Safety, Efficacy, and Durability of Stent Plus Balloon-Assisted Coiling for the Treatment of Wide-Necked Intracranial Bifurcation Aneurysms

Neurosurgery 88:1028–1037, 2021

Wide-necked bifurcation aneurysms remain a challenge for endovascular surgeons. Dual-stent-assisted coiling techniques have been defined to treat bifurcation aneurysms with a complex neck morphology. However, there are still concerns about the safety of dual-stenting procedures. Stent plus balloon-assisted coiling is a recently described endovascular technique that enables the coiling of wide-necked complex bifurcation aneurysms by implanting only a single stent.

OBJECTIVE: To investigate the feasibility, efficacy, safety, and durability of this technique for the treatment of wide-necked bifurcation aneurysms.

METHODS: A retrospective review was performed of patients with wide-necked intracranial bifurcation aneurysms treated with stent plus balloon-assisted coiling. The initial and follow-up clinical and angiographic outcomeswere assessed. Preprocedural and follow-up clinical statuses were assessed using modified Rankin scale.

RESULTS: A total of 61 patients (mean age: 54.6 ± 10.4 yr) were included in the study. The immediate postprocedural digital subtraction angiography revealed complete aneurysm occlusion in 86.9% of the cases. A periprocedural complication developed in 11.5% of the cases. We observed a delayed ischemic complication in 4.9%. There was no mortality in this study. The permanent morbidity rate was 3.3%. The follow-up angiography was performed in 55 of 61 patients (90.1%) (the mean follow-up period was 25.5 ± 27.3 mo). The rate of complete aneurysm occlusion at the final angiographic follow-up was 89.1%. The retreatment rate was 1.8%.

CONCLUSION: The results of this study showed that stent plus balloon-assisted coiling is a feasible, effective, and relatively safe endovascular technique for the treatment of widenecked bifurcation aneurysms located in the posterior and anterior circulation.

Stent PlusBalloon-Assisted Coiling for the Treatment ofWide-Necked Intracranial Bifurcation Aneurysms

Neurosurgery 88:1028–1037, 2021

Wide-necked bifurcation aneurysms remain a challenge for endovascular surgeons. Dual-stent-assisted coiling techniques have been defined to treat bifurcation aneurysms with a complex neck morphology. However, there are still concerns about the safety of dual-stenting procedures. Stent plus balloon-assisted coiling is a recently described endovascular technique that enables the coiling of wide-necked complex bifurcation aneurysms by implanting only a single stent.

OBJECTIVE:To investigate the feasibility, efficacy, safety, and durability of this technique for the treatment of wide-necked bifurcation aneurysms.

METHODS:A retrospective review was performed of patients with wide-necked intracranial bifurcation aneurysms treated with stent plus balloon-assisted coiling. The initial and follow-up clinical and angiographic outcomes were assessed. Preprocedural and follow-up clinical statuses were assessed using modified Rankin scale.

RESULTS:A total of 61 patients (mean age: 54.6±10.4 yr) were included in the study. The immediate postprocedural digital subtraction angiography revealed complete aneurysm occlusion in 86.9% of the cases. A periprocedural complication developed in 11.5% of the cases. We observed a delayed ischemic complication in 4.9%. There was no mortality in this study. The permanent morbidity rate was 3.3%. The follow-up angiography was performed in 55 of 61 patients (90.1%) (the mean follow-up period was 25.5±27.3 mo).The rate of complete aneurysm occlusion at the final angiographic follow-up was 89.1%. The retreatment rate was 1.8%.

CONCLUSION:The results of this study showed that stent plus balloon-assisted coiling is a feasible, effective, and relatively safe endovascular technique for the treatment of wide-necked bifurcation aneurysms located in the posterior and anterior circulation.

 

Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience

J Neurosurg 133:1756–1765, 2020

Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device.

METHODS This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.

RESULTS A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a devicerelated intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2.

CONCLUSIONS PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist’s armamentarium, especially with regard to its off-label use.

PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience

J Neurosurg 133:1756–1765, 2020

Traditionally, stent-assisted coiling and balloon remodeling have been the primary endovascular treatments for wide-necked intracranial aneurysms with complex morphologies. PulseRider is an aneurysm neck reconstruction device that provides parent vessel protection for aneurysm coiling. The objective of this study was to report early postmarket results with the PulseRider device.

METHODS This study was a prospective registry of patients treated with PulseRider at 13 American neurointerventional centers following FDA approval of this device. Data collected included clinical presentation, aneurysm characteristics, treatment details, and perioperative events. Follow-up data included degree of aneurysm occlusion and delayed (> 30 days after the procedure) complications.

RESULTS A total of 54 aneurysms were treated, with the same number of PulseRider devices, across 13 centers. Fourteen cases were in off-label locations (7 anterior communicating artery, 6 middle cerebral artery, and 1 A1 segment anterior cerebral artery aneurysms). The average dome/neck ratio was 1.2. Technical success was achieved in 52 cases (96.2%). Major complications included the following: 3 procedure-related posterior cerebral artery strokes, a devicerelated intraoperative aneurysm rupture, and a delayed device thrombosis. Immediately postoperative Raymond-Roy occlusion classification (RROC) class 1 was achieved in 21 cases (40.3%), class 2 in 15 (28.8%), and class 3 in 16 cases (30.7%). Additional devices were used in 3 aneurysms. For those patients with 3- or 6-month angiographic follow-up (28 patients), 18 aneurysms (64.2%) were RROC class 1 and 8 (28.5%) were RROC class 2.

CONCLUSIONS PulseRider is being used in both on- and off-label cases following FDA approval. The clinical and radiographic outcomes are comparable in real-world experience to the outcomes observed in earlier studies. Further experience is needed with the device to determine its role in the neurointerventionalist’s armamentarium, especially with regard to its off-label use.

Numerical Analysis of Bifurcation Angles and Branch Patterns in Intracranial Aneurysm Formation

Neurosurgery 85 (1): E31–E39. 2019

Hemodynamic factors, especially wall shear stress (WSS), are generally thought to play an important role in intracranial aneurysm (IA) formation. IAs frequently occur at bifurcation apices, where the vessels are exposed to the impact of WSS.

OBJECTIVE: To elucidate the relationship between bifurcation geometry and WSS for IA formation.

METHODS: Twenty-one bifurcation models varying in branch angles and branch diameters were made with 3-dimensional computer-aided design software. In all models, the value of maximum WSS (WSSMAX), the area of high WSS (AREA), and the magnitude of wall shear force over AREA (|Fw |) were investigated by the steady-flow simulation of computational fluid dynamics.

RESULTS: On the basis of statistical analysis, WSSMAX tended to be high when the bifurcation angle and/or branch diameter was small. AREA and |F⃗ | significantly increase as the bifurcation and/or the branch angle became larger.

CONCLUSION: The magnitude of WSS strongly correlated with bifurcation geometry. In addition to high WSS, AREA and |F⃗ | were thought to affect IA formation. Observed bifurcation geometry may predict IA formation. Large branch angles and small branch may increase the risk of IA formation.