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引入跨导管大动脉装置批准的客观性能标准的考虑和建议

Stuart J Head1, Darren Mylotte2, Michael J Mack2

  • 1From Cardiothoracic Surgery (S.J.H., A.P.K.) and Cardiology (N.M.v.M.), Erasmus MC, Rotterdam, The Netherlands; Cardiology, University Hospital Galway, Ireland (D.M.); Baylor Health Care System, The Heart Hospital, Plano, TX (M.J.M.); Interventional Cardiology, McGill University Health Centre, Montreal, QC, Canada (N.P.); Cardiac Surgery, German Heart Centre Munich, Munich (N.P.); Interventional Vascular Therapy, Columbia University Medical Center, New York Presbyterian Hospital, New York (M.B.L.); and Cardiovascular Diseases, Mayo Clinic, Rochester, MN (D.R.H.). s.head@erasmusmc.nl.

Circulation
|May 25, 2016
PubMed
概括

客观的性能标准 (OPC) 可以简化美国的跨导管心脏门 (THV) 批准. 这一审查表明高风险患者的OPC,但随机试验对其他群体至关重要.

关键词:
大动脉大动脉狭窄症设备的批准心脏门假体植入通过导管更换大动脉

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