title: Epicardial leads in adult cardiac resynchronization therapy recipients: a study on lead performance, durability, and safety.
abstract: BACKGROUND
  Transvenous left ventricular (LV) lead placement for cardiac resynchronization therapy-defibrillator (CRT-D) delivery is unsuccessful in 8% to 10% of cases. These patients might benefit from an epicardial lead. However, data on long-term epicardial lead performance are scarce. Furthermore, extracting an epicardial lead requires a rethoracotomy.
  
  
  OBJECTIVE
  The purpose of this study was to determine data on almost a decade of experience with epicardial leads and investigate the safety of partially leaving this lead in place after device infection.
  
  
  METHODS
  All adult patients receiving an epicardial lead (Medtronic CapSure Epi, model 4968) for CRT-D in the Leiden University Medical Center were included. Leads were implanted during a standalone procedure or in combination with other cardiothoracic procedures. Electrical lead parameters were assessed at implantation and every 6 months thereafter. In case of device infection the epicardial lead was cut off parasternal, just outside the thoracic cavity, leaving the distal part of the lead in place.
  
  
  RESULTS
  Two-hundred sixteen patients were included with a median follow-up of 3 years (25th-75th percentile 1.0-5.5). LV pacing threshold decreased within 6 months after implantation [1.1 V (95% confidence interval [CI] 0.9-1.2) vs 0.8 V (95% CI 0.7-0.9), P = .01] and stabilized thereafter. Mean LV electrogram was 15.2 ± 7.5 mV, and average lead impedance was 633.5 ± 174.0 Ω. Five-year cumulative incidence was 1.6% for lead failure and 9.6% for device infection. The retained epicardial lead caused skin erosion in 3 patients and fistula formation in 1.
  
  
  CONCLUSIONS
  This study demonstrates that epicardial LV leads have an excellent long-term performance. Partially retaining the lead after device infection was associated with a risk of reinfection with limited long-term clinical implications for the patient.
authors.affiliation: Department of Cardiology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.
authors.forename: Maurits S
authors.initials: MS
authors.lastname: Buiten
authors.affiliation: Department of Cardiology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.
authors.forename: Aafke C
authors.initials: AC
authors.lastname: van der Heijden
authors.affiliation: Department of Cardiothoracic Surgery, LUMC, Leiden, The Netherlands.
authors.forename: Robert J M
authors.initials: RJM
authors.lastname: Klautz
authors.affiliation: Department of Cardiology, Leiden University Medical Center (LUMC), Leiden, The Netherlands.
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Schalij
authors.affiliation: Department of Cardiology, Leiden University Medical Center (LUMC), Leiden, The Netherlands. Electronic address: l.van_ervan@lumc.nl.
authors.forename: Lieselot
authors.initials: L
authors.lastname: van Erven
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D058406:Cardiac Resynchronization Therapy / Q000009:adverse effects* / Q000379:methods* / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices / Q000009:adverse effects*; D006348:Cardiac Surgical Procedures / Q000379:methods; D004567:Electrodes, Implanted; D019544:Equipment Failure Analysis / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000503:physiopathology*; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D061214:Patient Safety / Q000706:statistics & numerical data*; D010496:Pericardium / Q000601:surgery; D016459:Prosthesis-Related Infections / Q000453:epidemiology / Q000601:surgery; D019616:Thoracic Surgical Procedures / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000503:physiopathology / Q000601:surgery
keywords: Cardiac resynchronization therapy; Cardiac resynchronization therapy–defibrillator; Epicardial lead; Lead performance; Left ventricular lead