Safety and Efficacy of the Argon Cleaner Rotational Thrombectomy System for Hemodialysis Access Interventions

Purpose: This retrospective study evaluates the safety and efficacy of the Argon Cleaner Rotational Thrombectomy System in hemodialysis access interventions. Factors including technical and clinical success, access type and presence of aneurysmal dilatation, adjuvant therapies, and patency rates were reviewed.

Materials and Methods: A total of 123 patients underwent 216 declotting procedures using the Cleaner device between February 2013 and June 2019. Access site types included native arteriovenous fistulas (AVFs; n = 25), HeRO graft systems (HeRO; n = 54), and all other AV grafts (AVGs; n = 137). Twenty-three patients were noted to have at least one segment of aneurysmal dilatation along their fistulas. Adjunctive therapies included balloon angioplasty and maceration (n = 214), thrombolytics (tissue plasminogen activator) (n = 188), additional mechanical thrombectomy devices (n = 39), stent deployment (n = 30), and rheolytic thrombectomy (n = 3). Three-month follow-up data were available for 159 procedures, and 6-month follow-up data were available for 145 procedures.

Results: The overall technical success rate was 95% (206 of 216 procedures), and the clinical success rate was 79% (170 of 216). Technical success (AVF, 92%, HeRO, 98%, AVG, 95%) and clinical success rates (AVF, 72%; HeRO, 87%; AVG, 77%) were similar across access types. The complication rate was 6.9% (minor n = 14; major n = 1), none of which resulted in technical failure. The single major complication was a periprocedural cardiac arrest secondary to volume overload not attributed to the device or procedure. The overall patency rates were 38% at 3 months (61 of 159) and 15% at 6 months (22 of 145). Use of adjunctive therapies did not affect success or patency rates. Among patients with aneurysmal dilatation, the technical success rate was 96% (22 of 23 procedures), and the clinical success rate was 61% (14 of 23); there were no complications. Within this subgroup, patency rates were 58% at 3 months and 20% at 6 months.

Conclusions: The Cleaner device is safe and effective in the treatment of thrombosed long-term hemodialysis access sites. Technical and clinical success rates were similar to comparable studies using other devices, with fewer complications and with potential added benefit in cases in which other thrombectomy techniques are not sufficient.