Department of Biomedical Sciences for Health, University of Milan, Milan, Italy.
Division of General and Foregut Surgery, IRCCS Policlinico San Donato, Piazza E. Malan, 1, 20097, San Donato Milanese, MI, Italy.
Sci Rep. 2020 Aug 13;10(1):13753. doi: 10.1038/s41598-020-70742-3.
The magnetic sphincter augmentation (MSA) device has been proven safe and effective in controlling typical reflux symptoms and esophageal acid exposure for up to 6-year follow-up. Longer term outcomes have not been reported yet. A prospectively maintained database was reviewed to assess long-term safety and efficacy of the laparoscopic MSA procedure at a single referral center. Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL), use of proton-pump inhibitors (PPI), and esophageal acid exposure were compared to baseline. Favorable outcomes were defined as ≥ 50% improvement of GERD-HRQL total score and PPI discontinuation. Between March 2007 and March 2020, 335 patients met the study inclusion criteria, and 124 of them were followed from 6 to 12 years after surgery (median 9 years, IQR 2). Mean total GERD-HRQL score significantly improved from 19.9 to 4.01 (p < 0.001), and PPI were discontinued by 79% of patients. The mean total percent time with pH < 4 decreased from 9.6% at baseline to 4.1% (p < 0.001), with 89% of patients achieving pH normalization. Independent predictors of a favorable outcome were age at intervention < 40 years (OR 4.17) and GERD-HRQL score > 15 (OR 4.09). We confirm long-term safety and efficacy of MSA in terms of symptom improvement, decreased drug dependency, and reduced esophageal acid exposure.
磁括约肌增强（MSA）装置已被证明在控制典型反流症状和食管酸暴露方面是安全有效的，随访时间长达 6 年。尚未报告更长时间的结果。本研究回顾了一个前瞻性维护的数据库，以评估单一转诊中心腹腔镜 MSA 手术的长期安全性和疗效。胃食管反流病健康相关生活质量（GERD-HRQL）、质子泵抑制剂（PPI）的使用和食管酸暴露与基线进行比较。将 GERD-HRQL 总评分和 PPI 停药≥50%改善定义为良好结局。2007 年 3 月至 2020 年 3 月，335 例患者符合研究纳入标准，其中 124 例患者在手术后 6 至 12 年（中位数 9 年，IQR 2 年）进行了随访。平均总 GERD-HRQL 评分从 19.9 分显著改善至 4.01 分（p<0.001），79%的患者停止使用 PPI。平均总 pH<4 的时间百分比从基线时的 9.6%降至 4.1%（p<0.001），89%的患者实现了 pH 正常化。良好结局的独立预测因素是干预时年龄<40 岁（OR 4.17）和 GERD-HRQL 评分>15（OR 4.09）。我们证实了 MSA 在改善症状、减少药物依赖和减少食管酸暴露方面具有长期安全性和疗效。
