Clinical comparison study between a newly developed optical-based fractional flow reserve device and the conventional fractional flow reserve device.

Abstract

Fractional flow reserve (FFR) measurement is the gold standard for identifying the functional severity of coronary artery disease. Although we can use newly developed pressure wires with optical fibers are now available, their safety and accuracy for FFR measurement are not clear. Therefore, we planned a clinical comparison study between pressure wires with optical fibers and the conventional FFR device. We prospectively enrolled 51 patients (51 lesions) with intermediate coronary artery stenosis. For these lesions, FFR measurements with pressure wires with optical fibers were compared with those obtained with a conventional wire. All procedures were successfully completed without any complications. The procedure time with pressure wires with optical fibers and a conventional wire was 6.8 ± 3.0 and 6.9 ± 2.6 minutes (P = 0.89), respectively. There was no significant difference in FFR values between pressure wires with optical fibers and a conventional wire (0.83 ± 0.10 vs. 0.83 ± 0.12, P = 0.66). An excellent correlation was observed between FFR obtained with pressure wires with optical fibers and FFR obtained with a conventional wire (r = 0.81, P < 0.001). The pressure drift before and after FFR measurements was not significantly different between pressure wires with optical fibers and a convention wire (-0.01 ± 0.02 vs. -0.02 ± 0.06, P = 0.42). There was no significant difference in pressure drift defined as >0.03 or <-0.03 between pressure wires with optical fibers and a convention wire (13.7 vs. 17.6%, P = 0.79). Excellent correlations were observed between FFR values measured using pressure wires with optical fibers and a conventional wire. Furthermore, measurement of FFR with pressure wires with optical fibers was as well tolerated and reliable as that with a conventional wire.