Author + information
- Joseph Atallah,
- Vicki Freedenberg,
- Anne Dubin,
- Mitchell Cohen,
- Christopher Erickson,
- Ian Law,
- Bryan Cannon,
- Martin LaPage,
- Frank Cecchin,
- Terrence Chun,
- Charles Berul,
- on behalf of the Pediatric and Congenital EP Society (PACES)
Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease (CHD) patients is hindered by poor long-term lead survival. Distinct lead design changes including thinner diameter leads were introduced in order to improve extractability; however, a subset of these leads was recalled due to high failure rates.
We examined the outcomes of the recalled Sprint Fidelis® leads in pediatric and CHD patients as a sub-analysis within the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study, an international registry involving 24 centers. Pediatric and CHD patients who underwent ICD lead implants from 2005–2010 were eligible.
Study subjects comprised 878 young ICD patients (44% CHD). Mean±SD age at implant was 18.6±9.8 years. Of the 965 total ICD leads, 54% were Thin (≤ 7Fr) with 300 (58%) being Fidelis® leads. There was a total of 139 (14%) failed leads in 132 (15%) patients at mean lead age of 2.0±1.4 years. Of the Fidelis® leads, 33% (98/300) failed, accounting for 71% (98/139) of all failed leads and 85% (98/115) of all failed thin leads. For the 4 Fidelis® models (6930, 6931, 6948 and 6949) the number of failed leads was 0/1, 57/138 (41%), 3/16 (19%), and 38/145 (26%), respectively. Of the failed single coil leads, 72% (57/79) were Fidelis®model 6931. The majority (44%) of failed Fidelis® leads were associated with inappropriate shocks. The actuarial yearly failure rate was 9.1% for Fidelis® leads compared to 2.1% for non-thin leads.
Fidelis® leads accounted for the majority of ICD lead failures and associated inappropriate shocks during the study period. The annual failure rate is several-fold higher compared to non-thin leads as well as published Fidelis® annual failure rates in adult cohorts. The steady and high annual failure rate represents an ongoing burden for these young patients. Although children may have potentially benefitted from a thinner ICD lead, unfortunately they have been disproportionately impacted by this specific lead failure and recall. More robust ICD lead designs are critical for the long-term well-being of pediatric device patients. Clinical Trial Registration: NCT00335036
Poster Sessions, Expo North
Monday, March 11, 2013, 9:45 a.m.-10:30 a.m.
Session Title: Arrhythmias: AF/SVT X
Abstract Category: 14. Congenital Cardiology Solutions: Therapy
Presentation Number: 1279-51
- 2013 American College of Cardiology Foundation