Lead replacement due to non-infectious reasons in patients with cardiac resynchronization therapy in long-term follow-up
Ewa Jędrzejczyk-Patej, Mazurek Michał, Sokal Adam, Kotalczyk Agnieszka, Gumprecht Jakub, Kowalczyk Jacek, Pruszkowska Patrycja, Kowalski Oskar, Lenarczyk Radosław, Kalarus ZbigniewAbstract
Background
Traditional cardiac resynchronization therapy (CRT) is an effective treatment for patients with heart failure.
Objective
The study aimed to determine the long-term durability of CRT leads, factors predisposing to lead replacement, and the outcomes of lead replacement in CRT patients.
Methods
The study population comprised 1059 consecutive patients who received conventional CRT implants at a university hospital between 2002 and 2019.
Results
During a median follow-up of 1661 days (IQR: 815–2792), a total of 324 leads were replaced in 251 patients (23.7%) for non-infectious reasons. The overall crude incidence of lead replacement was 19.4 events per 1000 lead-years. Of those who required lead replacement, 126 subjects (50.2%) underwent the procedure within the first year after CRT implantation. Among patients followed for more than ten years (n=143; 13.5%), 67 subjects (46.8%) had one or more lead replacements. Duration of the index CRT procedure and fluoroscopy time were independent predictors of lead replacement in a multivariable analysis (HR 1.03, 95% CI 1.01–1.06, P=0.02 and HR 1.11, 95% CI 1.02–1.15, P=0.01, respectively). The leads that required replacement were left ventricular (11.2%), right ventricular (10.8%), and right atrial (4%), corresponding to approximate rates of 21.4, 20.5, and 7.6 replacements per 1000 lead-years, respectively. Compared with no need for re-intervention, lead-related re-do procedures were not associated with overall long-term mortality (55.3% vs 51%, P=0.3) or the incidence of device-related infective endocarditis (5.6% vs 4.5%, P=0.82).
Conclusions
Almost 25% of patients with CRT require lead replacement during long-term follow-up for non-infectious reasons, and half of those require replacement within the first year. Over ten years, nearly every second patient requires a lead-related redo procedure. Lead replacement was not associated with long-term all-cause mortality. Systematic proficiency-based training should be introduced as a routine strategy in the education of novice implanters.