First-in-man study of transcatheter aortic valve implantations in aortic stenosis using the Hydra self-expanding bioprosthesis

Suphot Srimahachota, Wacin Buddhari, et al
AsiaIntervention 2017;3:177-182, DOI: 10.4244/AIJ-D-17-00007

Abstract
Aims: The aim of this study was to document the initial experience with transcatheter aortic valve implantations with the Hydra self-expanding aortic bioprosthetic valve.

Methods and results: Implantation of the Hydra aortic valve was performed in patients with symptomatic, severe aortic stenosis at the King Chulalongkorn Memorial Hospital, Thailand. Surgical treatment was deferred based on Heart Team assessment of an estimated high surgical risk. The Hydra valve was implanted in 15 patients with mean STS score 6.2%, mean age 82 years, mean aortic valve area 0.68 cm2, mean aortic pressure gradient 49 mmHg. All procedures were performed under general anaesthesia. Percutaneous transfemoral access was used in 13 patients, whereas the remainder had a transaxillary approach. There was one procedural death due to a major vascular complication. At 30-day follow-up, the median aortic valve area and pressure gradient were 1.53 cm2 and 9 mmHg, respectively. The prevalence of more than mild paravalvular leakage and new permanent pacemaker implantation was 7.7% and 14.3%, respectively. No patient suffered from stroke or TIA.

Conclusions: The Hydra aortic bioprosthetic valve is useful for transcatheter treatment of severe aortic stenosis. Initial results indicate a high haemodynamic performance and complication rates similar to those reported for second-generation transcatheter aortic bioprostheses.

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