Abstract
BACKGROUND: There is a need for additional data to assess procedural efficacy and risks associated with mechanical thrombectomy for treating pulmonary embolism (PE) due to its increased utilization and diversity of patient populations presenting with PE. This study evaluated the safety and efficacy of percutaneous mechanical aspiration thrombectomy with the AlphaVac F18(85) System (AngioDynamics) in patients with acute intermediate-risk PE. METHODS: Patients with acute intermediate-risk PE and a right ventricular (RV)/left ventricular (LV) diameter ratio of ≥0.9 were eligible for enrollment in this prospective, multicenter, single-arm study. The primary effectiveness end point was reduction in the RV/LV ratio at 48 hours. The primary safety end point was the rate of major adverse events (MAEs) defined as subjects who experienced major bleeding, device-related deaths, clinical deterioration, or pulmonary vascular or cardiac injury within 48 hours postprocedurally. RESULTS: In total, 122 subjects were enrolled at 25 sites. Mean procedure time was 37.2 ± 17.7 minutes. There were statistically significant reductions in mean 48-hour postprocedural RV/LV diameter ratio (-0.45 ± 0.27; P < .001). Postprocedural mean pulmonary arterial pressure also significantly declined from 27.8 ± 7.8 mm Hg before the procedure to 21.8 ± 7.2 mm Hg (P < .001). There was a 35.5% mean reduction in clot burden as measured by the modified Miller index score. Five (4.1%) subjects developed 7 MAEs during the postprocedural 48-hour assessment period, the majority of which were access site bleeding. CONCLUSIONS: Percutaneous mechanical aspiration thrombectomy with the AlphaVac system provided a safe and effective treatment for acute intermediate-risk PE with a significant reduction in RV/LV ratio and clot burden with a low rate of adverse events.