Venous stenting is commonly used to restore outflow and relieve the symptoms of chronic venous insufficiency. When these stents thrombose, limited treatment options exist, often providing only palliative care. Recently, the RevCore Thrombectomy Catheter (Inari Medical) has been introduced as a tool to mechanically debulk venous in-stent thrombosis (IST). This study represents the first evaluation of the feasibility and safety of this novel device. Between March and July 2023, 18 consecutive patients with lower extremity venous IST treated with RevCore were retrospectively analyzed. Thrombus removal and technical success—defined as complete patency—–were evaluated along with safety metrics including stent integrity and adverse events. The median age was 60 years and 61.1% were female. The median stent age was 3 years (n=13, 1 month-16 years). Most patients had unilateral stents (94.4%), predominantly placed in the iliac (74%) and femoral (21%) veins. Five stent types were treated (Table 600.1), with preexisting stent damage noted in 2 patients. Procedures were completed in a single session in 100% of cases with a median of 4 passes through the stented segments. Adjunctive venoplasty was used in 88.9% of cases. No thrombolytics were used and median thrombus removal was 90%. Technical success was achieved in 83.3% of patients, with partial patency achieved in the remaining 16.7% of patients. No stents required relining due to residual stent occlusion; stent compression necessitated relining in three patients and two patients had their stented segments extended. No new stent damage or migration was observed. At median follow-up of 45 days (n=17, 31-114 days), there were no device-related adverse events and 88.2% (15/17) of patients had patent stents; one patient rethrombosed following non-compliance of anticoagulation and one patient was partially patent. At follow-up, 88.2% of patients reported no pain. Follow-up is ongoing and further data will be available for the presentation. Results from this early experience demonstrate safe restoration and sustained patency of venous stents after use of the RevCore system, despite the variety of stent types. Further studies are warranted to validate the safety and effectiveness of RevCore.
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Shaikh et al. (2024) studied this question.
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