从超过 100 例连续的 HeartMate II 左心室辅助装置中获得的经验教训。
Lessons learned from experience with over 100 consecutive HeartMate II left ventricular assist devices.
机构信息
Division of Cardiothoracic Surgery, University of Minnesota, 420 Delaware St SE, MMC 207, Minneapolis, MN 55455, USA.
出版信息
Ann Thorac Surg. 2011 Nov;92(5):1593-9; discussion 1599-600. doi: 10.1016/j.athoracsur.2011.06.081. Epub 2011 Oct 31.
BACKGROUND
Continuous-flow left ventricular assist devices (LVADs) such as the HeartMate II have become the therapy of choice in patients with end-stage heart failure. The aim of this study is to report the outcomes in patients receiving the HeartMate II LVAD at a single center and review the lessons learned from this experience.
METHODS
From June 2005 to June 2010, 130 consecutive patients received the HeartMate II LVAD. Of these, 102 were bridge-to-transplant (BTT), 17 destination therapy, and 11 exchanges for failed HeartMate XVE. This study focuses on the 102 BTT patients. The HeartMate II was approved by the US Food and Drug Administration (FDA) as BTT in April 2008 and 64 patients received this device as BTT since that date. We review our experience with the device as BTT and report on patient survival and adverse events as well as the impact of FDA approval on outcomes.
RESULTS
Overall, mean age was 52.6 ± 12.8 years; 26 (25.5%) were female. Disease etiology was ischemic in 58, nonischemic in 36, and other in 8. Overall, 30-day, 6-month, and 1-year survival for the BTT patients was 95.1%, 83.5%, and 78.8%, respectively. The 6-month survival in 38 patients in the clinical trial (pre-FDA) was 88.8% and was not statistically significant compared with the 76.2% 6-month survival in the 64 patients in the post-FDA approval period (p value = 0.1). Major adverse events among the 102 BTT patients included right ventricular failure in 5 (4.9%), LVAD driveline infections in 25 (24.5%), neurologic events in 10 (9.8%), and gastrointestinal bleeding in 18 (17.6%) patients. In addition, 1 patient (0.98%) had pump thrombus requiring device replacement.
CONCLUSIONS
Despite significant morbidity, use of the HeartMate II LVAD as BTT provides excellent hemodynamic support and is associated with excellent survival and low mortality. In addition, there needs to be improvement and focused strategies in the areas of gastrointestinal bleeding, driveline infections, and adverse neurologic events for these devices to be able to provide a real long-term alternative to heart transplantation.
背景
连续流动左心室辅助装置（LVAD），如 HeartMate II，已成为终末期心力衰竭患者的首选治疗方法。本研究旨在报告在单一中心接受 HeartMate II LVAD 治疗的患者的结局，并回顾从该经验中吸取的教训。
方法
从 2005 年 6 月至 2010 年 6 月，130 例连续患者接受了 HeartMate II LVAD。其中，102 例为桥接移植（BTT），17 例为终末期心力衰竭治疗，11 例为 HeartMate XVE 失败后的交换。本研究重点关注 102 例 BTT 患者。HeartMate II 于 2008 年 4 月获得美国食品和药物管理局（FDA）的 BTT 批准，此后有 64 例患者接受了该设备作为 BTT。我们回顾了该设备作为 BTT 的使用经验，并报告了患者的存活率和不良事件，以及 FDA 批准对结局的影响。
结果
总体而言，平均年龄为 52.6±12.8 岁；26 例（25.5%）为女性。病因在缺血性 58 例，非缺血性 36 例，其他 8 例。总的来说，BTT 患者的 30 天、6 个月和 1 年存活率分别为 95.1%、83.5%和 78.8%。临床试验（FDA 前）中 38 例患者的 6 个月存活率为 88.8%，与 FDA 批准后 64 例患者的 76.2%6 个月存活率相比，无统计学意义（p 值=0.1）。102 例 BTT 患者的主要不良事件包括 5 例（4.9%）右心室衰竭、25 例（24.5%）LVAD 驱动线感染、10 例（9.8%）神经事件和 18 例（17.6%）胃肠道出血。此外，1 例（0.98%）患者因泵血栓形成需要更换装置。
结论
尽管存在显著的发病率，但使用 HeartMate II LVAD 作为 BTT 可提供出色的血液动力学支持，与出色的存活率和低死亡率相关。此外，这些设备在胃肠道出血、驱动线感染和不良神经事件方面需要改进和有针对性的策略，以便能够为心脏移植提供真正的长期替代方案。
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