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《HeartWare 心室辅助装置(HVAD):单中心 10 年经验》。

The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience.

机构信息

Clinic for Thoracic and Cardiovascular Surgery, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany.

Clinic for Interventional Cardiology, Heart and Diabetes Centre North Rhine Westphalia, Ruhr-University Bochum, University Hospital, Bad Oeynhausen, Germany.

出版信息

Thorac Cardiovasc Surg. 2022 Sep;70(6):482-492. doi: 10.1055/s-0042-1742779. Epub 2022 Mar 2.

Abstract

OBJECTIVES

The aim of this study was to analyze our 10-year experience with the HVAD in a real-world scenario in a high-volume German heart center.

METHODS

We retrospectively analyzed outcomes of adults (≥18 years) with terminal heart failure (HF), who underwent HVAD implantation for durable LVAD therapy in our center between October 2009 and March 2020. Primary and secondary end points were all-cause death after implantation and LVAD-associated complications, respectively. We focused the distinct analyses on risk profiles at the time of implantation and implant strategies, i.e., bridge-to-transplant (BTT) or destination therapy (DT).

RESULTS

A total of 510 patients were included, with 229 and 281 individuals in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1 (45%) and 2 to 4, respectively. Median follow-up was 26 months (IQR: 5-54 months). Overall survival at 1, 3, and 5 years after HVAD implantation was 66% (95% CI; 61.7-70%), 49.4% (95% CI; 44.9-53.8%), and 37.4% (95% CI; 32.8-42%), not censored for LVAD exchange, LVAD explantation, or heart transplantation. INTERMACS level 1 and peri-operative temporary right heart assistance were independent risk factors for survival. Survival was best in BTT patients undergoing heart transplantation at any time during follow-up. The INTERMACS level at time of HVAD implantation did not affect survival after heart transplantation. Freedom from the combined end point of any device-associated severe complication and death was 44.5% (95% CI; 40-48.8%) at 1-year after implantation.

CONCLUSION

The HVAD is a reliable pump for durable mechanical circulatory support even in high-risk patients. Still, heart transplantation outperforms durable MCS therapy for a superior long-term survival.

摘要

目的

本研究旨在分析我们在德国一家大容量心脏中心的真实环境中使用 HVAD 的 10 年经验。

方法

我们回顾性分析了 2009 年 10 月至 2020 年 3 月期间在我们中心接受 HVAD 植入以进行持久 LVAD 治疗的终末期心力衰竭(HF)成人(≥18 岁)的结局。主要和次要终点分别为植入后的全因死亡和与 LVAD 相关的并发症。我们专注于植入时的风险特征和植入策略的具体分析,即桥接移植(BTT)或目的地治疗(DT)。

结果

共纳入 510 例患者,其中 INTERMACS 级别 1(45%)和 2 至 4 级分别为 229 例和 281 例。中位随访时间为 26 个月(IQR:5-54 个月)。HVAD 植入后 1、3 和 5 年的总生存率分别为 66%(95%CI;61.7-70%)、49.4%(95%CI;44.9-53.8%)和 37.4%(95%CI;32.8-42%),未对 LVAD 更换、LVAD 取出或心脏移植进行 censoring。INTERMACS 级别 1 和围手术期临时右心辅助是生存的独立危险因素。在任何随访期间接受心脏移植的 BTT 患者的生存率最佳。HVAD 植入时的 INTERMACS 级别并不影响心脏移植后的生存率。植入后 1 年时无任何设备相关严重并发症和死亡的联合终点发生率为 44.5%(95%CI;40-48.8%)。

结论

即使在高危患者中,HVAD 也是一种可靠的持久机械循环支持泵。尽管如此,心脏移植在长期生存方面仍优于持久的 MCS 治疗。

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