This study was performed to compare haemodynamic properties of a novel transcatheter heart valve (THV) with two established valve technologies for treatment of failing surgical aortic bioprosthetic valves (SAV). The ALLEGRA THV has been recently described with a proven safety and performance profile.
The study was designed as a retrospective, single-centre study investigating 112 patients (77.7 ± 7.1 years, 53.8% female, STS score 6.8 ± 5.8% and logEuroSCORE I 27.4 ± 16.1%) with failing SAV. Patients were treated with the ALLEGRA THV (NVT, n = 24), the CoreValve/EvolutR (MTD, n = 64) or the Edwards Sapien/Sapien XT/Sapien 3 (EDW, n = 24). Adverse events, haemodynamic outcomes and patient safety were analysed according to VARC-3 definitions. Overall procedural success was high (94.6%), even though 58.9% of the treated SAV were classified as small (true inner diameter < 21 mm). After treatment, the mean pressure gradient was significantly reduced (baseline: 33.7 ± 16.5 mmHg, discharge: 18.0 ± 7.1 mmHg), with a corresponding increase in effective orifice area (EOA). The complication rates did not differ in between groups. There was a trend to lower mean transvalvular gradients after implantation of self-expanding THV with supra-annular valve function, despite a higher frequency of smaller SAVs in the NVT and MTD group. Additionally, comparison between NVT and MTD revealed statistically lower transvalvular gradients (NVT 14.9 ± 5.0 mmHg, MTD 18.7 ± 7.5 mmHg, p = 0.0295) in a subgroup analysis.
Valve-in-valve (ViV) treatment of failing SAV with supra-annular design like the ALLEGRA THV resulted in favourable haemodynamic outcomes with similar low clinical event rates and may therefore be an interesting alternative for VIV TAVI.
The online version contains supplementary material available at 10.1007/s00392-023-02181-9.
这项研究是为了比较新的经导管心脏瓣膜(THV)的血液动力学特性与两种已建立的阀门技术,用于治疗失败的手术主动脉生物植物瓣膜(SAV)。
该研究被设计为一项回顾性单中心研究,研究了112名患者(77.7±7.1岁,女性53.8%,STS得分为6.8±5.8%,Logeuroscore I 27.4±16.1%,患者使用了aledgra thv(nvt thv,n = 24),n = 24)。 /sapien 3(edw,n = 24)。根据VARC-3的定义分析了不良事件,血液动力学结局和患者的安全性。 ifice区域(EOA)在组之间没有差异。 7.5 mmhg, p = 0.0295)在亚组分析中。
阀内阀(VIV)治疗失败的SAV上的超隔nular设计(如Allegra Thv)导致有利的血液动力学结果,其临床事件率相似,因此对于VIV TAVI来说可能是一个有趣的替代方法。
在线版本包含的补充材料可获得10.1007/S00392-023-02181-9。