title: Major bleeding during HeartMate II support.
abstract: OBJECTIVE
  The aim of this study was to characterize a single-center experience of major bleeding complications during HeartMate II (HMII) (Thoratec Corp., Pleasanton, California) left ventricular assist device support, with focus on the subtypes and temporal patterns of post-operative bleeding.
  
  
  BACKGROUND
  Bleeding complications are the most common post-operative adverse events after HMII implantation. The timing of bleeding events, relationship to coagulation status, and effect on post-operative survival are incompletely understood.
  
  
  METHODS
  From October 2004 to June 2010, 139 HMII recipients at the Cleveland Clinic received 145 devices as a bridge to transplant or destination therapy for advanced heart failure. Major bleeding was defined using Interagency Registry for Mechanically Assisted Circulatory Support criteria, with an additional category created to maximize sensitivity for events. Pre-operative variables, coagulation status, and bleeding recurrence were assessed for correlation to primary events using modulated renewal within a multivariable analysis.
  
  
  RESULTS
  The cumulative occurrence of major bleeding was 58% during 171 patient-years of follow-up. There were 1.14 major bleeds per patient-year, with 44% occurring as repeat bleeding events. A first bleed did not predict subsequent bleeding. The greatest risk of bleeding was noted within 2 weeks post-implantation. The international normalized ratio profile correlated poorly with the risk of bleeding. Bleeding early after surgery was associated with reduced survival while on HMII support.
  
  
  CONCLUSIONS
  The risk of bleeding peaks early after HMII implantation. Bleeding of thoracic and gastrointestinal sources dominates these events, although many patients undergo transfusions for anemia without an apparent source of hemolysis or bleeding.
authors.affiliation: Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio.
authors.forename: Matthew C
authors.initials: MC
authors.lastname: Bunte
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
authors.forename: Lucy
authors.initials: L
authors.lastname: Thuita
authors.forename: Jeff
authors.initials: J
authors.lastname: Fowler
authors.forename: Lee
authors.initials: L
authors.lastname: Joseph
authors.forename: Aska
authors.initials: A
authors.lastname: Ozaki
authors.forename: Randall C
authors.initials: RC
authors.lastname: Starling
authors.forename: Nicholas G
authors.initials: NG
authors.lastname: Smedira
authors.forename: Maria M
authors.initials: MM
authors.lastname: Mountis
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology* / Q000401:mortality; D006333:Heart Failure / Q000601:surgery*; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006801:Humans; D019934:International Normalized Ratio; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009820:Ohio; D019106:Postoperative Hemorrhage / Q000209:etiology* / Q000401:mortality; D012189:Retrospective Studies; D013997:Time Factors; D014850:Waiting Lists
keywords: AUS; BTT; GI; HMII; HeartMate II; INR; anemia of undetermined source; anticoagulation; bleeding; bridge to transplant; gastrointestinal; international normalized ratio