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E-037 Durability of Treatment for the Penumbra SMART COIL System at One Year in Patients with Ruptured Aneurysms: Subset Analysis of the SMART Registry
  1. D Fiorella1,
  2. B Bohnstedt2,
  3. C Schirmer3,
  4. R Bellon4,
  5. R DeLeacy5,
  6. R Starke6,
  7. A Spiotta7
  1. 1Cerebrovascular Center, Stony Brook University Medical Center, Stony Brook, NY
  2. 2Oklahoma University Medical Center, Oklahoma City, OK
  3. 3Geisinger Medical Center, Danville, PA
  4. 4Department of Interventional Neuro Radiology, Swedish Medical Center, Englewood, CO
  5. 5The Mount Sinai Hospital, New York, NY
  6. 6University of Miami Hospital, Miami, FL
  7. 7Medical University of South Carolina, Charleston, SC


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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