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.

Safety and Efficacy of Endovascular Treatment of Basilar Tip Aneurysms by Coiling With and Without Stent Assistance: A Review of 235 Cases

Neurosurgery 71:785–794, 2012

Endovascular therapy is now the preferred treatment option for basilar tip aneurysms (BTAs).

OBJECTIVE: To compare the safety and efficacy of common endovascular techniques in the treatment of BTAs.

METHODS: A retrospective review was conducted of 235 patients with BTAs treated with endovascular means in our institution between 2004 and 2011. Categorization was based on the presence and type of stent assistance (none, single, and Y stenting). The rates of perioperative complications, recanalization, rehemorrhage, and retreatment were analyzed.

RESULTS: A total of 147 patients were treated with coil embolization and 88 patients with stent-assisted coiling (72 single stents, 16 Y stents). Thromboembolic complications occurred in 6.8% of patients in both groups. There was no associated mortality. Angiographic follow-up (mean, 23.5 months) was available in 172 patients (77.1%). Stented patients had significantly lower recanalization (17.2% vs 38.9%; P = .003) and retreatment (7.8% vs 27.8%; P = .002) rates compared with nonstented patients. Four rehemorrhages (2.7%) occurred in the coiled group, whereas none were noted in the stented group (P = .3). In paired comparisons, lower recanalization (8.3% vs 19.2%; P = .21) and retreatment (0% vs 9.6%; P = .19) rates were seen in the Y-stent group compared with the single-stent group. Thromboembolic complications occurred in 6.9% and 6.2% of patients in the single-stent and Y-stent groups, respectively (P = .91). In multivariate analysis, larger aneurysms, nonstented aneurysms, incomplete initial occlusion, and subarachnoid hemorrhage were predictors of aneurysm recanalization.

CONCLUSION: Stent-assisted coiling has significantly lower recurrence, retreatment, and rehemorrhage rates than coiling alone for the treatment of BTAs. Y stenting has the highest efficacy with low complication rates.