Self-Expanding Versus Balloon-Expandable Transcatheter Heart Valves in Patients with Excessive Aortic Valve Cusp Calcification.
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BORIS DOI
Publisher DOI
PubMed ID
40975195
Description
Background
Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.Objectives
To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.Methods
Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.Results
Among 1,345 patients, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, p=0.030). SEV had a lower transprosthetic gradient (8.0 mmHg vs. 11.2 mmHg, p <0.001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs. 58.1%, p=0.008) and new permanent pacemaker implantation (22.6% vs. 15.5%, p=0.001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs. 50.2%, p=0.173).Conclusions
In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.Clinical Trial Registration
https://www.Clinicaltrials
gov. NCT01368250.
Excessive aortic cusp calcification increases the risk of periprocedural complications after transcatheter aortic valve replacement (TAVR). Differences in device performance in patients with excessive calcification may affect long-term clinical outcomes.Objectives
To compare periprocedural and long-term outcomes between self-expanding (SEV) and balloon-expandable (BEV) prostheses in patients with excess cusp calcification undergoing TAVR.Methods
Consecutive patients with severe aortic stenosis and aortic valve complex calcium volume ≥235 mm³ (on contrast images with Hounsfield unit threshold of 850) who underwent TAVR with either CoreValve/Evolut SEV or SAPIEN BEV from August 2007 to June 2023 were included from a prospective-single center registry. A 1:1 propensity-matched analysis was performed to account for baseline differences between groups.Results
Among 1,345 patients, 271 matched pairs were identified. Procedural success was achieved in >85% of patients with no difference between groups. Annular rupture occurred more frequently with BEV compared to SEV (2.2% vs 0%, p=0.030). SEV had a lower transprosthetic gradient (8.0 mmHg vs. 11.2 mmHg, p <0.001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs. 58.1%, p=0.008) and new permanent pacemaker implantation (22.6% vs. 15.5%, p=0.001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs. 50.2%, p=0.173).Conclusions
In patients with excessive leaflet calcification undergoing TAVR, BEV had a higher risk of annular rupture, but a lower risk of paravalvular regurgitation, and a lower risk of permanent pacemaker implantation compared to SEV. Mortality was comparable between SEV and BEV throughout 5 years of follow-up.Clinical Trial Registration
https://www.Clinicaltrials
gov. NCT01368250.
Date of Publication
2026-02
Publication Type
Article
Language(s)
en
Contributor(s)
Alaour, Bashir | |
Nakase, Masaaki |
Series
American Heart Journal
Publisher
Elsevier
ISSN
1097-6744
0002-8703
Access(Rights)
open.access