E-052 Initial Institutional Experience with the Sceptre XC Balloon for the Endovascular Treatment of Cerebral Aneurysms
Authors: Delgado Almandoz J , Kadkhodayan Y , Fease J , Scholz J , Blem A , Tran K , Crandall B 
Published: July 2014

Background and purpose

The Sceptre XC balloon is a novel extra-compliant dual-lumen balloon microcatheter designed for the endovascular treatment of cerebral aneurysms and arteriovenous malformations. This study aims to describe our initial institutional experience with the Sceptre XC balloon for the treatment of cerebral aneurysms.

Methods

We performed a retrospective review of endovascular treatments of cerebral aneurysms with the Sceptre XC balloon at our institution from April 11th, 2012 until February 28th, 2014. Baseline patient and aneurysm characteristics, procedural variables, packing density, intra- operative and post-operative complications, and clinical outcomes using the modified Rankin Scale (mRS) were recorded.

Results

Forty-five patients underwent endovascular treatment of 54 cerebral aneurysms with assistance of the Sceptre XC balloon at our institution during the study period, 33 females (73%) and 12 males (27%), mean age 58.5 years (28–87 years). Fifty-three aneurysms were treated successfully (98.1%). Forty-two aneurysms were unruptured (78%) and 12 ruptured (22%); 5 aneurysms were recurrent (9%). Mean aneurysm size was 7 mm (median 6.3 mm, range 2–17 mm), mean neck size was 3.2 mm (median 2.8 mm, range 1–8.2 mm), mean dome-to-neck ratio was 1.8 (median 1.5, range 0.8–6.5). Aneurysm locations were 17 middle cerebral artery (32%), 13 anterior communicating artery (24%), 13 internal carotid artery (24%), 5 posterior communicating artery (9%), 2 pericallosal artery (4%) and 4 posterior circulation (7%). Balloon neck remodeling was performed in 49 aneurysms (91%), and stent-assistance was ultimately used in 3 aneurysms (5.6%). Three aneurysms were coiled directly through the Sceptre XC balloon (5.6%). Mean packing density was 39.4% (median 40%, range 12–72.2%). Immediate complete/near complete occlusion was achieved in 34 aneurysms (64%), residual neck in 7 aneurysms (13%) and residual sac in 12 aneurysms (23%). The table summarises the intra-operative and post-operative complications in our cohort. There were 3 intra-operative aneurysm ruptures (5.6%), 2 of previously-ruptured aneurysms (16.7%) and 1 of an unruptured aneurysm (2.4%), hemostasis was achieved by immediate balloon inflation in all cases and no patient developed a new neurological deficit. There was 1 distal branch vessel rupture during balloon inflation performed to reduce an intra-aneurysmal catheter loop for a wire exchange prior to stenting, resulting in the patient’s death (2.2%). There was 1 ipsilateral intracerebral haemorrhage on post-operative day 2 in a hypertensive patient with a clopidogrel hyper-response leading to permanent contralateral hemiparesis (2.2%). Overall, 2 complications led to either a new permanent disabling neurological deficit or the patient’s death (mRS ≥ 3, 4.4%).

Conclusion

The Sceptre XC balloon is a valuable adjunctive device for the endovascular treatment of cerebral aneurysms, allowing high treatment success rates and packing densities, achievement of immediate hemostasis in the event of an intra-operative aneurysm rupture, and reduction in the overall need of stent-assistance for cerebral aneurysm treatment.

Abstract E-052 Table 1

Intra-operative and post-operative complications

ComplicationNumber of occurrencesPercent of aneurysmsComplications resulting in new neurological deficit or deathPercent of patientsIntra-operative aneurysm rupture35.60Intra-operative distal vessel rupture11.91 (death)2.2Any coil loop herniation into parent artery7131 (transient neurological deficit)2.2Coil loop herniation requiring stenting11.90Distal coil migration requiring coil retrieval11.90Post-operative ipsilateral infarction11.91 (transient neurological deficit)2.2Post-operative ipsilateral intracerebral haemorrhage11.91 (permanent hemiparesis)2.2Complications resulting in a new permanent disabling neurological deficit or death (mRS ≥ 3)23.724.4

Disclosures

J. Delgado Almandoz: 2; C; Microvention/Terumo, Covidien/ev3, Penumbra Inc. Y. Kadkhodayan: 2; C; Covidien/ev3. J. Fease: None. J. Scholz: None. A. Blem: None. K. Tran: None. B. Crandall: 2; C; Covidien/ev3.