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Five-Year Outcomes for the HeartMate3 Left Ventricular Assist Device

Published:November 22, 2022DOI:https://doi.org/10.1053/j.jvca.2022.11.018
      Although heart transplantation remains the only definitive therapy for end stage heart failure, this path is not always an option. Instead, left ventricular assist devices (LVAD) may be offered to patients as a possible alternative for either bridge to later transplant or as a destination therapy. In recent years that have been three commercially available LVADs. These have included an axial flow pump (HeartMate II [HMII], Thoratec, Pleasanton, CA) and two centrifugal-flow pumps: the hybrid levitation (HeartWare HVAD [HVAD], Medtronic, St. Paul, MN) and the fully magnetic levitation (HeartMate3 [HM3], Abbott, Abbott Park, IL) pumps.1 However, in 2022, the HM3 device is the only LVAD left standing in the market following multiple recalls of the other 2 VAD's.
      Earlier head-to-head device trials left the field divided on pump selection. The ENDURANCE
      (ENDURANCE: The HeartWare Ventricular Assist System as Destination Therapy of Advanced Heart Failure) trial randomized patients 2:1 to either HVAD or HMII as destination therapy with a primary endpoint of survival free of disabling stroke or device failure at 2 years.2 The trial demonstrated non-inferiority however, the HVAD arm had statistically significant greater number of ischemic and hemorrhagic strokes.2 Follow up study with intensified blood pressure control once again favored the HMII device with regards to neurologic injury at 12 months but the HVAD missed the noninferiority margin.3
      The HM3 LVAD first came on the scene in 2019 as part of the MOMENTUM 3 (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical
      Circulatory Support Therapy with HeartMate 3) landmark trial.4 . Patients were randomized to receive either a HMII or HM3 device. Unlike prior studies, the MOMENTUM 3 trial did not distinguish between the “bridge to therapy” or “destination therapy” device designation. Two patient cohorts were enrolled: short term and long term both with a primary endpoint of survival free from disability stroke or re-operation to repair/replace the pump at 6 and 24 months respectively. Two-year outcomes reported an event free survival of 74.7% vs 60.6% (HR 0.60, 95% confidence interval CI 0.47 – 0.75) with similar actual survival of 79.0% versus 76.7% (HR 0.88 (95% CI 0.67-1.16) for both HM3 and HMII, respectively. The primary outcomes demonstrated both non-inferiority and superiority at 2 years. In addition, stroke, pump thrombosis, major bleeding and gastrointestinal hemorrhage were significantly lower in the HM3 group.
      These results led to the HM3 pushing ahead as the most implanted LVAD despite no randomized controlled trials performed comparing the hybrid and fully levitated centrifugal pumps (HVAD to HM3).6 However, in June 2021, the Food and Drug Administration released a health alert calling for cessation of any further HVAD implants. This came shortly after an Urgent Medical Device Communication in December the previous year informing providers of the pump's possible delay to restart or a failure to restart. This left the HM3 as the only commercially available VAD on the market. However, little was known about the LVAD's performance beyond the 2-year mark until recently.
      In August 2022, at the European Society of Cardiology Congress held in Barcelona, the 5-year extended MOMENTUM 3 observational follow up results were presented.7 Of the original cohort, 457/515 (88.7%) HM3 and 440/505 (87.1%) HMII patients had 5-year survival data available. Overall survival was set as the primary study endpoint. Additional endpoints included: 1) to investigate the original primary end point of event free survival from disabling stroke and reoperation at 5 years 2) to determine if the serious adverse event rate remained reduced. At 5 years, the overall survival was 58.4% vs 43.7% in the HM3 vs. HMII groups respectively with a HR 0.72 (95% CI 0.58-0.89, p=0.003). Similar survival benefit was seen for patients undergoing destination therapy with HM3 (54.8% vs 39.4%, HR 0.70; 95% CI 0.55-0.90, p=0.005). When reviewed in the context of the initial MOMENTUM 3 composite endpoint, the HM3 also conferred a significant event free survival advantage over the axial flow pump (54.0% vs 29.7%, HR 0.55; 95% CI 0.45- 0.67, p< 0.001). Hemocompatibility events including any stroke, bleeding or pump thrombosis were lower with the HM3 as seen previously. Even in the presence of the competing risk of transplant 27% HM3 vs 17% HM2 patients were alive at 5 years. These results are particularly encouraging for patients in whom transplant is not a clinical option.
      The perioperative issues with LVAD implantation are complex and require multidisciplinary planning. Reassuring outcomes data and a median survival exceeding 5 years associated with the HM3 are likely to be major improvements in quality of life and will extend overall survival of VAD eligible patients with HF. Anesthesiologists and intensivists can expect growing numbers of VAD eligible patients in their practices in the coming years.

      CONFLICT OF INTEREST

      The authors have no conflict of interest or financial involvement with this manuscript.
      The research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

      R eferences

      • 1
        Stawiarski K, Stulak JM, Ramakrishna H. HeartMate 3-Analysis of Recent Trial Data. J Cardiothorac Vasc Anesth. 2021 Oct;35(10):3105-3107.
      • 2
        Rogers JG, Pagani FD, Tatooles AJ, et al. Intrapericardial left ventricular assist device for advanced heart failure. N Engl J Med 2017;376:451–60.
      • 3
        Milano CA, Rogers JG, Tatooles AJ, et al. HVAD: The ENDURANCE supplemental trial. JACC Heart Fail 2018;6:792–802
      • 4
        Mehra MR, Uriel N, Naka Y, et al. A fully magnetically levitated left ventricular assist device: Final report. N Engl J Med 2019;380:1618–27.
      • 5
        Food and Drug Administration. FDA Alerts Health Care Providers to Stop New Implants of Certain Ventricular Assist Device System. June 3, 2021. Accessed September 27, 2022. https://www.fda.gov/news-events/press-announcements/fda-alerts-health-care-providers-stop-new-implants-certain-ventricular-assist-device-system.
      • 6
        Molina EJ, Shah P, Kiernan MS, Cornwell WK 3rd, Copeland H, Takeda K, Fernandez FG, Badhwar V, Habib RH, Jacobs JP, Koehl D, Kirklin JK, Pagani FD, Cowger JA. The Society of Thoracic Surgeons Intermacs 2020 Annual Report. Ann Thorac Surg. 2021 Mar;111(3):778-792. doi: 10.1016/j.athoracsur.2020.12.038.
      • 7
        Mehra MR, Golstein DJ, Cleveland JC, et al. 5-year outcomes in patients with fully magnetically levitates vs axial-flow left ventricular assist devices in the MOMENTUM-3 randomized trial. European Society of Cardiology Congress 2022. August 2022, Barcelona, Spain.