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

Abstract

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.