A Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults: Results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) Study
Background—Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease (CHD) 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 CHD patients.
Methods and Results—The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24 center international registry. Pediatric and CHD patients with ICD lead implants from 2005-2010 were eligible. Study subjects comprised 878 ICD patients (44% CHD). Mean±SD age at implant was 18.6±9.8 years. Of the 965 total leads, 54% were Thin (≤ 7Fr), of which 57% where Fidelis®, and 23% ePTFE coated. There were 139 (14%) ICD lead failures in 132 (15%) patients at mean lead age of 2.0±1.4 years, causing shocks in 53 (40%) patients. Independent predictors of lead failure included younger implant age and Fidelis® leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implant: <8 years compared to >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% ePTFE 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 CHD 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.
- Received January 4, 2013.
- Revision received March 30, 2013.
- Accepted April 22, 2013.