Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA.
Harvard Medical School Boston MA.
J Am Heart Assoc. 2019 Jun 4;8(11):e012756. doi: 10.1161/JAHA.119.012756. Epub 2019 Jun 1.
Background Regulators increasingly rely on registries for decision making related to high-risk medical devices in the United States. However, the limited uniform standards for registries may create substantial variability in registry implementation and utility to regulators. We surveyed the current landscape of US cardiovascular device registries and chart the extent of inconsistency in goals, administration, enrollment procedures, and approach to data access. Methods and Results A systematic review using Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines identified studies (1995-2017) referencing cardiovascular device registries with a US-based institution. Registries were then evaluated by reviewing associated articles and websites. Extracted data included device type, primary scientific aim(s), funding, stewardship (eg, administration of registry procedures), enrollment procedures, informed consent process, and mechanisms to access data for research. The 138 cardiovascular device registries in the cohort covered devices addressing interventional cardiology (65.9%), arrhythmias (15.2%), heart failure (10.1%), and valvular disease (10.1%). While the majority (55.8%) were industry-funded, stewardship was predominantly overseen by academic centers (74.0%). Most registry participation was voluntary (77.5%), but a substantial minority (19.7%) were required as a condition of device implantation. Informed consent requirements varied widely, with written consent required in only 55.1% of registries. Registry data were primarily accessible only to stewards (84.1%), with 13.8% providing pathways for external applications. Conclusions The majority of cardiovascular device registries were funded privately under the auspices of academic institutions, which set the rules for data access. The substantial variation between cardiovascular device registries suggests a role for regulators to further strengthen guidelines to improve quality, consistency, and ethical standards.
背景
监管机构越来越依赖注册系统来为美国高风险医疗器械的决策提供依据。然而，注册系统缺乏统一标准，可能会导致实施和对监管机构的应用存在巨大差异。我们调查了美国心血管设备注册系统的现状，并绘制了目标、管理、登记程序和数据获取方法不一致的程度图。
方法和结果
采用系统评价首选报告项目（PRISMA）指南进行系统综述，确定了（1995 年至 2017 年）提到美国机构的心血管设备注册系统的研究。然后通过审查相关文章和网站对注册系统进行评估。提取的数据包括设备类型、主要科学目标、资金、管理（例如，注册程序的管理）、登记程序、知情同意程序以及用于研究的数据访问机制。队列中的 138 个心血管设备注册系统涵盖了介入心脏病学（65.9%）、心律失常（15.2%）、心力衰竭（10.1%）和瓣膜病（10.1%）的设备。虽然大多数（55.8%）是由行业资助的，但管理主要由学术中心负责（74.0%）。大多数登记参与是自愿的（77.5%），但相当一部分（19.7%）是作为设备植入的条件。知情同意要求差异很大，只有 55.1%的登记系统需要书面同意。注册系统的数据主要只能由管理者访问（84.1%），有 13.8%的注册系统为外部应用提供了途径。
结论
大多数心血管设备注册系统都是在学术机构的主持下由私人资助的，这些机构制定了数据访问规则。心血管设备注册系统之间存在很大差异，这表明监管机构有必要进一步加强指导方针，以提高质量、一致性和道德标准。
