Treatment of intracranial aneurysms with the Enterprise stent: a multicenter registry

Clinical article

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  • 1 Departments of Neurosurgery and Radiology, and Toshiba Stroke Research Center, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York, Buffalo;
  • 4 Division of Neurosurgery, Albany Medical Center Hospital, Albany, New York;
  • 2 Department of Neurosurgery, Barrow Neurological Institute, Phoenix, Arizona;
  • 3 Departments of Neurological Surgery and Radiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois;
  • 5 Interventional Neuroradiology, Department of Radiology, West Virginia University School of Medicine, Morgantown, West Virginia;
  • 6 Departments of Neurosurgery and Neuroradiology, Cleveland Clinic Foundation, Cleveland, Ohio;
  • 7 Department of Neurosurgery, University of Florida College of Medicine Gainesville, Florida;
  • 8 Neurological Institute of Savannah, Georgia;
  • 9 Department of Neurological Surgery, University of Pittsburgh Medical Center, Pittsburgh;
  • 10 Division of Neurovascular Surgery and Endovascular Neurosurgery, Department of Neurological Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania; and
  • 11 Department of Neurosurgery, University of Puerto Rico, San Juan, Puerto Rico
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Object

The development of self-expanding stents dedicated to intracranial use has significantly widened the applicability of endovascular therapy to many intracranial aneurysms that would otherwise have been untreatable by endovascular techniques. Recent Food and Drug Administration approval of the Enterprise Vascular Reconstruction Device and Delivery System (Cordis) has added a new option for self-expanding stent-assisted intracranial aneurysm coiling.

Methods

The authors established a collaborative registry across multiple institutions to rapidly provide largevolume results regarding initial experience in using the Enterprise in real-world practice. Ten institutions (University at Buffalo, Thomas Jefferson University, University of Florida, Cleveland Clinic, Northwestern University, West Virginia University, University of Puerto Rico, Albany Medical Center Hospital, the Neurological Institute of Savannah, and the Barrow Neurological Institute) have provided consecutive data regarding their initial experience with the Enterprise.

Results

In total, 141 patients (119 women) with 142 aneurysms underwent 143 attempted stent deployments. The use of Enterprise assistance with aneurysm coiling was associated with a 76% rate of ≥ 90% occlusion. An inability to navigate or deploy the stent was experienced in 3% of cases, as well as a 2% occurrence of inaccurate deployment. Procedural data demonstrated a 6% temporary morbidity, 2.8% permanent morbidity, and 2% mortality (0.8% unruptured, 12% ruptured).

Conclusions

The authors report initial results of the largest series to date in using the Enterprise for intracranial aneurysm treatment. The Enterprise is associated with a high rate of successful navigation and low occurrence of inaccurate stent deployment. The overall morbidity and mortality rates were low; however, caution should be exercised when considering Enterprise deployment in patients with subarachnoid hemorrhage as the authors' experience demonstrated a high rate of associated hemorrhagic complications leading to death.

Abbreviations used in this paper: FDA = Food and Drug Administration; HDE = Humanitarian Device Exemption; ICA = internal carotid artery; ICH = intracerebral hemorrhage; SAH = subarachnoid hemorrhage.

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Contributor Notes

Address correspondence to: Elad I. Levy, M.D., Department of Neurosurgery, University at Buffalo, Millard Fillmore Gates Hospital, Kaleida Health, 3 Gates Circle, Buffalo, New York 14209.

Current address for Drs. Liebman and Veznedaroglu: Stroke and Cerebrovascular Center of New Jersey, Hamilton, New Jersey.

Current address for Dr. Fiorella: Barrow Neurological Institute, Phoenix, Arizona.

Please include this information when citing this paper: published online October 31, 2008; DOI: 10.3171/2008.7.JNS08322.

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