title: Adverse neurologic events in patients bridged with long-term mechanical circulatory support: A device-specific comparative analysis.
abstract: BACKGROUND
  Neurologic complications are among the principal causes of morbidity and mortality after continuous-flow left ventricular assist device (CF-LVAD) implantation. The aim of this study was to describe a focused "real-world" multicenter comparison of neurologic outcomes between HeartMate II (HMII) and HeartWare HVAD CF-LVAD recipients.
  
  
  METHODS
  Between March 2009 and October 2014, 497 patients underwent primary CF-LVAD implantation as a bridge to transplantation at centers included in the Mechanical Circulatory Support Research Network; 314 patients (63%) received HMII, and 183 patients (37%) received HVAD. Ischemic cerebrovascular accident, hemorrhagic cerebrovascular accident, and transient ischemic attack were the neurologic outcomes assessed.
  
  
  RESULTS
  Median follow-up time for HMII recipients was 0.95 years (0.48, 1.85, range) and for HVAD recipients was 0.44 years (0.19, 0.97, range) (p < 0.001). HMII recipients had significantly fewer neurologic events per patient year for ischemic cerebrovascular accident (0.071) and transient ischemic attack (0.012) compared with HVAD recipients (0.157 and 0.072, respectively). Univariate analysis showed that 51 HMII recipients (16%) had any neurologic event, whereas 34 HVAD recipients (19%) had any neurologic event (p = 0.504). After adjusting for pre-specified covariates (device type, age, sex, atrial fibrillation, diabetes, and Interagency Registry for Mechanically Assisted Circulatory Support profile), multivariable analysis showed only advanced age was able to predict neurologic events (p = 0.02). Neurologic events were comparable between HMII and HVAD recipients after multivariable analysis.
  
  
  CONCLUSIONS
  CF-LVAD placement incurs a low but significant risk of neurologic complications in patients receiving CF-LVADs as a bridge to transplantation. Advancing age is a risk factor for any adverse neurologic outcome. This multicenter analysis demonstrated comparable hazard of adverse neurologic events among patients implanted with HMII or HVAD.
authors.affiliation: Division of Cardiovascular Medicine.
authors.forename: Samuel T
authors.initials: ST
authors.lastname: Coffin
authors.affiliation: Division of Cardiovascular Medicine.
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Haglund
authors.affiliation: Division of Cardiac Surgery.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Davis
authors.affiliation: Department of Biostatistics, Vanderbilt University Medical Center, Nashville, Tennessee.
authors.forename: Meng
authors.initials: M
authors.lastname: Xu
authors.affiliation: Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.
authors.forename: Shannon M
authors.initials: SM
authors.lastname: Dunlay
authors.affiliation: Cardiovascular Services, St. Vincent Heart Center, Indianapolis, Indiana.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Cowger
authors.affiliation: Cardiovascular Medicine, Inova Fairfax Hospital, Falls Church, Virginia.
authors.forename: Palak
authors.initials: P
authors.lastname: Shah
authors.affiliation: Division of Cardiovascular Medicine.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.affiliation: Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan.
authors.forename: Frank D
authors.initials: FD
authors.lastname: Pagani
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota.
authors.forename: John M
authors.initials: JM
authors.lastname: Stulak
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic, Rochester, Minnesota. Electronic address: simon.maltais@vanderbilt.edu.
authors.forename: Simon
authors.initials: S
authors.lastname: Maltais
mesh_terms: D005260:Female; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000209:etiology*; D011474:Prosthesis Design; D012189:Retrospective Studies; D013997:Time Factors
keywords: adult; adverse event; complications; mechanical circulatory support; neurological