143 - AlphaVac F18-85 Thrombectomy Catheter for the Treatment of PE: A Single-Center Retrospective Observational Experience.

Michelle Klueppelberg, MD – Integrated Interventional and Diagnostic Radiology Resident, Indiana University School of Medicine; Sabah Butty, MD – Associate Professor of Clinical Radiology & Imaging Sciences, Interventional Radiology, Indiana University School of Medicine

Purpose: Evaluate pulmonary artery (PA) thrombectomy outcomes utilizing the AlphaVac F18-85 thrombectomy catheter from the current largest single-center case repository since FDA approval 04/01/2024.

Material and Methods: This non-industry sponsored single-center retrospective observational study evaluated consecutive patients who underwent thrombectomy with the AlphaVac F18-85 thrombectomy catheter (AngioDynamics, Latham, New York) from May 2024 to September 2024; patients were excluded if other thrombectomy devices were utilized. Effectiveness was defined by technical success (uncomplicated device access to the pulmonary artery with device, thrombus reduction, and successful removal of the device), mean PA pressure reduction, and clinical improvement. Additional endpoints included procedure time, estimated thrombus volume reduction, estimated procedural blood loss, hospital length of stay, and hemodynamic changes. Adverse events, including major bleeding, major vascular complications, in-hospital mortality, and 30-day mortality, were reported utilizing the SIR AE classification system.

Results: A total of 20 patients treated with the AlphaVac F18-85 thrombectomy catheter were identified. One patient was excluded as another thrombectomy device was utilized. The 19 patients included in the study had a mean age of 65.3-years-old [33-94]. Two massive and 17 submassive PE patients were treated. Technical success was achieved in 100% of patients. Mean PA pressure reduction was 4 mmHg from 31 +/- 8 to 27 +/- 6 mmHg (p < 0.005). Clinical improvement was noted in 100% of patients. Mean procedure time was 53.1 minutes [40-66]. Average estimated thrombus volume reduction was 89% [70-95%]. Average estimated procedural blood loss was 118 mL [40-275]. Average and median hospital stay were 7 and 4 days respectively [2-19]. No confirmed major bleeding, major vascular complications, in-hospital mortality, or 30-day mortality occurred. One patient had a small access site hematoma which resolved with nominal pain therapy (mild AE, Category 3 causality, self-resolved).

Conclusions: Our experience suggests that the AlphaVac F18-85 thrombectomy catheter has a similar and possibly superior effectiveness and safety profile compared to other FDA-approved PA thrombectomy catheters. A larger cohort of patients is needed to determine if these results can be consistently reproduced in varying clinical settings.