Top

Surgical Endoscopy

Published in:

01-09-2015

Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study

Authors: Pier Alberto Testoni, Sabrina Testoni, Giorgia Mazzoleni, Cristian Vailati, Sandro Passaretti

Published in: Surgical Endoscopy | Issue 9/2015

Abstract

Background

Transoral incisionless fundoplication (TIF) with the EsophyX™ device creates an antireflux valve with good functional results in patients with gastro-esophageal reflux disease (GERD). The aim of this study was to assess the long-term effect of TIF 2.0 on pathological reflux and symptoms in GERD patients with daily dependence on proton pump inhibitors (PPI).

Methods

Fifty patients underwent TIF. All underwent GERD-HRQL and GERD-QUAL questionnaires, upper GI endoscopy, esophageal manometry, and 24-h pH-impedance before and 6, 12, and 24 months after TIF, and subsequent yearly clinical re-evaluation.

Results

Patients were followed for up to six years (mean 52.7 ± 19.7 months). In all, 83.7, 79.6, 87.8, and 84.4 % of patients stopped or halved the PPI therapy 6, 12, 24, and 36 months after TIF. Three-year figure remained stable up to 6 years. Symptom scores off PPI were significantly lower at 6, 12, 24, and 36 months. At 6 months, Hill’s grade I of the newly created valve persisted in all pre-procedure Hill’s grade I patients, in 66.7 % of grade II and 58.3 % of grade III. This figure remained substantially unchanged at 12 and 24 months, too. Impedance monitoring indicated significantly fewer total and acid refluxes after treatment (p = 0.01). Factors predicting good outcomes were pre-procedure Hill’s grade I-II, no hiatal hernia or hernia ≤2 cm (p = 0.03), absence of ineffective esophageal motility (p < 0.0001), and number of fasteners deployed (p = 0.01).

Conclusions

TIF by the EsophyX achieved lasting elimination of daily dependence on PPI in 75–80 % of patients for up to 6 years. TIF seems an effective therapy for selected symptomatic GERD patients.

Draaisma WE, Rijnhart-de Jong HG, Broeders IA, Smout AJ, Furnee EJ, Gooszen HG (2006) Five-year subjective and objective results of laparoscopic and conventional Nissen fundoplication. Ann Surg 244:34–41PubMedCentralCrossRefPubMed

Smith CD (2009) Surgical therapy for gastroesophageal reflux disease: indications, evaluation and procedures. Gastrointest Endosc Clin N Am 19:35–48CrossRefPubMed

Broeders JA, Draaisma WA, Bredenoord AJ, Smout AJ, Broeders IA, Gooszen HG (2010) Long-term outcome of Nissen fundoplication in non-erosive and erosive gastro-esophageal reflux disease. Br J Surg 97:845–852CrossRefPubMed

Cadière GB1, Rajan A, Rqibate M, Germay O, Dapri G, Himpens J, Gawlicka AK (2006) Endoluminal fundoplication (ELF)—evolution of EsophyX™, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol 15:348–355

Cadière GB1, Rajan A, Germay O, Himpens J (2008) Endoluminal fundoplication by a transoral device for the treatment of GERD: a feasibility study. Surg Endosc 22:333–342

Bell RC, Cadière GB (2011) Transoral rotational esophagogastric fundoplication: technical, anatomical, and safety considerations. Surg Endosc 25:2387–2399PubMedCentralCrossRefPubMed

Cadière GB1, Buset M, Muls V, Rajan A, Rösch T, Eckardt AJ, Weerts J, Bastens B, Costamagna G, Marchese M, Louis H, Mana F, Sermon F, Gawlicka AK, Daniel MA, Devière J (2008) Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study. World J Surg 32:1676–1688

Cadière GB1, Van Sante N, Graves JE, Gawlicka AK, Rajan A (2009) Two-year results of a feasibility study on antireflux transoral incisionless fundoplication using Esophyx. Surg Endosc 23:957–964

Testoni PA, Corsetti M, Di Pietro S, Castellaneta AG, Vailati C, Masci E, Passaretti S (2010) Effect of transoral incisionless fundoplication on symptoms, PPI use, and pH-impedance refluxes of GERD patients. World J Surg 2010(34):750–757CrossRef

10.

Velanovich V (2010) Endoscopic, endoluminal fundoplication for gastroesophageal reflux disease: initial experience and lessons learned. Surgery 148:646–653CrossRefPubMed

11.

Demyttenaere SV, Bergman S, Pham T, Anderson J, Dettorre R, Melvin WS, Mikami DJ (2010) Transoral incisionless fundoplication for gastro-esophageal reflux disease in an unselected patient population. Surg Endosc 24:854–858CrossRefPubMed

12.

Bell RC, Freeman KD (2011) Clinical and pH-metric outcomes of transoral esophagogastric fundoplication for the treatment of gastroesophageal reflux disease. Surg Endosc 25:1975–1984PubMedCentralCrossRefPubMed

13.

Ihde GM, Besancon K, Deljkich E (2011) Short-term safety and symptomatic outcomes of transoral incisionless fundoplication with and without hiatal hernia repair in patients with chronic gastroesophageal reflux disease. Am J Surg 202:740–747CrossRefPubMed

14.

Testoni PA, Vailati C, Testoni S, Corsetti M (2012) Transoral incisionless fundoplication (TIF 2.0) with EsophyX for gastroesophageal reflux disease: long-term results and findings affecting outcome. Surg Endosc 26:1425–1435CrossRefPubMed

15.

TradKS Turgeon DG, Deljkich E (2012) Long-term outcomes after transoral incisionless fundoplication in patients with GERD and LPR symptoms. Surg Endosc 26:650–660CrossRef

16.

Petersen RP1, Filippa L, Wassenaar EB, Martin AV, Tatum R, Oelschlager BK (2012) Comprehensive evaluation of endoscopic fundoplication using the Esophyx device. Surg Endosc 26:1021–1027

17.

Muls V, Eckardt AJ, Marchese M, Bastens B, Buset M, Devière J, Louis H, Rajan A, Daniel MA, Costamagna G (2013) Three-year results of a multicenter prospective study of transoral incisionless fundoplication. Surg Innov 20:321–330CrossRefPubMed

18.

Bell RC, Mavrelis PG, Barnes WE, Dargis D, Carter BJ, Hoddinott KM, Sewell RW, Trad KS, DaCosta Gill B, Ihde GM (2012) A prospective multicenter registry of patients with chronic gastro-esophageal reflux disease receiving transoral incisionless fundoplication. J Am Coll Surg 215:794–809CrossRefPubMed

19.

Drossman DA (2006) The functional gastrointestinal disorders and the Rome III process. Gastroenterology 130:1377–1390CrossRefPubMed

20.

Lundell LR1, Dent J, Bennett JR, Blum AL, Armstrong D, Galmiche JP, Johnson F, Hongo M, Richter JE, Spechler SJ, Tytgat GN, Wallin L (1999) Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles Classification. Gut 45:172–180

21.

Velanovich V1, Vallance SR, Gusz JR, Tapia FV, Harkabus MA (1996) Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg 183:217–224

22.

Raymond JM1, Marquis P, Bechade D, Smith D, Mathiex Fortunet H, Poynard T, Galmiche JP, Amouretti M (1999) Assessment of quality of life of patients with gastroesophageal reflux. Elaboration and validation of a specific questionnaire. Gastroenterol Clin Biol 23:32–39

23.

Jobe BA1, Kahrilas PJ, Vernon AH, Sandone C, Gopal DV, Swanstrom LL, Aye RW, Hill LD, Hunter JG (2004) Endoscopic appraisal of the gastroesophageal valve after antireflux surgery. Am J Gastroenterol 99:233–243

24.

Jobe BA1, O’Rourke RW, McMahon BP, Gravesen F, Lorenzo C, Hunter JG, Bronner M, Kraemer SJ (2008) Transoral endoscopic fundoplication in the treatment of gastroesophageal reflux disease: the anatomic and physiologic basis for reconstruction of the esophago-gastric junction using a novel device. Ann Surg 248:69–76

25.

Hill D, Kozarek RA (1999) The gastroesophageal flap valve. J Clin Gastroenterology 28:194–197CrossRef

26.

Passaretti S, Zaninotto G, Di Martino N, Leo P, Costantini M, Baldi F (2000) Standards for esophageal manometry. A position statement of GISMAD. Dig Liver Dis 32:46–55CrossRefPubMed

27.

Spechler SJ, Castell DO (2001) Classification of oesophageal motility abnormalities. Gut 49:145–151PubMedCentralCrossRefPubMed

28.

Zerbib F, des Varannes SB, Roman S, Pouderoux P, Artigue F, Chaput U, Mion F, Caillol F, Verin E, Bommelaer G, Ducrotté P, Galmiche JP, Sifrim D (2005) Normal values and day-to-day variability of 24-h ambulatory oesophageal impedance-pH monitoring in a Belgian-French cohort of healthy subjects. Aliment Pharmacol Ther 22:1011–1021CrossRefPubMed

29.

Johnson LF, DeMeester TR (1986) Development of the 24-hour intraesophageal pH monitoring composite scoring system. J Clin Gastroenterol 8:52–58CrossRefPubMed

30.

Malmud LS, Fischer RS, Knight LC, Rock E (1982) Scintigraphic evaluation of gastric emptying. Semin Nucl Med 12:116–125CrossRefPubMed

31.

Richter JE (2007) The many manifestations of gastro-esophageal reflux disease: presentation, evaluation, and treatment. Gastroenterol Clin N Am 36:577–599CrossRef

32.

Nijjar RS1, Watson DI, Jamieson GG, Archer S, Bessell JR, Booth M, Cade R, Cullingford GL, Devitt PG, Fletcher DR, Hurley J, Kiroff G, Martin IJ, Nathanson LK, Windsor JA; International Society for the Diseases of the Esophagus-Australasian Section (2010) Five-year follow-up of a multicenter, double blind randomized clinical trail of laparoscopic Nissen vs. anterior 90 degrees partial fundoplication. Arch Surg 145:552–557

33.

Broeders JA, Mauritz FA, Ahmed Ali U, Draaisma WA, Ruurda JP, Gooszen HG, Smout AJ, Broeders IA, Hazebroek EJ (2010) Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastro-esophageal reflux disease. Br J Surg 97:1318–1330CrossRefPubMed

34.

Bell RCW, Hufford RJ, Fearon J, Freeman KD (2013) Revision of failed traditional fundoplication using Esophyx transoral fundoplication. Surg Endosc 27:761–767PubMedCentralCrossRefPubMed

35.

Furnée EJ, Broeders JA, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJ, van Rijn PJ, Broeders IA (2010) Laparoscopic Nissen fundoplication after failed Esophyx fundoplication. Br J Surg 97:1051–1055CrossRefPubMed

36.

Perry KA, Linn JG, Eakin JL, Onders RP, Velanovich V, Melvin WS (2013) Transoral incisionless fundoplication does not significantly increase morbidity of subsequent laparoscopic Nissen fundoplication. J Laparoendosc Adv Surg Tech A 23:456–458CrossRefPubMed

37.

Barnes WE, Hoddinott KM, Mundy S, Williams M (2011) Transoral incisionless fundoplication offers high patient satisfaction and relief of therapy-resistant typical and atypical symptoms of GERD in community practice. Surg Innov 18:119–129CrossRefPubMed

38.

Repici A, Fumagalli U, Malesci A, Barbera R, Gambaro C, Rosati R (2010) Endoluminal fundoplication (ELF) for GERD using Esophyx: a 12-month follow-up in a single-center experience. J Gastrointest Surg 14:1–6CrossRefPubMed

39.

Hoppo T, Immanuel A, Schuchert M, Dubrava Z, Smith A, Nottle P, Watson DI, Jobe BA (2010) Transoral incisionless fundoplication 2.0 procedure using EsophyX™ for gastroesophageal reflux disease. J Gastrointest Surg 14:1895–1901CrossRefPubMed

40.

Frazzoni M1, Conigliaro R, Manta R, Melotti G (2011) Reflux parameters as modified by EsophyX or laparoscopic fundoplication in refractory GERD. Aliment Pharmacol Ther 34(1):67–75

41.

Kim KY, Kim GH, Kim DU, Wang SG, Lee BJ, Lee JC, Park DY, Song GA (2008) Is ineffective esophageal motility associated with gastropharyngeal reflux disease? World J Gastroenterol 14:6030–6035PubMedCentralCrossRefPubMed

42.

Haack HG, Hansen RD, Malcolm A, Kellow JE (2008) Ineffective esophageal motility: manometric subsets exhibit different symptom profiles. World J Gastroenterol 14:3719–3724PubMedCentralCrossRefPubMed

43.

Bell RCW, Fox MA, Barnes WE, Mavrelis PG, Sewell RW, Carter BJ, Ihde GM, Trad KS, Dargis D, Hoddinott KM, Freeman KD, Gunsberger T, Hausmann MG, DaCosta Gill B, Wilson E (2014) Univariate and multivariate analyses of preoperative factors influencing symptomatic outcomes of transoral fundoplication. Surg Endosc doi: 10.1007/s00464-014-3557-z

Title: Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study
Authors: Pier Alberto Testoni
Sabrina Testoni
Giorgia Mazzoleni
Cristian Vailati
Sandro Passaretti
Publication date: 01-09-2015
Publisher: Springer US
Published in: Surgical Endoscopy / Issue 9/2015
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-014-4008-6

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Long-term efficacy of transoral incisionless fundoplication with Esophyx (Tif 2.0) and factors affecting outcomes in GERD patients followed for up to 6 years: a prospective single-center study

Abstract

Background

Methods

Results

Conclusions

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

Please log in to get access to this content

Other articles of this Issue 9/2015

Laparoscopic ventral/incisional hernia repair: updated guidelines from the EAES and EHS endorsed Consensus Development Conference

The effects of CO2-insufflation with 5 and 10 mmHg during thoracoscopy on cerebral oxygenation and hemodynamics in piglets: an animal experimental study

Peroral endoscopic myotomy for advanced achalasia with sigmoid-shaped esophagus: long-term outcomes from a prospective, single-center study

Spatial orientation in pathway surgery

The effect of ergonomic laparoscopic tool handle design on performance and efficiency

Interest of submucosal dissection knife for endoscopic treatment of Zenker’s diverticulum