Medtronic: HeartWare HV AD shows 95% freedom from disabling stroke at 2 years
Medtronic announced two-year outcomes from the LATERAL clinical trial evaluating the use of its HeartWare HVAD System in patients who received the system via a less-invasive, thoracotomy implant approach. The HVAD System is a heart pump, called a left ventricular assist device, that helps increase the amount of blood that circulates through the body in patients with advanced heart failure. Presented at the ASAIO 65th Annual Conference, the data showed that after two years of follow up, 95 percent of HVAD patients implanted via thoracotomy were free from disabling stroke. Additionally: A review of adverse events occurring in the LATERAL trial revealed that adverse events were more likely to occur during the first 30 days after implant, with a significant decline in bleeding, arrhythmias and strokes in the later time periods that patients are on LVAD support. Overall adverse event rates were meaningfully reduced one to six months post implant. The late risk of stroke was very low, with total strokes occurring at only 0.05 EPPY in years one to two post-implant. And previously published data from the LATERAL trial showed 87 percent survival at two years.