A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials
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. Twelve children (six male) median age 5 (2 to...
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Published in | Frontiers in cardiovascular medicine Vol. 7; p. 583360 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English |
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04.03.2021
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Abstract | 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.
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 (
= 5), and 18 mm (
= 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.
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 (
= 1), and peripheral stenosis of the branch pulmonary arteries (
= 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.
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.
www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708. |
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AbstractList | 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 18 mm (
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.
Clinical Trial Registration:
www.ClinicalTrials.gov
, identifier: NCT02700100 and NCT03022708. 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. 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 ( = 5), and 18 mm ( = 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. 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 ( = 1), and peripheral stenosis of the branch pulmonary arteries ( = 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. 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. www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708. 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 18 mm (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.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02700100 and NCT03022708. |
Author | Morell, Victor O Prodán, Zsolt Herrington, Cynthia Bennink, Gerardus Sivalingam, Sivakumar Cox, Martijn Mroczek, Tomasz Asch, Federico M Bacha, Emile A Morales, David L |
AuthorAffiliation | 1 Department of Cardiothoracic Surgery, Cincinnati Children's Hospital Medical Center , Cincinnati, OH , United States 7 Department of Cardiothoracic Surgery, Institut Jantung Negara , Kuala Lumpur , Malaysia 8 Xeltis BV , Eindhoven , Netherlands 10 Cardiovascular Core Laboratories, MedStar Health Research Institute , Washington, DC , United States 9 Department of Cardiothoracic Surgery, University Hospital of Cologne , Cologne , Germany 6 Department of Pediatric Cardiac Surgery, Jagiellonian University , Krakow , Poland 2 Division of Cardiothoracic Surgery, Children's Hospital Los Angeles , Los Angeles, CA , United States 5 Department of Pediatric Heart Surgery, Gottsegen György Hungarian Institute of Cardiology , Budapest , Hungary 3 Division of CardioThoracic Surgery, Columbia University Medical Center , New York, NY , United States 4 Division of Pediatric Cardiothoracic Surgery, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center , Pittsburgh, PA , United States |
AuthorAffiliation_xml | – name: 2 Division of Cardiothoracic Surgery, Children's Hospital Los Angeles , Los Angeles, CA , United States – name: 8 Xeltis BV , Eindhoven , Netherlands – name: 4 Division of Pediatric Cardiothoracic Surgery, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center , Pittsburgh, PA , United States – name: 5 Department of Pediatric Heart Surgery, Gottsegen György Hungarian Institute of Cardiology , Budapest , Hungary – name: 9 Department of Cardiothoracic Surgery, University Hospital of Cologne , Cologne , Germany – name: 3 Division of CardioThoracic Surgery, Columbia University Medical Center , New York, NY , United States – name: 10 Cardiovascular Core Laboratories, MedStar Health Research Institute , Washington, DC , United States – name: 1 Department of Cardiothoracic Surgery, Cincinnati Children's Hospital Medical Center , Cincinnati, OH , United States – name: 7 Department of Cardiothoracic Surgery, Institut Jantung Negara , Kuala Lumpur , Malaysia – name: 6 Department of Pediatric Cardiac Surgery, Jagiellonian University , Krakow , Poland |
Author_xml | – sequence: 1 givenname: David L surname: Morales fullname: Morales, David L organization: Department of Cardiothoracic Surgery, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, United States – sequence: 2 givenname: Cynthia surname: Herrington fullname: Herrington, Cynthia organization: Division of Cardiothoracic Surgery, Children's Hospital Los Angeles, Los Angeles, CA, United States – sequence: 3 givenname: Emile A surname: Bacha fullname: Bacha, Emile A organization: Division of CardioThoracic Surgery, Columbia University Medical Center, New York, NY, United States – sequence: 4 givenname: Victor O surname: Morell fullname: Morell, Victor O organization: Division of Pediatric Cardiothoracic Surgery, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, Pittsburgh, PA, United States – sequence: 5 givenname: Zsolt surname: Prodán fullname: Prodán, Zsolt organization: Department of Pediatric Heart Surgery, Gottsegen György Hungarian Institute of Cardiology, Budapest, Hungary – sequence: 6 givenname: Tomasz surname: Mroczek fullname: Mroczek, Tomasz organization: Department of Pediatric Cardiac Surgery, Jagiellonian University, Krakow, Poland – sequence: 7 givenname: Sivakumar surname: Sivalingam fullname: Sivalingam, Sivakumar organization: Department of Cardiothoracic Surgery, Institut Jantung Negara, Kuala Lumpur, Malaysia – sequence: 8 givenname: Martijn surname: Cox fullname: Cox, Martijn organization: Xeltis BV, Eindhoven, Netherlands – sequence: 9 givenname: Gerardus surname: Bennink fullname: Bennink, Gerardus organization: Department of Cardiothoracic Surgery, University Hospital of Cologne, Cologne, Germany – sequence: 10 givenname: Federico M surname: Asch fullname: Asch, Federico M organization: Cardiovascular Core Laboratories, MedStar Health Research Institute, Washington, DC, United States |
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ContentType | Journal Article |
Copyright | Copyright © 2021 Morales, Herrington, Bacha, Morell, Prodán, Mroczek, Sivalingam, Cox, Bennink and Asch. Copyright © 2021 Morales, Herrington, Bacha, Morell, Prodán, Mroczek, Sivalingam, Cox, Bennink and Asch. 2021 Morales, Herrington, Bacha, Morell, Prodán, Mroczek, Sivalingam, Cox, Bennink and Asch |
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Keywords | clinical trial RVOT reconstruction biocompatibility pulmonary valved conduit endogenous tissue restoration |
Language | English |
License | Copyright © 2021 Morales, Herrington, Bacha, Morell, Prodán, Mroczek, Sivalingam, Cox, Bennink and Asch. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
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Notes | Edited by: Paolo Madeddu, University of Bristol, United Kingdom This article was submitted to Cardiovascular Biologics and Regenerative Medicine, a section of the journal Frontiers in Cardiovascular Medicine Reviewed by: Huseyin Cagatay Yalcin, Qatar University, Qatar; Sharan Ramaswamy, Florida International University, United States |
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Snippet | 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... 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... 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... |
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StartPage | 583360 |
SubjectTerms | biocompatibility Cardiovascular Medicine clinical trial endogenous tissue restoration pulmonary valved conduit RVOT reconstruction |
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Title | A Novel Restorative Pulmonary Valve Conduit: Early Outcomes of Two Clinical Trials |
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