Division of Applied Regulatory Science, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Adv Exp Med Biol. 2018;1065:107-121. doi: 10.1007/978-3-319-77932-4_7.
When enough females and males are enrolled in clinical trials, much more relevant information is available on potential sex differences in device safety and effectiveness. Unfortunately, females have largely been underrepresented in clinical studies of cardiac medical device therapies for heart failure. In this chapter, sex differences in heart failure characteristics and cardiac electrophysiology and their influence on the safety, effectiveness, and application of implantable cardioverter defibrillators (ICDs), subcutaneous ICDs (S-ICDs), and cardiac resynchronization therapy (CRT) will be discussed. In this way, the research community will hopefully become more appreciative of the potential differences in device effects between females and males.
当足够多的女性和男性被纳入临床试验时，就可以获得更多关于器械安全性和有效性方面潜在性别差异的相关信息。不幸的是，在心力衰竭心脏医疗器械治疗的临床研究中，女性的代表性严重不足。在本章中，将讨论心力衰竭特征和心脏电生理学方面的性别差异，以及它们对植入式心脏复律除颤器（ICD）、皮下 ICD（S-ICD）和心脏再同步治疗（CRT）的安全性、有效性和应用的影响。希望通过这种方式，研究界能够更加重视器械对女性和男性的潜在影响差异。
