INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support): a new paradigm for translating registry data into clinical practice.
INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support): a new paradigm for translating registry data into clinical practice.
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INTERMACS（机械辅助循环支持机构间登记处）：将登记数据转化为临床实践的新范例。
DOI：
10.1016/j.jacc.2010.05.021
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发表时间：
2010
影响因子：
24
通讯作者：
J. T. Baldwin
中科院分区：
文献类型：
--
作者：
Marissa A. Miller;K. Ulisney;J. T. Baldwin
来自NHLBI的结果清楚地表明，与接受最佳医疗管理的患者相比，心室辅助装置治疗对终末期心力衰竭患者具有临床意义的生存获益和生活质量改善（5）。尽管有受益，但REMATCH试验中与器械使用相关的死亡率和不良事件突出表明，需要了解治疗对预期患者人群的影响，并密切监测器械性能和临床结局。随着器械技术的发展，预期这些改进将降低不良事件的风险，改善这些患者的生活质量，并提高其他患者的康复潜力（6，7）。由于MCS器械的性质和改善结局的愿望，对植入MCS器械的患者进行登记研究是合理的。大约20年前，当医学研究所（IOM）建议NHLBI将MCS器械接受者的登记作为"该护理的常规方面"时，就预见到了这种登记的必要性（8）。IOM基于患者对设备的依赖性以及长期益处和缺点的不确定性认识到这一需求。2003年，医疗保险和医疗补助服务中心（CMS）意识到了对这种登记的迫切需要。当时，在决定涵盖目标治疗时，CMS要求任何接受心室辅助装置作为目标治疗的患者都应进入国家稽查登记系统。由于对MCS器械注册的明确和专业披露的需求，NHLBI于2004年发布了一份关于终末期心力衰竭机械循环支持机构间注册的提案请求。登记研究的总体预期是，它将有助于促进对MCS的理解和应用，以改善晚期心力衰竭患者的死亡率、发病率和健康状况。招标的结果是2005年5月授予伯明翰亚拉巴马大学的竞争性合同（9），以建立和管理被称为INTERMACS（机械辅助循环支持机构间登记处）。自2006年6月注册启动以来，INTERMACS已成为接受FDA批准的耐用MCS器械治疗晚期心力衰竭患者的国家注册中心。INTERMACS的具体目标包括：1）收集和传播有助于改善患者选择和接受MCS器械的患者临床管理的质量数据; 2）推进现有和下一代器械的开发和监管; 3）实现心力衰竭和恢复研究（9，10）。截至2010年1月1日，INTERMACS有超过100家参与医院，超过2,000名患者进入登记，超过90%的数据报告和表格完整性（11）。INTERMACS是MCS临床医生、科学家、制造商和联邦合作伙伴共同努力的结果。涉及的3个联邦合作伙伴是：1）NHLBI，负责资助和监督登记; 2）FDA，负责监管MCS器械; 3）CMS，负责报销MCS器械的使用。利益攸关方在合同的第一年通过迭代过程合作制定标准定义、数据元素和数据收集时间点。这些程序和标准对于确保2006年6月开始的准确、及时和全面的数据收集是必要的。因此，INTERMACS已成为一个严格的工具，可以帮助制定指南和改善临床实践。
fromNHLBI results clearly demonstrated a clinically meaningful survival benefit and an improved quality of life with ventricular assist device therapy in end-stage heart failure patients as compared with those receiving optimal medical management (5). Despite the benefits, the mortality and adverse events associated with device use in the REMATCH trial highlighted the need to understand the implications of the therapy for the intended patient population and to monitor device performance and clinical outcomes closely over time. As device technology evolves, improvements are expected to reduce the risk of adverse events and to improve quality of life in these patients and enhance the potential for recovery in others (6, 7). Because of the nature of MCS devices and the desire to improve outcomes, a registry for patients who receive MCS devices is well justified. The need for such a registry was envisioned almost 2 decades ago when the Institute of Medicine (IOM) recommended that NHLBI maintain a registry of MCS device recipients as a “routine aspect of this care”(8). The IOM recognized this need based on patients’ dependence on the devices and the uncertainty of the long-term benefits and drawbacks. The immediate need for such a registry was realized in 2003 by the Centers for Medicare and Medicaid Services (CMS). At that time, in their decision to cover destination therapy, the CMS required that any patient who received a ventricular assist device as destination therapy should be entered into a nationally audited registry. With the clear and publically disclosed need for a MCS device registry, NHLBI issued a Request for Proposals in 2004 for an Interagency Registry of Mechanical Circulatory Support for End-Stage Heart Failure. The overall expectation of the registry was that it would help to advance the understanding and application of MCS to improve the mortality, morbidity, and health status in patients with advanced heart failure. The result of the solicitation was a competitive contract awarded in May 2005 to the University of Alabama at Birmingham (9) to establish and manage what has become known as the INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support). Since the registry’s launch in June 2006, INTERMACS has become the national registry of patients receiving FDA-approved durable MCS devices to treat advanced heart failure. Specific objectives of INTERMACS include: 1) collecting and disseminating quality data that help to improve patient selection and clinical management of patients receiving MCS devices; 2) advancing the development and regulation of existing and nextgeneration devices; and 3) enabling research into heart failure and recovery (9, 10). As of January 1, 2010, INTERMACS had more than 100 participating hospitals, more than 2,000 patients entered into the registry, and more than 90% data reporting and completeness of forms (11). INTERMACS resulted from the cooperative efforts of MCS clinicians, scientists, manufacturers, and federal partners. The 3 federal partners involved are: 1) the NHLBI, which funds and oversees the registry; 2) the FDA, which regulates MCS devices; and 3) the CMS, which reimburses for MCS device use. The stake holders worked cooperatively to develop standard definitions, data elements, and data collection time points through an iterative process over the first year of the contract. These processes and standards were necessary to assure accurate, timely, and comprehensive data collection, which began in June 2006. As a result, INTERMACS has become a rigorous tool that is well positioned to help develop guidelines and improve clinical practice …
影响因子：
158.5
作者：
Rose, EA;Gelijns, AC;Meier, P
通讯作者：
Meier, P
国家心肺血液研究所心血管科学校外部门。
影响因子：
24
作者：
Lauer,MichaelS;Skarlatos,SoniaI;Bild,DianeE
通讯作者：
Bild,DianeE