Impact of Gastrointestinal Bleeding Following LVAD Implant in a Destination Therapy Population

Abstract

<h3>Purpose</h3> To determine the association of gastrointestinal bleeding (GIB) over 5 years on morbidity and mortality in patients receiving the HeartWare^TM HVAD^TM System for destination therapy. <h3>Methods</h3> HVAD patients enrolled in the ENDURANCE and ENDURANCE Supplemental trials were eligible. Patients were separated into two groups: those who experienced a GIB and those who did not. Baseline characteristics, adverse events and survival through 5 years were examined. <h3>Results</h3> Of the 604 eligible patients, 284 (47.0%) suffered at least one GIB through 5 years post implant. The median time to first GIB was 260.5 days. Patients with GIB were older (65.2 vs 62.2, p=0.001), more likely to have a history of smoking (72.5% vs. 64.1%, p-0.03), and had greater incidence of atrial fibrillation (59.2% vs. 46.3%; p=0.002). (Fig 1A) Patients with GIB had lower rates of pump thrombosis (0.07 vs. 0.13; p<0.0001), thromboembolism (0.03 vs. 0.05; p=0.02), ICVA (0.10 vs. 0.14, p=0.02), HCVA (0.06 vs. 0.10, p=0.01), driveline infection (0.16 vs. 0.23; p=0.006), and arrhythmia (0.26 vs. 0.37; p=0.01) compared to the non-GIB cohort. (Fig 1B). Time in therapeutic range (TTR) prior to first GI bleed did not differ from TTR over 2 years for patients who did not have GI bleed (64.5% vs. 64.0%, p=0.92). Three-month mortality following GIB was 13.6%. Five-year KM survival for all patients with GIB was 28.3% while 5-yr survival for patients without a GIB was 27.3%. Of the 284 patients who had GI bleed, 155 (54.6%) had >1 GIB. Patients with >1 GIB were older (66.3 vs 63.9, p=0.04), and were more likely to have a history of smoking (79.4% vs 64.3%, p=0.005) and diabetes (55.5% vs. 42.6%, p=0.03) (Fig 1C), and were more likely to have other bleeding-related events. (Fig 1D) <h3>Conclusion</h3> HVAD patients experiencing a GIB event had significantly lower rates of stroke and pump thrombosis. The reason for this observation is uncertain and deserves further exploration. Patients with recurrent GIB were older, more commonly diabetic, and more likely to have serious bleeding events.