Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study
Rodrigo Modolo, Martijn van Mourik, Abdelhak El Bouziani, Hideyuki Kawashima, Liesbeth Rosseel, Mohammad Abdelghani, Jean-Paul Aben, Tristan Slots, Cherif Sahyoun, Jan Baan, Jose P S Henriques, Karel T Koch, Marije Vis, Osama Soliman, Yoshinobu Onuma, Joanna Wykrzykowska, Robbert de Winter, Patrick W Serruys, Rodrigo Modolo, Martijn van Mourik, Abdelhak El Bouziani, Hideyuki Kawashima, Liesbeth Rosseel, Mohammad Abdelghani, Jean-Paul Aben, Tristan Slots, Cherif Sahyoun, Jan Baan, Jose P S Henriques, Karel T Koch, Marije Vis, Osama Soliman, Yoshinobu Onuma, Joanna Wykrzykowska, Robbert de Winter, Patrick W Serruys
Abstract
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).
Keywords: aortic regurgitation; paravalvular leak; transcatheter aortic valve replacement.
Conflict of interest statement
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.
Source: PubMed