Comprehensive evaluation of endoscopic fundoplication using the EsophyX™ device.

Area of Science:

• Gastroenterology
• Minimally Invasive Surgery
• Medical Devices

Background:

• Limited studies evaluate endoscopic fundoplication (EF) efficacy for gastroesophageal reflux disease (GERD) using the EsophyX™ device, particularly the TIF-2 iteration.
• This study prospectively assessed early clinical experience with the EsophyX™ device for EF in GERD patients.

Purpose of the Study:

• To evaluate the efficacy and safety of EF with the EsophyX™ device in GERD patients.
• To assess changes in symptoms, 24-h pH monitoring, and manometry post-procedure.

Main Methods:

• Prospective study of 23 consecutive GERD patients undergoing EF with EsophyX™.
• Preoperative and 6-month follow-up assessments included symptom questionnaires, 24-h pH studies, and manometry.
• Proton-pump inhibitor (PPI) use was also recorded.

Main Results:

• Significant reductions observed in heartburn (P=0.02), acid contact time (P=0.002), DeMeester score (P=0.002), and PPI use (P=0.003) at 6 months.
• Despite improvements, 57% of patients still had abnormal pH studies, and 58% remained on PPI therapy.
• The procedure had a median hospitalization of 1 day with no major perioperative complications.

Conclusions:

• EF with EsophyX™ offers a significant reduction in heartburn and acid exposure for GERD patients.
• The majority of patients did not achieve normalized pH studies or discontinue PPIs, questioning the procedure's overall efficacy.
• The procedure demonstrates an acceptable safety profile.