Background
Pulmonary embolism (PE) is associated with significant morbidity and mortality. The AVENTUS thrombectomy system is an aspiration-based system integrating mechanical thrombectomy and blood filtration with reinfusion designed for efficient thrombus removal, minimal blood-loss and enhanced ease-of-use. This pivotal study evaluates AVENTUS System safety, efficacy, and performance in acute submassive PE patients.
Methods
This was a prospective, multi-center study. Primary efficacy endpoint was core laboratory-adjudicated change in right ventricular to left ventricular (RV/LV) ratio from baseline to 48 hours post-procedure, assessed via computed tomography pulmonary angiogram. The primary safety endpoint was a composite rate of device-related major adverse events (MAEs) within 48 hours. Observational endpoints included length of ICU and hospital stay, change in refined Miller score (RMS) at 48 hours, thrombolytic use, symptomatic PE recurrence, device-related significant adverse events and all-cause mortality within 30 days, change in 6-minute walk test and quality-of-life improvements (PEmb-QoL) through 30 days.
Results
(preliminary data 1/31/25)
A total of 120 patients (mean age 59, 55.8% male) underwent PE thrombectomy with the AVENTUS. There was a mean reduction of 0.47 (29%) in RV/LV ratio at 48 hours. No device-related MAEs were observed within and through 30 days. Mean pulmonary artery pressure (mPAP, mmHg) decreased from 28.2 pre-procedure to 23.6 post-procedure. Mean ICU and hospital length of stay was 1.7 and 2.0 days respectively. RMS improved by 37.1 % at 48 hours. One non-device related death occurred within 30 days post-procedure. There were recurrence. Six-minute walk test increased by 36% in distance at 30 days compared to 48 hours post procedure. An improvement of 0.26 in PEmb-QoL scores was noted at 30 days compared to pre-procedure. In 88.2% of patients, ≤2 passes through the heart were required with the device (60.2% had 1 pass).
Conclusions
The AVENTUS Pivotal Trial demonstrates that the AVENTUS Thrombectomy System is a safe, and effective treatment for acute intermediate-risk PE, significantly reducing RV/LV ratio and an improvement in functional outcomes by 30 days with no device-related MAEs.