OP04 Cardiac Implant Registries: Systematic Review Of Global Practices

Abstract

Introduction:

The importance of Cardiac Implant Registry (CIR) for ensuring a long-term follow-up in post-marked surveillance has been recognized and approved, but there is a 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.

Methods:

A systematic search on CIR was employed in line with the PRISMA guidelines. The following databases were searched: the PubMed (Medline), ScienceDirect, EMBASE and the Scopus database. After identifying the existing CIR, an inductive approach was used to explore key elements emerging in the identified registries.

Results:

The following eighty-two registries were identified: eighteen ICD registries, seven CRT registries, five pacemaker registries, and six Cardiovascular Implantable Electronic Device (CIED) registries which combined ICD, pacemaker and CRT implantation data; as well as twenty-two coronary stent registries and twenty-four TAVI registries. While seventy-one national or local registries are from a single country, forty-four are from European countries, and nine are located in USA. The following criteria have been summarized 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:

For HTA as well as regulatory decision making, medical device 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 approval issues of medical devices; for payers CIRs provide evidence on the medical device benefits and drive the decision as to whether the product should be reimbursed or not; for hospitals data from CIRs are important for sound procurement decisions, and CIRs also help patients and their physicians to reach a joint decision on which of the products is the most appropriate. However, many current CIRs are still lacking standards to inform on patient safety and ensure transparency.