Novel Aspiration Thrombectomy and Blood Reinfusion System for Acute Intermediate-Risk Pulmonary Embolism: AVENTUS Trial Results
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: 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.
Institutions: MedStar Georgetown University Hospital, Centennial Medical Center, CentraCare Health System, Emory University, OhioHealth, Riverside Methodist Hospital, Hackensack University Medical Center, ProMedica Toledo Hospital, The University of Texas at Austin, University Hospitals of Cleveland, University Hospitals Cleveland Medical Center
Language: English
Subfield: Internal Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,400
Funders: Medtronic, Abbott Vascular
OpenAlex ID: W4410038299