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Endoluminal Fundoplication (ELF) for GERD Using EsophyX: a 12-Month Follow-up in a Single-Center Experience

  • 2009 SSAT Plenary Presentation
  • Published:
Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

Several endoscopic antireflux therapies have been proposed to reduce the need for chronic medical therapy or laparoscopic fundoplication for gastroesophageal reflux disease (GERD). Aim of this study was to evaluate the short- and mid-term clinical results of endoluminal fundoplication (ELF) with EsophyX™.

Patients and Methods

From June 2006 to April 2008, 20 patients were enrolled in the study. All the ELFs were performed under general anesthesia.

Results

The mean duration of the procedure was 63 min (range 38–105). A median of 14 fasteners was placed. There were no major intraoperative complications. Two patients developed early complications and were treated conservatively. Four patients underwent, within the first year post-ELF, a laparoscopic fundoplication because of persistence of symptoms. One patient was lost to follow-up between 6 and 12 months. Among the other 15 patients who completed 12 months follow-up, the GERD health-related quality of life score decreased from a median of 40 to a median of 10 (p < 0.05), and seven patients were still off proton pump inhibitor. An improvement in esophageal acid exposure was recorded in 16.6% of patients, while in 66.7%, it worsened.

Conclusions

ELF induced improvement of GERD symptoms and patients quality of life in a subgroup of patients with a reduced need for medication. However, it did not significantly change esophageal acid exposure in these patients. The need for revisional standard laparoscopic fundoplication was high.

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Author information

Authors and Affiliations

  1. Department of Gastroenterology and Digestive Endoscopy, IRCCS Istituto Clinico Humanitas, Milan, Italy

    Alessandro Repici, Alberto Malesci, Roberta Barbera & Camilla Gambaro

  2. Minimally Invasive and General Surgery Unit, IRCCS Istituto Clinico Humanitas, Via Manzoni, 56, Rozzano, 20089, Milan, Italy

    Uberto Fumagalli & Riccardo Rosati

  3. University of Milan, Milan, Italy

    Alberto Malesci & Riccardo Rosati

Authors
  1. Alessandro Repici
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  2. Uberto Fumagalli
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  3. Alberto Malesci
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  4. Roberta Barbera
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  5. Camilla Gambaro
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  6. Riccardo Rosati
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Corresponding author

Correspondence to Uberto Fumagalli.

Additional information

Discussant

Dr. Brant Oelschlager (University of Washington, Seattle, WA): The search of the holy grail for incisionless endoscopic antireflux surgery is a journey littered with failed devices, procedures, and bankrupt companies.

The EsophyX procedure, as you presented it today, seems like it is kind of off to have a shaky start. It suggests that the procedure has some inherent risk as you describe with your bleeding episodes, and maybe a modest improvement in symptoms and minimal effect on gastroesophageal reflux disease, at least pH monitoring.

I have a few questions. You included patients with hiatal hernias up to 3 cm. How did you measure the hiatal hernias? And do you really think that we can fix gastroesophageal reflux disease endoscopically without a hiatal hernia repair with these endoscopic procedures. Should we not concentrate, if we are going to be successful, on moderate refluxers without hiatal hernia?

By the same token, you said all of your patients had esophagitis and I saw some conflicting information. Patients with esophagitis seem to be on the far end of the GERD spectrum.

Does that partially explain why your results were not better because you are attacking patients with too high a burden of disease?

Finally, one of the critiques of the original TIF 1 procedure is that it does not really recreate the esophagogastric plication the way that a Nissen fundoplication would. Instead, it has more of a gastrogastric plication. The newer TIF 2 procedures that you alluded to tries to do a better job of recreating the esophagogastric plication.

Can you comment on the limitations and whether you think this new procedure is going to be—allow the EsophyX to proceed on in the treatment of gastroesophageal reflux disease?

Closing Discussant

Dr. Uberto Fumagalli (Milan, Italy): Thank you, Dr. Oelschlager, for your comments and questions.

We think that this procedure probably should be considered only for the treatment of reflux disease in patients without hiatal hernias or with very small ones. The device realizes an endoluminal fundoplication: The endoscopic aspect of the valve is similar to the endoscopic view after a laparoscopic Nissen fundoplication, but nothing is done on the diaphragmatic crura during the endoluminal procedure, and a crural plasty may be needed in patients with hiatal hernias. For this reason, we included in our series only patients with small hernias. The hernias were measured endoscopically.

In our series, five out of 20 patients had a LA B or LA C esophagitis. Since the total number of patients evaluated was small, we could not compare the results obtained in patients with different grades of esophagitis; the results on the whole series were disappointing in terms of control of esophageal acid exposure. The reason of this has probably, at least in part, to do with technical reasons: The TIF 2 modification of the procedure may be able to give improved results, mimicking better what we do with a Nissen fundoplication.

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Repici, A., Fumagalli, U., Malesci, A. et al. Endoluminal Fundoplication (ELF) for GERD Using EsophyX: a 12-Month Follow-up in a Single-Center Experience. J Gastrointest Surg 14, 1–6 (2010). https://doi.org/10.1007/s11605-009-1077-2

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  • DOI: https://doi.org/10.1007/s11605-009-1077-2

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