Key result
TAVR yields larger valve areas and less mismatch than SAVR, but increases aortic regurgitation.
Why the study?
The study was conducted to compare echocardiographic findings in patients with critical aortic stenosis following surgical or transcatheter aortic valve replacement.
Does TAVR improve echocardiographic outcomes compared to SAVR in high surgical risk patients with severe aortic stenosis?
RCT (n=699)
Blinded core laboratory analysis
1:1 ratio, stratified by feasibility of transapical or transfemoral access
Yes
Does TAVR improve echocardiographic outcomes compared to SAVR in high surgical risk patients with severe aortic stenosis?
TAVR provides comparable intermediate-term hemodynamic durability to SAVR, with larger effective orifice areas but higher rates of paravalvular regurgitation.
Objectives To compare echocardiographic findings in patients with critical aortic stenosis following surgical (SAVR) or transcatheter aortic valve replacement (TAVR Background The Placement of Aortic Transcatheter Valves trial randomized patients 1:1 to SAVR or TAVR Methods Echocardiograms were obtained at baseline, discharge, 30 days, 6 months, 1 year, and 2 years post procedure and analyzed in a core laboratory. For the analysis of post-implant variables, the first interpretable study (≤ 6 mos) was used. Results Both groups showed a decrease in aortic valve gradients and increase in effective orifice area (EOA) (p < 0.0001) which remained stable over 2 years. Compared to SAVR, TAVR resulted in: larger indexed EOA (p = 0.038), less prosthesis-patient mismatch (p = 0.019), and more total and paravalvular aortic regurgitation (AR) (p < 0.0001). Baseline echocardiographic univariate predictors of death were: lower peak transaortic gradient in TAVR patients; low left ventricular diastolic volume (LVDV), low stroke volume, and greater severity of mitral regurgitation in SAVR patients. Post-implantation echocardiographic univariate predictors of death were: larger LVDV, systolic volume (LVSV) and EOA, decreased ejection fraction, and greater AR in TAVR patients; smaller LVSV and LVDV, low stroke volume, smaller EOA and prosthesis-patient mismatch in SAVR patients. Conclusions Patients randomized to either SAVR or TAVR experience enduring, significant reductions in transaortic gradients and increase in EOA. Compared to SAVR, TAVR patients had higher indexed EOA, lower prosthesis-patient mismatch and more AR. Univariate predictors of death for the TAVR group and SAVR groups differed and may allow future refinement in patient selection.
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Hahn et al. (2013) conducted an RCT in Severe, symptomatic aortic stenosis in high surgical risk patients (n=699). Transcatheter aortic valve replacement (TAVR) vs. Surgical aortic valve replacement (SAVR) was evaluated on Indexed effective orifice area (EOA) (p=0.038). Compared to SAVR, TAVR resulted in larger indexed effective orifice area (p=0.038), less prosthesis-patient mismatch (p=0.019), and more total and paravalvular aortic regurgitation (p<0.0001) over 2 years.
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