美敦力颅内动脉瘤栓塞装置治疗颅内动脉瘤：6 个月时的安全性和血管造影效果。
Medina® Embolization Device for the Treatment of Intracranial Aneurysms: Safety and Angiographic Effectiveness at 6 Months.
机构信息
Department of Interventional Neuroradiology, Pitié-Salpêtrière Hospital, Paris, France.
Department of Interventional Neuroradiology, Rouen University Hospital, Rouen, France.
出版信息
Neurosurgery. 2018 Feb 1;82(2):155-162. doi: 10.1093/neuros/nyx161.
BACKGROUND
The Medina Embolization Device (MED) is a new concept device that combines the design of a detachable coil and the one of an intrasaccular flow disruption device.
OBJECTIVE
To evaluate the feasibility, safety, and 6- to 9-mo effectiveness of this new device for the treatment of intracranial wide-necked aneurysms.
METHODS
Twelve patients (10 females, mean age = 56 yr) with 13 wide-necked intracranial aneurysms (3 ruptured; 10 unruptured) were treated by means of the MED from January 2015 to October 2015. In 15% of the cases, MEDs were used in a standalone fashion; in 85% of the cases, additional regular coils were used. Adjunctive compliant balloon was used in 4 of 13 cases (31%). Procedure-related complications were systematically recorded; discharge and 6- to 9-mo follow-up modified Rankin Scale was assessed. Angiographic follow-up was performed with a mean delay of 5.5 ± 1.7 mo. Occlusion rate was evaluated in postprocedure and at midterm follow-up using the Roy-Raymond scale.
RESULTS
The deployment of the MED was feasible in all cases. No perforation was recorded. One case of thromboembolic complication was observed in a ruptured anterior communicating artery aneurysm, without any clinical consequence at follow-up. Grade A occlusion rate was 61.5% in postprocedure and 83% at 6-mo follow-up. Two cases (17%) of recanalization were documented angiographically.
CONCLUSION
The MED is a new generation device combining the design of a detachable coil and an intrasaccular flow disruption device. According to our early experience, this device is safe and provides a satisfactory occlusion rate at angiographic follow-up of 6 mo.
背景
Medina 栓塞装置（MED）是一种新概念装置，结合了可解脱线圈和腔内血流破坏装置的设计。
目的
评估该新型装置治疗颅内宽颈动脉瘤的可行性、安全性和 6 至 9 个月的有效性。
方法
2015 年 1 月至 2015 年 10 月，12 例患者（10 例女性，平均年龄=56 岁）共 13 个颅内宽颈动脉瘤（3 个破裂；10 个未破裂）接受 MED 治疗。在 15%的病例中，单独使用 MED；在 85%的病例中，使用额外的常规线圈。在 13 例中有 4 例（31%）使用了顺应性球囊。系统记录了与操作相关的并发症；评估出院时和 6 至 9 个月时的改良 Rankin 量表。平均延迟 5.5±1.7 个月进行血管造影随访。采用 Roy-Raymond 分级评估术后即刻和中期随访的闭塞率。
结果
所有病例均可行 MED 部署。未记录穿孔。在前交通动脉瘤破裂中观察到 1 例血栓栓塞并发症，但在随访中无任何临床后果。术后即刻闭塞率为 61.5%，6 个月时为 83%。影像学上发现 2 例（17%）再通。
结论
MED 是一种结合可解脱线圈和腔内血流破坏装置设计的新一代装置。根据我们的早期经验，该装置安全，在 6 个月的血管造影随访中提供了令人满意的闭塞率。
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