{Reference Type}: Journal Article
{Title}: Clinical Outcomes of Arteriovenous Fistula Treatment Using the Penumbra SMART COIL System: A Subgroup Analysis from the Multicenter SMART Registry.
{Author}: Abdelsalam A;Silva M;Park MS;Eatz T;Schirmer CM;Sanikommu S;Wu EM;Bellon RJ;Burks JD;Spiotta AM;Starke RM;
{Journal}: World Neurosurg
{Volume}: 0
{Issue}: 0
{Year}: 2024 Jul 8
{Factor}: 2.21
{DOI}: 10.1016/j.wneu.2024.07.012
{Abstract}: <B>BACKGROUND: </B>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.<BR><B>METHODS: </B>Patients who had arteriovenous fistulas (AVF) 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 post-market registry that is prospective, multicenter, and single-arm in design. After the treatment, these patients were monitored for a period of 12 ± 6 months.<BR><B>RESULTS: </B>A total of 41 patients were included. No patients (0/41) had a procedural device-related serious adverse event (SAE). Re-access 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 re-treatment in 3.4% (1/29) of patients. At one year, the lesion occlusion was better or stable in 93.3% (28/30) of patients. The rate of serious adverse events (SAE) from 24 hours to 1 year (±6 months) following the procedure was 26.8% (11/41). The one-year all-cause mortality rate stood at 2.4% (1/ 41), and at the one-year follow-up, 90.9% (20/22) of patients had a modified Rankin Scale score within the range of 0 to 2.<BR><B>CONCLUSIONS: </B>The coiling procedure for arteriovenous fistulas using the SMART COIL System proved to be safe and effective at the one-year follow-up.