Use of a magnetic sphincter for the treatment of GERD: a feasibility study

Use of a magnetic sphincter for the treatment of GERD: a feasibility study
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DOI:
10.1016/j.gie.2007.07.027
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发表时间:
2008-02-01
影响因子:
7.7
通讯作者:
DeMeester, Tom R.
DeMeester, Tom R.
中科院分区:
医学1区
文献类型:
--
作者:
Ganz, Robert A.;Gostout, Christopher J.;DeMeester, Tom R.

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背景:胃底折叠术的成功与否差异很大;此外,胃底折叠术后的并发症也很常见。我们介绍了一种治疗GERD的新装置:使用磁力增强装置对下食道括约肌(LES)进行生物力学增强。目的:在猪模型中,确定磁力装置是否可以安全地增加LES压力,保持关闭的括约肌,并增加胃排出压。设计:体外工作评估设计变量,将增强反流屏障,同时仍保留吞咽功能。猪的急性和慢性(44周)移植后研究也是由宠物形成的。一只动物接受了计划中的装置移除。主要结果测量:胃排出压、动物行为、内窥镜检查、造影检查、球囊扩张研究、食道测压和组织学。结果:胃排出压与增加的磁场力相关(R-2=0.5608,P<.001)。括约肌增强装置在所有动物中都是安全的,没有观察到对进食行为和正常体重增加的影响。所有时间段的食道粘膜显示正常,没有装置移位,也没有明显的组织炎症。植入后平均LES压力升高(P<0.005)。气囊和X线检查显示吞咽时胃食道交界处正常张开,括约肌闭合。结论:磁性括约肌扩大术是治疗胃食管反流的一种新方法。这项研究证明了这种装置在猪模型中的安全性和可行性。对这种用于治疗人类GERD的设备进行进一步的研究似乎是有必要的。
Background: The success of fundoplication surgery varies widely; furthermore, complications after fundoplication can be common. We introduced a new device to treat GERD: biomechanical augmentation of the lower esophageal sphincter (LES) by use of a magnetic reinforcing appliance.Objectives: The aim was to determine whether a magnetic appliance could safely increase LES pressure, maintain a closed sphincter except during swallowing and belching, and increase the gastric yield pressure in a porcine model.Design: Ex vivo work-assessed design variables that would augment the reflux barrier yet still preserve swallow function. Porcine acute and chronic (44 weeks) postimplant studies were also pet-formed. A single animal under-went planned device removal.Main Outcome Measurements: Gastric yield pressure, animal behavior, endoscopy, barium studies, balloon expansion studies, esophageal manometry, and histology.Results: Gastric yield pressure correlated with increasing magnetic forces (R-2 = 0.5608, P < .001). The sphincter augmentation device was safe in all animals, with no observed effect on eating behavior and normal weight gain. The mucosa of the esophagus appeared normal at all intervals, and there was no device migration or significant tissue inflammation. The average LES pressure rose after implantation (P < .005). Balloon and barium studies demonstrated a closed sphincter with normal opening of the gastroesophageal junction during swallowing.Conclusions: Magnetic sphincter augmentation is a novel approach for the treatment of GERD. This study demonstrates the safety and feasibility of such a device in a porcine model. Further investigation of this device for the treatment of GERD in humans seems warranted.