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Comparative Study
. 2025 Mar;114(3):405-415.
doi: 10.1007/s00392-025-02611-w. Epub 2025 Mar 10.

Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison

M Saad  1 , H Seoudy  2   3 , K Bramlage  4 , P Bramlage  4 , J C Voran  2   3 , T Puehler  3   5 , G Lutter  3   5 , A Allali  5 , M Landt  6 , J Frank  2   3 , O Bisht  2 , M Salem  2 , H Wienemann  7 , M Adam  7 , T Zeus  8 , V Veulemans  8 , S Bleiziffer  9 , T K Rudolph  9 , D Frank  2   3
Affiliations
Comparative Study

Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison

M Saad et al. Clin Res Cardiol. 2025 Mar.

Abstract

Background: Heavy calcifications in severe aortic stenosis (AS) pose a major challenge in patients undergoing transcatheter aortic valve replacement (TAVR). Only a few studies have addressed the performance of different transcatheter heart valves (THV) in this subgroup of patients.

Objectives: We aimed to investigate the outcomes of the self-expanding Medtronic CoreValve Evolut valve frame and the balloon-expandable Edwards SAPIEN-3/3 Ultra THV in this challenging patient population.

Materials and methods: This was a multicenter registry including a total of 1513 patients with heavily calcified AS undergoing TAVR. The primary endpoint was the incidence and degree of paravalvular leak (PVL) after TAVR. Secondary endpoints were post-implant hemodynamics as well as clinical endpoints according to the VARC-3 definitions.

Results: The CoreValve Evolut R but not the Evolut PRO showed significantly higher rates of PVL compared to the SAPIEN-3/3 Ultra (44.8% vs. 29.5% for mild PVL, p < 0.001), while there was no significant difference in ≥ moderate PVL between both groups (p = 0.399). The CoreValve Evolut R and Evolut PRO showed superior THV hemodynamics compared to the SAPIEN-3/3 Ultra group. These findings were confirmed in a propensity score-matched analysis. There were no significant differences regarding short-term outcomes including permanent pacemaker implantation and all-cause mortality between the three groups.

Conclusion: In patients with severely calcified AS, both CoreValve Evolut PRO and SAPIEN-3/3 Ultra THV showed lower rates of PVL than the CoreValve Evolut R. The self-expanding CoreValve platform had superior post-implant hemodynamics than the SAPIEN-3/3 Ultra system.

Keywords: Aortic valve stenosis; Calcification; Paravalvular leak; Transcatheter aortic valve replacement.

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Conflict of interest statement

Declarations. Conflict of interest: MS received honoraria for clinical support and consulting for both Medtronic and Edwards Lifesciences. DF has received honoraria from Medtronic and Edwards Lifesciences for consulting services and has received unrestricted research funding from Edwards Lifesciences. VV has received received consulting fees, travel expenses, or study honoraria from Medtronic, Edwards Lifesciences, and/or Boston Scientific. All other authors have no commercial or financial relationships that could be construed as a potential conflict of interest. Ethical approval: The study was conducted according to the guidelines of the Declaration of Helsinki, and approved by the local Ethics Committees of the participating centers.

Figures

Fig. 1
Fig. 1
A Medtronic Evolut R vs. SAPIEN-3/3 Ultra. B Medtronic Evolut PRO vs. SAPIEN-3/3 Ultra. C Medtronic Evolut R or PRO vs. SAPIEN-3/3 Ultra
See this image and copyright information in PMC

References

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