BackgroundInadvertent damage to leads for transvenous pacemakers, implantable cardioverterâdefibrillators, and cardiac resynchronization therapy defibrillators is an important complication associated with generatorâreplacement procedures. We sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement.Methods and ResultsUsing the Truven Health Analytics MarketScan Commercial Research Database, we identified health care claims between 2009 and 2013 for lead damage following generator replacement. Patients were identified by claims with a procedure code for cardiac implantable electronic device replacement and then evaluated for 1Â year. All followâup visits for lead damage were identified, and incidence, risk factors, and hospitalization costs were determined. A total of 22Â 557 patients with pacemakers, 20Â 632 with implantable cardioverterâdefibrillators, and 2063 with cardiac resynchronization therapy defibrillators met selection criteria. Incidence of lead damage was 0.46% for pacemaker replacement, 1.27% for implantable cardioverterâdefibrillator replacement, and 1.94% for cardiac resynchronization therapy defibrillator replacement procedures (P<0.001). After adjusting for patient characteristics, patients with implantable cardioverterâdefibrillators and cardiac resynchronization therapy defibrillators demonstrated risk of lead damage that was, respectively, double (hazard ratio 2.00, 95% CI 1.57â2.55) and >2.5 times (hazard ratio 2.58, 95% CI 1.73â3.83) that of patients with pacemakers. Lead revision or repair procedures were associated with increased inpatient hospitalization costs (mean $19Â 959 for pacemaker, $24Â 885 for implantable cardioverterâdefibrillator, and $46Â 229 for cardiac resynchronization therapy defibrillator; P=0.048, KruskalâWallis test).ConclusionsThese findings establish the first objective assessment of the incidence, risk factors, and economic burden of lead damage following cardiac implantable electronic device replacement in the United States. New care algorithms are warranted to avoid these events, which impose substantial burdens on patients, physicians, and payors.