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Randomized Controlled Trial
. 2021 Aug;23(8):1392-1400.
doi: 10.1002/ejhf.2211. Epub 2021 May 18.

Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants

Mandeep R Mehra  1 , Joseph C Cleveland Jr  2 , Nir Uriel  3 , Jennifer A Cowger  4 , Shelley Hall  5 , Douglas Horstmanshof  6 , Yoshifumi Naka  3 , Christopher T Salerno  7 , Joyce Chuang  8 , Christopher Williams  8 , Daniel J Goldstein  9 ; MOMENTUM 3 Investigators
Affiliations
Randomized Controlled Trial

Primary results of long-term outcomes in the MOMENTUM 3 pivotal trial and continued access protocol study phase: a study of 2200 HeartMate 3 left ventricular assist device implants

Mandeep R Mehra et al. Eur J Heart Fail. 2021 Aug.

Abstract

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.

Keywords: Advanced heart failure; Clinical trial; Learning curve; Left ventricular assist device; MOMENTUM 3; Outcome.

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Figures

Figure 1
Figure 1
Composite endpoint and overall survival. Comparison of (A) survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump and (B) overall survival between the pivotal and continued access protocol (CAP) cohorts. CI, confidence interval; HR, hazard ratio. *Adjusted HRs and P‐values are calculated with Cox regression. HRs are presented for CAP vs. pivotal cohorts and adjusted for age, sex, race (Caucasian or non‐Caucasian), intended use (bridge to transplant or candidacy, or destination therapy), and INTERMACS profile (1–3 or 4–7).
Figure 2
Figure 2
Overall survival by intended goal of implant. Comparison of survival between pivotal and continued access protocol (CAP) cohorts in (A) bridge to transplant or candidacy (BTT/BTC) and (B) destination therapy (DT) patients. CI, confidence interval; HR, hazard ratio. *Adjusted HRs and P‐values are calculated with Cox regression. HRs are presented for CAP vs. pivotal cohorts and adjusted for age, sex, race (Caucasian or non‐Caucasian), and INTERMACS profile (1–3 or 4–7).
Figure 3
Figure 3
Impact of clinical severity on outcomes. Comparison of (A) the composite endpoint and (B) overall survival between INTERMACS profiles 1–2 (‘unstable’ advanced heart failure), profile 3 (‘stable’ on inotropic therapy) and profiles 4–7 (‘stable’ ambulatory advanced heart failure). CI, confidence interval; HR, hazard ratio. *Adjusted HRs and P‐values are calculated with Cox regression. HRs are presented for profiles 3 vs. 1–2 and profiles 4–7 vs. 1–2 and adjusted for age, sex, race (Caucasian or non‐Caucasian), and intended use (bridge to transplant or candidacy, or destination therapy).
Figure 4
Figure 4
Net burden of adverse events. Comparison of the adverse event burden between the pivotal and continued access protocol (CAP) cohorts. CI, confidence interval; EPPY, events per patient‐year. *Adjusted rate ratios and P‐values are calculated with Poisson regression. Rate ratios are presented for CAP vs. pivotal cohorts and adjusted for age, sex, race (Caucasian or non‐Caucasian), intended use (bridge to transplant or candidacy, or destination therapy), and INTERMACS profile (1–3 or 4–7).
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