Netuka I, Pya Y, Zimpfer D, Potapov E, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, PhD, Sood P, Gazzola C, Schmitto J. Journal of Heart and Lung Transplantation (2021) DOI: https://doi.org/10.1016/j.healun.2021.01.001.

Zimpfer D, Gustafsson F, Potapov E, Pya Y, Schmitto J, Berchtold-Herz M, Morshuis M, Shaw S, Saeed D, Lavee J, Heatley G, Gazzola C, Garbade J; on behalf of the ELEVATE Investigators. European Heart Journal (2020) 41, pg. 3801–3809.

Multi-center, multi-national, observational registry. Enrollment of 540 consecutive patients in 26 centers. After 2-year follow-up post-implant ELEVATE demonstrates good 2-year survival and improvement in functional capacity and quality of life with the HeartMate 3 LVAS system in a real-world population. Low stroke rate and pump thrombosis rates are sustained up to 2 years. Low transplant rate (10%).

Final 2-yr follow-up of the full cohort (n=1,028 patients) looking at survival at 2 years free of disabling stroke (>3 mRS) or reoperation to replace or remove a malfunctioning device. Mehra, et al. NEJM 2019. DOI: 10.1056/NEJMoa1900486

The data from two-year follow-up of the MOMENTUM 3 full cohort demonstrates:

• Clinical superiority of the HeartMate 3 LVAS when compared to the HeartMate II LVAS
• Significantly less frequent rate for pump replacement with HeartMate 3 LVAS
• Significantly lower rate of stroke and disabling stroke with HeartMate 3 LVAS
• Significantly lower rate of GI bleeding with HeartMate 3 LVAS
• Significantly lower rate of pump thrombosis with HeartMate 3 LVAS

A comprehensive list of the publications and presentations of analysis from the MOMENTUM 3 IDE trial and CAP study.