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Revista chilena de cardiología

versión On-line ISSN 0718-8560

Resumen

MALUENDA, Gabriel et al. Clinical results of percutaneous aortic valve replacement using the MyVal prosthesis in patients with severe aortice stenosis and hisgh surgical risk. Rev Chil Cardiol [online]. 2020, vol.39, n.3, pp.237-246. ISSN 0718-8560.  http://dx.doi.org/10.4067/S0718-85602020000300237.

Background:

The recently approved balloon expandable MyVal (Meril Life Sciences, India) transcatheter aortic valve replacement (TAVR) prosthesis is available for commercial use in Chile and the European Union. The aim of this study is to provide early and mid-term data on the safety and efficacy of patients with severe aortic stenosis (AS) at high surgical risk undergoing TAVR using the MyVal device. Methods: All patients with symptomatic severe AS at high surgical risk undergoing intended TAVR with MyVal prosthesis at San Borja-Arriarán Hospital entered to a retrospective registry.

Results:

Between October 2018 and November 2019, 14 patients entered to the registry. The mean age was 82.5±7.8 years-old with a high-surgical riskprofile (mean STS score of 11.6±5.1% for 30-day mortality). Device and procedural success were achieved in 12 patients (86%) with substantial decrease in the mean aortic gradient, persistent at 6 months follow-up, all with mild or trace aortic regurgitation. Device failure occurred in 2 patients, one due to failed delivery and other due to device embolization into the left ventricle, which resulted in patient death. There were one death attributed aortic dissection/rupture and two major bleeding episodes. Three patients receiving MyVal implant required the implantation of a permanent pacemaker (23%).

Conclusion:

The present registry rises a question upon the safety of the MyVal TAVR device in high-risk AS. However, once a successfully implant was achieved the MyVal prosthesis showed an adequate performance to mid-term follow-up.

Palabras clave : Aortic stenosis; Transcatheter aortic valve replacement; Registry.

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