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

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

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=7

YEAR=2021

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2020.583360

DOI=10.3389/fcvm.2020.583360

ISSN=2297-055X

ABSTRACT=<p><bold>Objectives:</bold> 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.</p><p><bold>Methods:</bold> 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 (<italic>n</italic> = 5), and 18 mm (<italic>n</italic> = 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.</p><p><bold>Results:</bold> 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 &gt;40 mm Hg were observed in three patients in group 1 due to kinking of the conduit (<italic>n</italic> = 1), and peripheral stenosis of the branch pulmonary arteries (<italic>n</italic> = 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.</p><p><bold>Conclusions:</bold> 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.</p><p><bold>Clinical Trial Registration:</bold><ext-link ext-link-type="uri" xlink:href="http://www.ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">www.ClinicalTrials.gov</ext-link>, identifier: NCT02700100 and NCT03022708.</p>