Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
World Journal of Surgery
Published in: World Journal of Surgery 8/2008

Open Access 01-08-2008

Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study

Authors: Guy-Bernard Cadière, Michel Buset, Vinciane Muls, Amin Rajan, Thomas Rösch, Alexander J. Eckardt, Joseph Weerts, Boris Bastens, Guido Costamagna, Michele Marchese, Hubert Louis, Fazia Mana, Filip Sermon, Anna K. Gawlicka, Michael A. Daniel, Jacques Devière

Published in: World Journal of Surgery | Issue 8/2008

Login to get access

Abstract

Background

A novel transoral incisionless fundoplication (TIF) procedure using the EsophyX system with SerosaFuse fasteners was designed to reconstruct a full-thickness valve at the gastroesophageal junction through tailored delivery of multiple fasteners during a single-device insertion. The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial.

Methods

Patients (n = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia > 2 cm.

Results

The TIF procedure (n = 84) reduced all hiatal hernias (n = 49) and constructed valves measuring 4 cm (2–6 cm) and 230° (160°–300°). Serious adverse events consisted of two esophageal perforations upon device insertion and one case of postoperative intraluminal bleeding. Other adverse events were mild and transient. At 12 months, aggregate (n = 79) and stratified Hill grade I tight (n = 21) results showed 73% and 86% of patients with ≥50% improvement in GERD health-related quality of life (HRQL) scores, 85% discontinuation of daily PPI use, and 81% complete cessation of PPIs; 37% and 48% normalization of esophageal acid exposure; 60% and 89% hiatal hernia reduction; and 62% and 80% esophagitis reduction, respectively. More than 50% of patients with Hill grade I tight valves had a normalized cardia circumference. Resting pressure of the lower esophageal sphincter (LES) was improved significantly (p < 0.001), by 53%. EsophyX-TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation.

Conclusion

The 12-month results showed that EsophyX-TIF was safe and effective in improving quality of life and for reducing symptoms, PPI use, hiatal hernia, and esophagitis, as well as increasing the LES resting pressure and normalizing esophageal pH and cardia circumference in chronic GERD patients.
Literature
1.
El-Serag HB (2007) Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol 5:17–26PubMedCrossRef
2.
Lundell L (2004) Surgery of gastroesophageal reflux disease: a competitive or complementary procedure? Dig Dis 22:161–170PubMedCrossRef
3.
Metz DC (2004) Managing gastroesophageal reflux disease for the lifetime of the patient: evaluating the long-term options. Am J Med 117( Suppl 5A):49S–55SPubMed
4.
5.
Nandurkar S, Talley NJ (2000) Epidemiology and natural history of reflux disease. Best Pract Res Clin Gastroenterol 14:743–757CrossRef
6.
Smout AJ (2007) The patient with GORD and chronically recurrent problems. Best Pract Res Clin Gastroenterol 21:365–378PubMedCrossRef
7.
Stylopoulos N, Rattner DW (2005) The history of hiatal hernia surgery: from Bowditch to laparoscopy. Ann Surg 241:185–193PubMed
8.
Jones MP, Sloan SS, Rabine JC et al (2001) Hiatal hernia size is the dominant determinant of esophagitis presence and severity in gastroesophageal reflux disease. Am J Gastroenterol 96:1711–1717PubMedCrossRef
9.
10.
Mittal RK (1993) Hiatal hernia and gastroesophageal reflux: another attempt to resolve the controversy. Gastroenterology 105:941–943PubMed
11.
Moss SF, Kidd M, Modlin IM (2007) The status of the hiatus: the role of hernia in gastroesophageal reflux disease. J Clin Gastroenterol 41:S144–S153CrossRef
12.
Rydberg L, Ruth M, Lundell L (1999) Mechanism of action of antireflux procedures. Br J Surg 86:405–410PubMedCrossRef
13.
Allgood PC, Bachmann M (2000) Medical or surgical treatment for chronic gastrooesophageal reflux? A systematic review of published evidence of effectiveness. Eur J Surg 166:713–721PubMedCrossRef
14.
Cookson R, Flood C, Koo B et al (2005) Short-term cost effectiveness and long-term cost analysis comparing laparoscopic Nissen fundoplication with proton-pump inhibitor maintenance for gastro-oesophageal reflux disease. Br J Surg 92:700–706PubMedCrossRef
15.
Lundell L, Miettinen P, Myrvold HE et al (2007) Seven-year follow-up of a randomized clinical trial comparing proton-pump inhibition with surgical therapy for reflux oesophagitis. Br J Surg 94:198–203PubMedCrossRef
16.
Mahon D, Rhodes M, Decadt B et al (2005) Randomized clinical trial of laparoscopic Nissen fundoplication compared with proton-pump inhibitors for treatment of chronic gastro-oesophageal reflux. Br J Surg 92:695–699PubMedCrossRef
17.
Dallemagne B, Weerts J, Markiewicz S et al (2006) Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc 20:159–165PubMedCrossRef
18.
Coelho JC, Wiederkehr JC, Campos AC et al (1999) Conversions and complications of laparoscopic treatment of gastroesophageal reflux disease. J Am Coll Surg 189:356–361PubMedCrossRef
19.
Kamolz T, Granderath FA, Bammer T et al (2002) Dysphagia and quality of life after laparoscopic Nissen fundoplication in patients with and without prosthetic reinforcement of the hiatal crura. Surg Endosc 16:572–577PubMedCrossRef
20.
Lundell L (2004) Complications after anti-reflux surgery. Best Pract Res Clin Gastroenterol 18:935–945PubMed
21.
22.
Bessell JR, Finch R, Gotley DC et al (2000) Chronic dysphagia following laparoscopic fundoplication. Br J Surg 87:1341–1345PubMedCrossRef
23.
Hayden J, Jamieson G (2006) Optimization of outcome after laparoscopic antireflux surgery. ANZ J Surg 76:258–263PubMedCrossRef
24.
Cadiere GB, Rajan A, Rqibate M et al (2006) Endoluminal fundoplication (ELF)—evolution of EsophyXTM, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol 15:348–355PubMedCrossRef
25.
Aye RW, Hill LD, Kraemer SJ et al (1994) Early results with the laparoscopic Hill repair. Am J Surg 167:542–546PubMedCrossRef
26.
Hill LD, Kozarek RA, Kraemer SJ et al (1996) The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc 44:541–547PubMedCrossRef
27.
Kraemer SJ, Aye R, Kozarek RA et al (1994) Laparoscopic Hill repair. Gastrointest Endosc 40:155–159PubMed
28.
Kraemer SJ, Kozarek RA, Carter BJ et al (2006) EsophyX endoluminal fundoplication for the treatment of severe chronic GERD: multiple tissue fasteners secure valvuloplasty as demonstrated in an animal model. Gastrointest Endosc 63:AB235CrossRef
29.
Cadiere GB, Rajan A, Germay O et al (2008) Endoluminal fundoplication by a transoral device for the treatment of GERD: a feasibility study. Surg Endosc 22:333–342PubMedCrossRef
30.
Hirano I, Richter JE (2007) ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol 102:668–685PubMedCrossRef
31.
Lundell LR, Dent J, Bennett JR et al (1999) Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut 45:172–180PubMedCrossRef
32.
Velanovich V (2007) The development of the GERD-HRQL symptom severity instrument. Dis Esophagus 20:130–134PubMedCrossRef
33.
Velanovich V, Vallance SR, Gusz JR et al (1996) Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg 183:217–224PubMed
34.
Pleskow D, Rothstein R, Lo S et al (2005) Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc 61:643–649PubMedCrossRef
35.
Rothstein R, Filipi C, Caca K et al (2006) Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology 131:704–712PubMedCrossRef
36.
Tseng D, Rizvi AZ, Fennerty MB et al (2005) Forty-eight-hour pH monitoring increases sensitivity in detecting abnormal esophageal acid exposure. J Gastrointest Surg 9:1043–1051PubMedCrossRef
37.
Tutuian R, Castell DO (2006) Diagnostic procedures in GERD: principles and values of esophageal manometry and pH-monitoring. In: Granderath FA, Kamolz T, Pointner R (eds) Gastroesophageal reflux disease: principles of disease, diagnosis, and treatment. Springer, New York, pp 121–138
38.
Portale G, Peters J, Hsieh CC et al (2007) When are reflux episodes symptomatic? Dis Esophagus 20:47–52PubMedCrossRef
39.
Pandolfino JE, Richter JE, Ours T et al (2003) Ambulatory esophageal pH monitoring using a wireless system. Am J Gastroenterol 98:740–749PubMedCrossRef
40.
Jobe BA, Kahrilas PJ, Vernon AH et al (2004) Endoscopic appraisal of the gastroesophageal valve after antireflux surgery. Am J Gastroenterol 99:233–243PubMedCrossRef
41.
Seltman AK, Kahrilas PJ, Chang EY et al (2006) Endoscopic measurement of cardia circumference as an indicator of GERD. Gastrointest Endosc 63:22–31PubMedCrossRef
42.
43.
Nayar DS, Khandwala F, Achkar E et al (2005) Esophageal manometry: assessment of interpreter consistency. Clin Gastroenterol Hepatol 3:218–224PubMedCrossRef
44.
Huber-Lang M, Henne-Bruns D, Schmitz B et al (2006) Esophageal perforation: principles of diagnosis and surgical management. Surg Today 36:332–340PubMedCrossRef
45.
Raghunath AS, O’Morain C, McLoughlin RC (2005) Review article: the long-term use of proton-pump inhibitors. Aliment Pharmacol Ther 22(Suppl 1):55–63PubMedCrossRef
46.
Jalving M, Koornstra JJ, Wesseling J et al (2006) Increased risk of fundic gland polyps during long-term proton pump inhibitor therapy. Aliment Pharmacol Ther 24:1341–1348PubMedCrossRef
47.
Garcia Rodriguez LA, Ruigomez A, Panes J 2007) Use of acid-suppressing drugs and the risk of bacterial gastroenteritis. Clin Gastroenterol Hepatol 5:1418–1423PubMedCrossRef
48.
Fass R (2007) Erosive esophagitis and nonerosive reflux disease (NERD): comparison of epidemiologic, physiologic, and therapeutic characteristics. J Clin Gastroenterol 41:131–137PubMedCrossRef
49.
Johnson DA, Benjamin SB, Vakil NB et al (2001) Esomeprazole once daily for 6 months is effective therapy for maintaining healed erosive esophagitis and for controlling gastroesophageal reflux disease symptoms: a randomized, double-blind, placebo-controlled study of efficacy and safety. Am J Gastroenterol 96:27–34PubMedCrossRef
50.
Marchese M, Spada C, Costamagna G (2006) Endoluminal fundoplication. Minim Invasive Ther Allied Technol 15:356–365PubMedCrossRef
51.
Daniel MA (2007) EndoGastric solutions esophyX system with serosaFuse fasteners and accessories. U.S. Food and Drug Administration 510(k) Submission K071651:1–456
52.
Wynyard M, Kletschka HD (1966) The crural branches of the phrenic nerves: their surgical significance. Minn Med 49:1821–1824PubMed
53.
54.
Soper NJ (1999) Laparoscopic management of hiatal hernia and gastroesophageal reflux. Curr Probl Surg 36:765–838PubMed
55.
Bremner CG, Schlegel JF, Ellis FH Jr (1970) Studies of the “gastroesophageal sphincter mechanism”: the role of the phrenoesophageal membrane. Surgery 67:735–740PubMed
56.
Bombeck CT, Dillard DH, Nyhus LM (1966) Muscular anatomy of the gastroesophageal junction and role of phrenoesophageal ligament; autopsy study of sphincter mechanism. Ann Surg 164:643–654PubMedCrossRef
57.
Ciovica R, Gadenstatter M, Klingler A et al (2006) Quality of life in GERD patients: medical treatment versus antireflux surgery. J Gastrointest Surg 10:934–939PubMedCrossRef
58.
Kahrilas PJ (2001) Management of GERD: medical versus surgical. Semin Gastrointest Dis 12:3–15PubMed
59.
Lundell L (2007) Therapy of gastroesophageal reflux: evidence-based approach to antireflux surgery. Dig Dis 25:188–196PubMedCrossRef
Metadata
Title
Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12-Month Results of a Prospective Multicenter Study
Authors
Guy-Bernard Cadière
Michel Buset
Vinciane Muls
Amin Rajan
Thomas Rösch
Alexander J. Eckardt
Joseph Weerts
Boris Bastens
Guido Costamagna
Michele Marchese
Hubert Louis
Fazia Mana
Filip Sermon
Anna K. Gawlicka
Michael A. Daniel
Jacques Devière
Publication date
01-08-2008
Publisher
Springer-Verlag
Published in
World Journal of Surgery / Issue 8/2008
Print ISSN: 0364-2313
Electronic ISSN: 1432-2323
DOI
https://doi.org/10.1007/s00268-008-9594-9

Other articles of this Issue 8/2008

World Journal of Surgery 8/2008 Go to the issue

Letter

Should the Tube Cholangiostomy be Performed as a Supplement Procedure to Duodenostomy for Treatment or Prevention of Duodenal Fistula?

Letter

Reply

OriginalPaper

Functional Outcome After Redo Below-Knee Amputation

OriginalPaper

The Appendicitis Inflammatory Response Score: A Tool for the Diagnosis of Acute Appendicitis that Outperforms the Alvarado Score

OriginalPaper

Laparoscopic Adrenalectomy for Metachronous Metastasis from Renal Cell Carcinoma

Letter

Reply