Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial
Evaluation of a lateral thoracotomy implant approach for a centrifugal-flow left ventricular assist device: The LATERAL clinical trial
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DOI：
10.1016/j.healun.2019.02.002
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发表时间：
2019-04-01
影响因子：
8.9
通讯作者：
Cheung, Anson
中科院分区：
文献类型：
--
作者：
McGee, Edwin, Jr.;Danter, Matthew;Cheung, Anson
背景：HeartWare离心式心室辅助装置系统(HVAD)是治疗晚期心力衰竭的可行选择。在心脏手术中使用侵入性较小的技术是一种日益增长的趋势，而用于HVAD植入的开胸技术可能提供常规方法无法提供的好处。方法：侧向试验是一项多中心、前瞻性、非随机、单臂试验，使用了来自美国和加拿大26个中心的机构间机械辅助循环支持注册数据库(INTERMACS)的144名患者的数据。主要的复合终点是在最初植入的装置上被定义为活着的180天的成功，并且没有发生致残性中风(改良的Rankin量表评分)，移植或移植以供恢复。结果：88.1%的患者成功地达到了主要终点，显著高于根据历史胸骨切开数据设定的77.5%的预定义性能目标(p=0.0012)。关键的次要终点--首次住院的平均时间--为18天，显著短于从历史胸骨切开数据(p<；0.0001)中获得的26.1d的预先设定的绩效目标。不良事件描述进一步证明了开胸入路的安全性。总体患者存活率良好，需要再次手术的出血率明显低于使用胸骨切开入路的患者。结论：这项前瞻性临床试验证实，在选择胸骨正中切开术的患者中，通过侧向研究中使用的开胸入路植入HVAD系统是一种安全有效的替代胸骨正中切开术的方法，旨在成为移植桥的适应症。(C)由爱思唯尔公司代表国际心肺移植学会出版。版权所有。
BACKGROUND: The HeartWare centrifugal-flow ventricular assist device system (HVAD) is a viable option for treatment of advanced heart failure. There is a growing trend toward the use of less invasive techniques in cardiac surgery, and the thoracotomy technique for HVAD implantation may provide benefits not available with conventional approaches.METHODS: The LATERAL trial is a multicenter, prospective, non-randomized, single-arm trial that utilized data from 144 patients enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database at 26 centers in the United States and Canada. The primary composite end-point was success at 180 days defined as alive on the originally implanted device and free from disabling stroke (modified Rankin Scale score >3), transplanted or explanted for recovery. The key secondary end-point was mean length of initial hospital stay.RESULTS: The primary end-point was successfully achieved in 88.1% of patients and was significantly greater than the pre-defined performance goal of 77.5% set from historical sternotomy data (p = 0.0012). The key secondary end-point-mean length of initial hospital stay - was 18 days and was significantly shorter than the pre-defined performance goal of 26.1 days obtained from historical sternotomy data (p < 0.0001). The adverse event profile further demonstrated the safety of the thoracotomy approach. The overall patient survival was good, and bleeding requiring reoperation was significantly less frequent than that observed in previous studies using the sternotomy approach.CONCLUSIONS: This prospective clinical trial provides validation that implantation of the HVAD system via the thoracotomy approach used in the LATERAL study represents a safe and effective alternative to median sternotomy in selected patients intended for a bridge-to-transplant indication. (C) Published by Elsevier Inc. on behalf of International Society for Heart and Lung Transplantation. All rights reserved.