The goal of this observational study is to learn about the development and worsening of tricuspid regurgitation (TR) in patients who have cardiac implantable electronic devices (CIEDs). The main objective is to compare left bundle branch area pacing (LBBaP) and leadless pacemakers against conventional pacemakers in terms of TR exacerbation. Participants with these devices will have their retrospective and prospective clinical data analyzed and will undergo 3D transthoracic echocardiography to identify the exact mechanical causes of TR.
As the use of cardiac implantable electronic devices(CIED) increases, CIED-related tricuspid regurgitation (CIED-related TR) is emerging as a critical clinical issue. CIED-related TR is one of the most common causes of primary TR, with a reported incidence ranging from approximately 10% to 30%. Numerous studies have confirmed that the severity of CIED-related TR is closely associated with poor prognosis. This condition is particularly noteworthy because, unlike secondary TR, it possesses mechanical causes that are potentially intervenable. However, most studies published to date have reported results based on 2D echocardiography, which often leads to ambiguity in identifying the exact mechanisms behind the exacerbation of tricuspid regurgitation. Furthermore, there is a significant lack of data regarding TR associated with more recently introduced procedures, such as left bundle branch area pacing (LBBaP) and leadless pacemakers. Therefore, this study aims to perform 3D transthoracic echocardiography on patients with lead-based CIEDs and leadless pacemakers to comparatively analyze LBBaP and leadless pacemaker patients against conventional pacemaker patients in terms of TR exacerbation. By combining retrospective and prospective clinical data, this research will analyze the incidence and clinical impact of these conditions.
Study Type
OBSERVATIONAL
Enrollment
1,000
The incidence and mechanisms of worsening tricuspid regurgitation are identified through three-dimensional echocardiography, and the resulting structural and functional changes in the heart are evaluated.
Samsung Medical Center
Seoul, Seoul, South Korea
RECRUITINGhospitalization due to heart failure
Time frame: From the date of CIED implantation until the date of the first heart failure hospitalization or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
incidence of CIED related, associated TR
Time frame: Assessed at the time of the study 3D transthoracic echocardiography, performed at least 1 year after CIED implantation, up to 6 years after implantation.
re-admission due to any cause
Time frame: From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
Tricuspid valve intervention
Time frame: From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
transvenous lead extraction or reposition
Time frame: From the date of CIED implantation until the date of the first event or the date of the study 3D transthoracic echocardiography, whichever occurred first, assessed up to 6 years.
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