Abstract 18410: Gastrointestinal Bleeding in Recipients of the HeartWare Ventricular Assist System
Purpose: Gastrointestinal bleeding (GIB) is a significant problem with continuous flow left ventricular assist devices. The HeartWare HVAD was recently approved for bridge to transplantation (BTT). GIB in patients supported with the HVAD as part of the pivotal BTT trial and the Continued Access Protocol (CAP) is reviewed.
Methods: GIB events from 332 HeartWare recipients (140 BTT, 192 CAP patients) having at least 6 months of follow up (306 patient-years) were analyzed. Post implant anticoagulation consisted of heparin followed by Coumadin at a target INR of 2-3. Aspirin was recommended at 81-325 mg. Statistical analysis was performed using Fisher’s exact test for the comparison of proportions and Poisson regression for the comparison of event rates.
Results: Forty-two (12.7%) patients (78.6% men) age 55.3 ± 11.4 yrs experienced a GIB. Overall, the 42 patients had 82 GIB events that resulted in 0.27 events PPY (range 1-7 events) with 38% experiencing a recurrent GIB. Median time to first GIB was 89 days. GIB was more frequent in patients receiving 81mg aspirin vs. 325mg (0.14 vs. 0.09 PPY, P=0.018). Patients with GIB were more likely to have ischemic CHF etiology (54.8% vs. 34.1% P=0.016), and diabetes (47.6% vs. 33.1%, P=0.083). Most GIB events (71/82, 86.6%) occurred >30 days post implant and 94% required transfusions. Seventeen percent of events occurred in setting of INR >3. GIB resulted in 65 rehospitalizations in 32 patients with a median length of stay of 8 days. Source of bleeding was ascribed to a definite or suspected AVM in 28% of patients while in 29% of patients, no source was identified. Location was 22% upper GI, 32% small bowel, 11% lower GI and 33% unknown. Forty-six percent of patients with GIB had an intervention such as cautery or clipping. None required surgery. There were no deaths related to GIB.
Conclusion: GIB occurred in 12.7% of HVAD recipients followed for at least 6 months postop. GIB events were often recurrent, led to transfusions and were rarely associated with supratherapeutic INRs. Most occurred outside the perioperative window and AVMs were the predominant culprit lesion. Rehospitalizations were frequent and prolonged. Efforts to reduce the incidence of and readmissions for GIB are warranted.
- © 2013 by American Heart Association, Inc.