Bicuspid aortic valves represent a significant challenge in TAVR because of its anatomical complexity and the presence of important calcification. In addition, it more often affects young low-risk patients.
Estas válvulas no han sido incluidas en grandes estudios randomizados, y actualmente solo se dispone de registros con seguimiento a uno o dos años, sin datos a más largo plazo.
These valves have not been included in large randomized studies, and currently we only have one or two-year follow-up registries, and no long term data.
The Evolut Low Risk Bicuspid included 150 low risk patients with aortic stenosis for bicuspid valve
Primary outcome was all cause death or disabling stroke.
Mean patient age was 70, 48% were women and mortality STS was 1.3%. 74.7% of patients presented hypertension, 24.7% diabetes, 17.7% COPD, 4% had suffered MI, 7.3% had prior PCI and 1.3% prior CABG, 6.7% had had a stroke, 9.3% had peripheral vascular disease, 7.3% atrial fibrillation, and 2.7% definite pacemaker or AICD.
Ejection fraction was 63%, mean gradient 50 mmHg and aortic valve area 0.5 cm².
Sievert type I was the most frequent (90.7%, with right-left fusion, 78% being the most common, followed by right-non-coronary fusion with 19.9%, and left- non-coronary was the less frequent with 1.5%). Type 0 represented 9.3%, and there were no Type 2.
1,2 and 3-year primary outcomes were 1.3% (95% CI: 0.3%-5.3%), 3.4% (95% CI: 1.4%-8.1%) and 4.1% (95% CI: 1.6%-10.7%) respectively.
All-cause mortality at 1,2 and 3 years was 0.7% (95% CI: 0.1%-4.7%), 2.1% (95% CI: 0.7%-6.3%) and 2.8% (95% CI: 0.8%-9.1%) respectively, disabling stroke 0.7% (95% CI: 0.1%-4.8%), 1.4% (95% CI: 0.3%-5.6%) and 2.1% (95% CI: 0.5%-8.3%).
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Cardiovascular mortality at 1 and 3 years was 1.4% (95% CI: 0.2%-7.6%) and 4.9% (95% CI: 2.0%-11.8%) respectively.
Need for definite pacemaker implantation was 19.4% at 3 years and incidence of endocarditis, valve thrombosis and hospitalization for cardiac failure was low.
Echocardiographic analysis at 3 years showed 9.1 mmHg gradient, 2.2 cm² aortic valve area and there were no moderate or severe leaks.
All patients saw improved functional class and quality of life.
Conclusion
At 3-year follow-up, Estudio Evolut Low Risk Bicuspid outcomes showed low all-cause mortality or disabling stroke rates and favorable hemodynamic profile.
Original Title: 3-Year Outcomes From the Evolut Low Risk TAVR Bicuspid Study.
Reference: Firas Zahr, et al. JACC Cardiovasc Interv 2024;17:1667–1675.
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