David J Dargis, DO, Matthew S Ralph, DO. Allegan Surgical Associates, Allegan, Michigan
INTRODUCTION: Transoral incisionless fundoplication (TIF) using EsophyX offers a less invasive alternative to laparoscopic fundoplication. A retrospective community-based study investigated safety, symptom resolution, patient satisfaction, and medication use after TIF.
METHODS: Forty-one patients underwent TIF between April 2009 and June 2010 because they had GERD symptoms persistent on antisecretory therapy and gastroesophageal reflux proven by pH-metry or reflux esophagitis. Follow-up assessment consisted of typical and atypical symptom evaluation using three GERD-specific, validated questionnaires [GERD Health-related Quality of Life (HRQL), GERD Symptom Score (GERSS), Reflux Symptom Index (RSI)]. Symptoms were considered eliminated if individual scores were between 0 (none) to 2 (rare). Normalization rates were calculated for patients with abnormal scores at baseline.
RESULTS: At baseline all 41 treated patients [68% female, median age 58 (range 25-80) years, median BMI 32 (18-44) kg/m²] were taking proton pump inhibitors (PPIs), and 88% (36/41) of them continued to have moderate to severe typical and atypical symptoms despite medical therapy. Gastroesophageal reflux was proven by abnormal pH findings in 92% (34/37) of patients or the presence of esophagitis in 46% (19/41) of patients. All patients had an incompetent gastroesophageal junction. Hiatal hernia was diagnosed in 34 patients and repaired laparoscopically in 4 before TIF. The TIF procedure reduced hiatal hernia and created a 270 (180-310) degree wrap reaching 3 (2-4) cm above the Z-line and restored the gastroesophageal junction to Hill grade I. There were two cases of post-operative pleural effusion, which were treated conservatively with antibiotics and resolved within two weeks. At a median 7 (3-16) month follow-up, 79% (15/19) of patients were completely off PPIs, and 68% (13/19) were satisfied, 26% neutral (5/19) and 5% dissatisfied (1/19) with their current health condition (compared to 100% dissatisfied before TIF). Median HRQL scores were improved significantly [2 (0-20) vs. 29 (11-47) pre-TIF, n=19, P<0.001] and indicated heartburn elimination in 84% (16/19) of patients. Regurgitation present before TIF was eliminated in 89% (17/19) patients [median scores 0 (0-18) vs. 14 (0-30) pre-TIF, P < 0.001]. Atypical symptoms were significantly reduced [median RSI scores 2 (0-15) vs.16 (4-42) pre-TIF, P<0.001] and normalized in 79% (15/19) of patients. The effectiveness of TIF in eliminating typical and atypical symptoms was further supported by a significant reduction in GERSS scores [median GERSS scores of 1 (0-23) vs. 29 (8-54) pre-TIF, P<0.001] and their normalization in 68% (13/19) of patients.
CONCLUSION: The preliminary results at median 7-month follow-up support the safety of TIF and its effectiveness in alleviating typical and atypical GERD symptoms and eliminating completely the need for medication in 79% of patients. A longer-term objective assessment using pH testing is underway.
Program Number: S001