title: Adverse events in contemporary continuous-flow left ventricular assist devices: A multi-institutional comparison shows significant differences.
abstract: OBJECTIVE
  We review differences in the incidence and timing of adverse events in patients implanted with continuous-flow left ventricular assist devices (LVADs), using the Mechanical Circulatory Support Research Network registry.
  
  
  METHODS
  From May 2004 to September 2014, a total of 734 patients (591 men; median age: 59 years) underwent primary continuous-flow LVAD implantation at our institutions. Patients implanted with the HeartMate II (HMII) (560 [76%] patients), compared with the HeartWare ventricular assist device (HVAD; 174 [24%]) were more often receiving destination therapy (47% vs 20%; P < .01), had a lower preoperative creatinine level (1.2 vs 1.3; P = .01), and had less median preoperative right ventricular dysfunction (mild vs moderate; P < .01). Ischemic etiology, prior sternotomy, and median INTERMACS profile were similar.
  
  
  RESULTS
  Overall mortality was 54 of 734 (7.4%); 41 of 560 (7.3%) in the HMII group, and 13 of 174 (7.5%) in the HVAD group (P = .95). Follow-up was available in 100% of early survivors for a median of 1 year (max: 10 years) and a total of 1120 patient-years of support (HMII: 940 patient-years [median: 1.1 years, max: 5.3 years] and HVAD: 180 patient-years [median: 0.6 year, max: 10.4 years]). On multivariable analysis, GI bleeding (P = .63), any infection (P = .32), driveline infection (P = .10), and pump thrombus (P = .64) were similar between devices while HeartWare HVAD was associated with higher risk of stroke (HR: 1.8, [1.25, 2.5], P = .003).
  
  
  CONCLUSIONS
  In this pooled analysis, a trend was found for higher incidence of percutaneous driveline infections in patients treated with the HMII; a higher incidence of stroke and time-related cumulative risk of any infection and stroke was found in patients treated with the HVAD, which was independently associated with higher stroke risk.
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, Rochester, Minn. Electronic address: stulak.john@mayo.edu.
authors.forename: John M
authors.initials: JM
authors.lastname: Stulak
authors.affiliation: Department of Cardiac Surgery, Vanderbilt Heart and Vascular Institute, Nashville, Tenn.
authors.forename: Mary E
authors.initials: ME
authors.lastname: Davis
authors.affiliation: Department of Cardiac Surgery, Vanderbilt Heart and Vascular Institute, Nashville, Tenn.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Haglund
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, Rochester, Minn.
authors.forename: Shannon
authors.initials: S
authors.lastname: Dunlay
authors.affiliation: Division of Cardiovascular Diseases, St Vincent Heart Center, Indianapolis, Ind.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Cowger
authors.affiliation: Division of Cardiovascular Diseases, Inova Fairfax Hospital, Fairfax, Va.
authors.forename: Palak
authors.initials: P
authors.lastname: Shah
authors.affiliation: Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor, Mich.
authors.forename: Francis D
authors.initials: FD
authors.lastname: Pagani
authors.affiliation: Department of Cardiac Surgery, University of Michigan Health System, Ann Arbor, Mich.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.affiliation: Division of Cardiovascular Surgery, Mayo Clinic College of Medicine, Rochester, Minn.
authors.forename: Simon
authors.initials: S
authors.lastname: Maltais
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016009:Chi-Square Distribution; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology; D006333:Heart Failure / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D015994:Incidence; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D016459:Prosthesis-Related Infections / Q000453:epidemiology / Q000382:microbiology; D012042:Registries; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D020521:Stroke / Q000453:epidemiology; D013927:Thrombosis / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D016277:Ventricular Function, Left; D016278:Ventricular Function, Right; D055815:Young Adult
keywords: heart failure; mechanical circulatory support; ventricular assist device