The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience
The HeartWare Ventricular Assist Device (HVAD): A Single Institutional 10-Year Experience
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DOI：
10.1055/s-0042-1742779
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发表时间：
2022-03-02
影响因子：
1.5
通讯作者：
Schramm, Rene
中科院分区：
文献类型：
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作者：
Gyoten, Takayuki;Rojas, Sebastian, V;Schramm, Rene
目标 本研究的目的是分析我们在德国一家大容量心脏中心的真实场景中使用 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 治疗的晚期心力衰竭 (HF) 成人（≥ 18 岁）的结局。主要和次要终点分别是植入后全因死亡和 LVAD 相关并发症。我们将不同的分析重点放在植入时的风险状况和植入策略，即移植桥（BTT）或目标治疗（DT）。结果共纳入 510 名患者，其中机械辅助循环支持机构间登记 (INTERMACS) 1 级 (45%) 和 2 至 4 级分别有 229 名和 281 名患者。中位随访时间为 26 个月（IQR：5-54 个月）。 HVAD 植入后 1 年、3 年和 5 年的总生存率为 66%（95% CI；61.7-70%）、49.4%（95% CI；44.9-53.8%）和 37.4%（95% CI；32.8-42%），未针对 LVAD 交换、LVAD 外植或心脏移植进行审查。 INTERMACS 1 级和围手术期临时右心辅助是生存的独立危险因素。在随访期间的任何时间接受心脏移植的 BTT 患者的生存率最高。 HVAD 植入时的 INTERMACS 水平不影响心脏移植后的存活率。植入后 1 年，未发生任何与装置相关的严重并发症和死亡的综合终点为 44.5%（95% CI；40-48.8%）。结论 HVAD 是一种可靠的泵，即使对于高危患者也能提供持久的机械循环支持。尽管如此，心脏移植在长期生存方面仍优于持久的 MCS 疗法。
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.