Why the study?
Retrospective assessment of aortograms showed moderate feasibility, prompting investigation into the prospective feasibility of quantitative aortography using videodensitometry after a standardized acquisition protocol.
Does a protocoled acquisition improve the feasibility of quantitative aortography for assessing paravalvular regurgitation after TAVI?
Does a protocoled acquisition improve the feasibility of quantitative aortography for assessing paravalvular regurgitation after TAVI?
Protocoled acquisition significantly improves the feasibility of quantitative aortography for assessing paravalvular regurgitation after TAVI, enabling objective evaluation of novel devices.
Prospective protocol may improve aortographic feasibility post-TAVI; leaves open whether it refines regurgitation assessment in minimalist procedures.
AIMS: Quantitative aortography using videodensitometry is a valuable tool for quantifying paravalvular regurgitation after TAVI, especially in the minimalist approach - without general anaesthesia. However, retrospective assessment of aortograms showed moderate feasibility of assessment. We sought to determine the prospective feasibility of quantitative aortography after a protocol of acquisition. METHODS AND RESULTS: This was a multicentre registry in Japan, Canada, the Netherlands and Germany including consecutive patients with Heart Team indication to undergo TAVI over a median period of 12 months. Operators performed final aortograms according to a pre-planned projection (either by CT or visually - Teng's rule). An independent core laboratory (Cardialysis) analysed all images for feasibility and for regurgitation assessment. From the four centres included in the present analysis, a total of 354 patients underwent TAVI following the acquisition protocol and all the aortograms were analysed by the core lab. The analyses were feasible in 95.5% (95% confidence interval [CI]: 93.2% to 97.5%) of the cases. This rate of analysable assessment was significantly higher than the feasibility in previous validation studies, such as in the RESPOND population (95.5% vs. 57.5%, p<0.0001). No differences were observed among different planning strategies (CT 96.5% vs. Teng's rule 93%, p=0.159; or Circle 98.5% vs. 3mensio 95.8% vs. Teng's rule 93%, p=0.247). CONCLUSIONS: ASSESS-REGURGE showed a high feasibility of assessment of regurgitation with quantitative aortography with protocoled acquisition. This may be of great importance for quantifying regurgitation in TAVI procedures (optimisation, guidance of post-dilatation), and in future clinical trials, in order to address sealing features of novel devices for TAVI objectively. ClinicalTrials.gov Identifier: NCT03644784.
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Modolo et al. (2019) studied this question.
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