摘要

Authors' objectives: The aim of this report is to summarize the existing clinical and economic evidence on the remote monitoring of patients with CIEDs, i.e. ICDs, PMs, CRT-P, CRT-D, and ILRs and to investigate reimbursement practices in other countries in order to provide recommendations for a potential reimbursement of these technologies. The main research questions are: •What are the technical characteristics of RM systems for CIEDs and what health problems do they address? The aim of chapter 2 is to summarize the technology characteristics, mostly based on information provided by the RM systems providers. •What is the current use of RM of CIEDs in Belgium? The aim of chapter 3 is also to investigate the adoption and perception of these RMsystems by Belgian cardiology centres, mainly based on a short survey. •What are the clinical benefits and risks of remote monitoring of CIEDs? The aim of chapter 4 is to provide a clear synthesis of the evidence on the clinical effectiveness and safety based on other existing HTA reports, systematic reviews and randomized clinical trials. •What is the cost-effectiveness of remote monitoring of CIEDs? The aim of the chapter 5 is to provide a clear synthesis of the evidence on the cost-effectiveness based on other existing HTA reports, systematic reviews and economic evaluations. •Which legal aspects need to be considered? The aim of chapter 6 is to identify the changes in the legal frameworks affecting cardiac remote monitoring since the 2010 report and to discuss the current most debated issues in this sector. Therefore, the focus of this chapter is the impact of the new medical devices’ regulations and the new personal data protection rules as well as changes in the Belgian rules applicable to health care delivery •What forms of financing are available for health care professionals and for the equipment and services provided by RM systems providers in other countries? What are the quality criteria and other organizational aspects included in the reimbursement conditions? The aim of chapter 7 is to give examples of reimbursement conditions, financing mechanisms and quality criteria based on an international comparison in selected European countries. •Which models could be considered in Belgium and what may be their budget impact? The aim of chapter 8 is to discuss the impact of the financing models identified in chapter 7 for the Belgian context.