SMART Registry: Safety and Performance of the Penumbra SMART COIL System for Patients With Intracranial Aneurysms 4 mm and Smaller.

ABSTRACT

BACKGROUND: The Penumbra SMART COIL System includes a novel generation of embolic coils composed of complex and WAVE shape properties with varying levels of softness. OBJECTIVE: To assess safety and efficacy of the SMART COIL System through a 1-year follow-up in patients with small intracranial aneurysms. METHODS: This subset analysis of the SMART Registry, a prospective, multicenter study, includes patients with small intracranial aneurysms (≤4 mm) treated with the SMART COIL System. Registry end points include retreatment rates through 1 year, procedural device-related serious adverse events, and adequate occlusion postprocedure. RESULTS: Of 905 enrolled patients with aneurysms, 172 (19.0%) had small (≤4 mm) aneurysms (75.6% female; mean age 57.2 ± 13.4 years). 30.8% (53/172) of small aneurysms were ruptured, of which 50.9% (27/53) had Hunt and Hess ≥3. 79.5% (132/166) were wide-necked. Stent-assisted coiling and balloon-assisted coiling were performed in 37.2% (64/172) and 22.1% (38/172) of patients, respectively. The mean packing density for very small aneurysms was 44.9 (SD 25.23). Raymond Class I and Class II were achieved in 89.5% (154/172) postprocedure and 97.2% (137/141) at 1 year. The retreatment rate through 1 year was 5.6% (8/142), and the recanalization rate was 7.1% (10/141). The periprocedural device-related serious adverse event rate was 2.9% (5/172). Intraprocedural aneurysm rupture occurred in 0.8% of patients. CONCLUSION: This analysis suggests that the SMART COIL System is safe and efficacious in small aneurysms with satisfactory occlusion rates and low rates of rupture or rerupture. At 1 year, patients had low retreatment rates and good clinical outcomes.