Clinical Experience With a Novel Percutaneous LV Assist Device in High-Risk PCI: Primary Results From the SUPPORT I Study.

BACKGROUND

An early feasibility study was conducted to evaluate the performance of a low-profile, microaxial percutaneous ventricular assist device (pVAD; Supira Medical, Los Gatos, CA) capable of up to 5.5 L/min flow to provide hemodynamic support in high-risk percutaneous intervention (PCI).

METHODS

A prospective, single-arm feasibility study using the Supira pVAD in high-risk PCI was performed at 4 centers in the United States. The primary feasibility end point was defined as successful initiation and maintenance of hemodynamic support without sustained hypotension or need for alternative mechanical circulatory support. The primary safety end point was the occurrence of major device-related adverse events attributed to the study device or procedure from the time of device insertion to removal.

RESULTS

Fifteen patients underwent elective high-risk PCI with hemodynamic support using the Supira pVAD system. Multivessel PCI was performed in 80% of cases, including unprotected left main revascularization (67%) and atherectomy and intravascular lithotripsy (60%). Technical and procedural success rates were 93.3% and 86.7%, respectively. The primary feasibility end point was achieved in all 15 patients (100%). The primary safety end point occurred in 1 patient (6.7%). By 90 days, there were 2 deaths unrelated to the study device. There were no bleeding events, vascular/limb complications requiring intervention, cardiac structural/valve injury, or stroke attributed to the study device.

CONCLUSIONS

As an early feasibility study, treatment with the Supira pVAD demonstrated favorable performance and device-related safety. These findings add to existing experience with the Supira pVAD to support a forthcoming pivotal trial in high-risk PCI.

REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06087575.