Evolution of carotid stenting: regulatory issues.
Although carotid angioplasty and stenting have been performed for more than 20 years, the regulations surrounding its performance have remained a controversial issue. Intervention in the cerebral vascular bed is the only area in which regulations have limited the applicability of interventional techniques to vascular disease. Whether or not this is the correct approach remains to be seen, but knowledge of the regulations and requirements surrounding the performance of carotid stenting are of paramount importance for those performing these procedures. A review of the regulations affecting everything from the institutions to the physicians performing these procedures, as outlined in this article, will be helpful in clarifying for physicians and institutions what is mandated before performing carotid intervention.
Clair
Daniel G
DG
Department of Vascular Surgery, Heart and Vascular Institute, Cleveland Clinic, Cleveland, OH 44195, USA. claird@ccf.org
D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000295:instrumentation / Q000331:legislation & jurisprudence*; D016893:Carotid Stenosis / Q000628:therapy*; D002983:Clinical Competence; D003406:Credentialing; D004869:Equipment Safety; D033161:Government Regulation; D006268:Health Facilities / Q000331:legislation & jurisprudence; D006291:Health Policy; D006801:Humans; D028701:Patient Rights; D017410:Practice Guidelines as Topic; D011787:Quality of Health Care / Q000331:legislation & jurisprudence*; D012042:Registries; D015607:Stents