(CR-025) Outcomes of Mechanical Thrombectomy for the Treatment of Deep Vein Thrombosis-associated Venous Leg Ulcers

Introduction: Roughly half of patients with lower extremity deep vein thrombosis (DVT) develop a chronic sequela called postthrombotic syndrome (PTS). Collagen deposition rapidly converts thrombi to postthrombotic obstructions (PTOs) that adhere to vessel walls and form synechia. Chronic ambulatory hypertension from deep-vein PTOs can cause venous leg ulcers (VLUs), a recalcitrant symptom of severe PTS. However, mechanical thrombectomy (MT) may be effective for disrupting PTOs. This study aimed to determine if MT improves healing of DVT-associated VLUs.

Methods: All patients with VLUs secondary to DVT referred to our center from August 2021 through May 2022 who were deemed candidates for MT with the study device* were retrospectively assessed. Technical success was crossing the PTO and deploying the MT catheter. Stents were placed in iliac segments if >50% vessel area reduction was observed by intravascular ultrasound. Using the revised venous clinical severity score (rVCSS), clinical success was a decrease of ≥1 ulcer diameter category (rVCSS_diameter; no VLU: 0, mild [< 2 cm]: 1, moderate [2–6 cm]: 2, severe [ >6 cm]: 3) at last follow-up.

*ClotTriever Thrombectomy System, Inari Medical, Irvine, California

Results:

Eleven patients with 15 VLUs on 14 limbs underwent MT (age: 59.7±11.8 years, women: 4 [36.4%]). Median VLU duration was 11.0 [interquartile range 6.0–17.0] months; 2 (18.2%) patients presented with VLUs persisting >40 years. Baseline VLU area was 13.6±9.0 cm², and median rVCSS_diameter was 2 [2–2]. Technical success was achieved in all limbs. All limbs received adjunctive venoplasty, with stents placed in 10 (71.4%). No fibrinolytics were administered, and 0 adverse events occurred. No patient was admitted after thrombectomy due to the procedure. All VLUs demonstrated clinical success. The rVCSS_diameter improved to 0 [0–0] by last follow-up at 12.8±10.5 weeks. Twelve (80.0%) VLUs completely resolved by 10 [7–14] weeks. Three (20.0%) remaining VLUs demonstrated an 83.1±13.8% area reduction at 12 [6–12] weeks.

Discussion: All patients showed complete or near-complete VLU healing within months of a procedure that included MT. These preliminary results suggest that implementing MT with the study device in conjunction with adjuvant methods assists in reestablishing patency and cephalad flow, allowing VLUs to heal.

Trademarked Items: ClotTriever

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