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
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 protoc...
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| Veröffentlicht in: | European journal of heart failure Jg. 23; H. 8; S. 1392 - 1400 |
|---|---|
| Hauptverfasser: | , , , , , , , , , , |
| Format: | Journal Article |
| Sprache: | Englisch |
| Veröffentlicht: |
Oxford, UK
John Wiley & Sons, Ltd
01.08.2021
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| Schlagworte: | |
| ISSN: | 1388-9842, 1879-0844, 1879-0844 |
| Online-Zugang: | Volltext |
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| 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.
Accumulating post‐pivotal trial experience with the HeartMate 3 (HM3) left ventricular assist device (LVAD) suggests a lower adverse event burden, reduced hospitalizations and similar survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump as compared to the pivotal MOMENTUM 3 trial outcomes at 2 years. These beneficial outcomes were noted across the continuum of clinical severity in advanced heart failure and especially among transplant ineligible patients in whom outcomes may now compare favourably with those in transplant eligible patients at 2 years. |
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| AbstractList | 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.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.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.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.The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial.CONCLUSIONSThe primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial. 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. Accumulating post‐pivotal trial experience with the HeartMate 3 (HM3) left ventricular assist device (LVAD) suggests a lower adverse event burden, reduced hospitalizations and similar survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump as compared to the pivotal MOMENTUM 3 trial outcomes at 2 years. These beneficial outcomes were noted across the continuum of clinical severity in advanced heart failure and especially among transplant ineligible patients in whom outcomes may now compare favourably with those in transplant eligible patients at 2 years. Accumulating post‐pivotal trial experience with the HeartMate 3 (HM3) left ventricular assist device (LVAD) suggests a lower adverse event burden, reduced hospitalizations and similar survival free of disabling stroke or reoperation to replace or remove a malfunctioning pump as compared to the pivotal MOMENTUM 3 trial outcomes at 2 years. These beneficial outcomes were noted across the continuum of clinical severity in advanced heart failure and especially among transplant ineligible patients in whom outcomes may now compare favourably with those in transplant eligible patients at 2 years. 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. 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. The primary results of accumulating HM3 LVAD experience suggest a lower adverse event burden and similar survival compared to the pivotal MOMENTUM 3 trial. |
| Author | Naka, Yoshifumi Uriel, Nir Cleveland, Joseph C. Williams, Christopher Cowger, Jennifer A. Mehra, Mandeep R. Chuang, Joyce Salerno, Christopher T. Goldstein, Daniel J. Hall, Shelley Horstmanshof, Douglas |
| AuthorAffiliation | 2 University of Colorado School of Medicine Aurora CO USA 8 Abbott Abbott Park IL USA 1 Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston MA USA 6 INTEGRIS Baptist Medical Center Oklahoma City OK USA 9 Montefiore Einstein Center for Heart and Vascular Care New York NY USA 3 Columbia University College of Physicians and Surgeons and New York‐Presbyterian Hospital New York NY USA 4 Henry Ford Hospitals Detroit MI USA 7 St. Vincent Heart Center Indianapolis IN USA 5 Baylor University Medical Center Dallas TX USA |
| AuthorAffiliation_xml | – name: 9 Montefiore Einstein Center for Heart and Vascular Care New York NY USA – name: 7 St. Vincent Heart Center Indianapolis IN USA – name: 5 Baylor University Medical Center Dallas TX USA – name: 2 University of Colorado School of Medicine Aurora CO USA – name: 4 Henry Ford Hospitals Detroit MI USA – name: 1 Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School Boston MA USA – name: 8 Abbott Abbott Park IL USA – name: 3 Columbia University College of Physicians and Surgeons and New York‐Presbyterian Hospital New York NY USA – name: 6 INTEGRIS Baptist Medical Center Oklahoma City OK USA |
| Author_xml | – sequence: 1 givenname: Mandeep R. surname: Mehra fullname: Mehra, Mandeep R. email: mmehra@bwh.harvard.edu organization: Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School – sequence: 2 givenname: Joseph C. surname: Cleveland fullname: Cleveland, Joseph C. organization: University of Colorado School of Medicine – sequence: 3 givenname: Nir surname: Uriel fullname: Uriel, Nir organization: Columbia University College of Physicians and Surgeons and New York‐Presbyterian Hospital – sequence: 4 givenname: Jennifer A. surname: Cowger fullname: Cowger, Jennifer A. organization: Henry Ford Hospitals – sequence: 5 givenname: Shelley surname: Hall fullname: Hall, Shelley organization: Baylor University Medical Center – sequence: 6 givenname: Douglas surname: Horstmanshof fullname: Horstmanshof, Douglas organization: INTEGRIS Baptist Medical Center – sequence: 7 givenname: Yoshifumi surname: Naka fullname: Naka, Yoshifumi organization: Columbia University College of Physicians and Surgeons and New York‐Presbyterian Hospital – sequence: 8 givenname: Christopher T. surname: Salerno fullname: Salerno, Christopher T. organization: St. Vincent Heart Center – sequence: 9 givenname: Joyce surname: Chuang fullname: Chuang, Joyce organization: Abbott – sequence: 10 givenname: Christopher surname: Williams fullname: Williams, Christopher organization: Abbott – sequence: 11 givenname: Daniel J. surname: Goldstein fullname: Goldstein, Daniel J. organization: Montefiore Einstein Center for Heart and Vascular Care |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33932272$$D View this record in MEDLINE/PubMed |
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| Copyright | 2021 The Authors. published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. |
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| Keywords | Left ventricular assist device Clinical trial Advanced heart failure Learning curve MOMENTUM 3 Outcome |
| Language | English |
| License | Attribution-NonCommercial-NoDerivs 2021 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
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The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated... The MOMENTUM 3 pivotal trial established superiority of the HeartMate 3 (HM3) left ventricular assist device (LVAD), a fully magnetically levitated... Accumulating post‐pivotal trial experience with the HeartMate 3 (HM3) left ventricular assist device (LVAD) suggests a lower adverse event burden, reduced... |
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| SubjectTerms | Advanced heart failure Clinical trial Heart Failure - therapy Heart-Assist Devices Humans Learning curve Left ventricular assist device Lvad MOMENTUM 3 Outcome Prospective Studies Stroke Treatment Outcome |
| Title | 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 |
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