Introduction: Smart Coils are novel generation embolic coils designed with robust shape and multiple transitions of softness to promote dense packing and durable long term occlusion. We report data on the utility of the Penumbra Smart Coil System in treatment of a variety of intracranial vascular lesions such as aneurysms and other abnormalities.
Methods: SMART is a prospective, multicenter registry on the benefits of Smart Coils for treatment of cerebral aneurysms and malformations. This interim analysis aims to evaluate data from the initial 250 patients. Procedures must employ ≥75% of the Smart, PC400, or POD coils to meet the registry criteria. Study endpoints include procedural device-related serious adverse events (SAE), and the occlusion status immediately post procedure. Follow-up will be conducted through 1 year.
Results: A wide range of presenting lesions were observed in the first 250 consecutive patients enrolled, including aneurysms (87.9%), of which 27.6% were ruptured, arteriovenous malformations (1.2%), fistulae (6.1%), and other (4.9%). At presentation, 67.9% were female, and the mean age was 58.9 ± 14.6 years. Aneurysms were small (<11mm, 89.8%), large (11-25mm, 9.7%), and giant (>25mm, 9.7%), with 62.6% having a wide neck (≥4mm). Procedural metrics and outcome can be found in Table I; coil deployment time is defined as the time from the first coil deployed until the last coil detachment. For all patients, adequate occlusion as adjudicated by the investigator was achieved for 98.4% (242/246). In aneurysm patients, where known, class I & II Raymond Roy Occlusion was 82.7% (177/214). Procedural device-related SAE were observed in 7 subjects (2.8%). Mortality <24h of intervention was reported in 0.8% patients, and >24h in 2.8% patients; none were device-related. One-year follow-up data is ongoing.
Conclusion: Initial results suggest that Smart Coil achieves adequate embolization in a variety of neurovascular lesions.