Title

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

Authors

Visish M. Srinivasan, Departments of1Neurosurgery and.
Aditya Srivatsan, Departments of1Neurosurgery and.
Alejandro M. Spiotta, Department of Neurosurgery, Medical University of South Carolina, Charleston, South Carolina.
Benjamin K. Hendricks, Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.
Andrew F. Ducruet, Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.Follow
Felipe C. Albuquerque, Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona.Follow
Ajit Puri, Department of Radiology, University of Massachusetts, Worcester, Massachusetts.
Matthew R. Amans, Department of Radiology, University of California at San Francisco, San Francisco, California.
Steven W. Hetts, Department of Radiology, University of California at San Francisco, San Francisco, California.
Daniel L. Cooke, Department of Radiology, University of California at San Francisco, San Francisco, California.
Christopher S. Ogilvy, Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Ajith J. Thomas, Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Alejandro Enriquez-Marulanda, Neurosurgical Service, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
Ansaar Rai, Department of Radiology, West Virginia University Hospital, Morgantown, West Virginia.
SoHyun Boo, Department of Radiology, West Virginia University Hospital, Morgantown, West Virginia.
Andrew P. Carlson, Department of Neurosurgery, University of New Mexico School of Medicine, Albuquerque, New Mexico.
R Webster Crowley, Department of Neurosurgery, Rush Medical College, Chicago, Illinois.
Leonardo Rangel-Castilla, Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota.
Giuseppe Lanzino, Department of Neurosurgery, Mayo Clinic, Rochester, Minnesota.
Peng Roc Chen, Department of Neurosurgery, University of Texas Health Science Center, Houston, Texas.
Orlando Diaz, The Cerebrovascular Center, Houston Methodist Hospital, Houston, Texas; and.
Bradley N. Bohnstedt, Department of Neurosurgery, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
Kyle P. O'Connor, Department of Neurosurgery, University of Oklahoma College of Medicine, Oklahoma City, Oklahoma.
Jan-Karl Burkhardt, Departments of1Neurosurgery and.
Jeremiah N. Johnson, Departments of1Neurosurgery and.
Stephen R. Chen, Radiology, Baylor College of Medicine, Houston, Texas.
Peter Kan, Departments of1Neurosurgery and.

Document Type

Article

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 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.

Keywords

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, PulseRider, RROC = Raymond-Roy occlusion classification, SAC = stent-assisted coiling, aneurysm, basilar apex, basilar tip, bifurcation, broad neck, coiling, stent, tPA = tissue plasminogen activator, vascular disorders, wide neck

Publication Date

11-8-2019

Publication Title

Journal of neurosurgery

E-ISSN

1933-0693

First Page

1

Last Page

10

PubMed ID

31703202

Digital Object Identifier (DOI)

10.3171/2019.5.JNS19313

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