Morales, David L., Herrington, Cynthia, Bacha, Emile A., Morell, Victor O., Prodan, Zsolt, Mroczek, Tomasz, Sivalingam, Sivakumar, Cox, Martijn, Bennink, Gerardus and Asch, Federico M. (2021). A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials. Front. Cardiovasc. Med., 7. LAUSANNE: FRONTIERS MEDIA SA. ISSN 2297-055X

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Abstract

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 18mm (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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Morales, David L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Herrington, CynthiaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bacha, Emile A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morell, Victor O.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Prodan, ZsoltUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mroczek, TomaszUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sivalingam, SivakumarUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Cox, MartijnUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bennink, GerardusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Asch, Federico M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-598894
DOI: 10.3389/fcvm.2020.583360
Journal or Publication Title: Front. Cardiovasc. Med.
Volume: 7
Date: 2021
Publisher: FRONTIERS MEDIA SA
Place of Publication: LAUSANNE
ISSN: 2297-055X
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
VENTRICULAR OUTFLOW TRACT; HEART-VALVE; ALLOGRAFTS; FAILUREMultiple languages
Cardiac & Cardiovascular SystemsMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/59889

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