Is transoral fundoplication (TOF) a recommended treatment for gastroesophageal reflux disease (GERD) given its experimental status and lack of FDA approval?

Transoral Incisionless Fundoplication for GERD: Status and Recommendations

Transoral incisionless fundoplication (TIF) is recognized as an effective endoscopic option for carefully selected patients with proven GERD, but it should not be considered experimental as it is included in current clinical practice guidelines as a legitimate treatment option.

Patient Selection for TIF

• TIF should only be considered in patients with confirmed pathologic GERD through objective testing, including those with small or no hiatal hernia, normal esophageal peristaltic function, and absence of achalasia 1
• Ideal candidates include patients with regurgitation-predominant GERD who have not responded adequately to medical therapy 1
• Patients with esophagitis grade A and B or proven GERD by esophageal pH monitoring may benefit from TIF, while those with esophagitis C and D or large hiatal hernias (>2 cm) should be excluded 2
• Complete diagnostic workup before considering TIF should include:
  • Endoscopic evaluation for erosive esophagitis, diaphragmatic hiatus assessment, and screening for Barrett's esophagus 1
  • Ambulatory reflux monitoring to confirm GERD diagnosis 1
  • High-resolution manometry to exclude achalasia and assess esophageal peristaltic function 1

Efficacy and Clinical Outcomes

• According to the American Gastroenterological Association's 2022 clinical practice update, TIF is considered an effective endoscopic option for carefully selected patients with proven GERD 3
• Long-term studies show TIF can abolish reflux symptoms in 72.7% of PPI-responsive GERD patients at a median 59-month follow-up 2
• TIF has demonstrated significant improvement in GERD-related quality of life scores and symptom indices 4
• Heartburn elimination rates of 57.1%, regurgitation elimination rates of 88.2%, and chest pain elimination rates of 83.3% have been reported 2
• Overall patient satisfaction with TIF is approximately 72%, with PPI discontinuation rates of 67% at short-term follow-up 4

Safety Considerations and Complications

• TIF has a major complication rate of 3.2% across studies 4
• Potential complications include perforation (19.8%), laceration (17.6%), bleeding (9.2%), and pleural effusion (9.2%) 5
• Most common treatments for complications include endoscopic clips (12.3%), chest tube insertion (12.3%), use of endoscopic retriever device (11.1%), esophageal stent (8.6%), and emergent surgery (11.1%) 5
• The number of adverse events declined from 2011 to 2016 but increased from 2016 to 2020, suggesting ongoing safety concerns 5

Comparison with Other Treatment Options

• TIF is less invasive than surgical fundoplication, with fewer side effects like dysphagia and gas bloating 1
• For patients who experience recurrent GERD after TIF, subsequent laparoscopic Nissen fundoplication can be performed safely without increased operative morbidity 6
• In obese patients with GERD, Roux-en-Y gastric bypass is more effective as a primary anti-reflux intervention 3
• Sleeve gastrectomy should be avoided in GERD patients as it may worsen symptoms 3

Clinical Practice Recommendations

• TIF should be considered within a comprehensive GERD management algorithm that includes:
  • Initial trial of PPI therapy for 4-8 weeks 3
  • Objective reflux testing to confirm GERD diagnosis in partial or non-responders 3
  • Assessment of candidacy for invasive anti-reflux procedures including confirmatory evidence of pathologic GERD, exclusion of achalasia, and assessment of esophageal peristaltic function 3
• TIF may be particularly beneficial for patients with regurgitation-predominant symptoms who wish to avoid long-term PPI therapy 1, 2

Limitations and Future Directions

• While TIF shows promising short-term results, questions about its long-term durability remain 4
• The failure rate across studies is approximately 7.2%, indicating that some patients will require additional interventions 4
• A well-designed prospective clinical trial is needed to better assess the effectiveness and durability of TIF and to identify the optimal patient population 4