title: Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure.
abstract: 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.
  
  
  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.
authors.affiliation: Medtronic Advanced Energy, Portsmouth, NH.
authors.forename: Christine I
authors.initials: CI
authors.lastname: Nichols
authors.affiliation: Medtronic Advanced Energy, Portsmouth, NH.
authors.forename: Joshua G
authors.initials: JG
authors.lastname: Vose
authors.affiliation: Arrhythmia Institute of the Valley Health System, Ridgewood, NJ mittsu@valleyhealth.com.
authors.forename: Suneet
authors.initials: S
authors.lastname: Mittal
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects / Q000191:economics*; D058409:Cardiac Resynchronization Therapy Devices / Q000191:economics*; D016208:Databases, Factual; D017147:Defibrillators, Implantable / Q000191:economics*; D020878:Device Removal / Q000009:adverse effects / Q000191:economics*; D004554:Electric Countershock / Q000009:adverse effects / Q000191:economics* / Q000295:instrumentation; D005260:Female; D017721:Hospital Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012189:Retrospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
keywords: cardiac resynchronization therapy; cost; implantable cardioverter‐defibrillator; pacemaker