HeartMate 3 LVAS achieved 86.3% success at 24 months with lower mortality (6.2% vs 21.2%) and higher transplant rate (31.3% vs 1.9%) in bridge-to-transplant vs destination therapy patients.
Does the HeartMate 3 LVAS provide effective and safe mechanical circulatory support in South Korean patients with advanced heart failure?
The HeartMate 3 LVAS demonstrates favorable clinical outcomes and an acceptable safety profile in a South Korean population with advanced heart failure, particularly when used as a bridge to transplant.
Tasa de eventos absoluta: 0% vs 0%
Abstract Background The HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) provides mechanical circulatory support for patients with advanced heart failure (HF). However, clinical data regarding the use of HM3 in Asian populations are scarce. This study assessed the real-world performance of the HM3 in patients with advanced HF in South Korea. Methods This single-arm, multi-centre, post-market study enrolled patients approved for HM3 implantation in Korea as per Health Insurance Review and Assessment (HIRA) guidelines. Enrolled patients were followed until they experienced an outcome (transplanted, explanted, or expired), or reached the end of the 4-year surveillance period, whichever came first. The composite primary effectiveness endpoint was overall survival to transplant, myocardial recovery, or on-device support free of debilitating stroke or reoperation for pump replacement. The primary safety endpoint was the cumulative occurrence of pre-defined adverse events. Results A total of 358 patients were implanted with HM3 between June 2020 and June 2024. The median follow-up duration was 356 days. At 6, 12, and 24 months post-HM3 implant, the composite primary endpoint was achieved by 94.3%, 90.2%, and 86.3% of patients, respectively. A competing outcomes analysis showed that, at 24 months, 43 (12.0%) patients had ongoing HM3 support, 96 (26.8%) patients had received heart transplants, 50 patients (14.0%) expired, and 1 (0.3%) patient had withdrawn. The remaining 168 (46.9%) patients had ongoing HM3 support at the end of the surveillance period, but were enrolled for less than 24 months. The most frequently reported pre-defined adverse events (AEs) during the surveillance period were bleeding (0.15 events per patient-year EPPY) and major infection (0.25 EPPY). Subgroup analysis categorized patients by preimplant strategy into destination therapy (DT) (n=52) and possible bridge-to-transplant (BTT) (n=275). Compared to DT patients, BTT patients were younger (55.4 ± 13.6 vs 73.7 ± 5.7, p0.01), less likely to be female (17.8% vs 34.6%, p0.01), and less likely to have ischemic HF etiology (32.4% vs 55.8%, p0.01). At 6, 12, and 24 months, the success rates of the composite primary endpoint in BTT patients were higher than those in the DT patients at each time point (95.6% vs 88.0%, 92.2% vs 81.0%, and 90.3% vs 73.7%, log-rank p 0.01). At 24 months, the transplant rate was higher and mortality rate was lower in BTT patients than in DT patients (31.3% vs 1.9%, p0.01 and 6.2% vs 21.2%, p0.01). Major infection and bleeding occurred at similar rates in BTT and DT patients (0.24 vs 0.32 EPPY, and 0.14 vs 0.16 EPPY). Conclusions This study demonstrated that HM3 had favourable clinical outcomes with an acceptable safety profile in an Asian population. HM3 was implanted more often with a BTT intent, with better outcomes compared to those with a DT intent. These findings confirm that the benefits of HM3 can extend to an Asian population
Kim et al. (Sat,) reported a other. HeartMate 3 LVAS achieved 86.3% success at 24 months with lower mortality (6.2% vs 21.2%) and higher transplant rate (31.3% vs 1.9%) in bridge-to-transplant vs destination therapy patients.