BackgroundGastroesophageal reflux disease (GERD) results primarily from the loss of an effective antireflux barrier, which forms a mechanical barrier against the retrograde movement of gastric content. Restoration of the incompetent antireflux barrier is possible by longitudinal and rotational advancement of the gastric fundus about the lower esophagus, creating an esophagogastric fundoplication. This article describes the technique of performing a rotational and longitudinal esophagogastric fundoplication, performed transorally using EsophyX.MethodsThe transoral incisionless fundoplication (TIF) technique enables the creation of a full-thickness esophagogastric fundoplication with fixation extending longitudinally up to 3.5 cm above the Z-line and rotationally more than 270 degrees around the esophagus. A key element of the technique involves rotating the fundus around the esophagus with a tissue mold during gastric desufflation. Anatomic considerations and use of the device’s tissue invaginator to push the esophagus caudally are important to ensure safe positioning of the plications below the diaphragm. The steps of the technique are described in detail, and suggestions are given about patient selection and care, as well as prevention and management of complications.
ObjectiveNumber of reflux episodes, an adjunctive metric on pH-impedance monitoring, is incompletely studied. We aimed to determine if number of reflux episodes associates with therapeutic outcome in regurgitation predominant gastro-oesophageal reflux disease (GERD).DesignWe performed post hoc analysis of postintervention pH-impedance data from adult patients with moderate/severe regurgitation despite QD proton pump inhibitor (PPI), randomised to either two times a day PPI or magnetic sphincter augmentation (MSA) in 2:1 allocation. After 6 and 12 months, symptom response was defined by improvement in Foregut Symptom Questionnaire (FSQ) regurgitation score to none or minimal, ≥50% reduction in GERD health-related quality of life (HRQL) score and satisfaction with therapy. Univariate and multivariate analyses were performed to determine predictors of symptom improvement.ResultsOf 152 randomised patients, 123 (age 46.9±1.2 year, 43% female) had complete data. Symptom and satisfaction scores significantly improved after MSA compared with two times a day PPI. Both acid exposure time (13.4%±0.7% to 1.3±0.2%, p<0.001) and reflux episodes (86±4 to 48±4, p<0.001) declined with therapy. Reduction to <40 reflux episodes was significantly more frequent in those with symptom response by FSQ regurgitation score, GERD HRQL score and satisfaction with therapy (p≤0.03 for each); <35 episodes performed better on receiver operating characteristic analysis. On multivariate analysis, improvement in regurgitation score remained independently predictive of satisfaction with therapy (p<0.001 for each). In patients crossing over to MSA, >80 episodes pretreatment predicted improvement.ConclusionsReduction of reflux episodes on pH-impedance to physiological levels associates with improved outcomes, while pathological levels predict improvement with MSA in regurgitation predominant GERD.Trail registration numberClinicalTrials.gov: NCT02505945.
Background: The American Foregut Society (AFS) is dedicated to advancing patient care and digestive health within the realm of foregut disease. One of the most common and debilitating esophageal conditions is gastroesophageal reflux disease (GERD). The Hill grade is an endoscopic classification of the esophagogastric junction (EGJ) based on the appearance of the gastroesophageal flap valve from a retroflexed view of the hiatus. This endoscopic classification provides insight into the anatomic disruption of the EGJ which has been shown to correlate with GERD. However, clinical utilization of this classification by endoscopists has been limited due to the perceived relevance and subjectivity of the classification. With the advent of endoscopic treatment options for GERD, there is renewed enthusiasm to develop a grading system of the EGJ that can objectively define anatomical impairment and reduce interobserver grading variability. Methods: The AFS convened a 13-member working group tasked with reviewing the Hill grade classification and formulating a proposal for its revision utilizing a modified Delphi method. This white paper summarizes the output from this working group. Results: The working group concluded that all components of the antireflux barrier—the lower esophageal sphincter and its sling fibers, the crural diaphragm, and the gastroesophageal flap valve—contribute to EGJ integrity. Using defined objective parameters of extent of hiatal axial herniation and crural disruption and presence or absence of a flap valve, the new AFS classification stratifies EGJ integrity from normal (grade 1) to increasing degrees of EGJ disruption (grade 2-4) beginning with loss of the flap valve and progressing to increasing degrees of crural disruption and hiatus hernia. This AFS classification also stipulates appropriate endoscopic methodology to utilize in making the assessment and provides a basic nomenclature for communication among endoscopists. Conclusions: The AFS endoscopic classification of the EGJ expands on the Hill classification by including assessment of axial hiatal hernia length (L), hiatal aperture diameter (D), and presence or absence of the flap valve (F) making it more comprehensive - LDF components. Future directions include validation studies correlating the ability of the AFS classification in predicting the presence and severity of GERD.
Gastroesophageal reflux disease (GERD) is a chronic disease on a spectrum that has an array of management options ranging from lifestyle changes, acid suppressive therapy to laparoscopic anti-reflux surgery (LARS). Transoral incisionless fundoplication (TIF) is an endoscopic procedure in the management of GERD that re-establishes and augments the gastroesophageal flap valve (GEFV). TIF is appropriate for patients that do not have a hiatal hernia greater than 2 cm. Patients with a hiatal hernia greater than 2 cm have the option to have either a conventional LARS (laparoscopic hiatal hernia repair with complete or partial fundoplication) or a concomitant laparoscopic hiatal hernia repair with TIF, known as concomitant TIF (cTIF). This white paper summarizes the published outcome data for TIF 2.0 and cTIF to date and outline the best practice approaches including patient assessment, selection, and management for TIF and cTIF.
INTRODUCTION: Transoral Fundoplication (TIF 2.0) has become an accepted procedure to treat GERD. Long-term data on clinical success has been limited. We report results on 154 patients followed up to 9 years. METHODS: IRB approved retrospective study of prospective registry patients undergoing TIF 2.0 (without hernia repair) at single institution between 1/2008 and 7/2015. Perioperative complications, need for reintervention, and clinical response measured by GERD-HRQL and Regurgitation scores used in prior TIF studies, and changes in pH parameters were primary outcome measures. RESULTS: 154 patients with objectively documented GERD (88 F, mean age 54 (17-81), mean BMI 27 (19.6-38) underwent TIF 2.0 with the EsophyX-2 device. Using a combination of a caudal helical retractor, caudally-directed external advancement of the device to which the esophagus was adherent by suction, and a rotational movement of the tissue mold around one single helix engagement at 12 o’clock position, the fundus of the stomach was partially rotated around the distal esophagus and secured with multiple 6.5 mm H-shaped polypropylene fasteners. 131 (85%) patients were available for clinical follow-up at up to 9 years (0.7-9.7, Med 4.7, IQR 2-6.7); 75 (49%) were followed ≥ 5 years. 29 (19.3%) patients underwent laparoscopic fundoplication at median of 465 days after TIF (93-2643). QOL results were similar in this group (Figure 1). At a median of 4.7 years after TIF, GERD-HRQL and Regurgitation scores decreased by ≥50% in 70% and 78%. Figure 2 shows GERD-HRQL scores by year. Bloating by GERD-HRQL (score >2) decreased from 46% (58/126) preop to 18% (23/127) of patients postop. 89% (137/154) presented with medically refractory GERD. 72% of patients not undergoing reoperation were not using PPIs and 2 (2%) prn PPI at follow-up. 101 patients had pH testing at a mean of 20 months [1-94 R] post-procedure. Worst day DeMeester score decreased from a median of 32.7 [IQR 23.5-50] to 19.7 [IQR 7.4-35], p< 0.001, with 41/101 (41%) normalized. 3 complications required re-intervention: a GI bleed clipped endoscopically, an immediate laparoscopic repair of an esophageal leak, and an abscess at 5 days requiring laparoscopic drainage, repair, and fundoplication. CONCLUSION: Primary TIF 2.0 technique is durable with stable improvement in QOL and PPI use at up to 9 years, including 76/150 (51%) of patients followed ≥5 years. 72% non-reoperated TIF patients remained off PPI at up to 9 years of follow-up.
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