Comprehensive Evaluation of an Endoscopic Fundoplication Using the Esophyx Device

Rebecca P Petersen, MD MSc, Laura Filippa, MD, Eelco B Wassenaar, MD PhD, Ana V Martin, MD, Roger Tatum, MD, Brant K Oelschlager, MD. University of Washington Medical Center

Introduction: There are limited studies that evaluate the efficacy of an endoscopic fundoplication (EF) for GERD with EsophyXTM device, especially with the most recent procedural iteration (TIF-2). This study is a prospective evaluation of our early experience with this device and procedure.
Methods: Data were collected prospectively on 23 consecutive patients undergoing EF between March 2009 and August 2010. All patients completed a symptom questionnaire assessing frequency and severity of GI & respiratory symptoms, 24 hr pH and manometry studies preoperatively and were encouraged to repeat these at 6 months.
Results: All patients had an abnormal pH study and were on PPI therapy prior to EF. The mean age was 47±11 and 6 (27%) were male. Nine (41%) patients had a BMI>30, and three had a small hiatal hernia (< 2 cm) detected on endoscopy. The procedure was aborted in 2 patients for retained food, though subsequently successful in one. EF was incomplete in 2 patients due to difficulty with maintenance of insufflation. The median LOS was 1 day and there were no major perioperative complications. To date, 6 month follow-up is complete in 9 patients (Table 1). One patient, who had an incomplete EF, has undergone a subsequent Nissen fundoplication secondary to persistent GERD.
Conclusion: EF with EsophyXTM is associated with a significant reduction in heartburn and abnormal acid exposure at 6 months, although many patients ultimately resume PPI therapy. The procedure has an acceptable safety profile, but further study is necessary to determine its place in the treatment of GERD.

6 Month Outcome (n=9)PreopPostop: 6mosp value
7.2 ± 3.2
5.1 ± 3.6
4.3 ± 3.0
3.3 ± 3.7
PPI use9 (100%)7 (78%)0.47
LESP (mmHg)28 ± 3026 ± 250.90
Total % contact time ph<410.9 ± 4.64.2 ± 1.50.01

*Symptom Severity Scale: 0 (never) to 10 (worst)

Session: SS01
Program Number: S002

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