A novel fiber‐optic based 0.014″ pressure wire: Designs of the OptoWire™, development phases, and the O2 first‐in‐man results. Issue 1 (14th October 2020)

• Record Type: Journal Article
• Authors: Ulacia, Paola; Rimac, Goran; Lalancette, Sébastien; Belleville, Claude; Mongrain, Rosaire; Plante, Sylvain; Rusza, Zoltan; Matsuo, Hitoshi; Bertrand, Olivier F.
• Is Part Of: Catheterization and cardiovascular interventions. Volume 99:Issue 1(2022)
• Page Start: 59
• Page End: 67
• Publication Date: 2020-10-14
• Subjects: angiography -- catheterization -- coronary -- coronary artery disease -- coronary blood flow/physiology -- diagnostic -- fractional flow reserve; Heart -- Diseases -- Diagnosis -- Periodicals; Cardiac catheterization -- Periodicals; 616.1207572
• DOI: 10.1002/ccd.29321
• Languages: English
• ISSNs: 1522-1946

Abstract

Abstract: 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) O2 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™ (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™ steerability, pushability and torquability properties were closer to regular PCI wires than standard electrical pressure wires. In the First‐in‐Man O2 study, 60 patients were recruited at 2 centers in Canada. A total of 103 lesions were assessed with the OptoWire™ and OptoMonitor™, 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™ and Aegis™ (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™ provides superior wire handling with reduced risk of pressure drift allowing reliable pre‐ and post‐PCI physiology assessment.