Heartware’s first destination therapy clinical trial has achieved its primary endpoint, the devicemaker announced Thursday at the Opening Plenary Session of the 35th International Society for Heart and Lung Transplantation Annual Meeting in Nice, France.
An investigational device exemption study tested the HVAD Pump as long-term therapy for patients with end-stage heart failure ineligible for a heart transplant. The study was randomized, controlled and un-blinded, the company says.
In the U.S. multicenter trial, 446 patients were enrolled across 48 hospitals from August 2010 to May 2012. Patients received the HVAD Pump, or, in the control arm, an alternative left ventricular assist device approved by the FDA for destination therapy. The arm ratio was 2 to 1.
The study’s results demonstrated that 55 percent of the HVAD system arm and 57.4 percent of the control arm achieved the primary endpoint, stroke-free survival at two years. These results establish non-inferiority for the HVAD Pump, the devicemaker claims.
HVAD system treatment yielded a higher stroke rate, but device malfunction was evidenced more frequently in the control arm, says Dr. Joseph Rogers, a co-principal investigator. The study indicated that high blood pressure was the strongest neurologic event predictor.
Of the 200 patients who were implanted with the device with a sintered inflow cannula — a 2011 FDA-approved modification that enables better tissue adhesion — 57.5 percent of patients reached the primary endpoint. This enhancement resulted in a significant patient pump thrombosis decrease, said Dr. Francis D. Pagani, a co-principal investigator. The HVAD system is available only with this modification.
Heartware is planning a second destination therapy trial, with enrollment almost complete. It will include more patient blood monitoring to reduce potential neurological events.
The HVAD Pump has received FDA, CE Mark, TGA and Health Canada approval. In the U.S., it is indicated as a bridge to heart transplantation.
More than 8,000 heart failure patients worldwide have been implanted with the device. — Jason Scott