Negro Antonella, Pecoraro Valentina, Camerlingo Maria Domenica, Maltoni Susanna
Agenzia Sanitaria e Sociale Regionale - Regione Emilia-Romagna, Bologna.
G Ital Cardiol (Rome). 2020 Feb;21(2):128-137. doi: 10.1714/3300.32706.
Percutaneous ventricular assist devices (pVADs) are frequently used for the treatment of patients with cardiogenic shock (CS) due to acute myocardial infarction (AMI) and as a support in percutaneous coronary intervention (PCI) for high-risk patients. CS is a clinical condition characterized by inadequate tissue perfusion due to cardiac dysfunction and for 80% of cases it is caused by AMI with left ventricular insufficiency. CS is responsible for about 50% of deaths in patients with myocardial infarction. Usually, PCIs do not require hemodynamic support, which could be however necessary in patients undergoing high-risk PCI. Presently, available pVADs in Europe are Impella 2.5, Impella CP, HeartMate PHP, TandemHeart, PulseCath iVAC2L. The aim of this review is to evaluate the efficacy and safety of pVADs in patients with refractory CS complicating AMI or undergoing high-risk PCI.
We systematically searched for randomized controlled trials (RCTs) and controlled observational studies in PubMed, Embase and PubMed CENTRAL databases until September 2018. We included studies comparing pVADs with intra-aortic balloon pumps (IABP) or medical therapy in patients with CS complicating AMI or undergoing high-risk PCI. Researchers independently assessed records' eligibility, inclusion and methodological quality of included studies. If possible, data of included studies was combined in a meta-analysis. Risk ratio (RR) and 95% confidence interval (CI) were calculated using a random effects model.
Overall, 8 studies were included. Five studies (3 RCTs and 2 observational studies) evaluated pVADs in patients with SC complicating AMI. Meta-analyses showed that 30-day mortality did not differ between patients treated with pVADs and the control group (RR 1.05, 95% CI 0.84-1.31). However, risk of major bleeding was 2 times higher in patients treated with pVADs compared to controls. Three studies evaluated pVADs in patients undergoing high-risk PCI. Due to the lack of data, it was not possible to combine study results in a meta-analysis. One RCT reported no difference in 30- and 90-day mortality between patients randomized to Impella or IABP. Two non-randomized controlled studies reported no difference in terms of in-hospital all-cause mortality between the two groups.
Our meta-analysis suggests similar results in terms of efficacy and safety between pVADs and control (IABP and medical therapy) for the treatment of patients with CS complicating AMI or undergoing high-risk PCI.
经皮心室辅助装置（pVADs）常用于治疗因急性心肌梗死（AMI）导致的心源性休克（CS）患者，以及作为高危患者经皮冠状动脉介入治疗（PCI）中的一种支持手段。CS是一种临床状况，其特征是由于心脏功能障碍导致组织灌注不足，80%的病例由伴有左心室功能不全的AMI引起。CS导致心肌梗死患者约50%的死亡。通常，PCI不需要血流动力学支持，但在进行高危PCI的患者中可能有必要。目前，欧洲可用的pVADs有Impella 2.5、Impella CP、HeartMate PHP、TandemHeart、PulseCath iVAC2L。本综述的目的是评估pVADs在并发AMI的难治性CS患者或进行高危PCI患者中的疗效和安全性。
我们在PubMed、Embase和PubMed CENTRAL数据库中系统检索截至2018年9月的随机对照试验（RCTs）和对照观察性研究。我们纳入了比较pVADs与主动脉内球囊反搏（IABP）或药物治疗在并发AMI的CS患者或进行高危PCI患者中的研究。研究人员独立评估纳入研究的记录的合格性、纳入情况和方法学质量。如果可能，将纳入研究的数据合并进行荟萃分析。使用随机效应模型计算风险比（RR）和95%置信区间（CI）。
总体上，纳入了8项研究。5项研究（3项RCT和2项观察性研究）评估了pVADs在并发AMI的CS患者中的应用。荟萃分析表明，接受pVADs治疗的患者与对照组在30天死亡率上没有差异（RR 1.05，95% CI 0·84 - 1.31）。然而，接受pVADs治疗的患者发生大出血的风险是对照组的2倍。3项研究评估了pVADs在进行高危PCI患者中的应用。由于缺乏数据，无法将研究结果合并进行荟萃分析。一项RCT报告，随机分配至Impella或IABP的患者在30天和90天死亡率上没有差异。两项非随机对照研究报告两组在院内全因死亡率方面没有差异。
我们的荟萃分析表明，在治疗并发AMI的CS患者或进行高危PCI患者时，pVADs与对照组（IABP和药物治疗）在疗效和安全性方面结果相似。
