Medtronic has reported positive data from a retrospective analysis of the ENDURANCE and ENDURANCE Supplemental clinical trials.
The studies were performed to assess the HeartWare HVAD System as a therapy for advanced heart failure patients that are not eligible for transplant. This left ventricular assist device (LVAD) is designed to increase the amount of blood circulating through a patient’s body.
According to the results of the trials, treatment with the HeartWare HVAD System led to a reduction in the number of strokes experienced by patients, including the occurrence of disabling strokes and stroke-related mortality.
Around 91% of participants in the HeartWare group stopped having strokes, with effects lasting for two years. Survival was found to be higher for patients that had experienced non-disabling strokes compared to those with disabling strokes.
Compared to the subjects that received a control device, those in the HVAD pump arm tended to experience a lower stroke-related mortality rate.
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Participants in the ENDURANCE Supplemental HVAD group experienced a 23% reduction in the total number of strokes, a 36% decrease in disabling strokes and a 39% reduction in stroke-related mortality, compared to patients in the ENDURANCE HVAD arm.
These findings have been presented at the 2019 International Society for Heart and Lung Transplantation (ISHLT) Scientific Sessions.
Stanford University medicine associate professor Jeffrey Teuteberg said: “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.”
Medtronic also launched the DT PAS and Apogee studies to validate the safety and effectiveness of the HeartWare device in a real-world setting.
The prospective, observational DT PAS study will monitor long-term, complication-free survival in 300 newly implanted destination therapy patients over two years at around 50 US sites. The study will track patients for up to five years.
Apogee is a multi-site study involving DT PAS patients interested in additional heart failure management protocol and data collection for one year.