Evidence map›Paper›PMID 33932272›Full record

Trial reportEuropean journal of heart failure2021

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, Joseph C Cleveland, Nir Uriel, Jennifer A Cowger, Shelley Hall, Douglas Horstmanshof, Yoshifumi Naka, Christopher T Salerno, Joyce Chuang, Christopher Williams and 2 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of heart failure, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02892955 (Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol), which is not on this map. Cited by 66 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
66citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02892955 nacompletednot on this map

Multi-Center Study of MagLev Technology in Patients Undergoing MCS Therapy With HeartMate 3™ Continued Access Protocol: Post-Approval Continued Follow-up

TypeinterventionalSponsorAbbott Medical DevicesRan2016 to 2021Enrolled1,685ConditionsAdvanced Refractory Left Ventricular Heart FailureArmsHeartMate 3 LVAS
3 · Its place in the literature

Who cites it

66 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Artifactual declines in durable LVAD utilization among heart transplant candidates: Selection bias in transplant registries.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2026
    Article
  6. Preoperative predictors of low flow limit controller configuration following HeartMate 3 implantation.Journal of artificial organs : the official journal of the Japanese Society for Artificial Organs · 2026
    Observational
  7. Observational
  8. Article
  9. Low rates of inotropic support and durable left ventricular assist device placement among status 2 heart transplant candidates with temporary mechanical circulatory support.The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2026
    Article
  10. Article
  11. Review
  12. Article
  13. Observational
  14. Article
  15. Review
  16. Article
  17. Article
  18. Review
  19. Review
  20. Article

6 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Mandeep R MehraBrigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, MA, USA.
Joseph C ClevelandUniversity of Colorado School of Medicine, Aurora, CO, USA.
Nir UrielColumbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY, USA.
Jennifer A CowgerHenry Ford Hospitals, Detroit, MI, USA.
Shelley HallBaylor University Medical Center, Dallas, TX, USA.
Douglas HorstmanshofINTEGRIS Baptist Medical Center, Oklahoma City, OK, USA.
Yoshifumi NakaColumbia University College of Physicians and Surgeons and New York-Presbyterian Hospital, New York, NY, USA.
Christopher T SalernoSt. Vincent Heart Center, Indianapolis, IN, USA.
Joyce ChuangAbbott, Abbott Park, IL, USA.
Christopher WilliamsAbbott, Abbott Park, IL, USA.
Daniel J GoldsteinMontefiore Einstein Center for Heart and Vascular Care, New York, NY, USA.
MOMENTUM 3 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimThe 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

resultsWe 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.

conclusionsThe primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial.

Indexed as

Heart-Assist DevicesHeart FailureStrokeHumansProspective StudiesTreatment OutcomeAdvanced heart failureClinical trialLearning curveLeft ventricular assist deviceMOMENTUM 3Outcome

Identifiers

PMID33932272
PMCPMC8453814

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.