Evaluation of Structural Viability of Porcine Tracheal Scaffolds after 3 and 6 Months of Storage under Three Different Protocols.

Tracheal replacement with a bioengineered tracheal substitute has been developed for long-segment tracheal diseases. The decellularized tracheal scaffold is an alternative for cell seeding. It is not defined if the storage scaffold produces changes in the scaffold's biomechanical properties. We tested three protocols for porcine tracheal scaffold preservation immersed in PBS and alcohol 70%, in the fridge and under cryopreservation. Ninety-six porcine tracheas (12 in natura, 84 decellularized) were divided into three groups (PBS, alcohol, and cryopreservation). Twelve tracheas were analyzed after three and six months. The assessment included residual DNA, cytotoxicity, collagen contents, and mechanical properties. Decellularization increased the maximum load and stress in the longitudinal axis and decreased the maximum load in the transverse axis. The decellularization of the porcine trachea produced structurally viable scaffolds, with a preserved collagen matrix suitable for further bioengineering. Despite the cyclic washings, the scaffolds remained cytotoxic. The comparison of the storage protocols (PBS at 4 °C, alcohol at 4 °C, and slow cooling cryopreservation with cryoprotectants) showed no significant differences in the amount of collagen and in the biomechanical properties of the scaffolds. Storage in PBS solution at 4 °C for six months did not change the scaffold mechanics.

Tissue Engineering and Cell Therapy for Cartilage Repair: Preclinical Evaluation Methods.

A chondral injury is a limiting disease that can affect the quality of life and be an economic burden due to the cost of immediate treatment and loss in work productivity. If left untreated, such an injury may progress to osteoarthritis, a degenerative and debilitating joint disease characterized by pain and functional impairment. Mesenchymal stromal cells (MSCs), which have immune-modulatory properties and the ability to differentiate into chondroblasts and osteoblasts, are a predictable source for the treatment of cartilage injuries. This article presents tools to evaluate cartilage restoration by tissue engineering and cell therapy treatment in a translational and preclinical large animal model. In this controlled experimental study with 14 miniature pigs, a scaffold-free tissue engineering construct (TEC) derived from dental pulp and synovial MSCs for cartilage therapy was tested. Total thickness cartilage defects were performed in both posterior knees. The defect was left empty in one of the knees, and the other received the TEC. The tissue repair was morphologically assessed by magnetic resonance imaging (MRI) using the three-dimensional double echo steady-state (3D-DESS) sequence, and compositional assessment was carried out based on the T2 mapping technique. The osteochondral specimens were fixed for histopathology, decalcified, subjected to standard histological processing, sectioned, and stained with hematoxylin and eosin. The sections stained for immunohistochemical detection of collagen types were digested with pepsin and chondroitinase and incubated with antibodies against them. The mechanical evaluation involved analysis of Young's modulus of the cartilage samples based on the indentation and maximum compression test. In addition, a finite element model was used to simulate and characterize properties of the osteochondral block. At 6 months after surgery, there were no complications with the animals and the MRI, histological, immunohistochemical, and biomechanical evaluations proved to be effective and qualified to differentiate good quality chondral repair from inadequate repair tissue. The proposed methods were feasible and capable to properly evaluate the defect filled with TEC containing stromal cells after 6 months of follow-up in a large animal model for articular cartilage restoration. Impact Statement Articular chondral injuries are prevalent and represent an economic burden due to the cost of treatment. The engineering of cartilage tissue can promote the repair of chondral injuries and is dependent on selecting appropriate cells and biocompatible frameworks. In this article, methods for evaluation of a scaffold-free cell delivery system made from mesenchymal stromal cells were present in a translational study that allows further clinical safety and efficacy trials.

Behavior of lyophilized biological valves in a chronic animal model.

Glutaraldehyde is used in order to improve the mechanical and immunogenic properties of biological tissues, such as bovine pericardium membranes, used to manufacture heart valve bioprostheses. Lyophilization, also known as freeze-drying, preserves biological material without damage by freezing the water content and removing ice by sublimation. Through this process, dehydrated products of high quality may be obtained; also, the material may be easily handled. The lyophilization process reduces aldehyde residues in biological tissue previously treated with glutaraldehyde, thus promoting reduction of cytotoxicity, increasing resistance to inflammation, and possibly decreasing the potential for tissue calcification. The objective of this study was to chronically evaluate the calcification of bovine pericardium heart valve prostheses, previously lyophilized or not, in an animal model. Six-month-old sheep received implants of lyophilized and unlyophilized heart valve prostheses in the pulmonary position with right bypass. The study followed 16 animals for a period of 90 days. Right ventricle-pulmonary artery (RV/PA) transvalvular pressure gradient was evaluated before and immediately after implantation and before explantation, as were tissue calcium, inflammation intensity, and thrombosis and pannus formation. The t-test was used for statistical analysis. Twelve animals survived to the end of the experiment, but one of the animals in the control group had endocarditis and was excluded from the data. Four animals died early. The mean RV/PA gradient on implantation was 2.0 ± 1.6 mm Hg in the control group and 6.2 ± 4.1 mm Hg in the lyophilized group (P = 0.064). This mean gradient increased at explantation to 7.7 ± 3.9 mm Hg and 8.6 ± 5.8 mm Hg, respectively (P = 0.777). The average calcium content in the tissue leaflets after 3 months was 21.6 ± 39.1 mg Ca(2+)/g dry weight in the control group, compared with an average content of 41.2 ± 46.9 mg Ca(2+)/g dry weight in the lyophilized group (P = 0.478). In this experimental study there was no reduction of calcification after lyophilization. However, histological analysis showed less inflammation over the lyophilized tissue when compared with the control.

Estudo in vivo do comportamento de bioprótese liofilizada: seguimento de 3 meses em carneiros jovens / In vivo study of lyophilized bioprostheses: 3 month follow-up in young sheep

OBJETIVO: Para melhorar as propriedades mecânicas e imunogênicas, o glutaraldeído é utilizado no tratamento do pericárdio bovino que é utilizado em biopróteses. A liofilização do pericárdio bovino tratado com glutaraldeído diminui os radicais aldeído, com provável redução do potencial para calcificação. O objetivo deste estudo é avaliar os efeitos da liofilização em biopróteses valvares de pericárdio bovino como mecanismo protetor na diminuição da disfunção estrutural valvar. MÉTODOS: Foi realizado o implante de biopróteses de pericárdio bovino tratado com glutaraldeído, liofilizadas ou não, em carneiros de 6 meses de idade, sendo os animais eutanasiados com 3 meses de seguimento. As biopróteses foram implantadas em posição pulmonar, com auxílio de circulação extracorpórea. Um grupo controle e outro grupo liofilizado foram avaliados quanto ao gradiente ventrículo direito/artéria pulmonar (VD/AP) no implante e explante; análise quantitativa de cálcio; inflamação; trombose e pannus. O nível de significância estabelecido foi de 5%. RESULTADOS: O gradiente médio VD/AP, no grupo controle, no implante, foi 2,04 ± 1,56 mmHg e, no grupo de liofilização, foi 6,61 ± 4,03 mmHg. No explante, esse gradiente aumentou para 7,71 ± 3,92 mmHg e 8,24 ± 6,2 mmHg, respectivamente, nos grupos controle e liofilização. O teor de cálcio médio, após 3 meses, nas biopróteses do grupo controle foi 21,6 ± 39,12 µg Ca+2/mg de peso seco, em comparação com um teor médio de 41,19 ± 46,85 µg Ca+2/mg de peso seco no grupo liofilizado (P = 0,662). CONCLUSÃO: A liofilização de próteses valvares com pericárdio bovino tratado com glutaraldeído não demonstrou diminuição da calcificação neste experimento.

OBJECTIVE: Glutaraldehyde is currently used in bovine pericardium bioprosthesis to improve mechanical and immunogenic properties. Lyophilization is a process that may decrease aldehyde residues in the glutaraldehyde treated pericardium decreasing cytotoxicity and enhancing resistance to calcification. The aim of this study is to evaluate bioprosthetic heart valves calcification in adolescent sheep and to study the potential of lyophilization as a mechanism to protect calcification. METHODS: Two groups were evaluated: a control group in which a bovine pericardium prosthetic valve was implanted in pulmonary position and a lyophilized group in which the bovine pericardium prosthetic valve was lyophilized and further implanted. Sixteen sheeps 6 months old were submitted to the operation procedure. After 3 months the sheeps were euthanized under full anesthesia. RESULTS: Six animals of the control group reached 95.16 ± 3.55 days and six animals in the lyophilized group reached 91.66 ± 0.81 days of postoperative evolution. Two animals had endocarditis. Right ventricle/pulmonary artery (RV/PA) mean gradient, in the control group, at the implantation was 2.04 ± 1.56 mmHg, in the lyophilization group, the RV/PA mean gradient, at the implantation was 6.61 ± 4.03 mmHg. At the explantation it increased to 7.71 ± 3.92 mmHg and 8.24 ± 6.25 mmHg, respectively, in control and lyophilization group. The average calcium content, after 3 months, in the control group was 21.6 ± 39.12 µg Ca+2/mg dry weight, compared with an average content of 41.19 ± 46.85 µg Ca+2/mg dry weight in the lyophilization group (P=0.662). CONCLUSION: Freeze drying of the bovine pericardium prosthesis in the pulmonary position could not demonstrate calcification mitigation over a 3 month period although decreased inflammatory infiltration over the tissue.

In vivo study of lyophilized bioprostheses: 3 month follow-up in young sheep.

OBJECTIVE: Glutaraldehyde is currently used in bovine pericardium bioprosthesis to improve mechanical and immunogenic properties. Lyophilization is a process that may decrease aldehyde residues in the glutaraldehyde treated pericardium decreasing cytotoxicity and enhancing resistance to calcification. The aim of this study is to evaluate bioprosthetic heart valves calcification in adolescent sheep and to study the potential of lyophilization as a mechanism to protect calcification. METHODS: Two groups were evaluated: a control group in which a bovine pericardium prosthetic valve was implanted in pulmonary position and a lyophilized group in which the bovine pericardium prosthetic valve was lyophilized and further implanted. Sixteen sheep 6 months old were submitted to the operation procedure. After 3 months the sheep were euthanized under full anesthesia. RESULTS: Six animals of the control group reached 95.16 ± 3.55 days and six animals in the lyophilized group reached 91.66 ± 0.81 days of postoperative evolution. Two animals had endocarditis. Right ventricle/pulmonary artery (RV/PA) mean gradient, in the control group, at the implantation was 2.04 ± 1.56 mmHg, in the lyophilization group, the RV/PA mean gradient, at the implantation was 6.61 ± 4.03 mmHg. At the explantation it increased to 7.71 ± 3.92 mmHg and 8.24 ± 6.25 mmHg, respectively, in control and lyophilization group. The average calcium content, after 3 months, in the control group was 21.6 ± 39.12 µg Ca+2/mg dry weight, compared with an average content of 41.19 ± 46.85 µg Ca+2/mg dry weight in the lyophilization group (P=0.662). CONCLUSION: Freeze drying of the bovine pericardium prosthesis in the pulmonary position could not demonstrate calcification mitigation over a 3 month period although decreased inflammatory infiltration over the tissue.

In vitro and in vivo evaluation of lyophilized bioprosthetic valve.

Freeze-drying of biological tissues allows for dry storage and gamma ray sterilization, which may improve their use as a medical prosthesis. The objective of this study was to evaluate the rehydration characteristics and hydrodynamic performance of prosthetic valves before and after lyophilization. Two size 23 bovine pericardium aortic valve prostheses from different manufacturers were evaluated in a Shelhigh (Union, NJ, USA) pulse duplicator (80 ppm, 5 L/min) before and after lyophilization. Flow and transvalvular pressure gradient were registered in vitro and in vivo, and images of opening and closing of the prosthesis were obtained in the pulse duplicator in a digital camera. Rehydration was evaluated by comparison of dry valve weight with valve weight after 15 min, and 1, 24, 48, and 72 h in saline solution, inside the pulse duplicator. In vivo performance was assessed by surgical implantation in Santa Inês young male sheep in the pulmonary position after 30 min rehydration with 0.9% saline. Transvalvular pressure gradient and flow measurements were obtained immediately after implantation and 3 months after surgery when valves were explanted. Captured images showed a change in the profile opening and closing of valve prosthesis after lyophilization. The gradient measured (in vitro) in two valves was 17.08 ± 0.57 and 18.76 ± 0.70 mm Hg before lyophilization, and 34.24 ± 0.59 and 30.40 ± 0.97 mm Hg after lyophilization. Rehydration of both lyophilized valves was approximately 82%. Drying changed the profile of the opening and closing of valve prostheses, and increased on average by 83% the gradient in vitro tests. The result of the in vivo tests suggests maintaining pressure levels of the animal with the lyophilized prostheses within acceptable levels.

Natural and prosthetic heart valve calcification: morphology and chemical composition characterization.

Calcification is the most common cause of damage and subsequent failure of heart valves. Although it is a common phenomenon, little is known about it, and less about the inorganic phase obtained from this type of calcification. This article describes the scanning electron microscopy (SEM)/energy dispersive X-ray spectroscopy and Ca K-edge X-ray absorption near edge structure (XANES) characterization performed in natural and bioprosthetic heart valves calcified in vivo (in comparison to in vitro-calcified valves). SEM micrographs indicated the presence of deposits of similar morphology, and XANES results indicate, at a molecular level, that the calcification mechanism of both types of valves are probably similar, resulting in formation of poorly crystalline hydroxyapatite deposits, with Ca/P ratios that increase with time, depending on the maturation state. These findings may contribute to the search for long-term efficient anticalcification treatments.

Effect of freeze-drying on the mechanical, physical and morphological properties of glutaraldehyde-treated bovine pericardium: evaluation of freeze-dried treated bovine pericardium properties.

PURPOSE: Biomaterials have been widely used in the field of regenerative medicine. Bovine pericardium tissue has been successfully used as a bioprosthetic material in manufacturing heart valves, but studies concerning the tissue are ongoing in order to improve its storage, preservation and transportation. This article provides an overview of the characteristics of bovine pericardium tissue chemically treated after the freeze-drying process. These characteristics are essential to evaluate the changes or damage to the tissue during the process. METHODS: The mechanical properties of the tissue were analyzed by three different methods due to its anisotropic characteristics. The physical properties were analyzed by a colorimetric method, while the morphological properties were evaluated by scanning electron microscopy (SEM). RESULTS: The freeze-dried bovine pericardium showed no significant change in its mechanical properties. There was no significant change in the elasticity of the tissue (p>0.05) and no color change. In addition, SEM analysis showed that the freeze-dried samples did not suffer structural collapse. CONCLUSIONS: It was concluded that glutaraldehyde-treated bovine pericardium tissue showed no significant change in its properties after the freeze-drying process.

The influence of freezing rates on bovine pericardium tissue Freeze-drying

The bovine pericardium has been used as biomaterial in developing bioprostheses. Freeze-drying is a drying process that could be used for heart valve's preservation. The maintenance of the characteristics of the biomaterial is important for a good heart valve performance. This paper describes the initial step in the development of a bovine pericardium tissue freeze-drying to be used in heart valves. Freeze-drying involves three steps: freezing, primary drying and secondary drying. The freezing step influences the ice crystal size and, consequently, the primary and secondary drying stages. The aim of this work was to investigate the influence of freezing rates on the bovine pericardium tissue freeze-drying parameters. The glass transition temperature and the structural behaviour of the lyophilized tissues were determined as also primary and secondary drying time. The slow freezing with thermal treatment presented better results than the other freeze-drying protocols.

O pericárdio bovino é um material utilizado na fabricação de biopróteses. A liofilização é um método de secagem que vem sendo estudado para a conservação de válvulas cardíacas. A preservação das características do biomaterial é de fundamental importância no bom funcionamento das válvulas. Este artigo é a primeira etapa do desenvolvimento do ciclo de liofilização do pericárdio bovino. Liofilização é o processo de secagem no qual a água é removida do material congelado por sublimação e desorção da água incongelável, sob pressão reduzida. O congelamento influencia o tamanho do cristal de gelo e, consequentemente, a secagem primária e secundária. O objetivo deste estudo foi verificar a influência das taxas de congelamento nos parâmetros de liofilização do pericárdio bovino. Determinou-se a temperatura de transição vítrea e o comportamento estrutural do pericárdio bovino liofilizado. Determinou-se o tempo da secagem primária e secundária. O protocolo de liofilização utilizando-se congelamento lento com annealing apresentou os melhores resultados.

Histological evaluation of biocompatibility of lyophilized bovine pericardium implanted subcutaneously in rats.

This article aims at investigating in vivo evaluation of lyophilization procedure on the biocompatibility of bovine pericardium treated with glutaraldehyde (GA). The bovine pericardium was fixed with 0.5% glutaraldehyde during 10 days and preserved in 4% formaldehyde (FA). Two groups of samples were prepared from treated membranes: Group 1, nonlyophilized samples and Group 2, lyophilized samples. Male Sprague-Dawley rats (4 weeks after birth) were anesthetized (pentobarbital sodium 25 mg/kg of body weight) and in each one were implanted subcutaneously in the dorsal region a sample from Group 1 and another from Group 2. These samples were explanted after 30 days for histological analysis. No intercurrences took place after the surgery. No differences (P > 0.05) in the calcification, granulomatous reaction, mononuclear infiltration, and granulation tissue development was observed between both groups. The implanted lyophilized samples presented a trend for a reduced inflammatory reaction. Lyophilization of the bovine pericardium does not seem to increase the above listed tissue reaction.

Cytotoxicity and genotoxicity of bovine pericardium preserved in glycerol.

Bovine pericardium is a widely utilized biomaterial. Usually, after harvesting, it is advantageous that the pericardium be immersed in glycerol to improve its shelf life. This can induce some degree of toxicity in the material. The studies were performed in compliance with the rules of ISO 10993 and OECD 487, in the biological evaluation of medical devices. The material was prepared without previous washing. After sterilization by gamma radiation the pericardium was immersed in RPMI 1640 culture medium to fulfill the extraction condition. The same extract was employed in the cytotoxic and genotoxic tests. The procedures were carried out with Chinese hamster ovary cell line and to determine the cytotoxicity, a colorimetric method with the tetrazolium compound MTS was used. For the genotoxicity, following the in vitro micronucleus assay, the test was developed with and without metabolic activation. The Cytotoxicity Index was graphically estimated at the extract concentration of 78%. In the genotoxicity test, the average value of cell proliferation index was found to be 1.62 +/- 0.02 with S9 metabolic activator and 1.91 +/- 0.01 without S9 metabolic activator. Both values are similar to the negative control value in the micronucleus assay. We observed that although the pericardium preserved in glycerol shows a certain level of cytotoxicity, it does not show any genotoxicity.

Lyophilized bovine pericardium treated with a phenethylamine-diepoxide as an alternative to preventing calcification of cardiovascular bioprosthesis: preliminary calcification results.

This study investigated the calcification process that occurred on chemically treated bovine pericardium substrata through tests with simulated body fluid solutions. The use of bovine pericardium bioprosthetic valves in heart valve surgery has a significant drawback due to the calcification processes. Thus, many routes such as chemical treatments in the substratum or the adoption of systemic therapies are considered in the literature with the intention to inhibit or to decelerate this process. The presented treatment using the two different phenetylamine-diepoxide solutions showed no effects on calcification experiments as showed by the tests. However, the lyophilized bovine pericardium samples, treated with both solutions, did not show any detectable phosphate deposits. The lyophilization of bovine pericardium before chemical treatments with cross-link agents as epoxy compounds may be an alternative to the conventional calcification prevention methods, but further investigations are recommended to check if the same behavior is found in all lyophilized systems.

Glutaraldehyde-treated bovine pericardium: effects of lyophilization on cytotoxicity and residual aldehydes.

This work assesses the effect of lyophilization on the cytotoxicity and residual aldehyde concentration of glutaraldehyde-treated and lyophilized bovine pericardium (group A), comparing it to conventional glutaraldehyde-treated bovine pericardium (group B). Cytotoxicity was measured by incubating a pericardium sample from each group in saline and assessing the eluant's influence on cellular growth. Residual aldehydes were measured by HPLC. Although both groups' eluants exhibited some cytotoxicity, the eluant from group A was less cytotoxic, with a cytotoxicity index (IC50(%)) of 41%. Group B eluants all had marked cytotoxic effects; cell growth was 24.15% of the negative control at the most dilute eluant concentration (6.25%). The mean residual glutaraldehyde level was less in group A than in group B (2.36 +/- 0.11 and 9.90 +/- 3.70 g/l, respectively; n=3, P < 0.05), but residual formaldehyde levels did not differ. These results demonstrate that compared with conventional glutaraldehyde-treated bovine pericardium, lyophilized pericardium is less cytotoxic, with fewer glutaraldehyde residues.

Avaliaçäo da açäo concomitante do baläo intra-aórtico e da bomba centrífuga na assistência ao ventrículo esquerdo: estudo experimental em cäes / Evaluation of intraaortic balloon pump associated with centrifugal pump for left ventricular assistance: an esperimental study in dogs

Mechanical assist ventricular devices have been used in the treatment of low cardiac output syndrome. These devices can be generically grouped in pulsatile and nonpulsatile. There is a great controversy about the advantages and disadvantages of each one of these groups. The objective of this paper is to evaluate the influence of the centrifugal pump used for left ventricular assistance on the coronary and carotid flow in dogs with normal heart. The efficacy of the simultaneous use of an intraaortic balloon pump to compensate the possible deleterious effects of the circulatory assistance with continuous flow was analysed. Fifteen dogs with a mean weight of 16.3 kg were studied. Hemodynamic evaluation included serial measurements of pressures of the right atrium, pulmonary capillary wedge, pulmonary artery, systemic arterial circulation and heart rate. Cardiac output was measured and the following derived hemodynamic parameters were calculated: cardiac index, systolic index, systemic vascular resistance and pulmonary vascular resistance. Carotid and coronary blood flow were obtained by electromagnetic tranducers. The parameters were analysed in four situations: S1. Standard situation; S2. Test situation - the centrifugal pump as a left ventricular assist device; S3. Test situation - the centrifugal pump associated with intraaortic balloon pump; S4. Final situation, where the intraaortic balloon is turned off to confirm its influence. The hemodynamic evaluation didn't show significant statistic changes in the analysed parameters in the four situations. In relation to the coronary flow, however, the use of circulatory isolated assistence with centrifugal pump (S2 and S4) displayed a reduction (24.6 per cent ñ 6.1) in relation to the standard situation - S1 as much as to the associated intraaortic balloon - S3 (p = 0.0079); S1 and S3 showed similar coronary flow. In relation to the carotid flow, the profile analysis suggests the existence of a difference between the multiple situations, but it is not significant (p = 0.0582)...

Bandagem reversível do tronco pulmonar: modelo experimental para preparo rápido do ventrículo pulmonar / Reversible pulmonary trunk banding: experimental model for rapid pressure of the pulmonary ventricle

Um novo cateter-balao foi desenvolvido com o objetivo de induzir o preparo rápido do ventrículo pulmonar. O cateter apresenta três vias, uma para o balao e duas para medir pressoes, proximal e distal ao balao [ventrículo direito (VD) e tronco pulmonar (TP)]. Os coraçoes de 6 cabritos jovens (peso médio: 5,3 kg) foram submetidos à sobrecarga sistólica imposta pelo cateter e avaliados morfologicamente e pelo ecoardiograma. A via de saída do VD (VSVD) foi exposta através de toracotomia esquerda. Foram realizadas biópsias do miocárdio para estudos de microscopia óptica e eletrônica. O cateter-balao foi introduzido pelo VSVD e posicionado no TP. Após a convalescença pós-operatória, foi iniciado o treinamento do VD através da injeçao de 0,5 ml de água no balao. Posteriormente, volumes adicionais (0,5 ml) eram injetados no balao a cada 2 dias, causando sobrecarga sistólica progressiva. A avaliaçao ecocardiográfica foi realizada com intervalos de 1 a 2 dias. Os animais foram sacrificados após 2 a 3 semanas de treinamento do VD, para avaliaçao morfológica do coraçao. O diâmetro externo dos miócitos cardíacos, seccionados longitudinalmente, foi medido ao nível do núcleo, utilizando-se o sistema de análise de imagem (Quantimet-Leica). Secçoes de 1mu de espessura do VD foram examinados sob microscopia eletrônica para determinar a densidade de volume das mitocôndrias. O ecocardiograma revelou equalizaçao das massas musculares dos ventrículos com intervalo de 6 a 10 dias de treinamento do VD. A microscopia óptica, foi observado aumento significativo do diâmetro dos miócitos (p<0,001) e dos núcleos (p<0,003), embora sob a microscopia eletrônica nao tenha havido variaçao significativa da densidade média do volume de mitocôndrias do VD (p=0,385). O cateter-balao proposto neste trabalho permite a manipulaçao da luz do TP, possibilitando o preparo rápido e nao cirúrgico do ventrículo pulmonar e preservando a integridade anatômica das grandes artérias em pacientes com TGA.

Prótese para toracostomia: desenvolvimento e utilizaçäo clínica / Prosthesis for toracostomy: development and clinical utilization

O objetivo deste trabalho é o desenvolvimento de uma prótese em silicone para ser utilizada em toracostomia, à Eloesser modificado no tratamento dos empiemas crônicos, sobretudo nos empiemas pós-pneumectomia. Esse sistema deixa um aspecto estético bastante desagradável ao paciente, além de representar um ato cirúrgico relativamente complexo para a função a que se propõe. A proposição consiste de um tubo de silicone de 25 mm de diâmetro, corrugado, e com anteparo interno e externo, para evitar migrações que pode ser colocada através de uma incisão de 30 a 40 mm e ressecção segmentar de apenas uma costela, diminuindo o trauma cirúrgico, como também as seqüelas estéticas na parede torácica, enquanto mantém adequada e contínua drenagem do espaço pleural. Até a presente data, 13 pacientes foram submetidos à toracostomia utilizando a prótese desenvolvida, com tempo de acompanhamento entre 14 a 305 dias. Os resultados são satisfatórios e sugerem que a utilização da prótese apresenta vantagens quando comparadas aos métodos tradicionais.

Abstract - This paper presents the design and construction of a toracostomy silicone prosthesis. Its main utilization is in Clagett's and modified Eloesser toracostomies and for the treatment of chronic and post-pneúmonectomy empyemas. The new prosthesis designed consists of a silicone tube (25 mm diameter) corrugated and with one internal and one externa! flange to avoid migration. It can be placed through a 30 to 40 mm incision and resection of a segment of solely one rib, minimizing surgical trauma and resulting in a esthetically improved aspect, while maintaining adequate and continuous draining of the pleural space. Hitherto, the prosthesis was utilized in 13 patients subjected to toracostomy with a follow up period of 14 to 305 days. The results obtained suggest that its utilization presents many advantages in comparison to the traditional method utilized

Desenvolvimento de uma protese de ventrículo artificial implantável / Development of a prosthesis of implanted artificial ventricle

O objetivo deste trabalho foi o desenvolvimento de uma prótese de ventrículo artificial implantável (VAI), para utilização em pacientes com insuficiência cardíaca profunda que necessitam de assistência circulatória mecânica, como ponte para transplante de coração. Foi utilizado um programa CAD (Microstation) para o projeto mecânico do VAI. O dispositivo apresenta uma membrana livre fixada entre duas crianças de titânio, seu acionamento é do tipo pneumático. O dispositivo foi projetado para ser implantado na cavidade abdominal e conectado ao coração nativo via ápice do ventrículo esquerdo e aorta, por meio de cânulas confeccionados em silicone, acopladas a válvulas biológicas de pericárdio bovino.

Abstract - This paper describes the design of an implantable artificial ventricular assist device to support the heart as a bridge to heart transplantation, in patients with profound cardiac failure. The artificial ventricle presented has a free floating membrane, dividing two titanium carcass. The driving unit is pneumatic. Two silicone cannulae are used to conect the device to the patient's heart ( left ventricle apex and aorta). Each cannula is eqquiped with one bovine pericardium valve. A computer program (Microstation) was utilized to provide volumetric calculus, bidimensional and tridimensional visualization to optimize the design

Projeto, construção e testes de um dispositivo de assistência ventricular pulsátil / Design, manufacturing and testing of a pulsatile ventricular assist device

PURPOSE--To describe the design of a ventricular assist device (VAD), its manufacturing and testing. METHODS--The VAD is pulsatile, with a free floating membrane, smooth internal surfaces, and pericardium valves. It comprises also a pneumatic driving unit capable of operating in the ®full to empty®, EKG synchronized or asynchronous modes. The system was tested ®in vitro® to assess its mechanical durability, hydrodynamic performance and hemolysis. ®In vivo® tests were performed in 22 sheep and 8 calves aiming at optimizing cannulas and implant techniques. In these experiments, hemolysis and the device's capacity of restoring to normal hemodynamic parameters during induced cardiac failure were evaluated. RESULTS--The device was worked 4,000 hours without failure in a mock circulatory loop. Hydrodynamic performance was satisfactory for adult circulatory support. In ®full to empty® mode it displayed a frequency mediated ®Starling like® performance. Optimum output was achieved with a systole duration of 40//of the cycle. ®In vitro® hemolysis index was 6.7 +/- 2.1. Hemolysis in animal experiments was clinically non significant. In calves under induced cardiac failure the VAD was able to normalize hemodynamic parameters within 120 minutes. CONCLUSION--This VAD is capable to circulatory assist for cardiogenic shock in conditions needed for an adult patient and the average time span anticipated for bridge to transplantation or post cardiotomy cardiogenic shock