Early Feasibility Study of a Novel Mechanical Circulatory Support Device for High-Risk PCI

Mechanical circulatory support (MCS) devices provide hemodynamic stability during high-risk percutaneous coronary interventions (HR-PCI), potentially reducing the incidence of adverse events and permitting more complete revascularization.1,2 According to clinical guidelines in the United States, MCS is recommended during PCI for selected high-risk patients undergoing coronary artery revascularization (class IIb, level of evidence B).3 Current MCS devices have limitations related to device migration, hemolysis, and access site vascular and bleeding complications. The CHIP-BCIS3 trial (N=300) found that routine Impella CP use during complex high-risk PCI in patients with severe left ventricular dysfunction did not improve composite outcomes over 22 months (win ratio, 0.85 [95% CI, 0.63–1.15]; P=0.30) compared with standard care, and showed a trend toward higher mortality and periprocedural injury, highlighting the need for optimized MCS-supported PCI options.4