Author:
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,
Abstract
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.
Publisher
Springer Science and Business Media LLC
Subject
Cardiology and Cardiovascular Medicine,Radiology, Nuclear Medicine and imaging
Cited by
6 articles.
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