Why is this study important? 

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 the AVENTUS System's safety, efficacy, and performance in acute submassive PE patients. 

What question is this study supposed to answer? 

This was a prospective, multicenter study. The primary efficacy endpoint was the 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. 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. 

A total of 120 patients underwent PE thrombectomy with the AVENTUS. There was a mean reduction of 0.47 (29%) in RV/LV ratio at 48 hours. Mean pulmonary artery pressure (mPAP, mmHg) decreased from 28.2 pre-procedure to 23.6 post-procedure. The 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. The 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.  

What did the study show? 

The AVENTUS Pivotal Trial demonstrates that the AVENTUS Thrombectomy System is a safe and effective treatment for acute intermediate-risk PE, significantly reducing the RV/LV ratio and improving functional outcomes by 30 days with no device-related Material Adverse Events (MAEs).