Effects of Implantable Cardioverter-Defibrillator Leads on the Tricuspid Valve and Right Ventricle: A Randomized Trial

Darryl P Leong; Hisham Dokainish; Blandine Mondésert; Germano Cavalli; Aditya Khetan; Filipe Cirne; Rocio Baro Vila; Harry Klimis; Tais Araujo De Jesus; Naif Saad AlGhasab; Vahid Akbari; Asem Suliman; Osama Eltebi; Ali Almhri; Tahsin Ferdous; Angie Djuric; Jamil Bashir; Andrew D Krahn; Derek V Exner; François Philippon; David H Birne; Jacqueline Joza; Jeff S Healey

doi:10.1016/j.jacep.2024.04.034

Effects of Implantable Cardioverter-Defibrillator Leads on the Tricuspid Valve and Right Ventricle: A Randomized Trial

JACC Clin Electrophysiol. 2024 Sep;10(9):2088-2096. doi: 10.1016/j.jacep.2024.04.034. Epub 2024 Jul 10.

Authors

Darryl P Leong¹, Hisham Dokainish², Blandine Mondésert³, Germano Cavalli⁴, Aditya Khetan⁵, Filipe Cirne⁶, Rocio Baro Vila⁶, Harry Klimis⁵, Tais Araujo De Jesus⁷, Naif Saad AlGhasab⁸, Vahid Akbari⁹, Asem Suliman⁶, Osama Eltebi⁶, Ali Almhri¹⁰, Tahsin Ferdous⁴, Angie Djuric⁴, Jamil Bashir¹¹, Andrew D Krahn¹², Derek V Exner¹³, François Philippon¹⁴, David H Birne¹⁵, Jacqueline Joza¹⁶, Jeff S Healey¹⁷

Affiliations

¹ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. Electronic address: [email protected].
² Circulate Cardiac and Vascular Centre, Burlington, Ontario, Canada.
³ Montreal Heart Institute, Department of Medicine, Université de Montréal, Montreal, Quebec, Canada.
⁴ Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
⁵ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
⁶ Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
⁷ Department of Medicine, University of São Paulo, São Paulo, Brazil.
⁸ Department of Internal Medicine, Medical College, University of Ha'il, Ha'il, Saudi Arabia.
⁹ Division of Cardiology, Cardiac Sciences Department, Northern Ontario School of Medicine University, Thunder Bay, Ontario, Canada.
¹⁰ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.
¹¹ Division of Cardiovascular Surgery, University of British Columbia, Vancouver, British Columbia, Canada.
¹² Center for Cardiovascular Innovation, Division of Cardiology, University of British Columbia, Vancouver, British Columbia, Canada.
¹³ University of Calgary, Calgary, Alberta, Canada.
¹⁴ Institut universitaire de cardiologie et de pneumologie de Québec, Laval University, Quebec City, Quebec, Canada.
¹⁵ University of Ottawa, Ottawa, Ontario, Canada.
¹⁶ Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada.
¹⁷ Department of Medicine, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada. Electronic address: [email protected].

PMID: 39001765
DOI: 10.1016/j.jacep.2024.04.034

Abstract

Background: There are no randomized data to inform the extent to which transvenous cardiac leads cause tricuspid regurgitation (TR).

Objectives: This study sought to determine the effect of a transvenous implantable cardioverter-defibrillator (TV-ICD) on TR severity, and secondarily, on right ventricular (RV) size and function.

Methods: We evaluated TR severity before and 6 months after implantable cardioverter-defibrillator insertion in a post hoc analysis of adults randomized to receive a transvenous (n = 252) or subcutaneous implantable cardioverter-defibrillator (S-ICD) (n = 251) device. TR and RV size and systolic function were assessed by echocardiographic images analyzed in a core laboratory.

Results: At baseline, at least mild TR was present in 30% of individuals. At 6 months, the proportion of participants with any TR in the TV-ICD group was 42% vs 19% in the S-ICD group (P < 0.001). The proportion with moderate or severe TR was 7% in the TV-ICD group vs 2% in the S-ICD group (P = 0.021). At 6 months, the OR of at least 1 grade worsening of TR in the TV-ICD group as compared with the S-ICD group was 7.2 (95% CI: 3.3-15.8; P < 0.001). There were no differences between groups with respect to RV size or systolic function.

Conclusions: Six months following TV-ICD insertion, there was a 7-fold increase in the risk of at least 1 grade worsening of TR, with 7% of individuals having TR that was moderate or severe. There was no detectable difference in RV size or function; however, longer follow-up is needed.

Keywords: cardiovascular implantable electronic device; implantable cardioverter-defibrillator; lead; right ventricular; tricuspid regurgitation.

Publication types

Randomized Controlled Trial

MeSH terms

Adult
Aged
Defibrillators, Implantable* / adverse effects
Echocardiography
Female
Heart Ventricles* / diagnostic imaging
Heart Ventricles* / physiopathology
Humans
Male
Middle Aged
Tricuspid Valve Insufficiency*
Tricuspid Valve* / diagnostic imaging