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Long-term Results of Enterprise Stent-Assisted Coiling of Cerebral Aneurysms

Fargen, Kyle M. MD, MPH*; Hoh, Brian L. MD*; Welch, Babu G. MD; Pride, G. Lee MD; Lanzino, Giuseppe MD§; Boulos, Alan S. MD; Carpenter, Jeffrey S. MD; Rai, Ansaar MD; Veznedaroglu, Erol MD#; Ringer, Andrew MD**; Rodriguez-Mercado, Rafael MD‡‡; Kan, Peter MD§§; Siddiqui, Adnan MD, PhD§§; Levy, Elad I. MD§§; Mocco, J MD, MS¶¶

doi: 10.1227/NEU.0b013e3182571953
Research-Human-Clinical Studies

BACKGROUND: The Enterprise Vascular Reconstruction Device and Delivery System (Cordis; the Enterprise stent) was approved for use in conjunction with coiling of wide-necked aneurysms in 2007. No published long-term aneurysm occlusion or complication data exist for the Enterprise system.

OBJECTIVE: We compiled data on consecutive patients treated with Enterprise stent-assisted coiling of aneurysms from 9 high-volume neurointerventional centers.

METHODS: A 9 center registry was created to evaluate large volume data on the delayed safety and efficacy of the Enterprise stent system. Pooled data were compiled for consecutive patients undergoing Enterprise stent-assisted coiling at each institution prior to May 2009.

RESULTS: Two-hundred twenty-nine patients with 229 aneurysms, 32 of which were ruptured aneurysms, were included in the study. Mean clinical and angiographic follow-up was 619.6 ± 26.4 days and 655.7 ± 25.2 days, respectively. Mean aneurysm size was 9.2 ± 0.4 mm. Fifty-nine percent of patients demonstrated 100% coil obliteration and 81% had 90% or higher occlusion at last follow-up angiography. A total of 19 patients (8.3%) underwent retreatment of their aneurysms during the follow-up period. Angiographic in-stent stenosis was seen in 3.4% and thromboembolic events occurred in 4.4%. Overall, 90% of patients who underwent Enterprise-assisted coiling had a modified Rankin Scale score of 2 or less at last follow-up. A poor modified Rankin Scale score was strongly associated with rupture status (P < .001).

CONCLUSION: Although this study is limited by its retrospective nature, the Enterprise stent system appears to be an effective, safe, and durable treatment for intracranial aneurysms when used in conjunction with coiling.

ABBREVIATIONS: mRS, modified Rankin Scale

SAH, subarachnoid hemorrhage

*Department of Neurosurgery, University of Florida College of Medicine, Gainesville, Florida

Department of Neurosurgery, University of Texas-Southwestern, Dallas, Texas

§Department of Neurological Surgery, Mayo Clinic, Rochester, Minnesota

Division of Neurosurgery, Albany Medical Center Hospital, Albany, New York

Interventional Neuroradiology, Department of Radiology, West Virginia University School of Medicine, Morgantown, West Virginia

#Department of Neurosurgery, Capital Institute for Neurosciences, Trenton, New Jersey

**Mayfield Clinic, Department of Neurosurgery, University of Cincinnati, Cincinnati, Ohio

‡‡Department of Neurosurgery, University of Puerto Rico, San Juan, Puerto Rico

§§Departments of Neurosurgery and Radiology, Toshiba Stroke Research Center, School of Medicine and Biomedical Sciences, University at Buffalo, State University of New York at Buffalo

¶¶Department of Neurosurgery, Vanderbilt University, Nashville, Tennessee

Correspondence: Kyle M. Fargen, MD, MPH,Box 100265,Gainesville, FL 32610. E-mail: Kyle.fargen@neurosurgery.ufl.edu

Received September 23, 2011

Accepted March 7, 2012

Copyright © by the Congress of Neurological Surgeons