Neth Heart J. 2026 May 12. doi: 10.1007/s12471-026-02048-4. Online ahead of print.
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.
PMID:42118524 | DOI:10.1007/s12471-026-02048-4