Analysis of study of HeartWare HVAD System shows efficacy in heart failure

Medtronic announced the results of an analysis on the impact of stroke severity in patients receiving its HeartWare HVAD System as destination therapy, showing that targeted blood pressure management helped reduce serious strokes. The HVAD System is a left ventricular assist device (LVAD) that helps increase the amount of blood that circulates through the body in patients with advanced heart failure; the destination therapy indication (also known as DT) refers to patients who are not candidates for heart transplants. The retrospective analysis used data from both the ENDURANCE and ENDURANCE Supplemental randomized trials. In the latter trial patients received optimal blood pressure management. Presented at the 2019 International Society for Heart and Lung Transplantation (ISHLT) Scientific Sessions, the researchers found that freedom from disabling stroke at two years was 91 percent in the HVAD cohort.

In addition, survival was significantly higher for HVAD patients who experienced a non-disabling stroke compared to patients who had a disabling stroke (76 percent vs. 29 percent; one-year post-stroke event). For patients receiving the control device, survival was also greater in patients with non-disabling compared to disabling strokes (71 percent vs. 17 percent). In patients who experienced a stroke of any severity, those receiving the HVAD pump tended to have a lower stroke-related mortality rate than patients receiving the control device (17 percent vs. 27 percent). The current analysis demonstrated a 23 percent reduction in total strokes, a 36 percent reduction in disabling strokes, and a 39 percent reduction in stroke-related mortality in patients in the ENDURANCE Supplemental HVAD arm compared to those in the original ENDURANCE trial HVAD arm.

Comment: To further confirm the safety and effectiveness of the HVAD System in "real-world" clinical practice, Medtronic has initiated two studies: The Destination Therapy Post Approval Study (DT PAS) and the Apogee Study, which will look at how to improve patient outcomes through best practices in blood pressure management, anticoagulation/antiplatelet therapy, and implant procedure.