Universität zu Köln

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
Creators:	Creators Email ORCID ORCID Put Code Morales, David L. UNSPECIFIED UNSPECIFIED UNSPECIFIED Herrington, Cynthia UNSPECIFIED UNSPECIFIED UNSPECIFIED Bacha, Emile A. UNSPECIFIED UNSPECIFIED UNSPECIFIED Morell, Victor O. UNSPECIFIED UNSPECIFIED UNSPECIFIED Prodan, Zsolt UNSPECIFIED UNSPECIFIED UNSPECIFIED Mroczek, Tomasz UNSPECIFIED UNSPECIFIED UNSPECIFIED Sivalingam, Sivakumar UNSPECIFIED UNSPECIFIED UNSPECIFIED Cox, Martijn UNSPECIFIED UNSPECIFIED UNSPECIFIED Bennink, Gerardus UNSPECIFIED UNSPECIFIED UNSPECIFIED Asch, Federico M. UNSPECIFIED UNSPECIFIED UNSPECIFIED
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:	Keywords Language VENTRICULAR OUTFLOW TRACT; HEART-VALVE; ALLOGRAFTS; FAILURE Multiple languages Cardiac & Cardiovascular Systems Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/59889