Department of Cardiac Surgery, University Hospital Heidelberg, Heidelberg, Germany.
Department of Cardiology, University Heart Centre Zurich, University Hospital Zurich, Zurich, Switzerland.
Clin Res Cardiol. 2018 May;107(5):413-420. doi: 10.1007/s00392-017-1200-4. Epub 2018 Jan 2.
The Berlin Heart EXCOR Adult biventricular assist device (BiVAD) is an approved mechanical circulatory support for patients with end-stage biventricular heart failure. In this prospective post-market clinical follow-up study, we present the first clinical experience of the new EXCOR Adult pump with bileaflet (BL) valves in Europe.
After CE-mark approval in August 2014, a total of 12 patients were enrolled with a mean age of 44 years ± 11 (range 21-58 years). The majority of patients (n = 11) were in INTERMACS level 1 or 2. Eight patients had a median pre-operative extracorporeal life support (ECLS) of 6 days (range 1-37 days). Primary end point was survival, either to heart transplantation (HTx), recovery or alive at 12 months on device, whichever occurred first. Secondary end point was the number of adverse events throughout EXCOR BiVAD support. Median support time up to last follow-up on EXCOR BiVAD device was 248 days (range 57-381 days) and patient survival at 1 year was 92%. Half of the EXCOR BiVAD patients (n = 6) were transplanted and five patients were still on support at 1 year post-implantation. Complications during EXCOR BiVAD support were thoracic bleeding, exit site infection and ischemic cerebrovascular incidents in three cases, respectively.
The new EXCOR Adult pump with BL provides pulsatile high cardiac output with excellent outcome and successful bridging to HTx, particularly in critically ill patients with INTERMACS level 1 or 2 at the time of implantation.
柏林心脏 EXCOR 成人双心室辅助装置（BiVAD）是一种已批准的机械循环支持设备，用于治疗终末期双心室心力衰竭患者。在这项前瞻性上市后临床随访研究中，我们首次报告了欧洲新型带双叶瓣（BL）的 EXCOR 成人泵的临床经验。
在 2014 年 8 月获得 CE 标志批准后，共纳入 12 例患者，平均年龄为 44 岁±11 岁（范围 21-58 岁）。大多数患者（n=11）处于 INTERMACS 1 级或 2 级。8 例患者的术前体外生命支持（ECLS）中位数为 6 天（范围 1-37 天）。主要终点是生存率，即心脏移植（HTx）、恢复或在 12 个月内在设备上存活，以先发生者为准。次要终点是整个 EXCOR BiVAD 支持过程中的不良事件数量。截止到最后一次 EXCOR BiVAD 设备随访的中位支持时间为 248 天（范围 57-381 天），患者 1 年生存率为 92%。一半的 EXCOR BiVAD 患者（n=6）接受了移植，5 例患者在植入后 1 年仍在接受支持。EXCOR BiVAD 支持期间的并发症分别为 3 例患者出现胸壁出血、出口部位感染和缺血性脑血管事件。
新型带 BL 的 EXCOR 成人泵可提供脉动性高心输出量，具有出色的结果，并成功桥接 HTx，特别是在植入时处于 INTERMACS 1 级或 2 级的危重患者中。
