Interim Outcomes of Mechanical Thrombectomy for Deep Vein Thrombosis from the All-Comer CLOUT Registry. 

 -  2022 
<br/><br/> CONCLUSIONS: 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicity demonstrate favorable effectiveness, safety, and sustained clinical improvements. Copyright © 2022. Published by Elsevier Inc.  METHODS: All-comer patients with lower extremity DVT were enrolled, including those with bilateral DVT, those with previously failed DVT treatment, and regardless of symptom duration. The primary effectiveness endpoint is complete, or near-complete (>=75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events (SAEs) through 30 days and clinical outcomes include PTS severity, symptoms, pain, and quality of life through 6 months.  OBJECTIVES: The multicenter, prospective, single arm CLOUT registry assesses the safety and effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) for the treatment of acute and non-acute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients.  RESULTS: The median age was 62 years and 40% of patients had contraindications to thrombolytics. A range of thrombus chronicity (33% acute, 35% subacute, 32% chronic) was observed. No patients received thrombolytics and 99.6% were treated in a single session. Median thrombectomy time was 28 minutes. The primary effectiveness endpoint was achieved in 86% of limbs. Through 30 days, one device-related SAE occurred. At 6 months, 24% of patients had PTS. Significant and sustained improvements were observed in all clinical outcomes including rVCSS, NPRS, and EQ-5D. 
<br/><br/><br/>English 
<br/><br/><label>Standard No.: </label>10.1016/j.jvsv.2022.02.013 [doi] S2213-333X(22)00094-4 [pii] 
<br/><br/><label>Subjects--Geographic Terms: </label><br/>MedStar Washington Hospital Center
<br/><br/><label>Index Terms--Occupation: </label><br/>Surgery/Vascular Surgery
<br/><br/><label>Index Terms--Function: </label><br/>Journal Article