Article ; Online: Comparison of a novel self-expanding transcatheter heart valve with two established devices for treatment of degenerated surgical aortic bioprostheses.
Clinical research in cardiology : official journal of the German Cardiac Society
2023 Volume 113, Issue 1, Page(s) 18–28
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 ... ...
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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MeSH term(s) | Humans ; Female ; Male ; Transcatheter Aortic Valve Replacement/methods ; Bioprosthesis ; Retrospective Studies ; Heart Valve Prosthesis ; Treatment Outcome ; Aortic Valve/surgery ; Aortic Valve Stenosis/surgery ; Prosthesis Design ; Terfenadine/analogs & derivatives |
Chemical Substances | fexofenadine (E6582LOH6V) ; Terfenadine (7BA5G9Y06Q) |
Language | English |
Publishing date | 2023-04-05 |
Publishing country | Germany |
Document type | Journal Article |
ZDB-ID | 2213295-8 |
ISSN | 1861-0692 ; 1861-0684 |
ISSN (online) | 1861-0692 |
ISSN | 1861-0684 |
DOI | 10.1007/s00392-023-02181-9 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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