重新考虑FDA指导方针:长期Impella 5.5支持的单一中心经验
Carlos Alberto Valdes1, Griffin Stinson1, Omar M Sharaf1
1University of Florida, Gainesville, FL, USA.
Innovations (Philadelphia, Pa.)
|November 28, 2023
概括
长期使用Impella 5.5机械循环支超过14天,不会增加高风险患者的并发症或死亡率. 这项研究表明,延长Impella 5.5的支持对于心脏性休克患者来说是安全的.
科学领域:
- 心脏病学和心血管外科
- 医疗器械技术 医疗器械技术
- 临界护理医学 临界护理医学
背景情况:
- 伊佩拉5.5设备是FDA批准的机械循环支持长达14天.
- 与超过批准持续时间的Impella 5.5支持相关的安全性和结果尚未得到充分确立.
- 了解长期机械循环支持的风险对于管理高风险心脏病患者至关重要.
研究的目的:
- 评估Impella 5.5机械循环支持在需要超过FDA批准的14天限制的患者的治疗结果.
- 为了比较短期 (≤14天) 与长期 (>14天) 治疗的患者之间的设备相关并发症和死亡率,Impella 5.5支持.
- 在现实临床环境中评估扩展Impella 5.5使用的安全性.
主要方法:
- 在2020年5月至2023年4月期间接受Impella 5.5支持的成年患者 (≥18岁) 的回顾性评估.
- 患者被分为两组:长期支持 (>14天) 和标准支持 (≤14天).
- 分析的结果包括与设备相关的并发症,植入后30天的存活率和住院死亡率.
主要成果:
- 在31名患者中,14名 (45.2%) 接受了长时间的支持 (中位数为43.5天),而标准组的支持时间为8天 (P < 0.001).
- 设备相关并发症率 (9.7%) 和30天生存率 (71%) 在两组之间没有显著差异 (分别P=0.08和P=0.2).
- 住院死亡率为32%,并没有基于支持持续时间 (P>0.99) 的差异. 长期战略包括桥梁到VAD,移植或恢复.
结论:
- 患有心脏性休克的高风险患者可以在FDA批准的14天持续时间之外使用Impella 5.5.
- 延长Impella 5.5支持似乎与并发症或死亡风险的增加无关.
- 这一发现支持在选择的重症心脏病患者中明智地使用长期的机械循环支持.
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