Why the study?
The standard of care for patients with ICD or CRT-D includes remote monitoring, but the effects of individual remote monitoring factors on prognosis remain unclear.
Do specific remote monitoring components (device interrogation, alert transmission, and data transmission frequency) reduce hospitalisation due to cardiovascular disease, heart failure, and device-related complications in individuals with ICD or CRT-D?
Do specific remote monitoring components (device interrogation, alert transmission, and data transmission frequency) reduce hospitalisation due to cardiovascular disease, heart failure, and device-related complications in individuals with ICD or CRT-D?
This is a protocol for a systematic review and component network meta-analysis to evaluate the impact of specific remote monitoring components on prognosis in patients with ICDs or CRT-Ds.
Introduction Currently, 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 analysis A 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. Three reviewers will independently screen the titles and abstracts of identified studies. Two reviewers will extract data independently, and risk of bias will be assessed by one reviewer and verified by a second. 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 dissemination Ethics 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 number : CRD42024517406.
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Okazaki et al. (2024) studied this question.
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