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
Full text not available from this repository.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 | ||||||||||||||||||||||||||||||||||||||||||||
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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 | ||||||||||||||||||||||||||||||||||||||||||||
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URI: | http://kups.ub.uni-koeln.de/id/eprint/59889 |
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