Assessing the Accuracy of a Second-Generation Optical Sensor Pressure Wire in a Wire-to-Wire Comparison (The ACCURACY Study).
Coronary artery disease
Fractional flow reserve
Interventional cardiology
Percutaneous coronary intervention
Pressure wire
Journal
Cardiovascular revascularization medicine : including molecular interventions
ISSN: 1878-0938
Titre abrégé: Cardiovasc Revasc Med
Pays: United States
ID NLM: 101238551
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
20
01
2021
revised:
18
02
2021
accepted:
17
03
2021
pubmed:
30
3
2021
medline:
26
3
2022
entrez:
29
3
2021
Statut:
ppublish
Résumé
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. 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. Mean FFR measurements in Group OO were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group OP, 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). 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.
Sections du résumé
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 OO were not statistically different between the two sets of OSPW (overall 0.84±0.10; P = 0.52). In Group OP, 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.
Identifiants
pubmed: 33775553
pii: S1553-8389(21)00145-7
doi: 10.1016/j.carrev.2021.03.011
pii:
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
51-56Commentaires et corrections
Type : CommentIn
Informations de copyright
Copyright © 2021 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest There are no other conflicts of interest to disclose.