Department of Biomedical Sciences for Health, University of Milano Medical School, Milan, Italy.
J Am Coll Surg. 2013 Oct;217(4):577-85. doi: 10.1016/j.jamcollsurg.2013.04.039. Epub 2013 Jul 12.
This study was undertaken to evaluate our clinical experience during a 6-year period with an implantable device that augments the lower esophageal sphincter for gastroesophageal reflux disease (GERD). The device uses magnetic sphincter augmentation (MSA) to strengthen the antireflux barrier.
In a single-center, prospective case series, 100 consecutive patients underwent laparoscopic MSA for GERD between March 2007 and February 2012. Clinical outcomes for each patient were tracked post implantation and compared with presurgical data for esophageal pH measurements, symptom scores, and proton pump inhibitor (PPI) use.
Median implant duration was 3 years (range 378 days to 6 years). Median total acid exposure time was reduced from 8.0% before implant to 3.2% post implant (p < 0.001). The median GERD Health Related Quality of Life score at baseline was 16 on PPIs and 24 off PPIs and improved to a score of 2 (p < 0.001). Freedom from daily dependence on PPIs was achieved in 85% of patients. There have been no long-term complications, such as device migrations or erosions. Three patients had the device laparoscopically removed for persistent GERD, odynophagia, or dysphagia, with subsequent resolution of symptoms.
Magnetic sphincter augmentation for GERD in clinical practice provides safe and long-term reduction of esophageal acid exposure, substantial symptom improvement, and elimination of daily PPI use. For candidates of antireflux surgery who have been carefully evaluated before surgery to confirm indication for MSA, MSA has become a standard treatment at our institution because control of reflux symptoms and pH normalization can be achieved with minimal side effects and preservation of gastric anatomy.
本研究旨在评估我们在过去 6 年中使用一种可植入设备增强下食管括约肌(用于治疗胃食管反流病(GERD))的临床经验。该设备使用磁括约肌增强(MSA)来加强抗反流屏障。
在一项单中心、前瞻性病例系列研究中,2007 年 3 月至 2012 年 2 月期间,100 例连续 GERD 患者接受了腹腔镜 MSA。对每位患者的临床结果进行了跟踪,并与术前食管 pH 测量、症状评分和质子泵抑制剂(PPI)使用情况进行了比较。
中位植入时间为 3 年(范围 378 天至 6 年)。中位总酸暴露时间从植入前的 8.0%减少到植入后的 3.2%(p < 0.001)。基线时 PPI 治疗的 GERD 健康相关生活质量评分中位数为 16,PPI 治疗的 GERD 健康相关生活质量评分中位数为 24,改善至 2(p < 0.001)。85%的患者无需每日依赖 PPI。没有出现长期并发症,如设备迁移或侵蚀。三名患者因持续性 GERD、吞咽困难或吞咽困难而将设备经腹腔镜移除,随后症状缓解。
在临床实践中,MSA 治疗 GERD 可安全且长期减少食管酸暴露,显著改善症状,并消除每日 PPI 的使用。对于经过仔细评估后确认符合 MSA 适应证的抗反流手术候选者,MSA 已成为我们机构的标准治疗方法,因为可以通过最小的副作用和胃解剖结构的保留来控制反流症状和 pH 正常化。