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(Circulation. 2004;109:2423-2427.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Neurological Events During Long-Term Mechanical Circulatory Support for Heart Failure

The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) Experience

Ronald M. Lazar, PhD; Peter A. Shapiro, MD; Brian E. Jaski, MD; Michael K. Parides, PhD; Robert C. Bourge, MD; John T. Watson, PhD; Laura Damme, RN, MPH; Walter Dembitsky, MD; Jeffrey D. Hosenpud, MD; Lopa Gupta, RD, MPH; Anita Tierney, MPH; Tonya Kraus, RN, MSN; Yoshifumi Naka, MD

From the Departments of Neurology (R.M.L.), Psychiatry (P.A.S.), Biostatistics (M.K.P.), and Surgery (L.G., A.T., Y.N.), Columbia University College of Physicians and Surgeons, New York, NY; the Advanced Heart Failure and Cardiac Transplant Program (B.E.J., W.D.), Sharp Memorial Hospital, San Diego, Calif; the Division of Cardiovascular Disease (R.C.B.), University of Alabama at Birmingham; the Department of Bioengineering (J.T.W.), University of California San Diego; Thoratec Corp, Pleasanton, Calif (L.D.); the Organ Transplant Program (J.E.H.), St Luke’s Medical Center, Milwaukee, Wis; and Inova Fairfax Hospital, Fairfax, Va (T.K.).

Correspondence to Dr R.M. Lazar, Neurological Institute, 710 W 168th Street, New York, NY 10032. E-mail ral22{at}columbia.edu

Received October 28, 2003; revision received February 19, 2004; accepted February 25, 2004.

Background— Progression of heart failure can lead to cardiac transplantation, but when patients are ineligible, long-term mechanical circulatory support may improve survival. The REMATCH trial showed that left ventricular assist devices (LVADs) prolonged survival in patients with end-stage disease, but with a significant number of adverse events. We report on the neurological outcomes in the REMATCH trial.

Methods and Results— We examined new neurological events in the 129 patients randomized to either LVAD placement (n=68) or medical management (n=61), classified as stroke, transient ischemic attack, toxic-metabolic encephalopathy, and other. There were 46 neurological events: 42 in 30 LVAD patients and 4 in 4 patients in the medical arm (², 30/68 versus 4/61, P<0.001). Sixteen percent of the LVAD patients had a stroke, with a rate of 0.19 per year (95% CI, 0.10 to 0.33), many occurring in the postoperative period. The stroke rate in the medical arm was 0.052. A Kaplan-Meier survival analysis showed a 44% reduction in the risk of stroke or death in the LVAD group versus the optimal medical group (P=0.002). The mean interval from implantation to stroke was 221.8 days (±70.4 days). History of stroke, age, and sepsis were not stroke risk factors in the LVAD group.

Conclusions— Fewer than half of the patients in the LVAD group had a neurological event, and there were few neurological deaths. Survival analysis combining stroke or death demonstrated a significant benefit for long-term circulatory support with an LVAD over medical therapy. Future trials will need to address prospectively all neurological outcomes, including neurocognitive function, and the role of long-term neuroprotection.

Key Words: heart-assist device • stroke • heart failure

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