Randomized Trial of Medical versus Surgical Treatment for Refractory Heartburn.

BACKGROUND: Heartburn that persists despite proton-pump inhibitor (PPI) treatment is a frequent clinical problem with multiple potential causes. Treatments for PPI-refractory heartburn are of unproven efficacy and focus on controlling gastroesophageal reflux with reflux-reducing medication (e.g., baclofen) or antireflux surgery or on dampening visceral hypersensitivity with neuromodulators (e.g., desipramine). METHODS: Patients who were referred to Veterans Affairs (VA) gastroenterology clinics for PPI-refractory heartburn received 20 mg of omeprazole twice daily for 2 weeks, and those with persistent heartburn underwent endoscopy, esophageal biopsy, esophageal manometry, and multichannel intraluminal impedance-pH monitoring. If patients were found to have reflux-related heartburn, we randomly assigned them to receive surgical treatment (laparoscopic Nissen fundoplication), active medical treatment (omeprazole plus baclofen, with desipramine added depending on symptoms), or control medical treatment (omeprazole plus placebo). The primary outcome was treatment success, defined as a decrease of 50% or more in the Gastroesophageal Reflux Disease (GERD)-Health Related Quality of Life score (range, 0 to 50, with higher scores indicating worse symptoms) at 1 year. RESULTS: A total of 366 patients (mean age, 48.5 years; 280 men) were enrolled. Prerandomization procedures excluded 288 patients: 42 had relief of their heartburn during the 2-week omeprazole trial, 70 did not complete trial procedures, 54 were excluded for other reasons, 23 had non-GERD esophageal disorders, and 99 had functional heartburn (not due to GERD or other histopathologic, motility, or structural abnormality). The remaining 78 patients underwent randomization. The incidence of treatment success with surgery (18 of 27 patients, 67%) was significantly superior to that with active medical treatment (7 of 25 patients, 28%; P = 0.007) or control medical treatment (3 of 26 patients, 12%; P<0.001). The difference in the incidence of treatment success between the active medical group and the control medical group was 16 percentage points (95% confidence interval, -5 to 38; P = 0.17). CONCLUSIONS: Among patients referred to VA gastroenterology clinics for PPI-refractory heartburn, systematic workup revealed truly PPI-refractory and reflux-related heartburn in a minority of patients. For that highly selected subgroup, surgery was superior to medical treatment. (Funded by the Department of Veterans Affairs Cooperative Studies Program; ClinicalTrials.gov number, NCT01265550.).

Normal values and regional differences in oesophageal impedance-pH metrics: a consensus analysis of impedance-pH studies from around the world.

OBJECTIVE: Limitations of existing impedance-pH thresholds include small sample size of normative studies, inclusion of artefactual pH drops and incorrect identification of impedance reflux events. We aimed to obtain new impedance-pH thresholds from expert consensus analysis of tracings from a large number of healthy subjects. DESIGN: Of 541 studies performed worldwide using two different systems (Diversatek, USA, and Laborie, Netherlands), 150 tracings with oesophageal diagnoses, behavioural disorders and study-related artefacts were excluded. The remainder studies were subject to two reviewer consensus analysis, in-person or through video conference, consisting of editing meals and pH drops, identification of impedance reflux and postreflux swallow-induced peristaltic wave (PSPW) using strict pre-established criteria and measurement of distal mean nocturnal baseline impedance (MNBI). RESULTS: Consensus analysis was performed in 391 tracings (age 32.7 years, range 18-71, 54.2% female). Normative thresholds were significantly different between Diversatek and Laborie (total acid exposure time: 2.8% and 5%; reflux episodes: 55 and 78; MNBI at 3 cm: 1400 and 1500 ohms, at 5 cm: 1400 and 1800 ohms). Males had higher acid exposure, more reflux episodes and lower MNBI. Significant regional differences were identified, including higher PSPW scores in Western countries, and higher MNBI in Asia using Diversatek, and higher acid exposure in the Netherlands, higher MNBI in Asia and South Africa, and lower MNBI in Turkey using Laborie. CONCLUSION: Normal impedance-pH monitoring thresholds have regional and system-related differences. Clinical interpretation needs to use normal thresholds valid for the system used and world region, following careful editing of the tracings.

Durability of pneumatic dilation monotherapy in treatment-naive achalasia patients.

BACKGROUND: Pneumatic dilation (PD) is often billed as a "short term" treatment for achalasia but anecdotally can last years. This study sought to explore how long a single pneumatic dilation may induce symptom remission in a treatment-naïve achalasia patient. METHODS: A single center, retrospective chart review of patients with an ICD-9 or - 10 code of achalasia between 2005 and 2017 was performed. Treatment naïve patients with manometric diagnosis of primary achalasia were included. Outcomes (success or failure); single vs multiple PD; age; and estimated duration of effect were evaluated. Each patient underwent a single PD unless re-intervention was required for relapse. RESULTS: 83 patients (52% female, median 51.6 ± 3.6 years) were included. 43% underwent 2 PD and 13% underwent 3 PD. There was no significant relation between age, gender, and number of PDs. After 1 PD, 87.5% of patients reported > 1 year of symptom remission. 80.5% of relapsed patients reported success after a 2nd dilation. 1 PD was more likely to result in success than multiple PDs (p < 0.001). The measured median duration of remission after 1 PD was 4.23 years, and for 2 PDs, 3.71 years. The median estimated remission time after 1 PD was 8.5 years (CI 7.3-9.7, p = 0.03). CONCLUSIONS: PD is a safe, durable treatment for achalasia. A single PD is likely to last years. A second PD, if required, also has a high likelihood of success.

Plasma levels of TNF-α, IL-6, IFN-γ, IL-12, IL-17, IL-22, and IL-23 in achalasia, eosinophilic esophagitis (EoE), and gastroesophageal reflux disease (GERD).

An elevation of serum inflammatory biomarkers in achalasia patients compared with controls recently was demonstrated. It has not been determined whether the elevation of inflammatory cytokines is unique to achalasia or occurs with other diseases involving the esophagus. The primary aim of our study was to compare the differences in plasma immunological profiles (TNF- α receptor, IL-6, IFN-γ, IL-12, IL-17, IL-22, and IL-23) of patients with achalasia, eosinophilic esophagitis (EoE), and gastroesophageal reflux disease (GERD). A secondary aim of this study was to classify these same plasma cytokine profiles in the three achalasia subtypes. METHODS: Plasma from 53 patients with achalasia, 22 with EoE, and 20 with GERD (symptoms plus esophagitis or + reflux study) were analyzed. EXCLUSION CRITERIA: malignancy, autoimmune condition, immunodeficiency disorder, and treatment with steroids/immune modulating drugs. Cytokine levels were assayed via multiplex enzyme-linked immunosorbent assay (ELISA). RESULTS: Our key finding revealed significant elevations in IL- 6 (p = 0.0158) in achalasia patients compared with EoE patients. Overall, plasma inflammatory biomarker patterns were not different in the three subtypes of achalasia. CONCLUSION: There were no differences between the cytokine levels of any of the measured biomarkers between the achalasia and GERD groups suggesting that luminal stasis does increase biomarker levels for any of the cytokines examined in our study. While these results are an early first step towards clarifying some aspects of the pathogenesis of achalasia, they bring about many more questions that require further investigation and expansion. Further investigation with a larger cohort and a broader panel of biomarkers is needed.

Impact of Peppermint Therapy on Dysphagia and Non-cardiac Chest Pain: A Pilot Study.

BACKGROUND: Due to its smooth muscle relaxing properties, peppermint oil (PO) may relieve dysphagia and chest pain due to esophageal motility disorders. AIM: To explore the impact of PO on dysphagia and/or chest pain in patients referred for motility testing. METHODS: Patients initiated on PO for dysphagia and/or chest pain from 2013 to 2016 were identified. We excluded patients with obstructing esophageal lesions, patients lost to follow-up, and those with preexisting cardiac conditions. Concentrated PO was given as commercially available dissolvable peppermint tablets; two tablets before meals were prescribed to patients with dysphagia and on an as-needed basis for patients with chest pain. Patient-reported symptom response was assessed using a modified five-point Likert scale. RESULTS: Thirty-eight patients were included. Twenty-four patients (63%) reported improvement; 12 were much better and 12 were slightly better. Fourteen experienced no change and none reported feeling worse. Based on pre-treatment HRM, patients with distal esophageal spasm (DES) (n = 10) and esophagogastric junction outflow obstruction (EGJOO) (n = 8) appeared to demonstrate the best subjective improvement (83% and 100%, respectively) (P < 0.05). CONCLUSION: PO appears to provide symptomatic relief in some patients with dysphagia and CP. Presence of a well-defined manometric disorder, particularly DES or EGJOO, appeared to predict response.

Management options for patients with GERD and persistent symptoms on proton pump inhibitors: recommendations from an expert panel.

BACKGROUND: The aim of this study was to assess expert gastroenterologists' opinion on treatment for distinct gastroesophageal reflux disease (GERD) profiles characterized by proton pump inhibitor (PPI) unresponsive symptoms. METHODS: Fourteen esophagologists applied the RAND/UCLA Appropriateness Method to hypothetical scenarios with previously demonstrated GERD (positive pH-metry or endoscopy) and persistent symptoms despite double-dose PPI therapy undergoing pH-impedance monitoring on therapy. A priori thresholds included: esophageal acid exposure (EAE) time >6.0%; symptom-reflux association: symptom index >50% and symptom association probability >95%; >80 reflux events; large hiatal hernia: >3 cm. Primary outcomes were appropriateness of four invasive procedures (laparoscopic fundoplication, magnetic sphincter augmentation, transoral incisionless fundoplication, radiofrequency energy delivery) and preference for pharmacologic/behavioral therapy. RESULTS: Laparoscopic fundoplication was deemed appropriate for elevated EAE, and moderately appropriate for positive symptom-reflux association for regurgitation and a large hiatal hernia with normal EAE. Magnetic sphincter augmentation was deemed moderately appropriate for elevated EAE without a large hiatal hernia. Transoral incisionless fundoplication and radiofrequency energy delivery were not judged appropriate in any scenario. Preference for non-invasive options was as follows: H2RA for elevated EAE, transient lower esophageal sphincter relaxation inhibitors for elevated reflux episodes, and neuromodulation/behavioral therapy for positive symptom-reflux association. CONCLUSION: For treatment of PPI unresponsive symptoms in proven GERD, expert esophagologists recommend invasive therapy only in the presence of abnormal reflux burden, with or without hiatal hernia, or regurgitation with positive symptom-reflux association and a large hiatus hernia. Non-invasive pharmacologic or behavioral therapies are preferred for all other scenarios.

Symptom Index or Symptom Association Probability?: A Closer Look at Symptom Association in Suspected GERD Patients.

BACKGROUND: Symptom index (SI) and symptom association probability (SAP) are popular methods used to measure symptom association in patients with gastroesophageal reflux disease (GERD). AIM: To investigate whether these 2 methods yield similar results in analysis of both typical and atypical GERD symptoms. MATERIALS AND METHODS: Combined impedance-pH reflux studies of 1471 patients tested for possible GERD symptoms from January 2010 to May 2015 were reviewed. SI and SAP were analyzed for typical and atypical GERD symptoms including heartburn, regurgitation, indigestion, chest pain, cough, and throat clearing (TC). Patients who reported <3 symptom events during the 24-hour monitoring period were excluded. ON and OFF proton pump inhibitor (PPI) groups were reviewed. Kappa coefficient (κ) rather than simple percentage was used to measure the agreement rate. Simple percentage agreement is a less reliable method compared with κ. RESULTS: On PPI therapy, there was a good κ between SI and SAP for regurgitation (0.68) and indigestion (0.64), moderate for heartburn (0.48) and chest pain (0.51), and poor for cough (0.33) and TC (0.29). There was a lower κ OFF PPI therapy for heartburn (0.36), regurgitation (0.44), and indigestion (0.50). But there was no difference in κ for chest pain (0.61), cough (0.29), and TC (0.33). CONCLUSIONS: SI and SAP showed better agreement for patients with typical GERD symptoms and even better when tested ON PPI. A better symptom association method is needed for patients with atypical GERD symptoms.

Throat Clearing, Frequently Reported, But is it GERD Related?

GOALS: To identify the association of throat clearing (TC) with gastroesophageal reflux disease (GERD) during objective reflux monitoring in a large number of patients studied in our esophageal testing laboratory. BACKGROUND: TC is frequently reported and considered to be an atypical symptom of GERD. Atypical GERD symptoms have been widely investigated and empirically treated with proton pump inhibitors. STUDY: We reviewed ambulatory impedance-pH studies of 186 patients referred for evaluation of possible GERD from January 2011 to December 2015 to evaluate the symptom association (SA) of TC with both an abnormal number of reflux episodes and also abnormal esophageal acid exposure (EAE). Patients were divided into 2 groups; group 1: TC is the only reported symptom, group 2: TC is one of the symptoms. All patients were studied off proton pump inhibitors therapy. RESULTS: Group 1 where TC was the only symptom in 27/186 (14.5%) patients. There was no significant difference in positive SA between this group (6/27; 22%) and group 2 (43/159; 27%) (Z score P=0.59). There was also no significant association between SA and abnormal EAE whether TC was the only presenting symptom (χ, P=0.7) or one of the reported symptoms (χ, P=0.10). None of the 6/27 had abnormal EAE. CONCLUSION: Although TC is often considered a possible GERD-related symptom, we found a low probability of objective association. TC is not likely to be the only presenting symptom, and if it happens, it is unlikely to be associated with GERD. Perhaps, TC should not be considered as a GERD symptom, even as an atypical one.

A System to Assess the Competency for Interpretation of Esophageal Manometry Identifies Variation in Learning Curves.

BACKGROUND & AIMS: Quality esophageal high-resolution manometry (HRM) studies require competent interpretation of data. However, there is little understanding of learning curves, training requirements, or measures of competency for HRM. We aimed to develop and use a competency assessment system to examine learning curves for interpretation of HRM data. METHODS: We conducted a prospective multicenter study of 20 gastroenterology trainees with no experience in HRM, from 8 centers, over an 8-month period (May through December 2015). We designed a web-based HRM training and competency assessment system. After reviewing the training module, participants interpreted 50 HRM studies and received answer keys at the fifth and then at every second interpretation. A cumulative sum procedure produced individual learning curves with preset acceptable failure rates of 10%; we classified competency status as competency not achieved, competency achieved, or competency likely achieved. RESULTS: Five (25%) participants achieved competence, 4 (20%) likely achieved competence, and 11 (55%) failed to achieve competence. A minimum case volume to achieve competency was not identified. There was no significant agreement between diagnostic accuracy and accuracy for individual HRM skills. CONCLUSIONS: We developed a competency assessment system for HRM interpretation; using this system, we found significant variation in learning curves for HRM diagnosis and individual skills. Our system effectively distinguished trainee competency levels for HRM interpretation and contrary to current recommendations, found that competency for HRM is not case-volume specific.

Identification of Quality Measures for Performance of and Interpretation of Data From Esophageal Manometry.

BACKGROUND & AIMS: Esophageal manometry is the standard for the diagnosis of esophageal motility disorders. Variations in the performance and interpretation of esophageal manometry result in discrepant diagnoses and unnecessary repeated procedures, and could have negative effects on patient outcomes. We need a method to benchmark the procedural quality of esophageal manometry; as such, our objective was to formally develop quality measures for the performance and interpretation of data from esophageal manometry. METHODS: We used the RAND University of California Los Angeles Appropriateness Method (RAM) to develop validated quality measures for performing and interpreting esophageal manometry. The research team identified potential quality measures through a literature search and interviews with experts. Fourteen experts in esophageal manometry ranked the proposed quality measures for appropriateness via a 2-round process on the basis of RAM. RESULTS: The experts considered a total of 29 measures; 17 were ranked as appropriate and were as follows: related to competency (2), assessment before the esophageal manometry procedure (2), the esophageal manometry procedure itself (3), and interpretation of data (10). The data interpretation measures were integrated into a single composite measure. Eight measures therefore were found to be appropriate quality measures for esophageal manometry . Five other factors also were endorsed by the experts, although these were not ranked as appropriate quality measures. CONCLUSIONS: We identified 8 formally validated quality measures for the performance and interpretation of data from esophageal manometry on the basis of RAM. These measures represent key aspects of a high-quality esophageal manometry study and should be adopted uniformly. These measures should be evaluated in clinical practice to determine how they affect patient outcomes.

Characteristics of Consecutive Esophageal Motility Diagnoses After a Decade of Change.

BACKGROUND AND AIMS: Combined multichannel intraluminal impedance and esophageal manometry (MII-EM) measures concomitantly bolus transit and pressure changes allowing determination of the functional impact of esophageal motility abnormalities. Ten years ago our laboratory reported MII-EM results in 350 consecutive patients. Since then high-resolution impedance manometry (HRIM) became available and the definitions of ineffective esophageal motility (IEM) and nutcracker esophagus were revised. The aim of this study was to assess the impact of these developments on esophageal function testing. METHODS: From August 2012 through May 2013, HRIM was performed in 350 patients referred for esophageal function testing. Each patient received 10 liquid and 10 viscous swallows. While taking advantage of the new technology and revised criteria, HRIM findings were classified according to the conventional criteria to allow more appropriate comparison with our earlier analysis. RESULTS: Compared with the study performed 10 years ago, the prevalence of normal manometry (36% vs. 35%), achalasia (7% vs. 8%), scleroderma (1% vs. 1%), hypertensive lower esophageal sphincter (LES) (7% vs. 7%), and hypotensive LES (1% vs. 2%) remained the same, whereas the prevalence of distal esophageal spasm (9% vs. 3%), nutcracker esophagus (9% vs. 3%), and poorly relaxing LES (10% vs. 3%) decreased and the prevalence of IEM increased (20% vs. 31%) significantly. Compared with the early study, normal liquid bolus transit was significantly different in patients with hypertensive LES (96% vs. 57%) and poorly relaxing LES (55% vs. 100%). CONCLUSIONS: This study brings to light the increase in prevalence of IEM. In addition, it suggests that the hypertensive LES and poorly relaxing LES may each affect bolus transit in about half of these patients.

Cough and Throat Clearing: Atypical GERD Symptoms or Not GERD at All?

GOALS: To investigate the frequency of throat clearing (TC) and cough and how often each is associated with a positive symptom index (SI) for reflux. BACKGROUND: Many patients referred to our esophageal laboratory for gastroesophageal reflux disease (GERD) evaluation have "atypical" or "extraesophageal" symptoms. STUDY: We reviewed ambulatory impedance-pH studies of 267 patients referred for evaluation of possible GERD symptoms from January 2012 to December 2013 to evaluate the frequency of cough, TC, and their association with an abnormal number of reflux episodes. Patients with <3 symptom events/24 hours were excluded. Additional analysis was done for those with ≥24 (excessive) symptoms of TC or cough/24 hours. Eighty percent of patients were tested on proton pump inhibitor therapy. SI for either or both symptoms was calculated. RESULTS: A total of 112 of 267 patients (42%) reported both TC and cough on study day, 76/267 (28%) cough without TC and 79/267 (30%) TC without cough. Only 9/112 (8%) had a positive SI, versus 20/76 (26%) and 17/79 (22%) for cough (P=0.0006) and TC (P=0.007), respectively.A total of 136 of 267 patients (51%) reported 3 to 23 TC events/24 hours; 27/136 (20%) had a positive SI. Fifty-five of 267 (27%) had "excessive" TC. Only 7/55 (13%) had a positive SI (P=0.24).A total of 142 of 267 patients (53%) reported 3 to 23 cough events/24 hours; 43/142 (30%) had a positive SI. Forty-six of 267 (17%) had "excessive" cough. Only 6/46 (13%) had a positive SI (P=0.02).Analyses based on ON/OFF therapy, also showed same low rate of positive test and significantly higher number of reflux episodes in those with positive SI. CONCLUSIONS: Although cough and TC are often considered possible GERD symptoms, there is a low probability of objective association. This is even less likely if both symptoms are present. Those patients who reported "excessive" cough are less likely to have a positive SI.

Ineffective Esophageal Motility (IEM): the Old-New Frontier in Esophagology.

Ineffective esophageal motility (IEM) is characterized by distal esophageal contraction amplitude of <30 mmHg on conventional manometry (Blonski et al. Am J Gastroenterol. 103(3):699-704, 2008), or a distal contractile integral (DCI) < 450 mmHg*s*cm on high-resolution manometry (HRM) (Kahrilas et al. Neurogastroenterol Motil. 27(2):160-74, 2015) in≥50 % of test swallows. IEM is the most common abnormality on esophageal manometry, with an estimated prevalence of 20-30 % (Tutuian and Castell Am J Gastroenterol. 99(6):1011-9, 2004; Conchillo et al. Am J Gastroenterol. 100(12):2624-32, 2005). Non-obstructive dysphagia has been considered to be frequently associated with severe esophageal peristaltic dysfunction. Defective bolus transit (DBT) on multichannel intraluminal impedance testing was found in more than half of IEM patients who presented with dysphagia (Tutuian and Castell Am J Gastroenterol. 99(6):1011-9, 2004), highlighting the functional defect of this manometric finding. Treatment of IEM has been challenging because of lack of promotility agents that have a definite effect on esophageal function.

Association of Acute Gastroesophageal Reflux Disease With Esophageal Histologic Changes.

IMPORTANCE: The histologic changes associated with acute gastroesophageal reflux disease (GERD) have not been studied prospectively in humans. Recent studies in animals have challenged the traditional notion that reflux esophagitis develops when esophageal surface epithelial cells are exposed to lethal chemical injury from refluxed acid. OBJECTIVE: To evaluate histologic features of esophageal inflammation in acute GERD to study its pathogenesis. DESIGN, SETTING, AND PARTICIPANTS: Patients from the Dallas Veterans Affairs Medical Center who had reflux esophagitis successfully treated with proton pump inhibitors (PPIs) began 24-hour esophageal pH and impedance monitoring and esophagoscopy (including confocal laser endomicroscopy [CLE]) with biopsies from noneroded areas of distal esophagus at baseline (taking PPIs) and at 1 week and 2 weeks after stopping the PPI medication. Enrollment began May 2013 and follow-up ended July 2015. INTERVENTIONS: PPIs stopped for 2 weeks. MAIN OUTCOMES AND MEASURES: Twelve patients (men, 11; mean age, 57.6 year [SD, 13.1]) completed the study. Primary outcome was change in esophageal inflammation 2 weeks after stopping the PPI medication, determined by comparing lymphocyte, eosinophil, and neutrophil infiltrates (each scored on a 0-3 scale) in esophageal biopsies. Also evaluated were changes in epithelial basal cell and papillary hyperplasia, surface erosions, intercellular space width, endoscopic grade of esophagitis, esophageal acid exposure, and mucosal impedance (an index of mucosal integrity). RESULTS: At 1 week and 2 weeks after discontinuation of PPIs, biopsies showed significant increases in intraepithelial lymphocytes, which were predominantly T cells (median [range]: 0 (0-2) at baseline vs 1 (1-2) at both 1 week [P = .005] and 2 weeks [P = .002]); neutrophils and eosinophils were few or absent. Biopsies also showed widening of intercellular spaces (confirmed by CLE), and basal cell and papillary hyperplasia developed without surface erosions. Two weeks after stopping the PPI medication, esophageal acid exposure increased (median: 1.2% at baseline to 17.8% at 2 weeks; Δ, 16.2% [95% CI, 4.4%-26.5%], P = .005), mucosal impedance decreased (mean: 2671.3 Ω at baseline to 1508.4 Ω at 2 weeks; Δ, 1162.9 Ω [95% CI, 629.9-1695.9], P = .001), and all patients had evidence of esophagitis. CONCLUSIONS AND RELEVANCE: In this preliminary study of 12 patients with severe reflux esophagitis successfully treated with PPI therapy, stopping PPI medication was associated with T lymphocyte-predominant esophageal inflammation and basal cell and papillary hyperplasia without loss of surface cells. If replicated, these findings suggest that the pathogenesis of reflux esophagitis may be cytokine-mediated rather than the result of chemical injury. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01733810.

Diagnosis of Esophageal Motility Disorders: Esophageal Pressure Topography vs. Conventional Line Tracing.

OBJECTIVES: Enhanced characterization of esophageal peristaltic and sphincter function provided by esophageal pressure topography (EPT) offers a potential diagnostic advantage over conventional line tracings (CLT). However, high-resolution manometry (HRM) and EPT require increased equipment costs over conventional systems and evidence demonstrating a significant diagnostic advantage of EPT over CLT is limited. Our aim was to investigate whether the inter-rater agreement and/or accuracy of esophageal motility diagnosis differed between EPT and CLT. METHODS: Forty previously completed patient HRM studies were selected for analysis using a customized software program developed to perform blinded independent interpretation in either EPT or CLT (six pressure sensors) format. Six experienced gastroenterologists with a clinical focus in esophageal disease (attendings) and six gastroenterology trainees with minimal manometry experience (fellows) from three academic centers interpreted each of the 40 studies using both EPT and CLT formats. Rater diagnoses were assessed for inter-rater agreement and diagnostic accuracy, both for exact diagnosis and for correct identification of a major esophageal motility disorder. RESULTS: The total group agreement was moderate (κ=0.57; 95% CI: 0.56-0.59) for EPT and fair (κ=0.32; 0.30-0.33) for CLT. Inter-rater agreement between attendings was good (κ=0.68; 0.65-0.71) for EPT and moderate (κ=0.46; 0.43-0.50) for CLT. Inter-rater agreement between fellows was moderate (κ=0.48; 0.45-0.50) for EPT and poor to fair (κ=0.20; 0.17-0.24) for CLT. Among all raters, the odds of an incorrect exact esophageal motility diagnosis were 3.3 times higher with CLT assessment than with EPT (OR: 3.3; 95% CI: 2.4-4.5; P<0.0001), and the odds of incorrect identification of a major motility disorder were 3.4 times higher with CLT than with EPT (OR: 3.4; 2.4-5.0; P<0.0001). CONCLUSIONS: Superior inter-rater agreement and diagnostic accuracy of esophageal motility diagnoses were demonstrated with analysis using EPT over CLT among our selected raters. On the basis of these findings, EPT may be the preferred assessment modality of esophageal motility.

Multiple good options are available for achalasia management.

BACKGROUND: The aim of achalasia management is relieving functional obstruction at the esophagogastric junction. Pneumatic dilation (PD), Heller myotomy (HM), and Botox (BT) are available for this purpose. Many studies have compared efficacy of one treatment regimen to another however, many patients with achalasia undergo combinations of different procedures. AIM: : The aim of this study was to follow-up achalasia patients treated at a tertiary referral center over a 10-year period and to compare patient satisfaction and symptoms in patients who were treated with either a single treatment (ST) versus multiple treatments (MT). METHODS: A cohort of achalasia patients treated at the Medical University of South Carolina between 2002 and 2012 were identified, contacted by telephone, and completed a questionnaire about their treatments and symptoms. Symptomatic response was classified using the Eckardt score, and overall patient satisfaction was determined on a scale from 1 to 10. Data were analyzed using a paired Student t test. RESULTS: Data were collected from 57 patients and 3 patients were excluded from the study because they had no prior interventions for achalasia. Demographic analysis of the patients revealed a mean age of 62.7 years (range, 24 to 89 y) with 45% males and 55% females. The average elapsed time since the last definitive treatment was 2.82 years. Twenty-eight patients had an ST performed and 26 patients underwent MT. The average number of different interventions in the MT group was 3 procedures/patient. There were no significant differences in overall patient satisfaction (ST, 7.5 vs. MT, 8; P=0.66) and the Eckardt scores between the 2 groups (ST, 3.39 vs. MT, 3.3; P=0.77). CONCLUSIONS: MT options are available for management of achalasia. Improvement of clinical symptoms and overall patient satisfaction does not differ if the patient underwent an ST modality or a combination of different treatments.

A Novel Sleep Positioning Device Reduces Gastroesophageal Reflux: A Randomized Controlled Trial.

GOAL: We hypothesized that sleeping left-side down with the head/torso elevated reduces recumbent gastroesophageal reflux (GER). BACKGROUND: Previous studies show that sleeping with head of bed elevated or on wedge reduces GER and lying left-side down reduces GER versus right-side down and supine. No prior studies have evaluated the potential compounding effects of lying in an inclined position combined with lateral positioning on GER. STUDY: We evaluated a sleep-positioning device (SPD) consisting of an inclined base and body pillow that maintains lateral position while elevating the head/torso. This was a single institution, randomized controlled trial involving 20 healthy volunteers receiving 4 six-hour impedance-pH tests. After placement of reflux probe, subjects returned home, ate standardized meal, and lay down in randomly assigned positions: SPD right-side down (SPD-R), SPD left-side down (SPD-L), standard wedge any position (W), or flat any position (F). A wireless accelerometer documented position during each study. Number of reflux episodes (RE) and esophageal acid exposure (EAE) were calculated over 6 hours. RESULTS: Significantly less EAE occurred during sleeping SPD-L versus sleeping W, SPD-R, and F. The most EAE occurred during sleeping SPD-R despite use of the positioning device. RE were significantly less SPD-L than SPD-R. Patients sleeping SPD-L and SPD-R spent the majority of first 2 hours and greater than half of 6 hours in assigned position. Patients sleeping W and F averaged more time supine than right or left. CONCLUSIONS: The sleep positioning device maintains recumbent position effectively. Lying left-side down, it reduces recumbent esophageal acid exposure.

Interobserver variability in esophageal body measurements with high-resolution manometry among new physician users.

GOALS: To evaluate interobserver variability among 4 new physician users on measures of esophageal body function. BACKGROUND: Esophageal high-resolution manometry allows observation of esophageal motility by pressure topography plots. Little is known about the interobserver variability among physicians. STUDY: Two resident and 2 fellow level physicians each interpreted 10 liquid swallows of 20 esophageal high-resolution manometry studies (n = 200 swallows) using the BioVIEW Analysis Suite (Sandhill Scientific Inc.). Studies evaluated were from patients referred for evaluation of dysphagia but found to have normal esophageal manometry and complete liquid bolus transit. Physicians received an orientation session and reviewed recent literature. Each physician recorded contractile front velocity (CFV) and distal contractile integral (DCI) for each liquid swallow. STATISTICS: Interobserver agreements for CFV and DCI were assessed by intraclass correlation (ICC) values. Linear correlations between measurements by 2 readers were assessed using linear regression modeling techniques. RESULTS: CFV and DCI values of up to 200 data points were analyzed. Four reader results for CFV and DCI showed strong agreement although stronger for DCI measures (ICC = 0.94; range, 0.91 to 0.98) in comparison with CFV (ICC = 0.79; range, 0.52 to 0.82). Further correlation was performed with 2 readers; readers 1 and 2 revealed excellent correlation for DCI (r = 0.95, P < 0.001) and good correlation for CFV (r = 0.61, P < 0.001). CONCLUSIONS: With a thorough orientation session, good to excellent agreement for CFV and DCI measurements can be obtained from new physician users. CFV measures exhibit greater interobserver variability possibly due to the artifact produced by intraesophageal pressurization.