TY - JOUR
T1 - Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase
T2 - a study of 2200 HeartMate 3 left ventricular assist device implants
AU - On behalf of the MOMENTUM 3 Investigators
AU - Mehra, Mandeep R.
AU - Cleveland, Joseph C.
AU - Uriel, Nir
AU - Cowger, Jennifer A.
AU - Hall, Shelley
AU - Horstmanshof, Douglas
AU - Naka, Yoshifumi
AU - Salerno, Christopher T.
AU - Chuang, Joyce
AU - Williams, Christopher
AU - Goldstein, Daniel J.
N1 - Publisher Copyright:
© 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.
PY - 2021/8
Y1 - 2021/8
N2 - Aim: The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated centrifugal-flow pump, over the HeartMate II axial-flow pump. We now evaluate HM3 LVAD outcomes in a single-arm prospective continuous access protocol (CAP) post-pivotal trial study. Methods and results: We enrolled 2200 HM3 implanted patients (515 pivotal trial and 1685 CAP patients) and compared outcomes including survival free of disabling stroke or reoperation to replace or remove a malfunctioning device (primary composite endpoint), overall survival and major adverse events at 2 years. The 2-year primary endpoint [76.7% vs. 74.8%; adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.71–1.08, P = 0.21] and overall survival (81.2% vs. 79.0%) were similar among CAP and pivotal cohorts despite sicker patients (more intra-aortic balloon pump use and INTERMACS profile 1) in CAP who were more often intended for destination therapy. Survival was similar between the CAP and pivotal trial in transplant ineligible patients (79.1% vs. 76.7%; adjusted HR 0.89, 95% CI 0.68–1.16, P = 0.38). In a pooled analysis, the 2-year primary endpoint was similar between INTERMACS profiles 1–2 (‘unstable’ advanced heart failure), profile 3 (‘stable’ on inotropic therapy), and profiles 4–7 (‘stable’ ambulatory advanced heart failure) (75.7% vs. 77.6% vs. 72.9%, respectively). The net burden of adverse events was lower in CAP (adjusted rate ratio 0.93, 95% CI 0.88–0.98, P = 0.006), with consequent decrease in hospitalization. Conclusions: The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial.
AB - Aim: The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated centrifugal-flow pump, over the HeartMate II axial-flow pump. We now evaluate HM3 LVAD outcomes in a single-arm prospective continuous access protocol (CAP) post-pivotal trial study. Methods and results: We enrolled 2200 HM3 implanted patients (515 pivotal trial and 1685 CAP patients) and compared outcomes including survival free of disabling stroke or reoperation to replace or remove a malfunctioning device (primary composite endpoint), overall survival and major adverse events at 2 years. The 2-year primary endpoint [76.7% vs. 74.8%; adjusted hazard ratio (HR) 0.87, 95% confidence interval (CI) 0.71–1.08, P = 0.21] and overall survival (81.2% vs. 79.0%) were similar among CAP and pivotal cohorts despite sicker patients (more intra-aortic balloon pump use and INTERMACS profile 1) in CAP who were more often intended for destination therapy. Survival was similar between the CAP and pivotal trial in transplant ineligible patients (79.1% vs. 76.7%; adjusted HR 0.89, 95% CI 0.68–1.16, P = 0.38). In a pooled analysis, the 2-year primary endpoint was similar between INTERMACS profiles 1–2 (‘unstable’ advanced heart failure), profile 3 (‘stable’ on inotropic therapy), and profiles 4–7 (‘stable’ ambulatory advanced heart failure) (75.7% vs. 77.6% vs. 72.9%, respectively). The net burden of adverse events was lower in CAP (adjusted rate ratio 0.93, 95% CI 0.88–0.98, P = 0.006), with consequent decrease in hospitalization. Conclusions: The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial.
KW - Advanced heart failure
KW - Clinical trial
KW - Learning curve
KW - Left ventricular assist device
KW - MOMENTUM 3
KW - Outcome
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U2 - 10.1002/ejhf.2211
DO - 10.1002/ejhf.2211
M3 - Article
C2 - 33932272
AN - SCOPUS:85106322799
SN - 1388-9842
VL - 23
SP - 1392
EP - 1400
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
IS - 8
ER -