Abstract P44: Final Outcomes in Patients With Ruptured Aneurysms From the SMART Registry
Introduction: We report the durability of treatment with SMART COIL System at one-year 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 registry criteria. Patients with ruptured aneurysms presenting prior to the procedure were included in this analysis. SMART Registry endpoints include retreatment rates at one year, procedural device-related serious adverse events (SAE), and the ability to achieve adequate occlusion at immediate post-procedure. Results: Of the 905 enrolled patients with aneurysms, 31.8% (288/905) of patients had ruptured aneurysms (74.0% female; mean age 58.0 ± 13.5 years). Ruptured aneurysms were small (<4 mm) in 16.7% (48/288), medium (≥4mm to 10mm) in 68.4% (197/288), large (>10 to 25 mm) in 14.6% (42/288), giant (>25) in 0.3% (1/288), and the mean size was 6.9 mm (SD 3.5 ). Hunt and Hess grade ≥3 was reported in 43.8% (123/281) of patients. The anterior cerebral artery had 33.7% (97/288) of all ruptured aneurysms and the internal carotid artery had 30.6% (88/288). Stent-assisted coiling and balloon-assisted coiling were performed in 7.6% (22/288) and 31.3% (90/288) of patients, respectively. Mean packing density for ruptured aneurysms was 33.4% (SD 20.9). In patients with ruptured aneurysms, retreatment rate at one year was 16.5% (33/200). Procedural device-related SAEs were observed in 3.1% subjects (9/288). Raymond Class I or II was observed in 84.6% (242/286) at immediate post-procedure and in 84.3% (161/191) at one year. The multivariate analysis showed that neck width ≥4 mm (OR 2.56, 95% CI 1.21-5.44, P=0.0144) and male gender (OR 2.17 95% CI 1.05-4.49, P=0.0376) were predictors of Raymond Class III or retreatment at one year. Conclusion: This analysis suggests that the SMART COIL System achieves adequate embolization and retreatment rates in ruptured aneurysms at one year.