TAVI reduced 30-day mortality by 34% (RR 0.66) and 30-day stroke by 30% (RR 0.70) compared to SAVR in low-risk severe aortic stenosis patients, but SAVR had a small 11% lower 1-year mortality risk (RR 1.11).
Meta-Analysis (n=48,210)
Yes
Does transcatheter aortic valve replacement improve mortality and stroke compared to surgical aortic valve replacement in low-risk patients with severe aortic stenosis?
In low-risk patients with severe aortic stenosis, TAVI offers early procedural safety advantages over SAVR, but is associated with higher risks of pacemaker implantation and paravalvular leak, and potentially higher 1-year mortality driven by observational data.
Effect estimate: 30-day mortality RR 0.66; 30-day stroke RR 0.70; 1-year mortality RR 1.11 (95% CI 30-day mortality 0.50–0.76; 30-day stroke 0.53–0.92; 1-year mortality 1.01–1.21)
The optimal revascularization strategy for low-risk patients with severe aortic stenosis (AS), transcatheter (TAVI) versus surgical aortic valve replacement (SAVR), remains a subject of ongoing debate, particularly regarding long-term outcomes. We aimed to synthesize the evidence on the comparative safety and efficacy of TAVI and SAVR in this population. We conducted a systematic review and meta-analysis, searching PubMed, Scopus, Web of Science, and Cochrane Library until March 2025. We included randomized controlled trials (RCTs) and comparative observational studies enrolling low-risk patients with severe AS. Primary outcomes were all-cause mortality and stroke, analyzed at different time points. Data were pooled using random-effects models, with subgroup analyses based on study design. Thirty studies, including 48,210 patients, were included. TAVI was associated with a significantly lower risk of 30-day mortality (Relative Risk RR 0.66, 95% CI 0.50–0.76) and 30-day stroke (RR 0.70, 95% CI 0.53–0.92). However, in the overall analysis, SAVR was favored for one-year mortality (RR 1.11, 95% CI 1.01–1.21), with equipoise in long-term follow-up. TAVI significantly reduced the risks of 30-day major bleeding (RR 0.38, 95% CI 0.21–0.70) and atrial fibrillation (RR 0.41, 95% CI 0.22–0.76). Conversely, TAVI was associated with a persistently higher risk of permanent pacemaker implantation (RR 2.44 at 30 days, 95% CI 1.76–3.40) and paravalvular leakage (RR > 5-fold at both 30 days and 1 year). In low-risk patients with severe AS, TAVI offers clear early procedural safety advantages, particularly regarding stroke, bleeding, and atrial fibrillation. While the overall analysis suggested a 30-day mortality benefit for TAVI and a 1-year mortality benefit for SAVR, these findings were driven principally by observational data and were not statistically significant in the subgroup of randomized controlled trials. These procedural benefits are counterbalanced by a persistently higher risk of permanent pacemaker implantation and paravalvular leakage with TAVI. The choice of intervention requires a nuanced, individualized approach through shared decision-making, weighing early recovery benefits against device-related risks and the divergence between trial and registry outcomes.
Fadl et al. (2026) conducted a meta-analysis in Low-risk adult patients (STS score <4% or Logistic Euro Score I <5% or Euro Score II <10%) with severe aortic stenosis (n=48,210). Transcatheter aortic valve implantation (TAVI) vs. Surgical aortic valve replacement (SAVR) was evaluated on All-cause mortality at 30 days and 1 year, and stroke at 30 days (30-day mortality RR 0.66; 30-day stroke RR 0.70; 1-year mortality RR 1.11, 95% CI 30-day mortality 0.50–0.76; 30-day stroke 0.53–0.92; 1-year mortality 1.01–1.21). TAVI reduced 30-day mortality by 34% (RR 0.66) and 30-day stroke by 30% (RR 0.70) compared to SAVR in low-risk severe aortic stenosis patients, but SAVR had a small 11% lower 1-year mortality risk (RR 1.11).