背景:这项研究是关于安全性的第一份多中心报告,功效,以及在神经血管介入治疗中利用大孔(0.081″内径)通路导管的技术性能。
方法:通过大口径0.081英寸内径进入导管(BenchmarkBMX81,Penumbra,Inc.).主要结果是技术上的成功,定义为进入导管到达其目标血管。安全性结果包括围手术期器械相关并发症和进入部位并发症。
结果:纳入90例连续患者。患者的中位年龄为63岁(IQR:53,68);53%为女性。最常见的干预措施是动脉瘤栓塞(33.3%),颈动脉支架置入术(12.2%),动静脉畸形栓塞(11.1%)。最常用的是经桡动脉入路(56.7%),其次是经股(41.1%)。具有挑战性的解剖变异包括严重的血管弯曲(8/90,8.9%),2型主动脉弓(7/90,7.8%),3型主动脉弓(2/90,2.2%),牛弓(2/90,2.2%),锁骨下动脉与靶血管之间的严重角度(<30°)(1/90,1.1%)。98.9%的病例(89/90)取得技术成功,其中6例需要从桡骨切换到股骨(6.7%),1例需要从股骨切换到桡骨(1.1%)。无介入部位并发症或与0.081″导管相关的并发症。术后并发症2例(2.2%),与导管无关。
结论:BMX™81大口径导管在各种神经血管手术中的桡骨和股骨入路均安全有效。实现了很高的技术成功,没有任何访问部位或设备相关的并发症。
BACKGROUND: This study is the first multicentric report on the safety, efficacy, and technical performance of utilizing a large bore (0.081″ inner diameter) access catheter in neurovascular interventions.
METHODS: Data were retrospectively collected from seven sites in the United States for neurovascular procedures via large bore 0.081″ inner diameter access catheter (Benchmark BMX81, Penumbra, Inc.). The primary outcome was technical success, defined as the access catheter reaching its target vessel. Safety outcomes included periprocedural device-related and access site complications.
RESULTS: There were 90 consecutive patients included. The median age of the patients was 63 years (IQR: 53, 68); 53% were female. The most common interventions were aneurysm embolization (33.3%), carotid stenting (12.2%), and arteriovenous malformation embolization (11.1%). The transradial approach was most used (56.7%), followed by transfemoral (41.1%). Challenging anatomic variations included severe vessel tortuosity (8/90, 8.9%), type 2 aortic arch (7/90, 7.8%), type 3 aortic arch (2/90, 2.2%), bovine arch (2/90, 2.2%), and severe angle (<30°) between the subclavian artery and target vessel (1/90, 1.1%). Technical success was achieved in 98.9% of the cases (89/90), with six cases requiring a switch from radial to
femoral (6.7%) and one case from
femoral to radial (1.1%). There were no access site complications or complications related to the 0.081″ catheter. Two postprocedural complications occurred (2.2%), unrelated to the access catheter.
CONCLUSIONS: The BMX™ 81 large-bore access catheters was safe and effective in both radial and
femoral access across a wide range of neurovascular procedures, achieving high technical success without any access site or device-related complications.