Alexandru Stan, Ayman Elkahlout, Marius Mihai Harpa, Marian Pop, Mihaly Veres, Antonela Delia Stan, Paul-Adrian Călburean, Anda-Cristina Scurtu, Klara Brînzaniuc, Horatiu Suciu
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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], <i>p</i> = 0.03), pre-dilatation did not influence mortality (HR = 0.71[0.48-1.04], <i>p</i> = 0.08), and post-dilatation significantly increased mortality (HR = 1.51[1.05-2.19], <i>p</i> = 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 (<i>p</i> = 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 (<i>p</i> = 0.06), which was independent of the transprosthetic gradient. 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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], <i>p</i> = 0.03), pre-dilatation did not influence mortality (HR = 0.71[0.48-1.04], <i>p</i> = 0.08), and post-dilatation significantly increased mortality (HR = 1.51[1.05-2.19], <i>p</i> = 0.03). 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引用次数: 0
摘要
本研究的主要目的是比较重度主动脉瓣狭窄患者经导管主动脉瓣植入术(TAVI)的长期疗效,重点研究自扩张瓣膜(SEV)与球囊扩张瓣膜(BEV)假体的差异,以及球囊扩张前后对临床结果的影响。次要目的是报告罗马尼亚TAVI术后的长期结果。2016年11月至2025年5月期间在罗马尼亚三级中心接受严重AS TAVI手术的所有患者均纳入本研究。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%)行术前扩张,189例(26.9%)行术后扩张。每100名患者年的全因死亡率和心血管原因死亡率分别为10.5和7.8。单变量Cox回归分析显示,BEV的死亡率显著低于SEV (HR = 0.67[0.46-0.96], p = 0.03),扩张前不影响死亡率(HR = 0.71[0.48-1.04], p = 0.08),扩张后显著增加死亡率(HR = 1.51[1.05-2.19], p = 0.03)。多变量Cox回归分析显示,扩张前和瓣膜平台对患者的生存无影响,而扩张后患者的死亡率有升高的趋势(p = 0.06)。BEV和SEV具有相似的生存率,在大量的TAVI平台中没有异质性。虽然扩张前对死亡率没有影响,但扩张后与死亡率增加的趋势相关(p = 0.06),这与经假体梯度无关。罗马尼亚TAVI后的生存率与西方国家的记录相当。
Impact of Pre- and Post-Dilatation on Long-Term Outcomes After Self-Expanding and Balloon-Expandable TAVI.
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.
期刊介绍:
Journal of Functional Biomaterials (JFB, ISSN 2079-4983) is an international and interdisciplinary scientific journal that publishes regular research papers (articles), reviews and short communications about applications of materials for biomedical use. JFB covers subjects from chemistry, pharmacy, biology, physics over to engineering. The journal focuses on the preparation, performance and use of functional biomaterials in biomedical devices and their behaviour in physiological environments. Our aim is to encourage scientists to publish their results in as much detail as possible. Therefore, there is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. Several topical special issues will be published. Scope: adhesion, adsorption, biocompatibility, biohybrid materials, bio-inert materials, biomaterials, biomedical devices, biomimetic materials, bone repair, cardiovascular devices, ceramics, composite materials, dental implants, dental materials, drug delivery systems, functional biopolymers, glasses, hyper branched polymers, molecularly imprinted polymers (MIPs), nanomedicine, nanoparticles, nanotechnology, natural materials, self-assembly smart materials, stimuli responsive materials, surface modification, tissue devices, tissue engineering, tissue-derived materials, urological devices.