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Published on: June 2, 2015
Six-Month Deep Vein Thrombosis Outcomes by Chronicity: Analysis of the Real-World ClotTriever Outcomes Registry
Steven D Abramowitz1, Herman Kado2, Jonathan Schor3
1MedStar Health, Washington, DC.
Insights
Mechanical thrombectomy with the ClotTriever System effectively treats acute, subacute, and chronic deep vein thrombosis (DVT). This real-world study shows significant improvements in patient outcomes and quality of life across all DVT types.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Medical Device Technology
Background:
- Deep vein thrombosis (DVT) is a significant vascular condition affecting millions globally.
- Current treatment modalities for DVT, including anticoagulation and thrombolysis, have limitations.
- Mechanical thrombectomy offers a minimally invasive approach to DVT treatment.
Purpose of the Study:
- To evaluate the safety and effectiveness of the ClotTriever System for mechanical thrombectomy in patients with acute, subacute, and chronic deep vein thrombosis (DVT).
- To analyze real-world outcomes from the prospective, multicenter ClotTriever Outcomes (CLOUT) registry.
Main Methods:
- Prospective, multicenter registry of 250 patients with lower extremity DVT treated with the ClotTriever System.
- Thrombus chronicity (acute, subacute, chronic) determined by visual inspection.
- Assessment of serious adverse events (SAEs) through 30 days and clinical/quality-of-life outcomes through 6 months.
Main Results:
- High rates of complete or near-complete thrombus removal (81.9%–90.8%) across all DVT chronicity groups.
- Significant improvements in Villalta scores (P < .0001) and EQ-5D scores (P < .0001) at 6 months.
- One device-related SAE (fatal pulmonary embolism) occurred in the subacute group; outcomes were similar across subgroups.
Conclusions:
- Mechanical thrombectomy using the ClotTriever System is a safe and effective treatment for acute, subacute, and chronic DVT.
- The procedure demonstrates consistent efficacy and positive patient outcomes regardless of thrombus chronicity.
- Adjunctive venoplasty and stent placement can be utilized at physician discretion.
Purpose:
To analyze the first 250 patients from the prospective, multicenter, industry-sponsored ClotTriever Outcomes (CLOUT) registry, assessing the safety and effectiveness of mechanical thrombectomy for acute, subacute, and chronic deep vein thrombosis (DVT).
Materials And Methods:
Real-world patients with lower extremity DVT were treated with the ClotTriever System (Inari Medical, Irvine, California). Adjuvant venoplasty, stent placement, or both were performed at the physician's discretion. Thrombus chronicity was determined by visual inspection of removed thrombus, categorizing patients into acute, subacute, and chronic subgroups. Serious adverse events (SAEs) were assessed through 30 days. Clinical and quality-of-life (QoL) outcomes are reported through 6 months.
Results:
Thrombus chronicity was designated for 244 of the 250 patients (acute, 32.8%; subacute, 34.8%; chronic, 32.4%) encompassing 254 treated limbs. Complete or near-complete (≥75%) thrombus removal was achieved in 90.8%, 81.9%, and 83.8% of the limbs with acute, subacute, and chronic thrombus, respectively. No fibrinolytics were administered, and 243 (99.6%) procedures were single sessions. One (0.4%) patient in the subacute group experienced a device-related SAE, a fatal pulmonary embolism. On comparing baseline and 6-month data, improvements were demonstrated in median Villalta scores (acute, from 10 to 1; subacute, from 9 to 1; chronic, from 10 to 3; for all, P < .0001) and mean EuroQol group 5-dimension (EQ-5D) self-report questionnaire scores (acute, 0.58 to 0.89; subacute, 0.65 to 0.87; chronic, 0.58 to 0.88; for all, P < .0001). There were no significant differences in outcomes across the subgroups.
Conclusions:
Mechanical thrombectomy using the ClotTriever System with adjunctive venoplasty and stent placement is safe and similarly effective for acute, subacute, and chronic DVT.
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