A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation
| dc.contributor.advisor | Zilla, Peter | |
| dc.contributor.author | Scherman, Jacques | |
| dc.date.accessioned | 2025-04-03T12:43:16Z | |
| dc.date.available | 2025-04-03T12:43:16Z | |
| dc.date.issued | 2024 | |
| dc.date.updated | 2025-04-01T10:27:21Z | |
| dc.description.abstract | 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. | |
| dc.identifier.apacitation | Scherman, J. (2024). <i>A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation</i>. (). University of Cape town ,Faculty of Health Sciences ,Division of General Surgery. Retrieved from http://hdl.handle.net/11427/41345 | en_ZA |
| dc.identifier.chicagocitation | Scherman, Jacques. <i>"A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation."</i> ., University of Cape town ,Faculty of Health Sciences ,Division of General Surgery, 2024. http://hdl.handle.net/11427/41345 | en_ZA |
| dc.identifier.citation | Scherman, J. 2024. A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation. . University of Cape town ,Faculty of Health Sciences ,Division of General Surgery. http://hdl.handle.net/11427/41345 | en_ZA |
| dc.identifier.ris | TY - Thesis / Dissertation AU - Scherman, Jacques AB - 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. DA - 2024 DB - OpenUCT DP - University of Cape Town KW - Rheumatic Heart Disease LK - https://open.uct.ac.za PB - University of Cape town PY - 2024 T1 - A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation TI - A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation UR - http://hdl.handle.net/11427/41345 ER - | en_ZA |
| dc.identifier.uri | http://hdl.handle.net/11427/41345 | |
| dc.identifier.vancouvercitation | Scherman J. A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation. []. University of Cape town ,Faculty of Health Sciences ,Division of General Surgery, 2024 [cited yyyy month dd]. Available from: http://hdl.handle.net/11427/41345 | en_ZA |
| dc.language.rfc3066 | eng | |
| dc.publisher.department | Division of General Surgery | |
| dc.publisher.faculty | Faculty of Health Sciences | |
| dc.publisher.institution | University of Cape town | |
| dc.subject | Rheumatic Heart Disease | |
| dc.title | A novel trans-catheter heart valve system for low- to middle-income countries: need assessment, surgical feasibility and preclinical translation | |
| dc.type | Thesis / Dissertation | |
| dc.type.qualificationlevel | Doctoral | |
| dc.type.qualificationlevel | PhD |