When should endoscopic fundoplication be approved or rejected for patients with gastroesophageal reflux disease (GERD)?

Endoscopic Fundoplication for GERD: Approval and Rejection Criteria

Endoscopic fundoplication should be approved for carefully selected patients with proven gastroesophageal reflux disease (GERD) who have inadequate response to medical therapy, particularly those with regurgitation-predominant symptoms and without large hiatal hernias. 1

Patient Selection Criteria for Approval

Required Diagnostic Confirmation

• Patients must have confirmatory evidence of pathologic GERD through objective testing before considering any invasive anti-reflux procedure 1
• Complete endoscopic evaluation should document:
  • Presence/absence of erosive esophagitis (graded by Los Angeles classification)
  • Diaphragmatic hiatus assessment (Hill grade of flap valve)
  • Axial hiatal hernia length
  • Inspection for Barrett's esophagus 1

Appropriate Candidates

• Patients with PPI-dependent GERD who desire an alternative to lifelong medication 2
• Patients with regurgitation-predominant symptoms, which often respond better to mechanical anti-reflux procedures 1
• Patients with small or no hiatal hernia (<2 cm) 3
• Patients with normal esophageal peristaltic function confirmed by manometry 1
• Patients who have failed optimal PPI therapy but have objective evidence of GERD 4

Procedural Considerations

• Transoral incisionless fundoplication (TIF) is the most studied endoscopic option with demonstrable value in regurgitation-predominant GERD 1
• Recent data suggest efficacy of TIF with combined laparoscopic hiatal hernia repair in patients with minor crural defects 1

Rejection Criteria

Anatomical Contraindications

• Patients with large hiatal hernias (>2 cm) 3
• Patients with severe erosive esophagitis (Los Angeles grade C or D) 1
• Patients with esophageal motility disorders or impaired peristaltic function 1
• Patients with Barrett's esophagus or other GERD complications 1

Clinical Contraindications

• Patients with isolated extra-esophageal symptoms without proven GERD 1
• Patients who have not undergone objective reflux testing to confirm GERD 1
• Patients with functional heartburn or reflux hypersensitivity rather than true GERD 1
• Patients who have not attempted adequate trials of medical therapy 1
• Patients with failed previous anti-reflux surgery (insufficient evidence for endoscopic revision) 1

Evidence-Based Outcomes and Considerations

Efficacy

• Endoscopic fundoplication improves quality of life and reduces PPI dependence in properly selected patients 5
• Approximately 63% of patients can reduce or eliminate PPI use following the procedure 5
• Symptom improvement is significant but normalization of acid exposure is less consistent 1

Limitations

• Long-term durability beyond 1-2 years remains unclear for most endoscopic techniques 1
• Many patients continue to require some PPI therapy despite symptomatic improvement 5
• The presence of even small hiatal hernias may reduce effectiveness 5

Safety Considerations

• Complication rates are generally low (approximately 8-9% for minor complications) 5, 3
• Major complications are rare but can include bleeding, perforation, or aspiration 3
• Previous endoscopic anti-reflux devices have been withdrawn from the market due to safety concerns or lack of efficacy 1

Clinical Approach Algorithm

1. Confirm GERD diagnosis with objective testing (endoscopy, pH monitoring) 1
2. Ensure optimal medical therapy has been attempted (PPI trial for 4-8 weeks) 1
3. Assess for anatomical suitability (hiatal hernia <2 cm, normal esophageal motility) 3
4. Evaluate predominant symptom pattern (regurgitation vs. heartburn) 1
5. Consider patient preferences regarding long-term PPI use versus procedural intervention 1
6. For suitable candidates, proceed with endoscopic fundoplication 1
7. For unsuitable candidates, consider alternative approaches (continued medical therapy or surgical fundoplication) 6

By following these evidence-based criteria, endoscopic fundoplication can be appropriately offered to selected patients with GERD, potentially improving quality of life and reducing medication dependence while avoiding unnecessary procedures in patients unlikely to benefit.