The efficacy of second-generation transoral incisionless fundoplication (TIF 2.0) with the EsophyX device (EndoGastric Solutions, Inc, Redmond, WA) is well established for treating typical gastroesophageal reflux.
A systematic review and meta-analysis by researchers at Brigham and Women’s Hospital indicates TIF 2.0 is also effective for atypical GERD (laryngopharyngeal reflux) and improves patient-centered outcomes. Christopher C. Thompson, MD, MS, director of Endoscopy in the Division of Gastroenterology, Hepatology and Endoscopy, Muhammad Haseeb, MD, an internist in the Division, and colleagues report in Gastrointestinal Endoscopy.
Methods
The authors found 10 studies searching PubMed, Embase, the Web of Science Core Collection, and the Cochrane Central Register of Controlled Trials of prospective and retrospective studies of TIF 2.0 with the EsophyX device in adults with chronic or refractory atypical GERD. Studies had to assess pre- and post-TIF symptoms with at least six months of follow-up. The studies were conducted between 2008 and 2021: one randomized controlled trial, four prospective studies, and five retrospective observational studies. The studies collectively involved 564 patients.
The primary outcome of interest was a change from baseline on the Reflux Symptom Index (RSI). That nine-item questionnaire was developed and validated for assessing atypical GERD symptoms: hoarseness, throat clearing, excess throat mucus, chronic cough, cough after eating or lying flat, globus sensation, breathing difficulty, and difficulty swallowing. The maximum total (worst) score is 45 and the normality threshold is 13.
Change in Symptoms
At six months:
- Data about RSI scores were available on 474 patients from eight studies
- The mean RSI after TIF decreased below the normality threshold in all studies
- The mean decrease (improvement) was 15.72 points
At 12 months:
- Data on 287 patients were available from six studies
- The mean RSI remained below the normality threshold for all studies
- The mean decrease was 14.73 points
At both time points, results were similar in a predefined subgroup analysis of 287 patients who underwent TIF with the concomitant repair of a hiatal hernia >2 cm.
Change in PPI Use
At six months:
- Data about the use of proton pump inhibitors (PPIs) were available on 384 patients from seven studies
- The pooled proportion of patients using PPIs was 99% before TIF and 19% afterward
At 12 months:
- Data on 218 patients were available from four studies
- The pooled proportion of patients using PPIs was 100% before TIF and 26% afterward
Patient Satisfaction
At six months:
- Data regarding patient satisfaction were available on 392 patients from seven studies
- The pooled proportion of patients satisfied with their health condition was 4% before TIF and 73% afterward
At 12 months:
- Data on 190 patients were available from three studies
- The pooled proportion of patients satisfied with their health condition was 11% before TIF and 75% afterward
TIF 2.0 with the EsophX device has the potential to be a minimally invasive treatment option for patients with chronic or refractory atypical GERD who either failed or want to avoid chronic medical therapy.
A prospective clinical trial in now underway.