Pre- and post-dilatation practices in transcatheter aortic valve implantation using self-expanding valves: a systematic review and meta-analysis

Abstract Background Transcatheter aortic valve implantation (TAVI) is a standard treatment for symptomatic severe aortic stenosis (AS). Pre-implantation balloon aortic valvuloplasty (BAV) is routinely performed to prepare the device landing zone and facilitate TAVI expansion, but concerns have arisen regarding its association with haemodynamic instability, permanent pacemaker (PPM) implantation, and cerebrovascular accidents (CVA). Similarly, balloon post-dilatation (BPD) aims to improve expansion of an implanted transcatheter heart valve (THV), reduce paravalvular leaks (PVL) and optimize haemodynamic result. BPD has however been linked to higher risks of CVA, mortality, and bioprosthetic leaflets damage, which impairs durability. These concerns have led to a shift toward TAVI techniques avoiding both BAV and BPD. More recently, THV malexpansion with self-expanding valves (SEV) has been associated with adverse clinical outcomes. Given conflicting evidence, this systematic review evaluates the available literature on the impact of BAV and BPD during TAVI with SEVs. Purpose This systematic review and meta-analysis assesses clinical outcomes of BAV or BPD compared to no balloon dilatation in TAVI with SEVs. Methods A systematic search was conducted across PubMed, Embase, Cochrane Library, and Scopus databases. Studies reporting clinical and echocardiographic outcomes of adult patients undergoing SEV TAVI for AS, comparing BAV or BPD with no balloon dilatation, were included. Random effects meta-analysis with HKSJ adjustment was used to analyse pooled odds ratios for key TAVI outcomes. Results Eight studies (6 observational, 2 randomised) with 4699 patients, were included for BAV, and six observational studies with 8902 patients were included for BPD. Of these, 3560 patients (75.8%) underwent BAV and 2181 patients (24.5%) underwent BPD. In the BAV meta-analysis, no significant differences were found across all key outcomes between BAV and no BAV. However, when considering only randomised studies, BAV was associated with reduced odds of requiring BPD (OR 0.43; 95% CI 0.42–0.43). In contrast, BPD was linked to higher odds of 30-day mortality (OR 1.32; 95% CI 1.15–1.52), myocardial infarction (MI) (OR 1.25; 95% CI 1.02–1.54), and PVL2+ (OR 3.65; 95% CI 2.59–5.15) compared to no BPD. All BPD studies were observational, with inherent selection bias, as operators decided on BPD based on clinical need, considering THV performance factors like significant PVL, incomplete THV expansion, and elevated THV gradients. Neither BAV nor BPD was associated with increased risk of CVA or PPM implantation. Conclusions In patients undergoing SEV TAVI, BAV was not associated with higher risks of adverse outcomes compared to no BAV. Randomised data suggest BAV reduces the odds of requiring BPD. BPD was associated with increased odds of 30-day mortality, MI, and PVL2+, though these findings are based on observational data and may be influenced by selection bias.