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A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation
My thesis covers the clinical translation of a unique initiative at a South African tertiary institution towards a comprehensive, tailor-made African answer to a global health problem affecting millions of indigent patients outside the industrialized world. Rheumatic Heart Disease is typically a dis...
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| Format: | Thesis |
| Language: | English |
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Division of General Surgery
2025
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| _version_ | 1867613248177569792 |
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| access_status_str | Open Access |
| author | Scherman, Jacques |
| author2 | Zilla, Peter |
| author_browse | Scherman, Jacques Zilla, Peter |
| author_facet | Zilla, Peter Scherman, Jacques |
| author_sort | Scherman, Jacques |
| collection | Thesis |
| description | My thesis covers the clinical translation of a unique initiative at a South African tertiary institution towards a comprehensive, tailor-made African answer to a global health problem affecting millions of indigent patients outside the industrialized world. Rheumatic Heart Disease is typically a disease of poverty, leading to different levels of destruction of patients' heart valves in an estimated 33 million patients of low- to middle income countries globally. Heart valve surgery is often the only life-saving remedy but seriously underprovided in developing countries. Moreover, replacement heart valve prostheses were developed for degenerative pathologies prevailing in high-income countries and poorly suited for the majority of patients suffering from rheumatic heart disease. As a clinician at the interface of the developing and developed world, I dedicated the first part of my thesis establishing the shortcomings of contemporary replacement heart valves in rheumatic patients. This included one of the rare follow-up studies in indigent patients confirming the need for a radically different concept. Providing the clinical end-goals to an engineering endeavor at the University of Cape Town to develop a replacement heart valve for rheumatic patients, the second part of my PhD focused on the in-vivo translation of this concept. In the absence of an established animal model for such a trans-catheter solution, the extensive implant series I performed achieved two goals: optimization of the devices in close interaction with the engineers and establishment of anatomical inclusion/exclusion criteria in both the sheep and pig model. Based on these accomplishments, I worked out an optimal implantation technique and demonstrated short and long-term performance of the developed heart valve devices in the animal models I established. Having successfully provided all the regulatory preclinical data required for ‘first-in-human' implants, I used a statistical analysis approach to extrapolate clinical and pre-clinical data towards size predictions for the replacement valves expected to be needed in an upcoming clinical trial while also defining anatomical exclusion criteria. I trust that this comprehensive clinical and laboratory-based PhD thesis that systematically progressed through the clinical translation process of a novel university-based development complies with the high standards defining the highest of postgraduate degrees. |
| format | Thesis |
| id | oai:open.uct.ac.za:11427/41345 |
| institution | University of Cape Town (South Africa) |
| language | eng |
| last_indexed | 2026-06-10T12:33:07.122Z |
| license_str | Not specified — see source repository |
| provenance_str_mv | Harvested via OAI-PMH from UCTD — University of Cape Town Open Access Repository |
| publishDate | 2025 |
| publishDateRange | 2025 |
| publishDateSort | 2025 |
| publisher | Division of General Surgery |
| publisherStr | Division of General Surgery |
| record_format | dspace |
| source_str | UCTD — University of Cape Town Open Access Repository |
| spelling | oai:open.uct.ac.za:11427/41345 A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation Scherman, Jacques Zilla, Peter Rheumatic Heart Disease My thesis covers the clinical translation of a unique initiative at a South African tertiary institution towards a comprehensive, tailor-made African answer to a global health problem affecting millions of indigent patients outside the industrialized world. Rheumatic Heart Disease is typically a disease of poverty, leading to different levels of destruction of patients' heart valves in an estimated 33 million patients of low- to middle income countries globally. Heart valve surgery is often the only life-saving remedy but seriously underprovided in developing countries. Moreover, replacement heart valve prostheses were developed for degenerative pathologies prevailing in high-income countries and poorly suited for the majority of patients suffering from rheumatic heart disease. As a clinician at the interface of the developing and developed world, I dedicated the first part of my thesis establishing the shortcomings of contemporary replacement heart valves in rheumatic patients. This included one of the rare follow-up studies in indigent patients confirming the need for a radically different concept. Providing the clinical end-goals to an engineering endeavor at the University of Cape Town to develop a replacement heart valve for rheumatic patients, the second part of my PhD focused on the in-vivo translation of this concept. In the absence of an established animal model for such a trans-catheter solution, the extensive implant series I performed achieved two goals: optimization of the devices in close interaction with the engineers and establishment of anatomical inclusion/exclusion criteria in both the sheep and pig model. Based on these accomplishments, I worked out an optimal implantation technique and demonstrated short and long-term performance of the developed heart valve devices in the animal models I established. Having successfully provided all the regulatory preclinical data required for ‘first-in-human' implants, I used a statistical analysis approach to extrapolate clinical and pre-clinical data towards size predictions for the replacement valves expected to be needed in an upcoming clinical trial while also defining anatomical exclusion criteria. I trust that this comprehensive clinical and laboratory-based PhD thesis that systematically progressed through the clinical translation process of a novel university-based development complies with the high standards defining the highest of postgraduate degrees. 2025-04-03T12:43:16Z 2025-04-03T12:43:16Z 2024 2025-04-01T10:27:21Z Thesis / Dissertation Doctoral PhD http://hdl.handle.net/11427/41345 eng application/pdf Division of General Surgery Faculty of Health Sciences University of Cape town |
| spellingShingle | Rheumatic Heart Disease Scherman, Jacques A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation |
| thesis_degree_str | Doctoral |
| title | A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation |
| title_full | A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation |
| title_fullStr | A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation |
| title_full_unstemmed | A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation |
| title_short | A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation |
| title_sort | novel trans catheter heart valve system for low to middle income countries need assessment surgical feasibility and preclinical translation |
| topic | Rheumatic Heart Disease |
| url | http://hdl.handle.net/11427/41345 |
| work_keys_str_mv | AT schermanjacques anoveltranscatheterheartvalvesystemforlowtomiddleincomecountriesneedassessmentsurgicalfeasibilityandpreclinicaltranslation AT schermanjacques noveltranscatheterheartvalvesystemforlowtomiddleincomecountriesneedassessmentsurgicalfeasibilityandpreclinicaltranslation |