LB-4
First-in-human experience with a novel (low profile, high flow) percutaneous ventricular assist device
Presenter
Gagan Singh, M.D., FSCAI, UC Davis Medical Center, Sacramento, CA
Gagan Singh, M.D., FSCAI, UC Davis Medical Center, Sacramento, CA, Azeem Latib, M.D., FSCAI, Montefiore Medical Center, Bronx, NY, Susheel K. Kodali, M.D., NewYork-Presbyterian Columbia University Irving Medical Center, New York, NY and Adrian A Ebner, M.D., Sanitorio Italiano, Asuncion, PY, Paraguay
Keywords: Cardiogenic Shock, Complex and High-risk Coronary Intervention (CHIP) and Hemodynamic Support
Background:
Current FDA approved pVAD devices have large profiles (e.g. > 14Fr) and are associated with high rates of morbidity (e.g. vascular complications). At maximum flow rates (i.e. RPMs), these devices are fraught with high rates of hemolysis. The Supira 10F system was designed and developed to address these limitations.
Methods:
6 patients underwent high risk PCI with the use of a novel Supira 10F system as part of an IRB approved FIH protocol. The device is an expandable axial flow 21 Fr pump in its nominal state and is sheathed to 10Fr for delivery and removal. In its nominal state, the device provides continuous unloading throughout the cardiac cycle. The system is delivered via rapid exchange ("RX") over a pre-established LV rail wire. Once positioned trans-valvular, the guidewire is removed and the axial pump is initiated. PCI was then performed to each of the 6 patients per local practices. Following PCI, the device is removed and hemostasis achieved. The primary outcomes was a composite endpoint of procedural and safety assessment. Procedural success was defined as: safe implantation of device, hemodynamic support during the PCI, and successful withdrawal of the device. Safety assessment was defined as freedom from device-related major adverse events (MAE), including vascular complications (access and central), aortic valve injury, mitral valve injury, and systemic embolization.
Results:
Baseline demographics of the enrolled patients consist of age 58±9 yrs, 83% male, and a BMI 30±2. Comorbid conditions consisted of prior MI (66%), DM (50%), tobacco use (50%) and pulmonary hypertension (50%). The EF ranged from 30-60% with at least 2 vessels treated in 66% of the patients. The device support time ranged from 42 - 96 minutes. Procedural success was 100% and none of the patients in this early series experienced device related adverse events peri-procedurally. There was no early indicators of clinically significant hemolysis.
Conclusions:
Herein we present our initial FIH experience with a novel expandable low profile and high flow Supira 10F system which addresses limitations of current FDA approved devices. In this early experience the device was safe and allowed for successful completion of high risk PCI.