Long-term Results of Enterprise Stent-Assisted Coiling of Cerebral Aneurysms 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 complica- tion 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 6 26.4 days and 655.7 6 25.2 days, respectively. Mean aneurysm size was 9.2 6 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. Angio- graphic 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. KEY WORDS: Cerebral aneurysm, Cerebrovascular, Coiling, Endovascular, Enterprise, Stent Neurosurgery 71:239–244, 2012 DOI: 10.1227/NEU.0b013e3182571953 www.neurosurgery-online.com I n 2007 the US Food and Drug Administration approved the Cordis Enterprise Vascular Reconstruction Device and Delivery System (Enterprise stent; Codman Neurovascular, Ratham, Massachusetts) for use in coil emboliza- tion of intracranial aneurysms with wide necks ($4 mm) or poor dome-to-neck ratios (,2). Approval was based on promising single-center coiling results. 1,2 Multicenter short-term results, published in 2009, reported promising immedi- ate occlusion and safety data for 141 patients, revealing a high rate of successful navigation, high aneurysm occlusion rate, and low morbidity and mortality rates. 3 Recently, mid-term results (mean follow-up of 144 days) after Enterprise- assisted embolization of 219 aneurysms in 213 patients were reported. 4 Nine patients (4%) experienced a thrombotic event, and, of the 110 patients with angiography 30 or more days after stent placement, 8 (7%) demonstrated angiographic stenosis, thrombosis, or dissection. Notably, 88% of patients had 90% or higher aneurysm occlusion. To date, no published long-term aneurysm occlusion or clinical outcome data exist for the Enterprise system. The longest follow-up period reported is a single-center experience of 46 patients with 9.1 months mean follow-up; there was a 2% complication rate and 45 of 46 patients had good outcomes. 5 Given the Kyle M. Fargen, MD, MPH* Brian L. Hoh, MD* Babu G. Welch, MD‡ G. Lee Pride, MD‡ Giuseppe Lanzino, MD§ Alan S. Boulos, MD¶ Jeffrey S. Carpenter, MDk Ansaar Rai, MDk Erol Veznedaroglu, MD# Andrew Ringer, MD** Rafael Rodriguez-Mercado, MD‡‡ Peter Kan, MD§§ Adnan Siddiqui, MD, PhD§§ Elad I. Levy, MD§§ J Mocco, MD, MS¶¶ *Department of Neurosurgery, University of Florida College of Medicine, Gaines- ville, Florida; ‡Department of Neurosur- gery, University of Texas-Southwestern, Dallas, Texas; §Department of Neurolog- ical Surgery, Mayo Clinic, Rochester, Minnesota; ¶Division of Neurosurgery, Albany Medical Center Hospital, Albany, New York; kInterventional Neuroradiol- ogy, Department of Radiology, West Virginia University School of Medicine, Morgantown, West Virginia; #Depart- ment of Neurosurgery, Capital Institute for Neurosciences, Trenton, New Jersey; **Mayfield Clinic, Department of Neuro- surgery, 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 Scien- ces, University at Buffalo, State University of New York at Buffalo; ¶¶Department of Neurosurgery, Vanderbilt University, Nash- ville, 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. Published Online, April 2, 2012. Copyright ª 2012 by the Congress of Neurological Surgeons ABBREVIATIONS: mRS, modified Rankin Scale; SAH, subarachnoid hemorrhage RESEARCH—HUMAN—CLINICAL STUDIES TOPIC RESEARCH—HUMAN—CLINICAL STUDIES NEUROSURGERY VOLUME 71 | NUMBER 2 | AUGUST 2012 | 239 Copyright © Congress of Neurological Surgeons. Unauthorized reproduction of this article is prohibited.