The Hydra CE has shown favorable one year efficacy for the new transcatheter aortic valve model, with large effective orifice and low transvalvular gradient associated to an acceptable complications rate. With this study, the Hydra will obtain the CE mark and go after FDA approval (just as all new devices).
This study looked at safety and performance of the new Hydra valve to treat severe aortic stenosis in high or extreme surgical risk patients.
Hydra presents a repositionable self-expanding system with supra-annular bovine pericardial leaflets. This emulates the big majority of self-expanding models currently available, as well as those to come.
The study included 157 patients (79.2 ± 7.1 mean age and 4.7 ± 3.4% STS) with 94.3% successful implantation.
At 30 días, mortality was 7%, including 5.7% cardiovascular deaths; 3.2% were device related.
There was significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg). These figures were maintained for a year.
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Moderate to severe paravalvular leak was observed in 6.3% of patients at 30 days and in 6.9% 1 year. This differs from the observed trend of the rest of self-expanding valves, which tend to show leak improvement at one year.
Pacemaker implantation rate was 11.7% at 30 days and 12.4% at one year.
Conclusion
This study aiming at obtaining the CE mark, has shown favorable efficacy for the new Hydra, with excellent hemodynamic results and acceptable complications rate.
Original Title: 30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.
Reference: Audrius Aidietis et al. JACC Cardiovasc Interv. 2022 Jan 10;15(1):93-104. doi: 10.1016/j.jcin.2021.09.004.
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