Effects of individual components of remote monitoring for implantable cardioverter defibrillators or cardiac resynchronisation therapy defibrillators: protocol for a systematic review and component network meta-analysis

Abstract

ABSTRACTIntroductionCurrently, the standard of care for patients with cardiac implantable electronic devices (CIEDs) such as implantable cardioverter-defibrillators (ICD) and cardiac resynchronisation therapy-defibrillators (CRT-D) involves a combination of in-person outpatient visits and remote monitoring (RM). RM consists of scheduled remote device interrogation and automated transmission of prespecified alerts (alert transmission) at varying frequencies depending on manufacturers and institutions. However, the effects of RM factors on prognosis remain unclear. This systematic review and component network meta-analysis (CNMA) will aim to investigate which RM components (device interrogation, alert transmission, and data transmission frequency) have the greatest impact on prognosis in patients with ICD or CRT-D.Methods and analysisA systematic review will be conducted using MEDLINE (PubMed), Embase, the Cochrane Central Register of Controlled Trials, the Web of Science, Clinical Trials.gov, the WHO International Clinical Trials Registry Platform (ICTRP), the European Union Clinical Trials Register (EU-CTR), and the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR). We will include randomised controlled trials (RCTs) assessing the effect of RM on patient outcomes in individuals with ICD or CRT-D. The primary outcome will be hospitalisation due to cardiovascular disease, heart failure, and device-related complications. Two authors will independently conduct literature screening, data extraction, and risk of bias assessment. Random-effects model pairwise meta-analysis, random-effects network meta-analysis (NMA), and additive CNMA will be applied in data synthesis. To assess the quality of evidence, we will employ the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach for pairwise meta-analysis and the Confidence in Network Meta-Analysis (CINeMA) approach for NMA.Ethics and disseminationEthics approval is not required as this study will use existing published data. The results will be submitted for publication in a peer-reviewed journal.PROSPERO registration numberCRD42024517406.