Clinical usefulness of esophageal high resolution manometry and adjunctive tests: An update.

High resolution manometry (HRM), developed from conventional manometry, is the gold standard for assessment of esophageal motor function worldwide. The Chicago Classification, now in its fourth iteration, is the modern standard for HRM categorization of esophageal motility disorders. The HRM protocol has expanded from the original 10 supine swallow standard, to include upright swallows, and provocative maneuvers such as multiple rapid swallows, rapid drink challenge and standardized test meal. Impedance has been incorporated into HRM for visualization of bolus clearance. Futhermore, barium radiography and functional lumen imaging probe complement HRM when evidence of esophagogastric junction obstruction is inconclusive. The biggest impact of HRM is in the improved diagnosis and subtyping of achalasia spectrum disorders, with implications on management. Spastic disorders and absent contractility are better characterized. Within the reflux spectrum, HRM provides definition of morphology and tone of the esophagogastric junction, and assesses integrity of esophageal body peristalsis, which have pathophysiologic implications for reflux and its clearance. HRM provides characterization of behavioral disorders such as supragastric belching and rumination syndrome, which can mimic reflux disease. Thus, HRM has revolutionized the evaluation of esophageal motor function, and has expanded the utility of esophageal manometry in clinical practice.

Chicago classification version 4.0© technical review: Update on standard high-resolution manometry protocol for the assessment of esophageal motility.

The Chicago Classification v4.0 (CCv4.0) is the updated classification scheme for esophageal motility disorders using metrics from high-resolution manometry (HRM). A key feature of CCv.4.0 is the more rigorous and expansive protocol that incorporates single wet swallows acquired in different positions (supine, upright) and provocative testing, including multiple rapid swallows and rapid drink challenge. Additionally, solid bolus swallows, solid test meal, and/or pharmacologic provocation can be used to identify clinically relevant motility disorders and other conditions (eg, rumination) that occur during and after meals. The acquisition and analysis for performing these tests and the evidence supporting their inclusion in the Chicago Classification protocol is detailed in this technical review. Provocative tests are designed to increase the diagnostic sensitivity and specificity of HRM studies for disorders of esophageal motility. These changes attempt to minimize ambiguity in prior iterations of Chicago Classification, decrease the proportion of HRM studies that deliver inconclusive diagnoses and increase the number of patients with a clinically relevant diagnosis that can direct effective therapy. Another aim in establishing a standard manometry protocol for motility laboratories around the world is to facilitate procedural consistency, improve diagnostic reliability, and promote collaborative research.

Comparison of motor diagnoses by Chicago Classification versions 2.0 and 3.0 on esophageal high-resolution manometry.

BACKGROUND: The Chicago Classification (CC) uses high-resolution manometry (HRM) software tools to designate esophageal motor diagnoses. We evaluated changes in diagnostic designations between two CC versions, and determined motor patterns not identified by either version. METHODS: In this observational cohort study of consecutive patients undergoing esophageal HRM over a 6-year period, proportions meeting CC 2.0 and 3.0 criteria were segregated into esophageal outflow obstruction, hypermotility, and hypomotility disorders. Contraction wave abnormalities (CWA), and 'normal' cohorts were recorded. Symptom burden was characterized using dominant symptom intensity and global symptom severity. Motor diagnoses, presenting symptoms, and symptom burden were compared between CC 2.0 and 3.0, and in cohorts not meeting CC diagnoses. KEY RESULTS: Of 2569 eligible studies, 49.9% met CC 2.0 criteria, but only 40.3% met CC 3.0 criteria (P<.0001). Between CC 2.0 and 3.0, 82.8% of diagnoses were concordant. Discordance resulted from decreasing proportions of hypermotility (4.4%) and hypomotility (9.0%) disorders, and increase in 'normal' designations (13.0%); esophageal outflow obstruction showed the least variation between CC versions. Symptom burden was higher with CC 3.0 diagnoses (P≤.005) but not with CC 2.0 diagnoses (P≥.1). Within 'normal' cohorts for both CC versions, CWA were associated with higher likelihood of esophageal symptoms, especially dysphagia, regurgitation, and heartburn, compared to truly normal studies (P≤.02 for each comparison). CONCLUSIONS AND INFERENCES: Despite lower sensitivity, CC 3.0 identifies esophageal motor disorders with higher symptom burden compared to CC 2.0. CWA, which are associated with both transit and perceptive symptoms, are not well identified by either version.

Artificial neural network classification of pharyngeal high-resolution manometry with impedance data.

OBJECTIVES/HYPOTHESIS: To use classification algorithms to classify swallows as safe, penetration, or aspiration based on measurements obtained from pharyngeal high-resolution manometry (HRM) with impedance. STUDY DESIGN: Case series evaluating new method of data analysis. METHODS: Multilayer perceptron, an artificial neural network (ANN), was evaluated for its ability to classify swallows as safe, penetration, or aspiration. Data were collected from 25 disordered subjects swallowing 5- or 10-mL boluses. Following extraction of relevant parameters, a subset of the data was used to train the models, and the remaining swallows were then independently classified by the ANN. RESULTS: A classification accuracy of 89.4 ± 2.4% was achieved when including all parameters. Including only manometry-related parameters yielded a classification accuracy of 85.0 ± 6.0%, whereas including only impedance-related parameters yielded a classification accuracy of 76.0 ± 4.9%. Receiver operating characteristic analysis yielded areas under the curve of 0.8912 for safe, 0.8187 for aspiration, and 0.8014 for penetration. CONCLUSIONS: Classification models show high accuracy in classifying swallows from dysphagic patients as safe or unsafe. HRM-impedance with ANN represents one method that could be used clinically to screen for patients at risk for penetration or aspiration.

Medical devices; cardiovascular devices; classification of implantable intra-aneurysm pressure measurement system. Final rule.

The Food and Drug Administration (FDA) is classifying the implantable intra-aneurysm pressure measurement system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System." The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.