Clinical Outcomes of Arteriovenous Fistula Treatment Using the Penumbra SMART COIL System: A Subgroup Analysis from the Multicenter SMART Registry.

Abstract

Endovascular embolization procedures are typically the primary treatment modality for arteriovenous fistula (AVF). The objective of this subset analysis was to evaluate the prospective long-term clinical outcomes of AVF patients treated with the SMART COIL System. Patients who had AVFs and underwent endovascular coiling using the Penumbra SMART COIL system were part of a subset analysis within the SMART registry. The SMART registry is a postmarket registry that is prospective, multicenter, and single-arm in design. After the treatment, these patients were monitored for a period of 12 ± 6 months. A total of 41 patients were included. No patients (0/41) had a procedural device-related serious adverse event (SAE). Reaccess involving a guidewire due to catheter kickout was unnecessary for 85.4% (35/41) of the patients. Complete occlusion after the procedure was achieved in 87.8% (36/41) of patients. The periprocedural SAE rate was 2.4% (1/41), and no periprocedural deaths occurred (0/41). During the follow-up period, there were instances of retreatment in 3.4% (1/29) of patients. At 1 year, the lesion occlusion was better or stable in 93.3% (28/30) of patients. The rate of SAE from 24 hours to 1 year (±6 months) following the procedure was 26.8% (11/41). The 1-year all-cause mortality rate stood at 2.4% (1/41), and at the 1-year follow-up, 90.9% (20/22) of patients had a modified Rankin Scale score within the range of 0 to 2. The coiling procedure for AVFs using the SMART COIL System proved to be safe and effective at the 1-year follow-up.