Key result
Self-expanding TAVR valves lower gradients vs. balloon-expandable valves but carry ~40% higher pacemaker risk.
Why the study?
Self-expanding valves (SEV) and balloon-expandable valves (BEV) are the two major platforms for transcatheter aortic valve replacement (TAVR) in severe aortic stenosis, but their comparative clinical and hemodynamic performance remained uncertain.
Does transcatheter aortic valve replacement with self-expanding valves improve permanent pacemaker implantation rates and mean pressure gradient compared to balloon-expandable valves in patients with severe aortic stenosis?
Meta-Analysis (n=21,609)
Does transcatheter aortic valve replacement with self-expanding valves improve permanent pacemaker implantation rates and mean pressure gradient compared to balloon-expandable valves in patients with severe aortic stenosis?
In patients undergoing TAVR for severe aortic stenosis, self-expanding valves offer superior hemodynamic performance with lower pressure gradients and less prosthesis-patient mismatch, but carry higher risks of pacemaker implantation, paravalvular leakage, and all-cause mortality compared to balloon-expandable valves.
Abstract: Transcatheter aortic valve replacement (TAVR) is an established treatment for severe aortic stenosis, with self-expanding valves (SEV) and balloon-expandable valves (BEV) representing the two major platforms. However, their comparative clinical and hemodynamic performance remains uncertain. We systematically searched four electronic databases through August 202 6 for studies comparing SEV and BEV in patients undergoing TAVR. The primary outcomes were permanent pacemaker implantation (PPI) and change in mean pressure gradient (MPG), while secondary outcomes included all-cause mortality, major adverse cardiovascular events (MACE), stroke, paravalvular leakage (PVL), heart failure hospitalization, coronary obstruction, and prosthesis-patient mismatch (PPM). Twenty-three studies involving 21,60 9 patients were included. Compared with BEV, SEV was associated with a significantly greater reduction in MPG (MD −4. 48 , 95% CI −5.29 to −3.67; P < 0.0001) and lower risks of moderate (RR 0.56, 95% CI 0.42–0.75) and severe PPM (RR 0.33, 95% CI 0.25–0.44). Conversely, SEV was associated with higher risks of PPI (RR 1.40, 95% CI 1.14–1.72; P < 0.0001), moderate-to-severe PVL (RR 2.28, 95% CI 1.65–3.14; P < 0.0001), and a small but significant increase in all-cause mortality. No significant differences were observed in MACE, stroke, heart failure hospitalization, or coronary obstruction..
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Elazab et al. (2026) conducted a meta-analysis in Severe aortic stenosis (n=21,609). Self-expanding valves (SEV) for TAVR vs. Balloon-expandable valves (BEV) for TAVR was evaluated on Permanent pacemaker implantation (PPI) and change in mean pressure gradient (MPG) (RR 1.40 (for PPI); MD -4.48 (for MPG), 95% CI 1.14-1.72 (for PPI); -5.29 to -3.67 (for MPG), p=<0.0001). Self-expanding valves reduced mean pressure gradient more than balloon-expandable valves (MD -4.48; P<0.0001) but increased permanent pacemaker implantation risk (RR 1.40; 95% CI 1.14-1.72).
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