Uriel Matan H, Clerkin Kevin J, Takeda Koji, Naka Yoshifumi, Sayer Gabriel T, Uriel Nir, Topkara Veli K
Division of Cardiology, Department of Medicine, Columbia University Irving Medical Center, New York, New York.
Division of Cardiothoracic Surgery, Department of Surgery, Columbia University Irving Medical Center, New York, New York.
J Heart Lung Transplant. 2023 Jan;42(1):124-133. doi: 10.1016/j.healun.2022.08.022. Epub 2022 Sep 10.
Following the MOMENTUM 3 trial and the discontinuation of the HeartWare HVAD, the HeartMate 3 LVAD (HM 3) has become the main durable device for bridging to transplantation; however, outcome of this strategy in the new heart allocation system is not well understood.
The United Network for Organ Sharing (UNOS) registry was queried to include adult patients (≥18 years old) listed for heart transplantation between 2010 and 2020. Trends in durable LVAD utilization and outcomes of patients with HM 3 LVAD were examined in the pre- vs post-heart allocation system.
From 2017 to 2020, there was a 28.3% decline in the number of patients waitlisted with an FDA-approved durable LVAD. Overall, 449 patients were waitlisted with HM 3 in the pre-allocation era compared to 1094 patients in the post-allocation. Cumulative incidence of heart transplantation (53.4% vs 50.7%, p = 0.76) and death or delisting for worsening status (5.0%, vs 4.2%, p = 0.43) at 1-year after listing with HM 3 LVAD was comparable in the pre- vs post-allocation era. Old age (>50), ischemic HF, poor functional status, elevated creatinine (>1.3 mg/dL), pulmonary hypertension (>3 WU), and obesity (body mass index > 33 kg/m) were predictors of post-transplant graft mortality after bridging with HM 3.
While the utilization of durable devices as BTT have declined under the new heart allocation system, bridging with HM 3 LVAD remains a safe strategy in carefully selected patients. Bridging decision should be individualized based on patient risk factors.
在MOMENTUM 3试验以及HeartWare HVAD停用之后,HeartMate 3左心室辅助装置(HM 3)已成为用于过渡到移植的主要耐用设备;然而,在新的心脏分配系统中该策略的结果尚不完全清楚。
查询器官共享联合网络(UNOS)登记处,纳入2010年至2020年间登记等待心脏移植的成年患者(≥18岁)。在心脏分配系统前后,研究了耐用左心室辅助装置的使用趋势以及使用HM 3左心室辅助装置患者的结局。
从2017年到2020年,等待FDA批准的耐用左心室辅助装置的患者数量下降了28.3%。总体而言,在分配前时代有449例患者等待使用HM 3,而在分配后时代有1,094例患者。使用HM 3左心室辅助装置登记后1年时,心脏移植的累积发生率(53.4%对50.7%,p = 0.76)以及因病情恶化导致的死亡或退出登记(5.0%对*4.2%,p = 0.43)在分配前后时代相当。老年(>50岁)、缺血性心力衰竭、功能状态差、肌酐升高(>1.3 mg/dL)、肺动脉高压(>3 Wood单位)和肥胖(体重指数>33 kg/m²)是使用HM 3过渡后移植后移植物死亡的预测因素。
虽然在新的心脏分配系统下,作为过渡到移植的耐用设备的使用有所下降,但对于精心挑选的患者,使用HM 3左心室辅助装置进行过渡仍然是一种安全的策略。应根据患者风险因素进行个体化的过渡决策。