Safety and efficacy of the ClotTriever device in extended deep vein thrombosis.
The endovascular treatment of thromboembolic disease has evolved and new devices have come out in the last few years to reduce morbimortality from its complications. Sub-treating this pathology has long term implications, such as reduced quality of life, limiting functional class and, worst case scenario, severe disabilities (observed in post-thrombotic syndrome [PTS]).
Potential benefits of the invasive treatment of deep vein thrombosis (DVP) include improved quality of life and reduced complications such as pulmonary thromboembolism (PTE) or PTS. With prolonged evolution times, local thromboembolic therapy has not shown benefits so far, which is why these cases are being treated with mechanical thrombectomy as a valid alternative with lower risk of bleeding.
The CLOUT was a prospective, multicenter study on the safety and efficacy of the ClotTriever device (Inari) in the treatment of lower limb DVT (Real-World population). It included patients from 43 centers in the US, 18+ years, with iliofemoral, unilateral or bilateral DVT. It excluded patients with ≤one-year life expectancy, prior target vessel stenting, inferior vena cava vein atresia or contraindications for anticoagulants or contrast. Part of the procedure could include some kind of venoplasty procedure, stenting or other therapies.
Primary efficacy end point was complete or near complete (≥75%) reduction of Marder score (24 representing complete thrombosis). Mean age was 61.9, 49.5% were men, 29.7% had some kind of absolute contraindication for fibrinolytics. Indication according to evolution time was very similar, with 48.8% acute (≤7 days) 48.3% ≥7 days, including a 6.8% with symptoms beyond 6 weeks.
99% were one-session interventions, with median 4 device passes, median thrombectomy time of 28 minutes, and mean blood loss of 40ml. Also, after intervention, 72.7% received a venoplasty procedure and 44% received a stent, with ICU time of 1 day.
Mean Marder score improved from 8.75 (RIC 6.25-12.25) to 0 (RIC 0-1.25) post-thrombectomy. Primary end point was reached in 91.2% of studies, 70.6% reaching ≥90% thrombus removal and 63.9% reaching 100%. There was a 2.6% rate of serious adverse events, the main one being residual thrombosis or rethrombosis.
As regards clinical outcomes, both edema and pain improved significantly at discharge, which was shown by reduced muscle circumference (from 54.5cm to 53cm) and calf edema (from 39cm at baseline to 37cm), while 76.9% showed improved pain according to analogous visual scale.
Conclusions
This analysis of the Real-World patients treated with ClotTriever showed the safety and efficacy of this device with 2.6% de adverse events rate and very good effectiveness through thrombus removal quantification. The clinical variables analyzed as regards edema and pain improvement should be assessed at longer followup and validated with randomized studies.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Reference: David Dexter, Herman Kado, Abdullah Shaikh, Jonathan Schor, Suman Annambhotla, Adam Zybulewski, Joseph Paulisin, Mohannad Bisharat, Nicolas J. Mouawad, Matthew C. Bunte, Thomas Maldonado, Edvard Skripochnik, Adam Raskin, Sagar Gandhi, Eugene Ichinose, Robert Beasley, Hamid Mojibian. Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry, Journal of the Society for Cardiovascular Angiography & Interventions, Volume 2, Issue 2, 2023. https://doi.org/10.1016/j.jscai.2023.100585.
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