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The Safety and Effectiveness of Flecainide in Children in the Current Era
Taylor Cunningham1, Orhan Uzun1,2, Rachel Morris2
1Children's Heart Centre, British Columbia's Children's Hospital, 1F9, 4480 Oak Street, Vancouver, BC, V6H 3V4, Canada.
Insights
Flecainide is a safe and effective antiarrhythmic drug for children, including those with congenital heart disease (CHD). This study found similar safety and effectiveness in children with and without CHD, with low adverse event rates.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
- Cardiac Electrophysiology
Background:
- Flecainide is an antiarrhythmic medication used in adults.
- Its safety and efficacy in pediatric populations, particularly those with congenital heart disease (CHD), require further investigation.
- Existing data on flecainide use in children with CHD is limited.
Purpose of the Study:
- To evaluate the safety and effectiveness of flecainide in children with normal hearts.
- To assess flecainide's safety and effectiveness in pediatric patients with congenital heart disease (CHD) or cardiomyopathy (CMO).
- To compare adverse event rates and treatment outcomes between children with and without CHD.
Main Methods:
- Retrospective study analyzing data from two pediatric cardiology sites (2000-2015).
- Included 175 pediatric patients receiving flecainide, with a subgroup of 20 patients having CHD and two with CMO.
- Compared outcomes, including adverse events and arrhythmia control, between patients with CHD and those with normal hearts.
Main Results:
- Flecainide was well-tolerated in the overall cohort, with fewer than 3% discontinuing due to adverse events.
- No significant difference in adverse event incidence was observed between children with normal hearts and those with CHD.
- Arrhythmia control rates were high in both groups (90% in CHD patients vs. 77% in normal heart patients), with no cardiac arrests during follow-up.
Conclusions:
- Flecainide is a safe and effective antiarrhythmic treatment for children, including those with underlying CHD.
- Contrary to some adult studies, flecainide demonstrated comparable safety in pediatric patients with and without CHD.
- The findings support the use of flecainide in pediatric patients requiring antiarrhythmic therapy, irrespective of underlying cardiac conditions.
Abstract:
This retrospective study sought to determine the safety and effectiveness of flecainide in children with normal hearts and those with congenital heart disease (CHD) or cardiomyopathy (CMO). Baseline and follow-up data at two pediatric cardiology sites were queried (2000-2015); a total of 175 patients (20 with CHD and two with CMO) receiving flecainide were assessed. When comparing patients with CHD to those with normal hearts, patients with CHD were younger at diagnosis (median age 19 days; IQR 3-157.5 days vs normal heart patients median age 21 days; IQR 7-172 days, p = 0.4) and severe cardiac dysfunction was more prevalent (30% in CHD patients vs 8% in normal heart patients, p = 0.009). Treatment duration did not differ between the two groups (CHD patients median duration 52 weeks; IQR 27-91.5 weeks vs normal heart patients median duration 55 weeks; IQR 32-156 weeks, p = 0.5). Cardiac dysfunction resulting in flecainide discontinuation occurred in two patients (1%), one with CHD and one without. Three patients experienced proarrhythmia (2%) and there were no cardiac arrests during follow-up. There was one death in this cohort in a patient with severe CHD and an RSV infection (<1%). Arrhythmia control did not differ between the groups (90% in CHD patients vs 77% in normal heart patients, p = 0.2). Flecainide was well tolerated in this cohort, with fewer than 3% discontinuing medication due to flecainide-associated adverse events. Contrary to adult studies, there was no difference in the incidence of adverse events between patients with normal hearts and patients with CHD. Flecainide is a safe and effective antiarrhythmic medication, even for children with underlying CHD.
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