Cardiac implant registries 2006-2016: a systematic review and summary of global experiences

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.

Keywords: cardiac implant; high-risk device; implant registry; real-world.

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram of study selection. CRT, cardiac resynchronisation therapy; CIED, cardiovascular implantable electronic device; ICD, implantable cardioverter defibrillator; PM, pacemaker; TAVI, transcatheter aortic heart valve implantation.

Figure 2

Location of identified cardiac implant registries. CRT, cardiac resynchronisation therapy; CIED, cardiovascular implantable electronic device; ICD, implantable cardioverter defibrillator; PM, pacemaker; TAVI, transcatheter aortic heart valve implantation.