Comparison of a novel self-expanding transcatheter heart valve with two established devices for treatment of degenerated surgical aortic bioprostheses

新型自膨胀式经导管心脏瓣膜与两种已建立的用于治疗退化性外科主动脉生物瓣膜的装置进行比较

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Abstract

AIMS: 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. METHODS AND RESULTS: 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. CONCLUSIONS: 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.

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