Aortic Valve Analysis and Area Prediction using Bayesian Modeling Miheer S. Ghotikar ABSTRACT Aortic valve stenosis affects approximately 5 out of every 10,000 people in the United States. [3] This disorder causes decrease in the aortic valve opening area increasing resistance to blood flow. Detection of early stages of valve malfunction is an important area of research to enable new treatments and develop strategies in order to delay degenerative progression. Analysis of relationship between valve properties and hemodynamic factors is critical to develop and validate these strategies. Porcine aortic valves are anatomically analogous to human aortic valves. Fixation agents modify the valves in such a manner to mimic increased leaflet stiffness due to early degeneration. In this study, porcine valves treated with glutaraldehyde, a cross-linking agent and ethanol, a dehydrating agent were used to alter leaflet material properties. The hydraulic performance of ethanol and glutaraldehyde treated valves was compared to fresh valves using a programmable pulse duplicator that could simulate physiological conditions. Hydraulic conditions in the pulse duplicator were modified by varying mean flow rate and mean arterial pressure. Pressure drops across the aortic valve, flow rate and back pressure (mean arterial pressure) values were recorded at successive instants of time. Corresponding values of pressure gradient were measured, while aortic valve opening area was obtained from photographic data. Effects of glutaradehyde cross-linking and ethanol dehydration on the aortic valve area for different hydraulic conditions that emulated hemodynamic physiological conditions were analyzed and it was observed that glutaradehyde and ethanol fixation causes changes in aortic valve opening and closing patterns. Next, relations between material properties, experimental conditions, and hydraulic measures of valve performance were studied using a Bayesian model approach. The primary hypothesis tested in this study was that a Bayesian network could be used to predict dynamic changes in the aortic valve area given the hemodynamic conditions. A Bayesian network encodes probabilistic relationships among variables of interest, also representing causal relationships between temporal antecedents and outcomes. A Learning Bayesian Network was constructed; direct acyclic graphs were drawn in GeNIe 2.0ʾ using an information theory dependency algorithm. Mutual Information was calculated between every set of parameters. Conditional probability tables and cut-sets were obtained from the data with the use of Matlabʾ. A Bayesian model was built for predicting dynamic values of opening and closing area for fresh, ethanol fixed and glutaradehyde fixed aortic valves for a set of hemodynamic conditions. Separate models were made for opening and closing cycles. The models predicted aortic valve area for fresh, ethanol fixed and glutaraldehyde fixed valves. As per the results obtained from the model, it can be concluded that the Bayesian network works successfully with the performance of porcine valves in a pulse duplicator. Further work would include building the Bayesian network with additional parameters and patient data for predicting aortic valve area of patients with progressive stenosis. The important feature would be to predict valve degenration based on valve opening or closing pattern.

Valve replacement for critical heart valve diseases is in many cases not an option. Our clinical experience in pediatric compassionate care has shown robust function of porcine small intestinal submucosa (PSIS) valves. We assessed functional effectiveness of 4ply (~320µm) and 2ply (~166µm) PSIS mitral valves under pediatric-relevant hemodynamic pulsatile conditions. Key conclusions: (i)PSIS valves demonstrated statistically similar acute functionality in comparison to a commercially available valve. (ii)Energy losses were similar (p>0.05) under pediatric conditions which was not the case under adult aortic conditions. (iii)2ply valves were observed to be superior to 4ply, based on the robust hydrodynamic data, the mechanical properties suitable for pediatric applications and de-novo tissue replacement potential with less demand on the body. Demonstrating somatic growth, valve tissue filling matching PSIS degradation and PSIS-valve fatigue assessment are critical endeavors that need to be carried out to ensure mid to long term function of these bioscaffold mitral valves.

Orientador: Eduardo Tavares Costa / Dissertação (mestrado) - Universidade Estadual de Campinas, Faculdade de Engenharia Eletrica e de Computação / Made available in DSpace on 2018-08-12T13:09:13Z (GMT). No. of bitstreams: 1 Cheade_EduardodeLima_M.pdf: 4329649 bytes, checksum: cccb5144d6d74ac9e7db94da82d1e776 (MD5) Previous issue date: 2008 / Resumo: A utilização de próteses de válvulas cardíacas tanto mecânicas quanto biológicas tem se tornado cada vez mais freqüente. Estas próteses devem ser avaliadas (testes in-vitro e in-vivo) para que sejam utilizadas clinicamente. Os testes de desempenho hidrodinâmico são realizados in vitro, e a análise dos resultados é importante para a classificação e caracterização de uma determinada prótese, sendo atualmente um dos requisitos obrigatórios exigido por órgãos reguladores para a aprovação de próteses a serem empregadas clinicamente. Os testes de desempenho hidrodinâmico são realizados por sistemas complexos, denominados duplicadores de pulso, cuja finalidade é reproduzir o comportamento hidrodinâmico do coração e simular as variáveis fisiológicas às quais as válvulas são normalmente submetidas em condições reais. Neste trabalho foi desenvolvido, para uso na empresa Braile Biomédica, utilizando a plataforma de programação LabVIEW®, um programa capaz de fazer a aquisição e interpretação dos sinais de fluxo e pressão provenientes de transdutores específicos, bem como a realização dos cálculos necessários e a geração de um relatório resultante do teste. Também foram desenvolvidos circuitos condicionadores de sinais para os transdutores de pressão e fluxo inerentes ao sistema duplicador de pulso existente na empresa. A partir das medidas e dos gráficos de pressão e fluxo é possível calcular os seguintes parâmetros: área específica do orifício, coeficiente de descarga, fração de regurgitação e índices de performance e eficiência da válvula. / Abstract: It has become very frequent the use of mechanic or biological cardiac valve prostheses. These prostheses must be evaluated (in vitro and in vivo tests) in order to be used clinically. The hydrodynamic performance tests are carried out in vitro. The analyses of the test results are very important for the characterizations and classification of a given prosthesis, being one of mandatory requirements of the regulatory organs in order to approve its clinical use. The hydrodynamic performance tests are carried out by complex systems often called pulse duplicators, which must reproduce the heart hydrodynamic behaviour and simulate the physiological variables that the cardiac valves are submitted in real conditions. In this work it has been developed a software program to be used at Braile Biomedica based on the LabVIEW® platform, capable of acquiring and processing flux and pressure signals from specific transducers, as well as all the necessary calculi and generation of the test results report. It has also been developed the signal conditioning circuits for the pressure and flux transducers inherent to the company pulse duplicator. The following parameters are calculated and reported with several graphics showing flux and pressure signals: orifice specific area, discharge coefficient, regurgitation fraction and valve performance and efficiency indices. / Mestrado / Engenharia Biomedica / Mestre em Engenharia Elétrica

Thesis (MScEng)--Stellenbosch University, 2012. / ENGLISH ABSTRACT: Bioprosthetic heart valves (BHVs) for transcatheter aortic valve implantation (TAVI) have been rapidly developing over the last decade since the first valve replacement using the TAVI technique. TAVI is a minimally invasive valve replacement procedure offering lifesaving treatment to patients who are denied open heart surgery. The biomedical engineering research group at Stellenbosch University designed a 19 mm balloon expandable BHV for TAVI in 2007/8 for testing in animal trials. In the current study the valve was enlarged to 23 mm and 26 mm diameters. A finite element analysis was performed to aid in the design of the stents. New stencils were designed and manufactured for the leaflets using Thubrikar‟s equations as a guide. The 23 mm valve was manufactured and successfully implanted into two sheep. Fluid structure interaction (FSI) simulations constitute a large portion of this thesis and are being recognized as an important tool in the design of BHVs. Furthermore, they provide insight into the interaction of the blood with the valve, the leaflet dynamics and valve hemodynamic performance. The complex material properties, pulsating flow, large deformations and coupling of the fluid and the physical structure make this one of the most complicated and difficult research areas within the body. The FSI simulations, of the current valve design, were performed using a commercial programme called MSC.Dytran. A validation study was performed using data collected from a cardiac pulse duplicator. The FSI model was validated using leaflet dynamics visualisation and transvalvular pressure gradient comparison. Further comparison studies were performed to determine the material model to be used and the effect of leaflet free edge length and valve diameter on valve performance. The results from the validation study correlated well, considering the limitations that were experienced. However, further research is required to achieve a thorough validation. The comparative studies indicated that the linear isotropic material model was the most stable material model which could be used to simulate the leaflet behaviour. The free edge length of the leaflet affects the leaflet dynamics but does not greatly hinder its performance. The hemodynamic performance of the valve improves with an increase in diameter and the leaflet dynamics perform well considering the increased surface area and length. Many limitations in the software prevented more accurate material models and flow initiation to be implemented. These limitations significantly restricted the research and confidence in the results. Further investigation regarding the implementation of FSI simulations of a heart valve using the commercial software is recommended. / AFRIKAANSE OPSOMMING: Bio-prostetiese hartkleppe (Bioprosthetic Heart Valves - BHVs) wat gebruik word vir transkateter aortaklep-inplantings (Transcatheter Aortic Valve Implantation - TAVI) het geweldig vinnige ontwikkeling getoon in die afgelope tien jaar sedert die eerste klepvervanging wat van die TAVI prosedure gebruik gemaak het. TAVI is ʼn minimaal indringende klepvervangingsprosedure wat lewensreddende behandeling bied aan pasiënte wat ope-hart sjirurgie geweier word. Die Biomediese Ingenieurswese Navorsingsgroep (BERG) by Stellenbosch Universiteit het in 2007/8 ʼn 19 mm ballon-uitsetbare BHV vir TAVI ontwerp vir eksperimente met diere, en hierdie tesis volg op die vorige projekte. In die huidige studie is die klep vergroot na 23 mm en 26 mm in deursnee. ʼn Eindige element analise is gedoen om by te dra tot die ontwerp van die rekspalke vir die klep. Nuwe stensils is ontwerp en vervaardig vir die klepsuile, deur gebruik te maak van Thubrikar se vergelykings. Die 23 mm klep is vervaardig en suksesvol in twee skape ingeplant. Vloeistruktuur interaksie (Fluid Structure Interaction (FSI)) simulasies vorm ‟n groot deel van die tesis en word gesien as ʼn noodsaaklike hulpmiddel in die ontwerp van BHVs. Die simulasies verskaf ook insig in die interaksie van die bloed met die klep, die klepsuil-dinamika en die klep se hemodinamiese werkverrigting. Die komplekse materiaal eienskappe, polsende vloei, grootskaalse vervorming, die verbinding van die vloeistof en die fisiese struktuur maak van hierdie een van die mees gekompliseerde voorwerpe om te simuleer. Die FSI simulasies van die huidige ontwerp, is uitgevoer deur van kommersiële sagteware, MSC.Dytran, gebruik te maak. ʼn Geldigheidstudie wat data gebruik het vanaf die hartklop-nabootser, is uitgevoer. Die FSI model word geverifieer deur klepsuil dinamika visualisering en ʼn vergelyking van die drukgradiënt gebruik te maak. Verdere vergelykende studies is uitgevoer om te bepaal watter materiaal model om te gebruik, asook die uitwerking van die klepsuil-vrye rand en klepdeursnee op die klep se werkverrigting. Die resultate van die studie korreleer goed, in ag genome die beperkings wat ervaar is. Verdere navorsing is egter nodig vir ʼn volledige geldigheidstudie. Vergelykende studies het getoon dat die liniêre isotropiese materiaalmodel die meer stabiele materiaalmodel is wat kan gebruik word om klepsuilgedrag te simuleer. Die vrye-rand lengte van die klepsuil affekteer die dinamika van die klepsuil, maar belemmer nie die werkverrigting grootliks nie. Die hemodinamiese werkverrigting van die klep verbeter met die toename in deursnee en die klepsuil-dinamika vertoon goed in ag genome die verhoogde oppervlak area en lengte. Die vele beperkings in die sagteware het die implementering van meer akkurate materiaalmodelle verhoed. Hierdie beperkings het ʼn verminderde vertroue in die resultate tot gevolg gehad. Verdere ondersoek rakende die implementering van die FSI simulasies van ʼn hartklep deur kommersieel beskikbare sagteware te gebruik, word aanbevel.