In the past few decades, the treatment options for patients with advanced heart failure (HF) have changed dramatically.¹ Since the introduction of (long-term) mechanical circulatory support (MCS), the prognosis and quality of life of these patients have improved significantly. Technological improvements have changed the landscape of left ventricular assist devices (LVADs): the first-generation pulsatile pumps were large devices that were implanted in the abdomen and the second-generation pumps (axial-flow pumps) were smaller devices implanted within the thorax, more suitable for long-term support. In the most recent decade the third-generation centrifugal continuous-flow LVADs have dominated the field of durable MCS: the HeartWare VAD (HVAD, Medtronic, Minneapolis, MN, USA) with hydro-magnetic (hybrid) levitation and the HeartMate 3 (HM3, Abbott Labs, Chicago, IL, USA) with full magnetic levitation. In large studies, these devices have demonstrated superior survival free from disabling stroke or reoperation to replace a malfunctioning device, compared with second-generation pumps.^2-4

Both HVAD and HM3 have been approved for long-term support in advanced HF patients as a bridge to transplantation option and for those patients ineligible to transplantation as ‘destination therapy’. However, in the past few years, the amount of de novo HM3 implants have outnumbered the HVAD implants.⁵ Recently, two observational studies from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) and the European Registry for Patients on Mechanical Circulatory Support (EUROMACS) have described worse outcomes for HVAD vs. HM3 implanted patients.^{6, 7} In addition, in 2020 Medtronic issued a Safety Notice regarding the HVAD related to a delayed or even failure to restart the LVAD after controller exchange. These factors may have led to the decision of Medtronic to stop the global production and distribution of the HVAD on 3 June 2021.⁸

In this viewpoint, we would like to shed light on the outcome data that preceded this decision and address the consequences and challenges it poses to our patients and their health care providers.

在过去的几十年中，晚期心力衰竭 (HF) 患者的治疗选择发生了巨大变化。¹自引入（长期）机械循环支持（MCS）以来，这些患者的预后和生活质量已显着改善。技术进步改变了左心室辅助装置 (LVAD) 的格局：第一代脉动泵是植入腹部的大型装置，第二代泵（轴流泵）是植入胸腔内的较小装置，更适合长期支持。在最近十年中，第三代离心式连续流动 LVAD 主导了耐用 MCS 领域：具有水磁（混合）悬浮的 HeartWare VAD（HVAD，Medtronic，明尼阿波利斯，明尼苏达州，美国）和 HeartMate 3 (HM3 ，雅培实验室，芝加哥，伊利诺伊州，美国）全磁悬浮。在大型研究中，^2-4

HVAD 和 HM3 均已被批准用于晚期 HF 患者的长期支持，作为移植选择的桥梁，以及那些不适合作为“目标治疗”移植的患者。然而，在过去几年中，从头HM3 植入物的数量已经超过了 HVAD 植入物。⁵最近，机械辅助循环支持机构间登记处 (INTERMACS) 和欧洲机械循环支持患者登记处 (EUROMACS) 的两项观察性研究描述了 HVAD 与 HM3 植入患者的更差结果。^6、7此外，美敦力在 2020 年发布了关于 HVAD 的安全通知，涉及控制器更换后延迟甚至无法重新启动 LVAD。这些因素可能导致美敦力决定于 2021 年 6 月 3 日停止全球生产和分销^HVAD。8

从这个角度来看，我们希望阐明该决定之前的结果数据，并解决它对我们的患者及其医疗保健提供者构成的后果和挑战。