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

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.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Goldstein reported receiving travel support from Abbott Laboratories outside the submitted work. Dr Naka reported receiving consulting fees from Abbott Laboratories during the conduct of the study and personal fees from CryoLife and Zimmer Biomet outside the submitted work. Dr Horstmanshof reported receiving research support from Abbott Laboratories during the conduct of the study and personal fees for consulting and speaker’s bureau participation from Abbott Laboratories outside the submitted work. Dr Ravichandran reported receiving travel support from Abbott Laboratories and Medtronic. Dr Schroder reported receiving consulting fees from Abbott Laboratories outside the submitted work and Medtronic. Dr Itoh reported receiving consulting fees and honoraria from Abbott Laboratories during the conduct of the study and personal fees from Abiomed and Medtronic outside the submitted work. Dr Cogswell reported receiving fees for consulting and speaker’s bureau from Abbott Laboratories and Medtronic and served on the heart failure advisory board for Medtronic. Dr Suarez reported receiving speaker’s bureau fees from Abiomed and serving on advisory boards for Abbott Laboratories and Medtronic outside the submitted work. Dr Uriel reported receiving grant support, consulting fees, and honoraria from Abbott Laboratories and Medtronic and serving on advisory boards for Leviticus Cardio and Livemetric/Cormetric. Dr Cleveland reported receiving grant support from Abbott Laboratories during the conduct of the study. Dr Lowes reported grants from Abbott Laboratories during the conduct of the study and consulting fees from Abbott Laboratories outside the submitted work. Dr Sheikh reported receiving consulting or lecture fees from Abbott Laboratories, Alnylam, Pfizer, and Eidos and serving on advisory boards for Alnylam and Pfizer. Drs Sood and Farrar are employees of Abbott Laboratories, and Dr Farrar reports being a stockholder in Abbott Laboratories as well. Dr Mehra reported receiving travel support and consulting fees paid to Brigham and Women’s Hospital from Abbott Laboratories, fees for serving on a steering committee from Medtronic and Janssen (Johnson & Johnson), fees for serving on a data and safety monitoring board from Mesoblast, consulting fees from Portola, Bayer, Triple Gene, Baim Institute for Clinical Research, and Xogenex, and fees for serving as a scientific board member from NuPulseCV, Leviticus, and FineHeart outside the submitted work. Dr Bonde reported serving as a consultant for Thoratec and Abbott Laboratories. No other disclosures were reported.

Figures

Figure 1.. Primary End Point Analysis

Survival at 2 years free of disabling stroke (defined as a modified Rankin score greater than 3) or reoperation to replace or remove a malfunctioning device in the bridge to transplant (BTT)/bridge to transplant candidacy (BTC) and destination therapy (DT) cohorts. HR indicates hazard ratio.

Figure 2.. Competing Outcomes in the Bridge to Transplant (BTT)/Bridge to Transplant Candidacy (BTC) and Destination Therapy (DT) Cohorts for Patients Implanted With HeartMate 3 (HM3) or HeartMate II (HMII)

Figure 3.. Comparison of Hemocompatibility-Associated Adverse Events With HeartMate 3 vs HeartMate II Devices in the Bridge to Transplant (BTT)/Bridge to Transplant Candidacy (BTC) and Destination Therapy (DT) Cohorts

Poisson regression was used to calculate the P value and relative risk (comparing HeartMate 3 [HM3] and HeartMate II [HMII] devices).