Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Women With Severe Aortic Stenosis: The RHEIA Trial.

BACKGROUND

In the RHEIA (Randomized Research in Women All Comers With Aortic Stenosis) trial, the incidence of the primary end point of death, stroke, or rehospitalization at 1 year was lower with transcatheter aortic valve implantation (TAVI) than with surgical aortic valve replacement. The objective of this substudy was to compare echocardiographic findings in women with severe aortic stenosis following surgical aortic valve replacement or TAVI.

METHODS

At 48 European centers, 443 women underwent randomization 1:1, and 420 were treated as randomized. Echocardiograms were available in 356 patients and were analyzed by a core laboratory.

RESULTS

Rates of or greater moderate paravalvular regurgitation was low (<1%) and similar between groups. At 30 days, TAVI was associated with higher mean transprosthetic gradient and smaller aortic valve area, but the rate of severe patient-prosthesis mismatch (3.0 versus 2.6%; P=1) was low and not different between groups. Valve hemodynamics were stable at 1 year. The rate of residual left ventricular hypertrophy (45.3 versus 28.6%; P=0.004) at 1 year was significantly higher with TAVI, whereas the rate of right ventricular systolic dysfunction (14.5 versus 40.7%; P<0.001) and evolution of cardiac damage stage (improved in 21.8 versus 18.1%; worsened in 16.8 versus 47.0%; P=0.001) were better with TAVI.

CONCLUSIONS

Among women with severe aortic stenosis, both TAVI and surgical aortic valve replacement achieve excellent valve hemodynamic results with low and similar rates of moderate or greater paravalvular regurgitation or severe patient-prosthesis mismatch. Surgical aortic valve replacement was associated with lower gradients and more pronounced regression of left ventricular hypertrophy, whereas TAVI was associated with better right ventricular systolic function and evolution of cardiac damage stage.

REGISTRATION: URL: https://clinicaltrials.gov/study/NCT04160130; Unique Identifier: NCT04160130.