Association of Clinical Outcomes With Left Ventricular Assist Device Use by Bridge to Transplant or Destination Therapy Intent

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.

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

“…Prior studies enforced such a dichotomy and reduced confidence in outcomes with those deemed transplant ineligible due to observations of lower survival in such patient cohorts. 16 , 17 The advent of the HM3 pump has led to greater confidence in LVAD use among transplant ineligible patients such that even regulatory authorities in the United States have abandoned the use of such terminology in preference for a single indication of use in patients refractory to pharmacological disease‐modifying therapy. 17 , 18 We now introduce further certainty that transplant ineligible patients experience excellent survival comparable to rates noted with heart transplantation, at least in the 2‐year observation period.…”

Left ventricular assist systems and infection-related outcomes: A comprehensive analysis of the MOMENTUM 3 trial

“…1,2 Indeed, implantation of an LVAD in patients with advanced heart failure is now suggested as a means of enhancing and prolonging life, irrespective of whether a patient is transplant-eligible or -ineligible, because outcomes seem comparable. 3 However, non−hemocompatibility-related outcomes continue to persist and determine quality of life and overall outcomes with LVADs, which are principally driven by infections and the morbidity conferred by the presence of an external driveline to power the device. 4,5 The MOMENTUM 3 trial, which randomized patients with advanced heart failure refractory to medical therapy to either the HM3 LVAD or the HeartMate II (HMII) axialflow LVAD and followed them for 2 years, provides a contemporary experience to evaluate the outcomes of infectionrelated events.…”

A Cavopulmonary Assist Device for Long-Term Therapy of Fontan Patients

“…To mitigate the risk of flow obstruction due to device dysfunction, we focused on a failsafe motor conception by redundant dual motor configuration. In addition, the experience with the HM3 may indicate device malfunction (1.6% at 2 years) 35 and pump thrombosis (<0.01 events per patient-year) 36 to be considered a rare event in RBPs with similar design characteristics. Thus, features which may contribute to this excellent failure rate and outcomes of the HM3 (large gap design of 500µm may prevent occlusive pump thrombosis)…”