Abstract：
BACKGROUND: Stent development has focused recently on low-profile, self-expandable stents compatible with 0.0165 inch microcatheters. The LVIS EVO is the second-generation version of the Low-Profile Visualized Intraluminal Support (LVIS) with improved visibility and resheathability. The LVIS EVO 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 (US).
METHODS: This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (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: Some 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 5.2 mm 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 <2 mm. All (100%) 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% of cases. There were no delayed thromboembolic or hemorrhagic complications.
CONCLUSIONS: The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (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.
METHODS: This was a multicenter, retrospective, observational study evaluating patients who underwent treatment of an intracranial aneurysm with an LVIS EVO stent after the limited PMR. All physicians who had placed an LVIS EVO stent were asked to input their cases after institutional review board approval was obtained. The data were then sent to a single center for analysis. Any patient aged 18 years or older who underwent treatment of an intracranial aneurysm with a LVIS EVO stent in the US was included from the initial PMR in December 2023 until April 2024. Patient age (or ≤90 years old), sex, preoperative modified Rankin Scale (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: Some 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 5.2 mm 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 <2 mm. All (100%) 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% of cases. There were no delayed thromboembolic or hemorrhagic complications.
CONCLUSIONS: The LVIS EVO is a braided, self-expanding, retrievable stent with enhanced visibility and smaller cell size. The drawn filled tube (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.
摘要：
背景：支架的开发最近集中在低调，自膨胀支架与0.0165英寸微导管兼容。LVISEVO是第二代版本的低轮廓可视化管腔内支持（LVIS），具有改进的可视性和可再渗性。LVISEVO于2023年12月进行了有限的上市前发布（PMR）。本研究旨在报告在美国（US）使用LVISEVO支架治疗颅内动脉瘤的早期安全性和可行性经验。
方法：这是一个多中心，回顾性,观察性研究评估在有限的PMR后接受LVISEVO支架治疗颅内动脉瘤的患者。在获得机构审查委员会批准后，所有放置LVISEVO支架的医生都被要求输入他们的病例。然后将数据发送到单个中心进行分析。从2023年12月的最初PMR到2024年4月，包括在美国接受LVISEVO支架治疗的任何18岁或以上的患者。患者年龄（或≤90岁），性别,术前改良Rankin量表（mRS），动脉瘤位置,动脉瘤测量,收集了术前抗血小板管理的信息。围手术期并发症的数据,30天死亡率，放电mRS,和逗留时间也被收集。
结果：约53例55个动脉瘤患者在15个机构接受了LVISEVO支架治疗。所有动脉瘤均未破裂。最常见的位置是前交通动脉（35％），其次是大脑中动脉分叉（31％）。所有患者均接受双重抗血小板治疗。平均动脉瘤大小为5.2mm，颈部大小为3.7mm。最小的远端亲代血管尺寸为1.2mm,并且36%的支架在<2mm的远端亲代血管中展开。所有（100％）病例均成功展开，并且在10％的病例中重新定位了支架。91%的病例使用了单支架。48例（87.2％）放置了线圈，其中98％的微导管被判入狱。立即获得雷蒙德·罗伊（RR）I类闭塞的33%，22%的II类，IIIa类占37%，和IIIb类在8%的病例中。没有延迟的血栓栓塞或出血性并发症。
结论：LVISEVO是编织的，自我扩张,具有增强的可视性和更小的细胞尺寸可回收支架。拉伸填充管（DFT）技术提高了支架的可见性，允许更受控的支架定位和血管壁并置的可视化。我们系列中的所有病例都具有完整的颈部覆盖和良好的壁并置。无血栓栓塞或出血并发症。
方法：这是一个多中心，回顾性,观察性研究评估在有限的PMR后接受LVISEVO支架治疗颅内动脉瘤的患者。在获得机构审查委员会批准后，所有放置LVISEVO支架的医生都被要求输入他们的病例。然后将数据发送到单个中心进行分析。从2023年12月的最初PMR到2024年4月，包括在美国接受LVISEVO支架治疗的任何18岁或以上的患者。患者年龄（或≤90岁），性别,术前改良Rankin量表（mRS），动脉瘤位置,动脉瘤测量,收集了术前抗血小板管理的信息。围手术期并发症的数据,30天死亡率，放电mRS,和逗留时间也被收集。
结果：约53例55个动脉瘤患者在15个机构接受了LVISEVO支架治疗。所有动脉瘤均未破裂。最常见的位置是前交通动脉（35％），其次是大脑中动脉分叉（31％）。所有患者均接受双重抗血小板治疗。平均动脉瘤大小为5.2mm，颈部大小为3.7mm。最小的远端亲代血管尺寸为1.2mm,并且36%的支架在<2mm的远端亲代血管中展开。所有（100％）病例均成功展开，并且在10％的病例中重新定位了支架。91%的病例使用了单支架。48例（87.2％）放置了线圈，其中98％的微导管被判入狱。立即获得雷蒙德·罗伊（RR）I类闭塞的33%，22%的II类，IIIa类占37%，和IIIb类在8%的病例中。没有延迟的血栓栓塞或出血性并发症。
结论：LVISEVO是编织的，自我扩张,具有增强的可视性和更小的细胞尺寸可回收支架。拉伸填充管（DFT）技术提高了支架的可见性，允许更受控的支架定位和血管壁并置的可视化。我们系列中的所有病例都具有完整的颈部覆盖和良好的壁并置。无血栓栓塞或出血并发症。
