title: Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System.
abstract: OBJECTIVE
  This study evaluated gastrointestinal bleeding (GIB) in patients receiving the HeartWare HVAD System (HeartWare Inc., Framingham, Massachusetts) in the pivotal BTT (Bridge to Transplant) trial and under the continued access protocol (CAP).
  
  
  BACKGROUND
  GIB has become a significant problem for recipients of continuous flow device left ventricular assist devices (CF-LVAD). The need for anticoagulation and antiplatelet therapies complicates the management of GIB.
  
  
  METHODS
  Bleeding events from 382 patients with advanced heart failure (140 patients enrolled in the BTT trial, and an additional 242 CAP patients) were analyzed. Post-implant anticoagulation consisted of heparin followed by warfarin at a target international normalized ratio of 2 to 3. Acetylsalicylic acid was recommended at 81 to 325 mg.
  
  
  RESULTS
  Overall, 59 of 382 (15.4%) patients experienced 108 GIB events (0.27 events per patient year). Mean time to first bleed was 273.1 days and 86.1% of events occurred beyond 30 days. Freedom from GIB was 84.1% at 1 year. Median international normalized ratio at the time of first bleed was 2.4 ± 1.4. The most common etiology of bleeding identified was arteriovenous malformation and the most common site was the small intestine. Repeat bleeding was infrequent, though GIB patients required more readmissions and developed nondevice infections more frequently. No patients required surgical intervention and no deaths directly related to GIB occurred.
  
  
  CONCLUSIONS
  Recipients of the HeartWare Ventricular Assist Device System had an incidence of 0.27 GIB/patient year with a freedom from GIB of 84.1% at 1 year. All patients with GIB events were managed with medical and endoscopic therapies, although 31% of patients experienced a recurrence of GIB. No surgical intervention was required. GIB did not impact survival. (Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure [ADVANCE]; NCT00751972).
authors.affiliation: Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, New York. Electronic address: dgoldste@montefiore.org.
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Goldstein
authors.affiliation: Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan.
authors.forename: Keith D
authors.initials: KD
authors.lastname: Aaronson
authors.affiliation: Division of Cardiovascular Surgery, Christ Advocate Medical Center, Oak Lawn, Illinois.
authors.forename: Antone J
authors.initials: AJ
authors.lastname: Tatooles
authors.affiliation: Division of Cardiothoracic Surgery, Washington University Hospital, St. Louis, Missouri.
authors.forename: Scott C
authors.initials: SC
authors.lastname: Silvestry
authors.affiliation: Department of Cardiac and Thoracic Surgery, University of Chicago, Chicago, Illinois.
authors.forename: Valluvan
authors.initials: V
authors.lastname: Jeevanandam
authors.affiliation: Division of Cardiology, Department of Medicine, Northwestern Memorial Hospital, Chicago, Illinois.
authors.forename: Robert
authors.initials: R
authors.lastname: Gordon
authors.affiliation: Clinical Affairs and Biostatistics, HeartWare Inc., Boston, Massachusetts.
authors.forename: David R
authors.initials: DR
authors.lastname: Hathaway
authors.affiliation: Clinical Affairs and Biostatistics, HeartWare Inc., Boston, Massachusetts.
authors.forename: Kevin B
authors.initials: KB
authors.lastname: Najarian
authors.affiliation: Thoracic and Cardiovascular Surgery Division, Department of Surgery, University of Louisville, Louisville, Kentucky.
authors.forename: Mark S
authors.initials: MS
authors.lastname: Slaughter
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects; D005260:Female; D006471:Gastrointestinal Hemorrhage / Q000209:etiology* / Q000401:mortality; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D016027:Heart Transplantation / Q000706:statistics & numerical data; D006353:Heart-Assist Devices / Q000009:adverse effects*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects; D011446:Prospective Studies
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors
keywords: LVAD; gastrointestinal bleeding; heart failure; left ventricular assist device