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
Schmitto J, Pya Y, Zimpfer D, Krabatsch T, Garbade J, Rao V, Morshuis M, Beyersdorf F, Marasco S, Sood P, Damme L, Netuka I. European Journal of Heart Failure (2018). DOI:10.1002/ejhf.1284.
Two years post-HeartMate 3 implantation, results show expected and acceptable survival, enhanced haemocompatibility, improved patient functional status and quality of life. This corroborates the success of HeartMate 3 since its first-in-man implantation case in Germany.
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%).
A comprehensive list of the publications and presentations of analysis from the MOMENTUM 3 IDE trial and CAP study.
MOMENTUM 3 Trial: 5 year HeartMate 3 LVAD Results
The MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy with HeartMate 3) investigational device exemption (IDE) clinical study was designed to evaluate the safety and effectiveness of HeartMate 3 Left Ventricular Assist System (LVAS) by demonstrating non-inferiority to the HeartMate II™ LVAS when used for the treatment of advanced refractory left ventricular heart failure.
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