Key result
Self-expanding valves show comparable 5-year mortality to balloon-expandable valves despite differing procedural complications.
Why the study?
Excessive aortic cusp calcification increases periprocedural complications after TAVR, and differences in device performance may affect long-term outcomes.
Do self-expanding transcatheter heart valves compared to balloon-expandable valves improve periprocedural and long-term outcomes in patients with severe aortic stenosis and excessive aortic valve cusp calcification?
Cohort (n=1,345)
No
Do self-expanding transcatheter heart valves compared to balloon-expandable valves improve periprocedural and long-term outcomes in patients with severe aortic stenosis and excessive aortic valve cusp calcification?
Answers are grounded in this paper and cite their sources.
In patients with severe aortic stenosis and excessive cusp calcification undergoing TAVR, self-expanding and balloon-expandable valves have comparable 5-year mortality but differing periprocedural complication profiles.
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.
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Tomii et al. (2025) conducted a cohort in Severe aortic stenosis with excessive aortic valve cusp calcification (n=1,345). Self-expanding transcatheter heart valves (SEV) vs. Balloon-expandable transcatheter heart valves (BEV) was evaluated on Mortality at 5 years (p=0.173). Self-expanding valves had comparable 5-year mortality to balloon-expandable valves (45.1% vs 50.2%, P=0.173), with lower annular rupture risk but higher pacemaker and regurgitation risks.
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