Article Text
Abstract
Background The LVIS EVO is the second generation version of the Low-Profile Visualized Intraluminal Support(LVIS) with improved visibility and resheathability and underwent a limited premarket release(PMR) in December 2023. This study aims to report the early safety and feasibility experience with the LVIS EVO stent for the treatment of intracranial aneurysms in the United States.
Methods This is a multicenter retrospective observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. Any patient 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the United States was included from the initial PMR in December 2023 until April 2024. Patient age(or ≤90 years old), sex, preoperative mRS, aneurysm location, aneurysm measurements, and information about preoperative antiplatelet management were all collected. Data on periprocedural complications, 30-day mortality, discharge mRS and length of stay were also collected.
Results 53 patients with 55 aneurysms underwent treatment with the LVIS EVO stent at 15 institutions. All aneurysms were unruptured. The most common location was the anterior communicating artery(35%) followed by the middle cerebral artery bifurcation(31%). All patients were on dual antiplatelet therapy. The average aneurysm size was 5.2mm with a neck size of 3.7 mm. The smallest distal parent vessel size was 1.2 mm and 36% of stents were deployed in distal parent vessels < 2mm. 100% of cases had successful deployment and the stent was repositioned in 10% of cases. A single stent was utilized in 91% of cases. Coils were placed in 48 cases(87.2%) and a microcatheter was jailed in 98% of those cases. Immediate Raymond Roy(RR) Class I occlusion was obtained in 33%, Class II in 22%, Class IIIa in 37% and Class IIIb in 8%. There were no delayed thromboembolic or hemorrhagic complications.
Conclusion The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The DFT technology results in improved visibility of the stent allowing for more controlled stent positioning and visualization of vessel wall apposition. All cases in our series had complete neck coverage and good wall apposition. There were no thromboembolic or hemorrhagic complications. The LVIS EVO is a good option when some degree of flow diversion is desired or when using a single stent to cover a bifurcation with ‘fluffing’ of the stent to provide better neck coverage.
Disclosures Y. Kayan: None. J. Delgado Almandoz: None. A. Copelan: 2; C; Microvention. 4; C; Piraeus Medical. I. Chaudry: None. C. Matouk: 2; C; Medtronic, Microvention, Stryker, Navigantis, Hybernia, Cerenovus, Silk Road. D. Altschul: None. M. Amir Essibayi: None. O. Goren: None. B. Yim: 2; C; Imperative Care, Q’apel. 3; C; Penumbra. S. Tsappidi: None. Y. Zhang: None. F. Hui: None. E. Samaniego: None. A. Gudino: None. A. Siddiqui: 2; C; Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Asahi Intecc Co Ltd., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., CerebrovaKP,. V. Jaikumar: None. A. Puri: 2; C; Microvention, Route 92, Stryker, Medtronic, Agile, Merit. 4; C; InNeuroCo, NTI, Agile, Galaxy, Perfuze. A. Kuhn: None. J. Singh: None. A. Ringer: None. R. Hanel: None. O. De Toledo: None. G. Dabus: None. M. Gooch: 2; C; Stryker, Rapid Medical. S. Sizdahkhani: None. N. Field: None. A. Custozzo: None. A. Paul: 2; C; Microvention, Penumbra, IRRAS, GT Medical, NICO.