Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease

Abstract

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.

New Options for the Management of GERD

“…However, four patients actually had an increased ([5 %) time pH \ 4 after TIF [16]. The average number of reflux episodes per 24 h was reduced from 20.8 to 8.4 (p \ 0.001) after TIF and normalized in 89 % of patients [16]. DeMeester scores were also significantly reduced from 37.1 to 16.9 and normalized in 56 % of patients [16].…”

“…However, four patients actually had an increased ([5 %) time pH \ 4 after TIF [16]. The average number of reflux episodes per 24 h was reduced from 20.8 to 8.4 (p \ 0.001) after TIF and normalized in 89 % of patients [16].…”

“…At 6 months, scores were reduced by more than 50 in 80 % of patients, but only normalized in 50 % of patients [16], whereas at 12 months, reduced GERD-HRQL (C50 %) scores were reported in 73 % (58/79) of patients [13]. Complete symptom elimination (GERD-HRQL score B12) occurred in 75 % of patients, and 65 % of patients were satisfied with their condition [13].…”

“…Objective measures of reflux control in 24 of 36 patients who underwent pre-and post-procedure pH testing off PPIs showed the mean % time pH \ 4 was reduced from 10.4 to 1.7 (p = 0.003) and had normalized post TIF in 61 % of patients [16]. However, four patients actually had an increased ([5 %) time pH \ 4 after TIF [16].…”

“…Two studies tracked patients who required additional procedures for refractory symptoms of GERD. First, a total of 5 (13.5 %) patients underwent additional procedures within 3-6 months including two patients who had a repeat TIF procedure and 3 that subsequently underwent LNF [16]. However, in a series of 38 patients at 36 months follow-up, 37 % (14/38) of patients requested revisional LNF because of persistent GERD symptoms [17].…”