Lead replacement due to non-infectious reasons in patients with cardiac resynchronization therapy in long-term follow-up

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.