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



      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)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'


      Subscribe to Seminars in Thoracic and Cardiovascular Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect


        • Konuma T.
        • Devaney E.J.
        • Bove E.L.
        • et al.
        Performance of CryoValve SG decellularized pulmonary allografts compared with standard cryopreserved allografts.
        Ann Thorac Surg. 2009; 88: 849-855
        • Bennink G.
        • Torii S.
        • Brugmans M.
        • et al.
        A novel restorative pulmonary valved conduit in a chronic sheep model: Mid-term hemodynamic function and histologic assessment.
        J Thorac Cardiovasc Surg. 2018; 155 (e3): 2591-2601
      1. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects – WMA – The World Medical Association n.d.

      2. ISO - ISO 14155:2011 - Clinical investigation of medical devices for human subjects — Good clinical practice n.d.

        • Williams R.V.
        • Minich L.L.A.
        • Shaddy R.E.
        • et al.
        Comparison of doppler echocardiography with angiography for determining the severity of pulmonary regurgitation.
        Am J Cardiol. 2002; 89: 1438-1441
        • Zoghbi W.A.
        • Enriquez-Sarano M.
        • Foster E.
        • et al.
        Recommendations for evaluation of the severity of native valvular regurgitation with two-dimensional and doppler echocardiography.
        J Am Soc Echocardiogr. 2003; 16: 777-802
        • Wells W.J.
        • Arroyo H.
        • Bremner R.M.
        • et al.
        Homograft conduit failure in infants is not due to somatic outgrowth.
        J Thorac Cardiovasc Surg. 2002; 124: 88-96
      3. FDA Executive Summary 020003 – prepared for the September 23, 2014 meeting of the FDA's Pediatric Advisory Committee, tables 2, 3 and 9. n.d.

      4. Xeltis Bioabsorbable Pulmonary Valved Conduit Early Feasibility Study - Full Text View - n.d.

        • Morales D.
        • Herrington C.
        • Bacha E.
        • et al.
        A novel restorative pulmonary valve conduit: early outcomes of two clinical trials.
        Front Cardiovasc Med - Accept Publ. 2021;
        • Śpiewak M.
        • Petryka-Mazurkiewicz J.
        • Mazurkiewicz Ł.
        • et al.
        The impact of pulmonary regurgitation on right ventricular size and function in patients with repaired tetralogy of Fallot and additional haemodynamic abnormalities.
        Polish J Radiol. 2020; 85: 607-612

      Linked Article

      • Commentary: Is The Vanishing Conduit The Answer For The Lack Of Ideal Conduit?
        Seminars in Thoracic and Cardiovascular SurgeryVol. 34Issue 3
        • Preview
          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.
        • Full-Text
        • PDF