In Vitro Hydrodynamic Evaluation of a Scaffold for Heart Valve Tissue Engineering.

Although prosthetic heart valves have saved many lives, the search for a living substitute continues with the aid of tissue engineering. Much progress has been made so far, but the translation of this technology to clinical reality remains a challenge, especially due to the structural complexity of heart valves and the harsh environment they are in. In a joint effort, researchers from Federal University of ABC and Institute Dante Pazzanese of Cardiology have conceived a new bioresorbable scaffold for heart valve tissue engineering (HVTE), whose hydrodynamic performance was first assessed and described in this work. The scaffold was studied at the mitral position of a left heart simulator from Escola Politécnica of the University of São Paulo, under 60 bpm and with no cell seeding. In this condition, two-dimensional particle image velocimetry was performed to investigate the flow during diastolic and systolic phases. The results indicate that the scaffold can withstand the required intraventricular pressures for a simulated normal physiologic condition in a bioreactor. Furthermore, the averaged (N = 150) velocity vector maps showed a smooth and well-distributed flow during diastole and qualitatively demonstrated no-significant regurgitation at systole.

Influence of Tricuspid Bioprosthetic Mitral Valve Orientation Regarding the Flow Field Inside the Left Ventricle: In Vitro Hydrodynamic Characterization Based on 2D PIV Measurements.

The flow patterns of a prosthetic heart valve in the aortic or mitral position can change according to its type and orientation. This work describes the use of 2D particle image velocimetry (PIV) applied to the in vitro flow fields characterization inside the upper part of a left ventricular model at various heart rates and as a function of two orientations of stented tricuspid mitral bioprostheses. In the ventricular model, each mitral bioprosthesis (27 and 31 mm diameter) was installed in two orientations, rotated by 180°, while the aortic bileaflet mechanical valve (27 mm diameter) remained in a fixed orientation. The results (N = 50) showed changes in the intraventricular flow fields according to the mitral bioprostheses positioning. Also, changes in the aortic upstream velocity profiles were noticed as a function of mitral orientations.

Experimental Validation of a Cardiac Simulator for in vitro Evaluation of Prosthetic Heart Valves.

OBJECTIVE: This work describes the experimental validation of a cardiac simulator for three heart rates (60, 80 and 100 beats per minute), under physiological conditions, as a suitable environment for prosthetic heart valves testing in the mitral or aortic position. METHODS: In the experiment, an aortic bileaflet mechanical valve and a mitral bioprosthesis were employed in the left ventricular model. A test fluid of 47.6% by volume of glycerin solution in water at 36.5ºC was used as blood analogue fluid. A supervisory control and data acquisition system implemented previously in LabVIEW was applied to induce the ventricular operation and to acquire the ventricular signals. The parameters of the left ventricular model operation were based on in vivo and in vitro data. The waves of ventricular and systemic pressures, aortic flow, stroke volume, among others, were acquired while manual adjustments in the arterial impedance model were also established. RESULTS: The acquired waves showed good results concerning some in vivo data and requirements from the ISO 5840 standard. CONCLUSION: The experimental validation was performed, allowing, in future studies, characterizing the hydrodynamic performance of prosthetic heart valves.

Duration of Systole and Diastole for Hydrodynamic Testing of Prosthetic Heart Valves: Comparison Between ISO 5840 Standards and in vivo Studies.

OBJECTIVE: To complement the ISO 5840 standards concerning the duration of left ventricular systole and diastole as a function of changes in heart rates according to in vivo studies from the physiologic literature review. METHODS: The systolic and diastolic durations from three in vivo studies were compared with the durations of systole proposed by the ISO 5840:2010 and ISO 5840-2:2015 for hydrodynamic performance assessment of prosthetic heart valves. RESULTS: Based on the in vivo studies analyzed, the systolic durations proposed by the ISO 5840 standard seemed consistent for 45 and 120 beats per minute (bpm), and showed diverse results for the 70 bpm condition. CONCLUSION: Information on the realistic validation of the operation of left ventricular models for different heart rates were obtained.

In vitro 2D PIV measurements and related aperture areas of tricuspid bioprosthetic mitral valves at the beginning of diastole.

PURPOSE: Besides ventricular parameters, the design and angular orientation of a prosthetic heart valve induce a specific flow field. The aim of this study was to know the inflow characteristics of a left ventricular model (LVM), investigating the behavior of tricuspid bioprosthetic mitral valves in terms of velocity profiles and related valve aperture areas at the beginning of diastole, under different conditions. METHODS: 3 heart rates (HRs) were established in the LVM and each mitral bioprosthesis (27 and 31 mm diameter) was installed in 2 orientations, rotated by 180° . For each experimental setup, 2-dimensional particle image velocimetry (2D PIV) measurements and simultaneous mitral valve (MV) area detection were obtained from 50 samples. RESULTS: The results from the velocity profiles immediately downstream of mitral bioprostheses showed the influence of valve orientation for moderate HRs, although for a similar magnitude of mean velocity vectors. The geometries of MV open areas for each HR were similar regardless of valve orientation, except for the 27-mm valve at 90 beats per minute (bpm), and for the 31-mm valve at 60 bpm. Moreover, for each HR, similar percentages of valve open area were obtained regardless of MV nominal diameters. CONCLUSIONS: In conclusion, the experimental setup for the 2D PIV measurements synchronized with the MV area detection was a useful tool for knowing the inflow characteristics of the LVM.

Laser Doppler anemometry measurements of steady flow through two bi-leaflet prosthetic heart valves.

INTRODUCTION: In vitro hydrodynamic characterization of prosthetic heart valves provides important information regarding their operation, especially if performed by noninvasive techniques of anemometry. Once velocity profiles for each valve are provided, it is possible to compare them in terms of hydrodynamic performance. In this first experimental study using laser doppler anemometry with mechanical valves, the simulations were performed at a steady flow workbench. OBJECTIVE: To compare unidimensional velocity profiles at the central plane of two bi-leaflet aortic prosthesis from St. Jude (AGN 21 - 751 and 21 AJ - 501 models) exposed to a steady flow regime, on four distinct sections, three downstream and one upstream. METHODS: To provide similar conditions for the flow through each prosthesis by a steady flow workbench (water, flow rate of 17L/min.) and, for the same sections and sweeps, to obtain the velocity profiles of each heart valve by unidimensional measurements. RESULTS: It was found that higher velocities correspond to the prosthesis with smaller inner diameter and instabilities of flow are larger as the section of interest is closer to the valve. Regions of recirculation, stagnation of flow, low pressure, and flow peak velocities were also found. CONCLUSIONS: Considering the hydrodynamic aspect and for every section measured, it could be concluded that the prosthesis model AGN 21 - 751 (RegentTM) is superior to the 21 AJ - 501 model (Master Series). Based on the results, future studies can choose to focus on specific regions of the these valves.

Design conception and experimental setup for in vitro evaluation of mitral prosthetic valves.

BACKGROUND: Since most complications related to the operation of prosthetic heart valves is due to disturbances of flow, its hydrodynamic characterization is a useful aid in the design of new prostheses. Simulations of pulsatile flow in cardiac prostheses began nearly 40 years ago, through the development of different mock human circulatory systems, improving the clinical results interpretation. A new design of a pulse duplicator system was developed at Polytechnic School of USP to study prosthetic heart valves. OBJECTIVE: To present the conception of a new mock circulatory system for hydrodynamic simulations of cardiac prosthetic valves and the assembly plan of an experiment whose focus is the test of mitral prosthesis. METHODS: Its conception is based on the state-of-art's review of these studies and the experience got with the previous mock circulatory systems, particularly the one used in the Instituto Dante Pazzanese de Cardiologia, São Paulo, SP, Brazil. RESULTS: In this design, an electric servomotor controlled by computer emits, through a hydraulic piston, a pulse to the left ventricular chamber model, where the heart valves are accomodated. To characterize, in the future, the dynamic operation of mitral prosthetic valves, an experimental setup was mounted to provide measurements of volumetric flow, instantaneous pressure and velocity fields on these valves. Optical access is conveniently provided on the design, making possible the use, in the future, of a LDA system. CONCLUSIONS: In order to improve the analysis of hydrodynamic shear stress and prediction of haemolysis, the experimental results may be used to regulate a numerical model using 'Computational Fluid Dynamics' (CFD).

Experimental validation of a cardiac simulator for in vitro evaluation of prosthetic heart valves

Abstract Objective: This work describes the experimental validation of a cardiac simulator for three heart rates (60, 80 and 100 beats per minute), under physiological conditions, as a suitable environment for prosthetic heart valves testing in the mitral or aortic position. Methods: In the experiment, an aortic bileaflet mechanical valve and a mitral bioprosthesis were employed in the left ventricular model. A test fluid of 47.6% by volume of glycerin solution in water at 36.5ºC was used as blood analogue fluid. A supervisory control and data acquisition system implemented previously in LabVIEW was applied to induce the ventricular operation and to acquire the ventricular signals. The parameters of the left ventricular model operation were based on in vivo and in vitro data. The waves of ventricular and systemic pressures, aortic flow, stroke volume, among others, were acquired while manual adjustments in the arterial impedance model were also established. Results: The acquired waves showed good results concerning some in vivo data and requirements from the ISO 5840 standard. Conclusion: The experimental validation was performed, allowing, in future studies, characterizing the hydrodynamic performance of prosthetic heart valves.

Duration of systole and diastole for hydrodynamic testing of prosthetic heart valves: comparison between iso 5840 standards and in vivo studies

Abstract Objective: To complement the ISO 5840 standards concerning the duration of left ventricular systole and diastole as a function of changes in heart rates according to in vivo studies from the physiologic literature review. Methods: The systolic and diastolic durations from three in vivo studies were compared with the durations of systole proposed by the ISO 5840:2010 and ISO 5840-2:2015 for hydrodynamic performance assessment of prosthetic heart valves. Results: Based on the in vivo studies analyzed, the systolic durations proposed by the ISO 5840 standard seemed consistent for 45 and 120 beats per minute (bpm), and showed diverse results for the 70 bpm condition. Conclusion: Information on the realistic validation of the operation of left ventricular models for different heart rates were obtained.

Laser Doppler anemometry measurements of steady flow through two bi-leaflet prosthetic heart valves / Velocimetria laser de escoamento permanente através de duas próteses cardíacas de duplo folheto

INTRODUCTION: In vitro hydrodynamic characterization of prosthetic heart valves provides important information regarding their operation, especially if performed by noninvasive techniques of anemometry. Once velocity profiles for each valve are provided, it is possible to compare them in terms of hydrodynamic performance. In this first experimental study using laser doppler anemometry with mechanical valves, the simulations were performed at a steady flow workbench. OBJECTIVE: To compare unidimensional velocity profiles at the central plane of two bi-leaflet aortic prosthesis from St. Jude (AGN 21 - 751 and 21 AJ - 501 models) exposed to a steady flow regime, on four distinct sections, three downstream and one upstream. METHODS: To provide similar conditions for the flow through each prosthesis by a steady flow workbench (water, flow rate of 17L/min.) and, for the same sections and sweeps, to obtain the velocity profiles of each heart valve by unidimensional measurements. RESULTS: It was found that higher velocities correspond to the prosthesis with smaller inner diameter and instabilities of flow are larger as the section of interest is closer to the valve. Regions of recirculation, stagnation of flow, low pressure, and flow peak velocities were also found. CONCLUSIONS: Considering the hydrodynamic aspect and for every section measured, it could be concluded that the prosthesis model AGN 21 - 751 (RegentTM) is superior to the 21 AJ - 501 model (Master Series). Based on the results, future studies can choose to focus on specific regions of the these valves.

INTRODUÇÃO: A caracterização hidrodinâmica in vitro de próteses de válvulas cardíacas fornece informações importantes quanto ao seu funcionamento, sobretudo se realizada por meio de métodos não-invasivos de anemometria. Uma vez obtidos os perfis de velocidade para cada válvula, é possível compará-las quanto ao seu desempenho hidrodinâmico. Neste primeiro estudo experimental de anemometria laser com válvulas mecânicas, as simulações foram realizadas em bancada de testes para escoamento permanente. OBJETIVO: Comparar perfis de velocidade unidimensional no plano central de duas próteses aórticas de duplo folheto St. Jude (modelos AGN 21 - 751 e 21 AJ - 501) submetidas a um regime de fluxo permanente, para quatro seções distintas, três à jusante e uma à montante. MÉTODOS: Proporcionar condições de similaridade para o escoamento através de cada prótese, por meio de bancada hidrodinâmica para escoamento permanente (água, à vazão de 17 L/min.) e, por meio de anemometria laser unidimensional, obter os perfis de velocidades para as mesmas seções e varreduras. RESULTADOS: Verificou-se que as maiores velocidades correspondem à prótese de diâmetro interno menor e que as instabilidades do fluxo são maiores à medida que a seção de interesse encontra-se mais próxima da válvula. Também foram verificadas as regiões de recirculação, de estagnação do fluxo e de baixa pressão, além dos picos de velocidade para o escoamento em questão. CONCLUSÕES: Sob o aspecto hidrodinâmico e para todas as seções de interesse, foi possível concluir a preferência da válvula de modelo AGN 21 - 751 (RegentTM) sobre a 21 AJ - 501 (Master Series). Os resultados obtidos permitiram escolher, para os próximos trabalhos, um foco de estudo mais específico para regiões concretas dessas próteses.

Concepção de bancada e montagem de experimento para a análise in vitro de próteses cardíacas mitrais / Design conception and experimental setup for in vitro evaluation of mitral prosthetic valves

INTRODUÇÃO: Uma vez que a maioria das complicações relacionadas ao funcionamento das próteses de válvulas cardíacas é decorrente de distúrbios de escoamento, a sua caracterização hidrodinâmica é um auxílio útil no projeto de novas próteses. Simulações do escoamento pulsátil em próteses cardíacas começaram há cerca de 40 anos, por meio do desenvolvimento de diferentes bancadas do sistema circulatório humano, melhorando a interpretação dos resultados clínicos. Um novo projeto de um sistema duplicador de pulsos foi desenvolvido na Escola Politécnica da USP para estudar próteses de válvulas cardíacas. OBJETIVO: Apresentar a concepção da nova bancada experimental de fluxo pulsátil para ensaios hidrodinâmicos de próteses de válvulas cardíacas e o plano de montagem de um experimento cujo foco é o ensaio de próteses mitrais. MÉTODOS: Sua concepção é baseada na revisão do estado da arte desses estudos e na experiência obtida nas bancadas do sistema circulatório, particularmente aquela usada no Instituto Dante Pazzanese de Cardiologia, em São Paulo, Brasil. RESULTADOS: Neste projeto, um servomotor elétrico controlado por computador emite, por meio de um pistão hidráulico, um pulso para o modelo da câmara do ventrículo esquerdo, onde as válvulas cardíacas são acomodadas. Para caracterizar, no futuro, a operação dinâmica das próteses de válvulas mitrais, foi montado um experimento para proporcionar medições de vazão volumétrica, pressão instantânea e campos de velocidade nessas válvulas. Acessos ópticos estão convenientemente previstos no projeto, tornando possível o uso, no futuro, de um sistema LDA. CONCLUSÕES: A fim de melhorar a análise das tensões hidrodinâmicas e a previsão de hemólise, os resultados experimentais podem ser utilizados para ajustar um modelo numérico usando 'Computational Fluid Dynamics' (CFD).

BACKGROUND: Since most complications related to the operation of prosthetic heart valves is due to disturbances of flow, its hydrodynamic characterization is a useful aid in the design of new prostheses. Simulations of pulsatile flow in cardiac prostheses began nearly 40 years ago, through the development of different mock human circulatory systems, improving the clinical results interpretation. A new design of a pulse duplicator system was developed at Polytechnic School of USP to study prosthetic heart valves. OBJECTIVE: To present the conception of a new mock circulatory system for hydrodynamic simulations of cardiac prosthetic valves and the assembly plan of an experiment whose focus is the test of mitral prosthesis. METHODS: Its conception is based on the state-of-art's review of these studies and the experience got with the previous mock circulatory systems, particularly the one used in the Instituto Dante Pazzanese de Cardiologia, São Paulo, SP, Brazil. RESULTS: In this design, an electric servomotor controlled by computer emits, through a hydraulic piston, a pulse to the left ventricular chamber model, where the heart valves are accomodated. To characterize, in the future, the dynamic operation of mitral prosthetic valves, an experimental setup was mounted to provide measurements of volumetric flow, instantaneous pressure and velocity fields on these valves. Optical access is conveniently provided on the design, making possible the use, in the future, of a LDA system. CONCLUSIONS: In order to improve the analysis of hydrodynamic shear stress and prediction of haemolysis, the experimental results may be used to regulate a numerical model using 'Computational Fluid Dynamics' (CFD).