School mate 2 hf11/12/2022 ![]() Thereafter, evidence emerged that LVAD therapy improved survival time to heart transplant, allowed better use of donor organs, and enhanced posttransplant survival. ![]() The first left ventricular assist device (LVAD) for treatment of advanced heart failure was approved by the US Food and Drug Administration 25 years ago for patients using it as a bridge to transplant (BTT). Trial Registration identifier: NCT02224755 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. Improvements in quality of life and functional capacity for either pump were not significantly different regardless of preimplant strategy.Ĭonclusions and Relevance In this trial, the superior treatment effect of HM3 over HMII was similar for patients in the BTT/BTC or DT groups. 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. 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 log-rank P = .02) and patients in the DT group (73.2% vs 58.7% hazard ratio, 0.61 log-rank P < .001). Of the patients initially deemed as transplant ineligible, 84 of 624 patients (13.5%) underwent heart transplant within 2 years of LVAD implant. Results Of the 1020 patients with implants (515 with HM3 devices and 505 with HMII devices ), 396 (38.8%) were in the BTT/BTC group (mean age, 55 years 310 men ) and 624 (61.2%) in the DT group (mean age, 63 years 513 men ). Secondary end points included adverse events, functional status, and quality of life. 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. Patients with advanced heart failure were randomized to an LVAD, irrespective of the intended goal of therapy (BTT/BTC or DT). ![]() It was conducted in 69 centers with expertise in managing patients with advanced heart failure in the United States. 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).ĭesign, 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. 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.
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