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

Abstract

Background: The 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 results: Data 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.

Conclusions: Incidence 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.

Keywords: complication; implantable cardioverter‐defibrillator; infection.

Figure 1

Kaplan‐Meier plot of lead revision associated with a diagnosis of infection (dashed line) or mechanical complications (solid line) for patients with an implantable cardioverter‐defibrillator (ICD; gray line) or cardiac resynchronization therapy defibrillator (CRT‐D; black line).

Figure 2

Univariate analysis of risk factors for lead procedures with mechanical diagnosis. Baseline variables associated with an increased risk of mechanical complication during the peri‐implantation and long‐term period. The 90‐day and 5‐year Kaplan‐Meier estimates are shown for each group. AF indicates atrial fibrillation; CI, confidence interval; ICD, implantable cardioverter‐defibrillator; LV, left ventricular; MI, myocardial infarction; PVD, peripheral vascular disease.

Figure 3

Univariate analysis of risk factors for lead procedures with infectious diagnosis. Baseline variables associated with an increased risk of infectious complication during the peri‐implantation and long‐term period. The 90‐day and 5‐year Kaplan‐Meier estimates are shown for each group. AF indicates atrial fibrillation; CI, confidence interval; ICD, implantable cardioverter‐defibrillator; LV, left ventricular; MI, myocardial infarction; PVD, peripheral vascular disease.

Figure 4

Time‐varying covariate model for the risk of infectious or mechanical implantable cardioverter‐defibrillator (ICD) lead complication(s). Risk of complications per baseline variables and noncomplicated procedures in time‐varying multivariable model. AF indicates atrial fibrillation; CI, confidence interval; LV, left ventricular; MI, myocardial infarction; PVD, peripheral vascular disease.

Figure 5

Costs relative to de novo and complication procedure. The costs during the de novo procedure month (top) and the complication procedure month (bottom) grouped by type of complication the patient experienced during follow‐up. Months before and after procedure are shown in quarters (Qs).

Figure 6

Mechanical complication by year of implantation. The freedom from mechanical complication, as calculated by Kaplan‐Meier analysis, for leads implanted in each year between 2003 and 2014 over a 10‐year follow‐up. Noticeably, leads implanted in 2005, 2006, and 2007 have increased failure rates compared with leads implanted before or after that time period.