Reginald C. W Bell, MD, Katherine D. Freeman, NP, Rachel Hufford, RN. SurgOne P.C.
Recurrent gastroesophageal reflux disease (GERD) after traditional fundoplication occurs due to loosening of the fundoplication without a weakening of the hiatal closure in 10-30% of cases. Although laparoscopic revision of failed fundoplication has been reported to be effective and safe in specialty centers, the surgery is tedious and involves risk of gastric, esophageal, and vagal nerve injury that is higher than with primary fundoplication. The EsophyX device offers an alternative, less invasive, transoral approach to revision of loose fundoplication with avoidance of the dissection and risks associated with the conventional revision.
Patients who had previously undergone a traditional Nissen or Toupet fundoplication and had symptomatic and objective evidence of recurrent GERD due to loosening of the wrap without any evidence of loosening of the hiatal closure, were offered the EsophyX TIF procedure for revision. This study was approved by Western Institutional Review Board. The subjective outcomes were evaluated with GERD Health Related Quality of Life (GERD-HRQL) and Reflux Symptom Index (RSI) questionnaires. Secondarily, normalization of esophageal acid exposure and the number of reflux episodes measured objectively by ambulatory pH tests and proton pump inhibitors (PPIs) use after revision were evaluated.
Eleven patients underwent revision of a prior Nissen fundoplication using EsophyX; 9 completed follow-up and were included in this study. One patient underwent unsuccessful EsophyX revision of a Toupet and did not participate in follow-up. Median age was 60 (28-75) years, 4 were female, and median BMI was 24 (17-41) kg/m2. These 9 patients presented with typical and/or atypical medically refractory GERD symptoms at a median of 3 (1-15) years after primary fundoplication. All had objective evidence of GERD by endoscopy, barium esophagram, or ambulatory reflux testing. Endoscopy confirmed loosening of the fundoplication without evidence of transthoracic wrap migration, paraesophageal hernia, or > 2cm axial herniation. All patients successfully completed the TIF procedure with median operative time of 71 (47-90) minutes and were discharged within 24 hours. One patient early in our experience developed a postoperative bleed requiring transfusion and led to technique changes that have reduced this risk. At a median of 8 (5-19) month follow up, 7 of 9 patients completed GERD-HRQL and RSI questionnaires and 8 of 9 completed pH tests. Mean GERD-HRQL score improved significantly from 14.1 (2.5) preoperatively to 3.7 (1.2) post TIF (p=0.003). Mean RSI score improved >50% in 4 of 6 patients. Seven patients had impedance/pH or 48-h telemetry capsule pH testing off acid-suppressive medication preoperatively and postoperatively. In these 7 patients mean % time with pH < 4 improved from 9.8% (21%-4.8%) to 3.6% (13.4%-0.1%); p=0.09, Mann-Whitney U. Number of reflux episodes per 24-h decreased from 62 (105-21) to 16 (26-0); p=0.004, Mann-Whitney U. Only one patient remained on PPI therapy after TIF and that despite a pH test demonstrating 0.5% esophageal acid exposure. No denovo dysphagia or bloating was reported.
Transoral revision of failed fundoplication without herniation using EsophyX is technically feasible. It results in symptomatic and objective improvement of GERD without the risks of laparoscopic dissection.
Session Number: SS18 – Foregut
Program Number: S096