| Results of the post-U.S. Food and Drug Administration-approval study with a continuous flow left ventricular assist device as a bridge to heart transplantation: a prospective study using the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). | |
| | |
MedLine Citation:
|
PMID: 21545946 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
OBJECTIVES: The aim of this study was to determine whether results with the HeartMate (HM) II left ventricular assist device (LVAD) (Thoratec Corporation, Pleasanton, California) in a commercial setting are comparable to other available devices for the same indication. BACKGROUND: After a multicenter pivotal clinical trial conducted from 2005 to 2008, the U.S. Food and Drug Administration approved the HM II LVAD for bridge to transplantation (BTT). A post-approval study was required by the U.S. Food and Drug Administration to determine whether results with the device in a commercial setting are comparable to other available devices for the same indication. METHODS: The study was a prospective evaluation of the first 169 consecutive HM II patients enrolled in the national INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) who were listed for transplant or likely to be listed. Patients were enrolled from April through August 2008 at 77 U.S. centers and followed for at least 1 year after implant. A comparison group (COMP) included all patients (n = 169 at 27 centers) enrolled in the INTERMACS registry with other types of LVADs (79% HeartMate XVE, 21% Implantable Ventricular Assist Device [Thoratec Corporation]) for the same BTT indication in the same time period. Survival rates, adverse events, and quality of life with the EuroQol EQ-5D visual analog scale were obtained in the INTERMACS registry. RESULTS: Baseline characteristics were similar, but creatinine and blood urea nitrogen were lower in the HM II versus COMP groups, and there were fewer patients in the highest-risk INTERMACS patient profile Number 1 (24% for HM II vs. 39% for COMP). Adverse event rates were similar or lower for HM II versus COMP for all events. Bleeding was the most frequent adverse event for both groups (1.44 vs. 1.79 events/patient-year). Operative 30-day mortality for HM II was 4% versus 11% for COMP. The percentage of patients reaching transplant, cardiac recovery, or ongoing LVAD support by 6 months was 91% for HM II and 80% for COMP, and the Kaplan-Meier survival for patients remaining on support at 1 year was 85% for HM II versus 70% for COMP. Quality of life was significantly improved at 3 months of support and sustained through 12 months in both groups compared with baseline. CONCLUSIONS: The results in a post-market approval, actual patient care setting BTT population support the original findings from the pivotal clinical trial regarding the efficacy and risk profile of the HM II LVAD. These data suggest that dissemination of this technology after approval has been associated with continued excellent results. |
| | |
Authors:
|
Randall C Starling; Yoshifumi Naka; Andrew J Boyle; Gonzalo Gonzalez-Stawinski; Ranjit John; Ulrich Jorde; Stuart D Russell; John V Conte; Keith D Aaronson; Edwin C McGee; William G Cotts; David DeNofrio; Duc Thinh Pham; David J Farrar; Francis D Pagani |
Related Documents
:
|
21197536 - Effect of levosimendan and predictors of recovery in patients with peripartum cardiomyo... 18692786 - Artificial oocyte activation with calcium ionophore a23187 in intracytoplasmic sperm in... 18087656 - Surgical treatment of peyronie's disease: choosing the best approach to improve patient... 21340516 - The cox-maze iv procedure for lone atrial fibrillation: a single center experience in 1... 11999236 - How many patients with coronary heart disease are not achieving their risk-factor targe... 3365046 - Comparison of single versus multidose blood cardioplegia in arterial switch procedures. |
Publication Detail:
|
Type: Comparative Study; Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
|
Title: Journal of the American College of Cardiology Volume: 57 ISSN: 1558-3597 ISO Abbreviation: J. Am. Coll. Cardiol. Publication Date: 2011 May |
Date Detail:
|
Created Date: 2011-05-06 Completed Date: 2011-07-05 Revised Date: 2012-02-28 |
Medline Journal Info:
|
Nlm Unique ID: 8301365 Medline TA: J Am Coll Cardiol Country: United States |
Other Details:
|
Languages: eng Pagination: 1890-8 Citation Subset: AIM; IM |
Copyright Information:
|
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved. |
Affiliation:
|
Heart Failure and Cardiac Transplant Medicine, Department of Cardiovascular Medicine, Kaufman Center for Heart Failure, Cleveland Clinic, 9500 Euclid Avenue, Cleveland, OH 44195, USA. starlir@ccf.org |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adolescent Adult Aged Assisted Circulation / instrumentation, standards* Child Child, Preschool Device Approval / standards* Female Follow-Up Studies Heart Transplantation / instrumentation, standards* Heart-Assist Devices / standards* Humans Infant Infant, Newborn Male Middle Aged Product Surveillance, Postmarketing / methods, standards* Prospective Studies Registries / standards* United States Ventricular Dysfunction, Left / surgery, therapy Young Adult |
| Comments/Corrections | |
Comment In:
|
J Am Coll Cardiol. 2011 Sep 13;58(12):1285; author reply 1285-6
[PMID:
21903068
]
|
Erratum In:
|
J Am Coll Cardiol. 2011 Nov 8;58(20):2142 |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Central obesity and survival in subjects with coronary artery disease a systematic review of the lit...
Next Document: Effects of the adenosine A1 receptor antagonist rolofylline on renal function in patients with acute...