Minimally invasive interventions for persistent GERD

In patients with persistent gastroesophageal reflux disease (GERD), how does transoral incisionless fundoplication (TIF) compare with standard medical therapy?

Transoral incisionless fundoplication (TIF) has emerged as a minimally invasive endoscopic option for patients with persistent gastroesophageal reflux disease (GERD). According to available data, TIF 2.0 (EsophyX 2.0 device) shows promising short-term improvement in GERD symptoms. Clinical trials and cohort studies have noted the following:

1. Discontinuation of Proton Pump Inhibitors (PPIs):
   • A higher percentage of patients undergoing TIF are able to stop PPIs compared with those on standard medical therapy (77.6% vs 6.3% in some randomized controlled trials).
   • Longer-term follow-up (up to 8–10 years) indicates that approximately one-third of patients remain off PPIs.
2. Symptom Resolution and Acid Exposure:
   • TIF 2.0 is associated with more significant improvement in regurgitation-dominant symptoms and an overall higher likelihood of achieving GERD symptom relief compared with medical therapy at 6 months.
   • Acid exposure time is lower among those who undergo TIF compared with sham intervention, although normalization of acid exposure time has not always shown a statistically significant difference.
3. Safety Profile:
   • Overall adverse events are higher with TIF compared with medical therapy alone, but most severe complications are rare and can be managed with endoscopic intervention.
   • Post-TIF dysphagia occurs in a small percentage of patients (3.6% in some cohorts), and long-term serious adverse events are uncommon.
4. Costs:
   • TIF 2.0 costs are lower than surgical fundoplication but exceed the cost of long-term PPI therapy. However, TIF may be cost-effective in selected patients (for instance, those with refractory GERD or those who use high-resource medical care).

The American Society for Gastrointestinal Endoscopy (ASGE) suggests that TIF 2.0 can be considered an alternative to chronic medical management for patients with confirmed GERD and small hiatal hernias (≤2 cm) who meet specific criteria (chronic GERD of at least 6 months, refractory symptoms, regurgitation-predominant GERD, or a desire to avoid long-term PPI use).

In patients with confirmed GERD and a large hiatal hernia, how does hiatal hernia repair combined with TIF (cTIF) compare with standard medical therapy?

Combined hiatal hernia repair and transoral incisionless fundoplication (cTIF) is an emerging approach for patients with GERD who also have larger hiatal hernias (>2 cm). Evidence to date is limited but suggests:

1. Reduction in PPI Use:
   • Patients undergoing cTIF report a marked decrease in PPI dependence (from approximately 94.6% at baseline to 37.5% after the procedure).
2. Symptom Improvement:
   • Studies indicate a significant improvement in GERD-related symptoms and quality of life, although long-term durability data remain limited.
3. Safety Profile:
   • The rate of adverse events in cTIF studies appears to be low, with only a small percentage of serious complications and low rates of post-TIF dysphagia.

Given the very-low-quality evidence and relatively small number of studies, the ASGE makes a conditional recommendation for multidisciplinary evaluation of cTIF in patients with confirmed GERD, a large hiatal hernia (>2 cm), and Hill grade III or IV. Further randomized controlled trials are underway to clarify its long-term efficacy and safety.

In patients with persistent GERD, how does radiofrequency energy to the lower esophageal sphincter compare with standard medical therapy for GERD management?

Radiofrequency energy treatment to the lower esophageal sphincter (Stretta) has been examined as another minimally invasive option for GERD management. Studies yield mixed results:

1. Effect on PPI Discontinuation:
   • A higher proportion of patients undergoing Stretta are able to discontinue PPIs compared with those receiving standard medical therapy, although the difference is not always statistically significant in randomized trials.
2. Symptom Relief and Acid Exposure:
   • In randomized studies, Stretta does not consistently show superior symptom resolution or normalization of acid exposure time compared with PPIs or sham interventions.
   • Some cohort data indicate a reduction in acid exposure and GERD symptom scores after Stretta.
3. Safety Considerations:
   • Overall adverse events have been reported more frequently with Stretta in some randomized trials (42% vs 11.1%); however, serious complications are relatively uncommon across published series.
4. Patient Selection:
   • Stretta is primarily recommended for patients with confirmed GERD, small hiatal hernias (≤2 cm), and Hill grade I or II, particularly in scenarios where other endoscopic or surgical fundoplication methods are not available or feasible.

Despite these findings, Stretta remains an option for certain patients who prefer a minimally invasive approach or cannot undergo standard surgical or endoscopic fundoplication. Additional well-designed studies may further define optimal patient selection and long-term effectiveness.

Conclusion

Transoral incisionless fundoplication (TIF), combined TIF with hiatal hernia repair (cTIF), and radiofrequency energy (Stretta) each offer less invasive alternatives to surgical fundoplication for patients with persistent or refractory GERD. The choice among these therapies depends on individual patient profiles, such as the presence and size of a hiatal hernia and the severity of GERD symptoms. Although these interventions show potential advantages in reducing reliance on PPIs and improving quality of life, they may not achieve universal normalization of esophageal acid exposure, and each carries its own risk profile.

Reference

1. ASGE Standards of Practice Committee; Desai M, Ruan W, Thosani NC, et al; ASGE Standards of Practice Committee Chair. American Society for Gastrointestinal Endoscopy guideline on the diagnosis and management of GERD: summary and recommendations. Gastrointest Endosc 2025 (in press)