Lead Extraction in Pediatric and Congenital Heart Disease Patients

Cecchin, Frank; Atallah, Joseph; Walsh, Edward P.; Triedman, John K.; Alexander, Mark E.; Berul, Charles I.

doi:10.1161/circep.110.957324

Cited by 97 publications

(61 citation statements)

References 34 publications

(56 reference statements)

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“…Complications occurred mostly in the advanced extraction group; however, the difference was not statistically significant. The overall 4% major complication rate is in comparison to a 3% major complication rate previously reported in a similar patient population 4 and a recently reported rate of 7% in a systemic study of Fidelis lead revision in an adult patient population. 11 As previously reported, older lead age at extraction was the most important predictor of the need for an advanced extraction.…”

Section: Discussionsupporting

confidence: 43%

“…11 As previously reported, older lead age at extraction was the most important predictor of the need for an advanced extraction. 4 Coil insulation with either ePTFE or Optim was not a protective predictor on multivariable analysis in this study. The advantage of ePTFE leads during lead extraction remains to be proven in the pediatric population.…”

Section: Discussionmentioning

confidence: 48%

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Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults

et al. 2013

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Manufacturers have developed distinct strategies in an attempt to deal with these critical issues of long-term lead 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

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Section: Discussionsupporting

confidence: 43%

Section: Discussionmentioning

confidence: 48%

Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults

et al. 2013

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“…There are considerable risks associated with this approach given the limited experience and formal assessments of these modified devices, and a number of adverse events linked to adult device use in children have been reported. [3][4][5][6] Another common practice is to use adult devices "off label," or outside that device' s FDAapproved indication. In pediatric interventional cardiology, for example, reports have estimated that .60% of patients who undergo a therapeutic cardiac catheterization are exposed to off-label use of adult devices.…”

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confidence: 99%

Postmarketing Trials and Pediatric Device Approvals

2014

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BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development. The current state of trial evidence underpinning the approval of pediatric devices remains poorly described. METHODS: We identified all high-risk (ie, class III) devices approved through the premarket approval or humanitarian device exemption pathways for therapeutic use in children between 2008 and 2011. We collected key information on clinical trial design (randomization, blinding, controls, and types of end points) as well as age distribution of trial participants. We also identified US Food and Drug Administration (FDA)–mandated postmarketing trials. RESULTS: Twenty-two devices were approved for use in children via the premarket approval pathway and 3 via the humanitarian device exemption pathway. Twenty-two (88%) qualified as pediatric despite minimum approval ages of ≥18 years (the FDA Center for Devices and Radiologic Health considers patients 18–21 years old as pediatric). Most devices were approved on the basis of nonrandomized (59%), open-label (68%) studies with surrogate effectiveness end points (86%). Overall, 21 (84%) devices were not studied in any patients <18 years of age. Postmarketing studies were mandated by the FDA for 19 (76%) devices, although only 3 (18%) required enrollment of pediatric patients. CONCLUSIONS: Most high-risk pediatric devices are approved on the basis of trials in patients ≥18 years old, with few pediatric patients exposed to the devices before market availability. Few postmarketing studies require additional study in pediatric patients.

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“…These data join a small but consistent set of other data suggesting that pediatric lead extraction is feasible, reasonably safe, and difficult. 6,7 One limitation not discussed is the absence of a precise definition of lead failure. The meaning may have seemed selfevident at the time this study was initiated.…”

Section: Article See P 2393mentioning

confidence: 99%

Learning From Implantable Cardioverter-Defibrillator Leads in Children

Rottman

2013

Circulation

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Lead Extraction in Pediatric and Congenital Heart Disease Patients

Cited by 97 publications

References 34 publications

Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults

Multi-Institutional Study of Implantable Defibrillator Lead Performance in Children and Young Adults

Postmarketing Trials and Pediatric Device Approvals

Learning From Implantable Cardioverter-Defibrillator Leads in Children

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