Interventions for valvular disease and heart failure

Quantitative aortography for assessing aortic regurgitation after transcatheter aortic valve implantation: results of the multicentre ASSESS-REGURGE Registry

EuroIntervention 2019;15:420-426. DOI: 10.4244/EIJ-D-19-00362

Rodrigo Modolo
Rodrigo Modolo1,2, MD; Chun-Chin Chang3, MD; Hiroki Tateishi4, MD; Yosuke Miyazaki3,4, MD, PhD; Michele Pighi5, MD; Mohammad Abdelghani1,6, MD; Martin A. Roos3, BSc; Quinten Wolff3, BSc; Joanna J. Wykrzykowska1, MD, PhD; Robbert J. de Winter1, MD, PhD; Nicolo Piazza5, MD, PhD; Gert Richardt6, MD; Mohamed Abdel-Wahab6,7, MD; Osama I.I. Soliman3,8, MD, PhD; Yoshinobu Onuma3,8, MD, PhD; Nicolas M. Van Mieghem3, MD, PhD; Patrick W. Serruys9, MD, PhD
1. Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; 2. Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil; 3. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands; 4. Division of Cardiology - Department of Clinical Science and Medicine - Yamaguchi University Graduate School of Medicine, Ube, Yamaguchi, Japan; 5. Division of Cardiology, McGill University Health Centre, Montreal, QC, Canada; 6. The Heart Center, Segeberger Kliniken, Bad Segeberg, Germany; 7. Cardiology Department, Heart Center Leipzig at the University of Leipzig, Leipzig, Germany; 8. Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands; 9. Department of Cardiology, Imperial College London, London, United Kingdom

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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