Refractory Gastroesophageal Reflux Disease Symptoms Research Articles

455. SHOULD THE DIAGNOSTIC THRESHOLD FOR PH MONITORING IN GASTROESOPHAGEAL REFLUX DISEASE DIFFER BETWEEN THE EAST AND THE WEST?

Abstract Background The Montreal definition's reliance on troublesome typical symptoms alone is inadequate for diagnosing 'actionable' Gastroesophageal Reflux Disease (GERD). Lyon consensus 2.0 updated conclusive evidence of GERD, incorporating Los Angeles grade B or above esophagitis and Acid Exposure Time (AET) exceeding 6% in ambulatory reflux monitoring. The Seoul Consensus 2020 presents varied opinions on applying the same standards to the Asian population. A meta-analysis determined the Asian upper limit of AET as 3.2%. This study aims to compare Lyon 1.0 and 2.0 consensus compositions and assess the sensitivity and specificity of different AET thresholds in predicting Grade B or above esophagitis. Methods Patients with refractory GERD symptoms or considering anti-reflux surgery underwent objective GERD workup, including 24-hour catheter-based or 96-hour wireless ambulatory pH monitoring, High-Resolution Manometry, and upper endoscopy. This retrospective cohort study analyzed patient data from 2011-2023, excluding those with prior anti-reflux surgery, bariatric surgery, or myotomy for achalasia. Patients were categorized based on Lyon Consensus 1.0 and 2.0 as 'Non-GERD,' 'Borderline GERD,' 'Borderline GERD with evidence,' and 'Conclusive GERD.' Sensitivity, specificity, and Area-Under-Curve (AUC) were calculated using AET thresholds of 3.2%, 4%, 6%, and 7.2% to predict Grade B or above esophagitis. Results Between July 2011 and August 2023, 257 patients underwent pH monitoring and were included in the analysis, with 247 (93.8%) being ethnic Chinese. The number of patients categorized as conclusive GERD was significantly higher in Lyon 2.0 (134, 52.1%) compared to Lyon 1.0 (109, 42.4%), p < 0.001. Sensitivity and specificity for predicting Grade B or above esophagitis were as follows: AET 3.2% (83.3%, 48.8%), AET 4% (65.3%, 52.4%), AET 6% (73.8%, 66%), AET 7.2% (69.0, 72.1%). AET 7.2% demonstrated the highest AUC of 70.6% (Figure 1). Among patients classified as conclusive GERD, 67 (50%) underwent antireflux surgery. Conclusion Using the Asian threshold of AET 3.2% yields the highest sensitivity for detecting Grade B or above esophagitis. Additionally, the AUC is higher compared to using AET 4.0%. However, it is important to note that AET alone should not be the sole parameter for diagnosing actionable GERD, as even with the lowest AET threshold of 3.2%, 16.7% of patients with Grade B or above esophagitis would be missed.

Reflux After Sleeve Gastrectomy: Safety and Effectiveness of Laparoscopic Ligamentum Teres Cardiopexy, a Single-Center Experience.

Obesity is a well-known risk factor for gastroesophageal reflux disease (GERD). Even though symptoms may be mitigated or resolved with the weight loss caused by sleeve gastrectomy (SG), it may be associated with higher incidences of postoperative GERD. Ligamentum teres cardiopexy (LTC) is an alternative to Roux-en-Y gastric bypass, the gold standard treatment for GERD. This study was a retrospective single-center chart review, all patients in this cohort underwent LTC to treat refractory GERD at our institution. The option for LTC was presented after patients' refusal to undergo RYGB conversion. We collected baseline characteristics, standard demographics, pre-operative tests and imaging, and SG information, as well as intraoperative and perioperative data regarding LTC, and postoperative complications. Our cohort included 29 patients; most were Caucasian (44.8%) females (86.2%). The mean weight and BMI before LTC were 216.5 ± 39.3 lb and 36.1 ± 5.4 kg/m2, respectively. Mean total body-weight loss (TBWL) at 12 and 24 months were 28.7% ± 9.5% and 28.4% ± 12.4%, respectively. The mean interval between the index bariatric surgery and LTC was 59.9 ± 34.9 months, mean operative time was 67 ± 18.2 min, and median length of stay (LOS) was 1 day (IQR = 1-2 days). Twelve patients (57.1%) were able to discontinue antisecretory medications, while 9 (42.9%) still required them to remain asymptomatic. Mortality and reoperation rates were 0% and the incidence of complication was 19.4% (n = 6). LTC is a safe and effective surgical alternative to treat refractory GERD symptoms after SG.

Impact of CYP2C19 metabolizer status on esophageal mucosal inflammation, acid exposure, and motility among patients on chronic proton-pump inhibitor therapy with refractory symptoms of gastroesophageal reflux disease.

The extent of disease severity remains unclear among CYP2C19 rapid and ultra-rapid metabolizers with refractory symptoms of gastroesophageal reflux disease (GERD) on chronic proton-pump inhibitors (PPIs). To determine the impact of CYP2C19 metabolizer status in relation to chronic PPI therapy with a focus on the extent of esophageal inflammation, acid exposure, and motor function. This retrospective study included 54 patients with refractory GERD symptoms who underwent CYP2C19 genotyping for PPI metabolism, esophagogastroduodenoscopy, ambulatory pH study, and high-resolution esophageal manometry. Patients were divided into three groups: normal metabolizer (NM) group, intermediate metabolizer/poor metabolizer (IM/PM) group, and rapid metabolizer/ultra-rapid metabolizer (RM/UM) group. The Chi-square test was used to analyze categorical variables, and one-way ANOVA for comparing means. Rapid metabolizer/ultra-rapid metabolizer (RM/UM) group more frequently had either Los Angeles grade C or D GERD (7/19, 36.8% vs 1/21, 4.8%, P = 0.011) and metaplasia of the esophagus (9/19, 47.4% vs 2/21, 9.5%, P = 0.007) when compared to the NM group. RM/UM group were more frequently offered dilatation for nonobstructive dysphagia (8/19, 42.1% vs 3/21, 14.3%, P = 0.049) and more exhibited a hypotensive lower esophageal sphincter (LES) resting pressure compared to the NM group (10/19, 52.6% vs 4/21, 19%, P = 0.026). All three groups exhibited comparable DeMeester scores when PPIs were discontinued 72 hours before the ambulatory pH study. CYP2C19 RMs and UMs on chronic PPI with refractory GERD symptoms exhibited greater esophageal mucosal inflammation, as observed both endoscopically and histologically, and more were found to have hypotensive LES resting pressures and more were offered esophageal dilatation.

Refractory Gastroesophageal Reflux Disease: Diagnosis and Management.

Gastroesophageal reflux disease (GERD) is common, with increasing worldwide disease prevalence and high economic burden. A significant number of patients will remain symptomatic following an empiric proton pump inhibitor (PPI) trial. Persistent symptoms despite PPI therapy are often mislabeled as refractory GERD. For patients with no prior GERD evidence (unproven GERD), testing is performed off antisecretory therapy to identify objective evidence of pathologic reflux using criteria outlined by the Lyon consensus. In proven GERD, differentiation between refractory symptoms (persisting symptoms despite optimized antisecretory therapy) and refractory GERD (abnormal reflux metrics on ambulatory pH impedance monitoring and/or persistent erosive esophagitis on endoscopy while on optimized PPI therapy) can direct subsequent management. While refractory symptoms may arise from esophageal hypersensitivity or functional heartburn, proven refractory GERD requires personalization of the management approach, tapping from an array of non-pharmacologic, pharmacologic, endoscopic, and surgical interventions. Proper diagnosis and management of refractory GERD is critical to mitigate undesirable long-term complications such as strictures, Barrett's esophagus, and esophageal adenocarcinoma. This review outlines the diagnostic workup of patients presenting with refractory GERD symptoms, describes the distinction between unproven and proven GERD, and provides a comprehensive review of the current treatment strategies available for the management of refractory GERD.

A Comparison between Chicago Classification Versions 3.0 and 4.0 and Their Impact on Manometric Diagnoses in Esophageal High-Resolution Manometry Cases

High-resolution manometry (HRM) facilitates the detailed evaluation of esophageal motility. In December 2020, Chicago classification (CC) version 4.0 introduced modifications to improve consistency and accuracy. We conducted this study to compare the differences in the interpretations of HRM examinations between CC 3.0 and 4.0. Consecutive HRM records at a Taiwan tertiary medical center, including wet swallows and MRS performed in both supine and sitting positions from October 2019 to May 2021, were retrospectively reviewed and analyzed using both CC versions 3.0 and 4.0. A total of 105 patients were enrolled, and 102 patients completed the exam, while three could not tolerate HRM sitting up. Refractory gastroesophageal reflux disease (GERD) symptoms (n = 65, 63.7%) and dysphagia (n = 37, 36.3%) were the main indications. A total of 18 patients (17.6%) were reclassified to new diagnoses using CC 4.0. Of the 11 patients initially diagnosed with absent contractility, 3 (27.3%) were reclassified as having Type 1 achalasia. Of the 18 patients initially diagnosed with IEM, 6 (33.3%) were reclassified as normal. The incidence of diagnosis changes was similar in both the dysphagia and refractory GERD symptoms groups (21.6% versus 15.3%, p = 0.43). The use of CC 4.0 led to changes in the diagnoses of esophageal motility disease, irrespective of examination indications. Early adoption improves the accuracy of diagnoses and affects patient management.

Acupuncture Improved the Function of the Lower Esophageal Sphincter and Esophageal Motility in Chinese Patients with Refractory Gastroesophageal Reflux Disease Symptoms: A Randomized Trial.

Acupuncture is therapeutic for refractory gastroesophageal reflux disease by an unclear mechanism. This study was aimed at investigating the effect of acupuncture on esophageal motility in patients with symptoms of refractory gastroesophageal reflux disease. Sixty-eight patients with refractory gastroesophageal reflux disease symptoms were prospectively enrolled from August 2014 to December 2018 and randomized into acupuncture and control groups (n = 33 and 35, respectively). The acupuncture group received acupuncture, and the control group received sham acupuncture. Pre- and post-acupuncture high-resolution manometry was performed to evaluate the effect of acupuncture on esophageal motility. The GerdQ questionnaire was used to evaluate the pre- and post-intervention symptoms. After acupuncture, there was a significant increase in the length of lower esophageal sphincter (3.10 ± 1.08 cm vs. 3.78 ± 1.01 cm), length of intra-abdominal lower esophageal sphincter (2.14 ± 1.05 cm vs. 2.75 ± 1.16 cm), and mean basal pressure of lower esophageal sphincter (22.02 ± 10.03 mmHg vs. 25.06 ± 11.48 mmHg) in the acupuncture group (P = 0.014); moreover, the numbers of fragmented contraction and ineffective contraction decreased from 36 to 12 (P < 0.001) and 43 to 18 (P = 0.001), respectively, in the acupuncture group. However, no significant difference was observed in the control group. The GerdQ score decreased significantly from 9.45 ± 2.44 to 7.82 ± 2.21 points in the first week after acupuncture (P < 0.001). Acupuncture, which improves esophageal motility, has short-term efficacy in patients with symptoms of refractory gastroesophageal reflux disease. This trial is registered with Chinese Clinical Trial Registry (ChiCTR1800019646).

Esophageal manometry findings in patients with refractory symptoms of gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disorder. High-resolution esophageal manometry (HREM) and 24-h pH study help to properly evaluate GERD patients. The aim of the present study was to classify patients with refractory GERD symptoms into various groups based on endoscopic and physiological testing.The present study is a retrospective analysis of patients referred for HREM and 24-h pH recording between 2019 and 2021. We included all adult patients (age > 18 years) who were referred for evaluation of refractory GERD symptoms. Upper gastrointestinal endoscopy findings, HREM, and 24-h pH findings were noted. Patients were divided into erosive reflux disease (ERD), non-erosive reflux disease (NERD), reflux hypersensitivity (RH), and functional heartburn (FH) based on test results. Demographic details and HREM parameters were compared in the four groups. Statistics used are one-way analysis of variance (ANOVA) and Chi-squared tests. A p-value of <0.05 was considered statistically significant.A total of 144 patients were included-NERD (56, 38.9%), ERD (42, 29.2%), RH (28, 19.5%), and FH (18, 12.5%). Age (p 0.74), andsex distribution (p 0.47), and symptom profile (p 0.12) were similar. The presence of type 2/3 esophagogastric junction (EGJ) morphology was commoner in ERD and NERD (p <0.001). Moreover, the esophagogastric junction contractile integral (EGJ-CI) and basal inspiratory pressures were significantly lower in these two groups (p<0.05). EGJ-CI was low in 32 cases of ERD (76.2%), 41 cases with NERD (73.2%), 7 cases with RH (25%), and 3 cases with FH (16.7%), respectively (p-value < 0.00001).FH and RH account for 32% of cases with refractory GERD symptoms. Impaired EGJ function was more common in ERD and NERD patients compared to FH and RH patients.

POS0895 THE ROLE OF SURGERY IN THE ESOPHAGEAL INVOLVEMENT IN SYSTEMIC SCLEROSIS: A SYSTEMATIC LITERATURE REVIEW

BackgroundAmong gastrointestinal (GI) manifestations in Systemic Sclerosis (SSc) one of the predominant and challenging problems is gastroesophageal reflux disease (GERD), which occurs in ~75% of patients. Although proton pump inhibitors are useful, they are ineffective in 40% of cases with chronic use at high doses, against the background of long-term risks (e.g., cardiovascular disease and infections) which have been identified in the general population. Surgery might be an option following failure of medical therapy but currently, there is no consensus regarding the optimal surgical procedure for refractory GERD in SSc.ObjectivesTo evaluate, among the surgical approaches to GERD, the feasibility of fundoplication (FP) with regards to its safety, efficacy, indications, and timing.MethodsFour research questions based on the PICO framework were developed to guide the systematic literature review that was conducted up to 22 December 2021. The search and performed across different databases including PubMed, MEDLINE (OVID), EMBASE, Cochrane Library, Web of Science, Google Scholar, Emcare and Academic Search Premier. References were independently screened by two reviewers (PMC and AA) who also independently assessed the full text of eligible articles, and extracted data. Due to heterogeneity of retrieved studies, narrative summaries are used to present the data.ResultsThe search yielded 916 papers of which 30 were eligible for full text review. In these studies, out of 2919 clinically heterogeneous patients, 348 SSc patients were identified (mostly female, mean age 52.7 years). Out of these 348, only 257 underwent anti-reflux surgical procedure and were included in the analysis. Most of the studies were conducted in surgical settings and relevant rheumatological data were largely missing. Refractory GERD symptoms, were the commonest indication for surgery, with post-operative dysphagia being the most frequent complication. In 18 studies, FP was effective, whereas 4 studies had equivocal findings and in 5 a lack of efficacy was reported. The Collis-Nissen FP was the most popular procedure overall as well as in earlier studies, followed by Nissen FP, and Dor FP in relatively more recent studies, reflecting the change in surgical strategy over time. The data extracted shows also an acceptable rate of mortality and morbidity related to surgery, and heterogeneous outcome measures were used hampering any comparison of the studies (Table 1). Due to the heterogeneity of the data, it was not possible to separate the mortality and morbidity rate of SSc patients from the rest of the population.Table 1.GERD ASSESSMENT AND SURGICAL OUTCOMESDomain assessed/outcomeInstrument/MeasurementN° of studiesReflux severityDysphagia: 20Number of antireflux medications: 10High dose PPI: 9pH monitoring (pre-procedure): 11Oesophagitis/Barret 4Reflux improvement (post-procedure)Symptom resolution/reduction 24pH monitoring 12Repeat EGDS 8N° of patientsN° of surgical proceduresTotSSc 257Collis-Nissen FP 54Nissen FP 39Dor FP 37Collis-Belsey FP 20Toupet FP 18RYGB 23Others 30Undefined 36Post-operative surgical complications73 (2,5%)*Mortality (n° deaths)8 (0,27%)**rate in total population (2919)ConclusionOur SLR has highlighted that the surgical management of GERD in SSc patients is still highly challenging since the available evidence is scarce and of poor quality. Among the surgical approaches to the problem of GERD, overall FP seems a safe and effective procedure in SSc. Transient post-operative dysphagia was noted in many studies, particularly related with the posterior FP. In the future, it will be necessary to develop minimal requirement to conduct surgical studies in SSc as well as to design studies aimed at defining the clinical criteria for referral to surgery. Indeed, the right timing for surgery and the best surgical procedure in SSc still remains an unmet need.Disclosure of InterestsNone declared

Role of the Mean Nocturnal Baseline Impedance in Identifying Evidence Against Pathologic Reflux in Patients With Refractory Gastroesophageal Reflux Disease Symptoms as Classified by the Lyon Consensus.

Background/AimsMean nocturnal baseline impedance (MNBI) is a new reflux metric for mucosal integrity. It remains unclear whether MNBI can help identify evidence against pathological reflux by the Lyon Consensus in patients with refractory gastroesophageal reflux disease (GERD) symptoms.MethodsThree hundred and forty-nine patients with refractory GERD symptoms enrolled in this study were subjected to high-resolution manometry, 24-hour multichannel intraluminal impedance-pH (MII-pH) monitoring, and endoscopy. Conventional indexes (ie, reflux events and acid exposure time) and the novel index (MNBI) of MII-pH monitoring were extracted and analyzed. The value of MNBI in diagnosing patients with evidence against pathologic reflux was evaluated by receiver-operating-characteristic analysis.ResultsThere were 102 (29.2%) patients with evidence against pathologic reflux, 149 (42.7%) with inconclusive or borderline evidence and 98 (28.1%) with conclusive evidence for pathologic reflux. The MNBI was significantly higher while the proportion of pathological MNBI was significantly lower in subjects with evidence against pathologic reflux than in patients with inconclusive or borderline evidence and in patients with conclusive evidence for pathologic reflux (2444.3 [1977.9-2997.4] vs 1992.8 [1615.5-2253.6] and vs 1772.3 [758.6-2161.3], both P < 0.001; 42.2% vs 79.7% and vs 80.0%, both P < 0.05). When identifying evidence against pathologic reflux in patients with refractory GERD symptoms, the MNBI yielded an area under the curve of 0.749 (P < 0.001) at a cut-off value of 1941.8 Ω.ConclusionsThe MNBI has a good diagnostic value for evidence against pathological reflux in patients with refractory GERD symptoms. For its simplicity and reproducibility, we believe that MNBI should be referred to in reports of impedance-pH tracings by physicians.

Effectiveness of esophagogastroduodenoscopy in changing treatment outcome in refractory gastro-esophageal reflux disease

Background/aims The effectiveness of screening esophagogastroduodenoscopy (EGD) for refractory gastroesophageal reflux disease (GERD) symptoms alone has not been validated. Methods We performed an observational study of patients with refractory GERD who underwent EGD from 2013 to 2016 at a tertiary hospital. Among 928 patients with GERD, we excluded patients with other alarm features, other indications for EGD, history of gastroesophageal surgery, or EGD done for other diagnostic procedures, and identified 301 patients who underwent EGD solely for persistent reflux symptoms such as heartburn or regurgitation. Results Among 301 patients with refractory GERD, 81.4% of patients were taking PPIs. 49.8% of patients had completely normal EGD findings and 33.6% of patients had benign or incidental findings. Two patients (0.6%) had LA grade C or D esophagitis, and 16.3% of patients had irregular Z line or salmon-colored mucosa. 91.0% (122/134) who had a biopsy had normal or benign findings. 4.0% (12/301) of patients had biopsy-proven intestinal metaplasia which is similar to the previously known prevalence of intestinal metaplasia in patients without heartburn (5.6%) and none had dysplasia or malignancy. Male sex was associated with endoscopic intestinal metaplasia suspected lesions in multivariate analysis (OR: 1.96, 95% CI: 1.04–3.70, p = .036) but not biopsy-proven intestinal metaplasia. Elderly age, obesity, alcohol or cigarette consumption, PPI use, GERD duration >3–5 years did not predict endoscopically suspected or biopsy-proven intestinal metaplasia. Only 5% of patients had a pH-impedance study for refractory reflux symptoms. Conclusions Most patients who underwent EGD for refractory GERD symptoms alone did not have pathological findings requiring a change in management. Screening EGD for patients only with persistent reflux symptoms should not be routinely recommended.

Estimate of Refractory Reflux Disease in the United States: Economic Burden and Associated Clinical Characteristics.

To update the estimate of the prevalence of refractory gastroesophageal reflux disease (GERD) in the United States, and to assess the clinical and economic differences between patients with and without refractory GERD. GERD affects 18% to 28% of the US population, with nearly 40% of GERD patients presenting with refractory symptoms despite ongoing therapy. Retrospective analysis of the IBM MarketScan databases between January 2011 and June 2018. Inclusion criteria were prescription fill and subsequent refill of a proton pump inhibitor or H2-receptor antagonist (earliest claim=index date), diagnosis of GERD 60 days preceding and/or following index, continuous insurance enrolment for 12 months preceding/following index, and absence of prior GERD diagnosis or GERD medication. We derived refractory GERD symptom scores for all patients on the basis of a previously published algorithm. Health care costs and comorbidities were assessed for all patients and compared between those with and without refractory GERD. In total, 399,017 GERD patients qualified for the study; 103,654 (26%) met our definition of having indications of refractory GERD symptoms. Patients with refractory GERD symptoms reported significantly higher rates of hiatal hernia (25.1% vs. 5.9%), esophagitis (37.3% vs. 11.8%), esophageal stricture (11.3% vs. 1.5%), and dysphagia (26.8% vs. 7.1%; P<0.01 for each). The refractory GERD symptoms cohort incurred ~$10,000 greater health care costs per patient per year compared with patients without refractory GERD symptoms ($26,057±$58,948 vs. $15,285±$39,307; P<0.01). Refractory GERD symptoms were associated with a substantial increase in health care costs. Treatments aimed at improving refractory GERD symptoms may mitigate symptom burden, potentially reducing health care expenditure.

ESNM/ANMS consensus paper: Diagnosis and management of refractory gastro‐esophageal reflux disease

AbstractUp to 40% of patients with symptoms suspicious of gastroesophageal reflux disease (GERD) do not respond completely to proton pump inhibitor (PPI) therapy. The term “refractory GERD” has been used loosely in the literature. A distinction should be made between refractory symptoms (ie, symptoms may or may not be GERD‐related), refractory GERD symptoms (ie, persisting symptoms in patients with proven GERD, regardless of relationship to ongoing reflux), and refractory GERD (ie, objective evidence of GERD despite adequate medical management). The present ESNM/ANMS consensus paper proposes use the term “refractory GERD symptoms” only in patients with persisting symptoms and previously proven GERD by either endoscopy or esophageal pH monitoring. Even in this context, symptoms may or may not be reflux related. Objective evaluation, including endoscopy and esophageal physiologic testing, is requisite to provide insights into mechanisms of symptom generation and evidence of true refractory GERD. Some patients may have true ongoing refractory acid or weakly acidic reflux despite PPIs, while others have no evidence of ongoing reflux, and yet others have functional esophageal disorders (overlapping with proven GERD confirmed off therapy). In this context, attention should also be paid to supragastric belching and rumination syndrome, which may be important contributors to refractory symptoms.

981 RESECTION AND PLICATION (RAP): AN ENDOSCOPIC ANTI-REFLUX SOLUTION IN ALTERED ANATOMY

In recent years, significant advances have been made in the treatment of gastroesophageal reflux disease (GERD). Options for therapy have expanded in the surgical field, and new endoscopic options have emerged as alternative means of treating GERD in select populations. However, GERD remains a common problem in many polulations that do not quality for these new therapies, either due to severe co-morbidities or altered anatomy. The Resection and Plication (RAP) procedure is a novel endoscopic option for the treatment of medication refractory GERD. The RAP procedure can uniquely be empolyed in patietns unable to undergo surgical or alternate endoscopic anti-reflux therapies due to gastroesophageal junction (GEJ) anatomy that has been altered, for example in patients with prior nissen fundoplication, roux-en-Y gastric bypass, sleeve gastrectomy, or esophagectomy. The RAP procedure involves band endoscopic mucosal resection (EMR) semi-circumferential mucosectomy at the GEJ followed by full-thickness plication (RAP). Endoscopic suturing creats a gastro-gastric plication which serves to tighten the GEJ and decrease the rate of reflux into the esophagus. The following video demonstrates the RAP procedure in 2 patients with altered anatomy. Case 1, 66-year-old female with GERD previously treated with Nissen Fundoplication 10 years ago presents with refractory GERD symptoms. Case 2, 44-year-old female with history of morbid obesity treated with roux-en-Y gastric bypass with initial weight loss, now with significant weight gain and morbid obesity who is presenting with persistent GERD symptoms. 26 patients have undergone the RAP procedure at our institution. The average procedure time is 31 minutes. Ninety percent of were discharged the same day without major complications. Eighteen patients had altered anatomy (5 Fundoplication, 4 Gastric Bypass, 4 Esophagectomy, 2 failed TIF, 2 Endoscopic Sleeve Gastroplasty, 1 Sleeve Gastrectomy). We observed dramatic improvements in Reflux Disease Questionnaire (RDQ) and GERD Health Related Quality of Life (HRQL) questionnaires (RDQ Frequency 80%, RDQ Severity 76%, GERD-HRQL 85%). Sixty percent of patients were able to stop or decrease PPI use at follow-up. The average follow-up period was 6 months. The Resection and Plication (RAP) procedure is a novel endoscopic endoscopic anti-reflux procedure which results in gastro-gastric plications just below the level of the GEJ, thereby reducing the rate of reflux of gastric contents into the esophagus. This provides an effective endoscopic option in patients who otherwise cannot get other surgical or endoscopic therapies, specifically due to prior surgeries. This is a same day procedure and is overall safe, well tolerated and patients report a high degree of satisfaction following therapy.

Role of esophageal manometry and 24-h pH testing inpatients with refractory reflux symptoms.

A proportion of patients with gastroesophageal reflux disease (GERD) do not respond to proton pump inhibitor (PPI) therapy. To determine thefindings on high-resolution esophageal manometry (HREM) and 24-h pH recording in patients with typical GERD symptoms, refractory to PPI treatment. Retrospective analysis of prospectively maintained database of patients referred for HREM and 24-h pH recording was done. We selected patients who were referred for evaluation of refractory GERD symptoms despite > 8weeks of at least once-daily PPI treatment. Details noted were demographic profile, upper gastrointestinal endoscopy report, HREM findings and 24-h pH findings. Ninety-six patients had symptoms of GERD that were refractory to PPI therapy. Seven patients (7.1%) were diagnosedhaving diseases mimicking GERD: eosinophilic esophagitis (n=2), supragastric belching (n=4) and rumination (n=1). After excluding these patients and those with insufficient data, the final study cohort included 82 cases. Fifty patients (61%) had normal motility. Major motility disorders were detected in 8 (9.75%)patients: achalasia cardia (6) and distal esophageal spasm (2). Ineffective esophageal motility was noted in 24 patients. A total of 74 patients underwent 24-h pH testing. Significant acid reflux with good symptom correlation was noted in 56 patients. Eighteen patients did not have significant acid reflux (Johnson-DeMeester score < 14.7): hypersensitive esophagus (12) and functional heartburn (6). Fifty-six patients (68.3%) had definite diagnosis of GERD and 31.7% (26) had non-GERD conditions like motility disorders, functional heartburn and hypersensitive esophagus.

373 Routine EGD Has Minimal Impact on Refractory GERD Management

INTRODUCTION: Routine diagnostic esophagogastroduodenoscopy (EGD) is recommended for refractory gastro-esophageal reflux disease (GERD) symptoms despite lack of evidence that it impacts management or outcomes. This study aims to determine if diagnostic EGD impacts management in patients with refractory GERD compared to esophageal manometry, pH testing and intra-luminal impedance. METHODS: We performed an observational study of patients with refractory GERD who underwent EGD from 2013 to 2018 at a tertiary hospital. Among 1,213 patients with GERD, we strictly excluded patients with alarm features such as dysphagia, dyspepsia; history of gastroesophageal surgery, or EGD done for other diagnostic procedures, and identified 339 patients who underwent EGD solely for persistent reflux symptoms. We then identified those who had esophageal manometry or pH-impedance studies for further evaluation of GERD, as well as if the findings of these tests resulted in a change in management (medication change or de-escalation, referral for Nissen fundoplication, etc). RESULTS: Among 339 patients with refractory GERD, 80.5% of patients were taking PPIs prior to and/or at the time of EGD. The majority of patients had completely normal (163/339, 48.1%) or solely benign or incidental findings (106/339, 31.3%) on EGD. Only 10.6% of patients had esophageal manometry or pH-impedance studies for refractory reflux symptoms, of those, 6.2% followed EGD and only 7 patients had these studies after a completely normal EGD. The majority of patients undergoing manometry had normal studies or minor abnormalities (23/32, 71.8%). All patients who had been ordered for intraluminal impedance or 24 hr pH testing alone could not tolerate the procedure. Six of 15 patients (40%) undergoing 24 hr pH-impedance testing had findings leading to a change in management. Undergoing pH-impedance testing after EGD was associated with a change in management (OR 7.33, P = 0.018). PPI use was not associated DeMeester score or with results of manometry, impedance, or pH testing. CONCLUSION: Most patients who underwent EGD for refractory GERD symptoms alone did not have pathological findings prompting a change in management. There were no demographic variables that predicted pathologic findings on EGD. Very few patients underwent subsequent or concomitant esophageal manometry, impedance or pH testing. pH-impedance after EGD was associated with a change in management, and may be a better first step in evaluating patients with refractory GERD symptoms, than EGD.

2872 Efficacy of Robotic Dor Fundoplication on Severe Nocturnal Gastroesophageal Reflux Disease in Patients With Scleroderma

INTRODUCTION: Scleroderma is a systemic disease and its effect on the GI tract is atrophy and replacement fibrosis of the smooth muscles. The esophagus is invariably involved and approximately eighty percent of patients with scleroderma develop both gastroesophageal reflux disease (GERD) and dysphagia. The nocturnal GERD can lead to regurgitation and aspiration which further worsens the pulmonary fibrosis from scleroderma. Performing the standard fundoplication would worsen their dysphagia. Aim- Our goal was to investigate whether a Dor fundoplication (a 270-degree anterior wrap) can reduce nocturnal heartburn and regurgitation without worsening of the dysphagia in patients with scleroderma and severe GERD. METHODS: 5 scleroderma patients with drug refractory severe GERD underwent Dor fundoplication procedure (Figure 1) with a median follow up of 18 months. All had undergone a preoperative high-resolution manometry documenting very impaired esophageal motility. Patients were interviewed post operatively and were assessed for nocturnal and diurnal GERD symptoms and treatment response, status of dysphagia and adverse effects of surgery. RESULTS: All 5 patients were female with average age 50 years (range 36-65). 4 of the 5 patients (80%) reported 90% improvement in both diurnal and nocturnal GERD symptoms since surgery, they no longer suffered from nocturnal reflux, heart burn or regurgitation and that they are able to sleep well at night without requiring any more pillows or wedges. 50% of patients reported decrease in their proton pump inhibitor dosage after surgery compared to before surgery. There was no surgical complication reported and specifically no worsening of dysphagia. 100% of the patients were able to belch, burp better effectively after surgery. 4 out of 5 patients reported that they would strongly recommend this surgery to another scleroderma patient suffering from drug refractory GERD symptoms. In one patient, there was no change in symptoms after the surgery but no worsening of dysphagia. CONCLUSION: Robotic Dor fundoplication is very effective in drug refractory GERD secondary to scleroderma dominated by nocturnal regurgitation. This procedure resulted in significant symptom reduction in 80% of our patient group which in turn improved their quality of life and nocturnal sleep without affecting dysphagia.

Can Impedance-pH Testing on Medications Reliably Identify Patients with GERD as Defined by Pathologic Esophageal Acid Exposure off Medications?

IntroductionImpedance-pH testing (MII-pH) while patients are on acid suppression medications is frequently used to evaluate persistent reflux symptoms. The aim of this study was to determine whether MII-pH on medications can reliably identify patients with gastroesophageal reflux disease (GERD) as defined by pathologic esophageal acid exposure off medications, and to determine if there is a threshold of total reflux episodes on medications where pH testing off medications may be unnecessary. MethodsA retrospective review identified all patients between 1/2010 and 4/2017 who underwent MII-pH testing on PPI medications and subsequently had pH testing off medications. GERD was defined on pH testing off medications by an abnormal DeMeester Score (DMS) and on MII-pH on medications by ≥ 48 total reflux episodes. Patients with an abnormal DMS by MII-pH on medications were excluded. ResultsThere were 71 patients, (22 males; 49 females), with a median age of 52 years. Based on ≥ 48 total reflux episodes by MII-pH testing on medications, 42 patients (59%) had GERD. When tested off medications, an abnormal DMS was present in 44 patients (62%). Among those with GERD based on impedance testing on medications, 31% did not have GERD based on pH testing off medications. Further, in the 29 patients with ≤ 48 total reflux episodes on MII-pH (normal test), 15 patients (52%) had pathologic acid exposure off medications. When there were > 73 reflux events with MII-pH on medications, all 15 patients in our series had pathologic acid exposure on pH testing off medications. ConclusionMII-pH testing on medications in patients with refractory GERD symptoms does not reliably correlate with a diagnosis of GERD as defined by pathologic esophageal acid exposure off medications. The commonly used abnormal MII-pH test value of ≥ 48 total reflux episodes is not validated and should not be used. However, in our series, patients with > 73 total reflux episodes had a high likelihood of having pathologic acid exposure off medications. Overall, the preferred strategy to evaluate patients with persistent GERD symptoms on acid suppression therapy should be pH testing off medications.

Transoral Incisionless Fundoplication: Effectiveness in Improving Typical and Atypical Symptoms of Gastroesophageal Reflux Disease Incompletely Controlled With Medical Therapy

Introduction: With increasing prevalence of gastroesophageal reflux disease (GERD) worldwide, reflux symptoms have been associated with the cancer risk and reduced quality of life. Anti-reflux surgery has been the mainstay of treatment in GERD refractory to standard medical therapy; however adverse events such as dysphagia, flatulence, inability to belch, and invasiveness of surgical procedure remain a concern. Transoral incisionless fundoplication (TIF) has been considered a minimally invasive procedure. Studies have reported good efficacy and safety profile making TIF a promising procedure to fill the gap between medical and surgical approach. Our purpose was to assess the efficacy of TIF in patients with chronic refractory GERD in controlling heartburn, regurgitation, dysphagia or atypical symptoms using quality of life questionnaire and scoring system that assesses laryngopharyngeal reflux (LPR). Methods: Forty-one participants with a long-standing history of GERD refractory to adequate acid suppressants underwent TIF after appropriate pre-operative assessment. Median follow-up period was 9 months. The primary outcome was patient satisfaction by assessing pre and post GERD Health Related Quality of Life Questionnaire (GERD-HRQL) and Reflux Symptom Index (RSI) scores along with the reduction in the use of proton pump inhibitors (PPI) or histamine antagonists (H2 blockers). Results: Our study showed a significant difference in the scores for heartburn pre-TIF (M=15.81) and post-TIF (M=5.69); t(40)=7.16, p < .001. Dysphagia and regurgitation scores were reduced considerably after TIF with p-values < .006 and < .001, respectively. Mean GERD-HRQL scores were 31.44 pre-TIF and 11.79 post-TIF (p < .001). In all patients, pre and post-TIF Reflux Symptom Index (RSI) scores demonstrated statistical significance (p < .001). In patients requiring acid suppressants after the TIF, mean GERD-HRQL scores were 35.09 pre-TIF and 17.56 post-TIF (p < .002), and mean RSI scores were 8.09 pre-TIF and 5.63 post-TIF (p < .047). Conclusion: In conclusion, TIF improves quality of life by reducing both typical and atypical symptoms. At short-term follow-up, TIF eliminates the need for PPI therapy in a majority of patients. After the TIF, quality of life in those who went back on acid suppressants improved. Our study supports the recent findings of TIF's superiority to conventional medical therapy and its effectiveness in yielding significant improvement in patients with refractory GERD symptoms.770_A Figure 1. Mean Pre-TIF and Post-TIF scores evaluated by GERD-HRQL (individual heartburn, dysphagia and regurgitation scores) and RSI questionnaires at the median age of 9 months follow up after TIF.770_B Figure 2. Mean Pre-TIF and Post-TIF scores evaluated by GERD-HRQL and RSI questionnaires at the median age of 9 months follow up after TIF in patients who started acid suppressants (PPI or H2 blockers) after TIF.

An analysis of 342 patients with refractory gastroesophageal reflux disease symptoms using questionnaires, high-resolution manometry, and impedance-pH monitoring.

Symptoms of refractory gastroesophageal reflux disease (GERD) are commonly encountered in clinical practice. The aim of this study was to analyze the data obtained from questionnaires, high-resolution manometry (HRM), and ambulatory impedance-pH monitoring in patients with persisting GERD symptoms and to explore the possible underlying causes for this clinical presentation. After completing the questionnaires, the selected patients underwent endoscopy, HRM, and ambulatory impedance-pH monitoring. Based on the results of these investigations, we divided the patients into 4 groups: reflux esophagitis (RE), hypersensitive esophagus (HE), functional heartburn (FH), and nonerosive gastroesophageal reflux disease (NERD). The data from 342 patients were analyzed. One hundred twenty-nine (37.72%) patients experienced refractory GERD symptoms related to acid reflux. The scores on some scales in the Gastrointestinal Symptom Rating Scale (GSRS) questionnaire differed significantly among groups (all P < 0.05). Liquid reflux occurred more frequently in patients with GERD (RE and NERD), while gas reflux was more common in non-GERD patients (FH and HE; all P < 0.05). The RE and NERD groups showed more percent bolus exposure time (BET) when upright (all P < 0.05). Acid exposure time (AET) in the RE and NERD groups was longer than that in the HE and FH groups (all P < 0.05). Fewer than half of the patient symptoms were related to acid reflux. The GSRS questionnaire may be an optimal indicator for patients with refractory GERD symptoms. BET and AET are useful indices to distinguish GERD from other diseases. Gas reflux is probably related to persisting symptoms in FH and HE patients.

Transoral Incisionless Fundoplication for Refractory Gastroesophageal Reflux Disease: Where Do We Stand?

Gastroesophageal reflux disease (GERD) is a chronic, progressive, and costly medical condition affecting a substantial proportion of the world population, predominantly the Western population. The available treatment options for patients with refractory GERD symptoms are limited to either laparoscopic surgery with significant sequelae or potentially lifelong, high-dose proton pump inhibitor therapy. The restoration of the antireflux competence of the gastroesophageal junction at the anatomic and physiologic levels is critical for the effective long-term treatment of GERD. Transoral incisionless fundoplication (TIF) surgery is a safe, well-tolerated, and effective treatment that has yielded significant symptomatic improvement in patients with medically refractory GERD symptoms. In this review article, we have summarized case series and reports describing the role of TIF for patients with gastroesophageal reflux symptoms. The reported indications, techniques, complications, and success rates are also discussed.