Rutgers University-Robert Wood Johnson Medical School, New Brunswick, NJ, USA.
, New Brunswick, USA.
J Cardiothorac Surg. 2022 May 23;17(1):124. doi: 10.1186/s13019-022-01871-1.
The Impella 5.5® was approved by the FDA for use for mechanical circulatory support up to 14 days in late 2019 at limited centers in the United States. Our single center's experience with Impella 5.5® can expand the overall understanding for achieving successful patient outcomes as well as provide support for the expansion of its FDA-approved use.
This study is an IRB-approved single-center retrospective cohort analysis of hospitalized adult patient characteristics and outcomes in cases where the Impella 5.5® was utilized for mechanical circulatory support.
A total of 26 implanted Impella 5.5® devices were identified in 24 hospitalized patients at our institution from January 2020 to January 2021. The overall survival rate during index hospitalization was 75%. Eleven Impella 5.5® devices were identified in 10 patients with an average device implantation greater than 14 days. Average device implantation for this subgroup was 27 days with a range of 15-80 days. Survival rate for Impella 5.5® use greater than 14 days was 67%. In the entire cohort and subgroup of device implantation > 14 days, evidence of end organ damage improved with Impella 5.5® use. Complications in our cohort and subgroup of device implantation > 14 days were similar to previously reported complication incidence of axillary inserted LVAD devices.
Our institution's experience with the Impella 5.5® has been strongly positive with favorable outcomes and helps to establish the Impella 5.5® as a viable option for mechanical circulatory support beyond 14 days.
Impella 5.5® 于 2019 年末在美国有限的中心获得 FDA 批准,用于机械循环支持长达 14 天。我们单中心的 Impella 5.5® 使用经验可以扩大对实现成功患者结果的整体理解,并为其 FDA 批准用途的扩展提供支持。
这项研究是一项经过机构审查委员会批准的单中心回顾性队列分析,研究对象为在我们机构接受 Impella 5.5® 机械循环支持的住院成年患者的特征和结局。
在我们机构,从 2020 年 1 月至 2021 年 1 月,共确定了 24 名住院患者的 26 个植入的 Impella 5.5® 设备。指数住院期间的总生存率为 75%。在 10 名患者中发现了 11 个 Impella 5.5® 设备,平均设备植入时间超过 14 天。该亚组的平均设备植入时间为 27 天,范围为 15-80 天。超过 14 天使用 Impella 5.5® 的生存率为 67%。在整个队列和设备植入时间超过 14 天的亚组中,Impella 5.5® 的使用改善了终末器官损伤的证据。我们队列和设备植入时间超过 14 天的亚组中的并发症与以前报道的腋插入 LVAD 设备的并发症发生率相似。
我们机构对 Impella 5.5® 的经验非常积极,结果良好,并有助于确立 Impella 5.5® 作为超过 14 天机械循环支持的可行选择。