Antireflux transoral incisionless fundoplication using EsophyX: 12-month results of a prospective multicenter study

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, 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

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 degrees (160 degrees -300 degrees ). 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 >or=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.

Figures

Fig. 1
Fig. 1
Usage and dosage of proton pump inhibitors. TIF: transoral incisionless fundoplication
Fig. 2
Fig. 2
Hill grade distribution of the valves
Fig. 3
Fig. 3
Resting pressure of lower esophageal sphincter (LES) determined by manometry before and after the EsophyX-TIF procedure
Fig. 4
Fig. 4
Endoscopic images of gastroesophageal valves from two patients who had Hill grade IV valves, esophagitis A, and a 2 cm hiatal hernia before TIF. At 6 and 12 months post-TIF both patients had Hill grade I valves, no hiatal hernia, and no esophagitis
Fig. 5
Fig. 5
Study population divided into three groups depending on the degree of cure from gastroesophageal reflux disease (GERD) based on the long-term clinical effectiveness of EsophyX-TIF. Cured: patients demonstrated clinically significant alleviation of their symptoms and discontinued their usage of proton pump inhibitor (PPI) therapy. Improved: patients required only occasional PPI therapy and had reduced heartburn. Ongoing GERD: patients showed no alleviation of their symptoms and required daily usage of PPIs. Among the cured patients, 24% were “completely cured” of GERD based on total elimination of heartburn and regurgitation, completely healed esophagitis, reduced hiatal hernia, and normalized or significantly reduced esophageal acid exposure

References

    1. El-Serag HB. Time trends of gastroesophageal reflux disease: a systematic review. Clin Gastroenterol Hepatol. 2007;5:17–26. doi: 10.1016/j.cgh.2006.09.016.
    1. Lundell L. Surgery of gastroesophageal reflux disease: a competitive or complementary procedure? Dig Dis. 2004;22:161–170. doi: 10.1159/000080315.
    1. Metz DC. Managing gastroesophageal reflux disease for the lifetime of the patient: evaluating the long-term options. Am J Med. 2004;117( Suppl 5A):49S–55S.
    1. Moayyedi P, Talley NJ. Gastro-oesophageal reflux disease. Lancet. 2006;367:2086–2100. doi: 10.1016/S0140-6736(06)68932-0.
    1. Nandurkar S, Talley NJ. Epidemiology and natural history of reflux disease. Best Pract Res Clin Gastroenterol. 2000;14:743–757. doi: 10.1053/bega.2000.0122.
    1. Smout AJ. The patient with GORD and chronically recurrent problems. Best Pract Res Clin Gastroenterol. 2007;21:365–378. doi: 10.1016/j.bpg.2007.01.007.
    1. Stylopoulos N, Rattner DW. The history of hiatal hernia surgery: from Bowditch to laparoscopy. Ann Surg. 2005;241:185–193.
    1. Jones MP, Sloan SS, Rabine JC, et al. Hiatal hernia size is the dominant determinant of esophagitis presence and severity in gastroesophageal reflux disease. Am J Gastroenterol. 2001;96:1711–1717. doi: 10.1111/j.1572-0241.2001.03926.x.
    1. Mittal RK. Hiatal hernia: myth or reality? Am J Med. 1997;103:33S–39S. doi: 10.1016/S0002-9343(97)00318-5.
    1. Mittal RK. Hiatal hernia and gastroesophageal reflux: another attempt to resolve the controversy. Gastroenterology. 1993;105:941–943.
    1. Moss SF, Kidd M, Modlin IM. The status of the hiatus: the role of hernia in gastroesophageal reflux disease. J Clin Gastroenterol. 2007;41:S144–S153. doi: 10.1097/MCG.0b013e31804bbe38.
    1. Rydberg L, Ruth M, Lundell L. Mechanism of action of antireflux procedures. Br J Surg. 1999;86:405–410. doi: 10.1046/j.1365-2168.1999.01025.x.
    1. Allgood PC, Bachmann M. Medical or surgical treatment for chronic gastrooesophageal reflux? A systematic review of published evidence of effectiveness. Eur J Surg. 2000;166:713–721. doi: 10.1080/110241500750008475.
    1. Cookson R, Flood C, Koo B, et al. 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. 2005;92:700–706. doi: 10.1002/bjs.4933.
    1. Lundell L, Miettinen P, Myrvold HE, et al. Seven-year follow-up of a randomized clinical trial comparing proton-pump inhibition with surgical therapy for reflux oesophagitis. Br J Surg. 2007;94:198–203. doi: 10.1002/bjs.5492.
    1. Mahon D, Rhodes M, Decadt B, et al. Randomized clinical trial of laparoscopic Nissen fundoplication compared with proton-pump inhibitors for treatment of chronic gastro-oesophageal reflux. Br J Surg. 2005;92:695–699. doi: 10.1002/bjs.4934.
    1. Dallemagne B, Weerts J, Markiewicz S, et al. Clinical results of laparoscopic fundoplication at ten years after surgery. Surg Endosc. 2006;20:159–165. doi: 10.1007/s00464-005-0174-x.
    1. Coelho JC, Wiederkehr JC, Campos AC, et al. Conversions and complications of laparoscopic treatment of gastroesophageal reflux disease. J Am Coll Surg. 1999;189:356–361. doi: 10.1016/S1072-7515(99)00182-9.
    1. Kamolz T, Granderath FA, Bammer T, et al. Dysphagia and quality of life after laparoscopic Nissen fundoplication in patients with and without prosthetic reinforcement of the hiatal crura. Surg Endosc. 2002;16:572–577. doi: 10.1007/s00464-001-9136-0.
    1. Lundell L. Complications after anti-reflux surgery. Best Pract Res Clin Gastroenterol. 2004;18:935–945.
    1. Wills VL, Hunt DR. Dysphagia after antireflux surgery. Br J Surg. 2001;88:486–499. doi: 10.1046/j.1365-2168.2001.01662.x.
    1. Bessell JR, Finch R, Gotley DC, et al. Chronic dysphagia following laparoscopic fundoplication. Br J Surg. 2000;87:1341–1345. doi: 10.1046/j.1365-2168.2000.01634.x.
    1. Hayden J, Jamieson G. Optimization of outcome after laparoscopic antireflux surgery. ANZ J Surg. 2006;76:258–263. doi: 10.1111/j.1445-2197.2006.03691.x.
    1. Cadiere GB, Rajan A, Rqibate M, et al. Endoluminal fundoplication (ELF) - evolution of EsophyXTM, a new surgical device for transoral surgery. Minim Invasive Ther Allied Technol. 2006;15:348–355. doi: 10.1080/13645700601040024.
    1. Aye RW, Hill LD, Kraemer SJ, et al. Early results with the laparoscopic Hill repair. Am J Surg. 1994;167:542–546. doi: 10.1016/0002-9610(94)90254-2.
    1. Hill LD, Kozarek RA, Kraemer SJ, et al. The gastroesophageal flap valve: in vitro and in vivo observations. Gastrointest Endosc. 1996;44:541–547. doi: 10.1016/S0016-5107(96)70006-8.
    1. Kraemer SJ, Aye R, Kozarek RA, et al. Laparoscopic Hill repair. Gastrointest Endosc. 1994;40:155–159.
    1. Kraemer SJ, Kozarek RA, Carter BJ, et al. EsophyX endoluminal fundoplication for the treatment of severe chronic GERD: multiple tissue fasteners secure valvuloplasty as demonstrated in an animal model. Gastrointest Endosc. 2006;63:AB235. doi: 10.1016/j.gie.2006.03.602.
    1. Cadiere GB, Rajan A, Germay O, et al. Endoluminal fundoplication by a transoral device for the treatment of GERD: a feasibility study. Surg Endosc. 2008;22:333–342. doi: 10.1007/s00464-007-9618-9.
    1. Hirano I, Richter JE. ACG practice guidelines: esophageal reflux testing. Am J Gastroenterol. 2007;102:668–685. doi: 10.1111/j.1572-0241.2006.00936.x.
    1. Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut. 1999;45:172–180.
    1. Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20:130–134. doi: 10.1111/j.1442-2050.2007.00658.x.
    1. Velanovich V, Vallance SR, Gusz JR, et al. Quality of life scale for gastroesophageal reflux disease. J Am Coll Surg. 1996;183:217–224.
    1. Pleskow D, Rothstein R, Lo S, et al. Endoscopic full-thickness plication for the treatment of GERD: 12-month follow-up for the North American open-label trial. Gastrointest Endosc. 2005;61:643–649. doi: 10.1016/S0016-5107(04)02648-3.
    1. Rothstein R, Filipi C, Caca K, et al. Endoscopic full-thickness plication for the treatment of gastroesophageal reflux disease: a randomized, sham-controlled trial. Gastroenterology. 2006;131:704–712. doi: 10.1053/j.gastro.2006.07.004.
    1. Tseng D, Rizvi AZ, Fennerty MB, et al. Forty-eight-hour pH monitoring increases sensitivity in detecting abnormal esophageal acid exposure. J Gastrointest Surg. 2005;9:1043–1051. doi: 10.1016/j.gassur.2005.07.011.
    1. Tutuian R, Castell DO. Diagnostic procedures in GERD: principles and values of esophageal manometry and pH-monitoring. In: Granderath FA, Kamolz T, Pointner R, editors. Gastroesophageal Reflux Disease: Principles of Disease, Diagnosis, and Treatment. New York: Springer; 2006. pp. 121–138.
    1. Portale G, Peters J, Hsieh CC, et al. When are reflux episodes symptomatic? Dis Esophagus. 2007;20:47–52. doi: 10.1111/j.1442-2050.2007.00650.x.
    1. Pandolfino JE, Richter JE, Ours T, et al. Ambulatory esophageal pH monitoring using a wireless system. Am J Gastroenterol. 2003;98:740–749. doi: 10.1111/j.1572-0241.2003.07398.x.
    1. Jobe BA, Kahrilas PJ, Vernon AH, et al. Endoscopic appraisal of the gastroesophageal valve after antireflux surgery. Am J Gastroenterol. 2004;99:233–243. doi: 10.1111/j.1572-0241.2004.04042.x.
    1. Seltman AK, Kahrilas PJ, Chang EY, et al. Endoscopic measurement of cardia circumference as an indicator of GERD. Gastrointest Endosc. 2006;63:22–31. doi: 10.1016/j.gie.2005.07.030.
    1. Gideon RM. Manometry: technical issues. Gastrointest Endosc Clin N Am. 2005;15:243–255. doi: 10.1016/j.giec.2004.10.004.
    1. Nayar DS, Khandwala F, Achkar E, et al. Esophageal manometry: assessment of interpreter consistency. Clin Gastroenterol Hepatol. 2005;3:218–224. doi: 10.1016/S1542-3565(04)00617-2.
    1. Huber-Lang M, Henne-Bruns D, Schmitz B, et al. Esophageal perforation: principles of diagnosis and surgical management. Surg Today. 2006;36:332–340. doi: 10.1007/s00595-005-3158-5.
    1. Raghunath AS, O’Morain C, McLoughlin RC. Review article: the long-term use of proton-pump inhibitors. Aliment Pharmacol Ther. 2005;22(Suppl 1):55–63. doi: 10.1111/j.1365-2036.2005.02611.x.
    1. Jalving M, Koornstra JJ, Wesseling J, et al. Increased risk of fundic gland polyps during long-term proton pump inhibitor therapy. Aliment Pharmacol Ther. 2006;24:1341–1348. doi: 10.1111/j.1365-2036.2006.03127.x.
    1. Garcia Rodriguez LA, Ruigomez A, Panes J. Use of acid-suppressing drugs and the risk of bacterial gastroenteritis. Clin Gastroenterol Hepatol. 2007;5:1418–1423. doi: 10.1016/j.cgh.2007.09.010.
    1. Fass R. Erosive esophagitis and nonerosive reflux disease (NERD): comparison of epidemiologic, physiologic, and therapeutic characteristics. J Clin Gastroenterol. 2007;41:131–137. doi: 10.1097/01.mcg.0000225631.07039.6d.
    1. Johnson DA, Benjamin SB, Vakil NB, et al. 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. 2001;96:27–34. doi: 10.1111/j.1572-0241.2001.03443.x.
    1. Marchese M, Spada C, Costamagna G. Endoluminal fundoplication. Minim Invasive Ther Allied Technol. 2006;15:356–365. doi: 10.1080/13645700601040594.
    1. Daniel MA. EndoGastric Solutions EsophyX system with SerosaFuse fasteners and accessories. U.S. Food and Drug Administration 510(k) Submission. 2007;K071651:1–456.
    1. Wynyard M, Kletschka HD. The crural branches of the phrenic nerves: their surgical significance. Minn Med. 1966;49:1821–1824.
    1. Fumagalli U, Bona S, Battafarano F et al (2007) Persistent dysphagia after laparoscopic fundoplication for gastro-esophageal reflux disease. Dis Esophagus. doi: 10.1111/j.1442-2050.2007.00773.x
    1. Soper NJ. Laparoscopic management of hiatal hernia and gastroesophageal reflux. Curr Probl Surg. 1999;36:765–838.
    1. Bremner CG, Schlegel JF, Ellis FH., Jr Studies of the “gastroesophageal sphincter mechanism”: the role of the phrenoesophageal membrane. Surgery. 1970;67:735–740.
    1. Bombeck CT, Dillard DH, Nyhus LM. Muscular anatomy of the gastroesophageal junction and role of phrenoesophageal ligament; autopsy study of sphincter mechanism. Ann Surg. 1966;164:643–654.
    1. Ciovica R, Gadenstatter M, Klingler A, et al. Quality of life in GERD patients: medical treatment versus antireflux surgery. J Gastrointest Surg. 2006;10:934–939. doi: 10.1016/j.gassur.2006.04.001.
    1. Kahrilas PJ. Management of GERD: medical versus surgical. Semin Gastrointest Dis. 2001;12:3–15.
    1. Lundell L. Therapy of gastroesophageal reflux: evidence-based approach to antireflux surgery. Dig Dis. 2007;25:188–196. doi: 10.1159/000103883.

Source: PubMed

スポンサーと協力者

医学的状態

薬物療法

3
購読する