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

TLDR

Self‑expanding stents have expanded endovascular treatment of intracranial aneurysms, and FDA approval of the Enterprise device introduced a new stent‑assisted coiling option. The study aimed to rapidly collect large‑volume real‑world data on the initial experience using the Enterprise stent for intracranial aneurysm treatment. A multicenter registry collected consecutive data from 10 institutions on 141 patients with 142 aneurysms undergoing 143 Enterprise stent deployments. In this largest series to date, Enterprise‑assisted coiling achieved a 76 % rate of ≥90 % occlusion, high navigation success, low inaccurate deployment (2 %), and overall low morbidity (6 % temporary, 2.8 % permanent) and mortality (2 %), though caution is advised in subarachnoid hemorrhage patients due to higher hemorrhagic complications.

Abstract

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.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.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 > or = 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).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.