Efficacy and Safety of the HeartMate Percutaneous Heart Pump During High-Risk Percutaneous Coronary Intervention (from the SHIELD I Trial)

This study aimed to evaluate the use of the HeartMate percutaneous heart pump, a catheter-based axial flow pump designed to provide partial left ventricular support, in patients who underwent high-risk percutaneous coronary intervention (PCI). Patients who are hemodynamically unstable, or at risk of being hemodynamically unstable, while undergoing PCI may require mechanical circulatory support. Fifty high-risk patients were enrolled in a prospective, nonrandomized, multicenter, open-label trial. Primary end points were freedom from hemodynamic compromise during PCI and a composite measure of major adverse events. Patients were followed for 30 days. No patient met the primary performance end point. Six safety end points in 5 patients occurred, including 1 access site complication requiring intervention, 1 cerebrovascular accident, 2 major bleeding complications, and 2 cases of new or worsening aortic insufficiency. No cardiac deaths, myocardial infarctions, or surgical interventions occurred. In conclusion, initial results of the HeartMate percutaneous heart pump for mechanical circulatory support during high-risk PCI are encouraging. Hemodynamic stability was achieved in all patients with a low incidence of adverse events.