CONGENITAL – Original SubmissionInitial Clinical Trial of a Novel Pulmonary Valved Conduit
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INTRODUCTION
The requirements for an ideal pulmonary valved conduit in children and infants are availability and durability, the ability to grow, low antigenicity and finally ease of implantation.1 None of the currently available allografts or xenografts meets all these requirements. We have previously reported favorable short-term outcome of a novel bioabsorbable restorative pulmonary valved conduit in a sheep model.2 In this study, which is part of an ongoing prospective, multicenter non-randomized,
The Valved Conduit
The valved conduit is fully synthetic, seamless, flexible, highly porous, and bioabsorbable (Xeltis Pulmonary Valved Conduit; XPV). The building blocks are based on supramolecular 2-ureido-4[1H]-pyrimidone (UPy). The conduit wall consists of poly-caprolactone-based UPy which gives a robust structure. The valve leaflets are made of poly-carbonate-based UPy, which provides flexibility for leaflet motion (Fig. 1). The XPV is designed to be absorbed and replaced by growing autologous tissue (Fig. 2
RESULTS
There were no early nor late deaths. There was no need for additional surgery in the immediate postoperative period and no conduit related acute adverse events were observed. All children were discharged within seven to 10 days after surgery. None of them has undergone reoperation. Compared to the preoperative functional class (five patients in NYHA class I, six patients in NYHA class II and one in NYHA class III), nine patients were in NYHA class I at 24 months, and three patients in NYHA
DISCUSSION
RVOT repair is a frequent procedure in children presenting with a congenital heart malformation. Types of repair include commissurotomy of the pulmonary valve, infra- and/or supravalvular patches or implantation of a RV-PA conduit using a homograft or xenograft. Pulmonary homografts would be the preferred material but they are not always available due to the scarce number of organ procurements in this age group. Xenografts are probably the most frequently used material but have also major
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Cited by (12)
Strategies for development of synthetic heart valve tissue engineering scaffolds
2023, Progress in Materials ScienceNovel Valve Choices for Pulmonary Valve Replacement
2023, Seminars in Thoracic and Cardiovascular SurgeryCommentary: Is The Vanishing Conduit The Answer For The Lack Of Ideal Conduit?
2022, Seminars in Thoracic and Cardiovascular SurgeryEvidence from clinical trials on high-risk medical devices in children: a scoping review
2024, Pediatric Research
Funding: This study was funded by an unrestricted research grant from Xeltis B.V. the Netherlands.
Conflicts of interest: Cox, Schutte and Svanidze are employees of, or hold shares/ options in Xeltis. Dr.Carrel is a member of the Advisory Board of Xeltis (without clinical involvement). F.Asch directs an academic cardiovascular imaging core laboratory with institutional contracts to Xeltis (with no personal conflict of interest). All other authors have nothing to disclose.
ClinicalTrials.gov No: NCT02700100
Regulatory approvals: Hungary: Authority: Health Registration and Training Center, Division of Medical Devices
Date: 06 June 2016
Number: 035976-005/2016/OTIG
Poland: Authority: The Office for Registration of Medicinal Products, medical Devices and Biocidal Products
Date: 20 July 2016
Number: UR.D.WM.DNB.61.2016
Malaysia: Authority: Medical Device Authority, Ministry of Health Malaysia
Date: 20 Sept 2016
Number: MDA/IDE/2016/002