Six-Month Outcomes of Mechanical Thrombectomy for Treating Deep Vein Thrombosis: Analysis from the 500-Patient CLOUT Registry

• Published in: Cardiovascular and interventional radiology 2023-11, Vol.46 (11), p.1571-1580
• Main Authors: Shaikh, Abdullah, Zybulewski, Adam, Paulisin, Joseph, Bisharat, Mohannad, Mouawad, Nicolas J., Raskin, Adam, Ichinose, Eugene, Abramowitz, Steven, Lindquist, Jonathan, Azene, Ezana, Shah, Neil, Nguyen, James, Cockrell, Josh, Khalsa, Bhavraj, Khetarpaul, Vipul, Murrey, Douglas A., Veerina, Kalyan, Skripochnik, Edvard, Maldonado, Thomas S., Bunte, Matthew C., Annambhotla, Suman, Schor, Jonathan, Kado, Herman, Mojibian, Hamid, Dexter, David
• Format: Article
• Language: English
• Subjects: Adverse events; Cardiology; Clinical Investigation; Compressibility; Femoral Vein; Follow-Up Studies; Humans; Iliac Vein; Imaging; Medicine; Medicine & Public Health; Nuclear Medicine; Pain; Patients; Postthrombotic Syndrome; Quality of Life; Radiology; Thrombectomy - adverse effects; Thromboembolism; Thrombolytic Therapy - adverse effects; Thrombosis; Treatment Outcome; Ultrasound; Vascular Patency; Veins; Venous Interventions; Venous Thrombosis - diagnostic imaging; Venous Thrombosis - therapy
• ISSN: 0174-1551; 1432-086X; 1432-086X
• DOI: 10.1007/s00270-023-03509-8

Purpose Mechanical thrombectomy for the treatment of deep vein thrombosis (DVT) is being increasingly utilized to reduce symptoms and prevent postthrombotic syndrome (PTS), but more data on clinical outcomes are needed. Mechanical thrombectomy was studied in the ClotTriever Outcomes (CLOUT) registry with 6-month full analysis outcomes reported herein. Materials and Methods The CLOUT registry is a prospective, all-comer study that enrolled 500 lower extremity DVT patients across 43 US sites treated with mechanical thrombectomy using the ClotTriever System. Core-lab assessed Marder scores and physician-assessed venous patency by duplex ultrasound, PTS assessment using Villalta score, venous symptom severity, pain, and quality of life scores through 6 months were analyzed. Adverse events were identified and independently adjudicated. Results All-cause mortality at 30 days was 0.9%, and 8.6% of subjects experienced a serious adverse event (SAE) within the first 30 days, 1 of which (0.2%) was device related. SAE rethrombosis/residual thrombus incidence was 4.8% at 30 days and 8.0% at 6 months. Between baseline and 6 months, venous flow increased from 27.2% to 92.5% of limbs ( P