Frontiers in Cardiovascular Medicine (Mar 2021)

A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials

  • David L. Morales,
  • Cynthia Herrington,
  • Emile A. Bacha,
  • Victor O. Morell,
  • Zsolt Prodán,
  • Tomasz Mroczek,
  • Sivakumar Sivalingam,
  • Martijn Cox,
  • Gerardus Bennink,
  • Federico M. Asch

DOI
https://doi.org/10.3389/fcvm.2020.583360
Journal volume & issue
Vol. 7

Abstract

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Objectives: We report the first use of a biorestorative valved conduit (Xeltis pulmonary valve–XPV) in children. Based on early follow-up data the valve design was modified; we report on the comparative performance of the two designs at 12 months post-implantation.Methods: Twelve children (six male) median age 5 (2 to 12) years and weight 17 (10 to 43) kg, had implantation of the first XPV valve design (XPV-1, group 1; 16 mm (n = 5), and 18 mm (n = 7). All had had previous surgery. Based on XPV performance at 12 months, the leaflet design was modified and an additional six children (five male) with complex malformations, median age 5 (3 to 9) years, and weight 21 (14 to 29) kg underwent implantation of the new XPV (XPV-2, group 2; 18 mm in all). For both subgroups, the 12 month clinical and echocardiographic outcomes were compared.Results: All patients in both groups have completed 12 months of follow-up. All are in NYHA functional class I. Seventeen of the 18 conduits have shown no evidence of progressive stenosis, dilation or aneurysm formation. Residual gradients of >40 mm Hg were observed in three patients in group 1 due to kinking of the conduit (n = 1), and peripheral stenosis of the branch pulmonary arteries (n = 2). In group 2, one patient developed rapidly progressive stenosis of the proximal conduit anastomosis, requiring conduit replacement. Five patients in group 1 developed severe pulmonary valve regurgitation (PI) due to prolapse of valve leaflet. In contrast, only one patient in group 2 developed more than mild PI at 12 months, which was not related to leaflet prolapse.Conclusions: The XPV, a biorestorative valved conduit, demonstrated promising early clinical outcomes in humans with 17 of 18 patients being free of reintervention at 1 year. Early onset PI seen in the XPV-1 version seems to have been corrected in the XPV-2, which has led to the approval of an FDA clinical trial.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708.

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