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, Peter A. Shapiro, Brian E. Jaski, Michael K. Parides, Robert C. Bourge, John T. Watson, Laura Damme, Walter Dembitsky, Jeffrey D. Hosenpud, Lopa Gupta, Anita Tierney, Tonya Kraus, Yoshifumi Naka

Research output: Contribution to journalArticle

123 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)2423-2427
Number of pages5
JournalCirculation
Volume109
Issue number20
DOIs
StatePublished - May 25 2004
Externally publishedYes

Fingerprint

Heart-Assist Devices
Heart Failure
Stroke
Therapeutics
Survival Analysis
Neurotoxicity Syndromes
Metabolic Brain Diseases
Survival
Transient Ischemic Attack
Kaplan-Meier Estimate
Risk Reduction Behavior
Heart Transplantation
Postoperative Period
Sepsis

Keywords

  • Heart failure
  • Heart-assist device
  • Stroke

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

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

In: Circulation, Vol. 109, No. 20, 25.05.2004, p. 2423-2427.

Research output: Contribution to journalArticle

Lazar, Ronald M. ; Shapiro, Peter A. ; Jaski, Brian E. ; Parides, Michael K. ; Bourge, Robert C. ; Watson, John T. ; Damme, Laura ; Dembitsky, Walter ; Hosenpud, Jeffrey D. ; Gupta, Lopa ; Tierney, Anita ; Kraus, Tonya ; Naka, Yoshifumi. / 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. In: Circulation. 2004 ; Vol. 109, No. 20. pp. 2423-2427.
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abstract = "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.",
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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.

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