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Ann Thorac Surg 2004;78:2123-2130
© 2004 The Society of Thoracic Surgeons

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Original article: cardiovascular

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

^a USA
^b USA
^c Sharp Memorial Hospital, San Diego, California; St. Luke's Medical Center, Milwaukee, Wisconsin, USA
^d California Pacific Medical Center, San Francisco, California, USA
^e International Center for Health Outcomes and Innovation Research (InCHOIR); Columbia University, New York, New York, USA
^f Rush Presbyterian, Chicago, Illinois, USA
^g University of Alabama at Birmingham, Birmingham, Alabama, USA
^h Temple University Hospital, Philadelphia, Pennsylvania, USA
ⁱ Thoratec Corp, Pleasanton, California, USA
^j Latter-Day Saints (LDS) Hospital, Salt Lake City, Utah, USA

Accepted for publication February 10, 2004.

^* Address reprint requests to Dr Gelijns, International Center for Health Outcomes and Innovation Research, Columbia University, 600 W 168th St, 7th Floor, New York, NY 10032, USA
acp10{at}columbia.edu

Presented at the Thirty-ninth Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 31–Feb 2, 2003.

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.

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