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Background <p>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.</p> Objectives <p>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.</p> Materials and methods <p>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.</p> Results <p>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 &lt; 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.</p> Conclusion <p>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.</p> Graphical Abstract <p></p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年3月10日

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  • 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

摘要

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.

Graphical Abstract