title: Multicentre Canadian experience with the HeartWare ventricular assist device: concerns about adverse neurological outcomes.
abstract: BACKGROUND
  The HeartWare left ventricular assist device (HVAD; HeartWare Inc, Framingham, MA) was first implanted in Canada in 2010. We performed a multicentre analysis of the real world outcomes associated with its use.
  
  
  METHODS
  Between May 2010 and January 2013, 4 Canadian centres inserted a total of 72 HVADs in 71 patients. Data were collected prospectively and analyzed retrospectively for the 1-year estimate of the principal outcome of transplant, explant for recovery, or death in patients who had a bridge to transplantation indication. Adverse event rates were estimated as events per patient-year (PPY).
  
  
  RESULTS
  In the 67 patients who received the HVAD with the indication of bridge to transplant, 26 (38.8%) received a successful transplant, 2 (3%) received an explant for recovery, and 10 (14.9%) patients died during support. Median follow-up time with the HVAD was 6.9 months (range, 2 days to 30.4 months). Despite having 74% of the patients with Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scores of level 1 and 2 at the time of implantation, the rate estimate for survival at 1 year was 86.3% (95% confidence interval, 76.7-93.3). With 48.2 total patient years of support, the rates of ischemic and hemorrhagic strokes were 0.21 and 0.19 events PPY, respectively. Women made up 40% of the cohort and an adverse neurologic event occurred with an event rate of 0.38 PPY in women.
  
  
  CONCLUSIONS
  The HVAD adequately supports acutely ill heart failure patients until the time of transplant or recovery. A high incidence of adverse neurologic outcomes might be related to the large percentage of female patients, the high INTERMACS levels, or unknown factors; further surveillance is required.
authors.affiliation: University of British Columbia, Division of Cardiovascular Surgery, Vancouver, British Columbia, Canada. Electronic address: jmlbashir@gmail.com.
authors.forename: Jamil
authors.initials: J
authors.lastname: Bashir
authors.affiliation: Dalhousie University, Division of Cardiovascular Surgery, Halifax, Nova Scotia, Canada.
authors.forename: Jean-Francois
authors.initials: JF
authors.lastname: Legare
authors.affiliation: University of Manitoba, Section of Cardiac Surgery, Department of Surgery, Winnipeg, Manitoba, Canada.
authors.forename: Darren H
authors.initials: DH
authors.lastname: Freed
authors.affiliation: University of British Columbia, Division of Cardiovascular Surgery, Vancouver, British Columbia, Canada.
authors.forename: Anson
authors.initials: A
authors.lastname: Cheung
authors.affiliation: University of Toronto, Division of Cardiac Surgery, Toronto, Ontario, Canada.
authors.forename: Vivek
authors.initials: V
authors.lastname: Rao
authors.affiliation: University of British Columbia, Division of Cardiology, Vancouver, British Columbia, Canada.
authors.forename: Mustafa
authors.initials: M
authors.lastname: Toma
mesh_terms: D002170:Canada / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000453:epidemiology / Q000209:etiology*; D011379:Prognosis; D011446:Prospective Studies; D012042:Registries; D015996:Survival Rate / Q000639:trends; D016896:Treatment Outcome