-
Multicenter Study
Clinical Outcomes of Arteriovenous Fistula Treatment Using the Penumbra SMART COIL System: A Subgroup Analysis from the Multicenter SMART Registry.
- Ahmed Abdelsalam, Michael Silva, Min S Park, Tiffany Eatz, Clemens M Schirmer, Sai Sanikommu, Eva M Wu, Richard J Bellon, Joshua D Burks, Alejandro M Spiotta, and Robert M Starke.
- Department of Neurological Surgery, University of Miami, Miami, Florida, USA. Electronic address: aaa824@miami.edu.
- World Neurosurg. 2024 Oct 1; 190: e77e92e77-e92.
BackgroundEndovascular 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.MethodsPatients 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.ResultsA 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.ConclusionsThe coiling procedure for AVFs using the SMART COIL System proved to be safe and effective at the 1-year follow-up.Copyright © 2024 Elsevier Inc. All rights reserved.
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