Key result
Dedicated Trilogy TAVI achieves 100% device success vs non-dedicated valves in pure native AR.
Why the study?
Severe native aortic regurgitation poses anchoring challenges for TAVI due to absent calcifications, and real-world data comparing dedicated versus non-dedicated transcatheter heart valves remain scarce.
Does TAVI with a dedicated transcatheter heart valve improve device success and early safety compared to non-dedicated valves in high-surgical-risk patients with pure native aortic regurgitation?
Cohort (n=42)
No
Does TAVI with a dedicated transcatheter heart valve improve device success and early safety compared to non-dedicated valves in high-surgical-risk patients with pure native aortic regurgitation?
Absolute Event Rate: 100% vs 61.9%
p-value: p=0.002
In high-surgical-risk patients with pure native aortic regurgitation, a dedicated transcatheter heart valve (Trilogy) achieved 100% device success and shorter hospital stays compared to non-dedicated valves.
May support Trilogy TAVI in high-risk native AR; leaves open need for RCTs on durability and outcomes.
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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Assis et al. (2026) conducted a cohort in Pure native aortic regurgitation (n=42). Dedicated transcatheter heart valves (Trilogy device) vs. Non-dedicated transcatheter heart valves was evaluated on Device success at 30 days (p=0.002). TAVI with the dedicated Trilogy valve system achieved 100% device success compared to 61.9% with non-dedicated valves in high-risk patients with pure native aortic regurgitation.
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