Division of Cardiology, Department of Medical Science, University of Turin, Turin, Italy.
Division of Cardiology, Ospedale San Giovanni Bosco, Turin, Italy.
Catheter Cardiovasc Interv. 2022 Jan 1;99(1):27-36. doi: 10.1002/ccd.29757. Epub 2021 May 24.
Aim of this study is to evaluate short term safety and efficacy of Impella in high risk percutaneous coronary intervention (HR-PCI) population.
While several studies demonstrated the clinical significance of Impella in HR-PCI, few data exist about its impact on short term outcome.
All studies reporting short term outcomes of PCI with any Impella device were included. The primary endpoint was either in-hospital or 30-day mortality, while vascular complications, post-procedural stroke, post-procedural dialysis and bleeding complications were assessed as secondary outcomes.
Nine studies with 7448 patients were included. Median age was 69.5 years old (67-73), with a mean ejection fraction of 29.7% (20%-39%) and a Syntax score of 30.2 (25. 5-33, interquartile [IQR]). Impella 2.5 was the most commonly used axial flow pump used to support these PCIs (88.7%). In-hospital death was observed in 5.09% of patients (95% confidence interval [CI] 3.69-6.49, I = 78%), while vascular complications in 2.53% of patients (1.07-4.00, I = 89%) and post-procedural stroke in 2.77% of patients (0.50-6.05, I = 98%). Major bleeding occurred in 5.98% of patients (3.66-8.31, I = 90%) and post-procedural dialysis in 4.44% of patients (1.50-7.37, I = 93% all CI 93%).
Use of Impella in high risk PCI appears to have an acceptable rate of complication, especially regarding vascular complications and major bleedings.
本研究旨在评估 Impella 在高危经皮冠状动脉介入治疗（HR-PCI）人群中的短期安全性和疗效。
虽然多项研究表明 Impella 在 HR-PCI 中的临床意义，但关于其对短期结局影响的数据较少。
纳入所有报告使用任何 Impella 装置进行 PCI 的短期结局研究。主要终点为住院期间或 30 天死亡率，次要终点为血管并发症、术后卒中、术后透析和出血并发症。
纳入 9 项研究共 7448 例患者。中位年龄为 69.5 岁（67-73 岁），平均射血分数为 29.7%（20%-39%），Syntax 评分 30.2（25.5-33，四分位距 [IQR]）。最常使用的轴向血流泵为 Impella 2.5 以支持这些 PCI（88.7%）。住院期间死亡发生率为 5.09%（95%置信区间 [CI] 3.69-6.49，I ² = 78%），血管并发症发生率为 2.53%（1.07-4.00，I ² = 89%），术后卒中发生率为 2.77%（0.50-6.05，I ² = 98%）。大出血发生率为 5.98%（3.66-8.31，I ² = 90%），术后透析发生率为 4.44%（1.50-7.37，I ² = 93%，所有 CI 均为 93%）。
高危 PCI 中使用 Impella 的并发症发生率似乎可以接受，尤其是血管并发症和大出血。
