Cardiac implant registries 2006-2016: a systematic review and summary of global experiences
Zhang S, Gaiser S, Kolominsky-Rabas P (2018)
Publication Type: Journal article
Publication year: 2018
Journal
Book Volume: 8
Journal Issue: 4
DOI: 10.1136/bmjopen-2017-019039
Abstract
OBJECTIVES: The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in postmarket surveillance has been recognised and approved, but there is lack of consensus standards on how to establish a CIR. The aim of this study is to investigate the structure and key elements of CIRs in the past decade (2006-2016) and to provide recommendations on 'best practice' approaches. SETTINGS AND PARTICIPANTS: A systematic search on CIR was employed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect and the Scopus database, EMBASE. After identifying the existing CIRs, an aggregative approach will be used to explore key elements emerging in the identified registries. RESULTS: The following 82 registries were identified: 18 implantable cardioverterdefibrillator (ICD) registries, 7 cardiac resynchronisation therapy (CRT) registries, 5 pacemaker registries and 6 cardiovascular implantable electronic device registries which combined ICD, pacemaker and CRT implantation data; as well as 22 coronary stent registries and 24 transcatheteraortic heart valve implantation registries. While 71 national or local registries are from a single country, 44 are from European countries and 9 are located in USA. The following criteria have been summarised from the identified registries, including: registry working group, ethic issues, transparency, research objective, inclusion criteria, compulsory participation, endpoint, sample size, data collection basement, data collection methods, data entry, data validation and statistical analysis. CONCLUSIONS: Registries provide a 'real-world' picture for patients, physicians, manufacturers, payers, decision-makers and other stakeholders. CIRs are important for regulatory decisions concerning the safety and therefore approval issues of the medical device; for payers CIRs provide evidence on the medical device benefit and drive the decision whether the product should be reimbursed or not; for hospitals CIRs' data are important for sound procurement decisions, and CIRs also help patients and their physicians to joint decision-making which of the products is the most appropriate.
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APA:
Zhang, S., Gaiser, S., & Kolominsky-Rabas, P. (2018). Cardiac implant registries 2006-2016: a systematic review and summary of global experiences. BMJ Open, 8(4). https://dx.doi.org/10.1136/bmjopen-2017-019039
MLA:
Zhang, Shixuan, Sebastian Gaiser, and Peter Kolominsky-Rabas. "Cardiac implant registries 2006-2016: a systematic review and summary of global experiences." BMJ Open 8.4 (2018).
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