Ferrall Joel, Vaidya Ajay S, Kawaguchi Eric S, Patel Sanjeet G, Lee Raymond C, Lee Emily S, Wolfson Aaron M
Keck School of Medicine, University of Southern California, Los Angeles, California, USA.
Department of Anthropology, University of Southern California, Los Angeles, California, USA.
Artif Organs. 2025 Feb;49(2):281-291. doi: 10.1111/aor.14884. Epub 2024 Oct 9.
Durable biventricular support may be necessary to bridge patients with end-stage biventricular failure to heart transplantation. This study compares waitlist and post-transplant outcomes between patients supported with continuous flow, durable biventricular assist devices (BiVAD), and total artificial heart (TAH).
Using the UNOS registry, we analyzed adult (≥18 years old), first-time transplant candidates with TAH or BiVAD at the time of listing or transplantation from 10/1/2010-10/31/2020, with follow-up through 3/31/2022. Multivariable proportional subdistribution hazards models and cause-specific Cox proportional hazards models were used to compare death/deterioration or heart transplantation on the waitlist between cohorts. Kaplan-Meier and multivariable Cox proportional hazards model were used to evaluate one-year post-transplant survival and evaluate difference in outcomes based on annual transplant center volume.
The waitlist cohort included a total of 228 patients (25% BiVAD). Waitlist outcomes between device types were similar. The transplanted cohort included a total of 352 patients (25% BiVAD). There was a trend towards worse one-year post-transplant survival in patients bridged with TAH versus BiVAD (log-rank p-value = 0.072) that persisted after adjusting for age, gender, policy, and removing dual-organ recipients (HR 1.94 (0.94, 3.98) p-value = 0.07). There was a difference in one-year post-transplant survival amongst TAH-bridged patients when stratified by annual transplant center volume (log-rank p-value = 0.013). One-year post-transplant survival between TAH-supported patients from high annual transplant volume centers and BiVAD-supported patients was similar (p-value = 0.815).
BiVAD and TAH are reasonable support strategies with TAH implantation at high-volume transplant centers (51+ transplants/year) having similar 1-year post-transplant survival to BiVAD-supported patients.
对于终末期双心室衰竭患者，可能需要持久的双心室支持以过渡到心脏移植。本研究比较了接受持续血流、持久双心室辅助装置（BiVAD）和全人工心脏（TAH）支持的患者在等待名单上的情况以及移植后的结局。
利用器官共享联合网络（UNOS）登记系统，我们分析了2010年10月1日至2020年10月31日期间在列入名单或移植时使用TAH或BiVAD的成年（≥18岁）首次移植候选者，并随访至2022年3月31日。使用多变量比例子分布风险模型和特定病因的Cox比例风险模型来比较队列之间在等待名单上的死亡/病情恶化或心脏移植情况。使用Kaplan-Meier法和多变量Cox比例风险模型来评估移植后一年的生存率，并根据年度移植中心手术量评估结局差异。
等待名单队列共有228例患者（25%为BiVAD）。不同装置类型在等待名单上的结局相似。移植队列共有352例患者（25%为BiVAD）。与BiVAD相比，接受TAH过渡的患者移植后一年生存率有变差的趋势（对数秩检验p值 = 0.072），在调整年龄、性别、政策并排除双器官受者后该趋势仍然存在（风险比1.94（0.94，3.98），p值 = 0.07）。根据年度移植中心手术量分层时，TAH过渡患者的移植后一年生存率存在差异（对数秩检验p值 = 0.013）。来自高年度移植量中心的TAH支持患者与BiVAD支持患者的移植后一年生存率相似（p值 = 0.815）。
BiVAD和TAH都是合理的支持策略，在高手术量移植中心（每年51例以上移植手术）植入TAH的患者移植后一年生存率与BiVAD支持的患者相似。
