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Published on: August 8, 2025
Isolated Transcatheter and Surgical Aortic Valve Replacement in the Evolut Low-Risk Trial: 5-Year Comparative
Basel Ramlawi1, G Michael Deeb2, Steven J Yakubov3
1Department of Cardiovascular Surgery, Lankenau Heart Institute, Philadelphia, Pennsylvania.
Insights
Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) show similar 5-year survival and reintervention rates in low-risk patients. TAVR had higher pacemaker needs, but paravalvular regurgitation was comparable.
Area of Science:
- Cardiology
- Cardiovascular Surgery
- Medical Devices
Background:
- Severe aortic stenosis necessitates valve replacement.
- Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are primary treatment options.
- Low-risk patient populations are increasingly candidates for TAVR.
Purpose of the Study:
- To compare the 5-year clinical and echocardiographic outcomes of isolated TAVR versus isolated SAVR in low-risk patients.
- To evaluate the safety and efficacy of TAVR compared to SAVR in a low-risk cohort.
- To assess long-term results including mortality, stroke, reintervention, and valve function.
Main Methods:
- Post hoc analysis of the Evolut Low Risk Trial.
- Inclusion of 1,164 low-risk patients who underwent isolated TAVR (667) or SAVR (497).
- Exclusion of patients with concomitant procedures or treatment arm crossover.
Main Results:
- At 5 years, the composite of all-cause mortality or disabling stroke was similar: 15.5% for TAVR vs. 14.6% for SAVR (P=.84).
- All-cause mortality (13.5% vs. 12.8%) and cardiovascular mortality (6.9% vs. 8.3%) were comparable.
- New permanent pacemaker implantation was significantly higher with TAVR (27.3% vs. 8.9%, P<.001).
- Aortic valve reintervention rates (3.0% vs. 2.2%, P=.51) and moderate/greater paravalvular regurgitation (0.5% vs. 0%, P=.52) were similar.
Conclusions:
- Isolated TAVR and SAVR demonstrate comparable 5-year outcomes regarding mortality, reintervention, and paravalvular regurgitation in carefully selected low-risk patients.
- Evolut TAVR is a suitable option for isolated valve replacement in this population.
- Higher rates of pacemaker implantation with TAVR require consideration in patient selection.
Background:
This study aimed to compare the 5-year outcomes of patients who underwent isolated transcatheter aortic valve replacement (TAVR) vs patients who underwent isolated surgical aortic valve replacement (SAVR) from the Evolut Low Risk trial.
Methods:
In the Evolut Low Risk trial, 1414 low-risk patients with severe aortic stenosis underwent TAVR using a self-expanding, supraannular CoreValve, Evolut R, or PRO bioprosthesis (Medtronic) or SAVR. This post hoc analysis excluded 250 patients, those with concomitant procedures (eg, percutaneous coronary intervention and coronary artery bypass grafting) and those who experienced crossover between treatment arms. The 5-year clinical and echocardiographic outcomes are reported.
Results:
A total of 1164 patients underwent an isolated procedure (667 TAVR, 497 SAVR). At 5 years, the composite of all-cause mortality or disabling stroke was similar between the isolated groups (15.5% TAVR, 14.6% SAVR; P = .84). All-cause mortality (13.5% TAVR, 12.8% SAVR; P = .85) and cardiovascular mortality (6.9% TAVR, 8.3% SAVR; P = .36) were also comparable. New permanent pacemaker implantation was higher with TAVR (27.3% vs 8.9%; P < .001). The 5-year rate of aortic valve reintervention was 3.0% for TAVR and 2.2% for SAVR (P = .51). Moderate or greater paravalvular regurgitation occurred in 0.5% of TAVR patients and none of the SAVR patients (P = .52) at 5 years.
Conclusions:
This post hoc analysis of the Evolut Low Risk trial in patients undergoing isolated TAVR or SAVR demonstrates similar rates of all-cause mortality, reintervention, and moderate or greater paravalvular regurgitation at 5 years, supporting Evolut TAVR as a suitable treatment option in carefully selected low-risk patients undergoing isolated valve replacement.
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