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Abstract 1122‐000113: Periprocedural Safety of Intracranial Aneurysm Embolization with Extra Soft Coils: Interim Analysis of SURF Study


 Introduction
 : Coiling with extra soft coils is a widely accepted safe and durable treatment option for intracranial aneurysms but lacks prospective real‐world outcomes. Extra soft coils are specifically designed as fill and finish coils. The primary objective of the SURF study, a postmarket registry, is to assess the real‐world experience of extra soft coils as fill and finish coils to support adequate aneurysm occlusion at 1‐year follow‐up. This study is an interim analysis of periprocedural safety results and ramp‐up of a trial during the COVID‐19 pandemic.
 
 
 Methods
 : The SURF trial is a postmarket, prospective, multicenter, single‐arm, observational trial aiming to enroll about 800 patients. Patients undergoing embolization of intracranial aneurysm with an extra soft coil as the finishing coil were enrolled at 34 centers globally from November 2019 through July 20, 2021, and will be followed up for approximately 1 year. During the first wave of COVID‐19 in the US, enrollment was behind expectations but has caught up with projections as of July 2020. The primary safety endpoints for this interim analysis were serious adverse events (SAEs) within 24 hours after the procedure and device‐related SAEs up to 7 days after the procedure or to discharge.
 
 
 Results
 : This interim analysis is for 346 enrolled patients, characterized by a mean age of 60.1 years and being predominantly (73.1%) female. Medical history included 62.4% of patients with hypertension and 18.2% of patients with a previous history of stroke. The most common aneurysm locations were the internal carotid artery (35.2%) and the anterior cerebral artery (31.1%). Unassisted coiling was the modality of choice in 49.6% of procedures, followed by stent‐assisted coiling in 30.0% and balloon‐assisted coiling in 16.9%. The rate of SAEs within 24 hours after the procedure was 7.8% (27/346; 95% CI, 5.0%‐10.6%). Device‐related SAEs occurred in 1.4% (5/346; 95% CI, 0.2%‐2.7%) of patients up to 7 days after the procedure or to discharge. The rate of major ipsilateral stroke up to discharge was 0.6% (2/346; 95% CI, 0.0%‐1.4%), and the rate of symptomatic intracerebral hemorrhage was 1.4% (5/346; 95% CI, 0.2%‐2.7%), including 2 intraprocedural ruptures and 3 patients who had ruptured aneurysm at baseline and had intraventricular and intracerebral hemorrhage. Patient follow‐up is ongoing.
 
 
 Conclusions
 : We report interim outcomes from the SURF study. This postmarket registry evaluates the safety of extra soft coils as fill and finish coils in the treatment of intracranial aneurysms. Trial ramp‐up, despite temporary delay during the initial COVID‐19 wave, has been progressing along with expectations.
