title: Pulsatility and the risk of nonsurgical bleeding in patients supported with the continuous-flow left ventricular assist device HeartMate II.
abstract: BACKGROUND
  Bleeding is an important cause of morbidity and mortality in patients with continuous-flow left ventricular assist devices (LVADs). Reduced pulsatility has been implicated as a contributing cause. The aim of this study was to assess the effects of different degrees of pulsatility on the incidence of nonsurgical bleeding.
  
  
  RESULTS
  The Utah Transplantation Affiliated Hospitals (U.T.A.H.) heart failure and transplant program databases were queried for patients with end-stage heart failure who required support with the continuous-flow LVAD HeartMate II (Thoratec Corp, Pleasanton, CA) between 2004 and 2012. Pulsatility was evaluated by means of the LVAD parameter pulsatility index (PI) and by the echocardiographic assessment of aortic valve opening during the first 3 months of LVAD support. PI was analyzed as a continuous variable and also stratified according to tertiles of all the PI measurements during the study period (low PI: <4.6, intermediate PI: 4.6-5.2, and high PI: >5.2). Major nonsurgical bleeding associated with a decrease in hemoglobin ≥2 g/dL (in the absence of hemolysis) was the primary end point. A total of 134 patients (median age of 60 [interquartile range: 49-68] years, 78% men) were included. Major bleeding occurred in 33 (25%) patients (70% gastrointestinal, 21% epistaxis, 3% genitourinary, and 6% intracranial). In multivariable analysis, PI examined either as a categorical variable, low versus high PI (hazard ratio, 4.06; 95% confidence interval, 1.35-12.21; P=0.04), or as a continuous variable (hazard ratio, 0.60; 95% confidence interval, 0.40-0.92; P=0.02) was associated with an increased risk of bleeding.
  
  
  CONCLUSIONS
  Reduced pulsatility in patients supported with the continuous-flow LVAD HeartMate II is associated with an increased risk of nonsurgical bleeding, as evaluated by PI.
authors.affiliation: Utah Transplantation Affiliated Hospitals, Cardiac Transplant Program, Salt Lake City, UT, USA. omar.wever.pinzon@hsc.utah.edu
authors.forename: Omar
authors.initials: O
authors.lastname: Wever-Pinzon
authors.forename: Craig H
authors.initials: CH
authors.lastname: Selzman
authors.forename: Stavros G
authors.initials: SG
authors.lastname: Drakos
authors.forename: Abdulfattah
authors.initials: A
authors.lastname: Saidi
authors.forename: Gregory J
authors.initials: GJ
authors.lastname: Stoddard
authors.forename: Edward M
authors.initials: EM
authors.lastname: Gilbert
authors.forename: Mohamed
authors.initials: M
authors.lastname: Labedi
authors.forename: Bruce B
authors.initials: BB
authors.lastname: Reid
authors.forename: Erin S
authors.initials: ES
authors.lastname: Davis
authors.forename: Abdallah G
authors.initials: AG
authors.lastname: Kfoury
authors.forename: Dean Y
authors.initials: DY
authors.lastname: Li
authors.forename: Josef
authors.initials: J
authors.lastname: Stehlik
authors.forename: Feras
authors.initials: F
authors.lastname: Bader
mesh_terms: D000368:Aged; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology* / Q000503:physiopathology*; D006333:Heart Failure / Q000503:physiopathology / Q000628:therapy*; D006353:Heart-Assist Devices; D006801:Humans; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D011673:Pulsatile Flow; D012189:Retrospective Studies; D018570:Risk Assessment
keywords: HeartMate II; aortic valve opening; bleeding; left ventricular assist device; pulsatility