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Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp
Daijiro Tomii1, Bashir Alaour1, Dik Heg2
1Department of Cardiology, Cardiovascular Center, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.
Insights
In transcatheter aortic valve replacement (TAVR) for patients with excessive aortic calcification, balloon-expandable valves (BEV) showed higher annular rupture risk but lower paravalvular regurgitation. Self-expanding valves (SEV) had higher pacemaker implantation rates, with similar 5-year mortality for both.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomaterials Science
Background:
- Excessive aortic calcification poses risks for transcatheter aortic valve replacement (TAVR) periprocedural complications.
- Device performance differences in calcified aortic valves may impact long-term TAVR outcomes.
Purpose of the Study:
- Compare periprocedural and long-term outcomes of self-expanding (SEV) versus balloon-expandable (BEV) prostheses in TAVR patients with excess aortic calcification.
- Evaluate the safety and efficacy of different TAVR valve types in complex calcific aortic stenosis.
Main Methods:
- Prospective registry analysis of 1,345 patients with severe aortic stenosis and high aortic valve calcium volume (≥235 mm³).
- 1:1 propensity-matched analysis comparing CoreValve/Evolut SEV and SAPIEN BEV from August 2007 to June 2023.
- Assessment of procedural success, annular rupture, transprosthetic gradients, paravalvular regurgitation, pacemaker implantation, and mortality at 5 years.
Main Results:
- Procedural success was >85% in both groups; annular rupture was more frequent with BEV (2.2% vs. 0%, P=.030).
- SEV showed lower gradients (8.0 vs. 11.2 mmHg, P<.001) but higher mild/greater paravalvular regurgitation (69.7% vs. 58.1%, P=.008) and pacemaker implantation (22.6% vs. 15.5%, P=.001).
- No significant difference in 5-year mortality between SEV and BEV groups (45.1% vs. 50.2%, P=.173).
Conclusions:
- In TAVR with excessive calcification, BEV carries a higher risk of annular rupture, while SEV has higher rates of paravalvular regurgitation and pacemaker implantation.
- Both SEV and BEV demonstrate comparable 5-year mortality in patients with excessive aortic calcification undergoing TAVR.
- Choice of TAVR prosthesis in calcified aortic valves involves balancing risks of annular rupture, regurgitation, and conduction disturbances.
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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