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Initial Clinical Trial of a Novel Pulmonary Valved Conduit
Zsolt Prodan1, Tomasz Mroczek2, Sivakumar Sivalingam3
1Pediatric Cardiac Surgery, Children's Heart Center, Budapest, Hungary.
Insights
A novel bioabsorbable pulmonary valve conduit (XPV) shows promise for right ventricular outflow tract reconstruction in children. While durable at 24 months, further design improvements are needed to address pulmonary valve insufficiency.
Area of Science:
- Pediatric Cardiac Surgery
- Biomaterials in Medicine
- Cardiovascular Engineering
Background:
- Current valved conduits (allografts, xenografts) for right ventricular outflow tract (RVOT) reconstruction in children have limited durability and do not promote growth.
- This necessitates the development of innovative, long-lasting alternatives for pediatric cardiac surgery.
Purpose of the Study:
- To report the initial clinical outcomes of the first use of a completely bioabsorbable valved conduit (Xeltis pulmonary valve - XPV) in pediatric patients undergoing RVOT reconstruction.
Main Methods:
- Twelve children with complex congenital heart defects requiring RVOT reconstruction received the XPV conduit.
- Conduit diameters of 16mm and 18mm were utilized.
- Patients were followed for 24 months post-implantation.
Main Results:
- No patient required re-intervention within 24 months.
- Most patients (9/12) were in NYHA functional class I, with three in class II.
- No conduit showed stenosis, dilation, or aneurysm, but three had residual gradients. Severe pulmonary valve insufficiency (PI) occurred in five patients, primarily due to leaflet prolapse.
Conclusions:
- The XPV conduit represents a promising innovation for RVOT reconstruction in children, demonstrating durability at 24 months.
- Further design modifications, particularly for valve leaflet geometry and thickness, are necessary to mitigate progressive pulmonary valve insufficiency.
Abstract:
Valved allografts and xenografts for reconstruction of the right ventricular outflow tract (RVOT) lack durability and do not grow. We report the first clinical use of a completely bioabsorbable valved conduit (Xeltis pulmonary valve - XPV) in children. Twelve children (six male), median age five (two to twelve) years and median weight 17 (10 to 43) kg, underwent RVOT reconstruction with the XPV. Diagnoses were: pulmonary atresia with ventricular septal defect (VSD) (n = 4), tetralogy of Fallot (n = 4), common arterial trunk (n = 3), and transposition of the great arteries with VSD and pulmonary stenosis (n = 1). All had had previous surgery, including prior RVOT conduit implantation in six. Two diameters of conduit 16mm (n = 5) and 18mm (n = 7) were used. At 24 months none of the patients has required surgical re-intervention, 9 of the 12 are in NYHA functional class I and three patients in NYHA class II. None of the conduits has shown evidence of progressive stenosis, dilation or aneurysm formation. Residual peak gradient of >40 mm Hg was observed in three patients, caused by kinking of the conduit at implantation in 1 and distal stenosis in the peripheral pulmonary arteries in 2 patients. Five patients developed severe pulmonary valve insufficiency (PI); the most common mechanism was prolapse of at least one of the valve leaflets. The XPV conduit is a promising innovation for RVOT reconstruction. Progressive PI requires however an improved design (geometry, thickness) of the valve leaflets.
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