B.4. What is the latest version of the most common LVAD and why is it better than the previous version?
Answer:
The HeartMate 3 (HM 3), approved in 2017 by the FDA for BTT and bridge to recovery, is a fully magnetically levitated pump. The wider gap between the impeller and housing decreases shear forces on blood cells as they pass through the pump. The MOMENTUM 3 trial compared the performance of HM 3 to the HM 2 in patients with advanced heart failure, and found that 86% of patients implanted with HM 3 versus 77% of patients with HM 2 survived to 6 months (without a disabling stroke or need to replace the pump), and no HM 3 patients experienced pump thrombosis at 6-months after implantation versus 10% with HM 2.
The ENDURANCE trial demonstrated noninferiority of the intrapericardial continuous-flow HeartWare HVAD compared to the HeartMate 2 for survival in patients with advanced heart failure ineligible for heart transplantation, but stroke was more common. In 2021, Medtronic stopped the sale and distribution of the HeartWare HVAD given the risk of mortality and neurologic adverse events, and a malfunction where the device did not start, causing injuries and death.
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