Elsevier

The Annals of Thoracic Surgery

Volume 78, Issue 6, December 2004, Pages 2123-2130
The Annals of Thoracic Surgery

Original article: cardiovascular
Left Ventricular Assist Device Performance With Long-Term Circulatory Support: Lessons From the REMATCH Trial

Presented at the Thirty-ninth Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 31–Feb 2, 2003.
https://doi.org/10.1016/j.athoracsur.2004.02.030Get rights and content

Abstract

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.

Section snippets

Study Design

The REMATCH trial was designed to compare the outcomes of long-term support with HeartMate VE LVAD to optimal medical management (OMM) in patients with end-stage heart failure who were ineligible for cardiac transplantation. Patients were randomly assigned to the above two therapies in a 1:1 fashion. The study was conducted in 20 centers and supported by a cooperative agreement among the National Heart, Lung, and Blood Institute (Bethesda, MD), Thoratec Corp (Pleasanton, CA), and Columbia

Baseline Characteristics, Survival, and Quality of Life

The patients enrolled in the REMATCH trial were suffering from advanced heart failure symptoms. The mean age in the LVAD arm was 66 years. These patients indicated a mean left ventricular ejection fraction of 17%, a cardiac index of 1.9 l/min, serum creatinine of 1.8 mg/dl, and 65% of these patients were on intravenous (IV) inotropic support (Table 1).

The 1-year survival rate, based on an intention to treat analysis, was 52% (95% CL; 40%–63%) for LVAD patients versus 28% (95% CL; 17%–39%) for

Comment

The REMATCH trial established the survival and quality of life benefit of LVAD destination therapy (DT) for chronic end-stage heart failure patients. As of July 2003 (the closure date for the dataset analyzed here), 14 patients were alive on LVAD support (including 3 patients who crossed over from the medical arm). This trial has also characterized the adverse event profile of LVAD patients. The most common serious adverse event for LVAD patients was sepsis, of which there were 36 episodes in

Acknowledgements

We would like to thank all of the participating REMATCH investigators for the tremendous effort in patient care and data collection that made this publication possible. REMATCH was supported in part by a cooperative agreement (HL-53986) with the National Heart, Lung and Blood Institute of the National Institutes of Health (Bethesda, MD) and Thoratec Corp (Pleasanton, CA).

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