Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp calcification
Daijiro Tomii, Bashir Alaour, Dik Heg, Taishi Okuno, Masaaki Nakase, Daryoush Samim, Fabien Praz, Jonas Lanz, Stefan Stortecky, David Reineke, Stephan Windecker, Thomas Pilgrim
Abstract
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 with excessive cusp calcification undergoing TAVR, 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 = .030). SEV had a lower transprosthetic gradient (8.0 mmHg vs 11.2 mmHg, P < .001) but higher rates of mild or greater paravalvular regurgitation (69.7% vs 58.1%, P = .008) and new permanent pacemaker implantation (22.6% vs 15.5%, P = .001). At 5 years, there was no statistically significant difference in mortality between groups (45.1% vs 50.2%, P = .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.