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<1>
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Accession Number
2011627825
Authors
Steil G.M. Langer M. Jaeger K. Alexander J. Gaies M. Agus M.S.D.
Institution
(Steil, Langer, Jaeger, Alexander, Agus) Department of Surgery and
Medicine, Children's Hospital Boston, Harvard Medical School, Boston, MA,
United States
(Gaies) Department of Pediatrics and Communicable Diseases, University of
Michigan, C.S. Mott Children's Hospital, Ann Arbor, MI, United States
Title
Value of continuous glucose monitoring for minimizing severe hypoglycemia
during tight glycemic control.
Source
Pediatric Critical Care Medicine. 12 (6) (pp 643-648), 2011. Date of
Publication: November 2011.
Publisher
Lippincott Williams and Wilkins (530 Walnut Street,P O Box 327,
Philadelphia PA 19106-3621, United States)
Abstract
Objective: Tight glycemic control can potentially reduce morbidity and
mortality in the intensive care unit but increases the risk of
hypoglycemia. The most effective means to avoid hypoglycemia is to obtain
frequent blood glucose samples, but this increases the burden to nursing
staff. The objective of this study was to assess the ability of a
real-time continuous glucose monitor to reduce hypoglycemia (blood glucose
<60 mg/dL [3.3 mmol/L]) during standard care or tight glycemic control
effected with a proportional integral derivative insulin titration
algorithm. Design: Real-time continuous glucose monitor profiles obtained
from an ongoing prospective randomized trial of tight glycemic control
were retrospectively analyzed to determine whether the continuous glucose
measure had prevented instances of hypoglycemia. Setting: Cardiac
intensive care unit. Patients: Children 3 yrs of age or younger undergoing
cardiac surgery were studied. Interventions: Intravenous insulin infusion
and rescue glucose guided by the real-time continuous glucose monitor and
the proportional integral derivative algorithm in the tight glycemic
control arm (n = 155; target glucose 80-110 mg/dL [4.4-6.1 mmol/L]) and
the real-time continuous glucose monitor in the standard care arm (n =
156). Measurements and Main Results: No reduction in hypoglycemia was
observed with real-time continuous glucose monitor alarms set at 60 mg/dL
(3.3 mmol/L) (zero of 19 occurrences of blood glucose <60 mg/dL [3.3
mmol/L] detected); 18 of 40 subsequent incidences of hypoglycemia were
detected after the alarm threshold was increased to 70 mg/dL (3.9 mmol/L).
In the tight glycemic control arm, eight incidences were reduced in
duration and an additional eight events were prevented with intravenous
glucose. In the standard care arm, three of nine occurrences of
hypoglycemia were detected with the duration reduced in all cases. On
average, one to two false hypoglycemia alarms were observed in each
patient. Conclusions: The real-time continuous glucose monitor in
combination with proportional integral derivative control can reduce
hypoglycemia during tight glycemic control. The real-time continuous
glucose monitor can also reduce hypoglycemia during standard care.
However, false alarms increase the overall nursing workload. 2011 by the
Society of Critical Care Medicine and the World Federation of Pediatric
Intensive and Critical Care Societies.
<2>
Accession Number
2011628548
Authors
Sorice M. Tritto F.P. Sordelli C. Gregorio R. Piazza L.
Institution
(Sorice, Tritto, Gregorio, Piazza) Department of Cardiac Surgery, S. Anna
e S. Sebastiano Hospital, Caserta, Italy
(Sorice, Tritto, Gregorio, Piazza) Via F. Palasciano, 81100 (CE), Italy
(Sordelli) Department of Cardiothoracic Sciences, Monaldi Hospital, Second
University of Naples, Naples, Italy
(Sordelli) Via L. Bianchi, 80131 (NA), Italy
Title
N-3 polyunsaturated fatty acids reduces post-operative atrial fibrillation
incidence in patients undergoing "on-pump" coronary artery bypass graft
surgery.
Source
Monaldi Archives for Chest Disease - Cardiac Series. 76 (2) (pp 93-98),
2011. Date of Publication: June 2011.
Publisher
Fondazione Salvatore Maugeri (Via Ferrata 8, Pavia 27100, Italy)
Abstract
Background: The aim of this study was to evaluate the efficacy of
preoperative and postoperative therapy with n-3 polyunsaturated fatty
acids in reducing the incidence of atrial fibrillation after coronary
artery bypass graft surgery. Methods: 201 patients undergoing coronary
artery bypass graft surgery were randomized to 1) a control group (105
patients), or 2) n-3 polyunsaturated fatty acids 2 g/day group (96
patients) for at least 5 days before surgery and until hospital discharge.
Groups were further subdivided in four subgroups according to the
operative technique: "off-pump"or "on-pump". The primary end point was to
evaluate the reduced incidence of postoperative in-hospital atrial
fibrillation in the (N-3 PUFA) group. Secondary end points were the impact
of the surgical technique on the incidence of postoperative arrhythmia and
the impact of n-3 polyunsaturated fatty acids therapy on post-operative
hospital length of stay. Results: The overall incidence of post-operative
atrial fibrillation was 17.4% (35/201). The arrhythmia occurred in 11.4%
(11/96) of the patients in therapy with n-3 polyunsaturated fatty acids
and in 22.8% (24/105) in the control groups. In particular, the
statistical analysis of subgroups showed a significant reduction of
postoperative atrial fibrillation only in the group including patients
treated with n-3 polyunsaturated fatty acids undergoing "on-pump" coronary
artery bypass graft surgery. The length of hospital stay did not differ
among all groups. Conclusions: N-3 polyunsaturated fatty acids
administration significantly reduces the incidence of post-operative
atrial fibrillation in patients undergoing "on-pump" coronary artery
bypass graft surgery. N-3 polyunsaturated fatty acids therapy is not
associated with a shorter hospital stay.
<3>
Accession Number
2011604859
Authors
Morice M.-C. Feldman T.E. Mack M.J. Stahle E. Holmes D.R. Colombo A. Morel
M.-A. Van Den Brand M. Serruys P.W. Mohr F. Carrie D. Fournial G. James S.
Leadley K. Dawkins K.D. Kappetein A.P.
Institution
(Morice) Institut Hospitalier Jacques Cartier, 6, Avenue du Noyer Lambert,
F-91349 Massy, France
(Feldman) Evanston Hospital, Evanston, IL, United States
(Mack) Heart Hospital Baylor Plano, Dallas, TX, United States
(Stahle, James) University Hospital Uppsala, Uppsala, Sweden
(Holmes) Mayo Clinic, Rochester, MN, United States
(Colombo) San Raffaele Scientific Institute, Milan, Italy
(Morel, Van Den Brand) Cardialysis, Rotterdam, Netherlands
(Serruys, Kappetein) Erasmus University Medical Center, Rotterdam,
Netherlands
(Mohr) University of Leipzig Heart Center, Leipzig, Germany
(Carrie, Fournial) Centre Hopital Universitaire Rangueil, Toulouse, France
(Leadley, Dawkins) Boston Scientific Corporation, Inc., Natick, MA, United
States
Title
Angiographic outcomes following stenting or coronary artery bypass surgery
of the left main coronary artery: Fifteen-month outcomes from the synergy
between PCI with TAXUS express and cardiac surgery left main angiographic
substudy (SYNTAX-LE MANS).
Source
EuroIntervention. 7 (6) (pp 670-679), 2011. Date of Publication: October
2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Aims: The SYNTAX-LE MANS substudy prospectively evaluated 15-month
angiographic and clinical outcomes in patients with treated left main (LM)
disease. Methods and results: In the SYNTAX trial, 1,800 patients with
three-vessel and/or LM disease were randomised to either CABG or PCI; of
these, 271 LM patients were prospectively assigned to receive a 15-month
angiogram. The primary endpoint for the CABG arm was the ratio of >=50% to
<100% obstructed/occluded grafts bypassing LM lesions to the number
placed. The primary endpoint for the PCI arm was the proportion of
patients with <=50% diameter stenosis ('patent' stents) of treated LM
lesions. Per protocol, no formal comparison between CABG and PCI arms was
intended based on the differing primary endpoints. Available 15-month
angiograms were analysed for 114 CABG and 149 PCI patients. At 15 months,
9.9% (26/263) of CABG grafts were 100% occluded and an additional 5.7%
(15/263) were >=50% to <100% occluded. Overall, 27.2% (31/114) of patients
had >=1 obstructed/occluded graft. The 15-month CABG MACCE rate was 8.8%
(10/114) and MACCE at 15 months was not significantly associated with
graft obstruction/occlusion (p=0.85). In the PCI arm, 92.4% (134/145) of
patients had <=50% diameter LM stenosis at 15 months (89.7% [87/97] distal
LM lesions and 97.9% [47/48] non-distal LM lesions). The 15-month PCI
MACCE rate was 12.8% (20/156) and this was significantly associated with
lack of stent patency at 15 months (p<0.001), mainly due to repeat
revascularisation. Conclusions: At 15 months, 15.6% (41/263) of grafts
were at least 50% obstructed but this was not significantly associated
with MACCE; 92.4% (134/145) of patients had stents that remained patent at
15 months, and stent restenosis was significantly associated with MACCE,
predominantly due to revascularisation. Europa Edition 2011. All rights
reserved.
<4>
Accession Number
2011618912
Authors
Maj G. Landoni G. Biondi-Zoccai G. Bignami E. Cabrini L. Buratti L. Greco
M. Zambon M. Zangrillo A.
Institution
(Maj, Landoni, Bignami, Cabrini, Buratti, Greco, Zambon, Zangrillo)
Department of Anesthesia and Intensive Care, Universita Vita-Salute San
Raffaele, Via Olgettina 60, Milano, 20132, Italy
(Biondi-Zoccai) Interventional Cardiology, Division of Cardiology,
University of Turin, Turin, Italy
Title
Nesiritide and clinically relevant outcomes in cardiac surgery: A
meta-analysis of randomized studies.
Source
Signa Vitae. 6 (2) (pp 17-23), 2011. Date of Publication: 2011.
Publisher
Pharmamed Mado Ltd (Zatisje 8 g, Zabreb 10000, Croatia)
Abstract
B-type natriuretic peptide is a cardiac hormone that relaxes vascular
smooth muscle and causes arterial dilatation. Nesiritide has been
associated with increased urine output; reduced diuretic requirements; and
suppression of aldosterone, endothelin, and norepinephrine. We have
independently conducted the first systematic review and meta-analysis of
randomized trials to determine the impact of nesiritide on renal
replacement therapy and death in patients undergoing cardiac surgery. We
performed a meta-analysis of 6 randomized controlled studies including 560
patients (280 receiving nesiritide and 280 assigned to the control group).
Two unblinded reviewers selected randomized trials studying nesiritide in
patients undergoing cardiac surgery. Nesiritide doses ranged from 0.005
mcg/kg/min to 0.01 mcg/kg/min. Nesiritide did not reduce postoperative
creatinine peak values: -0.16 [-0.42, 0.10], p for effect=0.23, p for
heterogeneity<0.01, I2=90.5%) or the need for renal replacement therapy
(1/177 in the nesiritide group vs 4/176 in the control group OR 0.39
[0.07, 2.06], p for effect=0.27, p for heterogeneity=0.70, I2=0%). We
observed an interesting trend toward a reduction in mortality in the
nesiritide group:13/280 (4.6%) vs 22/280 (7.8%) OR 0.57 [0.28, 1.15], p
for effect=0.12, p for heterogeneity=0.43, I2=0%. Nesiritide did not
reduce time of mechanical ventilation -8.77 hours [-21.42, 3.88], p=0.17,
length of hospital stay -2.67 days [-6.50, 1.16], p=0.17 or intensive care
unit (ICU) stay -0.94 days [-2.83, 0.95], p=0.33. In conclusion, further
randomized controlled trials are needed to support the hypothesis that
nesiritide improves clinically relevant outcomes in cardiac surgery.
<5>
Accession Number
2011625393
Authors
Johansson B. Houltz B. Edvardsson N. Schersten H. Karlsson T. Wandt B.
Berglin E.
Institution
(Johansson, Karlsson) Department of Cardiology, Sahlgrenska University
Hospital/Ostra, Department of Internal Medicine, S-416 85 Goteborg, Sweden
(Houltz) Department of Clinical Physiology, Sahlgrenska University
Hospital, Gothenburg, Sweden
(Schersten, Berglin) Department of Cardiothoracic Surgery, Sahlgrenska
University Hospital, Gothenburg, Sweden
(Edvardsson) Sahlgrenska Academy, Sahlgrenska University Hospital,
Gothenburg, Sweden
(Wandt) Department of Research and Development, Orebro University
Hospital, Orebro, Sweden
Title
Cardiac function in relation to rhythm outcome after intraoperative
epicardial left atrial cryoablation.
Source
Scandinavian Cardiovascular Journal. 45 (6) (pp 327-335), 2011. Date of
Publication: December 2011.
Publisher
Informa Healthcare (69-77 Paul Street, London EC2A 4LQ, United Kingdom)
Abstract
Objectives. To assess the effects of intraoperative left atrial epicardial
cryoablation on rhythm and atrial and ventricular function. Design. Thirty
five patients with coronary artery disease and documented atrial
fibrillation underwent coronary artery bypass surgery and concomitant
cryoablation. An age and gender matched control group of 35 patients with
atrial fibrillation underwent bypass surgery alone. Echocardiography was
performed 9 +/- 32 days before and 22 +/- 6 months after surgery. Results.
The proportion of patients in sinus rhythm at follow-up was 63% and 34% (p
= 0.04) in the cryoablation and control groups, respectively. In patients
with sinus rhythm both before surgery and at follow-up, the left atrial
area increased (p = 0.002) and the mitral annular excursion during atrial
contraction decreased (p = 0.01) after cryoablation. The mitral flow
velocity during atrial systole decreased after cryoablation (p = 0.002).
The LV diameter increased (p = 0.03) and the left ventricular ejection
fraction (LVEF) decreased (p = 0.03) in cryoablated but not in control
patients. Continued deterioration was seen in patients with atrial
fibrillation both pre- and postoperatively. Conclusions. At long-term
follow-up, a significantly higher proportion of patients was in sinus
rhythm in the cryoablation than in the control group. The atrial and
ventricular function had decreased at follow-up two years after surgery.
This decrease was small and occurred within or close to the reference
values in patients with sinus rhythm at follow-up, while patients
remaining in atrial fibrillation showed a significant continued
deterioration. Some subgroups were small, and the findings, although
statistically significant, should be interpreted with caution. 2011
Informa Healthcare.
<6>
Accession Number
2011621202
Authors
Dunlop R.A.
Institution
(Dunlop) Heart Research Institute, Newtown, NSW, Australia
Title
Supplementary evidence to support tai chi as an 'alternative' exercise for
patients undergoing cardiac rehabilitation.
Source
Focus on Alternative and Complementary Therapies. 16 (4) (pp 307-308),
2011. Date of Publication: December 2011.
Publisher
Wiley-Blackwell (350 Main Street, Malden MA 02148, United States)
<7>
Accession Number
2011606541
Authors
Poerner T.C. Otto S. Gassdorf J. Janiak F. Danzer C. Ferrari M. Figulla
H.R.
Institution
(Poerner, Otto, Gassdorf, Janiak, Danzer, Ferrari, Figulla) 1st Dept. of
Medicine, Cardiology Division, University Hospital of Jena, Germany
Title
A prospective randomised study using optical coherence tomography to
assess endothelial coverage and neointimal proliferation at 6-months after
implantation of a coronary everolimus-eluting stent compared with a bare
metal stent postdilated with a paclitaxel-eluting balloon (OCTOPUS trial):
Rationale, design and methods.
Source
EuroIntervention. 7 (SUPPL. K) (pp K93-K99), 2011. Date of Publication:
May 2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Background: Safety concerns regarding use of drug-eluting stent systems
(DES) are related mostly to late stent thrombosis, which is facilitated by
incomplete stent endothelial coverage. Specific information about time
course and amount of endothelial strut coverage of different DES is
required, in order to further refine the concept of antiplatelet therapy
after DES implantation. Optical coherence tomography (OCT) is emerging as
a new gold standard for endovascular imaging of stents, atherosclerosis
progression, vulnerable plaque, and neointimal proliferation. The aim of
this study is a comparative evaluation using OCT of the XIENCE V
everolimuseluting stent (Abbot Vascular, Santa Clara, CA, USA) on one
hand, and the bare metal stent Coroflex Blue postdilated with the
paclitaxel-eluting balloon Sequent Please (both from B Braun Melsungen AG,
Melsungen, Germany) on the other hand, with respect to endothelial
coverage and neointimal proliferation. Methods: Eighty patients scheduled
for elective percutaneous coronary intervention (PCI) of a native coronary
stenosis suitable for DES implantation and OCT imaging are scheduled to be
openly randomised 1:1 to either XIENCE or Coroflex Blue/Sequent Please.
The study is conducted prospectively at a university high-volume PCI
centre with OCT expertise. Angiographic follow-up and time-domain OCT
imaging with motorised pull-back at 1 mm/s are planned six months after
study stent implantation in all patients. OCT endpoints are: (1)
endothelial coverage, expressed as % of struts without coverage and % of
stent length containing non-covered struts, and respectively (2)
neointimal proliferation, given as % neointimal volumetric proliferation
within the whole stent and also as peak focal % neointimal area
proliferation. The study is not powered for clinical endpoints, which are:
subacute or late stent thrombosis and need for revascularisation of the
stent segment. Given the high number of measurements (15 cross-section
images / 1 mm stent length), OCT endpoints are likely to reach
significance at the level p <.05, if the drop-out rate in follow-up does
not exceed 20%. Current status: The study is currently on-going and its
termination is scheduled for February 2010. (ClinicalTrials. gov
identifier: NCT01056744). Europa Edition 2011. All rights reserved.
<8>
Accession Number
2011606540
Authors
Ali R.M. Degenhardt R. Zambahari R. Tresukosol D. Ahmad W.A.W. Kamar
H.B.H. Kui-Hian S. Ong T.K. Ismail O.B. Elis S.B. Udychalerm W. Ackermann
H. Boxberger M. Unverdorben M.
Institution
(Ali, Zambahari) National Heart Institute, Kuala Lumpur, Malaysia
(Degenhardt, Unverdorben) Clinical Research Institute, Center for
Cardiovascular Diseases, Heinz-Meise-Strasse 100, D-36199 Rotenburg an der
Fulda, Germany
(Tresukosol) Siriraj Hospital Mahidol University, Bangkok, Thailand
(Ahmad, Kamar) University Malaya Medical Center, Kuala Lumpur, Malaysia
(Kui-Hian, Ong) Sarawak Hospital, Kuching, Malaysia
(Ismail, Elis) Penang Hospital, Pulau Penang, Malaysia
(Udychalerm) King Chulalongkorn Hospital, Bangkok, Thailand
(Ackermann) Institute for Biomedical Statistics, Goethe-University,
Frankfurt/Main, Germany
(Boxberger) Clinical Science, Vascular System, BBraun, Berlin, Germany
(Unverdorben) Scientific Affairs, BBraun Medical Inc, Bethlehem, PA,
United States
Title
Paclitaxel-eluting balloon angioplasty and cobalt-chromium stents versus
conventional angioplasty and paclitaxel-eluting stents in the treatment of
native coronary artery stenoses in patients with diabetes mellitus.
Source
EuroIntervention. 7 (SUPPL. K) (pp K83-K92), 2011. Date of Publication:
May 2011.
Publisher
EuroPCR (5 Rue Saint-Pantaleon, Toulouse 31015, France)
Abstract
Aims: Coronary lesions in diabetics (DM) are associated with a high
recurrence following percutaneous coronary intervention (PCI), even after
drug-eluting stent (DES) deployment. Encouraging clinical data of the
drug-eluting balloon catheter (DEB) SeQuent Please warrant its
investigation in these patients. Methods and results: Eighty-four diabetic
patients (60.8+/-9.1years, 76.2% male) were randomised to either the DEB
SeQuent Please or the DES Taxus Liberte to compare the 9-month clinical
and angiographic outcome of PCI in native coronary arteries. Comparing the
DEB vs. the DES the 9-month results (follow-up DEB 39/45 [86.7%], DES
36/39 [92.3%]) are statistically not different at the 0.05 level for the
primary end- point of in-segment (0.37+/-0.59 mm vs. 0.35 +/-0.63 mm) and
in-stent (0.51+/-0.61 mm vs. 0.53+/-0.67 mm) late lumen loss, overall and
cardiac deaths (2/45 [4.4%] and 3/45 [6.7%] vs. 0), target lesion
revascularisation (3/45 [8.9%] vs. 4/39 [10.3%]), the total MACE rate
(6/45 [13.3%] vs. 6/39 [15.4%]), and the event free survival after
10.2+/-3.8 months (Kaplan-Meier analysis, p<0.80, log rank test).
Conclusions: The clinical and angiographic outcome of the combination of
the drug-eluting balloon SeQuent Please with a cobalt chromium stent
compared to the drug eluting Taxus stent are similar. Europa Edition
2011. All rights reserved.
<9>
Accession Number
70574382
Authors
Visnansky M. Mesaros S.
Institution
(Visnansky) SLOVAHTA, Bratislava, Slovakia
(Mesaros) SMs Consulting Ltd., Bratislava, Slovakia
Title
Patient self-testing of oral anticoagulation therapy by coaguchek xs
system. Rapid health technology assessment in Slovak health care
environment.
Source
Value in Health. Conference: ISPOR 14th Annual European Congress Madrid
Spain. Conference Start: 20111105 Conference End: 20111108. Conference
Publication: (var.pagings). 14 (7) (pp A257-A258), 2011. Date of
Publication: November 2011.
Publisher
Elsevier Ltd
Abstract
OBJECTIVES: to explore the effects of patient self-testing (PST) of oral
anticoagulation therapy (OAT) by CoaguChek XS System compared to standard
available care (laboratory testing) for selected group of patients.
METHODS: Health Economy Model (HECON), using Cost-Effectiveness Analysis
(CEA), complemented by Budget- Impact Analysis (BIA) on public health
insurance coverage in Slovakia. We searched MEDLINE, Cochrane and
available grey literature (Industrial Sources and Expert Opinions) for
meta analyses, systematic reviews, economic evaluation studies and health
technology reports on PST of OAT. Outcomes analyzed were feasibility and
accuracy of PST, thromboembolic events, hemorrhagic complications and
mortality. Real-world data from General Health Insurance, Inc. were used
for costs associated with corresponding diagnoses, complications and
management of patients on OAT, including full cohort of patients (n=100,
average age of 63 years) on PST. Markov Model (life time horizon) for OAT
patient management was developed, comparing PST with standard care.
Outcomes observed were major thromboembolic events, major hemorrhagic
complications and mortality. Payer perspective and direct healthcare costs
only, associated with OAT management were considered in CEA and BIA for
diagnosis subgroups. Discount rate of 5% was used for costs as well as
outcomes. Sensitivity analysis for major complications was performed.
RESULTS: CEA for PST vs. standard care associated with OAT shows that
intervention is cost-effective (dominant) for all diagnosis subgroups. Net
costs (BIA) associated with PST for expanding the existing cohort of
patients 10 times (n=1000) are 1.596 mil. in Year 1 (up to 3.579 in Year
5). CONCLUSIONS: PST of OAT is considered cost-effective in terms of
International Normalized Ratio (INR) regulation and safer in terms of
complications. Moreover, analysis of selected subpopulations (mitral
and/or aortic mechanical heart valve implantation, aortic and/or other
aneurysm and congenital cardiovascular malformations) shows that PST
brings the most significant cost-savings especially for those OAT patient
segments.
<10>
Accession Number
70574374
Authors
Campbell J. Faivre P. Kumar P. Drummond M.
Institution
(Campbell) OptumInsight, Medford, MA, United States
(Faivre, Kumar) OptumInsight, Uxbridge, United Kingdom
(Drummond) University of York, Heslington, York, United Kingdom
Title
The cost-effectiveness of transcatheter aortic valve implantation in
elderly patients with severe aortic stenosis who are contraindicated for
conventional surgical aortic valve replacement in the United Kingdom.
Source
Value in Health. Conference: ISPOR 14th Annual European Congress Madrid
Spain. Conference Start: 20111105 Conference End: 20111108. Conference
Publication: (var.pagings). 14 (7) (pp A256), 2011. Date of Publication:
November 2011.
Publisher
Elsevier Ltd
Abstract
OBJECTIVES: To assess the cost-effectiveness of transcatheter aortic valve
implantation (TAVI) versus medical management (MM) for severe aortic
stenosis (AS) in elderly patients with excessive surgical risk. METHODS: A
Markov model was developed of survival, quality-adjusted life-years
(QALYs) and medical costs, in elderly patients in the UK with severe AS
and excessive risk for conventional aortic valve replacement (cAVR).
Incremental cost-effectiveness ratios (ICERs) were estimated as cost per
QALY-gained, from the National Health Service (NHS) perspective, over 3
years. Clinical and utility outcomes over the first year were derived from
published results of a head-to-head randomized controlled trial comparing
[transfemoral] TAVI and MM. Base-case analyses assumed no additional
procedure-related adverse events after the first year-not including
re-hospitalizations due to cardiovascular events-and constant
treatment-specific mortality after the first month. Costs of procedures,
adverse events, re-hospitalizations and long-term health care utilization
were estimated using NHS tariff and reference cost schedules, National
Institute of Health and Clinical Excellence reports, peer-reviewed
literature and clinical experts. Outcomes and costs (2010) were discounted
at 3.5% per annum. RESULTS: Under conservative assumptions, treatment with
transfemoral TAVI is estimated to result in better survival (35% vs. 13%
at three years) and more QALYs (1.17 vs. 0.76) than MM. TAVI is also
associated with higher costs of initial treatment and procedure-related
adverse events, partially offset by lower costs of re-hospitalizations
(net costs of 34,500 vs. 23,700). The base-case ICER of 26,100 is
sensitive to variation in assumptions about long-term mortality for MM and
long-term cardiovascular events for TAVI but remains below 30,000; the
model is also sensitive to assumptions on long-term care use. CONCLUSIONS:
In elderly patients who are contraindicated for cAVR, TAVI is estimated to
result in better survival and fewer re-hospitalizations over a three-year
period compared with MM, and can be considered cost-effective at 3 years
with a base-case ICER of ~26,000.
<11>
Accession Number
70582119
Authors
Khawaja M.Z. Asress K. Haran H. Nadra I. Wilson K. MacGillivray K. Hancock
J. Young C. Bapat V. Redwood S. Thomas M.
Institution
(Khawaja, Asress, Wilson, MacGillivray, Hancock, Young, Bapat, Redwood,
Thomas) Department of Cardiology, Guy's and St Thomas' NHS Foundation
Trust, London, United Kingdom
(Khawaja, Asress, Haran, Redwood) King's College, London, London, United
Kingdom
(Nadra) Nottingham University Hospitals NHS Trust, Nottingham, United
Kingdom
Title
The effects of pre-existing significant coronary artery disease defined by
QCA analysis upon outcome after transcatheter aortic valve implantation
using the Edwards bioprosthesis.
Source
Journal of the American College of Cardiology. Conference: 23rd Annual
Symposium of the Transcatheter Cardiovascular Therapeutics, TCT 2011 San
Francisco, CA United States. Conference Start: 20111107 Conference End:
20111111. Conference Publication: (var.pagings). 58 (20 SUPPL. 1) (pp
B201-B202), 2011. Date of Publication: 08 Nov 2011.
Publisher
Elsevier USA
Abstract
Background: Patients undergoing surgical aortic valve replacement (sAVR)
routinely undergo simultaneous coronary artery bypass grafting (CABG) for
significant coronary artery disease (CAD) due to adverse prognostic
impact. Whilst manufacturers advise percutaneous intervention (PCI) to
significant CAD prior to transcatheter aortic valve implantation (TAVI)
there is considerable variation amongst operators. We sought to analyse
the impact of CAD in our centre's patients. Methods: We performed a
retrospective analysis of 164 patients who underwent TAVI using the
Edwards bioprosthesis from March 2008 to October 2010. 6 angiograms were
not available for analysis. Patients were classified using pre-TAVI
quantitative coronary angiographic (QCA) analysis as 'CAD' (patients with
>=1 coronary stenosis of >=70% severity or >=50% if left main stem) and
'No CAD' (Group 2). Results: 54 patients (32.9%) had significant CAD prior
to TAVI, with 10 (6.5%) undergoing PCI prior to their procedure. The CAD
group had more males (70.4% v 51.0%, p=0.02) and a greater proportion with
previous PCI (27.8% v 11.5%, p=0.01). [|#7#|][|#7#|]At a mean follow up of
337+/-275 days (mean+/-SD), the overall mortality in the CAD group was
higher (35.2% v 16.3%, p=0.007), as were 30-day (16.7% v 3.8%, p=0.005)
and 12 month mortalities (31.5% v 14.4%, p=0.01). Kaplan Meier analysis
confirmed the increase in mortality with the presence of CAD
(logrank=0.02). The incidence of MACCE was not significantly different
(35.2% v 23.1%, p=0.11). [|#7#|][|#7#|]Amongst the 10 patients who
underwent PCI in Group 1, 8 had single vessel intervention and 2 had PCI
to 2 vessels. Mortality in this sub-group was not significantly different
from the CAD patients who did not receive PCI (50% versus 31.8%, p=0.28).
Conclusion: The presence of significant CAD as defined by QCA analysis
increased overall, 30-day and 12 month mortality in patients after TAVI in
our study. As yet, the impact of PCI to significant CAD upon outcome after
TAVI is not clear and will be assessed in a prospective, randomised
controlled trial.
<12>
Accession Number
70581767
Authors
Kunadian V. Pugh A. Qiu W.
Institution
(Kunadian) Institute of Cellular Medicine, Faculty of Medical Sciences,
Newcastle University, Newcastle upon Tyne, United Kingdom
(Pugh) Faculty of Medical Sciences, Newcastle University Medical School,
Newcastle upon Tyne, United Kingdom
(Qiu) Department of Medicine, Harvard Medical School, Brigham and Women's
Hospital, Boston, MA, United States
Title
Percutaneous coronary intervention in patients with severe left
ventricular dysfunction: A meta-analysis of 19 studies.
Source
Journal of the American College of Cardiology. Conference: 23rd Annual
Symposium of the Transcatheter Cardiovascular Therapeutics, TCT 2011 San
Francisco, CA United States. Conference Start: 20111107 Conference End:
20111111. Conference Publication: (var.pagings). 58 (20 SUPPL. 1) (pp
B108), 2011. Date of Publication: 08 Nov 2011.
Publisher
Elsevier USA
Abstract
Background: Coronary artery disease (CAD) is the most common cause for
left ventricular dysfunction (LVD). Coronary artery bypass surgery (CABG)
results in equivalent benefit in reducing mortality compared with medical
therapy in patients with CAD and severe LVD. However, the benefit of
percutaneous coronary intervention (PCI) in patients with severe LVD is
not clear. A meta-analysis of studies utilising PCI in patients with
severe LVD (EF<=40%) was performed to determine inhospital (IH) and
long-term (LT) [>=1year] mortality. Methods: A systematic computerised
literature search was performed. Studies of patients undergoing PCI for
CAD in the presence of severe LVD were included. Studies that did not
report LT mortality and same centre studies were excluded. Results: In
total, 4766 patients (19 studies) were included. The mean (pooled
estimate) age was 64.7 years with a mean (estimate) EF of 29.9% and 79.7%
were men. The IH mortality rate using random effects model (13 studies,
total PCI n=2202, 39 deaths) was 1.8% (95% CI 1.0-2.9%). The LT mortality
rate (23.86 months) using random effects model (19 studies, total
follow-up n=2937, 401 deaths) was 15.6% (95% CI 11.0-20.7%). Five studies
compared PCI versus CABG (n=455 vs. n=502) and provide LT mortality data
(PCI n=102 vs. CABG n=115 deaths). The relative risk using random effects
model (PCI vs. CABG) was 0.98 (95% CI 0.78-1.22, p value 0.83). (Table
Presented) Conclusion: This meta-analysis demonstrates that based on
available clinical studies, PCI among patients with severe LVD is feasible
with acceptable in-hospital and longterm mortality and yields comparable
outcomes with CABG.
<13>
Accession Number
70581521
Authors
Eaton J.N. Mealing S. Nicolo P. Moat N. Pascale B. Busca R. Sculpher M.
Watt M.
Institution
(Eaton, Mealing, Sculpher, Watt) Health Economics, Oxford Outcomes,
Oxford, United Kingdom
(Pascale, Busca) Medtronic Ltd, Tolochenaz, Switzerland
(Nicolo) German Heart Centre, Munich, Germany
(Moat) Royal Brompton and Harefield NHS Trust, London, United Kingdom
Title
TAVI for high risk patients with Severe Aortic Stenosis who satisfy all
the criteria for conventional aortic valve replacement: A United Kingdom
based cost-utility analysis.
Source
Journal of the American College of Cardiology. Conference: 23rd Annual
Symposium of the Transcatheter Cardiovascular Therapeutics, TCT 2011 San
Francisco, CA United States. Conference Start: 20111107 Conference End:
20111111. Conference Publication: (var.pagings). 58 (20 SUPPL. 1) (pp
B37-B38), 2011. Date of Publication: 08 Nov 2011.
Publisher
Elsevier USA
Abstract
Background: SAVR is an invasive intervention, carrying a risk of
perioperative mortality and an alternative treatment option, transcatheter
aortic valve implantation (TAVI), has been developed. The clinical
efficacy of TAVI was demonstrated in a recently published randomized
controlled trial (PARTNER). To date, however, there is little information
about the cost-effectiveness of TAVI relative to SAVR. Methods: A 20 year
Markov model was developed in Microsoft Excel from the perspective of the
UK NHS. Treatment options included were TAVI and SAVR. Treatment specific
mortality and adverse event data were taken from the PARTNER study (Cohort
A) which was supplemented by UK specific life table information. Resource
use and cost data were drawn, where possible, on information from publicly
available national databases. Other parameters were taken from published
literature. Decrements were applied to age-specific EQ-5D population norms
to generate Quality Adjusted Life Years (QALYs). Alternative modelling
approaches and data sources for key parameters were included into the
model. Extensive probabilistic and deterministic sensitivity analyses were
performed. Costs and benefits were discounted at an annual rate of 3.5%
Results: The base case Incremental Cost-Effectiveness Ratio (ICER) was
30,538 per QALY gained (95% Crl 21,322 to 39,287). At willingness to pay
thresholds of 30,000 per QALY, the probability that TAVI is cost-effective
is 44%. Results were not sensitive to changes in baseline survival curve,
approach used to model the benefit of TAVI, or procedure time, but
sensitive to changes in procedure cost and resource use. Conclusion: TAVI
may be a cost-effective alternative to conventional surgery at a threshold
accepted by the United Kingdom reimbursement agency. Further examination
of the resource use and treatment pathway in this patient group will help
to reduce the uncertainty in the ICER.
<14>
Accession Number
70583750
Authors
Conceica-Souza G.E. Osawa E.A. Oliveira E.S. Ayub-Ferreira S.M. Issa V.S.
Baca F. Chizzola P.R. Bocchi E.A.
Institution
(Conceica-Souza, Osawa, Ayub-Ferreira, Issa, Baca, Chizzola, Bocchi) Heart
Institute-InCor, Sao Paulo, Brazil
(Oliveira) Clinicas' Hospital-Nephrology Division, Sao Paulo, Brazil
Title
Peritoneal dialysis as an alternative approach to end stage refractory
heart failure contraindicated for heart transplantation: A retrospective
controlled cohort study.
Source
European Journal of Heart Failure, Supplement. Conference: Heart Failure
Congress 2011 Gothenburg Sweden. Conference Start: 20110521 Conference
End: 20110524. Conference Publication: (var.pagings). 10 (pp S30),
2011. Date of Publication: May 2011.
Publisher
Oxford University Press
Abstract
Purpose: To evaluate the impact of peritoneal dialysis (PD) in end stage
systolic heart failure (SHF) who are not candidates for heart
transplantation (HT) Methods: Retrospective Cohort study. Inclusion
criteria: SHF defined by Framigham's criteria and left ventricular
ejection fraction (LVEF) < 35%; inpatient stage D SHF defined at heart
failure specialist discretion (under evaluation for HT), dependant on
intravenous inothropic therapy; presence of at least one absolute
contraindication for HT. Exclusion criteria: patients with severe
comorbidities which could affect survival in the next 6 months or with end
stage renal disease with clear indication of dialysis. Patients were
followed by clinical inpatient and outpatient visits and/or telephone
contact after one year of the index admission. Data were additionally
extracted from electronic chart review and telephonic interview with
patients and/or their families. Two goups were followed separately:
(G1)-with patients who underwent PD (under clinical discretion) and
(G2)-with patients who underwent standard therapy. P value was considered
statistically significant if < 0,05. Comparative statistical analysis used
Fischer's exact test for categoric variables; non-paired T-student test
for parametric continuous variables. Results: From january 2007 to june
2009, 12 patients were included-3 patients in G1 and 9 patients in G2.
Medical treatment, clinical, laboratorial and echocardiographic variables
were similar in both groups. Among G1 and G2 patients, respectively, the
main contraindication for HT in both groups was fixed pulmonary
hypertension (67% vs 55%-p = ns). After 12 months follow-up, mortality
incidence was 0% among G1 patients and 67% among G2 patients. In average,
G1 and G2 patients survived for 540+/-176 days vs 255+/-264 days,
respectively. All survivors in G1 group improved their functional class
and there were no complications regarding PD catheter use. Among G2
patients most of the survivors maintained a poor functional status.
Conclusions: PD appear to be safe and seems to benefit end stage
refractory SHF patients who were ineligible for HT. A large randomized
controlled trial is necessary to fully investigate its utility.
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