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A Multicenter MRI Protocol for the Evaluation and Quantification of Deep Vein Thrombosis
Published on: June 2, 2015
Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity
Thomas S Maldonado1, David J Dexter2, Herman Kado3
1New York Langone Health, New York, NY.
Insights
Thrombus in deep vein thrombosis (DVT) may be more chronic than symptoms suggest, impacting treatment. The ClotTriever system effectively removes acute, subacute, and chronic thrombus in one session.
Area of Science:
- Vascular Medicine
- Interventional Cardiology
- Thrombosis Research
Background:
- Deep vein thrombosis (DVT) chronicity assessment is crucial for treatment planning.
- Symptom duration alone may not accurately reflect thrombus age.
- Accurate thrombus characterization aids in evaluating treatment efficacy.
Purpose of the Study:
- To assess thrombus chronicity indicators in patients with lower extremity DVT.
- To evaluate the effectiveness of the ClotTriever System across different thrombus chronicity subgroups.
- To compare thrombus chronicity assessment methods.
Main Methods:
- Analysis of the all-comer ClotTriever Outcomes registry data.
- Assessment of thrombus chronicity based on symptom duration, pre-thrombectomy imaging, and post-thrombectomy thrombus morphology.
- Comparison of baseline and procedural characteristics across acute, subacute, and chronic thrombus subgroups.
- Evaluation of thrombus removal using Marder scores, with a primary endpoint of ≥75% removal.
Main Results:
- Symptom duration mismatched post-thrombectomy thrombus chronicity in 55.1% of cases.
- Pre-thrombectomy imaging mismatched chronicity in 17.5% of cases.
- High rates of complete or near-complete thrombus removal (≥75%) were achieved regardless of chronicity: 90.8% (acute), 81.9% (subacute), and 83.8% (chronic).
- 99.6% of procedures were completed in a single session without thrombolytics.
Conclusions:
- Thrombus in DVT can be more chronic than indicated by symptom duration.
- Imaging provides valuable information for assessing thrombus response to therapy.
- The ClotTriever system demonstrates effectiveness in removing acute, subacute, and chronic DVT thrombus in a single session.
Objective:
The all-comer ClotTriever Outcomes registry assessed indicators of thrombus chronicity in patients with acute, subacute, and chronic lower extremity deep vein thrombosis (DVT). The effectiveness of the ClotTriever System (Inari Medical, Irvine, CA) by chronicity subgroup was also assessed and reported here in this subanalysis.
Methods:
All-comer patients with lower extremity DVT were enrolled, with no limitation based on the patients' symptom duration. Chronicity was assessed three times and compared: before the procedure based on symptom duration, during the procedure based on available pre-thrombectomy imaging, and visual inspection of the extracted thrombus morphology after thrombectomy. Patients were grouped into acute, subacute, and chronic subgroups according to their post-thrombectomy thrombus chronicity based on thrombus morphology. Analyses on baseline and procedural characteristics along with thrombus removal were performed across subgroups. The effectiveness of thrombus removal was determined by Marder scores adjudicated by an independent core laboratory, with a prespecified primary effectiveness end point of complete or near-complete (≥75%) thrombus removal.
Results:
Of the 260 treated limbs from 250 patients, using symptom duration alone, 70.7% were considered acute, 20.9% subacute, and 8.4% chronic. Upon visual inspection, the extracted thrombus chronicity was approximately one-third in each subgroup: 32.7% had acute thrombus, 35.4% subacute thrombus, and 31.9% chronic thrombus. Chronicity assessed using symptom duration alone mismatched the post-thrombectomy chronicity in 55.1% of limbs (P < .0001) with 49.0% being more chronic than suggested by the patients' duration of symptoms. Chronicity assessed using pre-thrombectomy imaging mismatched the post-thrombectomy chronicity in 17.5% of limbs (P < .0001). No patients received thrombolytics and 99.6% were treated in a single session. Complete or near-complete thrombus removal was achieved in a high percentage of limbs regardless of thrombus chronicity: 90.8%, 81.9%, and 83.8% in limbs with acute, subacute, and chronic thrombus, respectively.
Conclusions:
This subanalysis from the all-comer ClotTriever Outcomes registry demonstrates that extracted thrombus in DVT may be more chronic than suggested by the patients' duration of symptoms. The addition of imaging is helpful to determine the ability of thrombus to respond to therapy. Irrespective of thrombus chronicity, the ClotTriever system can be effective at removing acute, subacute, and chronic thrombus in a single-session procedure without the need for thrombolytics.
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