TY - JOUR
T1 - Neurological events during long-term mechanical circulatory support for heart failure
T2 - The Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) experience
AU - Lazar, Ronald M.
AU - Shapiro, Peter A.
AU - Jaski, Brian E.
AU - Parides, Michael K.
AU - Bourge, Robert C.
AU - Watson, John T.
AU - Damme, Laura
AU - Dembitsky, Walter
AU - Hosenpud, Jeffrey D.
AU - Gupta, Lopa
AU - Tierney, Anita
AU - Kraus, Tonya
AU - Naka, Yoshifumi
PY - 2004/5/25
Y1 - 2004/5/25
N2 - 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 (χ2, 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.
AB - 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 (χ2, 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.
KW - Heart failure
KW - Heart-assist device
KW - Stroke
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U2 - 10.1161/01.CIR.0000129414.95137.CD
DO - 10.1161/01.CIR.0000129414.95137.CD
M3 - Article
C2 - 15123534
AN - SCOPUS:2542474026
SN - 0009-7322
VL - 109
SP - 2423
EP - 2427
JO - Circulation
JF - Circulation
IS - 20
ER -