Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study.

Autor:	Modolo R; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil; Department of Cardiology, Hospital Vera Cruz de Campinas, Campinas, Brazil., van Mourik M; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., El Bouziani A; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., Kawashima H; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland., Rosseel L; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland., Abdelghani M; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands; Department of Cardiology, Al-Azhar University, Cairo, Egypt., Aben JP; Pie Medical Imaging, Maastricht, the Netherlands., Slots T; Pie Medical Imaging, Maastricht, the Netherlands., Sahyoun C; Philips Healthcare, Best, the Netherlands., Baan J; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., Henriques JPS; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., Koch KT; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., Vis M; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., Soliman O; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland., Onuma Y; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland., Wykrzykowska J; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., de Winter R; Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands., Serruys PW; Department of Cardiology, National University of Ireland, Galway, Galway, Ireland; Department of Cardiology, Imperial College of London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
Jazyk:	angličtina
Zdroj:	JACC. Cardiovascular interventions [JACC Cardiovasc Interv] 2021 Mar 08; Vol. 14 (5), pp. 531-538. Date of Electronic Publication: 2021 Feb 10.
DOI:	10.1016/j.jcin.2020.11.014
Abstrakt:	Objectives: The aim of this study was to investigate the online assessment feasibility of aortography using videodensitometry in the catheterization laboratory during transcatheter aortic valve replacement (TAVR). Background: Quantitative assessment of regurgitation after TAVR through aortography using videodensitometry is simple, reproducible, and validated in vitro, in vivo, in clinical trials, and in "real-world" patients. However, thus far the assessment has been done offline. Methods: This was a single center, prospective, proof-of-principle, feasibility study. One hundred consecutive patients with aortic stenosis and indications to undergo TAVR were enrolled. All final aortograms were analyzed immediately after acquisition in the catheterization laboratory and were also sent to an independent core laboratory for blinded offline assessment. The primary endpoint of the study was the feasibility of the online assessment of regurgitation (percentage of analyzable cases). The secondary endpoint was the reproducibility of results between the online assessment and the offline analysis by the core laboratory. Results: Patients' mean age was 81 ± 7 years, and 56% were men. The implanted valves were either SAPIEN 3 (97%) or SAPIEN 3 Ultra (3%). The primary endpoint of online feasibility of analysis was 92% (95% confidence interval [CI]: 86% to 97%) which was the same feasibility encountered by the core laboratory (92%; 95% CI: 86% to 97%). Reproducibility assessment showed a high correlation between online and core laboratory evaluations (R 2  = 0.87, p < 0.001), with an intraclass correlation coefficient of 0.962 (95% CI: 0.942 to 0.975; p < 0.001). Conclusions: This study showed high feasibility of online quantitative assessment of regurgitation and high agreement between the online examiner and core laboratory. These results may pave the way for the application of videodensitometry in the catheterization laboratory after TAVR. (Online Videodensitometric Assessment of Aortic Regurgitation in the Cath-Lab [OVAL]; NCT04047082). Competing Interests: Funding Support And Author Disclosures Dr. Modolo has received research grants from Biosensors and SMT, not related to the present work. Mr. Aben is an employee of Pie Medical Imaging. Mr. Slots is employed by the company that developed CAAS A-Valve. Dr. Sahyoun is a full-time employee of Philips Healthcare. Dr. Baan has received an unrestricted research grant from Edwards Lifesciences. Prof. Serruys has received personal fees from Abbott Laboratories, AstraZeneca, Biotronik, Cardialysis, GLG Research, Medtronic, Sino Medical Sciences Technology, Société Europa Digital Publishing, and Stentys. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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