Incidence and Costs Related to Lead Damage Occurring Within the First Year After a Cardiac Implantable Electronic Device Replacement Procedure

Abstract

BackgroundInadvertent 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 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 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).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.

Shape memory polyurethanes with oxidation-induced degradation: In vivo and in vitro correlations for endovascular material applications

“…By 1993 it was estimated that the failure of polyurethane pacemaker leads alone would result in above $55 million dollars for device replacement [8]. A more recent 2016 study found that for pacemaker/defibrillator lead damage within the first year of device implantation results in approximately $1.1 billion costs, with damage to the leads occurring in 0.47% to 1.94% of implanted devices, depending on specific application [9]. In a smaller case study, 27 pacemaker leads were returned to the manufacturer and analyzed, with 8 of the devices having undergone material failure that lead to 4 high voltage failures and one death, with an average implantation time of approximately of 25.5 months [10].…”

“…In a smaller case study, 27 pacemaker leads were returned to the manufacturer and analyzed, with 8 of the devices having undergone material failure that lead to 4 high voltage failures and one death, with an average implantation time of approximately of 25.5 months [10]. Based upon the study being performed and the device selected for analysis, this failure rate may range from 0.47% over two and half years to 2.71% per year or higher [9,10]. Failures for commercially available medical devices result in patient morbidity and mortality, and a major cause of this is the lack of analysis that is performed prior to implantation of the devices [1–10].…”

Medium-term prognosis of survival and hospitalization of patients after permanent pacemaker implantation based on BNP, high-sensitivity troponin T, and left atrium volume index

“…In the study, damage to the electrodes was found, which was the cause of the exchange of the device in 0.46% of cases after pacemaker implantation, in 1.27% of cases after cardioverter implantation, and in 1.94 % of cases after implantation of the resynchronisation device. In each case, the complications were associated with costly hospitalisation [24]. Regional single-centre studies also confirmed the usefulness of the determination of BNP peptide, high-sensitivity troponin T, and LAVI in the evaluation of patients who had undergone permanent pacemaker implantation [25].…”

Longevity decoded: Insights from power consumption analyses into device construction and their clinical implications

“…The longevity of cardiac implantable electronic devices (CIEDs) should be an important if not the primary performance attribute in model choice, as battery depletion is the dominant cause of device replacement, which entails not only fiscal cost but also risk of infection and lead failure . The longevities quoted by manufacturers for their latest generation of device models are inevitably projections (typically based on nonuniform settings) and have historically turned out to be overestimates in clinical practice, even after correction for use conditions .…”