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

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. 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 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.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This study did not receive any funding.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

Data sharing not applicable as no datasets were generated and/or analysed for this study.

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