Assessing the Accuracy of a Second-Generation Optical Sensor Pressure Wire in a Wire-to-Wire Comparison (The ACCURACY...

Area of Science:

• Cardiology
• Medical Devices
• Interventional Cardiology

Background:

• Pressure drift in fractional flow reserve (FFR) measurements introduces uncertainty.
• The OptoWire Deux™, a novel optical pressure sensor guidewire, aims to mitigate pressure drift.
• This study evaluates its real-world clinical performance against existing technologies.

Purpose of the Study:

• To assess the performance of the OptoWire Deux™ optical sensor guidewire.
• To compare its measurement agreement and propensity to pressure drift against piezoelectric coronary pressure wires.
• To evaluate its in vivo clinical utility in FFR assessment.

Main Methods:

• A prospective, non-blinded clinical study involving 45 patients undergoing FFR assessment.
• Simultaneous lesion assessment using either two optical sensor pressure wires (OSPW) or one OSPW and one piezoelectric pressure wire (PEPW).
• Significant drift defined as a pressure ratio deviation >0.03.

Main Results:

• No significant difference in mean FFR between two OSPWs (0.84±0.10).
• Numerically lower mean FFR with PEPW (0.85±0.09) compared to OSPW (0.88±0.08) in the OSPW/PEPW group (P=0.09).
• Higher Bland-Altman agreement with two OSPWs. Significantly lower drift rate with OSPW (4.8%) vs. PEPW (26.7%, P=0.02).

Conclusions:

• The optical sensor guidewire demonstrates high agreement when used simultaneously.
• Significantly reduced pressure drift observed with optical sensor guidewires compared to piezoelectric ones.
• OptoWire Deux™ offers improved reliability for FFR measurements.