University of Florida, Gainesville, FL, USA.
Innovations (Phila). 2024 Jan-Feb;19(1):46-53. doi: 10.1177/15569845231212157. Epub 2023 Nov 27.
Impella 5.5 (Abiomed, Danvers, MA, USA) is approved by the US Food and Drug Administration (FDA) for mechanical circulatory support for ≤14 days. It is unknown whether prolonged support is associated with worse outcomes. We sought to review our single-center experience with Impella 5.5 and compare outcomes based on support duration.
We retrospectively reviewed adult patients (≥18 years old) supported with Impella 5.5 at our institution (May 2020 to April 2023). Patients on prolonged support (>14 days) were compared with those supported for ≤14 days.
There were 31 patients supported with Impella 5.5 including 14 (45.2%) supported >14 days. Median support duration for those on prolonged support was 43.5 (interquartile range [IQR] 25 to 63.5) days versus 8 (IQR 6, 13) days for those who were not ( < 0.001). Overall, the device-related complication rate was 9.7% and did not differ between groups ( = 0.08). Overall, 30-day postimplant survival was 71% and did not differ by support duration ( = 0.2). In-hospital mortality was 32% and did not differ between cohorts ( > 0.99). Among those surviving to explant ( = 22), long-term strategy included bridge to durable ventricular assist device (18%, = 4), cardiac transplant (55%, = 12), and cardiac recovery (27%, = 6).
High-risk patients with cardiogenic shock may be supported with Impella 5.5 beyond the FDA-approved duration without increased risk of complications or mortality.
Impella 5.5（美国生物梅里埃公司，马萨诸塞州丹弗斯）已获得美国食品和药物管理局（FDA）批准，可用于机械循环支持≤14 天。目前尚不清楚延长支持时间是否会导致更差的结果。我们试图回顾我们在单中心使用 Impella 5.5 的经验，并根据支持时间来比较结果。
我们回顾性分析了我院（2020 年 5 月至 2023 年 4 月）接受 Impella 5.5 支持的成年患者（≥18 岁）。将接受长时间支持（>14 天）的患者与接受≤14 天支持的患者进行比较。
共 31 例患者接受 Impella 5.5 支持，其中 14 例（45.2%）接受支持时间>14 天。接受长时间支持的患者中位支持时间为 43.5（四分位距[IQR]25 至 63.5）天，而未接受长时间支持的患者为 8（IQR 6，13）天（<0.001）。总体而言，器械相关并发症发生率为 9.7%，两组间无差异（=0.08）。总体而言，植入后 30 天存活率为 71%，与支持时间无关（=0.2）。住院死亡率为 32%，两组间无差异（>0.99）。在幸存至撤机的患者中（=22），长期策略包括桥接至耐用性心室辅助装置（18%，=4）、心脏移植（55%，=12）和心脏恢复（27%，=6）。
高危心源性休克患者可在 FDA 批准的时间之外使用 Impella 5.5 进行支持，而不会增加并发症或死亡率的风险。
