Multi-institutional study of implantable defibrillator lead performance in children and young adults results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study

Joseph Atallah, Christopher C Erickson, Frank Cecchin, Anne M. Dubin, Ian H. Law, Mitchell I. Cohen, Martin J. LaPage, Bryan C. Cannon, Terrence U H Chun, Vicki Freedenberg, Marcin Gierdalski, Charles I. Berul

Research output: Contribution to journalArticle

82 Citations (Scopus)

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. Methods and 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.

Original languageEnglish (US)
Pages (from-to)2393-2402
Number of pages10
JournalCirculation
Volume127
Issue number24
DOIs
StatePublished - Jun 18 2013

Fingerprint

Implantable Defibrillators
Young Adult
Pediatrics
Survival
Heart Diseases
Polytetrafluoroethylene
Actuarial Analysis
Lead
Registries
Shock
Morbidity
Mortality

Keywords

  • Congenital abnormalities
  • Death
  • Defibrillators
  • Implantable
  • Pediatrics
  • Sudden

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)

Cite this

Multi-institutional study of implantable defibrillator lead performance in children and young adults results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study. / Atallah, Joseph; Erickson, Christopher C; Cecchin, Frank; Dubin, Anne M.; Law, Ian H.; Cohen, Mitchell I.; LaPage, Martin J.; Cannon, Bryan C.; Chun, Terrence U H; Freedenberg, Vicki; Gierdalski, Marcin; Berul, Charles I.

In: Circulation, Vol. 127, No. 24, 18.06.2013, p. 2393-2402.

Research output: Contribution to journalArticle

Atallah, J, Erickson, CC, Cecchin, F, Dubin, AM, Law, IH, Cohen, MI, LaPage, MJ, Cannon, BC, Chun, TUH, Freedenberg, V, Gierdalski, M & Berul, CI 2013, 'Multi-institutional study of implantable defibrillator lead performance in children and young adults results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study', Circulation, vol. 127, no. 24, pp. 2393-2402. https://doi.org/10.1161/CIRCULATIONAHA.112.001120
Atallah, Joseph ; Erickson, Christopher C ; Cecchin, Frank ; Dubin, Anne M. ; Law, Ian H. ; Cohen, Mitchell I. ; LaPage, Martin J. ; Cannon, Bryan C. ; Chun, Terrence U H ; Freedenberg, Vicki ; Gierdalski, Marcin ; Berul, Charles I. / Multi-institutional study of implantable defibrillator lead performance in children and young adults results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study. In: Circulation. 2013 ; Vol. 127, No. 24. pp. 2393-2402.
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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. Methods and 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.",
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AU - Dubin, Anne M.

AU - Law, Ian H.

AU - Cohen, Mitchell I.

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AU - Cannon, Bryan C.

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