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Background: Questions remain about the therapeutic durability of transoral incisionless fundoplication (TIF). In this study, clinical outcomes were evaluated at 5 years post-TIF 2.0., Methods: A total of 63 chronic gastroesophageal reflux disease (GERD) sufferers with troublesome symptoms refractory to proton pump inhibitor (PPI) therapy, absent or ≤2 cm hiatal hernia, and abnormal esophageal acid exposure were randomized to the TIF group or PPI group. Following the 6-month evaluation, all patients in the PPI group elected for crossover to TIF; therefore, all 63 patients underwent TIF 2.0 with EsophyX 2 device. Primary outcome was elimination of daily troublesome regurgitation and atypical symptoms at the 5-year follow-up. Secondary outcomes were improvement in symptom scores, PPI use, reoperations, and patient health satisfaction. The cost-effectiveness of TIF 2.0 was also estimated., Results: Of 63 patients, 60 were available at 1 year, 52 at 3 years, and 44 at 5 years for evaluation. Troublesome regurgitation was eliminated in 88% of patients at 1 year, 90% at 3 years, and 86% at 5 years. Resolution of troublesome atypical symptoms was achieved in 82% of patients at 1 year, 88% at 3 years, and 80% at 5 years. No serious adverse events occurred. There were 3 reoperations by the end of the 5-year follow-up. At the 5-year follow-up, 34% of patients were on daily PPI therapy as compared with 100% of patients at screening. The total GERD Health-related quality-of-life score improved by decreasing from 22.2 to 6.8 at 5 years ( P < .001)., Conclusion: In this patient population, the TIF 2.0 procedure provided safe and sustained long-term elimination of troublesome GERD symptoms.

Background: Four randomized controlled trials have demonstrated the short-term efficacy and safety of transoral esophagogastric fundoplication (TF) performed with the EsophyX ® device in eliminating troublesome gastroesophageal reflux disease (GERD) symptoms in well-selected patient populations. The aim of this study was to assess the durability of these outcomes at 3 years post-procedure., Methods: The TF EsophyX versus Medical PPI Open Label trial was conducted in seven US sites. Between June and August 2012, we enrolled patients with small (<2 cm) or absent hiatal hernias who suffered from troublesome GERD symptoms while on PPI therapy for at least 6 months and had abnormal esophageal acid exposure (EAE). Randomization was to TF group (n = 40) or to PPI group (n = 23). Following evaluation at 6 months, all remaining PPI patients (n = 21) elected to undergo crossover to TF. Fifty-two patients were assessed at 3 years for (1) GERD symptom resolution using three GERD-specific quality of life questionnaires, (2) healing of esophagitis using endoscopy, (3) EAE using 48-h Bravo testing, and (4) discontinuation of PPI use. Two patients who underwent revisional procedures by year 3 were included in the final analysis., Results: At 3-year follow-up, elimination of troublesome regurgitation and all atypical symptoms was reported by 90 % (37/41) and 88 % (42/48) of patients, respectively. The mean Reflux Symptom Index score improved from 22.2 (9.2) on PPIs at screening to 4 (7.1) off PPIs 3 years post-TF, p < 0.0001. The mean total % time pH <4 improved from 10.5 (3.5) to 7.8 (5.7), p = 0.0283. Esophagitis was healed in 86 % (19/22) of patients. At the end of study, 71 % (37/52) of patients had discontinued PPI therapy. All outcome measures remained stable between 1-, 2-, and 3-year follow-ups., Conclusion: This study demonstrates that TF can be used to achieve long-term control of chronic GERD symptoms, healing of esophagitis, and improvement in EAE.

Background: Incomplete control of troublesome regurgitation and extraesophageal manifestations of chronic gastroesophageal reflux disease (GERD) is a known limitation of proton pump inhibitor (PPI) therapy. This multicenter randomized study compared the efficacy of transoral incisionless fundoplication (TIF) against PPIs in controlling these symptoms in patients with small hiatal hernias., Methods: Between June and August 2012, 63 patients were randomized at 7 US community hospitals. Patients in the PPI group were placed on maximum standard dose (MSD). Patients in the TIF group underwent esophagogastric fundoplication using the EsophyX2 device. Primary outcome was elimination of daily troublesome regurgitation or extraesophageal symptoms. Secondary outcomes were normalization of esophageal acid exposure (EAE), PPI usage and healing of esophagitis., Results: Of 63 randomized patients (40 TIF and 23 PPI), 3 were lost to follow-up leaving 39 TIF and 21 PPI patients for analysis. At 6-month follow-up, troublesome regurgitation was eliminated in 97% of TIF patients versus 50% of PPI patients, relative risk (RR) = 1.9, 95% confidence interval (CI) = 1.2-3.11 (P = .006). Globally, 62% of TIF patients experienced elimination of regurgitation and extraesophageal symptoms versus 5% of PPI patients, RR = 12.9, 95% CI = 1.9-88.9 (P = .009). EAE was normalized in 54% of TIF patients (off PPIs) versus 52% of PPI patients (on MSD), RR = 1.0, 95% CI = 0.6-1.7 (P = .914). Ninety percent of TIF patients were off PPIs., Conclusion: At 6-month follow-up, TIF was more effective than MSD PPI therapy in eliminating troublesome regurgitation and extraesophageal symptoms of GERD., (© The Author(s) 2014.)

The aim of this study was to assess prospectively 2-year outcomes of transoral incisionless fundoplication (TIF) in a multicenter setting. A 14-center U.S. registry was designed to evaluate the effects of the TIF 2.0 procedure on chronic gastroesophageal reflux disease (GERD) in over 100 patients. Primary outcome was symptom assessment. Secondary outcomes were proton pump inhibitor (PPI) use, degree of esophagitis, safety, and changes in esophageal acid exposure. One hundred twenty-seven patients underwent TIF between January 2010 and April 2011, 19 (15%) of whom were lost to follow-up. Eight patients undergoing revisional surgery were included, as failures, in the 108 remaining patients. No serious adverse events were reported. GERD Health-related Quality of Life and regurgitation scores improved by 50 per cent or greater in 63 of 96 (66%) and 62 of 88 (70%) patients who had elevated preoperative scores. The Reflux Symptom Index score normalized in 53 of 82 (65%) patients. Daily PPI use decreased from 91 to 29 per cent. In patients amenable to postoperative testing, esophagitis healed in 12 of 16 (75%) and esophageal acid exposure normalized in eight of 14 (57%). TIF safely achieved sustained symptomatic control over a 2-year period in two-thirds of patients with a virtual absence of de novo side effects.

Background: Preoperative factors predicting symptomatic improvement after transoral fundoplication (TF) in chronic gastroesophageal reflux disease (GERD) patients with persistent symptoms on proton-pump inhibitors (PPIs) therapy have not been elucidated fully., Methods: Univariate and multivariate logistic regression analyses were performed on data from 158 consecutive patients who underwent TF with the EsophyX device between January 2010 and June 2012 in 14 community centers. Variables included age, gender, body mass index, GERD duration, PPIs therapy duration, presence of hiatal hernia, esophagitis, Hill grade, quality of life scores (QOL) on PPIs, % total time pH < 4, and DeMeester score on reflux testing off PPIs., Results: All patients suffered from typical GERD symptoms. Additionally, 78% (124/158) of patients suffered from atypical symptoms. Six percent (10/158) with recurrent GERD symptoms refractory to PPI therapy underwent revisional procedure (9 laparoscopic Nissen, 1 TF). Median follow-up was 22 (range 10-43) months. For patients with typical symptoms, univariate analyses revealed 4 preoperative factors predictive of successful outcomes: age ≥ 50 [odds ratio (OR) = 2.4, 95% confidence interval (CI) = 1.2-4.8, p = 0.014], GERD Health-related Quality of Life score (GERD-HRQL) ≥ 15 on PPIs (OR = 6.0, CI = 1.2-29.4, p = 0.026, Reflux Symptom Index score > 13 on PPIs (OR = 2.4, CI = 1.1-5.2, p = 0.027), and Gastroesophageal Reflux Symptom Score ≥ 18 on PPIs (OR = 2.6, CI = 1.2-5.8, p = 0.018). Age and GERD-HRQL score remained significant predictors by multivariate analysis. For patients with atypical symptoms, only GERD-HRQL score ≥ 15 on PPIs (OR = 9.9, CI = 0.9-4.6, p = 0.036) was associated with successful outcomes., Conclusions: Elevated preoperative QOL scores on PPIs and age ≥ 50 were most closely associated with successful outcome of TF in patients with persistent symptoms despite medical therapy.

Purpose: This study aimed to assess the impact of transoral incisionless fundoplication (TIF) on patients with chronic gastroesophageal reflux disease (GERD) at 12-month follow-up., Methods: Clinical outcomes of 100 consecutive patients with chronic GERD who underwent TIF between January 2010 and February 2011 were analyzed., Results: There were no major complications reported. Esophageal acid exposure was normalized in 14/27 (52%) of patients who underwent 12-month pH testing. Seventy-four percent of all patients were off proton pump inhibitors versus 92% on daily proton pump inhibitors before TIF, P<0.001. Daily bothersome heartburn and regurgitation symptoms were eliminated in 66/85 (78%) and 48/58 (83%) of patients. Median reflux symptom index score was reduced from 20 (0 to 41) to 5 (0 to 44), P<0.001. Two patients reported de novo dysphagia and 1 patient reported bloating (scores 0 to 3). Six patients underwent revision; 5 laparoscopic Nissen fundoplication and 1 TIF., Conclusions: TIF provided a safe and effective therapeutic option for carefully selected patients with chronic GERD.

Background & aimsWireless pH monitoring measures esophageal acid exposure time (AET) for up to 96 hours. We evaluated competing methods of analysis of wireless pH data.MethodsAdult patients with persisting reflux symptoms despite acid suppression (n = 322, 48.5 ± 0.9 years, 61.7% women) from 2 tertiary centers were evaluated using symptom questionnaires and wireless pH monitoring off therapy, from November 2013 through September 2017; 30 healthy adults (control subjects; 26.9 ± 1.5 years; 60.0% women) were similarly evaluated. Concordance of daily AET (physiologic 6%) for 2 or more days constituted the predominant AET pattern. Each predominant pattern (physiologic, borderline, or pathologic) in relation to data from the first day, and total averaged AET, were compared with other interpretation paradigms (first 2 days, best day, or worst day) and with symptoms.ResultsAt least 2 days of AET data were available from 96.9% of patients, 3 days from 90.7%, and 4 days from 72.7%. A higher proportion of patients had a predominant pathologic pattern (31.4%) than control subjects (11.1%; P = .03). When 3 or more days of data were available, 90.4% of patients had a predominant AET pattern; when 2 days of data were available, 64.1% had a predominant AET pattern (P < .001). Day 1 AET was discordant with the predominant pattern in 22.4% of patients and was less strongly associated with the predominant pattern compared with 48 hour AET (P = .059) or total averaged AET (P = .02). Baseline symptom burden was higher in patients with a predominant pathologic pattern compared with a predominant physiologic pattern (P = .02).ConclusionsThe predominant AET pattern on prolonged wireless pH monitoring can identify patients at risk for reflux symptoms and provides gains over 24 hours and 48 hours recording, especially when results from the first 2 days are discordant or borderline.

Background: The incidence of de novo gastroesophageal reflux disease (GERD) after LSG is substantial. However, an objective correlation with the structural gastric and EGJ changes has not been demonstrated yet. We aimed to prospectively evaluate the effects of laparoscopic sleeve gastrectomy (LSG) on the structure and function of the esophagogastric junction (EGJ) and stomach. Methods: Investigations were performed before and after > 50% reduction in excess body weight (6–12 months after LSG). Subjects with GERD at baseline were excluded. Magnetic Resonance Imaging (MRI), high-resolution manometry (HRM), and ambulatory pH-impedance measurements were used to assess the structure and function of the EGJ and stomach before and after LSG. Results: From 35 patients screened, 23 (66%) completed the study (age 36 ± 10 years, BMI 42 ± 5 kg/m2). Mean excess weight loss was 59 ± 18% after 7.1 ± 1.7-month follow-up. Esophageal acid exposure (2.4 (1.5–3.2) to 5.1 (2.8–7.3); p = 0.040 (normal < 4.0%)) and reflux events increased after surgery (57 ± 24 to 84 ± 38; p = 0.006 (normal < 80/day)). Esophageal motility was not altered by surgery; however, intrabdominal EGJ length and pressure were reduced (both p < 0.001); whereas the esophagogastric insertion angle (35° ± 11° to 51° ± 16°; p = 0.0004 (normal < 60°)) and esophageal opening diameter (16.9 ± 2.8 mm to 18.0 ± 3.7 mm; p = 0.029) were increased. The increase in reflux events correlated with changes in EGJ insertion angle (p = 0.010). Patients with > 80% reduction in gastric capacity (TGV) had the highest prevalence of symptomatic GERD. Conclusion: LSG has multiple effects on the EGJ and stomach that facilitate reflux. In particular, EGJ disruption as indicated by increased (more obtuse) esophagogastric insertion angle and small gastric capacity were associated with the risk of GERD after LSG. clinicaltrials.gov: NCT01980420 [ABSTRACT FROM AUTHOR]

OBJECTIVES:This study applies concurrent magnetic resonance imaging (MRI) and high-resolution manometry (HRM) to test the hypothesis that structural factors involved in reflux protection, in particular, the acute insertion angle of the esophagus into the stomach, are impaired in gastroesophageal reflux disease (GERD) patients.METHODS:A total of 24 healthy volunteers and 24 patients with mild-moderate GERD ingested a test meal. Three-dimensional models of the esophagogastric junction (EGJ) were reconstructed from MRI images. Measurements of the esophagogastric insertion angle, gastric orientation, and volume change were obtained. Esophageal function was assessed by HRM. Number of reflux events and EGJ opening during reflux events were assessed by HRM and cine-MRI. Statistical analysis applied mixed-effects modeling.RESULTS:The esophagogastric insertion angle was wider in GERD patients than in healthy subjects (+7°±3°; P=0.03). EGJ opening during reflux events was greater in GERD patients than in healthy subjects (19.3 mm vs. 16.8 mm; P=0.04). The position of insertion and gastric orientation within the abdomen were also altered (both P<0.05). Median number of reflux events was 3 (95% CI: 2.5-4.6) in GERD and 2 (95% CI: 1.8-3.3) in healthy subjects (P=0.09). Lower esophageal sphincter (LES) pressure was lower (−11±2 mm Hg; P<0.0001) and intra-abdominal LES length was shorter (−1.0±0.3 cm, P<0.0006) in GERD patients.CONCLUSIONS:GERD patients have a wider esophagogastric insertion angle and have altered gastric morphology; structural changes that could compromise reflux protection by the 'flap valve' mechanism. In addition, the EGJ opens wider during reflux in GERD patients than in healthy volunteers: an effect that facilitates volume reflux of gastric contents. [ABSTRACT FROM AUTHOR]

Abstract: This article discusses the investigation and management of gastro-oesophageal reflux disease, para-oesophageal hernias and achalasia. [Copyright &y& Elsevier]

Background & Aims: The prevalence of complicated gastroesophageal reflux disease (GERD) increases with age; however, the mechanism by which this occurs is uncertain. This study assessed (1) whether physiologic degradation of the gastroesophageal junction and esophageal motility occurs with aging, and (2) whether these effects are associated with increased esophageal acid exposure and reflux symptoms in the elderly. Methods: Retrospective study of 1307 patients referred for investigations of reflux symptoms (median age, 49 years; range, 15–92 years) was conducted. Manometry assessed LES pressure, LES length, and esophageal peristalsis. Ambulatory pH studies assessed esophageal acid exposure (% time pH <4) during a period of 24 hours; reflux symptoms were assessed by validated questionnaire. Results: On multivariate regression, esophageal acid exposure was associated independently with decreasing LES pressure (P < .0001) and abdominal LES length (P < .0004). Dysmotility exacerbated reflux in the recumbent position (P < .004). Acid exposure increased with age (P < .0001), a 1.1%/24 hours (95% confidence interval, 0.4%–1.4%) increase in acid exposure every decade (more pronounced in the recumbent position). The age-related increase in acid exposure was associated independently with decreasing abdominal LES length (P < .001) and increasing dysmotility (P < 0.01). Reflux symptoms increased with acid exposure (P < .001); however, at any given level of exposure, symptom severity was less in the elderly (P < .006). Conclusions: Age was associated with an increase in esophageal acid exposure; however, the severity of reflux symptoms reduced with age. These changes were associated with progressive decrease in abdominal LES length and esophageal motility. Increasing GERD severity in the elderly is related to degradation of the gastroesophageal junction and impaired esophageal clearance. [Copyright &y& Elsevier]

INTRODUCTION: Prolonged, 4-day (96 h) measurement by the wireless Bravo® system provides an opportunity to assess the variance, diagnostic reproducibility, and yield of 24- and 48-h pH and symptom association studies. METHOD: Retrospective analysis of 83 patients with suspected reflux symptoms undergoing wireless pH monitoring with the intention of 96-h measurement. Study periods were classified based on esophageal acid exposure, the DeMeester score (DMS), and the association of reflux events and symptoms (symptom index). The technical success of prolonged pH recording and diagnostic accuracy of 24-, 48-, and 72-h pH studies compared to the 96-h “gold standard” were assessed. RESULTS: Prolonged Bravo® pH studies were possible and well tolerated in routine clinical practice. Complete 96-h recordings were available for 34/83 (41%) patients. Variation in pH measurements reduced with increasing study duration (24-h 45% vs 48-h 27%, P < 0.01), but no change in reflux severity over time was observed (ANOVA, P= ns). Abnormal acid exposure was found in 7 (19%) on every test day and 21 (58%) on at least one of four test days. A diagnosis consistent with the 96-h “gold standard” was present in 22 (63%), 29 (83%), and 32 (91%) patients for 24-, 48-, and 72-h test periods, respectively, with a significant improvement of diagnostic sensitivity with study duration ( P < 0.01). Similar findings were present for symptom association. CONCLUSION: Increasing the duration of pH studies progressively improves measurement variance and the diagnostic reproducibility of reflux studies. Future studies must address the impact of prolonged pH studies on clinical management. [ABSTRACT FROM AUTHOR]

The article discusses the highlights of the Ascona Conference on Advances in Clinical Investigation of Esophageal Dysmotility and Reflux Disease that was held in Ascona, Switzerland in Aoril 2011. One of the objectives of the conference is to introduce the Chicago Classification Criteria of Esophageal Motility Disorders Defined in High Resolution Esophageal Pressure Topography, which is the result of a series of meetings of the High-Resolution Manometry Working Group.

The article presents the second of a three part interactive case report series of a young man with persistent regurgitation and vomiting after meals. After treatment with acid suppression and prokinetics, the patient was found not to have gastro-esophageal reflux disease. The article discusses oral esomeprazole, pantoprazole, and the patient's relationship with his mother.

The nadir esophageal pH of reflux observed during pH monitoring in the postprandial period is often more acidic than the concomitant intragastric pH. This paradox prompted the discovery of the 'acid pocket', an area of unbuffered gastric acid that accumulates in the proximal stomach after meals and serves as the reservoir for acid reflux in healthy individuals and gastroesophageal reflux disease (GERD) patients. However, there are differentiating features between these populations in the size and position of the acid pocket, with GERD patients predisposed to upward migration of the proximal margin onto the esophageal mucosa, particularly when supine. This upward migration of acid, sometimes referred to as an 'acid film', likely contributes to mucosal pathology in the region of the squamocolumnar junction. Furthermore, movement of the acid pocket itself to a supradiaphragmatic location with hiatus hernia increases the propensity for acid reflux by all conventional mechanisms. Consequently, the acid pocket is an attractive target for GERD therapy. It may be targeted in a global way with proton pump inhibitors that attenuate acid pocket development, or with alginate/antacid combinations that colocalize with the acid pocket and displace it distally, thereby demonstrating the potential for selective targeting of the acid pocket in GERD. [ABSTRACT FROM AUTHOR]