Key result
ICD and CRT-D replacements linked to ~2-fold higher 1-year lead damage risk versus pacemakers.
Why the study?
Inadvertent lead damage is an important complication after cardiac implantable electronic device replacement, but its incidence and associated costs were not well established in the United States.
Cohort (n=45,252)
Yes
Lead damage following CIED replacement is a notable complication that occurs more frequently and incurs higher hospitalization costs in patients with ICDs and CRT-Ds compared to pacemakers.
Answers are grounded in this paper and cite their sources.
Lead damage occurs in 0.5-2% of CIED replacements with substantial added costs; leaves open whether prevention algorithms reduce events in practice.
BACKGROUND: Inadvertent damage to leads for transvenous pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy defibrillators is an important complication associated with generator-replacement procedures. We sought to estimate the incidence and costs associated with transvenous lead damage following cardiac implantable electronic device replacement. METHODS AND RESULTS: Using 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 1 year. All follow-up visits for lead damage were identified, and incidence, risk factors, and hospitalization costs were determined. A total of 22 557 patients with pacemakers, 20 632 with implantable cardioverter-defibrillators, and 2063 with cardiac resynchronization therapy defibrillators met selection criteria. Incidence of lead damage was 0.46% for pacemaker replacement, 1.27% for implantable cardioverter-defibrillator replacement, and 1.94% for cardiac resynchronization therapy defibrillator replacement procedures (P<0.001). After adjusting for patient characteristics, patients with implantable cardioverter-defibrillators and cardiac resynchronization therapy defibrillators demonstrated risk of lead damage that was, respectively, double (hazard ratio 2.00, 95% CI 1.57-2.55) and >2.5 times (hazard ratio 2.58, 95% CI 1.73-3.83) that of patients with pacemakers. Lead revision or repair procedures were associated with increased inpatient hospitalization costs (mean $19 959 for pacemaker, $24 885 for implantable cardioverter-defibrillator, and $46 229 for cardiac resynchronization therapy defibrillator; P=0.048, Kruskal-Wallis test). CONCLUSIONS: These 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.
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Nichols et al. (2016) conducted a cohort in Cardiac implantable electronic device replacement (n=45,252). Implantable cardioverter-defibrillator replacement vs. Pacemaker replacement was evaluated on Incidence of lead damage (HR 2.00, 95% CI 1.57-2.55, p=<0.001). Compared with pacemaker replacement, the risk of lead damage within 1 year was double for ICD replacement (HR 2.00; 95% CI 1.57-2.55) and >2.5 times higher for CRT-D replacement (HR 2.58).
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