Six-month outcomes of mechanical thrombectomy for treating deep vein thrombosis: Analysis from the 500-patient CLOUT registry

Abdullah Shaikh, Allegheny Health Network Research Institute, 4 Allegheny Square East, Pittsburgh, PA, 15212, USA. Abdullah.shaikh@gmail.com.
Adam Zybulewski, Mount Sinai Medical Center of Florida, Miami, FL, USA.
Joseph Paulisin, Ascension Genesys Hospital, Grand Blanc, MI, USA.
Mohannad Bisharat, HCA Florida Memorial Hospital, Jacksonville, FL, USA.
Nicolas J. Mouawad, McLaren Health System, Bay City, MI, USA.
Adam Raskin, Mercy Health - The Heart Institute, Cincinnati, OH, USA.
Eugene Ichinose, Oklahoma Heart Institute, Tulsa, OK, USA.
Steven Abramowitz, MedStar Health Research Institution, Washington, DC, USA.
Jonathan Lindquist, University of Colorado, Denver, CO, USA.
Ezana Azene, Gundersen Health, La Crosse, WI, USA.
Neil Shah, Advocate Aurora HealthFollow
James Nguyen, Manatee Memorial Hospital, Bradenton, FL, USA.
Josh Cockrell, Alabama Clinical Therapeutics, Birmingham, AL, USA.
Bhavraj Khalsa, Heart and Vascular Center, Providence St. Joseph Hospital, Orange, CA, USA.
Vipul Khetarpaul, Washington University, St. Louis, MO, USA.
Douglas A. Murrey, Inland Imaging at Providence Sacred Heart Medical Center, Spokane, WA, USA.
Kalyan Veerina, Opelousas General, Opelousas, LA, USA.
Edvard Skripochnik, Columbia University Irving Medical Center, New York, NY, USA.
Thomas S. Maldonado, NYU Langone Medical Center, New York, NY, USA.
Matthew C. Bunte, Saint Luke's Mid-America Heart Institute, Kansas City, MO, USA.
Suman Annambhotla, Longstreet Clinic, Gainesville, GA, USA.
Jonathan Schor, Northwell Health, Staten Island University Hospital, Staten Island, NY, USA.
Herman Kado, William Beaumont Hospital, Royal Oak, MI, USA.
Hamid Mojibian, Yale School of Medicine, New Haven, CT, USA.
David Dexter, Sentara Vascular Specialists, Norfolk, VA, USA.

Affiliations

Aurora St. Luke's Medical Center

Abstract

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 < 0.0001), and venous compressibility improved from 28.0% to 91.8% (P < 0.0001), while median Villalta scores improved from 9.0 at baseline to 1.0 at 6 months (P < 0.0001). Significant improvements in venous symptom severity, pain, and quality of life were also demonstrated. Outcomes from iliofemoral and isolated femoral-popliteal segments showed similar improvements.

Conclusion:Outcomes from the CLOUT study, a large prospective registry for DVT, indicate that mechanical thrombectomy is safe and demonstrates significant improvement in symptoms and health status through 6 months. Level of Evidence 3: Non-randomized controlled cohort/follow-up study.

Type

Article

PubMed ID

37580422

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