Initial Clinical Trial of a Novel Pulmonary Valved Conduit

Prodán, Zsolt; Mroczek, Tomasz; Sivalingam, Sivakumar; Bennink, Ger B.W.E.; Asch, Federico M.; Cox, Martijn; Carrel, Thierry; Yakub, Mohd Azhari; Nagy, Z; Skalski, Janusz; Svanidze, Oleg; Verhees, Luc; Klersy, Catherine; Virmani, Renu; Sreeram, Narayanswami

doi:10.1053/j.semtcvs.2021.03.036

Cited by 14 publications

(16 citation statements)

References 7 publications

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“…In situ tissue engineered heart valves provide an off-the-shelf supply that is less expensive than in vitro [60]. However, these valves have demonstrated limitations in preclinical and clinical trials, including inadequate cell adaptation and regurgitation [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]61]. Furthermore, the limited supply of correctly sized allografts presents a challenge for clinical use [34].…”

Section: Discussionmentioning

confidence: 99%

“…However, these valves have demonstrated limitations in preclinical and clinical trials, including inadequate cell adaptation and regurgitation [20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]61]. Furthermore, the limited supply of correctly sized allografts presents a challenge for clinical use [34]. Partial heart transplantation offers an alternative replacement approach for neonates and infants with irreparable congenital valvular disease.…”

Section: Discussionmentioning

confidence: 99%

“…Additionally, follow-up was not long enough to prove somatic growth of the valve with the recipient. Researchers are now testing a new design to address the challenge of regurgitation [34], but to date, this valve has not passed early clinical trials.…”

Section: Tehvs In Clinical Studies With Pediatric Patientsmentioning

confidence: 99%

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Growing Heart Valve Implants for Children

Konsek

Sherard

Bisbee

et al. 2023

JCDD

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The current standard of care for pediatric patients with unrepairable congenital valvular disease is a heart valve implant. However, current heart valve implants are unable to accommodate the somatic growth of the recipient, preventing long-term clinical success in these patients. Therefore, there is an urgent need for a growing heart valve implant for children. This article reviews recent studies investigating tissue-engineered heart valves and partial heart transplantation as potential growing heart valve implants in large animal and clinical translational research. In vitro and in situ designs of tissue engineered heart valves are discussed, as well as the barriers to clinical translation.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Growing Heart Valve Implants for Children

Konsek

Sherard

Bisbee

et al. 2023

JCDD

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“…As a result, there is considerable interest in developing biodegradable polymeric substrates for heart valve tissue engineering. Many of the substrates employed for in vitro or in vivo tissue engineering have isotropic microstructures and mechanical properties that differ from those found in native tissue, which can result in a pathological cell response leading to complications like leaflet retraction and calcification. , Therefore, mimicking the structural and mechanical properties of native heart valve leaflets could be vital for successful heart valve tissue engineering. , Polymeric substrates can be solid-porous, hydrogel, or micro-/nanofibrous. Ultimately, microfibrous substrates produced through electrospinning have exhibited the most potential to mimic the mechanical properties, fiber structure, and orientation of native leaflet tissue …”

Section: Introductionmentioning

confidence: 99%

“…The primary treatment for VHD is surgical intervention involving heart valve replacement with mechanical or bioprosthetic valves. Nonetheless, mechanical valves induce thrombosis, necessitating lifelong anticoagulation treatments for patients . Alternatively, bioprosthetic valves do not cause thrombosis but have limited durability and a relatively high prevalence of calcification and immune-medicated complications, particularly in younger patients.…”

Section: Introductionmentioning

confidence: 99%

Electrospun Elastomeric Leaflet Substrates that Structurally and Mechanically Mimic Human Aortic Valve Leaflets

Snyder

Jana

2023

ACS Appl. Polym. Mater.

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Creating leaflet substrates that accurately mimic the trilayered structure, anisotropic tensile characteristics, and elastomeric features of native human heart valve leaflets is essential to the success of heart valve tissue engineering. Earlier leaflet substrates have successfully replicated the mechanical properties of animal (porcine) heart valve leaflets. However, not one of them has been able to simultaneously replicate the trilayered structure and the highly anisotropic and elastomeric mechanical properties of human aortic heart valve leaflets. In this study, we employed a combination of polymers − polycaprolactone (PCL), poly-(trimethylene carbonate-co-L-lactide) (PTMC-LA), and poly-(trimethylene carbonate-co-caprolactone) (PTMC-CL) − in an electrospinning system to create elastomeric trilayer PCL/PTMC leaflet substrates that possess mechanical, flexural, and anisotropic properties similar to those of human native heart valve leaflets. We then compared these substrates with non-elastomeric trilayer PCL leaflet substrates to determine their effect on leaflet tissue engineering. Porcine valvular interstitial cells (PVICs) were cultured on these substrates for 1 month in static conditions to develop trilayer PCL and PCL/PTMC cell-cultured constructs. The PCL/PTMC substrates exhibited lower crystallinity and hydrophobicity than the PCL substrate, resulting in better cell adhesion and infiltration. The PCL/PTMC substrates demonstrated significantly greater cell proliferation, extracellular matrix production, and preferable gene and protein expression than the PCL substrates. Furthermore, in an osteogenic environment, the PCL/PTMC substrates showed superior resistance to calcification compared to the PCL substrates. The development of trilayer PCL/PTMC substrates with mechanical and structural characteristics resembling native tissue enhances leaflet tissue engineering.

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Electrospun Scaffolds are Not Necessarily Always Made of Nanofibers as Demonstrated by Polymeric Heart Valves for Tissue Engineering

Wang,

Gao,

Zhai

et al. 2024

Adv Healthcare Materials

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In the last 30 years, there have been nearly 60, 000 publications about electrospun nanofibers, but it is still unclear whether nanoscale fibers are really necessary for electrospun tissue engineering scaffolds. The present report puts forward this argument and reveals that compared with electrospun nanofibers, microfibers with diameter of about 3 μm (named as “oligo‐micro fiber” by us) is more appropriate for tissue engineering scaffolds owing to its better cell infiltration ability caused by larger pores with available nuclear deformation. To further increase pore sizes, electrospun poly(ε‐caprolactone) scaffolds were fabricated using latticed collectors with meshes. Fiber orientation led to sufficient mechanical strength albeit increased porosity. The latticed scaffolds exhibited good biocompatibility and improved cell infiltration. Under aortic conditions in vitro, the performances of latticed scaffolds were satisfactory in terms of the acute systolic hemodynamic functionality, except for the higher regurgitation fraction caused by the enlarged pores. This hierarchical electrospun scaffold with sparse fibers in macropores and oligo‐micro fibers in filaments provides new insight into the design of tissue engineering scaffolds, and tissue engineering may provide living heart valves with regenerative capabilities for patients with severe valve disease in the future.This article is protected by copyright. All rights reserved

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Initial Clinical Trial of a Novel Pulmonary Valved Conduit

Cited by 14 publications

References 7 publications

Growing Heart Valve Implants for Children

Growing Heart Valve Implants for Children

Electrospun Elastomeric Leaflet Substrates that Structurally and Mechanically Mimic Human Aortic Valve Leaflets

Electrospun Scaffolds are Not Necessarily Always Made of Nanofibers as Demonstrated by Polymeric Heart Valves for Tissue Engineering

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