Key result
Pre-dilatation BAV shows no 30-day mortality benefit over direct TAVR but reduces post-dilatation need.
Why the study?
Pre-dilatation balloon aortic valvuloplasty and post-dilatation facilitate delivery and valve expansion in SEV-TAVI, but both may increase procedural complications.
Does pre-dilatation or post-dilatation improve clinical and procedural outcomes compared to direct implantation or as-deployed strategies in patients undergoing TAVI with self-expanding valves?
Meta-Analysis (n=31,669)
Yes
Does pre-dilatation or post-dilatation improve clinical and procedural outcomes compared to direct implantation or as-deployed strategies in patients undergoing TAVI with self-expanding valves?
Odds Ratio: 1.17 (95% CI 0.71–1.93)
Pre-dilatation in SEV-TAVI appears safe and may reduce the need for subsequent post-dilatation, whereas post-dilatation is associated with worse outcomes that are likely driven by baseline confounding by indication.
Supports omitting routine pre-dilatation in SEV-TAVI; extends RCT evidence favoring direct implantation for procedural efficiency.
Introduction: Pre-dilatation balloon aortic valvuloplasty (PRE-BAV) and post-dilatation (POST-DIL) are commonly used during transcatheter aortic valve implantation with self-expanding valves (SEV-TAVI) to facilitate device delivery and optimize valve expansion, but both may increase procedural complications. Methods: We conducted a systematic review and meta-analysis to evaluate outcomes associated with PRE-BAV and POST-DIL compared with direct implantation (DIRECT) and valves left as deployed (AS-DEPLOYED), respectively. Eleven studies (nine observational, two randomised; 24,143 patients) were included for PRE-BAV and five observational studies (7,526 patients) for POST-DIL. Key outcomes included mortality, stroke, permanent pacemaker implantation, and moderate or greater paravalvular leak (PVL2+). Random-effects meta-analyses with Hartung-Knapp-Sidik-Jonkman adjustment were used to estimate pooled odds ratios (ORs) with 95% confidence intervals (CIs). Results: Compared with DIRECT, PRE-BAV was not associated with differences in mortality, stroke, pacemaker implantation, or PVL2+, but randomised data showed a reduced need for POST-DIL (OR 0.43; 95% CI 0.24-0.74). Compared with AS-DEPLOYED, observational series suggested that POST-DIL was linked to higher 30-day mortality (OR 1.39; 95% CI 1.18-1.63), increased PVL2+ (OR 3.76; 95% CI 2.13-6.63), and more frequent surgical conversion (OR 1.22; 95% CI 1.06-1.41), with no differences in stroke or pacemaker implantation. Discussion: PRE-BAV was not associated with increased adverse outcomes and may reduce the need for post-dilatation, whereas the adverse outcomes observed with POST-DIL in observational studies are most likely explained by confounding by indication rather than a causal effect. Further adequately powered randomised trials are needed to define the optimal balloon dilatation strategy in SEV-TAVI. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024610604.
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Soh et al. (2026) conducted a meta-analysis in Aortic stenosis undergoing transcatheter aortic valve implantation with self-expanding valves (n=31,669). Pre-dilatation balloon aortic valvuloplasty (PRE-BAV) and post-dilatation (POST-DIL) vs. Direct implantation (DIRECT) and valves left as deployed (AS-DEPLOYED) was evaluated on 30-day mortality (PRE-BAV vs DIRECT) (OR 1.17, 95% CI 0.71-1.93). Pre-dilatation balloon aortic valvuloplasty was not associated with differences in 30-day mortality (OR 1.17) compared to direct implantation, but reduced the need for post-dilatation in randomized trials.
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