title: The HVAD Left Ventricular Assist Device: Risk Factors for Neurological Events and Risk Mitigation Strategies.
abstract: OBJECTIVE
  The purpose of this study was to determine the risk factors for ischemic in hemorrhage cerebrovascular events in patients supported by the HeartWare ventricular assist device (HVAD).
  
  
  BACKGROUND
  Patients supported with left ventricular assist devices are at risk for both ischemic and hemorrhagic cerebrovascular events.
  
  
  METHODS
  Patients undergoing implantation with a HVAD as part of the bridge-to-transplant trial and subsequent continued access protocol were included. Neurological events (ischemic cerebrovascular accidents [ICVAs] and hemorrhagic cerebrovascular accidents [HCVAs]) were assessed, and the risk factors for these events were evaluated in a multivariable model.
  
  
  RESULTS
  A total of 382 patients were included: 140 bridge-to-transplant patients from the ADVANCE (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure) clinical trial and 242 patients from the continued access protocol. Patients had a mean age of 53.2 years; 71.2% were male, and 68.1% were white. Thirty-eight percent had ischemic heart disease, and the mean duration of support was 422.7 days. The overall prevalence of ICVA was 6.8% (26 of 382); for HCVA, it was 8.4% (32 of 382). Pump design modifications and a protocol-driven change in the antiplatelet therapy reduced the prevalence of ICVA from 6.3% (17 of 272) to 2.7% (3 of 110; p = 0.21) but had a negligible effect on the prevalence of HVCA (8.8% [24 of 272] vs. 6.4% [7 of 110]; p = 0.69). Multivariable predictors of ICVA were aspirin ≤81 mg and atrial fibrillation; predictors of HCVA were mean arterial pressure >90 mm Hg, aspirin ≤81 mg, and an international normalized ratio >3.0. Eight of the 30 participating sites had established improved blood pressure management (IBPM) protocols. Although the prevalence of ICVA for those with and without IBPM protocols was similar (5.3% [6 of 114] vs. 5.2% [14 of 268]; p = 0.99), those with IBPM protocols had a significantly lower prevalence of HCVA (1.8% [2 of 114] vs. 10.8% [29 of 268]; p = 0.0078).
  
  
  CONCLUSIONS
  Anticoagulation, antiplatelet therapy, and blood pressure management affected the prevalence of cerebrovascular events after implantation of the HVAD. Attention to these clinical parameters can have a substantial impact on the occurrence of serious neurological events. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. Electronic address: teutebergjj@upmc.edu.
authors.forename: Jeffrey J
authors.initials: JJ
authors.lastname: Teuteberg
authors.affiliation: University of Louisville, Louisville, Kentucky.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
authors.affiliation: Duke University, Durham, North Carolina.
authors.forename: Joseph G
authors.initials: JG
authors.lastname: Rogers
authors.affiliation: Loyola University, Chicago, Illinois.
authors.forename: Edwin C
authors.initials: EC
authors.lastname: McGee
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.affiliation: Northwestern University, Evanston, Illinois.
authors.forename: Robert
authors.initials: R
authors.lastname: Gordon
authors.affiliation: University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Rame
authors.affiliation: University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Michael
authors.initials: M
authors.lastname: Acker
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Kormos
authors.affiliation: St. Vincent's Hospital, Indianapolis, Indiana.
authors.forename: Christopher
authors.initials: C
authors.lastname: Salerno
authors.affiliation: St. Vincent's Hospital, Indianapolis, Indiana.
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Schleeter
authors.affiliation: Montefiore Hospital, Bronx, New York.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Goldstein
authors.affiliation: Montefiore Hospital, Bronx, New York.
authors.forename: Julia
authors.initials: J
authors.lastname: Shin
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Randall C
authors.initials: RC
authors.lastname: Starling
authors.affiliation: Indiana University, Bloomington, Indiana.
authors.forename: Thomas
authors.initials: T
authors.lastname: Wozniak
authors.affiliation: Indiana University, Bloomington, Indiana.
authors.forename: Adnan S
authors.initials: AS
authors.lastname: Malik
authors.affiliation: Florida Hospital Transplant Institute, Orlando, Florida.
authors.forename: Scott
authors.initials: S
authors.lastname: Silvestry
authors.affiliation: Washington University, St. Louis, Missouri.
authors.forename: Gregory A
authors.initials: GA
authors.lastname: Ewald
authors.affiliation: Montefiore Hospital, Bronx, New York.
authors.forename: Ulrich P
authors.initials: UP
authors.lastname: Jorde
authors.affiliation: Columbia University, New York, New York.
authors.forename: Yoshifumi
authors.initials: Y
authors.lastname: Naka
authors.affiliation: University of Louisville, Louisville, Kentucky.
authors.forename: Emma
authors.initials: E
authors.lastname: Birks
authors.affiliation: HeartWare, Framingham, Massachusetts.
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Najarian
authors.affiliation: HeartWare, Framingham, Massachusetts.
authors.forename: David R
authors.initials: DR
authors.lastname: Hathaway
authors.affiliation: University of Michigan, Ann Arbor, Michigan.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000209:etiology / Q000401:mortality / Q000503:physiopathology; D002423:Cause of Death; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000601:surgery*; D016027:Heart Transplantation / Q000379:methods; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology* / Q000401:mortality / Q000503:physiopathology; D015996:Survival Rate; D016896:Treatment Outcome; D014850:Waiting Lists
keywords: CVA; VAD; cerebrovascular event; heart failure; stroke; ventricular assist device