Introduction Cerebral vasospasm (CV) is a devastating medical complication of aneurysmal subarachnoid hemorrhage (SAH). Despite treatment of the aneurysm, CV is still associated with high morbidity and mortality rates. The current endovascular approach to treating CV includes IA infusion of vasodilators and angioplasty using Comaneci, stentrievers, or balloons. We present interim data from a multi-center study evaluating the safety and effectiveness of the Comaneci device in treating symptomatic CVs.

Methods This is a single-arm, open, multi-center, prospective registry study. The primary outcome is a procedural success, defined as a 50% or greater vessel caliber on DSA compared to baseline. Safety primary outcomes are intraoperative and post-treatment events. Radiological evaluation is based on a 4-level scale.The study enrolled patients (age ≥18) who presented with cerebral vasospasm following aneurysmal subarachnoid hemorrhage (SAH) and were treated with the Comaneci device. The major inclusion criteria are symptomatic, severe, or critical vasospasm or radiographic evidence of vasospasm of patients following aneurysmal SAH, whose symptoms cannot be assessed (such as intubated patients), with narrowing higher than 50% compared to pre-spasm baseline in one or more of the following vessels: ICA, M1-M3, A1-A3, VA, BA and P1-P2 that are accessible to endovascular treatment with Comaneci. Comaneci had to be used as a first-line endovascular treatment on the treated segments.

Results Ten (40% male, mean age 47.8) subjects from 5 different European sites were enrolled. The mean baseline Glasgow Coma Scale and Hunt and Hess grade were 12.2 and 3, respectively. A total of 18 vessel segments, including ICA, M1, M2, A1, A2, VA, BA, P1, M3, A3, and P2, were treated with Comaneci as a first-line endovascular treatment. Procedural success (50% or greater vessel diameter compared to baseline diameter) was achieved in 17 out of the 18 treated segments (94%). One intraoperative complication (i.e., worsening of angiographic vasospasm) was reported. No mortality was reported. In addition, vasospasm recurrence, defined as an increase of at least one point on the vasospasm scale in the defined vessel segment (when compared to the last post-treatment measurement), was reported for 2 vessels (11%). Moreover, pre-treatment and 30 days post-treatment mRS was measured and is available from 6 subjects. In 4 out of 6 (67%) subjects mRS was decreased by one point, unchanged in one subject and increased by one point in one subject. Data is still under monitoring process and imaging core lab review.

Discussion The interim results of this this study demonstrate a high rate of angiographic success with a very low rate of complications and a trend towards improved clinical outcomes. Comaneci may be a viable approach for safely treating vasospasm following aneurysmal SAH.

Disclosures J. Hensler: None. N. Larsen: None. F. Wodarg: None. V. Hesselmann: None. C. Riedel: None. P. Schramm: None. J. Hoeltje: None. H. Nordmeyer: None. C. Deuschl: None. T. Phung: None. S. Schob: None. O. Jansen: None.