Medtronic Announces Solid HeartWare LVAD Stroke Data and Initiates Two Real-World Studies
Posted on April 05, 2019 by Medtech[y] Staff
Medtronic announced the results of a retrospective analysis with their HeartWare left-ventricular assist device, showing targeted blood pressure management helped reduce serious strokes in patients who received the HVAD as a destination therapy.
The ENDURANCE supplemental trial randomized 465 patients at a two-to-one ratio to receive the HVAD or an alternative LVAD system approved for destination therapy. Patients received a blood pressure management strategy to help reduce the stroke rate seen in earlier trials.
Using data from both the ENDURANCE1 and ENDURANCE, researchers found that 91% of the participants in the HVAD cohort were free from disabling stroke at two years. Additionally, survival was significantly higher for the HVAD patients who experienced a non-disabling stroke compared to patients compared to patients who had a disabling stroke (76 percent vs. 29 percent).
Survival was also greater for patients who received the control device with non-disabling compared to disabling strokes 71 percent vs. 17 percent. Overall, the analysis showed a 23% 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.
"This analysis shows that stroke severity is an important determinant of outcomes, and the use of the HVAD System with a guidelines-based blood pressure management strategy can, in addition to reducing overall stroke rates, reduce the occurrence of disabling stroke and improve survival in patients who experience strokes," said Jeffrey Teuteberg, M.D., section chief of Heart Failure, Cardiac Transplantation, and Mechanical Circulatory Support, and associate professor of medicine at Stanford University. "We also found that patients with a stroke in the HVAD cohort had better survival than those who received the control device. These results reinforce the importance of blood pressure management with the HVAD for end-stage heart failure patients."
The data was presented at the 2019 International Society for Heart and Lung Transplantation (ISHLT) Scientific Sessions.
Additionally, Medtronic announced they have initiated two post-approval studies to confirm the safety and effectiveness of the HVAD System in "real-world" clinical practice. The two studies, The Destination Therapy Post Approval Study (DT PAS) and the Apogee Study, will help try and understand how to improve patient outcomes through best practices in blood pressure management, anticoagulation/antiplatelet therapy, and implant procedure.
Both will be prospective, multisite, observational studies and will be led by co-principal investigators Nader Moazami, M.D., surgical director of Heart Transplantation and Mechanical Circulatory Support at NYU Langone in New York, and Jennifer Cowger, M.D., cardiologist and transplant specialist who directs the Mechanical Circulatory Support Program at Henry Ford Health System in Detroit.
"Medtronic aims to advance the field of mechanical circulatory support and, consequently, the overall management of heart failure patients who can benefit from the therapy," said Rob Kowal, M.D., Ph.D., vice president and chief medical officer of the Cardiac Rhythm and Heart Failure division, which is part of the Cardiac and Vascular Group at Medtronic. "Continuing to define and drive best practices that reduce pump-related adverse events in a real-world setting is central to this patient-first strategy."
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