Objectives To review the technical limitations of available pressure-wires, present
the design evolution of a nitinol fiber-optic pressure wire and to summarize the First-in-Man
(FIM) O-2 pilot study results. Background Despite increasing use of physiology assessment
of coronary lesions, several technical limitations persist. We present technical details,
design evolution and early clinical results with a novel 0.014 '' nitinol fiber-optic
based pressure-wire. Methods and Results The 0.014' OptoWire (TM) (Opsens Medical,
Quebec, Canada) was designed to combine improved handling properties compared to standard
pressure-wires and to offer extremely reliable pressure recording and transmission
due to fiber-optic properties compared to piezo-electric sensors and electrical wires.
In vitro assessment showed that OptoWire (TM) steerability, pushability and torquability
properties were closer to regular PCI wires than standard electrical pressure wires.
In the First-in-Man O(2)study, 60 patients were recruited at 2 centers in Canada.
A total of 103 lesions were assessed with the OptoWire (TM) and OptoMonitor (TM),
75 lesions at baseline and 28 lesions post-PCI (without disconnection). In all crossed
lesions (n = 100, 97%), mean Pd/Pa and FFR could be adequately measured. In 11 cases
assessed successively with OptoWire (TM) and Aegis (TM) (Abbott Vascular, USA) bland-Altman
analysis showed a mean difference of 0.002 +/- 0.052 mmHg (p = .91) for Pd/Pa and
0.01 +/- 0.06 for FFR calculation (p= .45). There was no device-related complication.
Upon these initial results, several design changes aimed to improve overall performance
including torquability, stiffness, resistance to kink and pressure drift were completed.
Conclusion The novel 0.014 '' fiber-optic OptoWire (TM) provides superior wire handling
with reduced risk of pressure drift allowing reliable pre- and post-PCI physiology
assessment.
