Department of Heart and Lung, University Medical Center, Utrecht, The Netherlands.
Eur J Cardiothorac Surg. 2010 Feb;37(2):357-61. doi: 10.1016/j.ejcts.2009.05.043. Epub 2009 Jul 18.
The HeartMate II (HM II) LVAD is a small, quiet, continuous-flow, left ventricular assist device (LVAD) for circulatory support in advanced heart-failure patients, with over 2000 implants worldwide. This article reports on the European experience with this device.
The HM II was implanted in 571 patients at 64 European institutions. In 72% of cases (411 patients), implantation has taken place at least 6 months before the closing date of the study (1 August 2008). Patients (19% female, 70% ischaemic aetiology) were on maximum medical therapy, including inotropic support. Body surface area ranged from 1.30 to 2.50 m(2) and age from 14 to 75 years (mean: 51+/-14 years; n=115, 28% over age 60 years). The intention of support was to provide a bridge to transplantation (73%), destination therapy (21%) and a bridge to recovery (6%). Adverse events were documented in the first 53 patients - for obtaining the Conformité Européenne (CE) Mark (group A) - from a European multicentric study (Strüber et al. [Strüber M, Sander K, Lahpor J, Ahn H, Litzler P-Y, Drakos SG, Musumeci F, Schlensak C, Friedrich I, Gustafsson R, Oertel F, Leprince P. HeartMate II left ventricular assist device; early European experience. Eur J Cardiovasc Surg 2008;34(2):289-94.]: 101 patients) and from a single-centre study (UMCU, The Netherlands: 30 patients).
The mean support duration ranged from 0 to 1019 days with a mean of 236+/-214 days (249 patients: >6 months, 119: 1 year, 12: >2 years; total support time: 293 years). The overall survival to transplantation, recovery or ongoing device support at the end of the study was 69% (284) with an early mortality of 17.5% and late mortality of 13.5%. Of the surviving patients, 23% have been transplanted, 4% had their device removed after recovery of the left ventricle and 42% are still ongoing. Adverse events included bleeding (ranging from 42% in group C to 59% in group A), percutaneous lead infections (A: 0.19, B: 0.61 and C: 0.18 events per patient year), pocket infections (A: 0.08, B: 0.07 and C: 0.09 events per patient year), ischaemic stroke (A: 0.06, B: 0.09 and C: 0.04 events per patient year), haemorrhagic stroke (B: 0.07, C: 0.04 events per patient year) and transient ischaemic attacks (TIAs; A: 0.08, B: 0.02 and C: 0.13 events per patient year).
These results support the use of the HM II continuous-flow LVAD for long-term support as a bridge to transplantation and possibly for destination therapy. Future emphasis should focus on minimising adverse events such as infections, bleeding and neurological events.
HeartMate II（HM II）左心室辅助装置（LVAD）是一种小型、静音、连续流的 LVAD，用于为晚期心力衰竭患者提供循环支持，目前全球已有超过 2000 例植入。本文报告了该设备在欧洲的使用经验。
在 64 家欧洲机构中，571 例患者植入了 HM II。在 72%的病例中（411 例），在研究截止日期（2008 年 8 月 1 日）至少 6 个月前进行了植入。患者（19%为女性，70%为缺血性病因）接受了最大的药物治疗，包括正性肌力支持。体表面积为 1.30 至 2.50m²，年龄为 14 至 75 岁（平均：51+/-14 岁；n=115，28%年龄超过 60 岁）。支持的目的是为移植（73%）、终末期治疗（21%）和恢复（6%）提供桥接。在 53 例患者（获得 CE 标志的第一组 A）中记录了不良事件，这是从一项欧洲多中心研究（Strüber 等人[Strüber M、Sander K、Lahpor J、Ahn H、Litzler P-Y、Drakos SG、Musumeci F、Schlensak C、Friedrich I、Gustafsson R、Oertel F、Leprince P. HeartMate II 左心室辅助装置；早期欧洲经验。欧洲心血管外科学杂志 2008；34（2）：289-94.）和一项单中心研究（荷兰 UMCU：30 例患者）中获得的。
平均支持时间从 0 至 1019 天，平均 236+/-214 天（249 例：>6 个月，119 例：1 年，12 例：>2 年；总支持时间：293 年）。研究结束时，移植、恢复或继续设备支持的总体存活率为 69%（284 例），早期死亡率为 17.5%，晚期死亡率为 13.5%。存活患者中，23%已接受移植，4%在左心室恢复后取出设备，42%仍在继续。不良事件包括出血（C 组为 42%，A 组为 59%）、经皮导线感染（A 组：0.19，B 组：0.61，C 组：0.18 例/患者年）、口袋感染（A 组：0.08，B 组：0.07，C 组：0.09 例/患者年）、缺血性中风（A 组：0.06，B 组：0.09，C 组：0.04 例/患者年）、出血性中风（B 组：0.07，C 组：0.04 例/患者年）和短暂性脑缺血发作（TIA；A 组：0.08，B 组：0.02，C 组：0.13 例/患者年）。
这些结果支持 HM II 连续流 LVAD 用于移植桥接和可能的终末期治疗的长期支持。未来应重点关注减少感染、出血和神经事件等不良事件。
