Clearance of Chronic Venous Fibrotic Occlusions with Mechanical Thrombectomy for Venous Leg Ulcer Prevention and Healing

Introduction: Up to 50% of deep vein thrombosis (DVT) patients develop post-thrombotic syndrome (PTS), a form of chronic venous disease (CVD) that can present with venous leg ulcers (VLUs) and has a debilitating impact on quality-of-life1, 2. DVTs can rapidly transform into chronic venous fibrotic obstructions (CVFOs)3 that impede cephalad flow, producing VLUs. In the US, VLUs amount to a $32B annual cost4, 5. Clearance of CVFOs to restore cephalad flow may prevent VLU formation and promote healing of established VLUs. Mechanical thrombectomy (MT) has been shown to effectively treat acute-to-chronic DVTs6, 7,8. We aim to examine the ability of a MT toolkit* to treat CVFOs and assess the subsequent impact on VLU prevention and healing.Methods:Seven consecutive patients with CVFOs, including one with an established VLU, treated with MT using one or more of the study devices* between November 2021 and April 2024 were retrospectively analyzed. The ability to cross the CVFO with the MT catheter, patency, and VLU status were assessed.Results:Seven patients with CEAP-4 (71%; 1 CEAP-4B), CEAP-5 (14%), and CEAP-6 (14%) were treated with MT in both outpatient (71%) and inpatient (29%) settings. The CEAP-6 patient had a preexisting VLU that was >1 year old, and the patient was treated again with MT to address a thrombosed iliac stent. The CVFO was successfully crossed in all cases. All procedures were completed in a single session with a mean procedure time of 98.4±37.5 minutes. Estimated blood loss was 20±16.0 mL, and no thrombolytics were administered. Adjunctive procedures included post-thrombectomy venoplasty in 100% of procedures and stent placement in 50% of procedures. Mean CVFO removal was 94%, resulting in complete patency in all cases. No complications occurred, and no ICU stay was required. Mean follow-up time was 84 days. No new VLU formation was observed, and PTS symptoms improved. The preexisting VLU in the CEAP-6 patient showed near-complete healing by 3 months and complete healing by 6 months.Discussion: Using the MT toolkit*, CVFOs were successfully cleared to reestablish patency, allowing for VLU prevention or promotion of healing. These early results demonstrate the potential of MT as both a preventative measure and treatment option for VLUs for improving clinical outcomes and mitigating economic impact of CVD.References:1. Wang J, Smeath E, Lim HY, Nandurkar H, Kok HK, Ho P. Current challenges in the prevention and management of post-thrombotic syndrome-towards improved prevention. Int J Hematol. 2023;118(5):547-67. 2. Bistervels IM, Bavalia R, Beyer-Westendorf J, Ten Cate-Hoek AJ, Schellong SM, Kovacs MJ, et al. Postthrombotic syndrome and quality of life after deep vein thrombosis in patients treated with edoxaban versus warfarin. Res Pract Thromb Haemost. 2022;6(5):e12748. 3. Czaplicki C, Albadawi H, Partovi S, Gandhi RT, Quencer K, Deipolyi AR, et al. Can thrombus age guide thrombolytic therapy? Cardiovasc Diagn Ther. 2017;7(Suppl 3):S186-s96. 4. Probst S, Saini C, Gschwind G, Stefanelli A, Bobbink P, Pugliese MT, et al. Prevalence and incidence of venous leg ulcers-A systematic review and meta-analysis. Int Wound J. 2023;20(9):3906-21. 5. Raffetto JD, Ligi D, Maniscalco R, Khalil RA, Mannello F. Why Venous Leg Ulcers Have Difficulty Healing: Overview on Pathophysiology, Clinical Consequences, and Treatment. J Clin Med. 2020;10(1). 6. Maldonado TS, Dexter DJ, Kado H, Schor J, Annambhotla S, Mojibian H, et al. Outcomes from the ClotTriever Outcomes Registry show symptom duration may underestimate deep vein thrombus chronicity. J Vasc Surg Venous Lymphat Disord. 2022. 7. Mouawad NJ. Percutaneous mechanical thrombectomy to remove post-thrombotic obstructions and manage post-thrombotic syndrome-associated venous leg ulceration. J Vasc Surg Venous Lymphat Disord. 2023;11(5):964-71.e1. 8. Bisharat MB, Ichinose EJ, Veerina KK, Khetarpaul V, Azene EM, Plotnik AN, et al. One-Year Clinical Outcomes Following Mechanical Thrombectomy for Deep Vein Thrombosis: A CLOUT Registry Analysis. Journal of the Society for Cardiovascular Angiography & Interventions. 2024;3(3).