Department of Surgery, Mayo Clinic Florida, Jacksonville, FL.
Department of Medicine, Division of Gastroenterology, Mayo Clinic Florida, Jacksonville, FL.
J Am Coll Surg. 2014 Apr;218(4):776-81. doi: 10.1016/j.jamcollsurg.2013.12.034. Epub 2014 Jan 8.
A new device for mechanical sphincter augmentation (MSA) of the lower esophageal sphincter was approved by the FDA on March 22, 2012. We report early experience with MSA, specifically addressing postoperative management.
Between October 1, 2011 and June 1, 2013, 150 patients were evaluated for MSA. Of these, 66 patients underwent device implantation; the first implant was April 10, 2012. All patients had objectively confirmed gastroesophageal reflux disease (GERD) with pH testing, acceptable esophageal motility, and no significant hiatal hernia (>3 cm). All patients experienced clinical improvement on antisecretory medication, but incomplete symptom control or medication intolerance.
All patients were successfully implanted without intra- or perioperative complications. Average length of hospital stay was 0.7 days. At an average follow-up of 5.8 months (range 1 to 18.6 months), 92% of patients are satisfied or neutral with their GERD condition, and 83% are proton pump inhibitor free. The GERD-Health-Related Quality of Life (HRQL) scores are similar to those of patients without GERD. There were no device ulcers or erosions and no devices explanted. Thirteen patients underwent additional testing for dysphagia or persistent symptoms. Calls with questions and nursing involvement in the first 6 months postoperatively were 3 times what is typical for fundoplication patients. Dysphagia and regurgitation were the most common concerns. All these symptoms were improving over time.
Single-center early results are promising and parallel those from a multicenter trial. There is significant interest in MSA, with referrals and direct patient appointments specifically for MSA. Outcomes improve over time after implantation. The surgeon learning curve is different than with the Nissen, both in operative technique and postoperative management. This is a promising new offering for patients with GERD, and surgeons will need to learn how to integrate this into their practices.
一种新型的机械括约肌增强装置（MSA）于 2012 年 3 月 22 日获得 FDA 批准。我们报告了 MSA 的早期经验，特别是针对术后管理。
2011 年 10 月 1 日至 2013 年 6 月 1 日期间，有 150 名患者接受了 MSA 的评估。其中，66 名患者接受了器械植入；首例植入于 2012 年 4 月 10 日进行。所有患者均经 pH 检测客观证实存在胃食管反流病（GERD），食管动力可接受，且无明显食管裂孔疝（>3cm）。所有患者在使用抗分泌药物时均有临床改善，但症状控制不完全或不耐受药物。
所有患者均成功植入，无围手术期并发症。平均住院时间为 0.7 天。平均随访 5.8 个月（1 至 18.6 个月）时，92%的患者对 GERD 状况满意或中立，83%的患者无需质子泵抑制剂。GERD-健康相关生活质量（HRQL）评分与无 GERD 的患者相似。无器械溃疡或糜烂，也无器械取出。13 名患者因吞咽困难或持续症状接受了额外检查。术后 6 个月内的咨询电话和护理参与次数是胃底折叠术患者的 3 倍。最常见的问题是吞咽困难和反流。所有这些症状都在随着时间的推移而改善。
单中心的早期结果令人鼓舞，与多中心试验结果相似。MSA 受到了广泛关注，有转诊和直接预约 MSA 的患者。植入后，结果随着时间的推移而改善。外科医生的学习曲线与 Nissen 不同，无论是手术技术还是术后管理。这是 GERD 患者的一种有前途的新治疗方法，外科医生需要学习如何将其纳入他们的实践。
