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

Background: 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.

Methods: 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.

Results: 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.

Conclusions: The coiling procedure for AVFs using the SMART COIL System proved to be safe and effective at the 1-year follow-up.