Dedicated versus non-dedicated transcatheter valves for pure native aortic regurgitation: a single-centre experience

BACKGROUND: Aortic regurgitation (AR) is the third most common valvular heart disease in the Western world. Management of high-surgical-risk patients is challenging. The absence of calcifications in the aortic valve presents anchoring challenges for transcatheter aortic valve implantation (TAVI) in patients with severe native AR. The Trilogy device is a dedicated transcatheter heart valve for the treatment of AR and anchors by clipping onto the native aortic valve leaflets. Real-world data comparing dedicated vs. non-dedicated THVs remains scarce. METHODS: We evaluated 42 consecutive high- or prohibitive-surgical-risk patients with pure native AR who underwent transfemoral TAVI. Twenty-one patients received the Trilogy device, and 21 received non-dedicated transcatheter valves (THV). Co-primary endpoints were device success and early safety at 30 days. Secondary endpoints included valve embolisation, residual moderate-to-severe AR, new pacemaker implantation, mortality, and length of hospital stay. RESULTS: Device success was significantly higher with dedicated THVs (100% vs. 61.9%; p = 0.002). Early safety was comparable (71.4% vs. 61.9%; p = 0.513). There were 4 valve embolisations (9.5%) and two cardiovascular deaths (4.8%) in the non-dedicated group. Residual moderate-to-severe AR was absent in the dedicated cohort and occurred in 2 of 21 non-dedicated cases. Overall, new permanent pacemaker implantation occurred in 19%, with no significant difference between the 2 cohorts (p = 1.00). Median hospital stay was significantly shorter in the dedicated cohort (2 vs. 5 days; p = 0.015). CONCLUSION: TAVI with the Trilogy valve system had higher device success as compared to non-dedicated valves and should become the preferred transcatheter strategy for patients with severe native AR at high-operative risk.

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Publication Details

Journal
Netherlands Heart Journal
Published
2026-05-12
DOI
https://doi.org/10.1007/s12471-026-02048-4
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
Field-Weighted Citation Impact
0.00

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article

Dedicated versus non-dedicated transcatheter valves for pure native aortic regurgitation: a single-centre experience

G.M. Mondellini, Isabella Kardys, Lucas Uchoa de Assis, Antigone Kostea et al.
Netherlands Heart Journal
Cardiac Valve Diseases and Treatments
article

Dedicated versus non-dedicated transcatheter valves for pure native aortic regurgitation: a single-centre experience

G.M. Mondellini, Isabella Kardys, Lucas Uchoa de Assis, Antigone Kostea, A Mariani, R J Nuis, N M Van Mieghem, Joost Daemen, Mark M. P. van den Dorpel
article en

Abstract

BACKGROUND: Aortic regurgitation (AR) is the third most common valvular heart disease in the Western world. Management of high-surgical-risk patients is challenging. The absence of calcifications in the aortic valve presents anchoring challenges for transcatheter aortic valve implantation (TAVI) in patients with severe native AR. The Trilogy device is a dedicated transcatheter heart valve for the treatment of AR and anchors by clipping onto the native aortic valve leaflets. Real-world data comparing dedicated vs. non-dedicated THVs remains scarce. METHODS: We evaluated 42 consecutive high- or prohibitive-surgical-risk patients with pure native AR who underwent transfemoral TAVI. Twenty-one patients received the Trilogy device, and 21 received non-dedicated transcatheter valves (THV). Co-primary endpoints were device success and early safety at 30 days. Secondary endpoints included valve embolisation, residual moderate-to-severe AR, new pacemaker implantation, mortality, and length of hospital stay. RESULTS: Device success was significantly higher with dedicated THVs (100% vs. 61.9%; p = 0.002). Early safety was comparable (71.4% vs. 61.9%; p = 0.513). There were 4 valve embolisations (9.5%) and two cardiovascular deaths (4.8%) in the non-dedicated group. Residual moderate-to-severe AR was absent in the dedicated cohort and occurred in 2 of 21 non-dedicated cases. Overall, new permanent pacemaker implantation occurred in 19%, with no significant difference between the 2 cohorts (p = 1.00). Median hospital stay was significantly shorter in the dedicated cohort (2 vs. 5 days; p = 0.015). CONCLUSION: TAVI with the Trilogy valve system had higher device success as compared to non-dedicated valves and should become the preferred transcatheter strategy for patients with severe native AR at high-operative risk.

Netherlands Heart Journal
Erasmus MC (NL), University of Naples Federico II (IT), Erasmus University Rotterdam (NL)
Edwards Lifesciences, Boston Scientific Corporation, Vifor Pharma, Abbott Vascular
Good health and well-being
Openalex Percentile: Top 6%
Cardiac Valve Diseases and Treatments
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