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Transvenous pacing in pediatric patients with bipolar lumenless lead: Ten-year clinical experience
Paolo De Filippo1, Fabrizio Giofrè1, Cristina Leidi1
1Cardiac Electrophysiology and Pacing Unit, Cardiovascular Department, Ospedale Papa Giovanni XXIII, Bergamo, Italy.
Insights
The Select Secure™ lead demonstrated safe and effective performance in pediatric patients, including those with congenital heart disease. This study confirms its reliability for long-term cardiac device implantation in children.
Area of Science:
- Pediatric Cardiology
- Cardiac Electrophysiology
- Medical Device Technology
Background:
- Long-term performance of endocardial implanted systems in pediatric patients presents unique challenges.
- The Select Secure™ lead is a potential solution for this patient population.
- Evaluating lead performance in children with and without congenital heart disease is crucial.
Purpose of the Study:
- To assess the long-term performance of the Select Secure™ lead in pediatric patients.
- To analyze implantation success, complications, and electrical parameters.
- To evaluate lead efficacy in children with and without congenital heart disease.
Main Methods:
- Retrospective analysis of pediatric patients (<16 years) implanted with Select Secure™ leads (2006-2016).
- Evaluation of clinical characteristics, electrical lead parameters, and complications.
- Analysis included surgical revisions and other adverse events.
Main Results:
- 40 pediatric patients received 57 Select Secure™ leads; 77.5% used axillary vein access.
- Implantation was uneventful in all patients, with one lead dislodgement successfully managed.
- Adequate pacing parameters were achieved during a mean follow-up of 6±2.9 years.
Conclusions:
- The Select Secure™ lead, axillary vein access, intra-atrial loop, and sub-pectoral generator placement ensure safe pediatric implantation.
- Effective cardiac stimulation was achieved at medium-term follow-up in this pediatric cohort.
- This approach is suitable for pacemaker or ICD implantation in children.
Introduction:
A number of challenges can affect long-term performance of endocardial implanted systems in pediatric patients. Select Secure™ lead offers potential advantages for this population. This analysis aims to evaluate long-term performance of this lead in children, with and without congenital heart disease.
Methods:
A retrospective analysis of all patients younger than 16years, implanted with at least one Select Secure™ lead at our institution, was performed. Clinical patient characteristics, electrical lead parameters, implant related complications, occurrence of surgical revisions and other complications were analyzed.
Results:
From 2006 to 2016, 40 pediatric patients (26 males; age: 10.3±4.6years) underwent a cardiac device implantation with at least one Select Secure™ lead. Axillary vein access was chosen in 77.5% of the procedures. The intra-atrial loop of the leads was successfully created and the generator was placed in a sub-pectoral pocket in all patients. A total of 57 Select Secure™ leads were implanted: 23 in the right atrium and 34 in the right ventricle. PM/ICDs implantation was uneventful in all 40 patients. One lead, dislodged the day after implantation, was successfully extracted and replaced in the same day. Adequate pacing parameters were achieved during a follow-up of 6±2.9years (range 0.9-10.8years).
Conclusions:
In a pediatric population, the Select Secure™ lead used in the axillary vein, the creation of an intra-atrial loop and the placement of the generator in a sub-pectoral pocket ensured a safe implantation of pacemaker or ICD and an effective stimulation at medium-term follow-up.
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