Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms

Abstract

Background: A retrospective study evaluated safety, symptom resolution, patient satisfaction, and medication use 1-2 years after transoral incisionless fundoplication (TIF) in patients with gastroesophageal reflux disease (GERD) and/or laryngopharyngeal reflux (LPR) symptoms.

Methods: Thirty-four patients with a confirmed diagnosis of GERD symptoms that were inadequately controlled by antisecretory medications, and who where either dissatisfied with their current therapy or not willing to continue taking medication, underwent TIF using EsophyX at our community-based hospital. Follow-up assessments were completed in 28 patients.

Results: Median age of the study group was 57 (range = 23-77) years, BMI was 25.7 (18.3-36.4) kg/m(2), and 50% were female. All patients had documented chronic GERD for a median 5 (1-20) years and refractory symptoms to proton pump inhibitors (PPIs). Hiatal hernia was present in 75% (21/28) of patients, and 21% (6/28) had erosive esophagitis (LA grade A or B). TIF was performed following a standardized TIF-2 protocol and resulted in reducing hiatal hernia and restoring the natural anatomy of the gastroesophageal (GE) junction (Hill grade I). There were no postoperative complications. At a median 14-months follow-up, 82% (23/28) of patients were off daily PPIs (64% completely off PPIs), and 68% (19/28) were satisfied with their current health condition compared to 4% before TIF. Median GERD Health-Related Quality of Life scores were significantly reduced to 4 (0-25) from 26 (0-45) before TIF (P < 0.001). Heartburn was eliminated in 65% (17/26) and improved by >50% in 86% (24/28) of patients. Regurgitation was eliminated in 80% (16/20) of patients. Atypical LPR symptoms such as hoarseness, coughing, and throat clearing were eliminated in 63% (17/27) of patients as measured by Reflux Symptom Index scores.

Conclusion: Our results in 28 patients confirm the safety and effectiveness of TIF, documenting symptomatic improvement of GERD and LPR symptoms and clinically significant discontinuation of daily PPIs in 82% of patients.

Fig. 1

Modified schematic drawings of the esophagogastric transoral incisionless fundoplication (TIF) technique with a depiction of fastener placement. A similar drawing was presented by Dr. Barnes and Dr. Hoddinott [15]

Fig. 2

Percentage of patients (n = 13) with predominant troublesome atypical GERD symptoms as evaluated by RSI questionnaires before TIF on daily PPIs and at the median of 17 (range = 3–29) months follow-up after TIF. P < 0.02 in all cases with significant differences. Associations not statistically significant are indicated by * (two-tailed Fisher’s exact test)

Fig. 3

Percentage of patients (n = 15) with predominant troublesome typical GERD symptoms as evaluated by GERD-HRQL questionnaires, before TIF on daily PPIs (87%) and at the median of 13 (range = 4–27) months follow-up after TIF. In all cases with significant differences, P < 0.005, except for **, where P = 0.04. Association not statistically significant is indicated by * (two-tailed Fisher’s exact test)

Fig. 4

Percentage of patients (n = 28) with troublesome typical and atypical GERD symptoms as evaluated by GERSS questionnaires before TIF on PPIs and at the median of 14 (range = 3–29) months follow-up after TIF. *P < 0.005; **P = 0.05; ***P = 0.13 (two-tailed Fisher’s exact test)

Fig. 5

Percentage of patients (n = 28) with troublesome atypical GERD symptoms before TIF on PPIs and at the median of 14 (range = 3–29) months follow-up after TIF. Symptom scores were obtained using RSI questionnaires. In all cases with significant differences, P ≤ 0.02, except for **, where P = 0.055 (approaching significance). Association not statistically significant is indicated by * (two-tailed Fisher’s exact test)

Fig. 6

Bars represent number of patients on daily, occasionally, and completely off PPI therapy before and after TIF. Post-TIF, only 18% (5/28) of patients remained on daily PPIs at 14-months follow-up compared to 89% (25/28) before TIF; P < 0.001