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

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. Graphical abstract

Antithrombotic Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation

“…The U.S. CoreValve [31] trial enrolled patients with severe aortic stenosis considered to be at increased surgical risk, and randomized to TAVI with the self-expanding [32] transcatheter valve (TAVI group) or to surgical aortic-valve replacement (surgical group) from 2011 to 2012. Similarly, DAPT with aspirin and clopidogrel was initiated before TAVI and recommended for 3 months afterward, followed by monotherapy with either aspirin or clopidogrel.…”

Antithrombotic Therapy in Patients Undergoing Transcatheter Aortic Valve Implantation

“…The U.S. CoreValve [31] trial enrolled patients with severe aortic stenosis considered to be at increased surgical risk, and randomized them to receive either TAVI with the selfexpanding [32] transcatheter valve (TAVI group) or a surgical aortic valve replacement (surgical group) from 2011 to 2012. Similarly, DAPT with aspirin and clopidogrel was initiated before TAVI and recommended for 3 months afterward, followed by monotherapy with either aspirin or clopidogrel.…”