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大脑中动脉和基底动脉顶端宽颈分叉部动脉瘤的血管内治疗:一项多中心、核心实验室评估的闭塞安全性和耐久性评估的研究(BRANCH)

Wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques: a multicentre, core lab adjudicated study evaluating safety and durability of occlusion (BRANCH).

机构信息

Department of Neurosurgery, Mount Sinai Hospital, New York City, New York, USA.

Department of Neurological Surgery, Wake Forest University, Winston-Salem, North Carolina, USA.

出版信息

J Neurointerv Surg. 2019 Jan;11(1):31-36. doi: 10.1136/neurintsurg-2018-013771. Epub 2018 Jun 1.

Abstract

BACKGROUND AND PURPOSE

BRANCH (wide-neck bifurcation aneurysms of the middle cerebral artery and basilar apex treated by endovascular techniques) is a multicentre, retrospective study comparing core lab evaluation of angiographic outcomes with self-reported outcomes.

MATERIALS AND METHODS

Consecutive patients were enrolled from 10 US centres, aged between 18 and 85 with unruptured wide-neck middle cerebral artery (MCA) or basilar apex aneurysms treated endovascularly. Patient demographics, aneurysm morphology, procedural information, mortality and morbidity data and core lab and self-reported modified Raymond Roy (RR) outcomes were obtained.

RESULTS

115 patients met inclusion criteria. Intervention-related mortality and significant morbidity rates were 1.7% (2/115) and 5.8% (6/103) respectively. Core lab adjudicated RR1 and 2 occlusion rates at follow-up were 30.6% and 32.4% respectively. The retreatment rate within the follow-up window was 10/115 (8.7%) and in stent stenosis at follow-up was 5/63 (7.9%). Self-reporting shows a statistically significant direction to angiographic RR one outcomes at follow-up compared with core lab evaluation, with OR 1.75 (95% CI 1.08 to 2.83).

CONCLUSION

Endovascular treatment of wide-neck MCA and basilar apex aneurysms resulted in a core lab adjudicated RR1 occlusion rate of 30.6%. Self-reported results at follow-up favour better angiographic outcomes, with OR 1.75 (95% CI 1.08 to 2.83). These data demonstrate the need for novel endovascular devices specifically designed to treat complex intracranial aneurysms, as well as the importance of core lab adjudication in assessing outcomes in such a trial.

摘要

背景与目的

BRANCH(采用血管内技术治疗大脑中动脉和基底动脉尖部宽颈分叉动脉瘤)是一项多中心回顾性研究,比较了核心实验室评估的血管造影结果与自我报告的结果。

材料与方法

连续纳入了来自 10 个美国中心的患者,年龄在 18 至 85 岁之间,患有未破裂的大脑中动脉(MCA)或基底动脉尖部宽颈动脉瘤,采用血管内治疗。获取了患者人口统计学、动脉瘤形态、手术信息、死亡率和发病率数据以及核心实验室和自我报告的改良 Raymond Roy(RR)结果。

结果

115 名患者符合纳入标准。与介入相关的死亡率和显著发病率分别为 1.7%(2/115)和 5.8%(6/103)。核心实验室判定的 RR1 和 2 闭塞率在随访时分别为 30.6%和 32.4%。在随访窗口内的再治疗率为 10/115(8.7%),随访时支架内狭窄率为 5/63(7.9%)。与核心实验室评估相比,自我报告在随访时显示出与血管造影 RR1 结果有统计学意义的方向,OR 为 1.75(95%CI 1.08 至 2.83)。

结论

血管内治疗大脑中动脉和基底动脉尖部宽颈动脉瘤的核心实验室判定 RR1 闭塞率为 30.6%。随访时自我报告的结果倾向于更好的血管造影结果,OR 为 1.75(95%CI 1.08 至 2.83)。这些数据表明,需要专门设计用于治疗复杂颅内动脉瘤的新型血管内装置,以及在这种试验中使用核心实验室判定来评估结果的重要性。

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