Irish medical technology company Medtronic announced the results of an analysis on the impact of stroke severity in patients receiving its HeartWare HVAD System as destination therapy.
Image: Medtronic has applied a pre-specified blood pressure management strategy to the patients in the HVAD arm. Photo: Courtesy of Medtronic.
The results of the analysis showed that the targeted blood pressure management using HeartWare HVAD System has helped the patients in reducing serious strokes.
The HVAD System is a left ventricular assist device (LVAD) used in patients with advanced heart failure, to increase the amount of blood that circulates through the body.
The destination therapy indication, also known as DT refers to patients who are not candidates for heart transplants.
ENDURANCE1 and ENDURANCE Supplemental2 are the two randomized trials, from which data has been used for the retrospective analysis and in the ENDURANCE Supplemental2 trial patients received optimal blood pressure management.
Medtronic said that the results of the analysis are presented at the 2019 International Society for Heart and Lung Transplantation (ISHLT) Scientific Sessions, and scientists found that 91% risk lowered in the HVAD cohort from disabling stroke at two years; and patients with HVAD who experienced a non-disabling stroke showed a significantly higher survival rate compared to patients who had a disabling stroke.
The analysis also showed that in patients receiving the control device, survival of patients with non-disabling stroke is high compared to disabling strokes; and in patients who experienced a stroke of any severity, the patients receiving HVAD pump showed a tendency to have a lower mortality rate than patients receiving the control device.
In addition, in patients in the ENDURANCE Supplemental HVAD arm a 23% reduction in total strokes, a 36% reduction in disabling strokes, and a 39% reduction in stroke-related mortality, compared to those in the original ENDURANCE trial HVAD arm.
Medtronic said that a total of 465 patients were randomized in a two-to-one ratio in the ENDURANCE Supplemental Trial and a pre-specified blood pressure management strategy was applied, in an effort to reduce the stroke rate seen in earlier trials.
Medtronic cardiac and vascular group vice president and cardiac rhythm and heart failure division chief medical officer Rob Kowal said: “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.
“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.”