Author + information
- Received July 30, 2014
- Revision received October 31, 2014
- Accepted November 14, 2014
- Published online April 1, 2015.
- Daniel J. Goldstein, MD∗∗ (, )
- Keith D. Aaronson, MD†,
- Antone J. Tatooles, MD‡,
- Scott C. Silvestry, MD§,
- Valluvan Jeevanandam, MD‖,
- Robert Gordon, MD¶,
- David R. Hathaway, MD#,
- Kevin B. Najarian, MS#,
- Mark S. Slaughter, MD∗∗,
- ADVANCE Investigators
- ∗Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, New York
- †Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan
- ‡Division of Cardiovascular Surgery, Christ Advocate Medical Center, Oak Lawn, Illinois
- §Division of Cardiothoracic Surgery, Washington University Hospital, St. Louis, Missouri
- ‖Department of Cardiac and Thoracic Surgery, University of Chicago, Chicago, Illinois
- ¶Division of Cardiology, Department of Medicine, Northwestern Memorial Hospital, Chicago, Illinois
- #Clinical Affairs and Biostatistics, HeartWare Inc., Boston, Massachusetts
- ∗∗Thoracic and Cardiovascular Surgery Division, Department of Surgery, University of Louisville, Louisville, Kentucky
- ↵∗Reprint requests and correspondence:
Dr. Daniel J. Goldstein, Montefiore Medical Center, 3400 Bainbridge Avenue, MAP 5, Bronx, New York 10367.
Objectives 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)
HeartWare Inc. (Framingham, Massachusetts) was the sponsor of the study. Dr. Goldstein is a surgical proctor for and is on the advisory board of HeartWare Inc.; and is on the medical advisory board of Thoratec Inc. Dr. Aaronson has received grant and research support from HeartWare Inc. and Thoratec; and serves on the advisory board (without remuneration) for HeartWare Inc. and Thoratec. Dr. Tatooles has served as an investigator for HeartWare Inc. and Thoratec. Dr. Silvestry has served as a consultant for HeartWare Inc. and Thoratec. Dr. Jeevanandam has served as a consultant for HeartWare Inc. Dr. Hathaway was formerly an employee of and has served as a consultant for HeartWare Inc. Mr. Najarian is an employee of and owns stock in HeartWare Inc. Dr. Slaughter has received research grant support from HeartWare Inc. Dr. Gordon has reported that he has no relationships relevant to the contents of this paper to disclose.
- Received July 30, 2014.
- Revision received October 31, 2014.
- Accepted November 14, 2014.
- American College of Cardiology Foundation