Safety and Feasibility of the RevCore Catheter for Venous In-Stent Thrombosis: A Multicenter, Retrospective Study

After venous stent placement, patients may develop in-stent thrombosis (IST). The RevCore thrombectomy catheter (Inari Medical) is a novel device specifically designed to treat venous IST. Herein, the safety and feasibility of this device are evaluated.

Patients were retrospectively included if they were ≥18 years old, had lower extremity venous IST, and were treated using the study device. The primary end point is technical success, defined as an average postprocedural effective diameter ≥50% and calculated using stent diameter and flow channel diameter on intravascular ultrasound. The safety end points are 30-day device-related serious adverse events, namely mortality, readmission, clinically significant pulmonary embolism, and vessel perforation.

Data from 44 patients (48 treated limbs, 6 treated stent types) from 4 centers were analyzed. Mean age was 54.8 ± 17.1 years, and 23 (52.3%) patients were female. Median IST symptom duration was 8.0 (IQR, 2.0-104.0) weeks. The primary end point was achieved in all 48 limbs. Comparing baseline with postprocedural measurements, effective stent diameter increased from 21.1% ± 26.5% to 89.6% ± 10.1%. No patient met a safety end point. On the first follow-up at 40.0 (29.0-62.5) days, primary patency was demonstrated in 32 (94.1%) of the 34 treated limbs with available data. Six (85.7%) limbs with Clinical-Etiology-Anatomy-Pathophysiology scores of C₆ at baseline had longer-term data available (3.1 ± 0.7 months), and all limbs demonstrated improvement of C₆ disease, with 3 (50.0%) improving to class C₅.

A thrombectomy procedure for deep-vein IST reestablished patency in all cases and across multiple stent types. Patency was sustained through the first follow-up in 94% of limbs.