Assessing the Accuracy of a second-generation optical sensor pressor wire in a wire to wire comparison (The ACCURACY study).

Abstract Background The phenomenon of “pressure drift” increases uncertainty about the correct FFR value. Redesigned and incorporating an optical pressure sensor, the “OptoWire Deux™” is purported to be less prone to the pressure drift seen with piezoelectric coronary pressure wires. The aim of this first in vivo real-world clinical study is to evaluate the performance of OptoWire Deux™ in terms of measurements agreement and propensity to pressure drift in a wire to wire comparison. Methods This is a single center, prospective, non-blinded clinical investigation enrolling 45 consecutive patients with a clinical indication for coronary lesion FFR assessment. Lesions were either simultaneously assessed with two optical sensor pressure wires (OSPW) (Group O-O; 30 patients, 34 lesions) or one OSPW and one piezoelectric pressure wire (PEPW) simultaneously (Group O-P; 15 patients, 15 lesions). Significant drift was defined as a pressure ratio deviation of >0.03. Results Mean FFR measurements in Group O O were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group O P, however, mean FFR measurement with PEPW (0.85±0.09) was numerically lower than that observed with the OSPW (0.88±0.08; P = 0.09). Level of agreement using the Bland-Altman method was higher when 2 OSPW were used for FFR assessment (−0.002 95% CI [−0.033,0.029] vs. 0.026 95% CI [−0.078, 0.130], respectively). The rate of drift was significantly lower with an OSPW compared to a PEPW (4.8% vs. 26.7% respectively, P = 0.02). Conclusion The optical sensor guidewire showed a high level of readings' agreement after simultaneous usage of 2 optical sensor guidewires. There was also significantly less drift when compared to a piezoelectric guidewire.