A Large-Diameter Thrombus Retrieving Device for Intermediate-Risk Acute Pulmonary Embolism Treatment: A Single-Arm Prospective Clinical Trial

What is the clinical question being addressed? How can acute pulmonary embolism be treated more safely and effectively?What is the main finding?Treating intermediate-risk patients with acute pulmonary embolism with a large-diameter thrombus aspiration and mechanical thrombectomy device may have acceptable clinical benefits.Globally, acute pulmonary embolism (PE) is the third leading cause of cardiovascular-related deaths after myocardial infarction and stroke [1].Several studies have reported increased annual incidence of PE and consequently social medical burden [2].Determining how to treat acute PE more safely and effectively, while decreasing long-term complications, remains an important issue in medicine.The aim of this study was to report the results of a single-arm clinical trial in intermediate-risk patients with acute PE treated with a device for large-diameter thrombus aspiration (16 F or greater) and mechanical thrombectomy.This prospective, single-arm clinical trial was conducted between March 2022 and January 2023 at Xiamen Cardiovascular Hospital, Xiamen University, China.The clinical trial was registered at http://clinicaltrials.gov (Clinical Trial ID: NCT 05443919).A comprehensive description of the study design, data collection methods, inclusion and exclusion criteria, and outcome measure can be found at https://clinicaltrials.gov/ study/NCT05443919.PE severity was evaluated in accordance with the scoring criteria outlined in the ESC acute PE guidelines [2], and patients with intermediate-risk acute PE were included in the study.All 13 patients (average age: 66.85 y) were treated with the device consisting of thrombus aspiration and pulmonary artery retrieval systems (Figure 1).Most patients were women (n = 8, 61.54%).The median PE severity index score at admission was 102 (interquartile range, IQR: 73-106).Ten patients presented with bilateral PE.Table 1 provides a detailed summary of the perioperative