Barold Helen S
Department of Cardiology, National Naval Medical Center, Bethesda, MD 20889, USA.
Card Electrophysiol Rev. 2003 Dec;7(4):443-6. doi: 10.1023/B:CEPR.0000023166.65777.6f.
The results of the MADIT II study have generated a great deal of controversy in the world of electrophysiology. Much of the controversy appears related to the sheer numbers of potential Implantable Cardioverter Defibrillator (ICD) implants and their potential cost to the healthcare system. Two federal regulatory agencies, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have been highly visible in discussions. The FDA approved the MADIT II indications for Guidant ICDs, while CMS covered a limited subset of the patients studied. This review explores some the issues surrounding the trial and the key participants in this discussion with emphasis on the role of the Food and Drug Administration (FDA) and how regulatory decisions may impact on clinical practice.
MADIT II研究的结果在电生理学领域引发了诸多争议。许多争议似乎与潜在的植入式心脏复律除颤器（ICD）植入数量及其对医疗保健系统的潜在成本有关。两个联邦监管机构，即食品药品监督管理局（FDA）和医疗保险与医疗补助服务中心（CMS），在相关讨论中备受关注。FDA批准了Guidant ICD的MADIT II适应症，而CMS仅涵盖了所研究患者中的有限子集。本综述探讨了围绕该试验的一些问题以及此次讨论中的关键参与者，重点关注食品药品监督管理局（FDA）的作用以及监管决策可能如何影响临床实践。
