Thermal compensation algorithm in ManoScan™ high resolution esophageal manometry: does it really affect manometry...

Area of Science:

• Gastroenterology
• Medical Devices
• Diagnostic Accuracy

Background:

• High-resolution manometry (HRM) accuracy can be compromised by pressure drift (PD) due to temperature variations.
• Thermal compensation (TC) is a software algorithm designed to mitigate PD in ManoScan™ HRM systems.
• The clinical impact of TC on HRM metrics and diagnoses remains understudied.

Purpose of the Study:

• To evaluate the impact of the TC algorithm on esophageal HRM metrics.
• To determine if TC affects the final clinical diagnosis of esophageal motility disorders.
• To assess the consequences of omitting or incorrectly applying TC.

Main Methods:

• Retrospective review of 124 esophageal HRM studies using ManoScan™ catheters.
• Comparison of manometry metrics and diagnoses under different TC application scenarios: formal TC (fTC), no TC (nonTC), and early TC (TC1, TC5, TC10).

Main Results:

• Significant differences in integrated relaxation pressure (IRP) and distal contractile integral (DCI) were observed between fTC and early TC groups.
• Incorrect TC application led to contrary IRP values in a substantial number of studies.
• Diagnosis discrepancies were noted, with fewer esophagogastric junction outflow obstruction (EGJ-OO) and more normal esophageal motility (NEM) diagnoses in the fTC group.

Conclusions:

• Omission or incorrect timing of TC in ManoScan™ HRM studies can result in inaccurate IRP measurements.
• Diagnostic errors, particularly differentiating NEM from EGJ-OO, can occur without proper TC application.