Farhat Kassem, Pollanen Sara, Damrongwatanasuk Rongras, DiChiacchio Laura, Salerno Colby, Sikand Nikhil, Khalife Wissam I, Hu Jiun-Ruey
Department of Internal Medicine, Yale School of Medicine, Yale University, New Haven, CT 06510, USA.
Temerty Faculty of Medicine, University of Toronto, Toronto, ON M5S 3K3, Canada.
Biomedicines. 2025 Sep 8;13(9):2198. doi: 10.3390/biomedicines13092198.
The microaxial flow pump (mAFP) is a mechanical circulatory support device designed to directly unload the left ventricle, restore cardiac output, and improve systemic perfusion in the setting of cardiogenic shock (CS). CS is a devastating complication of acute myocardial infarction (AMI) and advanced heart failure, characterized by systemic hypoperfusion and myocardial dysfunction, carrying an in-hospital mortality of 30-50%. However, there has been controversy about whether these theoretical physiological mechanisms behind mAFP translate into actual survival or recovery in this patient population that has historically been difficult to study in prospective trials. The lack of consensus has resulted in differing national guidelines, resource allocation, and clinical decision-making in time-sensitive clinical scenarios. Earlier studies were limited to retrospective analyses and a single small, underpowered randomized trial, none of which showed a mortality benefit. In 2024, the DanGer Shock trial emerged as the first multi-center trial to demonstrate mortality benefit in patients with STEMI complicated by CS treated with Impella CP, albeit at the cost of increased risk of major bleeding, hemolysis, and vascular complications, an effect sustained in the 10 year outcomes published in 2025. In this review, we examine reasons for the differing results of preceding studies and compare how multinational guidelines have reacted to this new evidence. Finally, we provide practical considerations regarding the use, complications, and troubleshooting of this technology, and identify gaps in evidence regarding patient selection and timing of placement.
微轴流泵(mAFP)是一种机械循环支持装置,旨在直接减轻左心室负荷、恢复心输出量并改善心源性休克(CS)患者的全身灌注。CS是急性心肌梗死(AMI)和晚期心力衰竭的一种严重并发症,其特征为全身灌注不足和心肌功能障碍,住院死亡率为30%-50%。然而,mAFP背后的这些理论生理机制是否能转化为该患者群体的实际生存或康复,一直存在争议,而该患者群体历来难以在前瞻性试验中进行研究。缺乏共识导致在时间敏感的临床场景中,各国指南、资源分配和临床决策存在差异。早期研究仅限于回顾性分析和一项规模小、效力不足的单一随机试验,这些研究均未显示出死亡率获益。2024年,DanGer Shock试验成为首个多中心试验,证明使用Impella CP治疗的STEMI合并CS患者有死亡率获益,尽管代价是大出血、溶血和血管并发症风险增加,这一效果在2025年发表的10年结果中得到持续。在本综述中,我们研究了先前研究结果不同的原因,并比较了多国指南对这一新证据的反应。最后,我们提供了关于该技术的使用、并发症及故障排除的实际考虑因素,并确定了在患者选择和植入时机方面的证据空白。