Same Session Validation of a Custom-Built 22G With the Commercial 25G System for EUS-Guided Portal Pressure Gradient...

Area of Science:

• Gastroenterology
• Medical Devices
• Diagnostic Technology

Background:

• Endoscopic ultrasound-guided portal pressure gradient (EUS-PPG) measurement is an emerging alternative to hepatic venous pressure gradient (HVPG) assessment.
• The existing 25-gauge (25G) EUS-PPG system shows good correlation with HVPG but has limitations including small caliber and proprietary components.
• A custom-built 22-gauge (22G) conventional intravascular pressure transducer system was developed to address these limitations.

Purpose of the Study:

• To validate a custom-built 22G EUS-PPG system against a commercial 25G system.
• To assess the correlation and variability of portal pressure gradient (PPG), portal vein pressure (PVP), and hepatic vein pressure (HVP) measurements between the two systems.

Main Methods:

• A prospective cohort study involving 26 patients.
• Simultaneous EUS-PPG measurements were performed using both the 25G commercial system and the custom-built 22G system.
• Primary outcome: correlation of PPG values; Secondary outcomes: correlation and variability of PVP and HVP.

Main Results:

• Excellent correlation was found between PPG values from both systems (r=0.901, p<0.001).
• The 25G EUS-PPG system correctly identified clinically significant portal hypertension (PPG ≥ 10mmHg) in 96.2% of cases.
• Significant correlations were observed for PVP (r=0.776) and HVP (r=0.673) between systems, with low variability.

Conclusions:

• Measurements from the commercial 25G and custom-built 22G EUS-PPG systems are validated and show high agreement.
• The custom-built 22G system is advantageous due to its pressure-tracing quality control, wider availability, and cost-effectiveness.
• This study supports the clinical utility of the 22G EUS-PPG system as a reliable tool for assessing portal hypertension.