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Abstract
Objectives The effect of subclinical leaflet thrombosis, characterised by hypoattenuated leaflet thickening (HALT), on the valve haemodynamic function and durability of the bioprosthetic valve, is not yet determined. We determined the impact of HALT on valve haemodynamics after transcatheter aortic valve replacement (TAVR) and the predictors of haemodynamic structural valve deterioration (SVD).
Methods The Anticoagulation vs Dual Antiplatelet Therapy for Prevention of Leaflet Thrombosis and Cerebral Embolization after Transcatheter Aortic Valve Replacement(ADAPT-TAVR) trial is a multicenter, randomised trial that compared edoxaban and dual antiplatelet therapy in patients who had undergone successful TAVR. The presence of HALT was evaluated by four-dimensional CT at 6 months and serial echocardiography performed at baseline, immediately post-TAVR and after 6 months. SVD was defined as at least one of the following: (1) mean transprosthetic gradient ≥20 mm Hg, (2) change in the mean gradient ≥10 mm Hg from baseline, or (3) new or increase in intraprosthetic aortic regurgitation of at least ≥1 grade, resulting in moderate or greater regurgitation.
Results At 6 months, HALT was found in 30 of 211 (14.2%) patients. The presence of HALT did not significantly affect aortic valve mean gradients (with vs without HALT; 14.0±4.8 mm Hg vs 13.7±5.5 mm Hg; p=0.74) at 6 months. SVD was reported in 30 of 206 patients (14.6%) at 6-month follow-up echocardiography. Older age (OR: 1.138; 95% CI: 1.019 to 1.293; p=0.033), use of aortic valve size ≤23 mm (OR: 6.254; 95% CI: 2.230 to 20.569; p=0.001) and mean post-TAVR pressure gradient (OR: 1.233; 95% CI: 1.123 to 1.371; p<0.001) were independent predictors of haemodynamic SVD; however, the presence of HALT was not identified as a predictor of SVD.
Conclusions In patients who had undergone successful TAVR, aortic valve haemodynamic status was not influenced by the presence of HALT. Although HALT was not a predictor of haemodynamic SVD at 6 months, it warrants further longer-term follow-up to evaluate the effect on long-term valve durability.
Trial registration number NCT03284827 (https://www.clinicaltrials.gov).
- aortic valve stenosis
- transcatheter aortic valve replacement
Data availability statement
All data relevant to the study are included in the article or uploaded as supplemental information. Data of this study may not be available because of the ongoing projects using these data.
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Data availability statement
All data relevant to the study are included in the article or uploaded as supplemental information. Data of this study may not be available because of the ongoing projects using these data.
Footnotes
Correction notice This article has been corrected since it was first published. D-WP's affiliations have been updated.
Contributors Conception and design—S-JP and D-WP. Analysis and interpretation of data—MHJ, S-JP and D-WP. Drafting of the manuscript—MHJ, J-MA, D-YK, S-JP and D-WP. Critical revision of the manuscript for important intellectual content—MHJ, J-MA, D-YK, KWK, HJK, DHY, SCJ, BK, YTAW, CCSL, W-HY, JW, Y-TL, H-LK, M-SL, T-YK, W-JK, SHK, S-AL, EK, HK, D-HK, Y-WC, J-HL, S-JP and D-WP. Final approval of the manuscript—MHJ, J-MA, D-YK, KWK, HJK, DHY, SCJ, BK, YTAW, CCSL, W-HY, JW, Y-TL, H-LK, M-SL, T-YK, W-JK, SHK, S-CY, S-AL, EK, HK, D-HK, Y-WC, J-HL, S-JP and D-WP. Obtaining research funding—D-WP and S-JP. Administrative, technical or logistic support—MHJ, J-MA, D-YK, KWK, HJK, DHY, SCJ, BK, YTAW, CCSL, W-HY, JW, Y-TL, H-LK, M-SL, T-YK, W-JK, SHK, S-AL, EK, HK, D-HK, Y-WC, J-HL, S-JP and D-WP. Acquisition of data—MHJ, J-MA, D-YK, KWK, HJK, DHY, SCJ, BK, YTAW, CCSL, W-HY, JW, Y-TL, H-LK, M-SL, T-YK, W-JK, SHK, S-AL, EK, HK, D-HK, Y-WC, J-HL, S-JP and D-WP. Guarantors—D-WP.
Funding This investigator-initiated trial was funded by the CardioVascular Research Foundation (Seoul, Korea) (grant number: AMCCV 2017–08) and Daiichi Sankyo Korea Co.
Disclaimer The funders assisted in the design of the protocol but had no role in the conduct of the trial or in the analysis, interpretation, or reporting of the results.
Competing interests D-WP reports grants from Daiichi Sankyo, ChongKunDang Pharm and Daewoong Pharm; personal fees from Edwards and Medtronic; and grants and personal fees from Abbott Vascular outside the submitted work. S-JP reports grants and personal fees from Abbott Vascular; grants from Daiichi Sankyo, ChongKunDang Pharm and Daewoong Pharm; and grants and personal fees from Edwards outside the submitted work.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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