Five-Year Survival and Incidence of Adverse Events in Patients Implanted with HeartMate 3 Left Ventricular Assist Device at a High Volume Center

G. Mondellini, A. Vinogradsky, M. Kirschner,P. A. Kurlansky, Y. Ning, J. Y. Sun,M. Tiburcio, A. Kleet, Y. Naka, Y. Kaku, G. T. Sayer,N. Uriel, M. Yuzefpolskaya, K. Takeda, P. C. Colombo

The Journal of Heart and Lung Transplantation(2023)

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摘要
PurposeThe HeartMate3 (HM3) is the dominant durable left ventricular assist device (LVAD) therapy for patients (pts) with advanced heart failure refractory to medical therapy. However, information on HM3 outcomes beyond 2 years (y) are limited to the recently published results of the MOMENTUM 3 trial, which showed a 5-year survival of 56%. We report 5-year actuarial survival and cumulative incidence of major adverse events of HM3 pts implanted at a single large-volume center.MethodsWe retrospectively reviewed all pts who underwent HM3 implant from 11/2014 to 7/2022 at our institution. Survival and major adverse events (de novo long-term renal replacement therapy (RRT), stroke, gastrointestinal bleeding (GIB) and driveline infection (DLI)) up to 5 y after implant were analyzed. Survival was estimated using Kaplan-Meier method. Nelson-Aelen nonparametric method was used to estimate cumulative incidence function for each adverse event.Results280 HM3 pts (age 60±13 years, 44 (16%) female, 144(41%) ischemic etiology 176 (63%) INTERMACS profile 1-2, 238 (85%) destination therapy)) were studied. Over a follow up of 590 [295-1101] days, 45 (16%) died, 68 (24%) had heart transplant, 2(1%) were explanted, 6 (2%) transferred care and 159 (57%) remained on LVAD support. Two (1%) pts required de novo RRT at discharge, 19 (7%) experienced a stroke and 49 (17%) a DLI. Ninety-two GIBs occurred in 64 (23%) pts. Five-year actuarial survival was 68% (95%CI 57-79%) (Fig 1A). Cumulative probability of stroke was 0.08 (95%CI 0.05-0.12) (Fig 1B), GIB 0.35 (95%CI 0.27-0.42) (Fig 1C) and DLI 0.33 (95%CI 0.24-0.42) (Fig 1D). The probability of stroke was 0.04 at 30 days, 0.06 at 180 days, and 0.08 at 5 years.ConclusionThis observational single center report of HM3 pts shows excellent survival and acceptable rates of adverse events up to 5 years. These results suggest that an established multidisciplinary and protocolized approach to LVAD care may yield improved long-term outcomes for HM3 pts. The HeartMate3 (HM3) is the dominant durable left ventricular assist device (LVAD) therapy for patients (pts) with advanced heart failure refractory to medical therapy. However, information on HM3 outcomes beyond 2 years (y) are limited to the recently published results of the MOMENTUM 3 trial, which showed a 5-year survival of 56%. We report 5-year actuarial survival and cumulative incidence of major adverse events of HM3 pts implanted at a single large-volume center. We retrospectively reviewed all pts who underwent HM3 implant from 11/2014 to 7/2022 at our institution. Survival and major adverse events (de novo long-term renal replacement therapy (RRT), stroke, gastrointestinal bleeding (GIB) and driveline infection (DLI)) up to 5 y after implant were analyzed. Survival was estimated using Kaplan-Meier method. Nelson-Aelen nonparametric method was used to estimate cumulative incidence function for each adverse event. 280 HM3 pts (age 60±13 years, 44 (16%) female, 144(41%) ischemic etiology 176 (63%) INTERMACS profile 1-2, 238 (85%) destination therapy)) were studied. Over a follow up of 590 [295-1101] days, 45 (16%) died, 68 (24%) had heart transplant, 2(1%) were explanted, 6 (2%) transferred care and 159 (57%) remained on LVAD support. Two (1%) pts required de novo RRT at discharge, 19 (7%) experienced a stroke and 49 (17%) a DLI. Ninety-two GIBs occurred in 64 (23%) pts. Five-year actuarial survival was 68% (95%CI 57-79%) (Fig 1A). Cumulative probability of stroke was 0.08 (95%CI 0.05-0.12) (Fig 1B), GIB 0.35 (95%CI 0.27-0.42) (Fig 1C) and DLI 0.33 (95%CI 0.24-0.42) (Fig 1D). The probability of stroke was 0.04 at 30 days, 0.06 at 180 days, and 0.08 at 5 years. This observational single center report of HM3 pts shows excellent survival and acceptable rates of adverse events up to 5 years. These results suggest that an established multidisciplinary and protocolized approach to LVAD care may yield improved long-term outcomes for HM3 pts.
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left ventricular assist device,heartmate,five-year
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