Carotid angioplasty and stenting in the elderly

描述（由申请人提供）：每年约有100,000名美国老年人接受颈动脉内膜切除术（CEA）以降低中风和死亡的风险。该手术需要一个开放的外科切口，可能有很大的发病率和死亡率风险。颈动脉成形术和支架植入术（CAS）是替代CEA的一种有前景的创新方法，这是一种微创的血管内手术，对高危患者可能特别有益。自2004年获得美国食品和药物管理局（FDA）的初步批准以来，CAS的使用在美国迅速普及。尽管人们对这种方法的热情越来越高，但关于其在“现实世界”中的使用和结果的数据有限。例如，目前尚不清楚CAS是否主要用于高危患者作为CEA的替代品，或者是否用于可能根本没有接受过治疗的患者。此外，使用CAS的选择也可能受到执行CAS的内科专家类型的严重影响。CAS不仅由血管外科医生执行，也由介入性心脏病专家和放射科医生执行，这些医生传统上不参与CEA或一般的中风护理。正如其他心血管手术的研究表明，医生的专业和经验可能是手术使用和患者结果的重要决定因素。提高对这些问题的理解将对临床医生、政策制定者和支付者产生重要影响。事实上，医疗保险和医疗补助服务中心（CMS）最近考虑对目前CAS的全国覆盖决定进行实质性修改。CMS的讨论不仅集中在扩大该手术的可能适应症上，而且限制了可以确定任何个体患者是否适合该手术的医师专家的类型。在此背景下，我们建议研究两个相关的具体目标。具体目标1将检查CAS在美国医疗保健市场的传播。具体目标2将评估老年人CAS的实际结果。对于本提案，我们将使用国家医疗保险数据（2004-2007），并对医生专业和经验在使用CAS和结果中的作用特别感兴趣。我们希望我们的研究结果将为决策者、支付者、提供者和患者提供信息，以确定这一创新程序的作用。公共卫生相关性：每年约有10万名患有严重颈动脉狭窄的美国老年人接受颈动脉内膜切除术（CEA），以降低中风和死亡的风险。颈动脉成形术和支架植入术（CAS）是替代CEA的一种很有前途的创新方法，但人们对这种微创手术在现实世界中的应用和结果知之甚少。我们预计，这项研究的发现将为这两个领域增添新的知识，并帮助决策者、支付者、提供者和患者努力确定CAS在预防中风和死亡方面的最佳作用。

DESCRIPTION (provided by applicant): Each year approximately 100,000 elderly Americans undergo carotid endarterectomy (CEA) to reduce their risk of stroke and death. This procedure involves an open surgical incision and may be associated with substantial risks of morbidity and mortality. A promising and innovative alternative to CEA is carotid angioplasty and stenting (CAS), a minimally-invasive, endovascular procedure that may be of particular benefit in high-risk patients. Since its initial approval by the Food and Drug Administration (FDA) in 2004, the use of CAS has disseminated rapidly across the United States. Despite growing enthusiasm for this procedure, data on its use and outcomes in the "real-world" are limited. It is unknown, for example, whether CAS is being used mostly as a substitute for CEA in high- risk patients or if it is being performed in patients who might otherwise not have been treated at all. Moreover, the choice to use CAS may also be heavily influenced by which types of physician specialists are performing it. CAS is performed not just by vascular surgeons, but by interventional cardiologists and radiologists - physicians not traditionally involved with CEA or stroke care in general. As suggested by research in other cardiovascular procedures, physician specialty and experience could be important determinants of procedure use, as well as patient outcomes. An improved understanding of these issues would have important implications for clinicians, policy- makers, and payers. Indeed, the Centers for Medicare & Medicaid Services (CMS) recently considered substantial modifications to its current national coverage decision for CAS. Discussions by CMS centered not only on expanding the possible indications for this procedure, but restricting the types of physician specialists who could determine its appropriateness in any individual patient. In this context, we propose to study two-related specific aims. Specific Aim 1 will examine the dissemination of CAS in healthcare markets across the United States. Specific Aim 2 will assess real- world outcomes of CAS in the elderly. For this proposal, we will use national Medicare data (2004-2007) and are particularly interested in the role of physician specialty and experience in use and outcomes of CAS. We anticipate our findings will inform policy-makers, payers, providers, and patients struggling to determine the role of this innovative procedure. PUBLIC HEALTH RELEVANCE: Each year approximately 100,000 elderly Americans with severe carotid artery stenosis undergo carotid endarterectomy (CEA) to reduce their risk of stroke and death. A promising and innovative alternative to CEA is carotid angioplasty and stenting (CAS), but little is known about the (1) use and (2) outcomes of this minimally-invasive procedure in the real world. We anticipate that findings from this study will add new knowledge to both these areas and help inform policy-makers, payers, providers and patients struggling to determine the optimal role of CAS in preventing stroke and death.