title: Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study.
abstract: BACKGROUND
  Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients.
  
  
  RESULTS
  The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation: <8 years compared with >18 years (P=0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality.
  
  
  CONCLUSIONS
  This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age.
  
  
  BACKGROUND
  URL: http://www.clinicaltrials.gov. Unique identifier: NCT00335036.
authors.affiliation: Division of Cardiology, Children's National Medical Center, Washington, DC, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Atallah
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Erickson
authors.forename: Frank
authors.initials: F
authors.lastname: Cecchin
authors.forename: Anne M
authors.initials: AM
authors.lastname: Dubin
authors.forename: Ian H
authors.initials: IH
authors.lastname: Law
authors.forename: Mitchell I
authors.initials: MI
authors.lastname: Cohen
authors.forename: Martin J
authors.initials: MJ
authors.lastname: Lapage
authors.forename: Bryan C
authors.initials: BC
authors.lastname: Cannon
authors.forename: Terrence U H
authors.initials: TU
authors.lastname: Chun
authors.forename: Vicki
authors.initials: V
authors.lastname: Freedenberg
authors.forename: Marcin
authors.initials: M
authors.lastname: Gierdalski
authors.forename: Charles I
authors.initials: CI
authors.lastname: Berul
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal / Q000379:methods; D004868:Equipment Failure / Q000706:statistics & numerical data; D006330:Heart Defects, Congenital / Q000628:therapy*; D006331:Heart Diseases / Q000151:congenital* / Q000628:therapy*; D006801:Humans; D007391:International Cooperation; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D011138:Polytetrafluoroethylene
keywords: congenital abnormalities; death, sudden; defibrillators, implantable; pediatrics