Background We report the largest multicenter experience to date of utilizing the Comaneci device for endovascular treatment of refractory intracranial vasospasm.
Methods Consecutive patients undergoing Comaneci mechanical dilatation for vasospasm were extracted from prospectively maintained registries in 11 North American centers (2020–2022). Intra-arterial vasodilators (IAV) were allowed, with the Comaneci device utilized after absence of vessel dilation post-infusion. Pre- and post-vasospasm treatment scores were recorded for each segment, with primary radiological outcome of score improvement post-treatment. Primary clinical outcome was safety/device-related complications, with secondary endpoints of functional outcomes at last follow-up.
Results A total of 129 vessels in 40 patients (median age 52 years; 67.5% females) received mechanical dilation, 109 of which (84.5%) exhibited pre-treatment severe-to-critical vasospasm (ie, score 3/4). Aneurysmal subarachnoid hemorrhage was the most common etiology of vasospasm (85%), with 65% of procedures utilizing Comaneci-17 (92.5% of patients received IAV). The most treated segments were anterior cerebral artery (34.9%) and middle cerebral artery (31%). Significant vasospasm drop (pre-treatment score (3–4) to post-treatment (0–2)) was achieved in 89.9% of vessels (96.1% of vessels experienced ≥1-point drop in score post-treatment). There were no major procedural/post-procedural device-related complications. Primary failure (ie, vessel unresponsive) was encountered in one vessel (1 patient) (1/129; 0.8%) while secondary failure (ie, recurrence in previously treated segment requiring retreatment in another procedure) occurred in 16 vessels (7 patients) (16/129; 12.4%), with median time-to-retreatment of 2 days. Favorable clinical outcome (modified Rankin Scale 0–2) was noted in 51.5% of patients (median follow-up 6 months).
Conclusions The Comaneci device provides a complementary strategy for treatment of refractory vasospasm with reasonable efficacy/favorable safety. Future prospective trials are warranted.
Data availability statement
Data are available upon reasonable request. The data that support the findings of this study are available from the corresponding author upon reasonable request.
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Contributors MMS and BTJ were the lead investigators. They were involved in the design of the study, acquisition and analysis of data, drafting and revising the manuscript for intellectual content, and final approval of the version to be published. JK, SD, VS, CB, ALK, AM, HS, AHS, JS, EIL, ML, RG, AJT, LML, OT, JKB, ASP, BAG, EN, AEH, and HAS were coinvestigators and were responsible for acquisition of the data, drafting and revising the manuscript for intellectual content, and final approval of the version to be published. All authors agree to be accountable for all aspects of the current work, including its accuracy and integrity, and sound investigative methodology.BTJ is the guarantor of the work and accepts full responsibility for the conduction of the study.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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