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

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Abstract

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 A ₁ 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.

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Author and article information

Journal

Title: Journal of Neurosurgery

Publisher: Journal of Neurosurgery Publishing Group (JNSPG)

ISSN (Print): 0022-3085

ISSN (Electronic): 1933-0693

Publication date Created: November 2019

Publication date (Print): November 2019

Pages: 1-10

Affiliations

[1 ]Departments of 1Neurosurgery and

[2 ]2Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina;

[3 ]3Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona;

[4 ]4Department of Radiology, University of Massachusetts, Worcester, Massachusetts;

[5 ]5Department of Radiology, University of California at San Francisco, San Francisco, California;

[6 ]6Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts;

[7 ]7Department of Radiology, West Virginia University Hospital, Morgantown, West Virginia;

[8 ]8Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico;

[9 ]9Department of Neurosurgery, Rush Medical College, Chicago, Illinois;

[10 ]10Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota;

[11 ]11Department of Neurosurgery, University of Texas Health Science Center, Houston, Texas;

[12 ]12The Cerebrovascular Center, Houston Methodist Hospital, Houston, Texas; and

[13 ]13Department of Neurosurgery, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma

[14 ]14Radiology, Baylor College of Medicine, Houston, Texas;

Article

DOI: 10.3171/2019.5.JNS19313

PubMed ID: 31703202

SO-VID: e012ea0b-cd68-4780-8966-11d00cbef29b

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