Penumbra's Indigo Thrombectomy Aspiration System Studied in Acutely Thrombosed Dialysis Arteriovenous Fistulas and Grafts

June 7, 2018—Clément Marcelin, MD, et al reported findings from a multicenter study that sought to analyze technical and clinical outcomes of percutaneous thrombectomy aspiration using a vacuum-assisted thrombectomy catheter in acutely thrombosed dialysis arteriovenous fistulas (AVFs) and/or arteriovenous grafts (AVGs). The study's results are available online in Journal of Vascular and Interventional Radiology (JVIR).

The study was composed of 35 patients (average age, 61.8 years; range, 33–81 years) presenting with acute thrombosis of a dialysis AVF and/or AVG from June 2016 to April 2017. Investigators prospectively evaluated patients treated by mechanical thrombectomy using the Indigo system (Penumbra, Inc.) and noted adjunctive therapies and procedure-related complications. They assessed technical success, clinical success, primary patency, primary assisted patency, and secondary patency of the dialysis fistula.

As summarized in JVIR, mean follow-up time in the study was 8.5 months (range, 3–12 months). Technical success was 97.1% (34/35 patients). Clinical success was 91.4% (32/35 patients). Complications included hematoma (n = 1), thrombosis < 24 hours (n = 1), and perforation (n = 1).

Other mechanical/aspiration thrombectomy devices were used in one site to clear the thrombus burden: Arrow-Trerotola (Teleflex, Inc.; 2.8% [1/35 patients]) and Fogarty (Edwards Lifesciences; 5.7% [2/35 patients]). The average procedure time was 38.1 minutes (range, 15–140 min). Average blood loss during the procedure was 122.5 mL (range, 50–300 mL). The 6-month primary patency, primary assisted patency, and secondary patency rates were 71%, 80%, and 88.5%, respectively. No risk factors for early dialysis fistula occlusion were identified. There was no 30-day mortality, reported the investigators.

Percutaneous mechanical thrombectomy aspiration of thrombosed dialysis AVFs and/or AVGs with a vacuum-assisted thrombectomy catheter is a safe procedure with a low complication rate and an effective method for restoring patency before hemodialysis, concluded the investigators in JVIR.