Valvular & structural heart disease
Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial
Authors' conclusion
Among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life.
Study context
- Population
- Women with small aortic annuli undergoing TAVR, Canada, Europe, Israel and USwomen of 716 in SMART
- Participants
- 621 women
- Comparison
- Self-expanding valve vs balloon-expandable valve in TAVR
- Self-expanding valve (SEV)n = 312
- Balloon-expandable valve (BEV)n = 309reference
- Primary endpoint
- Coprimary: death, disabling stroke or HF rehospitalization; and bioprosthetic valve dysfunction
- Follow-up
- 12 months
Methodological detailsmulticentre (83 centres)
- Multicentre (83 centres)
Primary result
As reported in the abstract
SEV
- Clinical end point
- 9.4%
- Bioprosthetic valve dysfunction
- 8.4%
BEV
- Clinical end point
- 11.8%
- Bioprosthetic valve dysfunction
- 41.8%
Clinical end point
SEV9.4%
BEV11.8%
Bioprosthetic valve dysfunction
SEV8.4%
BEV41.8%
SEV vs BEVAbsolute risk difference (95% CI)P value
Clinical end point
−2.3%(−7.2 to 2.5)
P = 0.35Bioprosthetic valve dysfunction
−33.4%(−40.4 to −26.4)
P < 0.001Secondary outcomes
Hemodynamics · 30 days and 12 months
- SEV: lower aortic valve gradients and larger effective orifice areas; less mild or greater aortic regurgitation at 12 months
Prosthesis-patient mismatch
- Significantly lower with SEVs, regardless of definition and BMI adjustment
Quality of life (VARC-3 ordinal measure)
- Better with SEVs
Original publication
Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli: Results From the SMART Randomized Clinical Trial. JAMA Cardiol. Published 1 December 2024. doi:10.
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