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

M Saad1, H Seoudy2,3, K Bramlage4

  • 1Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Arnold-Heller-Str.3, Haus K3, 24105, Kiel, Germany. mohammed.saad@uksh.de.

Clinical Research in Cardiology : Official Journal of the German Cardiac Society
|March 10, 2025
PubMed

Insights

In patients with severe aortic stenosis and heavy calcifications, the CoreValve Evolut PRO and SAPIEN-3/3 Ultra transcatheter heart valves demonstrated lower paravalvular leak rates than the CoreValve Evolut R. The CoreValve platform also offered superior hemodynamics.

Area of Science:

  • Cardiovascular Medicine
  • Interventional Cardiology
  • Medical Devices

Background:

  • Severe aortic stenosis (AS) with heavy calcifications presents challenges for transcatheter aortic valve replacement (TAVR).
  • Limited data exists on transcatheter heart valve (THV) performance in this specific patient subgroup.

Purpose of the Study:

  • To compare outcomes of the self-expanding Medtronic CoreValve Evolut (Evolut R and Evolut PRO) and balloon-expandable Edwards SAPIEN-3/3 Ultra THV.
  • To evaluate THV performance in patients with heavily calcified severe AS undergoing TAVR.

Main Methods:

  • A multicenter registry of 1513 patients with heavily calcified AS undergoing TAVR.
  • Primary endpoint: incidence and degree of paravalvular leak (PVL).
  • Secondary endpoints: post-implant hemodynamics and clinical outcomes (VARC-3 definitions).

Main Results:

  • CoreValve Evolut R showed higher mild PVL rates than SAPIEN-3/3 Ultra (44.8% vs. 29.5%). No significant difference in ≥ moderate PVL.
  • CoreValve Evolut R and PRO demonstrated superior post-implant hemodynamics compared to SAPIEN-3/3 Ultra.
  • No significant differences in permanent pacemaker implantation or all-cause mortality among the groups.

Conclusions:

  • CoreValve Evolut PRO and SAPIEN-3/3 Ultra THV exhibited lower PVL rates than CoreValve Evolut R in heavily calcified AS.
  • The self-expanding CoreValve platform provided superior post-implant hemodynamics compared to SAPIEN-3/3 Ultra.
Abstract

Keywords:
Aortic valve stenosisCalcificationParavalvular leakTranscatheter aortic valve replacement

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