Impact of Pre- and Post-Dilatation on Long-Term Outcomes After Self-Expanding and Balloon-Expandable TAVI.

Abstract

The main objective of this study was to compare the long-term outcomes of transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis, focusing on differences between self-expanding valve (SEV) versus balloon-expandable valve (BEV) prostheses and the influence of balloon pre- and post-dilatation on clinical results. The secondary objective was to report the long-term outcomes after TAVI in Romania. All patients who underwent a TAVI procedure for severe AS between November 2016 and May 2025 at a tertiary center in Romania were included in the present study. A total of 702 patients were included, of which 455 (64.8%) and 247 (35.1%) patients received a BEV (Sapien3 platform) and a SEV (Accurate, Boston, Portico, Evolut, or Navitor platforms), respectively. Pre-dilatation was performed in 514 (73.2%) cases, and post-dilatation was performed in 189 (26.9%) cases. There were 10.5 and 7.8 all-cause and cardiovascular-cause mortality event rates per 100 patient years, respectively. In regard to the univariable Cox regression, a BEV has significantly lower mortality than an SEV (HR = 0.67[0.46-0.96], p = 0.03), pre-dilatation did not influence mortality (HR = 0.71[0.48-1.04], p = 0.08), and post-dilatation significantly increased mortality (HR = 1.51[1.05-2.19], p = 0.03). In regard to the multivariable Cox regression, survival was not influenced by pre-dilatation or the valve platform, while post-dilatation had a trend towards higher mortality (p = 0.06). The BEV and SEV have similar survival rates, with no heterogeneity among a large number of TAVI platforms. While pre-dilatation had no impact on mortality, post-dilatation was associated with a trend towards increased mortality (p = 0.06), which was independent of the transprosthetic gradient. Survival after TAVI in Romania is comparable to that reported in Western registries.