Intracranial aneurysm embolization using Penumbra fill and finish coils: 1-year results of a prospective, real-world, multicenter SURF study.

BACKGROUND

SURF was a prospective, multicenter, single-arm, observational study with core lab adjudication of radiographic data, assessing embolization of intracranial aneurysms (IAs) using WAVE Extra Soft Coils as part of SMART Coil System.

METHODS

Adults undergoing IA embolization with the SMART Coil System (Penumbra, Inc.) comprising >75% of implanted coils and WAVE as the final finishing coil were enrolled at 43 global centers. Primary outcomes were adequate occlusion (Raymond-Roy Occlusion Classification, RROC I/II) at 1 year, serious adverse events (SAEs) within 24 hours, and device-related SAEs up to 7 days (or discharge).

RESULTS

A total of 572 patients (mean age 59.5 years, 72.6% female) were enrolled between November 2019 and August 2022. Among target IAs, 39.9% were ruptured, 78.7% saccular, 54.1% wide-necked, and 11.2% previously treated, with 37.1% located in the internal carotid artery and 30.6% in the anterior cerebral artery. The mean size was 6.6±3.45 mm. Unassisted coiling was used in 50.7% of cases. Adjunctive therapy included stent-assisted coiling (28.8%), balloon-assisted coiling (17.7%), and flow diverters or medications (5.6%). The mean packing density was 34%. RROC I/II was 87.4% immediately post-procedure and 92.4% at 1 year. The retreatment rate was 9.8%, and recanalization was 12.7% at 1 year. SAEs rate within 24 hours was 9.3%. Device-related SAEs occurred in 1.1% of patients. The rate of major ipsilateral stroke was 1.7%.

CONCLUSION

Penumbra's WAVE coils resulted in high packing density and effective and durable embolization of IAs in a diverse, real-world population, supporting coiling as the standard of care for IA treatment.

TRIAL REGISTRATION NUMBER: NCT04106583.