The effectiveness and safety of the Impella ventricular assist device for high‐risk percutaneous coronary interventions: A systematic review

Background Small randomized controlled trials (RCTs) and observational studies have examined the effectiveness and safety of the Impella device, a percutaneous left ventricular assist device, in the setting of high‐risk percutaneous coronary intervention (PCI). However, data are sparse and results are conflicting. Our objective was to evaluate the effectiveness and safety of the Impella device in high‐risk patients undergoing PCI via a systematic review of the literature. Methods We searched Medline, EMBASE, and the Cochrane Library for RCTs and observational studies that evaluated the Impella device in high‐risk patients undergoing PCI. Inclusion was restricted to studies in which ≥10 patients received the Impella device; both uncontrolled and controlled (versus intra‐aortic‐balloon pump [IABP]) studies were included. Results A total of 20 studies (4 RCTs, 2 controlled observational studies, and 14 uncontrolled observational studies; 1,287 patients) were included, with follow‐up ranging from 1 to 42 months. The use of Impella resulted in improved procedural and hemodynamic characteristics in controlled and uncontrolled studies. In controlled studies, the 30‐day rates of all‐cause mortality and MACE were similar across groups. In most uncontrolled studies, the 30‐day rates of all‐cause mortality were generally low (range: 3.7%–10%), though rates of MACE were slightly higher (range: 5%–20%). Conclusion The Impella device was found to improve procedural and hemodynamic parameters, but only limited randomized data are available regarding clinical outcomes associated with its use. Large, multicenter RCTs are needed to definitively establish the effectiveness of the Impella device among high‐risk PCI patients.