title: 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.
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.
  
  
  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 (chi2, 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.
authors.affiliation: Department of Neurology, Columbia University College of Physicians and Surgeons, New York, NY, USA. ral22@columbia.edu
authors.forename: Ronald M
authors.initials: RM
authors.lastname: Lazar
authors.forename: Peter A
authors.initials: PA
authors.lastname: Shapiro
authors.forename: Brian E
authors.initials: BE
authors.lastname: Jaski
authors.forename: Michael K
authors.initials: MK
authors.lastname: Parides
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bourge
authors.forename: John T
authors.initials: JT
authors.lastname: Watson
authors.forename: Laura
authors.initials: L
authors.lastname: Damme
authors.forename: Walter
authors.initials: W
authors.lastname: Dembitsky
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Hosenpud
authors.forename: Lopa
authors.initials: L
authors.lastname: Gupta
authors.forename: Anita
authors.initials: A
authors.lastname: Tierney
authors.forename: Tonya
authors.initials: T
authors.lastname: Kraus
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
mesh_terms: D001927:Brain Diseases / Q000453:epidemiology / Q000209:etiology; D018572:Disease-Free Survival; D006333:Heart Failure / Q000150:complications / Q000601:surgery*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000453:epidemiology / Q000209:etiology; D020521:Stroke / Q000453:epidemiology / Q000209:etiology*