Approximately 15 percent of patients with advanced heart failure experienced gastrointestinal bleeding after receiving the HeartWare Ventricular Assist Device System. However, none of the events impacted survival, and no surgical intervention was needed.
Lead researcher Daniel J. Goldstein, MD, of the Montefiore Medical Center in the Bronx, New York, and colleagues published their findings online on March 11 in the Journal of the American College of Cardiology: Heart Failure.
The HeartWare Ventricular Assist Device System is a miniaturized, implantable, continuous-flow blood pump that helps deliver blood from the heart to the rest of the body. The FDA has approved the device for patients with end-stage heart failure as a bridge to heart transplantation.
This prospective, multicenter analysis evaluated 382 patients who were implanted with the HeartWare Ventricular Assist Device System as a bridge to transplant. They enrolled in the trial between August 2008 and November 2012. The mean age was 53.2 years, approximately 70 percent were Caucasian and approximately 75 percent were male.
After a median follow-up of 365 days, a total of 108 gastrointestinal bleeding events occurred in 59 patients, which represented 0.27 events per patient year.
The mean time to first event was 273.1 days, and 86.1 percent of the events occurred more than 30 days after transplantation. Of the 59 patients who experienced bleeding, five had a thrombotic event, which was defined as pump thrombosis, transient ischemic attack, ischemic cerebrovascular accident or peripheral thrombosis. The mean time to the first thrombotic event was 155.4 days.
Although no deaths were directly related to gastrointestinal bleeding, one patient died six days after an event, which was attributed to intense anticoagulation. The person died of vasodilatory shock after developing right heart failure following a pump exchange.
Patients with gastrointestinal bleeding had significantly higher rates of bleeding requiring hospitalization (1.17 events per patient year vs. 0.07 events per patient year) and higher rates of non-device-related infections (0.74 events per patient year vs. 0.407 events per patient year).
Researchers defined gastrointestinal bleeding as bleeding from the gastrointestinal tract, which is identified by a decrease in hemoglobin level and/or the appearance of melena, hematochezia, hematemesis or guaiac positive stools.
The study had a few limitations, according to the researchers. They noted that the study was a post-hoc analysis and was not randomized, all patients received the device and comparisons were only available through historical literature.