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Original Investigation
January 15, 2020

Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent: The Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) Randomized Clinical Trial

Author Affiliations
  • 1Montefiore Einstein Center for Heart and Vascular Care, New York, New York
  • 2Columbia University College of Physicians and Surgeons, New York–Presbyterian Hospital, New York
  • 3INTEGRIS Baptist Medical Center, Oklahoma City, Oklahoma
  • 4St Vincent Heart Center, Indianapolis, Indiana
  • 5Duke University Medical Center, Durham, North Carolina
  • 6Baptist Health Medical Center, Little Rock, Arkansas
  • 7Washington University School of Medicine, St Louis, Missouri
  • 8University of Colorado School of Medicine, Aurora
  • 9Advent Health Transplant Institute, Orlando, Florida
  • 10University of Minnesota, Minneapolis
  • 11Houston Methodist Hospital, Houston, Texas
  • 12University of Nebraska Medical Center, Omaha
  • 13Pritzker School of Medicine, University of Chicago, Chicago, Illinois
  • 14University of Chicago Medical Center, Chicago, Illinois
  • 15Yale Medical School, New Haven, Connecticut
  • 16MedStar Washington Hospital Center, Washington, DC
  • 17Abbott Laboratories, Abbott Park, Illinois
  • 18Heart and Vascular Center, Center for Advanced Heart Disease, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Cardiol. Published online January 15, 2020. doi:10.1001/jamacardio.2019.5323
Key Points

Question  In patients with advanced heart failure, do outcomes with left ventricular assist device implantation differ by the initial intended goal of therapy as a bridge to transplant or destination therapy?

Findings  In this randomized clinical trial, the composite end point of survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years was significantly better with the magnetically levitated centrifugal-flow HeartMate 3 than the mechanical-bearing axial-flow HeartMate II, irrespective of preimplant therapeutic intent. Event-free survival was not different between patients in the bridge to transplant or destination therapy groups treated with the HeartMate 3 pump.

Meaning  Per this randomized clinical trial, use of categorizations based on current or future transplant eligibility should be abandoned in favor of a single treatment indication for use of left ventricular assist devices.

Abstract

Importance  Left ventricular assist devices (LVADs) are well established in the treatment of advanced heart failure, but it is unclear whether outcomes are different based on the intended goal of therapy in patients who are eligible vs ineligible for heart transplant.

Objective  To determine whether clinical outcomes in the Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3 (MOMENTUM 3) trial differed by preoperative categories of bridge to transplant (BTT) or bridge to transplant candidacy (BTC) vs destination therapy (DT).

Design, Setting, and Participants  This study was a prespecified secondary analysis of the MOMENTUM 3 trial, a multicenter randomized clinical trial comparing the magnetically levitated centrifugal-flow HeartMate 3 (HM3) LVAD to the axial-flow HeartMate II (HMII) pump. It was conducted in 69 centers with expertise in managing patients with advanced heart failure in the United States. Patients with advanced heart failure were randomized to an LVAD, irrespective of the intended goal of therapy (BTT/BTC or DT).

Main Outcomes and Measures  The primary end point was survival free of disabling stroke or reoperation to remove or replace a malfunctioning device at 2 years. Secondary end points included adverse events, functional status, and quality of life.

Results  Of the 1020 patients with implants (515 with HM3 devices [50.5%] and 505 with HMII devices [49.5%]), 396 (38.8%) were in the BTT/BTC group (mean [SD] age, 55 [12] years; 310 men [78.3%]) and 624 (61.2%) in the DT group (mean [SD] age, 63 [12] years; 513 men [82.2%]). Of the patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant. In the primary end point analysis, HM3 use was superior to HMII use in patients in the BTT/BTC group (76.8% vs 67.3% for survival free of disabling stroke and reoperation; hazard ratio, 0.62 [95% CI, 0.40-0.94]; log-rank P = .02) and patients in the DT group (73.2% vs 58.7%; hazard ratio, 0.61 [95% CI, 0.46-0.81]; log-rank P < .001). For patients in both BTT/BTC and DT groups, there were not significantly different reductions in rates of pump thrombosis, stroke, and gastrointestinal bleeding with HM3 use relative to HMII use. Improvements in quality of life and functional capacity for either pump were not significantly different regardless of preimplant strategy.

Conclusions and Relevance  In this trial, the superior treatment effect of HM3 over HMII was similar for patients in the BTT/BTC or DT groups. It is possible that use of arbitrary categorizations based on current or future transplant eligibility should be clinically abandoned in favor of a single preimplant strategy: to extend the survival and improve the quality of life of patients with medically refractory heart failure.

Trial Registration  ClinicalTrials.gov identifier: NCT02224755

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