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Published on: June 12, 2021
Gastrointestinal bleeding in recipients of the HeartWare Ventricular Assist System
Daniel J Goldstein1, Keith D Aaronson2, Antone J Tatooles3
1Cardiovascular and Thoracic Surgery, Montefiore Medical Center, Bronx, New York.
Insights
Gastrointestinal bleeding (GIB) occurred in 15.4% of HeartWare HVAD System recipients, with most events happening after 30 days. Medical management was effective, and GIB did not impact survival.
Area of Science:
- Cardiology
- Medical Devices
- Gastroenterology
Background:
- Gastrointestinal bleeding (GIB) is a significant complication in patients with continuous flow device left ventricular assist devices (CF-LVAD).
- Management of GIB is complicated by the necessary anticoagulation and antiplatelet therapies in CF-LVAD recipients.
Purpose of the Study:
- To evaluate the incidence and characteristics of gastrointestinal bleeding (GIB) in patients implanted with the HeartWare HVAD System.
- To assess the outcomes of GIB management in patients within the pivotal Bridge to Transplant (BTT) trial and the Continued Access Protocol (CAP).
Main Methods:
- Analysis of bleeding events in 382 patients with advanced heart failure who received the HeartWare HVAD System.
- Review of post-implant anticoagulation (heparin followed by warfarin) and antiplatelet (aspirin) regimens.
- Evaluation of GIB event timing, etiology, site, and management strategies.
Main Results:
- 15.4% of patients (59 of 382) experienced 108 GIB events, with an incidence of 0.27 events per patient-year.
- The mean time to the first GIB event was 273.1 days, with 86.1% occurring beyond 30 days post-implantation.
- Arteriovenous malformations were the most common cause, and the small intestine was the most frequent site of bleeding. Repeat bleeding was infrequent, and no surgical intervention or GIB-related deaths occurred.
Conclusions:
- The HeartWare HVAD System recipients experienced a 0.27 GIB/patient-year incidence, with 84.1% freedom from GIB at 1 year.
- GIB events were successfully managed with medical and endoscopic therapies, though 31% of affected patients had recurrent bleeding.
- Gastrointestinal bleeding did not adversely affect patient survival despite requiring more readmissions and non-device infections.
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).
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