TF was an effective treatment for patients with GERD symptoms, particularly in those with persistent regurgitation despite PPI therapy, based on evaluation 6 months after the procedure. Clinicaltrials.gov no: NCT01136980.

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Patients with GERD with moderate-to-severe regurgitation, especially despite once-daily PPI treatment, should be considered for minimally invasive treatment with MSA rather than increased PPI therapy. (Clinical trial registration number: NCT02505945.).

BackgroundTransoral treatment of gastroesophageal reflux disease (GERD) using the EsophyX device enables creation of an esophagogastric fundoplication with potential for better control of reflux than gastrogastric techniques. Efficacy and safety of a rotational/longitudinal esophagogastric transoral incisionless fundoplication (TIF) was evaluated retrospectively using subjective and objective outcomes.MethodsThirty-seven consecutive patients on antisecretory medication and with proven gastroesophageal reflux and limited hiatal hernia underwent TIF for persistent GERD symptoms. Five patients were reoperations for failed laparoscopic fundoplication.ResultsOf the 37 treated patients, 57% were female. The median age was 58 (range = 20–81) years and BMI was 25.5 (range = 15.9–36.1) kg/m2. Sixty-eight percent indicated GERD-associated cough, asthma, or aspiration as a primary complaint and 32% complained of heartburn or regurgitation. The TIF procedures created tight wraps of 230°–330° extending 3–4 cm above the Z-line. Two complications occurred: one mediastinal abscess treated laparoscopically and one postoperative bleeding requiring transfusion. At 6 (range = 3–14) months median follow-up TIF resulted in a significant improvement of both atypical and typical symptoms in 64% and 70–80% of patients, respectively, as indicated by the corresponding GERD health-related quality of life (HRQL) and reflux symptom index (RSI) score reduction by 50% or more compared to baseline on proton pump inhibitors (PPIs). No patient reported problems with dysphagia, bloating, or excess flatulence, and 82% were not taking any PPIs. Reflux characteristics were significantly improved and normalized in 61, 89, and 56% of patients in terms of acid exposure, number of refluxates, and DeMeester scores, respectively. TIF was effective in treating GERD in 75% of patients among whom 54% were in a complete “remission” and 21% were “improved.” The remaining 25% were considered failures, and five (13.5%) patients underwent revision.ConclusionRotational/longitudinal esophagogastric fundoplication using the EsophyX device significantly improved symptomatic and objective outcomes in over 70% of patients at median 6-month follow-up. Post-fundoplication side effects were not reported after TIF.

Laparoscopic Toupet fundoplication should be reserved for milder cases of GERD, as assessed by manometry and endoscopy.

IntroductionMagnetic sphincter augmentation (MSA) of the lower esophageal sphincter restores the antireflux barrier in patients with hiatal hernias ≤3 cm. We performed a prospective study in patients undergoing MSA with the LINX device during repair of paraesophageal and hernias over 3 cm axial component.Methods and proceduresMulticenter, prospective study of consecutive patients treated with MSA at the time of repair of hiatal hernias >3 cm.Results200 patients (110 female) were treated between March 2014 and February 2017 via laparoscopic hernia repair and MSA. Mean age was 59.5 years, mean BMI 29.4. 40% had esophagitis, 20% intestinal metaplasia, 72 of 77 tested had abnormal pH studies. Preoperative PPI use was reported by 87%. Eighteen patients had prior hiatal hernia/fundoplication. All had normal function. 78% of patients had axial hiatal hernia ≥5 cm or large paraesophageal component. Mean operative time was 81 min (38–193), EBL was 10 cc. Non-permanent mesh reinforcement of hiatal repair was performed in 83% of the patients. There were two readmissions for dehydration; 2 patients with pulmonary embolism, and 1 patient with cardiac ischemia. Nineteen patients required dilation. 156 pts were followed at a median of 8.6 months. GERD-HRQL scores improved from 26 preoperatively to 2 postoperatively. Complete PPI independence was achieved in 94% (147/156). Videoesophagram in 51 patients at median 11 months found 3 asymptomatic hernias <3 cm. One symptomatic patient underwent successful repair of the hernia without MSA manipulation. There have been no device explants, erosions, or migrations to date.ConclusionsThis prospective study of 200 patients with >3 cm hernias undergoing MSA with hiatoplasty resulted in favorable outcomes with median of 9 months follow-up. Comparing this to published reports of MSA in patients with <3 cm hernias, the safety and clinical efficacy of MSA are independent of initial hernia size.

TIF provided a safe and effective therapeutic option for carefully selected patients with chronic GERD.