], p=0.08). The risk of major bleeding was lower with
bivalirudin (0.57 [0.40-0.80], p=0.001) and the bleeding reduction was
more evident when high doses of heparin were used as comparator (p for
interaction <0.001). The risk of definite ST (2.09 [1.26-3.47], p=0.005)
and, in particular, the risk of acute ST (3.48 [1.66-7.28], p<0.001) was
increased by bivalirudin. Conclusions: Patients undergoing PCI randomised
to therapy with either bivalirudin or heparin display a similar mortality.
Bivalirudin as compared to heparin appears to reduce the risk of major
bleeding at the expense of a higher risk of acute ST.
<10>
Accession Number
2015167160
Authors
Ielasi A. Cortese B. Varricchio A. Tespili M. Sesana M. Pisano F. Loi B.
Granata F. Moscarella E. Orrego P.S. La Vecchia L. Steffenino G.
Institution
(Ielasi, Tespili) UOC Cardiologia, Cardiology Department, Bolognini
Hospital, 21 Via Paderno, Seriate (BG) 24068, Italy
(Cortese, Orrego) UO Emodinamica, A.O. Fatebenefratelli, Milan, Italy
(Varricchio, Granata, Moscarella) UO Cardiologia, Ospedale Monaldi,
Naples, Italy
(Sesana) Laboratorio di Emodinamica, A.O. Desenzano Del Garda (BS), Italy
(Pisano) Laboratorio di Emodinamica, Ospedale Regionale Parini, Aosta,
Italy
(Loi) UO Emodinamica e Cardiologia Interventistica, A.O. Brotzu, Cagliari,
Italy
(La Vecchia) USD Emodinamica, Ospedale San Bortolo, Vicenza, Italy
(Steffenino) USD Emodinamica, A.O. S. Croce e Carle, Cuneo, Italy
Title
Immediate and midterm outcomes following primary PCI with bioresorbable
vascular scaffold implantation in patients with ST-segment myocardial
infarction: Insights from the multicentre registro absorb italiano (RAI
registry).
Source
EuroIntervention. 11 (2) (pp 157-162), 2015. Date of Publication: 01 Jun
2015.
Publisher
EuroPCR
Abstract
Aims: In this multicentre prospective registry we sought to evaluate the
immediate and midterm clinical out-comes following single or multiple
overlapping bioresorbable vascular scaffold (BVS) implantation in the
STEMI setting. Methods and results: A prospective cohort analysis was
performed on all STEMI patients who underwent primary PCI with BVS
implantation. Between December 2012 and February 2014, 1,232 STEMI
patients underwent primary PCI at the participating centres. Of these, 74
(6.0%) received a BVS, 18 (24.3%) of them were multiple and overlapping.
Procedural success was obtained in 72 (97.3%) cases without differences
between the groups (overlapping BVS 100% vs. single BVS 96.4%, p=0.5). One
patient experienced a rein-farction due to subacute BVS thrombosis which
was successfully managed with balloon-only PCI while the other patient had
a slow-flow phenomenon (final TIMI flow 2). At six-month follow-up, two
non-fatal MI (2.7%), three target lesion revascularisations (4.1%), and
one subacute BVS thrombosis were reported in three patients (one [5.6%]
overlapping BVS and two [3.6%] in the single BVS group, p=0.5). All the
events were successfully managed with re-PCI. Conclusions: BVS
implantation in STEMI patients can be successfully performed with a high
procedural success rate and encouraging midterm outcomes. Larger
randomised trials and longer follow-up are needed to assess the potential
clinical benefit of BVS versus new-generation DES in this setting.
<11>
Accession Number
2015162866
Authors
Du Q. Zhou X. Wang X. Chen S. Yang X. Chen N. Liang J. Deng W. Sun K.
Institution
(Du, Zhou, Yang, Chen, Deng) Department of Rehabilitation Medicine, Xin
Hua Hospital Affiliated to Shanghai Jiao Tong University School of
Medicine, Shanghai, China
(Wang) Sport Medicine and Rehabilitation Centre, Shanghai University of
Sport, Shanghai, China
(Chen, Sun) Department of Pediatric Cardiology, Xin Hua Hospital
Affiliated to Shanghai Jiao Tong University School of Medicine, No. 1665
Kongjiang Road, Shanghai, China
(Liang) Department of Kinesiology, Shanghai University of Sport, Shanghai,
China
Title
Passive movement and active exercise for very young infants with
congenital heart disease: A study protocol for a randomized controlled
trial.
Source
Trials. 16 (1) , 2015. Article Number: 288. Date of Publication: June 30,
2015.
Publisher
BioMed Central Ltd.
Abstract
Background: Delayed motor development is reported in patients with
congenital heart disease (CHD). Exercise is widely used to facilitate
motor development and improve motor ability. Exercise for adolescents and
adults with CHD has been extensively studied. However, the evidence of
exercise for infants with CHD is sparse. This study aims to identify the
effect of passive movement and active exercise on motor development within
very young CHD infants with cardiac catheterization. Methods/Design: A
prospective and randomized controlled trial will be conducted in very
young CHD infants with cardiac catheterization. A total of 147 infants
with CHD will be randomized by a 1:1:1 allocation ratio by computer to an
exercise intervention group, a home-based intervention group and a control
group. The exercise intervention group will receive passive movement and
active exercise from experienced physiotherapists in pediatrics three
times a week for 12 weeks. The home-based intervention group will receive
passive movement and active exercise from their parents or caregivers at
home three times a week for 12 weeks. The control group will receive
follow up only. The follow-up duration is 20 months. The primary outcome
measures are the motor quotient measured by the Peabody Developmental
Motor Scales-II. The secondary outcome measures are the Ross score,
ventricular function, bone quality, body length, weight, head
circumference, upper arm circumference, and adverse events. Discussion:
This study has several important features, including the randomization
process, the long follow-up duration, the control group, and the large
sample size. The aim of this study is to determine whether 12-week passive
movement and active exercise promotes motor development and produces other
beneficial effects for very young CHD infants with cardiac
catheterization. Therefore, this study will contribute new knowledge
regarding the rehabilitation program in very young CHD infants with
cardiac catheterization. Trial registration: Current Controlled Trials
ChiCTR-IOR-15005909 (January 31, 2015).
<12>
Accession Number
2015164092
Authors
Toller W. Heringlake M. Guarracino F. Algotsson L. Alvarez J. Argyriadou
H. Ben-Gal T. Cerny V. Cholley B. Eremenko A. Guerrero-Orriach J.L.
Jarvela K. Karanovic N. Kivikko M. Lahtinen P. Lomivorotov V. Mehta R.H.
Music S. Pollesello P. Rex S. Riha H. Rudiger A. Salmenpera M. Szudi L.
Tritapepe L. Wyncoll D. Owall A.
Institution
(Toller) Department of Anaesthesiology and Intensive Care Medicine,
University Hospital of Graz, Auenbruggerplatz 29, Graz 8036, Austria
(Heringlake) Department of Anaesthesiology, University of Lubeck, Lubeck,
Germany
(Guarracino) Department of Anaesthesia and Critical Care Medicine, Azienda
Ospedaliero-Universitaria Pisana, Pisa, Italy
(Algotsson) Department of Cardiothoracic Surgery, Skanes University
Hospital Lund, Lund, Sweden
(Alvarez) Department of Anaesthesiology and Intensive Care, University
Hospital of Santiago de Compostela, Santiago de Compostela, Spain
(Argyriadou) Department of Anaesthesiology and Intensive Care Unit,
Aristotle University of Thessaloniki, AHEPA Teaching Hospital,
Thessaloniki, Greece
(Ben-Gal) Rabin Medical Centre, Heart Failure Unit, Petach Tikva, Israel
(Cerny) Department of Anaesthesiology and Intensive Care, University
Hospital Hradec Kralove, Hradec Kralove, Czech Republic
(Cholley) Department of Anaesthesiology and Intensive Care, Hopital
Europeen Georges Pompidou, Paris, France
(Cholley) Universite Paris Descartes, Paris, France
(Eremenko) B. v. Petrovsky Russian National Centre of Surgery, Moscow,
Russian Federation
(Guerrero-Orriach) Department of Cardio-Anaesthesiology, University
Hospital Virgen de la Victoria de Malaga, Malaga, Spain
(Jarvela) Heart Centre and Intensive Care Unit, Tampere University
Hospital, Tampere, Finland
(Karanovic) Department of Anaesthesiology and Intensive Care, University
Hospital Split, Split, Croatia
(Kivikko, Pollesello) Orion Pharma, Critical Care, Espoo, Finland
(Lahtinen) Department of Anaesthesiology and Intensive Care, Kuopio
University Hospital, Kuopio, Finland
(Lomivorotov) E. N. Meshalkin State Novosibirsk Research Institute of
Circulation Pathology, Novosibirsk, Russian Federation
(Mehta) Duke University Medical Center and Duke Clinical Research
Institute, Department of Internal Medicine and Cardiology, Durham, NC,
United States
(Music) Department of Cardio-Anaesthesiology, University Clinical Centre
Ljubljana, Ljubljana, Slovenia
(Rex) Department of Anaesthesiology, Campus Gasthuisberg, UZ Leuven,
Leuven, Belgium
(Riha) Cardiothoracic Anaesthesiology and Intensive Care, Department of
Anaesthesiology and Intensive Care Medicine, Institute for Clinical and
Experimental Medicine, Prague, Czech Republic
(Rudiger) Institute of Anaesthesiology, University Hospital of Zurich,
Zurich, Switzerland
(Salmenpera) Department of Anaesthesiology Intensive Care, Emergency and
Pain Medicine, Helsinki University Hospital, Helsinki, Finland
(Szudi) Department of Anaesthesiology and Intensive Care, Gottsegen Gyorgy
National Institute of Cardiology, Budapest, Hungary
(Tritapepe) Department of Anaesthesiology and Intensive Care Policlinico
Umberto I, La Sapienza University of Rome, Rome, Italy
(Wyncoll) Department of Critical Care, St. Thomas' Hospital, London,
United Kingdom
(Owall) Department of Cardiothoracic Surgery, Karolinska University
Hospital Solna, Stockholm, Sweden
Title
Preoperative and perioperative use of levosimendan in cardiac surgery:
European expert opinion.
Source
International Journal of Cardiology. 184 (1) (pp 323-336), 2015. Date of
Publication: 2015.
Publisher
Elsevier Ireland Ltd
Abstract
In cardiac surgery, postoperative low cardiac output has been shown to
correlate with increased rates of organ failure and mortality.
Catecholamines have been the standard therapy for many years, although
they carry substantial risk for adverse cardiac and systemic effects, and
have been reported to be associated with increased mortality. On the other
hand, the calcium sensitiser and potassium channel opener levosimendan has
been shown to improve cardiac function with no imbalance in oxygen
consumption, and to have protective effects in other organs. Numerous
clinical trials have indicated favourable cardiac and non-cardiac effects
of preoperative and perioperative administration of levosimendan. A panel
of 27 experts from 18 countries has now reviewed the literature on the use
of levosimendan in on-pump and off-pump coronary artery bypass grafting
and in heart valve surgery. This panel discussed the published evidence in
these various settings, and agreed to vote on a set of questions related
to the cardioprotective effects of levosimendan when administered
preoperatively, with the purpose of reaching a consensus on which patients
could benefit from the preoperative use of levosimendan and in which kind
of procedures, and at which doses and timing should levosimendan be
administered. Here,we present a systematic reviewof the literature to
report on the completed and ongoing studies on levosimendan, including the
newly commenced LEVO-CTS phase III study (NCT02025621), and on the
consensus reached on the recommendations proposed for the use of
preoperative levosimendan.
<13>
Accession Number
2015163649
Authors
Liu Y. Gao L. Song Y. Chen L. Xue Q. Tian J. Wang Y. Chen Y.
Institution
(Liu, Gao, Chen, Xue, Tian, Wang, Chen) Cardiology Department, Institute
of Geriatric Cardiology, General Hospital of People's Liberation Army, No.
28 Fuxing Road, Hai dian District, Beijing 100853, China
(Song) Tianjin Chest Hospital, Tianjin, China
Title
Efficacy and safety of limus-eluting versus paclitaxel-eluting coronary
artery stents in patients with diabetes mellitus: A meta-analysis.
Source
International Journal of Cardiology. 184 (1) (pp 680-691), 2015. Date of
Publication: 2015.
Publisher
Elsevier Ireland Ltd
Abstract
Background/objectives: The relative efficacy and safety of limus-eluting
stent (LES) versus paclitaxel-eluting stent (PES) in DM patients remain
unclear. Methods: The PubMed, EMBASE, and Cochrane Central Register of
Controlled Trials electronic databases were searched from January 2001 to
December 2013. Clinical trials that performed head-to-head comparisons of
LES versus PES implantation in patients with DM were considered for
inclusion. Results: This meta-analysis included 28 clinical trials
involving 23,678 patients: 9953 who underwent sirolimuseluting stent (SES)
implantation, 4209 underwent everolimus-eluting stent (EES) or
zotarolimus-eluting stent (ZES) implantation, and 9516 underwent PES
implantation. The short-term target lesion revascularization (TLR) rate
was significantly lower after SES implantation than after PES implantation
(3.6% vs 6.3%; odds ratio (OR): 0.659; P = 0.014), but there were no
significant differences in the rates of target vesel revascularization
(TVR), stent thrombosis (ST), myocardial infarction (MI), all-cause
mortality, or major adverse cardiac events (MACE). There were no
differences in the longer-termrates of TLR, TVR, ST,MI, all-cause
mortality, orMACE between SES versus PES. Second-generation LES (EES or
ZES) implantation resulted in lower rates of ST (2.1% vs 3.3%; OR: 0.586;
P < 0.001), MI (2.3% vs 4.1%; OR: 0.527; P = 0.001), and MACE (8.0% vs
10.3%; OR: 0.796; P = 0.007) than PES implantation. Conclusions: In
patients with DM, short- And longer-termMACE rates were similar after
first-generation LES and PES implantation. The second-generation LES may
be better than PES implantation in rates of ST,MI, and MACE.
<14>
Accession Number
2015833170
Authors
Valgimigli M. Gagnor A. Calabro P. Frigoli E. Leonardi S. Zaro T.
Rubartelli P. Briguori C. Ando G. Repetto A. Limbruno U. Cortese B.
Sganzerla P. Lupi A. Galli M. Colangelo S. Ierna S. Ausiello A. Presbitero
P. Sardella G. Varbella F. Esposito G. Santarelli A. Tresoldi S. Nazzaro
M. Zingarelli A. De Cesare N. Rigattieri S. Tosi P. Palmieri C. Brugaletta
S. Rao S.V. Heg D. Rothenbuhler M. Vranckx P. Juni P.
Institution
(Valgimigli) Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands
(Gagnor, Frigoli, Varbella) Cardiology Unit, ASL Torino 3, Ospedali
Riuniti di Rivoli, Turin, Italy
(Calabro) Division of Cardiology, Second University of Naples, Department
of Cardiothoracic Sciences, Naples, Italy
(Frigoli) EUSTRATEGY Association, Forli', Italy
(Leonardi, Repetto) UOC Cardiologia, Fondazione IRCCS Policlinico San
Matteo, Dipartimento CardioToracoVascolare, Pavia, Italy
(Zaro) A.O. Ospedale Civile di Vimercate (MB), Vimercate, Italy
(Rubartelli) Department of Cardiology, ASL3 Ospedale Villa Scassi, Genoa,
Italy
(Briguori) Clinica Mediterranea, Naples, Italy
(Ando) Azienda Ospedaliera Universitaria Policlinico Gaetano Martino,
University of Messina, Messina, Italy
(Limbruno) UO Cardiologia, ASL 9 Grosseto, Grosseto, Italy
(Cortese) Ospedale Fate Bene Fratelli, Milan, Italy
(Sganzerla) AO Ospedale Treviglio-Caravaggio, Treviglio, BG, Italy
(Lupi) University Hospital Maggiore della Carita, Novara, Italy
(Galli) Ospedaliera sant'Anna, Como, Italy
(Colangelo) San Giovanni Bosco Hospital, Turin, Italy
(Ierna) Ospedale Sirai - Carbonia, Carbonia, Italy
(Ausiello) Casa di Cura Villa Verde, Taranto, Italy
(Presbitero) IRCCS Humanitas, Rozzano, Italy
(Sardella) Department of Cardiovascular, Policlinico Umberto i Sapienza
University of Rome, Respiratory, Nephrologic, Anesthesiologic and
Geriatric Sciences, Rome, Italy
(Esposito) Division of Cardiology, Department of Advanced Biomedical
Sciences, Federico II University of Naples, Naples, Italy
(Santarelli) Cardiovascular Department, Infermi Hospital, Rimini, Italy
(Tresoldi) A.O. Ospedale di Desio (MB), Desio, Italy
(Nazzaro) San Camillo-Forlanini, Rome, Italy
(Zingarelli) IRCCS AOU San Martino, Genoa, Italy
(De Cesare) Policlinico San Marco, Zingonia, Italy
(Rigattieri) Interventional Cardiology Sandro Pertini Hospital, Rome,
Italy
(Tosi) Mater Salutis Hospital-Legnago, Verona, Italy
(Palmieri) Ospedale Pasquinucci, Massa, Italy
(Brugaletta) Hospital Clinic, Department of Cardiology, University of
Barcelona, Barcelona, Spain
(Rao) Duke Clinical Research Institute, Durham, NC, United States
(Vranckx) Department of Cardiology and Critical Care Medicine, Jessa
Ziekenhuis, Hartcentrum Hasselt, Hasselt, Belgium
(Heg, Rothenbuhler, Juni) Clinical Trials Unit, University of Bern, Bern,
Switzerland
(Juni) Institute of Primary Health Care, University of Bern, Bern,
Switzerland
(Heg) Institute of Social and Preventive Medicine, University of Bern,
Bern, Switzerland
Title
Radial versus femoral access in patients with acute coronary syndromes
undergoing invasive management: A randomised multicentre trial.
Source
The Lancet. 385 (9986) (pp 2465-2476), 2015. Date of Publication: 20 Jun
2015.
Publisher
Lancet Publishing Group
Abstract
Summary Background It is unclear whether radial compared with femoral
access improves outcomes in unselected patients with acute coronary
syndromes undergoing invasive management. Methods We did a randomised,
multicentre, superiority trial comparing transradial against transfemoral
access in patients with acute coronary syndrome with or without ST-segment
elevation myocardial infarction who were about to undergo coronary
angiography and percutaneous coronary intervention. Patients were randomly
allocated (1:1) to radial or femoral access with a web-based system. The
randomisation sequence was computer generated, blocked, and stratified by
use of ticagrelor or prasugrel, type of acute coronary syndrome
(ST-segment elevation myocardial infarction, troponin positive or
negative, non-ST-segment elevation acute coronary syndrome), and
anticipated use of immediate percutaneous coronary intervention. Outcome
assessors were masked to treatment allocation. The 30-day coprimary
outcomes were major adverse cardiovascular events, defined as death,
myocardial infarction, or stroke, and net adverse clinical events, defined
as major adverse cardiovascular events or Bleeding Academic Research
Consortium (BARC) major bleeding unrelated to coronary artery bypass graft
surgery. The analysis was by intention to treat. The two-sided alpha was
prespecified at 0025. The trial is registered at ClinicalTrials.gov,
number NCT01433627. Findings We randomly assigned 8404 patients with acute
coronary syndrome, with or without ST-segment elevation, to radial (4197)
or femoral (4207) access for coronary angiography and percutaneous
coronary intervention. 369 (88%) patients with radial access had major
adverse cardiovascular events, compared with 429 (103%) patients with
femoral access (rate ratio [RR] 085, 95% CI 074-099; p=00307),
non-significant at alpha of 0025. 410 (98%) patients with radial access
had net adverse clinical events compared with 486 (117%) patients with
femoral access (083, 95% CI 073-096; p=00092). The difference was driven
by BARC major bleeding unrelated to coronary artery bypass graft surgery
(16% vs 23%, RR 067, 95% CI 049-092; p=0013) and all-cause mortality (16%
vs 22%, RR 072, 95% CI 053-099; p=0045). Interpretation In patients with
acute coronary syndrome undergoing invasive management, radial as compared
with femoral access reduces net adverse clinical events, through a
reduction in major bleeding and all-cause mortality. Funding The Medicines
Company and Terumo.
<15>
Accession Number
2015831026
Authors
Kapadia S.R. Leon M.B. Makkar R.R. Tuzcu E.M. Svensson L.G. Kodali S. Webb
J.G. Mack M.J. Douglas P.S. Thourani V.H. Babaliaros V.C. Herrmann H.C.
Szeto W.Y. Pichard A.D. Williams M.R. Fontana G.P. Miller D.C. Anderson
W.N. Smith C.R. Akin J.J. Davidson M.J.
Institution
(Kapadia, Tuzcu, Svensson) Cleveland Clinic, Cleveland, OH, United States
(Leon, Kodali, Smith) Columbia University Medical Center, New York
Presbyterian Hospital, New York, NY, United States
(Makkar, Webb) Cedars Sinai Medical Center, Los Angeles, CA, United States
(Mack) St Paul's Hospital, Vancouver, BC, Canada
(Douglas) Baylor Scott and White Health, Plano, TX, United States
(Thourani, Babaliaros) Duke Clinical Research Institute, Duke University
Medical Center, Durham, NC, United States
(Herrmann, Szeto) Emory University, School of Medicine, Atlanta, GA,
United States
(Pichard) University of Pennsylvania, Philadelphia, PA, United States
(Williams) Medstar Washington Hospital Center, Washington, DC, United
States
(Fontana) NYU Langone Medical Center, New York, NY, United States
(Miller) Lenox Hill Hospital, New York, NY, United States
(Anderson) Stanford University School of Medicine, Falk CV Research
Center, Department of Cardiovascular Surgery, Stanford, CA, United States
(Anderson) Independent Consultant, Lake Forest, CA, United States
Title
5-year outcomes of transcatheter aortic valve replacement compared with
standard treatment for patients with inoperable aortic stenosis (PARTNER
1): A randomised controlled trial.
Source
The Lancet. 385 (9986) (pp 2485-2491), 2015. Date of Publication: 20 Jun
2015.
Publisher
Lancet Publishing Group
Abstract
Summary Background Based on the early results of the Placement of Aortic
Transcatheter Valves (PARTNER) trial, transcatheter aortic valve
replacement (TAVR) is an accepted treatment for patients with severe
aortic stenosis who are not suitable for surgery. However, little
information is available about the late clinical outcomes in such
patients. Methods We did this randomised controlled trial at 21
experienced valve centres in Canada, Germany, and the USA. We enrolled
patients with severe symptomatic inoperable aortic stenosis and randomly
assigned (1:1) them to transfemoral TAVR or to standard treatment, which
often included balloon aortic valvuloplasty. Patients and their treating
physicians were not masked to treatment allocation. The randomisation was
done centrally, and sites learned of the assignment only after a patient
had been screened, consented, and entered into the database. The primary
outcome of the trial was all-cause mortality at 1 year in the
intention-to-treat population, here we present the prespecified findings
after 5 years. This study is registered with ClinicalTrials.gov, number
NCT00530894. Findings We screened 3015 patients, of whom 358 were enrolled
(mean age 83 years, Society of Thoracic Surgeons Predicted Risk of
Mortality 117%, 54% female). 179 were assigned to TAVR treatment and 179
were assigned to standard treatment. 20 patients crossed over from the
standard treatment group and ten withdrew from study, leaving only six
patients at 5 years, of whom five had aortic valve replacement treatment
outside of the study. The risk of all-cause mortality at 5 years was 718%
in the TAVR group versus 936% in the standard treatment group (hazard
ratio 050, 95% CI 039-065; p<00001). At 5 years, 42 (86%) of 49 survivors
in the TAVR group had New York Heart Association class 1 or 2 symptoms
compared with three (60%) of five in the standard treatment group.
Echocardiography after TAVR showed durable haemodynamic benefit (aortic
valve area 152 cm<sup>2</sup> at 5 years, mean gradient 106 mm Hg at 5
years), with no evidence of structural valve deterioration. Interpretation
TAVR is more beneficial than standard treatment for treatment of
inoperable aortic stenosis. TAVR should be strongly considered for
patients who are not surgical candidates for aortic valve replacement to
improve their survival and functional status. Appropriate selection of
patients will help to maximise the benefit of TAVR and reduce mortality
from severe comorbidities. Funding Edwards Lifesciences.
<16>
Accession Number
2015831022
Authors
Mack M.J. Leon M.B. Smith C.R. Miller D.C. Moses J.W. Tuzcu E.M. Webb J.G.
Douglas P.S. Anderson W.N. Blackstone E.H. Kodali S.K. Makkar R.R. Fontana
G.P. Kapadia S. Bavaria J. Hahn R.T. Thourani V.H. Babaliaros V. Pichard
A. Herrmann H.C. Brown D.L. Williams M. Davidson M.J. Svensson L.G. Akin
J.
Institution
(Mack, Kapadia) Baylor Scott and White Health, Plano, TX, United States
(Leon, Smith, Moses, Kodali, Hahn) Columbia University Medical Center, New
York Presbyterian Hospital, New York, NY, United States
(Miller) Stanford University School of Medicine, Falk CV Research Center,
Department of Cardiovascular Surgery, Stanford, CA, United States
(Tuzcu, Blackstone, Kapadia, Svensson) Cleveland Clinic, Cleveland, OH,
United States
(Webb) St Paul's Hospital, Vancouver, BC, Canada
(Douglas) Duke Clinical Research Institute, Duke University Medical
Center, Durham, NC, United States
(Makkar) Cedars Sinai Medical Center, Los Angeles, CA, United States
(Fontana) Lenox Hill Hospital, New York, NY, United States
(Bavaria) University of Pennsylvania, Philadelphia, PA, United States
(Herrmann) Emory University School of Medicine, Atlanta, GA, United States
(Thourani, Babaliaros) Medstar Washington Hospital Center, Washington, DC,
United States
(Pichard) Heart Hospital, Plano, TX, United States
(Brown) NYU Langone Medical Center, New York, NY, United States
(Williams) Brigham and Women's Hospital, Boston, MA, United States
(Anderson, Davidson) Independent Consultant, Lake Forest, CA, United
States
Title
5-year outcomes of transcatheter aortic valve replacement or surgical
aortic valve replacement for high surgical risk patients with aortic
stenosis (PARTNER 1): A randomised controlled trial.
Source
The Lancet. 385 (9986) (pp 2477-2484), 2015. Date of Publication: 20 Jun
2015.
Publisher
Lancet Publishing Group
Abstract
Summary Background The Placement of Aortic Transcatheter Valves (PARTNER)
trial showed that mortality at 1 year, 2 years, and 3 years is much the
same with transcatheter aortic valve replacement (TAVR) or surgical aortic
valve replacement (SAVR) for high-risk patients with aortic stenosis. We
report here the 5-year outcomes. Methods We did this randomised controlled
trial at 25 hospitals, in Canada (two), Germany (one), and the USA (23).
We used a computer-generated randomisation sequence to randomly assign
high-risk patients with severe aortic stenosis to either SAVR or TAVR with
a balloon-expandable bovine pericardial tissue valve by either a
transfemoral or transapical approach. Patients and their treating
physicians were not masked to treatment allocation. The primary outcome of
the trial was all-cause mortality in the intention-to-treat population at
1 year, we present here predefined outcomes at 5 years. The study is
registered with ClinicalTrials.gov, number NCT00530894. Findings We
screened 3105 patients, of whom 699 were enrolled (348 assigned to TAVR,
351 assigned to SAVR). Overall mean Society of Thoracic Surgeons Predicted
Risk of Mortality score was 117%. At 5 years, risk of death was 678% in
the TAVR group compared with 624% in the SAVR group (hazard ratio 104, 95%
CI 086-124; p=076). We recorded no structural valve deterioration
requiring surgical valve replacement in either group. Moderate or severe
aortic regurgitation occurred in 40 (14%) of 280 patients in the TAVR
group and two (1%) of 228 in the SAVR group (p<00001), and was associated
with increased 5-year risk of mortality in the TAVR group (724% for
moderate or severe aortic regurgitation vs 566% for those with mild aortic
regurgitation or less; p=0003). Interpretation Our findings show that TAVR
as an alternative to surgery for patients with high surgical risk results
in similar clinical outcomes. Funding Edwards Lifesciences.
<17>
Accession Number
2015163659
Authors
Naganuma T. Latib A. Sgueglia G.A. Menozzi A. Castriota F. Micari A.
Cremonesi A. De Felice F. Marchese A. Tespili M. Presbitero P. Panoulas
V.F. Buffoli F. Tamburino C. Varbella F. Colombo A.
Institution
(Naganuma, Latib, Colombo) EMO-GVM Centro Cuore Columbus, Interventional
Cardiology Unit, 48 Via M. Buonarroti, Milan 20145, Italy
(Naganuma, Latib, Colombo) Interventional Cardiology Unit, San Raffaele
Scientific Institute, Milan, Italy
(Castriota) GVM Care and Research, Interventional Cardiology Unit, Citta
di Lecce Hospital, Lecce, Italy
(Micari) GVM Care and Research, Interventional Cardiology Unit, Maria
Eleonora Hospital, Palermo, Italy
(Cremonesi) GVM Care and Research, Interventional Cardiology Unit, Maria
Cecilia Hospital, Cotignola, Italy
(De Felice) Interventional Cardiology Unit, Ospedale San Camillo, Rome,
Italy
(Marchese) GVM Care and Research, Interventional Cardiology Unit, Anthea
Hospital, Bari, Italy
(Tespili) Interventional Cardiology Unit, Ospedale Bolognini, Seriate,
Bergamo, Italy
(Presbitero) Istituto Clinico Humanitas, Interventional Cardiology Unit,
Rozzano, Milan, Italy
(Sgueglia) Interventional Cardiology Unit, Ospedale Santa Maria Goretti,
Latina, Italy
(Buffoli) Interventional Cardiology Unit, Ospedale di Mantova, Mantova,
Italy
(Panoulas, Tamburino) Division of Cardiology, University of Catania,
Ferrarotto Hospital, Catania, Italy
(Varbella) Interventional Cardiology Unit, Ospedale di Rivoli, Torino,
Italy
(Menozzi) Cardiology Department, Interventional Cardiology Unit, Ospedale
di Parma, Parma, Italy
Title
A 2-year follow-up of a randomized multicenter study comparing a
paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small
coronary vessels the BELLO study.
Source
International Journal of Cardiology. 184 (1) (pp 17-21), 2015. Date of
Publication: 2015.
Publisher
Elsevier Ireland Ltd
Abstract
Background/objectives: A prospective, multi-center, randomized trial,
BELLO (Balloon Elution and Late Loss Optimization), showed that the
primary endpoint of in-stent (in-balloon) late loss was significantly less
with drug-eluting balloons (DEB) as compared with paclitaxel-eluting
stents (PES). At 6 months, DEB and PES were associated with similar rates
of angiographic restenosis, target lesion revascularization (TLR), and
major adverse cardiac events (MACE) defined as death, myocardial
infarction and target vessel revascularization. The aim of this study was
to report 2-year clinical outcomes after treatment of de novo small vessel
disease with DEB as compared with PES. Methods: A total of 182 patients
were enrolled and randomized to treatment with DEB (n=90) in 94 lesions or
PES (n= 92) in 98 lesions. The study endpoint was the incidence of MACE at
2-year follow-up. Results: Two-year follow-up was achieved in almost all
cases (97.8% in DEB group vs. 98.9% in PES group). There was a trend
towards a lower incidence of MACE in the DEB group as compared with the
PES group (14.8% vs. 25.3%; p= 0.08). TLR rates in the DEB group were
acceptable at 6 months, 1 year and 2 years and did not differ
significantly from the PES group (4.4% vs. 7.6%, p =0.37; 6.7% vs. 12.1%,
p =0.23; 6.8% vs. 12.1%, p =0.25, respectively). Conclusions: Our results
suggest that treatment of small vessel disease with a paclitaxel DEB is
associated with a trend for improved clinical outcomes as compared with
PES up to 2 years. Late catch-up phenomenon requiring repeat intervention
after treatment with DEB was not evident in this study.
<18>
Accession Number
2015153900
Authors
Esmail M. Nilufar D. Majid G.-E. Reza T.-N.M. Abolfazl M.
Institution
(Esmail, Abolfazl) Department of Anesthesiology, Arak University of
Medical Sciences, Arak, Iran, Islamic Republic of
(Nilufar) Department of Anesthesiology, Resident of Anesthesiology, Arak
University of Medical Sciences, Arak, Iran, Islamic Republic of
(Majid) Department of Anesthesiology, Arak University of Medical Sciences,
ShahidBeheshti, Iran, Islamic Republic of
(Reza) Department of Internal Medicine, General Practitioner, Arak
University of Medical Sciences, Arak, Iran, Islamic Republic of
(Abolfazl) Department of Epidemiology and Biostatistics, School O F
Health, Qom University of Medical Sciences, Qom, Iran, Islamic Republic of
Title
Prophylactic effect of amiodarone in atrial fibrillation after coronary
artery bypass surgery; a double-blind randomized controlled clinical
trail.
Source
Journal of Cardiovascular Disease Research. 6 (1) (pp 12-17), 2015. Date
of Publication: 2015.
Publisher
EManuscript Services
Abstract
Introduction: Atrial fibrillation is the most common complication after
coronary artery bypass surgery. It's known that increases morbidity and
mortality after Coronary artery bypass graft (CABG) surgery and also leads
to increased length of stay in the ICU and the hospital. The purpose of
this study is to evaluate the prophylactic effect of amiodarone in
reducing the incidence of atrial fibrillation after coronary artery bypass
surgery. Materials and Methods: In this randomized clinical trial study,
124 elective patients scheduled for CABG surgery were enrolled based on
inclusion and exclusion criteria and randomly divided into two equal
groups. Patients of intervention group before anesthesia, intravenously
received 300 mg amiodarone medication and the control group received
normal saline. Up to 24 hours after coronary artery bypass surgery, the
incidence of atrial fibrillation in the two groups was observed. Results:
The incidence of atrial fibrillation after CABG in intervention group was
16 people and in the control group was 35 people. The prevalence of atrial
fibrillation compared between two groups using chi-square analysis showed
that there is a significant difference between two groups (p=0.037) and
the incidence of atrial fibrillation in control group was significantly
lower than the intervention group. Conclusion: Although in the study the
amiodarone medication was used with lower dose and duration compared with
other studies, but the results of this study showed that even with the
same protocol it is possible to use amiodarone for prevention of atrial
fibrillation after coronary artery bypass surgery.
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Accession Number
71932769
Authors
Golcuk S.E. Aksu T. Guler T.E. Erden I.
Institution
(Golcuk, Aksu, Guler, Erden) Kocaeli Derince Training and Research
Hospital, Cardiology Clinic, Kocaeli, Turkey
Title
Neurocardioablation: Is the permanent pacemaker the only interventional
alternative in the neurocardiogenic syncope? The first case from Turkey.
Source
Anadolu Kardiyoloji Dergisi. Conference: 30th Turkish Cardiology Congress
Belek Turkey. Conference Start: 20141023 Conference End: 20141026.
Conference Publication: (var.pagings). 14 (pp 65), 2014. Date of
Publication: October 2014.
Publisher
AVES Ibrahim Kara
Abstract
Introduction: Neurocardiogenic shock is the most frequently encountered
etiological factor for syncope, and it stems from very intense vagal
reflex. With our case report, we investigated the effect of endocardial
radiofrequency (RF) catheter ablation of cardiac vagal system on
cardioinhibitor reflex. Case: A 52-year-old female patient applied to our
clinic with complaints of syncope attacks occurring for a total of 11
times (4 times within the previous year) ECG, and transthoracic
echocardiographic examination did not reveal any pathology, and at 25.
minute of the tilt table test syncope was developed after an episode of
asystole. The patient who was diagnosed as neurocardiogenic syncope
received prior training to prevent development of syncope.. During 6
months of follow-up she was exposed two additional attacks of syncope.
Then the patient was told about the alternatives of permanent pacemaker
implantation or application of neurocardioablation which is still in its
experimental phase. After consent of the patient, and approval of the
ethics committee were obtained, the patient was scheduled for the ablation
procedure. When atrial endocardial potentials in sinus rhythm are analyzed
using spectral studies, 2 types of myocardial potentials are observed. The
first one is compact myocardium (linear spectrum with high amplitude), and
the second one is fibrillar myocardium (segmental spectrum with lower
amplitude). In our case, standard conventional electrophysiologic leads
were placed over right atrium, coronary sinus, and left atrium.
Frequencies were recorded as 0-100 Hz, and 300-500 Hz using 3D NavX
electroanatomic mapping system. Potentials over 300 Hz were accepted as
fibrillar potentials, and RF energy was delivered to these regions using
irrigation catheter till disappearance of these potentials. The first
paracardiac ganglion (PG) was approached from the medial wall of vena cava
superior, and 2. PG from the periphery of both right pulmonary veins. The
last PG was approached from the periphery of coronary sinus ostium medial
to the inferior cardiac vein. (Figure 1-2) Heart rate was 50-60 bpm before
the procedure, and increased to 90 bpm after atropine administration, and
remained stable at 90 bpm after the procedure. Heart rate was still at 90
bpm, and it did not accelerated after administration of atropine.
Cardiologists working in the university hospital of our city independently
applied tilt table test on the patient 1 week, 1, and 6 months after the
procedure, and cardioinhibitor response could not be elicited. The patient
was still asymptomatic at 6 month of the follow-up period. Conclusion: In
selected patients, endocardial RF ablation appears to be an alternative
method to permanent pacemaker in the treatment of serious neurocardiogenic
syncope. However conduction of randomized controlled studies with
long-term outcomes, and larger patient population will determine the
future of this treatment modality. (Figure Presented).
