Tags

Type your tag names separated by a space and hit enter

Landscape of Cardiovascular Device Registries in the United States.
J Am Heart Assoc 2019; 8(11):e012756JA

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.

Authors+Show Affiliations

Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA. Harvard Medical School Boston MA.Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA. Harvard Medical School Boston MA.Harvard Medical School Boston MA. Program on Regulation, Therapeutics, and Law (PORTAL) Department of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women's Hospital Boston MA.Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA. Harvard Medical School Boston MA.Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology Beth Israel Deaconess Medical Center Boston MA. Harvard Medical School Boston MA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31433706

Citation

Rajan, Prashant V., et al. "Landscape of Cardiovascular Device Registries in the United States." Journal of the American Heart Association, vol. 8, no. 11, 2019, pp. e012756.
Rajan PV, Holtzman JN, Kesselheim AS, et al. Landscape of Cardiovascular Device Registries in the United States. J Am Heart Assoc. 2019;8(11):e012756.
Rajan, P. V., Holtzman, J. N., Kesselheim, A. S., Yeh, R. W., & Kramer, D. B. (2019). Landscape of Cardiovascular Device Registries in the United States. Journal of the American Heart Association, 8(11), pp. e012756. doi:10.1161/JAHA.119.012756.
Rajan PV, et al. Landscape of Cardiovascular Device Registries in the United States. J Am Heart Assoc. 2019 Jun 4;8(11):e012756. PubMed PMID: 31433706.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Landscape of Cardiovascular Device Registries in the United States. AU - Rajan,Prashant V, AU - Holtzman,Jessica N, AU - Kesselheim,Aaron S, AU - Yeh,Robert W, AU - Kramer,Daniel B, Y1 - 2019/06/01/ PY - 2019/8/22/entrez PY - 2019/8/23/pubmed PY - 2019/8/23/medline KW - post‐market surveillance KW - registry KW - systematic review SP - e012756 EP - e012756 JF - Journal of the American Heart Association JO - J Am Heart Assoc VL - 8 IS - 11 N2 - 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. SN - 2047-9980 UR - https://www.unboundmedicine.com/medline/citation/31433706/Landscape_of_Cardiovascular_Device_Registries_in_the_United_States L2 - http://www.ahajournals.org/doi/full/10.1161/JAHA.119.012756?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -