Stan Alexandru, Elkahlout Ayman, Harpa Marius Mihai, Pop Marian, Veres Mihaly, Stan Antonela Delia, Călburean Paul-Adrian, Scurtu Anda-Cristina, Brînzaniuc Klara, Suciu Horatiu
Doctoral School, George Emil Palade University of Medicine, Pharmacy, Science and Technology of Târgu Mureş, 540142 Târgu Mureş, Romania.
Department of Interventional Cardiology, Emergency Institute for Cardiovascular Diseases and Transplantation, 540136 Târgu Mureș, Romania.
J Funct Biomater. 2025 Aug 1;16(8):282. doi: 10.3390/jfb16080282.
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], = 0.03), pre-dilatation did not influence mortality (HR = 0.71[0.48-1.04], = 0.08), and post-dilatation significantly increased mortality (HR = 1.51[1.05-2.19], = 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 ( = 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 ( = 0.06), which was independent of the transprosthetic gradient. Survival after TAVI in Romania is comparable to that reported in Western registries.
本研究的主要目的是比较严重主动脉瓣狭窄患者经导管主动脉瓣植入术（TAVI）的长期疗效，重点关注自膨胀瓣膜（SEV）与球囊扩张瓣膜（BEV）假体之间的差异以及球囊预扩张和后扩张对临床结果的影响。次要目的是报告罗马尼亚TAVI术后的长期疗效。本研究纳入了2016年11月至2025年5月期间在罗马尼亚一家三级中心因严重主动脉瓣狭窄接受TAVI手术的所有患者。共纳入702例患者，其中455例（64.8%）和247例（35.1%）患者分别接受了BEV（Sapien3平台）和SEV（Accurate、Boston、Portico、Evolut或Navitor平台）。514例（73.2%）病例进行了预扩张，189例（26.9%）病例进行了后扩张。每100患者年的全因死亡率和心血管病因死亡率分别为10.5和7.8。在单变量Cox回归分析中，BEV的死亡率显著低于SEV（HR = 0.67[0.46 - 0.96]，P = 0.03），预扩张不影响死亡率（HR = 0.71[0.48 - 1.04]，P = 0.08），而后扩张显著增加死亡率（HR = 1.51[1.05 - 2.19]，P = 0.03）。在多变量Cox回归分析中，生存率不受预扩张或瓣膜平台的影响，而后扩张有死亡率升高的趋势（P = 0.06）。BEV和SEV的生存率相似，大量TAVI平台之间无异质性。虽然预扩张对死亡率无影响，但后扩张与死亡率升高趋势相关（P = 0.06），这与跨瓣压差无关。罗马尼亚TAVI术后的生存率与西方登记处报告的生存率相当。
