A novel intrasaccular aneurysm device with high complete occlusion rate: Initial results in a rabbit model

Christopher T. Zoppo, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Josephine W. Kolstad, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Robert M. King, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Thomas Wolfe, Advocate Aurora HealthFollow
Afif Kraitem, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Zeynep Vardar, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Aamir Badruddin, Department of Neurology, Community Hospital, Munster, Indiana, USA.Follow
Edgard Pereira, Vascular and Interventional Radiology, Biscayne Medical Arts Center, Miami, Florida, USA.
Boris Pabón Guerrero, Angioteam - Angiosur, Medellín, Colombia, Medellín, Colombia.
Arturo S. Rosqueta, Research and Development, Galaxy Therapeutics, Milpitas, California, USA.
Giovanni J. Ughi, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.
Matthew J. Gounis, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA matthew.gounis@umassmed.edu.
Osama O. Zaidat, Neuroscience, St Vincent Mercy Hospital, Toledo, Ohio, USA.
Vania Anagnostakou, New England Center for Stroke Research, Department of Radiology, University of Massachusetts Chan Medical School, Worcester, Massachusetts, USA.

Affiliations

Aurora Neuroscience Innovation Institute

Abstract

Background:Intrasaccular flow-disrupting devices are a safe and effective treatment strategy for intracranial aneurysms. We utilized high-frequency optical coherence tomography (HF-OCT) and digital subtraction angiography (DSA) to evaluate SEAL Arc, a new intrasaccular device, and compare the findings with the well-established Woven EndoBridge (WEB) device in an animal model of saccular aneurysms.

Methods:In a rabbit model, elastase-induced aneurysms were treated with SEAL Arc (n=11) devices. HF-OCT and DSA were performed after implant and repeated after 12 weeks. Device protrusion and malapposition were assessed at implant time and scored on a binary system. Aneurysm occlusion was assessed at 12 weeks with the WEB Occlusion Scale and dichotomized to complete (A and B) or incomplete (C and D) occlusion. The percentage of neointimal coverage after 12 weeks was quantified using HF-OCT. We compared these data to previously published historical controls treated with the gold-standard WEB device (n=24) in the same model.

Results:Aneurysm size and device placement were not significantly different between the two groups. Complete occlusion was demonstrated in 80% of the SEAL Arc devices, which compared favorably to the 21% of the aneurysms treated with WEB devices (P=0.002). Neointimal coverage across SEAL Arc devices was 86±15% compared with 49±27% for WEB (P=0.001). Protruding devices had significantly less neointimal coverage (P<0.001) as did incompletely occluded aneurysms (P<0.001). Histologically, all aneurysms treated with SEAL Arc devices were completely healed.

Conclusion:Complete early aneurysm occlusion was frequently observed in the SEAL Arc treated aneurysms, with significant neointimal coverage after 12 weeks.

Document Type

Article

PubMed ID

37527927

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