Clinical Study
Preliminary experience and short-term follow-up results of treatment of wide-necked or fusiform cerebral aneurysms with a self-expanding, closed-cell, retractable stent☆

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Abstract

The Cordis Enterprise stent (Cordis Corporation; Miami, FL, USA), is a novel self-expanding, closed-cell, retractable stent with a low profile, good navigability and flexibility, which has been recently introduced into China. We retrospectively analyzed the clinical data of 84 consecutive patients who presented to our institution from December 2008 to June 2009. They had a total of 90 wide-necked or fusiform aneurysms that were treated using Enterprise stents. A total of 97 stents were implanted into the parent arteries without technical failure. A total of 14 aneurysms were stented alone, while the remaining 76 aneurysms were treated using a combination of stent and coils, resulting in complete occlusion of 43 aneurysms, a residual neck in 11 and a residual aneurysm in 22. Procedure-related complications occurred in two patients, which resulted in one procedure-related mortality. The clinical follow-up (1–7 months) results demonstrated no neurological deterioration or re-bleeding. The short-term angiographic follow-up (3–6 months) results revealed one recurrence and no in-stent stenosis. Our results suggest that the Cordis Enterprise stent is easy to manipulate, and is safe and effective in the treatment of complex intracranial aneurysms.

Introduction

The International Subarachnoid Aneurysm Trial has already confirmed the safety and efficacy of endovascular treatment for intracranial aneurysms.[1], [2], [3] With the rapid development of interventional devices and technologies, particularly the advent of the intracranial stent, most intracranial aneurysms can be treated using an endovascular approach. Three types of intracranial stents are available in China: (i) the Neuroform stent (Boston Scientific, Natick, MA, USA); (ii) the LEO stent (Balt Extrusion; Montmorency, France) and the Enterprise stent (Cordis Corporation: Miami, FL, USA), with the last being introduced to China in December 2008. In this preliminary study, we retrospectively collected and analyzed the data of 84 consecutive patients who had a total of 90 wide-necked or fusiform cerebral aneurysms treated using the Enterprise stent to evaluate its feasibility, safety and efficacy.

Section snippets

Patient population

From December 2008 to June 2009, 84 patients (55 women, 29 men; age range 39–84 years; mean age 54.6 years) presented to our institution with a total of 90 wide-necked or fusiform intracranial aneurysms and were treated using Enterprise stents. Out of the 84 patients, 34 experienced acute/subacute subarachnoid hemorrhage (<14 days). Of the 90 aneurysms, two were recurrent aneurysms, 50 were unruptured aneurysms and 38 were ruptured aneurysms. According to the Hunt and Hess Scale, seven patients

Results

Overall, 97 stents were implanted into the parent arteries of the patients included in this study. Three stents measured 37 mm in length, 23 measured 28 mm, 65 measured 22 mm and six measured 14 mm. Successful stent placement was achieved in all patients, resulting in a technical success rate of 100%. No significant difficulty was encountered during the delivery of all stents. Fourteen of the 90 aneurysms were treated using stent alone. Of the remaining 76 aneurysms that underwent coil

Discussion

Higashida et al. reported the first stent-assisted coil embolization for a fusiform BA aneurysm in 1997.5 In 2000, we performed the first stent placement in China for a fusiform VA aneurysm.6 Two years later, the Neuroform stent, the first stent designed specifically for the treatment of intracranial aneurysms, was approved by the US Food and Drug Administration (FDA) under the Humanitarian Device Exemption (HDE) program. It has an open-cell design and cannot be retrieved. The LEO stent is the

Conclusion

Our preliminary experience demonstrates that the Cordis Enterprise stent can be delivered and deployed easily, positioned precisely with a low complication rate, and may be repositioned if needed. While the immediate embolization results are satisfactory, the choice of stent sizes is limited, and its long-term efficacy should be further evaluated.

Acknowledgements

This work was supported in part by Key Project from the Shanghai Committee of Science and Technology (074119506) and the Shanghai Municipal Natural Science Foundation (08ZR1404200).

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