Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience
Department of Radiology
Analytical, Diagnostic and Therapeutic Techniques and Equipment | Cardiovascular Diseases | Nervous System Diseases | Neurology | Radiology | Surgery
OBJECTIVE: 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 device-related 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.
anterior cerebral artery, anterior communicating artery, Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction, basilar apex aneurysm, distal access catheter, dual antiplatelet therapy, digital subtraction angiography, intracranial aneurysm, internal carotid artery, Low-profile Visualized Intraluminal Support Junior, middle cerebral artery, posterior cerebral artery, platelet response unit, PulseRider, Raymond-Roy occlusion classification, stent-assisted coiling, aneurysm, basilar apex, basilar tip, bifurcation, broad neck, coiling, stent, tissue plasminogen activator, vascular disorders, wide neck
DOI of Published Version
J Neurosurg. 2019 Nov 8:1-10. doi: 10.3171/2019.5.JNS19313. [Epub ahead of print] Link to article on publisher's site
Journal of neurosurgery
Srinivasan VM, Puri AS, Kan P. (2019). Early postmarket results with PulseRider for treatment of wide-necked intracranial aneurysms: a multicenter experience. Radiology Publications. https://doi.org/10.3171/2019.5.JNS19313. Retrieved from https://escholarship.umassmed.edu/radiology_pubs/512