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Initial Clinical Trial of a Novel Pulmonary Valved Conduit

      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.

      Graphical abstract

      Keywords

      Abbreviations:

      mm Hg (pressure in millimeters of mercury), NYHA (New York Heart Association), PI (pulmonary valve insufficiency), RV (right ventricle), RVEDD (right ventricular end-diastolic diameter), RVOT (right ventricular outflow tract), SD (standard deviation), VSD (ventricular septal defect), XPV (Xeltis pulmonary valve conduit)
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      Linked Article

      • Commentary: Is The Vanishing Conduit The Answer For The Lack Of Ideal Conduit?
        Seminars in Thoracic and Cardiovascular SurgeryVol. 34Issue 3
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          Reconstruction of the right ventricular outflow tract is commonly performed in congenital heart surgery. The ideal conduit that is readily available, associated with good handling properties, excellent hemodynamics, low antigenicity, growth potential and functional durability does not exist. The search for the ideal conduit is still ongoing and several innovative alternatives to homografts and xenografts have been adopted with various degrees of success, though still far from perfect.
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