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Feasibility, safety, and efficacy of Atrial Flow Regulator in children under 10 kg
Carles Bautista-Rodriguez1,2, Sébastien Hascoët3,4, Alain Fraisse1,2
1Pediatric Cardiology Services, Royal Brompton Hospital, Guy's & St Thomas' Foundation Trust, London, UK.
Insights
The Atrial Flow Regulator (AFR) is safe and feasible for children under 10kg, even with smaller delivery sheaths. This pediatric interatrial shunt shows promise for complex heart conditions.
Area of Science:
- Pediatric Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- The Atrial Flow Regulator (AFR) is a novel fenestrated device for creating an interatrial shunt.
- Previous reports detail AFR use in pediatric patients with Fontan failure, pulmonary hypertension, cardiomyopathy, and ECMO support.
- Limited data exists on AFR implantation in children weighing less than 10kg.
Purpose of the Study:
- To report the initial single-center experience of Atrial Flow Regulator (AFR) implantation in pediatric patients weighing under 10kg.
- To assess the feasibility and initial outcomes of AFR use in this specific low-weight pediatric population.
Main Methods:
- Retrospective analysis of four pediatric patients (<10kg) who underwent AFR implantation.
- Utilized AFR-6 and AFR-8 devices via femoral venous access with undersized delivery sheaths (9-11 Fr).
- Indications included left atrial unloading during ECMO and enlarging restrictive interatrial shunts.
Main Results:
- Successful implantation of AFR devices in all four patients, establishing unrestrictive interatrial shunts.
- Patients' ages ranged from 9-22 months, and weights from 5-8.7kg.
- One patient experienced a transient, non-occlusive inferior vena cava thrombus; all showed clinical improvement and femoral vein patency.
Conclusions:
- Atrial Flow Regulator (AFR) implantation is feasible and safe in selected pediatric patients under 10kg.
- The device can be successfully deployed using delivery sheaths 1-2 Fr smaller than manufacturer recommendations.
- Further research is warranted to confirm the long-term safety and efficacy of AFR in this pediatric cohort.
Introduction:
The Atrial Flow Regulator (AFR) is a new self-expandable percutaneous-delivered fenestrated device providing an interatrial shunt. Its use in pediatric population has been reported in failing Fontan, pulmonary hypertension, or in patients with cardiomyopathy and venoarterial extracorporeal membrane oxygenator (ECMO) support. Its use in small children under 10 kg has not been reported.
Methods:
We report the initial single center experience of the AFR implantation in children below 10 kg.
Results:
Four children underwent AFR implantation. Patients' age and weight ranged between 9 and 22 months and 5-8.7 kgs. Indications were to unload the left atrium during ECMO support for end-stage cardiomyopathy and to enlarge a restrictive interatrial shunt in two other patients with complex congenital heart diseases. Devices implanted were AFR-6 and AFR-8. Delivery sheaths used via venous femoral access were undersized and ranged from 9 to 11 Fr. Devices were successfully implanted and provided unrestrictive interatrial shunt in all cases. One child developed a nonocclusive thrombus in the inferior vena cava which resolved within 1 month. Clinical improvement and femoral vein patency were observed in all cases.
Conclusion:
AFR implantation is feasible in selected children under 10 kg. The AFR can be safely deployed through sheaths that are 1-2 Fr smaller than the recommended manufacturer size. More studies are needed to confirm safety and efficacy of the device in selected pediatric patients.
