The second-generation eCLIPs Endovascular Clip System: initial experience

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OBJECTIVE

Treatment of wide-necked intracranial aneurysms is associated with higher recanalization and complication rates; however, the most commonly used methods are not specifically designed to work in bifurcation lesions. To address these issues, the authors describe the evolution in the design and use of the eCLIPs (Endovascular Clip System) device, a novel hybrid stent-like assist device with flow diverter properties that was first described in 2008.

METHODS

A registry was established covering 13 international centers at which patients were treated with the second-generation eCLIPs device. Aneurysm morphology and rupture status, device neck coverage, coil retention, and procedural and late morbidity and mortality were recorded. For those patients who had undergone successful implantation more than 6 months earlier, the final imaging and clinical follow-up results and need for re-treatment were recorded.

RESULTS

Thirty-three patients were treated between June 2013 and September 2015. Twenty-five (76%) patients had successful placement of an eCLIPs device; 23 (92%) of these 25 patients had complete data. Eight cases of nondeployment occurred during the 1st year of use, consistent with a learning curve; no failures of deployment occurred thereafter. Two periprocedural transient ischemic attacks and 2 asymptomatic thrombotic events occurred. Twenty-one (91%) of 23 patients underwent follow-up at an average of 8 months (range 3–18 months); 9 (42.9%) of these 21 patients demonstrated an improvement in Raymond grade at follow-up; no cases of worsening Raymond grade were recorded, and 17 (81.0%) patients sustained a modified Raymond-Roy Classification class of I or II angiographic result at follow-up. Two delayed ruptures were recorded, both in previously coiled, symptomatic giant aneurysms where the device was used as a part of a salvage strategy.

CONCLUSIONS

The second-generation eCLIPs device is a viable treatment option for bifurcation aneurysms. The aneurysm occlusion rates in this initial clinical series are comparable to the initial experience with other bifurcation support devices.

ABBREVIATIONS ICA = internal carotid artery; MCA = middle cerebral artery; MRRC = modified Raymond-Roy Classification; PCA = posterior cerebral artery; WEB = Woven EndoBridge Aneurysm Embolization System.

Article Information

Correspondence Thomas R. Marotta, Diagnostic and Therapeutic Neuroradiology, St. Michael's Hospital, 30 Bond St., Toronto, ON M5B 1W8, Canada. email: marottat@smh.ca.

INCLUDE WHEN CITING Published online March 17, 2017; DOI: 10.3171/2016.10.JNS161731.

Drs. Chiu and Marotta contributed equally to this work.

Disclosures The authors report the following. Dr. De Vries: consultant for Evasc; and principal investigator for the EESIS trial, a multicenter postmarketing study evaluating the safety, technical feasibility, and efficacy of the eCLIPs family of products for the treatment of bifurcation intracranial aneurysms, an industry sponsored trial (Evasc). Dr. O'Kelly: proctor for Pipeline Embolization Device insertion for Medtronic. Dr. Riina: medical advisor to and financial stakeholder of Evasc Medical Systems. Mr. McDougall: ownership in, consultant for, and employed by Evasc Medical Systems. Mr. Tippett: employed by Evasc Medical Systems. Ms. Wan: employed by Evasc Medical Systems. Dr. Marotta: direct stock ownership in Evasc, and medical consultant and proctor for eCLIPs, part of Evasc.

© AANS, except where prohibited by US copyright law.

Headings

Figures

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    A: Schematic of the eCLIPs device, demonstrating the leaf section, designed to lie over the neck of the aneurysm with increased metal coverage to promote flow diversion and coil support, and the anchor section, designed to lie on the vessel wall beside the neck. B: Schematic demonstrating the different cross-sectional profiles of the eCLIPs device. The leaf section is wider, maximizing neck coverage. C: En face schematic of a bifurcation aneurysm demonstrating the intended deployment position of the eCLIPs device, which does not jail either branch of the bifurcation, and allows microcatheter access to the aneurysmal sac.

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    Scanning electron microscopy images of eCLIPs explants from a model of carotid aneurysm bifurcation in rabbits at 90 days. Sequential magnifications of the eCLIPs device showing complete incorporation of the device ribs with well-organized, endothelialized neointimal overgrowth. Original magnification ×50 (A), ×200 (B), and ×600 (C).

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    A: Right ICA rotational angiogram (anteroposterior view) of a representative case treated with eCLIPs and coils, demonstrating an unruptured 10-mm right ICA terminus aneurysm in a 64-year-old woman. B: Right ICA roadmap fluoroscopy image (frontal projection) demonstrating delivery of the eCLIPs device into the right A1 segment of the anterior cerebral artery. C: Deployment of the eCLIPs device across the neck of the aneurysm with stasis of contrast within the aneurysmal dome, indicative of flow diversion effect. D: Right ICA angiogram (frontal projection) demonstrating the immediate postprocedural appearance with coiling of the aneurysmal dome post-eCLIPs placement. E: Right ICA angiogram (frontal projection) demonstrating the appearance at the 6-month follow-up with no evidence of neck recurrence.

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    A: Left vertebral artery angiogram (frontal projection) showing a basilar tip aneurysm targeted for treatment with eCLIPs. B and C: Left vertebral angiogram (frontal projection) obtained after eCLIPs microcatheter delivery into the right PCA (arrowhead, B). Note lack of filling into the right PCA, after which further attempts at eCLIPs delivery were abandoned and the patient was treated with balloon-assisted coiling, resulting in a neck remnant (C). D: Frontal projection of a maximum-intensity projection Gd-enhanced MR angiogram obtained 2 months later, demonstrating a large aneurysmal recurrence (arrow).

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    Flowchart demonstrating the breakdown of data with regard to occlusion according to the MRRC. Raymond Class I, complete obliteration; Class II, residual neck; Class IIIa, central interstitial filling; and Class IIIb, interstitial filling adjacent to the aneurysm wall.

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    Bar graph demonstrating the initial and follow-up MRRC classes for all treated aneurysms with complete initial and followup data (n = 21).

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    Bar graph demonstrating the breakdown of changes in MRRC class between time of treatment and follow-up, comparing the eCLIPs device and stent-assisted coiling (data from the study by Hetts et al.). Worsening of MRRC class occurred in more than 20% of cases treated with stent-assisted coiling, whereas aneurysm filling remained stable or improved with the eCLIPs device.

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