Initial Clinical Trial of a Novel Pulmonary Valved Conduit

• Published in: Seminars in thoracic and cardiovascular surgery Vol. 34; no. 3; pp. 985 - 991
• Main Authors: Prodan, Zsolt, Mroczek, Tomasz, Sivalingam, Sivakumar, Bennink, Ger, Asch, Federico M., Cox, Martijn, Carrel, Thierry, Yakub, Mohd Azhari, Nagy, Zsolt, Skalski, Janusz, Svanidze, Oleg, Schutte, Eliane, Verhees, Luc, Klersy, Catherine, Virmani, Renu, Sreeram, Narayanswami
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-01-2022
• Subjects: Bioabsorbable; Conduit; Pulmonary valve; NYHA; SD; RV; Bioabsorbable; Conduit; VSD; PI; RVEDD; Pulmonary valve; mm Hg; RVOT; XPV; bioabsorbable; pulmonary valve; conduit
• ISSN: 1043-0679; 1532-9488
• DOI: 10.1053/j.semtcvs.2021.03.036

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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