Balloon-expandable valve vs. self-expandable valve for small aortic annuli: a GRADE-assessed systematic review and updated meta-analysis.

The risk of new permanent pacemaker implantation was similar between balloon-expandable valves and self-expandable valves in patients with small aortic annuli.

• OR = 1.03, 95% CI: 0.67–1.59, P = 0.89
• Analysis included 14 studies comprising 8451 patients (4797 BEV, 3654 SEV)
• Random-effects meta-analysis was used to pool odds ratios
• Certainty of evidence was rated as moderate using the GRADE approach

Balloon-expandable valves were associated with a near-significant increase in moderate or greater paravalvular leak compared to self-expandable valves.

• OR = 1.39, 95% CI: 1.00–1.93, P = 0.05
• The result did not reach conventional statistical significance (P < 0.05) but trended toward higher risk with BEV
• This was one of the two primary outcomes of the meta-analysis
• Certainty of evidence was rated as moderate

There was no significant difference in severe prosthesis-patient mismatch between balloon-expandable valves and self-expandable valves.

• OR = 0.61, 95% CI: 0.27–1.37, P = 0.23 for severe PPM
• OR = 0.78, 95% CI: 0.45–1.38, P = 0.40 for moderate/severe PPM
• Both comparisons were non-significant
• Random-effects models were used

Mean indexed effective orifice area did not differ significantly between balloon-expandable valves and self-expandable valves.

• MD = -0.01, 95% CI: -0.12 to 0.11, P = 0.93
• This was a secondary hemodynamic outcome
• Analysis was based on the pooled data from 14 included studies

Mean transvalvular gradients showed no significant difference between valve types, though self-expandable valves showed a trend toward lower gradients.

• MD = -0.91 mmHg, 95% CI: -3.38 to 1.57, P = 0.47
• The trend toward lower gradients with SEV did not reach statistical significance
• This was a secondary hemodynamic outcome assessed in the meta-analysis

The systematic review and meta-analysis included 14 studies with 8451 patients undergoing TAVR for small aortic annuli.

• 4797 patients received balloon-expandable valves and 3654 received self-expandable valves
• Studies were identified through a comprehensive electronic search of PubMed, Embase, Scopus, and other databases up to July 2025
• Data extraction and quality assessment followed Cochrane and PRISMA guidelines
• The GRADE approach was used to assess certainty of evidence, rated as moderate across most outcomes