Affiliation:
1. Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA
2. Harvard Medical School Boston MA
3. Program on Regulation, Therapeutics, and Law (PORTAL) Department of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital Boston MA
Abstract
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.
Publisher
Ovid Technologies (Wolters Kluwer Health)
Subject
Cardiology and Cardiovascular Medicine
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