Safety and Feasibility of the Supira System in High-Risk Percutaneous Coronary Interventions: 30-Day Results from the US SUPPORT I Early Feasibility Study (EFS)
Presenter
David E. Kandzari, M.D., MSCAI, Piedmont Heart Institute, Atlanta, GA
David E. Kandzari, M.D., MSCAI1, Andrea Mignatti, M.D.2, Annapoorna S. Kini, M.D.3, Alexandre Abizaid, M.D.4, Ricardo Campos, MD, PhD5, Gagan Singh, M.D., FSCAI6, Azeem Latib, M.D.7, Garrett B. Wong, M.D., FSCAI6 and Ricardo A. Costa, M.D., Ph.D.4, (1)Piedmont Heart Institute, Atlanta, GA, (2)Montefiore Health System, Bronx, NY, (3)Mount Sinai Hospital, New York, NY, (4)Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, (5)Dante Pazzanese Institute of Cardiology, São Paulo, São Paulo, Brazil, (6)UC Davis Medical Center, Sacramento, CA, (7)Montefiore Medical Center, Bronx, NY
Keywords: Cardiogenic Shock, Chronic Total Occlusion (CTO), Complex and High-risk Coronary Intervention (CHIP) and Hemodynamic Support
Background:
Percutaneous ventricular assist devices (pVADs) support high-risk percutaneous coronary intervention (HRPCI) in patients with advanced coronary artery disease, complex comorbidities, and left ventricular dysfunction. Current large bore pVAD catheters are limited by extent of circulatory support, major bleeding and vascular complications. The small access, high flow (5.5 L/min) Supira System pVAD (Supira Medical, Inc.) is designed to provide temporary (≤4 hours) hemodynamic support in HRPCI. To further examine the safety and efficacy with this device in HRPCI, a prospective, single-arm, multicenter early feasibility study was conducted at four sites in the United States.
Methods:
Eligibility for HRPCI with the Supira System was assessed by the sites’ Heart Team and the study Patient Selection Committee. An independent Clinical Event Committee and Data Safety Monitoring Board provided oversight per respective charters. The primary feasibility endpoint is successful initiation and maintenance of hemodynamic support without sustained hypotension. The primary safety endpoint is the rate of composite major device-related adverse events from device insertion through removal.
Results:
Fifteen patients were treated between Nov. 2024 and Jan. 2025 with ongoing data collection at 30- and 90-day post-procedure follow-up. Baseline characteristics included: mean age, 72 years; male, 74%; prior myocardial infarction, 60%; class III/IV heart failure, 26.6%; and mean left ventricular ejection fraction, 46%. PCI was successfully completed for all participants with one major device-related adverse event (arrhythmia) that resolved by the end of the procedure. The mean duration of PCI and Supira System support was 103 and 109 minutes, respectively, with no sustained hypotension requiring inotropes or alternative mechanical circulatory support. In-hospital outcomes included 1 death and 2 BARC
>3 bleeding events.
Conclusions:
In a US early feasibility study, HRPCI with the Supira pVAD was associated with favorable safety and performance. These findings encourage further clinical study with this lower profile, high flow pVAD that may offer meaningful advantages over current-generation devices.