Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results - Trial NCT05774821
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Study Focus
Sponsor & Location
Michele De Bonis
Ospedale San Raffaele
Timeline & Enrollment
N/A
Feb 04, 2022
Feb 27, 2022
Primary Outcome
TR recurrency
Summary
Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy
 demonstrated a meaningful decreased rates of sudden death but an increased rate of
 hospitalization for heart failure . At the time, the chance that an endocardial lead could
 cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not
 widely considered. Whereas, it is now well established that in patients with cardiac
 implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is
 associated with increased mortality and hospitalization for heart failure.
 
 The present study aims to report the long-term results of tricuspid valve repair and
 replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided
 in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR,
 the valve dysfunction is directly caused by the lead with several mechanism such as
 mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation
 (impingement), valve damage during lead placement or manipulation and sub-valvular
 entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly
 caused by the lead.
 
 In 2009 approximately 720 000 CIEDs were implanted worldwide [7] and since then a continuous
 increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs
 implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical
 or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in
 the past years and it likely will continue to increase in the next years. However, limited
 data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs,
 particularly for the long-term results. With this study we aim to report the long-term result
 of tricuspid valve repair and replacement in patients with CIEDs.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05774821
Non-Device Trial