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Prospective assessment after pediatric cardiac ablation: design and implementation of the multicenter study
George F Van Hare1, Dorit Carmelli, W Mcfate Smith
1Department of Pediatrics, Stanford University, California, USA. vanhare@Stanford.edu
Insights
Radiofrequency ablation is a safe and effective treatment for pediatric supraventricular tachycardia, with a 96% success rate and low complication rates. This study assessed risks in children undergoing ablation for common heart rhythm disorders.
Area of Science:
- Pediatric Cardiology
- Electrophysiology
- Medical Device Technology
Background:
- Supraventricular tachycardia (SVT) is a common arrhythmia in children.
- Radiofrequency ablation (RFA) is a primary treatment for pediatric SVT.
- Assessing the safety and efficacy of RFA in pediatric populations is crucial.
Purpose of the Study:
- To evaluate the risks and outcomes of radiofrequency ablation in pediatric patients with supraventricular tachycardia.
- To establish a national registry for pediatric ablation procedures.
- To ensure quality control through blinded review of electrophysiological and noninvasive studies.
Main Methods:
- A multicenter prospective study involving 317 children (age 0-15 years) with SVT.
- Patients underwent clinical evaluation, ECG, Holter monitoring, and echocardiography.
- A national registry collected data on all pediatric ablation procedures, with blinded outside review for quality control.
Main Results:
- The overall success rate for radiofrequency ablation was 96%.
- The complication rate for the electrophysiological study was 4.3%.
- The complication rate for the ablation procedure itself was 2.9%.
Conclusions:
- Radiofrequency ablation is a highly successful and safe procedure for treating pediatric supraventricular tachycardia.
- The study's findings support the safety profile of RFA in young patients.
- The comparable data between the prospective study and the national registry indicate a lack of bias in the study sample.
Abstract:
A multicenter prospective study was designed and implemented as an activity of the Pediatric Electrophysiology Society to assess the risks associated with radiofrequency ablation in children. Patients (age 0-15 years) with supraventricular tachycardia due to accessory pathways or atrioventricular nodal reentry were enrolled and studied prior to ablation and periodically by clinical evaluation, electrocardiogram (ECG), Holter monitor, and echocardiogram. In addition, a national registry was established, to which the contributing centers report all pediatric patients undergoing ablation at their center. Initial electrophysiological study tracings and all noninvasive studies undergo blinded outside review for quality control. Clinical endpoints were death, recurrence, proarrhythmia, and echocardiographic abnormality. A pilot study demonstrated excellent agreement concerning diagnoses of previously reported ablation patients between the reporting center and the blinded reviewer (kappa = 0.938 +/- 0.062). A total of 317 patients were enrolled in the ongoing study from April 1, 1999 to December 31, 2000. The success rate of ablations was 96% with a complication rate of 4.3% for electrophysiological study and 2.9% for the ablation procedure. Comparison of the registry group versus the study group shows that the groups are comparable in terms of patient characteristics, diagnoses, and the results of ablation making it less likely that the sample of prospectively enrolled patients is biased.