Transcatheter aortic valve replacement in heavily calcified aortic valve stenosis: a multicenter comparison
Year: 2025
Type: article
Study design: Observational Study
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.
Source: Clinical Research in Cardiology
Authors: M. Saad, H. Seoudy, K. Bramlage, P. Bramlage, J. C. Voran, T. Puehler, G. Lutter, A. Allali, M. Landt, J. Frank, O. Bisht, M. Salem, H. Wienemann, M. Adam, T. Zeus, V. Veulemans, S. Bleiziffer, T. K. Rudolph, D. Frank
Institutions: University Hospital Schleswig-Holstein, German Centre for Cardiovascular Research, IPPMed (Germany), Segeberger Kliniken, University of Cologne, University Hospital Cologne, Düsseldorf University Hospital, Heinrich Heine University Düsseldorf, Heart and Diabetes Center North Rhine-Westphalia
Language: English
Subfield: Cardiology and Cardiovascular Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,190
OpenAlex ID: W4408298235
