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The safety and efficacy of TIF for treating gastroesophageal reflux disease (GERD) were evaluated in a prospective multicenter trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients (<jats:italic>n<\/jats:italic> = 86) with chronic GERD treated with proton pump inhibitors (PPIs) were enrolled. Exclusion criteria included an irreducible hiatal hernia &gt; 2\u00a0cm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The TIF procedure (<jats:italic>n<\/jats:italic> = 84) reduced all hiatal hernias (<jats:italic>n<\/jats:italic> = 49) and constructed valves measuring 4\u00a0cm (2\u20136\u00a0cm) and 230\u00b0 (160\u00b0\u2013300\u00b0). 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\u00a0months, aggregate (<jats:italic>n<\/jats:italic> = 79) and stratified Hill grade I tight (<jats:italic>n<\/jats:italic> = 21) results showed 73% and 86% of patients with \u226550% improvement in GERD health\u2010related 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 (<jats:italic>p<\/jats:italic> &lt; 0.001), by 53%. EsophyX\u2010TIF cured GERD in 56% of patients based on their symptom reduction and PPI discontinuation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The 12\u2010month results showed that EsophyX\u2010TIF 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.<\/jats:p><\/jats:sec>","DOI":"10.1007\/s00268-008-9594-9","type":"journal-article","created":{"date-parts":[[2008,4,28]],"date-time":"2008-04-28T22:36:59Z","timestamp":1209422219000},"page":"1676-1688","source":"Crossref","is-referenced-by-count":136,"title":["Antireflux Transoral Incisionless Fundoplication Using EsophyX: 12\u2010Month Results of a Prospective Multicenter Study"],"prefix":"10.1002","volume":"32","author":[{"given":"Guy\u2010Bernard","family":"Cadi\u00e8re","sequence":"first","affiliation":[{"name":"Department of Digestive Surgery Centre Hospitalier Universitaire St. Pierre 322 rue Haute 1000 Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michel","family":"Buset","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Centre Hospitalier Universitaire St. Pierre 322 rue Haute 1000 Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vinciane","family":"Muls","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Centre Hospitalier Universitaire St. Pierre 322 rue Haute 1000 Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amin","family":"Rajan","sequence":"additional","affiliation":[{"name":"Clinique du Parc L\u00e9opold Centre Hospitalier R\u00e9gional d\u2019Edith Cavell (CHIREC) Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thomas","family":"R\u00f6sch","sequence":"additional","affiliation":[{"name":"Department of Hepatology and Gastroenterology Charite Universitatsmedizin Berlin Campus Virchow Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander J.","family":"Eckardt","sequence":"additional","affiliation":[{"name":"Department of Hepatology and Gastroenterology Charite Universitatsmedizin Berlin Campus Virchow Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph","family":"Weerts","sequence":"additional","affiliation":[{"name":"Department of Surgery Centre Hospitalier St. Joseph Li\u00e8ge Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Boris","family":"Bastens","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Centre Hospitalier St. Joseph Li\u00e8ge Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Guido","family":"Costamagna","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy Unit Catholic University of Rome Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michele","family":"Marchese","sequence":"additional","affiliation":[{"name":"Digestive Endoscopy Unit Catholic University of Rome Rome Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hubert","family":"Louis","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatopancreatology Universit\u00e9 Libre de Bruxelles, Erasme Hospital Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fazia","family":"Mana","sequence":"additional","affiliation":[{"name":"Academic Hospital Vrije Universiteit Brussel (AZ\u2010VUB) Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Filip","family":"Sermon","sequence":"additional","affiliation":[{"name":"Academic Hospital Vrije Universiteit Brussel (AZ\u2010VUB) Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna K.","family":"Gawlicka","sequence":"additional","affiliation":[{"name":"EndoGastric Solutions, Inc. 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