Introduction The Penumbra SMART COIL System includes a novel generation of embolic coils comprised of complex and WAVE shape properties with varying levels of softness to promote dense packing and durable long-term occlusion. We report a subset analysis to assess the durability of treatment with SMART COIL System at one year follow-up in patients with ruptured aneurysms enrolled in the SMART registry.
Materials and methods The SMART registry is a prospective, multi-center registry study. Procedures must employ ≥75% of the SMART, PC400, or POD coils to meet the registry criteria. SMART registry endpoints include retreatment rates through one year follow-up, procedural device-related serious adverse events (SAE), and the ability to achieve adequate occlusion at immediate post-procedure. Multivariate analysis was performed to identify predictors of outcomes at one year.
Results Of the first 500 patients with one year follow-up, 24.2% (121/500) of patients had ruptured aneurysms (74.4% female; mean age 56.4 ± 12.7 years). Ruptured aneurysms were small (<11 mm) in 89.3% (108/121), large (11 to 25 mm) in 9.9% (12/121), and giant (> 25 mm) in 0.8% (1/121) of patients and 30.8% (37/120) were wide-neck (dome-to-neck ratio <1.5 or neck width ≥ 4 mm). Stent-assisted coiling and balloon-assisted coiling were performed in 8.3% (10/121) and 32.2% (39/121) of patients, respectively. Median packing density for ruptured aneurysms was 29.7% (IQR 21.0–40.4).
In patients with ruptured aneurysms, Raymond Class I and II was observed in 90.9% (110/121) at immediate post-procedure and 80.2% (89/111) at one year follow-up. The recanalization rate at one year was 23.4% (26/111). The retreatment rate through one year was 14.4% (17/118). Procedural device-related SAE were observed in 4.1% subjects (5/121).
In multivariate models, independent predictors of Raymond Occlusion Class III at one-year follow-up included wide-neck aneurysm (odds ratio [OR]=5.69; 95% confidence intervals [CI] 1.69–19.15, p=0.0050), balloon-assisted coiling (OR=3.81; 95% CI 1.28–11.37, p=0.017), and age ≥ 65 yr (OR=0.15; 95% CI 0.027–0.78, p=0.025). Balloon-assisted coiling also predicted recanalization at one year follow-up (OR=2.54, 95% CI 1.03–6.27, p=0.043).
Conclusion This subset analysis suggests that the SMART COIL System achieves adequate embolization in ruptured aneurysms with adequate retreatment rates over one year.
Disclosures D. Fiorella: 1; C; Penumbra, Inc. 3; C; Penumbra, Inc. B. Bohnstedt: None. C. Schirmer: None. R. Bellon: 3; C; Penumbra, Inc. R. DeLeacy: None. R. Starke: None. A. Spiotta: 1; C; Penumbra, Inc. 2; C; Penumbra, Inc.
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