Section of Cardiac Surgery, University of Chicago, Chicago, IL.
Heart Failure and Transplant Unit, St Vincent's Hospital, Sydney, Australia.
Eur J Cardiothorac Surg. 2022 Jun 15;62(1). doi: 10.1093/ejcts/ezac169.
The HeartWare HVAD System (Medtronic) is a durable implantable left ventricular assist device that has been implanted in approximately 20,000 patients worldwide for bridge to transplant and destination therapy indications. In December 2020, Medtronic issued an Urgent Medical Device Communication informing clinicians of a critical device malfunction in which the HVAD may experience a delay or failure to restart after elective or accidental discontinuation of pump operation. Moreover, evolving retrospective comparative effectiveness studies of patients supported with the HVAD demonstrated a significantly higher risk of stroke and all-cause mortality when compared with a newer generation of a commercially available durable left ventricular assist device. Considering the totality of this new information on HVAD performance and the availability of an alternate commercially available device, Medtronic halted the sale and distribution of the HVAD System in June 2021. The decision to remove the HVAD from commercial distribution now requires the use of the HeartMate 3 left ventricular assist system (Abbott, Inc) if a patient previously implanted with an HVAD requires a pump exchange. The goal of this document is to review important differences in the design of the HVAD and HeartMate 3 that are relevant to the medical management of patients supported with these devices, and to assess the technical aspects of an HVAD-to-HeartMate 3 exchange. This document provides the best available evidence that supports best practices. (J Thorac Cardiovasc Surg 2022;-:1-8).
心脏辅助装置（HeartWare HVAD System）是一种耐用型植入式左心室辅助装置，已在全球约 20000 名患者中植入，用于桥接移植和治疗目的。2020 年 12 月，美敦力发布了一项紧急医疗器械通讯，告知临床医生一种关键的设备故障情况，即 HVAD 在电泵运行的选择性或意外中断后可能会出现延迟或重启失败。此外，对接受 HVAD 支持的患者进行的回顾性比较有效性研究表明，与新一代商业上可用的耐用型左心室辅助装置相比，中风和全因死亡率的风险显著增加。考虑到 HVAD 性能的所有新信息以及另一种商业上可用设备的可用性，美敦力于 2021 年 6 月停止了 HVAD 系统的销售和分销。现在，由于 HVAD 从商业供应中撤出，需要使用 HeartMate 3 左心室辅助系统（雅培公司），如果之前植入 HVAD 的患者需要更换泵。本文件的目的是审查 HVAD 和 HeartMate 3 在设计上的重要差异，这些差异与使用这些设备支持的患者的医疗管理相关，并评估 HVAD 到 HeartMate 3 交换的技术方面。本文件提供了支持最佳实践的最佳可用证据。（J 胸心血管外科 2022 年；-：1-8）。
