Polymeric Transcatheter Heart Valves

dc.contributor.advisorBezuidenhout, Deon
dc.contributor.advisorde Villiers, Jandre
dc.contributor.authorCoetzee, Johan
dc.date.accessioned2022-08-30T08:37:08Z
dc.date.available2022-08-30T08:37:08Z
dc.date.issued2019
dc.date.updated2022-07-20T09:36:23Z
dc.description.abstractRheumatic heart disease (RHD) is one of the main causes of heart disease in the emerging world. Once the disease has become symptomatic valve repair or replacement is the only treatment currently available. Commercial bioprosthetic valves (surgical and transcatheter) suffer from calcification and decreased durability, especially when implanted into younger patients, while mechanical surgical valves require life-long anticoagulation. Polymeric transcatheter aortic valve insertion (TAVI) is proposed as a solution to provide long-term durability without the need for anticoagulation. A manufacturing method involving the spray coating of polyurethane solutions onto valve moulds, pre-coating a TAVI stent with a polyurethane of higher durometer, and subsequently spraying the combination of the stent and the mould to form integral attachments of the leaflets, is described. Valves were tested for leaflet thickness distribution, hydrodynamic function and accelerated durability, and subsequently implanted in an acute ovine TAVI model as proof of concept. Effective Orifice Area (EOA) >1.7 cm2, regurgitation < 10% and transvalvular pressure gradient < 10 mmHg were achieved. Leaflet thickness correlated indirectly with the EOA and directly with transvalvular pressure gradient, but not regurgitation. After iterative improvements in the manufacturing process, valves with average thicknesses ranging from 140 to 160 μm showed highest durability (>150 million, and up to 600 million cycles). Surface roughness was reduced by applying a final pure solvent coat. Implanted valves showed good function, with no apparent central or paravalvular regurgitation, perfusion of coronaries, and EOA greater than1.6 cm2. In conclusion, a polymeric TAVI valve made by a new manufacturing method showed durability up to 15 years equivalent in vitro, and good hydrodynamic function in vitro and in vivo. The devices hold many potential advantages in terms of automation and cost of manufacturing, as well as function and longevity.
dc.identifier.apacitationCoetzee, J. (2019). <i>Polymeric Transcatheter Heart Valves</i>. (). ,Faculty of Health Sciences ,Division of General Surgery. Retrieved from http://hdl.handle.net/11427/36761en_ZA
dc.identifier.chicagocitationCoetzee, Johan. <i>"Polymeric Transcatheter Heart Valves."</i> ., ,Faculty of Health Sciences ,Division of General Surgery, 2019. http://hdl.handle.net/11427/36761en_ZA
dc.identifier.citationCoetzee, J. 2019. Polymeric Transcatheter Heart Valves. . ,Faculty of Health Sciences ,Division of General Surgery. http://hdl.handle.net/11427/36761en_ZA
dc.identifier.ris TY - Master Thesis AU - Coetzee, Johan AB - Rheumatic heart disease (RHD) is one of the main causes of heart disease in the emerging world. Once the disease has become symptomatic valve repair or replacement is the only treatment currently available. Commercial bioprosthetic valves (surgical and transcatheter) suffer from calcification and decreased durability, especially when implanted into younger patients, while mechanical surgical valves require life-long anticoagulation. Polymeric transcatheter aortic valve insertion (TAVI) is proposed as a solution to provide long-term durability without the need for anticoagulation. A manufacturing method involving the spray coating of polyurethane solutions onto valve moulds, pre-coating a TAVI stent with a polyurethane of higher durometer, and subsequently spraying the combination of the stent and the mould to form integral attachments of the leaflets, is described. Valves were tested for leaflet thickness distribution, hydrodynamic function and accelerated durability, and subsequently implanted in an acute ovine TAVI model as proof of concept. Effective Orifice Area (EOA) >1.7 cm2, regurgitation < 10% and transvalvular pressure gradient < 10 mmHg were achieved. Leaflet thickness correlated indirectly with the EOA and directly with transvalvular pressure gradient, but not regurgitation. After iterative improvements in the manufacturing process, valves with average thicknesses ranging from 140 to 160 μm showed highest durability (>150 million, and up to 600 million cycles). Surface roughness was reduced by applying a final pure solvent coat. Implanted valves showed good function, with no apparent central or paravalvular regurgitation, perfusion of coronaries, and EOA greater than1.6 cm2. In conclusion, a polymeric TAVI valve made by a new manufacturing method showed durability up to 15 years equivalent in vitro, and good hydrodynamic function in vitro and in vivo. The devices hold many potential advantages in terms of automation and cost of manufacturing, as well as function and longevity. DA - 2019_ DB - OpenUCT DP - University of Cape Town KW - Biomaterials LK - https://open.uct.ac.za PY - 2019 T1 - Polymeric Transcatheter Heart Valves TI - Polymeric Transcatheter Heart Valves UR - http://hdl.handle.net/11427/36761 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/36761
dc.identifier.vancouvercitationCoetzee J. Polymeric Transcatheter Heart Valves. []. ,Faculty of Health Sciences ,Division of General Surgery, 2019 [cited yyyy month dd]. Available from: http://hdl.handle.net/11427/36761en_ZA
dc.language.rfc3066eng
dc.publisher.departmentDivision of General Surgery
dc.publisher.facultyFaculty of Health Sciences
dc.subjectBiomaterials
dc.titlePolymeric Transcatheter Heart Valves
dc.typeMaster Thesis
dc.type.qualificationlevelMasters
dc.type.qualificationlevelMSc
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