Multicenter US clinical experience with the Scepter Mini balloon catheter

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.