Online Quantitative Aortographic Assessment of Aortic Regurgitation After TAVR: Results of the OVAL Study.
JACC Cardiovasc Interv
; 14(5): 531-538, 2021 03 08.
Article
en En
| MEDLINE
| ID: mdl-33582086
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).Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Insuficiencia de la Válvula Aórtica
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Estenosis de la Válvula Aórtica
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Prótesis Valvulares Cardíacas
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Reemplazo de la Válvula Aórtica Transcatéter
Tipo de estudio:
Etiology_studies
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Observational_studies
/
Risk_factors_studies
Límite:
Aged
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Aged80
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Humans
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Male
Idioma:
En
Revista:
JACC Cardiovasc Interv
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Brasil