Complex high-risk patients, especially those with impaired left ventricular systolic function and anatomically challenging coronary artery disease, continue to represent a major challenge in interventional cardiology. Although guideline-supported mechanical circulatory support devices such as Impella are available for use during high-risk percutaneous coronary intervention (PCI), their clinical utility is often limited by cost and complications such as hemolysis. CorVad is a novel axial flow percutaneous ventricular assist system featuring a dual-motor configuration designed to deliver efficient and stable hemodynamic support with favorable hemocompatibility.

To evaluate the safety and efficacy of the CorVad system in patients undergoing complex high-risk PCI, and to compare clinical outcomes with a propensity score–matched historical cohort of patients treated with coronary artery bypass grafting (CABG).

This prospective, multicenter, single-arm clinical study was conducted across 10 high-volume interventional cardiology centers. A total of 118 patients with a left ventricular ejection fraction (LVEF) ?40%, at least one complex coronary lesion, and a high risk of circulatory collapse were enrolled. Complex lesion characteristics included bifurcation lesions (71.2%), chronic total occlusions (53.4%), severely calcified lesions (36.4%), and left main coronary artery disease (27.1%). A two-stent strategy was employed in 15.3% of cases. The primary endpoint was the 30-day incidence of all-cause death, new myocardial infarction, stroke, and target lesion revascularization (TLR). Secondary endpoints included periprocedural hemodynamic performance, changes in LVEF, and safety outcomes such as bleeding, hemolysis, vascular complications, and device-related adverse events. Clinical results were compared to a propensity score–matched historical cohort of CABG patients (n=79).

The 30-day MACCE rate in the CorVad-assisted PCI group was 4.2%, including 3.4% all-cause mortality and 1.7% stroke. No new myocardial infarctions or target lesion revascularizations were observed. The use of CorVad provided significant hemodynamic stabilization during PCI, evidenced by increases in systolic and mean arterial pressure and a reduction in the need for vasoactive agents. The device also facilitated more complete coronary revascularization, with a marked reduction in SYNTAX score post-procedure (baseline: 30.7 ± 10.4; residual: 9.6 ± 8.2; △SYNTAX: 21.0 ± 9.4). The safety profile was favorable, with no device malfunctions or clinically significant hemolysis. Vascular complications and bleeding events occurred in 1.7% and 3.4% of cases, respectively. Echocardiographic assessment demonstrated a significant improvement in LVEF, increasing from 30.9% at baseline to 39.8% at 30 days (p<0.001). Compared with the matched CABG cohort, CorVad-assisted PCI showed similar 30-day event rates and a significantly lower incidence of acute kidney injury (10.1% vs. 45.6%, p<0.001).

CorVad-assisted PCI appears to be a safe and effective revascularization strategy in patients with complex coronary anatomy and reduced left ventricular function who are at high risk for hemodynamic compromise. The system provided reliable intraprocedural circulatory support, enabled more complete revascularization, and was associated with favorable early outcomes. These findings support CorVad as a viable percutaneous alternative to surgical revascularization in appropriately selected high-risk patients.

This study offers valuable early evidence supporting the use of the CorVad percutaneous ventricular assist system in a particularly vulnerable and therapeutically challenging patient population. By enrolling individuals with severely depressed left ventricular function and complex coronary anatomy—including high rates of calcification, chronic total occlusion, and left main involvement—the investigators addressed a real-world subset often excluded from randomized trials. The low rate of adverse events, combined with hemodynamic stabilization, improved procedural completeness, and favorable renal outcomes, reinforces the potential of CorVad as a practical and safe alternative to surgical revascularization in high-risk patients. Although limited by its single-arm design and short-term follow-up, the findings justify future randomized controlled trials to further define the role of CorVad in contemporary high-risk PCI strategies.