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Comprehensive evaluation of endoscopic fundoplication using the EsophyXTM device

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Abstract

Background

There are limited studies that evaluate the efficacy of endoscopic fundoplication (EF) for gastroesophageal reflux disease (GERD) with the EsophyXTM device, especially with the most recent procedural iteration (TIF-2). This study was a prospective evaluation of our early experience with this device and procedure.

Methods

Data were collected prospectively on 23 consecutive patients undergoing EF (March 2009 to August 2010). All patients completed a symptom questionnaire assessing frequency and severity of gastrointestinal and respiratory symptoms, 24-h pH, and manometry studies preoperatively and were encouraged to repeat these at 6 months.

Results

All patients had abnormal pH studies and were on proton-pump inhibitor (PPI) therapy prior to EF. Median age was 47 years (19–62 years), and six (23%) were male. Nine (41%) patients had Body Mass Index (BMI) ≥30 kg/m2, and three (14%) had a small hiatal hernia (≤2 cm). The procedure was aborted in two patients for retained food. Three patients underwent subsequent laparoscopic Nissen fundoplication for persistent or recurrent symptoms. Median hospitalization was 1 day, and there were no major perioperative complications. At 6 month follow-up, 19 (86%) patients completed a symptom questionnaire, and 14 (64%) and 11 (50%) patients underwent pH and manometry studies, respectively. There was a significant reduction in heartburn (P = 0.02), total percentage acid contact time (P = 0.002), DeMeester score (P = 0.002), and PPI use (P = 0.003). Overall, 8 out of 14 (57%) patients had abnormal pH studies and 11 out of 19 (58%) remained on PPI therapy at 6 months.

Conclusion

EF with EsophyXTM is associated with significant reduction in heartburn and abnormal acid exposure at 6 months, although the majority of patients did not experience normalization of their pH studies and remained on PPI therapy. The procedure has an acceptable safety profile, but the question remains as to whether it is effective enough to warrant a place in the armamentarium for the treatment of GERD.

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Acknowledgement

Supported by the Byers Endowment in Esophageal Research at the University of Washington

Disclosures

Authors R. P. Petersen, L. Filippa, E. B. Wassenaar, A. V. Martin, and R. P. Tatum have no conflicts of interest or financial ties to disclose. Author B. K. Oelschlager has received honoraria as an educational speaker and is a coinvestigator in a clinical trial on the results of endoscopic fundoplication sponsored by Endogastric Solutions, Inc.

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Correspondence to Rebecca P. Petersen.

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Petersen, R.P., Filippa, L., Wassenaar, E.B. et al. Comprehensive evaluation of endoscopic fundoplication using the EsophyXTM device. Surg Endosc 26, 1021–1027 (2012). https://doi.org/10.1007/s00464-011-1989-2

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Keywords

  • GERD
  • Endoscopic fundoplication
  • EsophyXTM