Percutaneous mechanical thrombectomy to remove post-thrombotic obstructions and manage post-thrombotic syndrome-associated venous leg ulceration

Background: Up to one half of patients with a diagnosis of deep vein thrombosis will develop post-thrombotic syndrome (PTS). Patients with PTS can develop venous leg ulcers (VLUs) due to post-thrombotic obstructions (PTOs) that contribute to prolonged ambulatory venous hypertension. The current treatments for PTS, which include chronic thrombus, synechiae, trabeculations, and inflow lesions, do not target PTOs, and such obstructions can affect stenting success. The aim of the present study was to determine whether removal of chronic PTOs using percutaneous mechanical thrombectomy would promote VLU resolution and positive outcomes. Methods: In this retrospective analysis, the characteristics and outcomes for patients with VLUs secondary to chronic PTO who were treated using the ClotTriever System (Inari Medical) between August 2021 and May 2022 were assessed. Technical success was considered the ability to cross a lesion and introduce the thrombectomy device. Clinical success was defined as a decrease of >= 1 in the severity category for the ulcer diameter using the revised venous clinical severity score (score 0, no VLU; score 1, mild VLU [size <2 cm]; score 2, moderate VLU [size 2-6 cm]; score 3, severe VLU [size >6 cm]) at the latest follow-up visit. Results: A total of 11 patients with 15 VLUs on 14 limbs were identified. Their mean age was 59.7 6 11.8 years, and four patients (36.4%) were women. The median VLU duration was 11.0 months (interquartile range [IQR], 6.0-17.0 months), and 2 patients had VLUs secondary to a deep vein thrombosis event >40 years previously. All treatments were performed in a single session, with technical success achieved in 100% of the 14 limbs. A median of five passes (IQR, four to six passes) with the ClotTriever catheter were performed per limb. Chronic PTOs were successfully extirpated, and intraprocedural intravascular ultrasound showed effective disruption of venous synechiae and trabeculations. Stents were placed in 10 limbs (71.4%). The time to VLU resolution or the latest follow-up was 12.8 6 10.5 weeks, and clinical success was achieved for all 15 VLUs (100%), with the revised venous clinical severity score for the ulcer diameter improving from a median of 2 (IQR, 2-2) at baseline to a median score of 0 (IQR, 0-0) at last follow-up. The VLU area had decreased by 96.6% 6 8.7%. Of the 15 VLUs, 12 (80.0%) had resolved completely, and 3 had demonstrated near-complete healing. Conclusions: All patients showed complete or near-complete VLU healing within a few months after mechanical thrombectomy. Mechanical extirpation and interruption of chronic PTOs allowed for luminal gain and restoration of cephalad inflow. With additional investigation, mechanical thrombectomy with the study device could prove a vital component to the treatment of VLUs secondary to PTOs. (J Vasc Surg Venous Lymphat Disord 2023;11:964-71.)