Novel Aspiration Thrombectomy and Blood Reinfusion System for Acute Intermediate-Risk Pulmonary Embolism: AVENTUS Trial Results.

BACKGROUND: Mechanical thrombectomy has become a first-line adjunctive therapy for anticoagulation in patients with acute intermediate-risk pulmonary embolism (PE). This prospective study evaluated the safety and efficacy of percutaneous mechanical aspiration thrombectomy with autologous blood reinfusion using the next-generation AVENTUS Thrombectomy System (Inquis Medical) in subjects with acute intermediate-risk PE. METHODS: Subjects with acute intermediate-risk PE with symptoms ≤14 days were enrolled in this prospective, multicenter, single-arm study. Primary efficacy (defined as the change in the right ventricle to left ventricle [RV/LV] ratio from baseline) and safety defined as a composite rate of device-related major adverse events were both assessed at 48 hours postprocedure. Six-minute walk distance and quality of life were assessed at 30 days. RESULTS: A total of 120 subjects were enrolled at 22 US sites. As compared to the baseline, the 48-hour RV/LV diameter ratio dropped significantly (0.47 ± 0.36; P < .0001), as did the refined modified Miller score (8.7 ± 5.5; P < .0001), reflecting a 35.9% reduction in clot burden. The mean estimated blood loss was 49.6 ± 38.9 mL, with no subjects requiring blood transfusion. Within 48 hours, no device-related major adverse events occurred. At 30 days, subjects exhibited a 132.9 m increase in 6-minute walk distance (P < .0001). PE-specific quality of life assessment at 30 days demonstrated decreased symptoms with a reduction of 25.3 points overall (P < .0001). CONCLUSIONS: This study confirms that thrombectomy and autologous blood reinfusion with the AVENTUS Thrombectomy System is a safe and effective primary treatment option in patients with acute intermediate-risk PE to improve RV function and reduce clot burden with minimal blood loss.