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

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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.

ABBREVIATIONS ACA = anterior cerebral artery; ACoA = anterior communicating artery; ANSWER = Adjunctive Neurovascular Support of Wide-neck aneurysm Embolization and Reconstruction; BAA = basilar apex aneurysm; DAC = distal access catheter; DAPT = dual antiplatelet therapy; DSA = digital subtraction angiography; IA = intracranial aneurysm; ICA = internal carotid artery; LVIS Jr. = Low-profile Visualized Intraluminal Support Junior; MCA = middle cerebral artery; PCA = posterior cerebral artery; PRU = platelet response unit; RROC = Raymond-Roy occlusion classification; SAC = stent-assisted coiling; tPA = tissue plasminogen activator.
Article Information

Contributor Notes

Correspondence Peter Kan: Baylor College of Medicine, Houston, TX. peter.kan@bcm.edu.ACCOMPANYING EDITORIAL DOI: 10.3171/2019.6.JNS191292.INCLUDE WHEN CITING Published online November 8, 2019; DOI: 10.3171/2019.5.JNS19313.Disclosures Dr. Spiotta reports the following: Penumbra: consulting, honorarium, and speakers bureau; Pulsar Vascular: consulting, honorarium, and speakers bureau; MicroVention: consulting, honorarium, speakers bureau, and research; Stryker: consulting, honorarium, and speakers bureau. He also reports serving as a consultant to Minnetronix and Cerenovus. Dr. Ducruet reports serving as a consultant to Cerenovus, Medtronic, and Penumbra. Dr. Puri reports receiving support of non–study-related clinical or research effort overseen by author from Stryker and Medtronic; receiving grant/research support from and serving as a consultant to Codman, Covidien, and Stryker Neurovascular; and having direct stock ownership in InNeuroCo. Dr. Amans reports serving as a consultant (Pipeline proctor) to Covidien. Dr. Hetts reports receiving a grant from Stryker Neurovascular; ownership of ThrombX; receiving support of non–study-related clinical or research effort overseen by author from Stryker, MicroVention-Terumo, and Siemens; and serving as a consultant to Neuravi. Dr. Rai reports serving as a consultant to Stryker Neurovascular and Cerenovus. Dr. Boo reports serving as a consultant to Stryker Neurovascular and MicroVention. Dr. Crowley reports being a PulseRider proctor for Cerenovus. Dr. Lanzino reports receiving an educational grant from Cerenovus. Dr. P. R. Chen reports receiving research grants from Stryker. Dr. Diaz reports having a consulting agreement with and serving as a consultant to Medtronic and MicroVention. Dr. Bohnstedt reports receiving support of non–study-related clinical or research effort overseen by author from Cerenovus, Penumbra, and Stryker. Dr. Kan reports serving as a consultant to Cerenovus, Stryker Neurovascular, and Medtronic and receiving research support from MicroVention.
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