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.
- cardiac implant
- high-risk device
- implant registry
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Contributors PLK-R provided substantial contributions to conception and design; SZ drafted the articles with acquisition of data, analysis and interpretation of data; SG revised the manuscript critically for important intellectual content; PLK-R made the final approval of the version to be published. The guarantor is PLK-R.
Funding The research is supported by the German Federal Ministry of Education and Research (BMBF), project grant no: 13EX1013B, as part of the National Leading-Edge Cluster Medical Technologies ‘Medical Valley EMN’. The present work was performed in (partial) fulfilment of the requirements for obtaining the degree “Dr. rer. biol. hum.” at the Medical Faculty of Friedrich-Alexander University of Erlangen-Nürnberg.
Competing interests None declared.
Patient consent Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional data are available.
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