This study aims to understand how the right side of the heart changes in people who receive an implantable cardiac electronic device (CIED), such as a pacemaker, ICD, or CRT device. The right ventricle (RV) can sometimes be affected after these devices are placed, but the reasons and timing are not well understood.
To investigate this, we will examine participants at two time-points: before their device is implanted and again six months later. At each visit, we will assess heart function using echocardiography, a non-contrast cardiac MRI scan, and an ultrasound score of venous congestion called the VEXUS score. We will also take a small blood sample to measure a biomarker called FGF-23, which may reflect changes in heart function.
The study does not involve any experimental treatment, and all implanted devices are part of routine medical care. The imaging tests and blood samples are for research purposes only. By comparing the measurements before and after device implantation, we hope to better understand how CIEDs influence right-sided heart function and whether imaging findings are related to changes in blood biomarkers.
Adults aged 18 years or older.
Scheduled to undergo implantation of a clinically indicated pacemaker, ICD, or CRT device.
Able to undergo transthoracic echocardiography, VEXUS ultrasound assessment, and non-contrast cardiac MRI.
Able to provide written informed consent.
Contraindication to cardiac MRI (e.g., severe claustrophobia or MRI-unsafe implanted material).
Inability to undergo echocardiography or ultrasound assessment.
Known pulmonary arterial hypertension (Group 1 PH).
Significant congenital heart disease.
Participants will be recruited from the cardiology clinics and electrophysiology unit of Istanbul University-Cerrahpaşa Cardiology Institute. The study population consists of adult patients scheduled for implantation of a clinically indicated pacemaker, ICD, or CRT device. All participants represent a routine tertiary-care population referred for device therapy due to bradyarrhythmia, heart failure, or ventricular arrhythmia indications.
Cohort
Prospective
Multimodal Right Ventricular Evaluation
Other interventionNon-invasive assessments including transthoracic echocardiography, VEXUS ultrasound scoring, non-contrast cardiac MRI using 1.5T scanner, and venous blood sampling for EDTA plasma biomarker analysis (FGF-23 and BNP). These procedures are for research measurements only and do not alter or replace routine clinical care. No therapeutic intervention or assignment is performed.
Change in Right Ventricular Ejection Fraction (RVEF) by Cardiac MRI
RVEF will be quantified using non-contrast 1.5T cardiac MRI cine imaging. The primary endpoint is the absolute change in RVEF between pre-implantation and 6-month follow-up.
Change in Tricuspid Regurgitation Severity
Tricuspid regurgitation will be graded (none, mild, moderate, severe) using echocardiography and confirmed by CMR-derived regurgitant volume.
Change in Right Ventricular End-Diastolic Volume (RVEDV) by Cardiac MRI
RVEDV will be measured from short-axis cine stacks. The endpoint is the change in volume between baseline and 6 months.
Change in VEXUS Score
VEXUS venous congestion score (IVC, hepatic vein Doppler, portal vein pulsatility, renal vein Doppler) will be calculated at each visit.
Change in Right Ventricular Longitudinal Strain (RV-FWLS)
Measured via speckle-tracking echocardiography.
Change in Plasma FGF-23 Concentration
EDTA plasma FGF-23 will be measured via ELISA. The endpoint is the change in concentration from baseline to 6 months.
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