Document Detail


Left ventricular assist device performance with long-term circulatory support: lessons from the REMATCH trial.
MedLine Citation:
PMID:  15561049     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Left ventricular assist device (LVAD) failure and malfunction rates are critical gauges for establishing LVADs as a long-term therapy for end-stage heart failure patients. These device performance measures, however, have been inadequately characterized in the bridge-to-transplantation literature. METHODS: REMATCH is a randomized trial that compares optimal medical management with LVAD implantation for patients with end-stage heart failure. An independent committee adjudicated patient outcomes. The primary endpoint--survival--was analyzed by intention to treat using the log-rank statistic. Frequency of event occurrence was analyzed by Poisson regression. The time to first event was analyzed by the product limit method. Device performance was disaggregated into confirmed malfunctions and system failures. The latter were events in which patients could not be rescued with backup circulatory support measures. RESULTS: The 1-year survival rate was 52% (95% confidence limit [CL]; 40%-63%) for LVAD patients versus 28% (95% CL; 17%-39%) for medical patients and the 2-year survival rate was 29% (95% CL; 19%-40%) for LVAD patients versus 13% (95% CL; 5%-22%) for medical patients. System failure was 0.13 per patient per year and the confirmed LVAD malfunction rate was 0.90. Freedom from device replacement was 87% at 1 year and 37% at 2 years. CONCLUSIONS: Despite the observed rates of device malfunction and replacement, LVAD implantation confers clinically significant improvement with regard to survival as compared with medical management. Device modifications and innovations for infection management exhibit great promise of improving device performance in the near future.
Authors:
Walter P Dembitsky; Alfred J Tector; Soon Park; Alan J Moskowitz; Annetine C Gelijns; Nuala S Ronan; William Piccione; William L Holman; Satoshi Furukawa; Alan D Weinberg; Gerald Heatley; Victor L Poirier; Laura Damme; James W Long
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  The Annals of thoracic surgery     Volume:  78     ISSN:  1552-6259     ISO Abbreviation:  Ann. Thorac. Surg.     Publication Date:  2004 Dec 
Date Detail:
Created Date:  2004-11-24     Completed Date:  2005-07-05     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  15030100R     Medline TA:  Ann Thorac Surg     Country:  Netherlands    
Other Details:
Languages:  eng     Pagination:  2123-9; discussion 2129-30     Citation Subset:  AIM; IM    
Affiliation:
Sharp Memorial Hospital, San Diego, California, USA.
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MeSH Terms
Descriptor/Qualifier:
Aged
Cardiovascular Agents / therapeutic use
Cause of Death
Female
Heart Failure / drug therapy,  mortality,  surgery*
Heart-Assist Devices* / adverse effects,  economics
Hemorrhage / etiology
Humans
Male
Middle Aged
Poisson Distribution
Prosthesis Failure
Sepsis / etiology
Stroke / etiology
Survival Rate
Grant Support
ID/Acronym/Agency:
HL-53986/HL/NHLBI NIH HHS
Chemical
Reg. No./Substance:
0/Cardiovascular Agents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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