Risk of Pacing-induced Cardiomyopathy

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Aalborg University Hospital
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Updated on 16 February 2024
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cardiomyopathy
atrioventricular block

Summary

This study will evaluate the association between right ventricular pacing and the risk of pacing-induced cardiomyopathy.

Description

Background

Right ventricular (RV) pacing may lead to pacing-induced cardiomyopathy (PICM) and heart failure (HF). The detrimental effects of RV pacing have been attributed to the abnormal and dyssynchronous electrical and mechanical activation of the myocardium. The activation is affected by the RV pacing site. Understanding the consequences of different RV pacing sites and the patterns of dyssynchrony may help to choose the optimal treatment for the individual patient.

Aim and objectives:

The overall aim of this project is to investigate the association between RV pacing site and the risk of PICM. Contrast enhanced cardiac computed tomography (CT) will be applied for precise localization of the RV pacing. Furthermore, investigation of the association between PICM and different mechanical and electrical myocardial activation patterns during RV pacing will be conducted using new echocardiographic and electrocardiographic methods.

Methods

The study is designed as a retrospective cohort study with clinical follow-up. Patients with prior pacemaker implantation due to advanced atrioventricular block will be included. The study baseline is retrospective and defined as time of pacemaker implantation and follow-up is time of inclusion. Baseline data will be extracted from the Danish Pacemaker- and ICD Registry, electronic medical records (EMR) and review of echocardiographs. Follow-up data will be extracted from existing data in the EMRs as well as generated during a follow-up visit with a clinical examination. For assessment of cardiac function, RV lead position and electrical and mechanical activations patterns, the examination will include a transthoracic echocardiography, an electrocardiogram, a 3-dimensional chest photo, and a contrast-enhanced cardiac CT. Data will be analysed for differences between those who develop PICM and those who do not.

Expected outcomes and perspectives:

The hope is that this project will generate knowledge and awareness on pacemaker treatment and the risk of PICM. Understanding the pathophysiology behind PICM is key to learning how to prevent it. Accordingly, this project has the potential to contribute to improving pacemaker treatment and the quality of care for the large and still growing PM population.

Details
Condition Atrioventricular Block, Pacemaker DDD, Pacing-Induced Cardiomyopathy
Age 18years - 100years
Treatment Right ventricular pacing
Clinical Study IdentifierNCT04269733
SponsorAalborg University Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Male or female 18 years and alive at time of follow-up
DDD PM implanted at Aalborg University Hospital prior to
March 2018
PM implantation due to advanced AV block
Baseline TTE prior to PM implantation with LVEF 50%
No history of HF with pre-existing diagnosis in the electronic medical record prior to PM implantation

Exclusion Criteria

No written informed consent
Baseline TTE not available or without an apical four-chamber (4CH) view and/or an apical two chamber (2CH) view sufficient for estimation of LVEF
Contraindications to cardiac CT with contrast including pregnant or lactating and/or severely decreased renal function and/or former serious reactions to contrast media
RV pacing load < 40%
Device complications with removal of original implanted pacing lead
Subjects with severe ischemic heart disease and severe valvular heart disease
Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
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