Global Consortium of Cardiovascular Registries: Transcatheter Valve initiative

摘要 FDA对医疗器械上市后监督的愿景强调了国家和 国际注册中心和注册联盟为上市后活动提供关键证据。2011年5月， FDA和威尔康奈尔医学院（WCMC）的MDEPiNet科学与基础设施中心 康奈尔大学是FDA为支持其使命而建立的， 骨科注册中心（ICOR）是一个分布式研究和监测网络，重点关注安全性和 骨科植入物的有效性。2013年5月，FDA和中心发起了 国际心血管登记联合会（ICCR）是一项专注于植入式 瓣膜和经导管瓣膜技术。随着瓣膜疾病的外科治疗选择被 较新的微创手术，如经导管瓣膜置换术，关于特定器械的问题 性能、安全性和有效性在现实环境中仍然没有答案。我们建议实施 国际经导管瓣膜登记研究联盟（ICTVR）的一个创新框架， 心血管器械的上市后监督。我们的提议建立了一个全球协作网络 在经导管瓣膜登记系统中进行分析项目。治理模式 和研究项目是创新的，我们从ICOR获得的经验建立。书记官处 参与这一网络将确定证据方面的差距，协调相关数据， 以分布式方式分析数据的方法。威尔康奈尔医学院的经验， 15年，包括我们被指定为设备中心的教育和研究治疗（CERT） 医疗保健研究和质量机构（AHRQ）和MDEPiNet科学和基础设施 中心由FDA，将作为一个强大的基础上，我们将实施这一举措。在目标1中， 建议建立一个多国分布式TAVR研究网络，包括建立一个治理机制， 该机构的领导将监督新的研究方法的建立， 建立公私伙伴关系，解决利益攸关方的需求和可持续性问题。在目标2中 我们通过以下方式调整TAVR登记研究罕见终点和其他支持分布式研究的关键变量定义： 审查登记系统中的当前日期字段;然后总结、定义数据元素并确定其优先级，以便 在世界各地的登记处负责人之间就这些定义达成共识。在目标3中，我们将进行分析 ICTVR项目使用分布式研究方法，通过描述国际 实践模式，特定患者和手术特征之间的关联评价， 罕见的手术相关不良结局，并确定特定器械属性之间的相关性 以及住院和中期结果。

Abstract The FDA's vision for post-market surveillance of medical devices highlights the importance of national and international registries and registry consortia to provide key evidence for post-market activities. In May 2011 the FDA and the MDEpiNet Science & Infrastructure Center at Weill Cornell Medical College (WCMC) of Cornell University, which the FDA established to support its mission, launched the International Consortium of Orthopedic Registries (ICOR) as a distributed research and surveillance network focusing on safety and effectiveness of orthopedic implants. In May 2013, the FDA and the Center initiated the creation of the International Consortium of Cardiovascular Registries (ICCR) as a pioneering effort focusing on implantable valves and transcatheter valve technology. As surgical treatment options for valve disease are replaced by newer, less invasive procedures such as transcatheter valve replacement, questions about specific device performance, safety, and effectiveness remain unanswered in real-world settings. We propose implementation of International Consortium of Transcatheter Valve Registries (ICTVR) to develop an innovative framework for post-market surveillance of cardiovascular devices. Our proposal establishes a collaborative global network among transcatheter valve registries to conduct analytic projects within this consortium. The governance model and research projects are innovative and we build from the experience gained from ICOR. The registries participating in this network will identify gaps in evidence, harmonize relevant data and create innovative methodologies to analyze data in a distributed way. Weill Cornell Medical College's experience gained over the 15 years, including our designation as Device Center for Education and Research on Therapeutics (CERT) by the Agency for Healthcare Research and Quality (AHRQ) and as the MDEpiNet Science and Infrastructure Center by the FDA, will serve as a robust base upon which we will implement this initiative. In Aim 1 we propose to develop a multi-national distributive TAVR research network, this includes creating a governance structure whose leadership will oversee the creation of new methodological approaches for research and the establishment of public-private partnerships that will address stakeholder's needs and sustainability. In Aim 2 we align TAVR registry rare endpoint and other key variable definitions that support distributive research by reviewing current date fields in registries; then summarizing, defining, and prioritizing data elements in order to reach consensus on those definitions among registry leads around the world. In Aim 3 we will conduct analytic ICTVR projects using distributive research methods through the description of the variation in international practice patterns, the evaluation of the association between specific patient and procedural characteristics and rare procedure-related adverse outcomes, and determine the association between specific device attributes and in-hospital and mid-term outcomes.