Cardiac magnetic resonance evaluation of valve function after Sapien versus Myval transcatheter aortic valve implantation: A COMPARE-TAVI 1 substudy
Alexandra Amalie Uglebjerg Pedersen, Won Yong Kim, Lene Hüche Nielsen, Henrik Nissen, Philip Freeman, Troels Thim, Evald Høj Christiansen, Mariann Tang Jensen, Karen Juel Andersen, Jordi Sanchez Dahl, Bjarne Linde Nørgaard, Julia Ellert-Gregersen, Tomas Zaremba, Christian Juhl TerkelsenAbstract
Background
New transcatheter heart valves (THVs) are continually introduced for transcatheter aortic valve implantation (TAVI), often without robust early haemodynamic data. Cardiac magnetic resonance (CMR) imaging offers quantification of aortic regurgitation fraction (ARF) and effective orifice area (EOA), key markers of THV performance.
Aims
This study aimed to compare CMR-derived ARF and EOA between patients randomized to treatment with Sapien 3/Sapien 3 Ultra or Myval/Myval Octacor THVs in the COMPARE-TAVI 1 trial.
Methods and Results
In this prespecified multicentre substudy, 387 patients undergoing TAVI at three Danish sites were enrolled. Of these, 327 patients (84.5%) underwent phase-contrast CMR one-month post-TAVI. Haemodynamic performance, including ARF and EOA, was compared between Sapien 3/Sapien 3 Ultra, Myval, and Myval Octacor THVs. Aortic regurgitation (AR) was classified according to Valve Academic Research Consortium 3 (VARC-3) criteria. First-generation Myval showed higher rates of VARC-3 categorical AR and greater absolute median ARF compared with Sapien THVs (ARF 7% [IQR 5-11] vs. 5% [3-8]; p=0.004). In contrast, second-generation Myval Octacor exhibited significantly larger median EOA than Sapien THVs (1.8 cm2 [IQR 1.5-2.1] vs. 1.6 cm2 [1.4-1.9]; p=0.033) with comparable ARF. When pooling generations, Sapien had lower ARF than Myval THVs, while EOA did not differ significantly. Moderate or greater AR occurred in one patient (0.3%); the remainder had trace to mild-moderate AR.
Conclusion
CMR demonstrated only minor aortic regurgitation with both THV series, but lower ARF was observed with Sapien compared with first-generation Myval, whereas EOA was larger with second-generation Myval Octacor than with Sapien.