TY - JOUR
T1 - Initial Clinical Trial of a Novel Pulmonary Valved Conduit
AU - the Xeltis BV Working Group
AU - Prodan, Zsolt
AU - Mroczek, Tomasz
AU - Sivalingam, Sivakumar
AU - Bennink, Ger
AU - Asch, Federico M.
AU - Cox, Martijn
AU - Carrel, Thierry
AU - Yakub, Mohd Azhari
AU - Nagy, Zsolt
AU - Skalski, Janusz
AU - Svanidze, Oleg
AU - Schutte, Eliane
AU - Verhees, Luc
AU - Klersy, Catherine
AU - Virmani, Renu
AU - Sreeram, Narayanswami
N1 - Funding Information:
Funding: This study was funded by an unrestricted research grant from Xeltis B.V. the Netherlands .
Publisher Copyright:
© 2021
PY - 2021
Y1 - 2021
N2 - 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.
AB - 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.
KW - Bioabsorbable
KW - Conduit
KW - Pulmonary valve
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U2 - 10.1053/j.semtcvs.2021.03.036
DO - 10.1053/j.semtcvs.2021.03.036
M3 - Comment/debate
C2 - 33984478
AN - SCOPUS:85107755112
JO - Seminars in Thoracic and Cardiovascular Surgery
JF - Seminars in Thoracic and Cardiovascular Surgery
SN - 1043-0679
ER -