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Safety and efficacy of magnetic sphincter augmentation dilation

机译:磁括约肌增强扩张的安全性和有效性

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Background The magnetic sphincter augmentation device (MSA) provides effective relief of gastroesophageal reflux symptoms. Dysphagia after MSA implantation sometimes prompts endoscopic dilation. The manufacturer's instructions are that it be performed 6 or more weeks after implantation under fluoroscopic guidance to not more than 15 mm keeping 3 or more beads closed. The purpose of this study was to assess adherence to these recommendations and explore the techniques used and outcomes after MSA dilation. Methods and procedures We conducted a multicenter retrospective review of patients undergoing dilation for dysphagia after MSA placement from 2012 to 2018. Results A total of 144 patients underwent 245 dilations. The median size of MSA placed was 14 beads (range 12-17) and the median time to dilation was 175 days. A second dilation was performed in 67 patients, 22 patients had a third dilation and 7 patients underwent 4 or more dilations. In total, 17 devices (11.8%) were eventually explanted. The majority of dilations were performed with a balloon dilator (81%). The median dilator size was 18 mm and 73.4% were done with a dilator larger than 15 mm. There was no association between dilator size and need for subsequent dilation. Fluoroscopy was used in 28% of cases. There were no perforations or device erosions related to dilation. Discussion There is no clinical credence to the manufacturer's recommendation for the use of fluoroscopy and limitation to 15 mm when dilating a patient for dysphagia after MSA implantation. Use of a larger size dilator was not associated with perforation or device erosion, but also did not reduce the need for repeat dilation. Given this, we would recommend that the initial dilation for any size MSA device be done using a 15 mm through-the-scope balloon dilator. Dysphagia prompting dilation after MSA implantation is associated with nearly a 12% risk of device explantation.
机译:背景磁括约肌增强装置(MSA)可有效缓解胃食管反流症状。MSA植入后的吞咽困难有时会引起内镜扩张。制造商的说明是,植入6周或更长时间后,在荧光镜指导下进行,不超过15 mm,保持3个或更多珠子闭合。本研究的目的是评估这些建议的依从性,并探讨MSA扩张后使用的技术和结果。方法和程序我们对2012年至2018年间因吞咽困难行扩张术的患者进行了多中心回顾性研究。结果144例患者共进行了245次扩张。MSA的平均大小为14粒(范围12-17),平均扩张时间为175天。67名患者进行了第二次扩张,22名患者进行了第三次扩张,7名患者进行了4次或更多次扩张。总共有17个设备(11.8%)最终被移植。大多数扩张是用球囊扩张器进行的(81%)。中位扩张器尺寸为18mm,73.4%的扩张器大于15mm。扩张器的大小与后续扩张器的需要无关。28%的病例使用了透视检查。没有与扩张有关的穿孔或器械腐蚀。讨论:制造商建议在MSA植入后对吞咽困难患者进行扩容时,应使用透视检查,并将其限制在15 mm以内,但临床上没有证据支持。使用较大尺寸的扩张器与穿孔或器械侵蚀无关,但也不能减少重复扩张的需要。鉴于此,我们建议对任何尺寸的MSA设备进行初始扩张,使用15 mm的直视球囊扩张器。MSA植入后吞咽困难导致扩张与近12%的器械植入风险相关。

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