title: Pre-operative risk factors of bleeding and stroke during left ventricular assist device support: an analysis of more than 900 HeartMate II outpatients.
abstract: OBJECTIVE
  This study sought to determine the pre-operative risk factors related to late bleeding, stroke, and pump thrombosis in patients with HeartMate II (HMII) left ventricular assist devices (LVADs) (Thoratec Corporation, Pleasanton, California) that might influence tailored improvements in patient management.
  
  
  BACKGROUND
  Adverse events in LVAD patients remain high. It is unclear whether pre-operative characteristics influence the likelihood of the development of post-operative hemorrhagic or thrombotic complications. Knowing which patients are at greater risk might assist in tailoring anticoagulation therapy for certain patients.
  
  
  METHODS
  Advanced heart failure patients (n = 956) discharged from the hospital after LVAD implantation in the HMII bridge to transplantation (n = 405) and destination therapy (n = 551) clinical trials were retrospectively evaluated. Bleeding requiring surgery or transfusion of >2 U of packed red blood cells, stroke (hemorrhagic and ischemic), and pump thrombosis were tracked from hospital discharge until patient outcome.
  
  
  RESULTS
  Adverse event rates for post-discharge bleeding (0.67 events/patient-year) were higher than those for hemorrhagic stroke (0.05), ischemic stroke (0.04), and pump thrombosis (0.03). The main sites of bleeding included gastrointestinal (45% of events), wound (12%), and epistaxis (4%). Older age (>65 years) (hazard ratio [HR]: 1.31), lower pre-operative hematocrit (≤31%) (HR: 1.31), ischemic etiology (HR: 1.35), and female (HR: 1.45) were statistically significant multivariable risk factors for bleeding. Female (HR: 1.92) and 65 years of age and younger (HR: 1.94) were multivariable risk factors for hemorrhagic stroke, whereas female (HR: 1.84) and history of diabetes (HR: 1.99) were risk factors for ischemic stroke. Female (HR: 1.90) and higher body mass index (HR: 1.71/10 kg/m(2) increase) were also multivariable risk factors for pump thrombosis.
  
  
  CONCLUSIONS
  The risk of bleeding and thrombotic events during LVAD support differs by patient demographics, including sex, age, body mass index, and etiology of heart failure. Further studies should focus on the potential of tailored anticoagulation strategies in these subgroups.
authors: Cleveland Clinic Florida, Weston, Florida. Electronic address: boylea2@ccf.org.
authors: Andrew J
authors: AJ
authors: Boyle
authors: Columbia University, New York, New York.
authors: Ulrich P
authors: UP
authors: Jorde
authors: Abbott Northwestern Hospital, Minneapolis, Minnesota.
authors: Benjamin
authors: B
authors: Sun
authors: Mayo Clinic, Rochester, Minnesota.
authors: Soon J
authors: SJ
authors: Park
authors: Duke University, Durham, North Carolina.
authors: Carmelo A
authors: CA
authors: Milano
authors: Texas Heart Institute, Houston, Texas.
authors: O Howard
authors: OH
authors: Frazier
authors: Thoratec Corporation, Pleasanton, California.
authors: Kartik S
authors: KS
authors: Sundareswaran
authors: Thoratec Corporation, Pleasanton, California.
authors: David J
authors: DJ
authors: Farrar
authors: Johns Hopkins Hospital, Baltimore, Maryland.
authors: Stuart D
authors: SD
authors: Russell
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006333:Heart Failure / Q000150:complications* / Q000628:therapy*; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006470:Hemorrhage / Q000150:complications* / Q000175:diagnosis; D006801:Humans; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D057234:Preoperative Period; D012189:Retrospective Studies; D012307:Risk Factors; D020521:Stroke / Q000150:complications* / Q000175:diagnosis; D013927:Thrombosis / Q000150:complications / Q000175:diagnosis; D055815:Young Adult
keywords: HeartMate II; LVAD; bleeding; heart failure; pump thrombosis; stroke