Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study |
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| Authors: | 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 |
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| Affiliation: | 1. Department of Cardiology, Amsterdam UMC, Amsterdam Cardiovascular Sciences, University of Amsterdam, Amsterdam, the Netherlands;2. Department of Internal Medicine, Cardiology Division, University of Campinas, Campinas, Brazil;3. Department of Cardiology, Hospital Vera Cruz de Campinas, Campinas, Brazil;4. Department of Cardiology, National University of Ireland, Galway, Galway, Ireland;5. Department of Cardiology, Al-Azhar University, Cairo, Egypt;6. Pie Medical Imaging, Maastricht, the Netherlands;7. Philips Healthcare, Best, the Netherlands;8. Department of Cardiology, Imperial College of London, London, United Kingdom |
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| Abstract: | ObjectivesThe 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).BackgroundQuantitative 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.MethodsThis 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.ResultsPatients’ 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).ConclusionsThis 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) |
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| Keywords: | aortic regurgitation paravalvular leak transcatheter aortic valve replacement AR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0030" }," $$" :[{" #name" :" text" ," _" :" aortic regurgitation CI" },{" #name" :" keyword" ," $" :{" id" :" kwrd0040" }," $$" :[{" #name" :" text" ," _" :" confidence interval ICC" },{" #name" :" keyword" ," $" :{" id" :" kwrd0050" }," $$" :[{" #name" :" text" ," _" :" intraclass correlation coefficient LVOT" },{" #name" :" keyword" ," $" :{" id" :" kwrd0060" }," $$" :[{" #name" :" text" ," _" :" left ventricular outflow tract PVR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0070" }," $$" :[{" #name" :" text" ," _" :" paravalvular regurgitation TAVR" },{" #name" :" keyword" ," $" :{" id" :" kwrd0080" }," $$" :[{" #name" :" text" ," _" :" transcatheter aortic valve replacement |
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