Interim outcomes of mechanical thrombectomy for deep vein thrombosis from the All-Comer CLOUT Registry
David Dexter, Herman Kado, Jonathan Schor, Suman Annambhotla, Brandon Olivieri, Hamid Mojibian, Thomas S. Maldonado, Sagar Gandhi, Joseph Paulisin, Matthew C. Bunte, Wesley Angel, Jon Roberts, Kalyan Veerina, Steven Abramowitz, Fakhir Elmasri, Jeffrey Hnath, Matthew Jung, Daniel Long, Luis A. Sánchez, Octavio Cosme, Edvard Skripochnik, Ankur Lodha, Abdullah Shaikh, Christopher S. King, Mohannad Bisharat, Robert Beasley
Abstract
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 nonacute lower extremity deep vein thrombosis (DVT) in all-comer patients. Reported here are the outcomes of the first 250 patients. 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 end point is complete or near-complete (≥75%) thrombus removal determined by independent core laboratory-adjudicated Marder scores. Safety outcomes include serious adverse events through 30 days and clinical outcomes include post-thrombotic syndrome severity, symptoms, pain, and quality of life through 6 months. 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. The median thrombectomy time was 28 minutes. The primary effectiveness end point was achieved in 86% of limbs. Through 30 days, one device-related serious adverse event occurred. At 6 months, 24% of patients had post-thrombotic syndrome. Significant and sustained improvements were observed in all clinical outcomes, including the Revised Venous Clinical Severity Score, the numeric pain rating scale, and the EuroQol Group 5-Dimension Self-Report Questionnaire. CONCLUSIONS: The 6-month outcomes from the all-comer CLOUT registry with a range of thrombus chronicities demonstrate favorable effectiveness, safety, and sustained clinical improvements.