TY - JOUR
T1 - Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR
T2 - Results of the OVAL Study
AU - Modolo, Rodrigo
AU - van Mourik, Martijn
AU - El Bouziani, Abdelhak
AU - Kawashima, Hideyuki
AU - Rosseel, Liesbeth
AU - Abdelghani, Mohammad
AU - Aben, Jean Paul
AU - Slots, Tristan
AU - Sahyoun, Cherif
AU - Baan, Jan
AU - Henriques, Jose P.S.
AU - Koch, Karel T.
AU - Vis, Marije
AU - Soliman, Osama
AU - Onuma, Yoshinobu
AU - Wykrzykowska, Joanna
AU - de Winter, Robbert
AU - Serruys, Patrick W.
N1 - Funding Information: 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. Publisher Copyright: © 2021 American College of Cardiology Foundation Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3/8
Y1 - 2021/3/8
N2 - 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 (R2 = 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)
AB - 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 (R2 = 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)
KW - aortic regurgitation
KW - paravalvular leak
KW - transcatheter aortic valve replacement
UR - http://www.scopus.com/inward/record.url?scp=85101162241&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.jcin.2020.11.014
DO - https://doi.org/10.1016/j.jcin.2020.11.014
M3 - Article
C2 - 33582086
SN - 1936-8798
VL - 14
SP - 531
EP - 538
JO - JACC: Cardiovascular Interventions
JF - JACC: Cardiovascular Interventions
IS - 5
ER -