Multicenter US clinical experience with the Scepter Mini balloon catheter

Mohamed M Salem; Paz Kelmer; Georgios S Sioutas; Sophie Ostmeier; Alex Hoang; Gustavo Cortez; Kareem El Naamani; Rawad Abbas; Ricardo Hanel; Omar Tanweer; Visish M Srinivasan; Pascal Jabbour; Peter Kan; Brian T Jankowitz; Jeremy J Heit; Jan-Karl Burkhardt

doi:10.1177/15910199241246135

Multicenter US clinical experience with the Scepter Mini balloon catheter

Interv Neuroradiol. 2024 Apr 13:15910199241246135. doi: 10.1177/15910199241246135. Online ahead of print.

Authors

Affiliations

¹ Department of Neurosurgery, Hospital of the University of Pennsylvania, Penn Medicine, Philadelphia, PA, USA.
² Department of Radiology and Neurosurgery, Stanford University, Stanford, CA, USA.
³ Department of Neurosurgery, Baylor College of Medicine, Houston, TX, USA.
⁴ Department of Cerebrovascular and Endovascular Surgery, Baptist Neurological Institute and Lyerly Neurosurgery, Jacksonville, FL, USA.
⁵ Department of Neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, PA, USA.
⁶ Department of Neurosurgery, University of Texas Medical Branch Galveston, Galveston, TX, USA.

PMID: 38613371
DOI: 10.1177/15910199241246135

Abstract

Introduction: Distal navigability and imprecise delivery of embolic agents are two limitations encountered during liquid embolization of cerebrospinal lesions. The dual-lumen Scepter Mini balloon (SMB) microcatheter was introduced to overcome these conventional microcatheters' limitations with few small single-center reports suggesting favorable results.

Methods: A series of consecutive patients undergoing SMB-assisted endovascular embolization were extracted from prospectively maintained registries in seven North-American centers (November 2019 to September 2022).

Results: Fifty-four patients undergoing 55 embolization procedures utilizing SMB were included (median age 58.5; 48.1% females). Cranial dural arteriovenous fistula embolization was the most common indication (54.5%) followed by cranial arteriovenous malformation (27.3%). Staged/pre-operative embolization was done in 36.4% of cases; and 83.6% of procedures using Onyx-18. Most procedures utilized a transarterial approach (89.1%), and SMB-induced arterial-flow arrest concurrently with transvenous embolization was used in 10.9% of procedures. Femoral access/triaxial setups were utilized in the majority of procedures (65.5% and 60%, respectively). The median vessel diameter where the balloon was inflated of 1.8 mm, with a median of 1.5 cc of injected embolic material per procedure. Technical failures occurred in 5.5% of cases requiring aborting/replacement with other devices without clinical sequelae in any of the patients, with SMB-related procedural complications of 3.6% without clinical sequelae. Radiographic imaging follow-up was available in 76.9% of the patients (median follow-up 3.8 months), with complete occlusion (100%) or >50% occlusion in 92.5% of the cases, and unplanned retreatments in 1.8%.

Conclusion: The SMB microcatheter is a useful new adjunctive device for balloon-assisted embolization of cerebrospinal lesions with a high technical success rate, favorable outcomes, and a reasonable safety profile.

Keywords: Scepter; balloon; dual-lumen; mini.