Risk Factors and Temporal Trends of Complications Associated With Transvenous Implantable Cardiac Defibrillator Leads

Abstract

BackgroundThe transvenous implantable cardioverter‐defibrillator (ICD) lead is the most common source of complications in a traditional ICD system. This investigation aims to determine the incidence, predictors, and costs associated with these complications using a large insurance database.Methods and ResultsData from the OptumLabs™ Data Warehouse, which include diagnosis, physician and procedure codes, and claims from patient hospitalizations, were analyzed. Patients with a de novo ICD or cardiac resynchronization therapy defibrillator implanted from January 1, 2003, through June 30, 2015, were included; those who did not have continuous coverage beginning 1 year before implantation were excluded, resulting in 40 837 patients followed up over an average of 2.3±2.1 years. Patients were followed up until they had the procedure or their last active date in the database. Of 20 580 device procedures, 2165 (5.3%) and 771 (1.9%) had mechanical and infectious complications, respectively. The 5‐year rate of freedom from mechanical complication was 92.0% and 89.3% for ICDs and cardiac resynchronization therapy defibrillators, respectively. Infectious complications were more likely in patients with a history of atrial fibrillation, diabetes mellitus, and renal disease, and the risk increased with subsequent device procedures. Younger age, female sex, lack of comorbidities, and implantations between 2003 and 2008 were associated with more mechanical complications.ConclusionsIncidence of mechanical and infectious complications of transvenous ICD leads over long‐term follow‐up is much higher in the real world than in clinical studies. In our study cohort, 1 of 4 transvenous ICD leads had mechanical complications when followed up to 10 years. The high rate of reintervention leads to additional complications.

Long‐term follow‐up of implantable cardioverter defibrillator patients with regard to appropriate therapy, complications, and mortality

“…Notably, our cohort was followed for a considerably longer time, which increases the number of lead‐related complications because leads are the weakest link of the system . The rate of mechanical complications affecting ICD leads after 10 years is approximately 25% . According to a systemic review, the pooled complication rate was 9.1% over a mean follow‐up time of 17.9 months .…”

Costs and complications associated with transvenous lead reoperation in cardiac implantable electronic devices

“…Costs began to rise roughly 90 days before the index interval, at which point they peaked, and then declined thereafter to initial levels ( Figure 3 of TV lead complications at 10 years range from 10% to 25%, 7,29,30 implicating TV leads as the component of ICD systems most likely to fail over time. Costs began to rise roughly 90 days before the index interval, at which point they peaked, and then declined thereafter to initial levels ( Figure 3 of TV lead complications at 10 years range from 10% to 25%, 7,29,30 implicating TV leads as the component of ICD systems most likely to fail over time.…”

“…Finally, while other studies have included diverse populations of private and publicly insured patients,[7][8][9][10][11] in which the distinction between actual payer costs and provider submitted charges may be less clear and result in inflated cost estimates, we F I G U R E 6 Adjusted length of stay and costs of inpatient lead removal, by the presence of infection. In this study, we observed an increase in complication rates beginning roughly 90 days before TV lead reoperation, and a decrease after reoperation, with a similar pattern in costs.…”

Healthcare utilization in patients with first‐time implantable cardioverter defibrillators (data from the WEBCARE study)

“…Besides the unequivocal medical benefits, ICD therapy is associated with a risk of complications and increased healthcare costs have been reported . Receiving an ICD is associated with high healthcare costs as the implantation device itself can be as expensive as 30 000 euros .…”

“…4 Besides the unequivocal medical benefits, ICD therapy is associated with a risk of complications and increased healthcare costs have been reported. 5 Receiving an ICD is associated with high healthcare costs as the implantation device itself can be as expensive as 30 000 euros. 6 In addition, after implantation, patients are generally followed-up at 1-to-4-month intervals (depending on patients' clinical status and device model) at the outpatient clinic.…”