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Rev. bras. cir. cardiovasc ; 36(1): 10-17, Jan.-Feb. 2021. tab, graf
Article in English | LILACS | ID: biblio-1155793


Abstract Introduction: There are scarce data comparing different mechanical valves in the aortic position. The objective of this study was to compare the early hemodynamic changes after aortic valve replacement between ATS, Bicarbon, and On-X mechanical valves. Methods: We included 99 patients who underwent aortic valve replacement with mechanical valves between 2017 and 2019. Three types of mechanical valves were used, On-X valve (n=45), ATS AP360 (n=32), and Bicarbon (n=22). The mean prosthetic valve gradient was measured postoperatively and after six months. Results: Preoperative data were comparable between groups, and there were no differences in preoperative echocardiographic data. Pre-discharge echocardiography showed no difference between groups in the ejection fraction (P=0.748), end-systolic (P=0.764) and end-diastolic (P=0.723) diameters, left ventricular mass index (P=0.348), aortic prosthetic mean pressure gradient (P=0.454), and indexed aortic prosthetic orifice area (P=0.576). There was no difference in the postoperative aortic prosthetic mean pressure gradient between groups when stratified by valve size. The changes in the aortic prosthetic mean pressure gradient of the intraoperative period, at pre-discharge, and at six months were comparable between the three prostheses (P=0.08). Multivariable regression analysis revealed that female gender (beta coefficient -0.242, P=0.027), body surface area (beta coefficient 0.334, P<0.001), and aortic prosthetic size (beta coefficient -0.547, P<0.001), but not the prosthesis type, were independent predictors of postoperative aortic prosthetic mean pressure gradient. Conclusion: The three bileaflet mechanical aortic prostheses (On-X, Bicarbon, and ATS) provide satisfactory early hemodynamics, which are comparable between the three valve types and among different valve sizes.

Humans , Male , Female , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Prosthesis Design , Echocardiography , Echocardiography, Doppler , Hemodynamics
Rev. bras. ortop ; 56(1): 104-108, Jan.-Feb. 2021. tab, graf
Article in English | LILACS | ID: biblio-1288657


Abstract Objective This study aims to evaluate and correlate the nutritional status with potential complications during the immediate postoperative period of elderly patients surgically treated for proximal femoral fractures. Methods A prospective, cross-sectional analytical study with a quantitative approach, targeting patients aged 60 years old or more who were admitted to a hospital in Amazonas, Brazil, for surgical treatment of proximal femoral fractures. Surgical complications during the immediate postoperative period and their relationship with the nutritional status of the patient were determined using the mini nutritional assessment (MNA); in addition, the lymphocyte numbers and serum albumin levels were determined and correlated with the length of hospital stay. Results The sample consisted of 19 elderly patients, of both genders, with a mean age of 70.8 years. Most of the subjects (68.4%) were female. Malnutrition was diagnosed in 15.8% of the subjects using the body mass index (BMI) as, an anthropometric variable, and the MNA identified 31.6% of the subjects with malnutrition. Regarding total lymphocyte count, 100% of the sample showed a positive association with malnutrition in varying degrees; using serum albumin level as a parameter, malnutrition was identified in 89.4% of the subjects. Malnourished patients had the highest average length of stay. Surgical complications as surgical site infections occurred in 10.5% of the patients at risk of malnutrition. Conclusion This study revealed a higher rate of postoperative complications in elderly patients diagnosed with malnutrition.

Resumo Objetivo Avaliar e correlacionar o estado nutricional com possíveis complicações no pós-operatório imediato de pacientes submetidos a tratamento cirúrgico de fraturas de fêmur proximal. Métodos Estudo transversal prospectivo analítico e de abordagem quantitativa, tendo como população-alvo pacientes com idade igual ou superior a 60 anos, internados em uma instituição hospitalar no Amazonas, submetidos a tratamento cirúrgico de fraturas de fêmur proximal. Foram avaliadas as complicações cirúrgicas no pós-operatório imediato e sua relação com o estado nutricional através da mini avaliação nutricional (MAN), assim como a mensuração da contagem de linfócitos e albumina e a sua correlação com o tempo de internação. Resultados A amostra foi composta por 19 pacientes idosos, de ambos os sexos, com média de idade de 70,8 anos. A maioria dos pacientes (68,4%) eram do sexo feminino. Por meio da variável antropométrica índice de massa corporal (IMC), identificou-se a presença de desnutrição em 15,8% dos pacientes e, por meio da MAN, de 31,6%. Na avaliação do cálculo da contagem total de linfócitos, 100% da amostra apresentou associação positiva com desnutrição em graus variáveis e, fazendo-se uso da albumina sérica como parâmetro, a desnutrição foi identificada em 89,4%. Os pacientes desnutridos apresentaram a maior média de tempo de internação. As complicações cirúrgicas, por infecções do sítio cirúrgico, ocorreram em 10,5% nos pacientes em risco nutricional. Conclusão Neste estudo, observou-se maior índice de complicações no pós-operatório em idosos diagnosticados com desnutrição.

Postoperative Complications , Prosthesis Design , Surgical Wound Infection , Prosthesis Failure , Arthroplasty, Replacement, Knee , Fractures, Bone , Knee Prosthesis
Rev. Asoc. Argent. Ortop. Traumatol ; 86(4) (Nro Esp - ACARO Asociación Argentina para el Estudio de la Cadera y Rodilla): 455-462, 2021.
Article in Spanish | LILACS, BINACIS | ID: biblio-1353946


Introducción: La mala alineación de los tallos femorales no cementados sigue siendo un tema controvertido. Algunos autores han comunicado una inadecuada osteointegración y hundimiento en los tallos en varo y otros no encontraron dichos efectos adversos, pese a la incorrecta alineación. Los objetivos de este estudio fueron determinar la prevalencia de tallos no cementados con cobertura total de hidroxiapatita en deseje coronal y mostrar los resultados clínico-radiográficos a largo plazo. materiales y métodos: Estudio retrospectivo entre 2006 y 2009. Se analizaron 220 reemplazos totales de cadera primarios con tallos no cementados con cobertura completa de hidroxiapatita. La alineación coronal fue analizada con radiografías anteroposteriores de ambas caderas en 10° de rotación interna. Se registraron datos, como osteointegración, hundimiento, osteólisis femoral proximal e hipertrofia cortical. Para el análisis clínico se utilizó el Harris Hip Score. El análisis de supervivencia contempló la necesidad de revisión por cualquier causa. Resultados: La prevalencia de tallos en deseje fue del 32,3%, con mayoría de implantes en varo (73,3%). El Harris Hip Score tuvo un incremento estadísticamente significativo (41,05 ± 6,5 vs. 90,05 ± 2,5; p <0,01). El 73,1% de los tallos desarrollaron una fijación ósea estable. Se observó osteólisis femoral proximal en el 3% de los casos. Hubo un 3% de fracturas periprotésicas femorales. La supervivencia de la prótesis fue del 100% a los 10.9 años. Conclusión: Los tallos no cementados con cobertura total de hidroxiapatita toleran adecuadamente la alineación coronal en varo/valgo a largo plazo. Nivel de Evidencia: IV

Introduction: Coronal malalignment of non-cemented stems remains controversial. It's been reported that femoral stems implanted with varus or valgus developed subsidence and lack of integration with femoral bone. The purpose of this study was to calculate prevalence of coronal malalignment in cementless, fully coated with hydroxialapatyte (HA) femoral stems focusing in their long-term clinical and radiographic outcomes. Materials and methods: A retrospective study was performed, assessing 220 primaries total hip replacements with non-cemented, fully coated with HA, femoral stems between 2006 and 2009. Coronal alignment was assessed with hips antero-posterior views with 10º of internal rotation of lower limbs. We registered data about subsidence, proximal femoral osteolysis and cortical hipertrophy. Functional outcomes were assessed with Harris Hip Score (HHS). Free revision rate implant survival was calculated. Results: Prevalence of femoral stems with malalignment was 32.3%. HHS showed an statistically significant increase after surgery (41.05 ± 6.5 versus 90.05 ± 2.5; p <0.01). There were 73.1% of femoral stems that achieved a bone stable fixation. We observed proximal femoral osteolysis in 3.0% of the patients and there were 3% of periprosthetic fractures. Free-revision survival rate was 100% at 10.9 years of follow-up. Conclusion: Cementless, fully coated with HA femoral stems with varus/valgus malalignment achieves good long-term clinical and radiographic outcomes. Level of Evidence: IV

Middle Aged , Aged , Prosthesis Design , Treatment Outcome , Arthroplasty, Replacement, Hip , Hip Joint/surgery
Clinics ; 76: e2812, 2021. tab, graf
Article in English | LILACS | ID: biblio-1249575


OBJECTIVES: We sought to analyze the hemodynamic effects of the multilayer flow-modulated stent (MFMS) in Thoracoabdominal aortic aneurysms (TAAAs). METHODS: The hemodynamic effects of MFMS were analyzed in aortic thoracoabdominal aneurysms in experimental swine models. We randomly assigned 18 pigs to the stent or control groups and underwent the creation of an artificial bovine pericardium transrenal aneurysm. In the stent group, an MFMS (Cardiatis, Isnes, Belgium) was immediately implanted. After 4 weeks, we evaluated aneurysm sac thrombosis and renal branch patency by angiography, duplex scan, and morphological analysis. RESULTS: All the renal arteries remained patent after re-evaluation in both groups. Aneurysmal sac thrombosis was absent in the control group, whereas in the stent group it was present in 66.7% of aneurysmal sacs (p=0.061). The mean final aneurysm sac diameter was significantly lower in the stent group (mean estimated reduction, 6.90 mm; p=0.021). The proximal neck diameter decreased significantly in the stent group (mean difference, 2.51 mm; p=0.022) and grew significantly in the control group (mean difference, 3.02 mm; p=0.007). The distal neck diameter increased significantly in the control group (mean difference, 3.24 mm; p=0.017). There were no significant findings regarding distal neck measurements in the stent group. CONCLUSION: The MFMSs remained patent and did not obstruct the renal arteries within 4 weeks. In the stent group, the device was also associated with a significant decrease in aneurysmal sac diameter and a large proportion (albeit non-significant) of aneurysmal sac thrombosis.

Animals , Aortic Aneurysm , Aortic Aneurysm, Abdominal/surgery , Blood Vessel Prosthesis Implantation , Endovascular Procedures , Prosthesis Design , Renal Artery/surgery , Renal Artery/diagnostic imaging , Swine , Blood Vessel Prosthesis , Cattle , Stents , Treatment Outcome , Models, Theoretical
Article in Chinese | WPRIM | ID: wpr-888212


The rotation center of traditional hip disarticulation prosthesis is often placed in the front and lower part of the socket, which is asymmetric with the rotation center of the healthy hip joint, resulting in poor symmetry between the prosthesis movement and the healthy lower limb movement. Besides, most of the prosthesis are passive joints, which need to rely on the amputee's compensatory hip lifting movement to realize the prosthesis movement, and the same walking movement needs to consume 2-3 times of energy compared with normal people. This paper presents a dynamic hip disarticulation prosthesis (HDPs) based on remote center of mechanism (RCM). Using the double parallelogram design method, taking the minimum size of the mechanism as the objective, the genetic algorithm was used to optimize the size, and the rotation center of the prosthesis was symmetrical with the rotation center of the healthy lower limb. By analyzing the relationship between the torque and angle of hip joint in the process of human walking, the control system mirrored the motion parameters of the lower on the healthy side, and used the parallel drive system to provide assistance for the prosthesis. Based on the established virtual prototype simulation platform of solid works and Adams, the motion simulation of hip disarticulation prosthesis was carried out and the change curve was obtained. Through quantitative comparison with healthy lower limb and traditional prosthesis, the scientificity of the design scheme was analyzed. The results show that the design can achieve the desired effect, and the design scheme is feasible.

Arthroplasty, Replacement, Hip , Artificial Limbs , Biomechanical Phenomena , Hip Joint , Hip Prosthesis , Humans , Prosthesis Design , Range of Motion, Articular , Walking
Article in Chinese | WPRIM | ID: wpr-880421


In recent years, the application of stent intervention in the treatment of non-vascular stenosis caused by benign and malignant factors has been widely concerned by researchers at home and abroad. The high incidence of malignant tumor diseases, further promotes the development of stent intervention. The conventional bare stents are prone to irritate luminal mucosa and produce restenosis and other complications. The emergence of drug-eluting stent is expected to solve this problem and become one of the important development trends of non-vascular stents. In this paper, the drug loading materials, drug loading layer drugs, preparation technology and quality evaluation methods of non-vascular drugeluting stent are described based on the recent research and clinical application documents, so as to provide basis and direction for the follow-up research and development.

Coronary Restenosis , Drug-Eluting Stents , Humans , Prosthesis Design , Treatment Outcome
Chinese Medical Journal ; (24): 2685-2691, 2021.
Article in English | WPRIM | ID: wpr-921223


BACKGROUND@#Nitinol-containing devices are widely used in clinical practice. However, there are concerns about nickel release after nitinol-containing device implantation. This study aimed to compare the efficacy and safety of a parylene-coated occluder vs. a traditional nitinol-containing device for atrial septal defect (ASD).@*METHODS@#One-hundred-and-eight patients with ASD were prospectively enrolled and randomly assigned to either the trial group to receive a parylene-coated occluder (n = 54) or the control group to receive a traditional occluder (n = 54). The plugging success rate at 6 months after device implantation and the pre- and post-implantation serum nickel levels were compared between the two groups. A non-inferiority design was used to prove that the therapeutic effect of the parylene-coated device was non-inferior to that of the traditional device. The Cochran-Mantel-Haenszel chi-squared test with adjustment for central effects was used for the comparison between groups.@*RESULTS@#At 6 months after implantation, successful ASD closure was achieved in 52 of 53 patients (98.11%) in both the trial and control groups (95% confidence interval (CI): [-4.90, 5.16]) based on per-protocol set analysis. The absolute value of the lower limit of the 95% CI was 4.90%, which was less than the specified non-inferiority margin of 8%. No deaths or severe complications occurred during 6 months of follow-up. The serum nickel levels were significantly increased at 2 weeks and reached the maximum value at 1 month after implantation in the control group (P  0.05).@*CONCLUSIONS@#The efficacy of a parylene-coated ASD occluder is non-inferior to that of a traditional uncoated ASD occluder. The parylene-coated occluder prevents nickel release after device implantation and may be an alternative for ASD, especially in patients with a nickel allergy.

Cardiac Catheterization , Heart Septal Defects, Atrial/surgery , Humans , Polymers , Prospective Studies , Prosthesis Design , Septal Occluder Device/adverse effects , Treatment Outcome , Xylenes
Article in Chinese | WPRIM | ID: wpr-879278


Lower extremity movement is a complex and large range of limb movement. Arterial stents implanted in lower extremity are prone to complex mechanical deformation, so the stent is required to have high comprehensive mechanical properties. In order to evaluate the mechanical property of different stents, in this paper, finite element method was used to simulate and compare the mechanical properties of six nitinol stents (Absolute Pro, Complete SE, Lifestent, Protégé EverFlex, Pulsar-35 and New) under different deformation modes, such as radial compression, axial compression/tension, bending and torsion, and the radial support performance of the stents was verified by experiments. The results showed that the comprehensive performance of New stent was better than other stents. Among which the radial support performance was higher than Absolute Pro and Pulsar-35 stent, the axial support performance was better than Complete SE, Lifestent and Protégé EverFlex stent, the flexibility was superior to Protégé Everflex stent, and the torsion performance was better than Complete SE, Lifestent and Protégé Everflex stent. The TTR2 type radial support force tester was used to test the radial support performance of 6 types, and the finite element analysis results were verified. The mechanical properties of the stent are closely related to the structural size. The result provides a reference for choosing a suitable stent according to the needs of the diseased location in clinical applications.

Alloys , Femoral Artery , Finite Element Analysis , Lower Extremity , Mechanical Phenomena , Prosthesis Design , Stents , Stress, Mechanical
Rev. bras. ortop ; 55(5): 597-604, Sept.-Oct. 2020. tab, graf
Article in English | LILACS | ID: biblio-1144213


Abstract Objective This study aims to compare the in vitro wear rate of crosslinked, high molecular weight polyethylene coupled to 36-mm diameter ceramic heads and 32-mm diameter metal heads. Methods Ceramic-on-polyethylene (36 mm) and metal-on-polyethylene (32 mm) tribological pairs were submitted to biomechanical tests in a simulator to determine the wear rate after 15 × 106 cycles. Results A statistically significant difference (p= 0.0005) was detected when comparing the wear rate of assemblies with metallic heads (average wear: 14.12 mg/MC) and ceramic heads (average wear: 7.46 mg/MC). Conclusion The present study demonstrated the lower wear rate in prosthetic assemblies using 36-mm crosslinked ceramic-on-polyethylene tribological pairs compared to 32-mm crosslinked metal-on-polyethylene assemblies. This finding demonstrates the effectiveness of ceramic-on-polyethylene tribological pairs, even with large diameter heads.

Resumo Objetivo: O objetivo do presente estudo foi comparar, in vitro, a taxa de desgaste do polietileno de alto peso molecular reticulado acoplado a cabeças cerâmicas de 36 mm de diâmetro e acoplado a cabeças metálicas de 32 mm de diâmetro. Métodos: Foram realizados ensaios biomecânicos em simulador de desgaste para os pares tribológicos cerâmica-poli (36 mm) e metal-poli (32 mm) a fim de verificar a taxa de desgaste após em 15 × 106 ciclos. Resultados: Na comparação entre as medidas de taxa de desgaste dos conjuntos com cabeças metálicas (média:14,12 mg/MC) e cerâmicas (média:7,46 mg/MC) houve diferença estatitsticamente significativa (p= 0,0005). Conclusão: O presente estudo demonstrou menor taxa de desgaste em conjuntos protéticos que utilizaram o par tribológico cerâmica-polietileno reticulado de 36 mm em comparação aos conjuntos com metal-polietileno reticulado de 32 mm. Tal achado demonstra a eficácia do par tribológico cerâmica-poli, mesmo com a utilização de cabeças de grande diâmetro.

Prosthesis Design , Weights and Measures , In Vitro Techniques , Ceramics , Arthroplasty, Replacement, Hip , Polyethylene , Hip
Arq. bras. cardiol ; 115(4): 680-687, out. 2020. graf
Article in Portuguese | SES-SP, LILACS, SES-SP | ID: biblio-1131356


Resumo Fundamento O implante valvar aórtico percutâneo (TAVR, do inglês Transcatheter Aortic Valve Replacement) reduz a mortalidade de pacientes portadores de estenose aórtica grave. O conhecimento da distribuição da pressão e tensão de cisalhamento na parede aórtica pode ajudar na identificação de regiões críticas, onde o processo de remodelamento aórtico pode ocorrer. Neste trabalho é apresentado um estudo de simulação computacional da influência do posicionamento do orifício valvar protético na hemodinâmica na raiz de aorta e segmento ascendente. Objetivos A presente análise apresenta um estudo da variação do padrão de fluxo devido a alterações no ângulo do orifício valvar. Métodos Um modelo tridimensional foi gerado a partir do exame de angiotomografia computadorizada da aorta de um paciente que foi submetido ao procedimento de TAVR. Diferentes vazões de fluxo foram impostas através do orifício valvar. Resultados Pequenas variações no ângulo de inclinação causaram mudanças no padrão de fluxo, com deslocamento na posição dos vórtices, na distribuição de pressão e no local de alta tensão cisalhante na parede aórtica. Conclusão Essas características hemodinâmicas podem ser importantes no processo de remodelamento aórtico e distribuição de tensão, além de auxiliar, em um futuro próximo, a otimização do posicionamento da prótese valvar percutânea. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Backgroud Transcatheter aortic valve replacement (TAVR) can reduce mortality among patients with aortic stenosis. Knowledge of pressure distribution and shear stress at the aortic wall may help identify critical regions, where aortic remodeling process may occur. Here a numerical simulation study of the influence of positioning of the prosthetic valve orifice on the flow field is presented. Objective The present analysis provides a perspective of great variance on flow behavior due only to angle changes. Methods A 3D model was generated from computed tomography angiography of a patient who had undergone a TAVR. Different mass flow rates were imposed at the inlet valve. Results Small variations of the tilt angle could modify the nature of the flow, displacing the position of the vortices, and altering the prerssure distribution and the location of high wall shear stress. Conclusion These hemodynamic features may be relevant in the aortic remodeling process and distribution of the stress mapping and could help, in the near future, the optimization of the percutaneous prosthesis implantation. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Humans , Aortic Valve Stenosis/diagnostic imaging , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation , Transcatheter Aortic Valve Replacement/adverse effects , Aorta , Aortic Valve/surgery , Aortic Valve/diagnostic imaging , Aortic Valve Stenosis/surgery , Prosthesis Design , Treatment Outcome , Computed Tomography Angiography , Hemodynamics
Arq. bras. cardiol ; 115(3): 515-524, out. 2020. tab, graf
Article in English, Portuguese | SES-SP, LILACS, SES-SP | ID: biblio-1131307


Resumo Fundamento A intervenção percutânea em pacientes com disfunção de prótese biológica mitral apresenta-se como uma alternativa ao tratamento cirúrgico convencional. Objetivo Relatar a primeira experiência brasileira de implante transcateter de bioprótese valve-in-valve mitral via transeptal (TMVIV-via transeptal). Métodos Foram incluídos pacientes portadores de disfunção de bioprótese cirúrgica submetidos ao TMVIV-transeptal em 12 hospitais brasileiros. Foram considerados estatisticamente significativos valores de p<0,05. Resultados Entre junho/2016 e fevereiro/2019, 17 pacientes foram submetidos ao TMVIV-via transeptal. A mediana de idade foi 77 anos (IIQ,70-82), a mediana do escore STS-PROM foi 8,7% (IIQ,7,2-17,8). Todos os pacientes tinham sintomas limitantes de insuficiência cardíaca (CF≥III), tendo 5 (29,4%) sido submetidos a mais de uma toracotomia prévia. Obteve-se sucesso do TMVIV-via transeptal em todos os pacientes. A avaliação ecocardiográfica demonstrou redução significativa do gradiente médio (pré-intervenção, 12±3,8 mmHg; pós-intervenção, 5,3±2,6 mmHg; p<0,001), assim como aumento da área valvar mitral (pré-intervenção, 1,06±0,59 cm2; pós-intervenção, 2,18±0,36 cm2; p<0,001) sustentados em 30 dias. Houve redução significativa e imediata da pressão sistólica de artéria pulmonar, com redução adicional em 30 dias (pré-intervenção, 68,9±16,4 mmHg; pós-intervenção, 57,7±16,5 mmHg; 30 dias, 50,9±18,7 mmHg; p<0,001). Durante o seguimento, com mediana de 162 dias (IIQ, 102-411), observou-se marcada melhora clínica (CF≤II) em 87,5%. Um paciente (5,9%) apresentou obstrução de via de saída de ventrículo esquerdo (VSVE), evoluindo para óbito logo após o procedimento, e outro morreu aos 161 dias de seguimento.Conclusão: A primeira experiência brasileira de TMVIV-transeptal demonstra a segurança e a efetividade dessa nova técnica. A obstrução da VSVE é uma complicação potencialmente fatal, reforçando a importância da seleção dos pacientes e do planejamento do procedimento. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Background Percutaneous intervention in patients with bioprosthetic mitral valve dysfunction is an alternative to conventional surgical treatment. Objectives To report the first Brazilian experience with transseptal transcatheter bioprosthetic mitral valve-in-valve implantation (transseptal-TMVIV). Methods Patients with surgical bioprosthetic dysfunction submitted to transseptal-TMVIV in 12 Brazilian hospitals were included. The significance level adopted was p<0.05. Results From June/2016 to February/2019, 17 patients underwent transseptal-TMVIV. Their median age was 77 years (IQR,70-82) and median Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) score was 8.7% (IQR,7.2-17.8). All patients had limiting symptoms of heart failure (FC≥III) and 5 (29.4%) had undergone more than one previous thoracotomy. Transseptal-TMVIV was successful in all patients. Echocardiographic assessment showed a significant reduction in mean mitral valve gradient (pre-intervention, 12±3.8 mmHg; post-intervention, 5.3±2.6 mmHg; p<0.001), in addition to an increase in mitral valve area (pre-intervention, 1.06±0.59 cm2; post-intervention, 2.18±0.36 cm2; p<0.001) sustained for 30 days. There was a significant and immediate reduction in the pulmonary artery systolic pressure, with an additional reduction in 30 days (pre-intervention, 68.9±16.4 mmHg; post-intervention, 57.7±16.5 mmHg; 30 days, 50.9±18.7 mmHg; p<0.001). During follow-up (median, 162 days; IQR, 102-411), significant clinical improvement (FC≤II) was observed in 87.5% of the patients. One patient (5.9%) had left ventricular outflow tract (LVOT) obstruction and died right after the procedure, and another died at 161 days of follow-up. Conclusion The first Brazilian experience with transseptal-TMVIV shows the safety and effectivity of the new technique. The LVOT obstruction is a potentially fatal complication, reinforcing the importance of patients' selection and of procedural planning. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Humans , Aged , Aged, 80 and over , Heart Valve Prosthesis , Heart Valve Prosthesis Implantation , Mitral Valve Insufficiency/surgery , Prosthesis Design , Brazil , Cardiac Catheterization , Treatment Outcome , Mitral Valve/surgery , Mitral Valve/diagnostic imaging
Arch. cardiol. Méx ; 90(3): 313-320, Jul.-Sep. 2020. tab, graf
Article in Spanish | LILACS | ID: biblio-1131049


Resumen Los pacientes con cardiopatías congénitas que afectan la continuidad del ventrículo derecho con la arteria pulmonar deben someterse con frecuencia a intervenciones debido a la limitada vida útil de los conductos quirúrgicos, lo que lleva al desarrollo de disfunción ventricular derecha por cambios en la geometría ventricular y predisposición a arritmias letales, con el consiguiente riesgo de reintervenciones. El implante valvular percutáneo pulmonar es una nueva alternativa terapéutica, menos invasiva en comparación con la quirúrgica, para pacientes seleccionados. Se realiza una revisión de las publicaciones médicas actuales disponibles y se describe la experiencia inicial del implante valvular pulmonar percutáneo en un centro colombiano de alta complejidad para el tratamiento de enfermedades cardiovasculares, en dos pacientes con disfunción del homoinjerto aórtico en posición pulmonar con doble lesión valvular, en los cuales el implante valvular pulmonar percutáneo fue una conducta exitosa. Se eligió a pacientes con cardiopatías congénitas, conductos quirúrgicos disfuncionales con estenosis o insuficiencia pulmonar significativa, y disfunción y dilatación ventricular derechas. Se empleó la técnica regular para el implante de la válvula pulmonar Melody, sin documentarse complicaciones durante el procedimiento ni al año de seguimiento. El implante percutáneo de la válvula pulmonar es un gran avance en el tratamiento de pacientes con cardiopatías congénitas, con resultados favorables a corto y mediano plazos, lo cual hace posible la restauración de la función ventricular con riesgo mínimo, frente al reemplazo quirúrgico en pacientes seleccionados.

Abstract Patients with congenital heart disease that involves reconstruction of the right ventricular outflow tract must frequently undergo interventions derived from the limited useful life of the surgical canals, which leads to the development of right ventricular dysfunction due to changes in the ventricular geometry and predisposition to lethal arrhythmias, with the consequent risk of reinterventions. The percutaneous pulmonary valvular implant is a new therapeutic alternative, less invasive, compared to surgery, for selected patients. A review of the available literature is made and the initial experience of percutaneous pulmonary valve implantation in a Colombian center of high complexity for the treatment of cardiovascular diseases is described, in two patients with aortic homograft dysfunction in a pulmonary position with double valvular lesion, in which the percutaneous pulmonary valve implant was a successful strategy. Patients with congenital heart disease were chosen, with dysfunctional surgical conduits with stenosis or significant pulmonary insufficiency, with dysfunction and right ventricular dilatation. The standard technique for the implantation of the Melody pulmonary valve was used, without complications during the procedure or one year of follow-up. Percutaneous implantation of the pulmonary valve is a great advance in the management of patients with congenital heart diseases, with favorable results in the short and medium term, allowing the restoration of ventricular function with minimal risk, compared to surgical replacement in selected patients.

Humans , Male , Adolescent , Pulmonary Valve Insufficiency/surgery , Pulmonary Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/methods , Prosthesis Design , Pulmonary Valve/surgery , Pulmonary Valve/pathology , Pulmonary Valve Insufficiency/congenital , Pulmonary Valve Stenosis/congenital , Colombia
Gac. méd. Méx ; 156(4): 276-282, Jul.-Aug. 2020. graf
Article in English | LILACS | ID: biblio-1249911


Abstract Introduction: A drug-eluting coronary stent is being developed at the National Institute of Cardiology of Mexico for the treatment of ischemic heart disease. Objective: To establish the best animal model for the tests, to show the advances in the drug-eluting stent prototype, to assess two drugs’ antiproliferative activity and histological results. Method: Smooth muscle cell culture tests were performed in order to assess sirolimus and paclitaxel antiproliferative properties. The drugs were encapsulated inside the polymeric matrix of the stents. Rabbits and pigs were used as animal models. Results: Sirolimus and paclitaxel showed an inhibitory effect, which was higher for the latter. Infrared spectroscopy and light and optical microscopy showed that the drug/polymer layer properly adhered to the stent. At a four-week follow-up, both animal models showed satisfactory clinical evolution and adequate histological response, although the porcine model was shown to be more suitable for future protocols. Conclusions: Preliminary tests of the drug-eluting stent provided bases for the development of a study protocol with an adequate number of pigs and with clinical angiographic and histopathological three-month follow-up.

Resumen Introducción: En el Instituto Nacional de Cardiología de México se desarrolla una endoprótesis (stent) coronaria liberadora de fármacos para el tratamiento de la cardiopatía isquémica. Objetivo: Establecer el mejor modelo animal para las pruebas, mostrar los avances en el prototipo del stent liberador de fármacos, evaluar la actividad antiproliferativa de dos fármacos y los resultados histológicos. Método: Se realizaron cultivos de células de músculo liso para evaluar las propiedades antiproliferativas de sirolimus y paclitaxel. Los fármacos fueron encapsulados en el interior de la matriz polimérica de los stents. Se emplearon conejos y cerdos como modelos animales. Resultados: Sirolimus y paclitaxel mostraron efecto inhibitorio, mayor en el segundo. La espectroscopia infrarroja y la microscopia óptica y electrónica mostraron que la capa del polímero con el fármaco se adhería adecuadamente al stent. A las cuatro semanas de seguimiento, ambos modelos animales mostraron evolución clínica satisfactoria y adecuada respuesta histológica, si bien el modelo porcino resultó más conveniente para protocolos futuros. Conclusiones: Las pruebas preliminares del stent liberador de fármaco brindó bases para desarrollar el protocolo con un número adecuado en cerdos y con seguimiento clínico angiográfico e histopatológico a tres meses.

Animals , Male , Female , Rabbits , Paclitaxel/administration & dosage , Sirolimus/administration & dosage , Drug-Eluting Stents , Prosthesis Design , Spectrophotometry, Infrared , Swine , Follow-Up Studies , Disease Models, Animal , Microscopy
Rev. bras. cir. cardiovasc ; 35(4): 411-419, July-Aug. 2020. tab, graf
Article in English | SES-SP, LILACS, SES-SP | ID: biblio-1137311


Abstract Introduction: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. Methods: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. Results: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). Conclusion: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Humans , Male , Female , Middle Aged , Aged , Bioprosthesis/adverse effects , Heart Valve Prosthesis/adverse effects , Heart Valve Prosthesis Implantation/adverse effects , Endocarditis, Bacterial/surgery , Aortic Valve/surgery , Prosthesis Design , Reoperation , Treatment Outcome , Propensity Score
Arq. bras. cardiol ; 115(1): 80-89, jul. 2020. tab, graf
Article in Portuguese | SES-SP, LILACS, SES-SP | ID: biblio-1131255


Resumo Fundamento O uso do stent farmacológico (SF) comparado ao stent não farmacológico (SNF) na intervenção coronariana percutânea (ICP) reduziu o percentual de reestenose, porém sem impacto na mortalidade, com aumento no custo. A literatura carece de estudos randomizados que comparem economicamente esses dois grupos de stents na realidade do Sistema Único de Saúde (SUS). Objetivo Estimar a razão custo-efetividade incremental (RCEI) entre SF e SNF na coronariopatia uniarterial em pacientes do SUS Métodos Pacientes com coronariopatia uniarterial sintomática foram randomizados em 3 anos para uso de SF ou SNF durante a ICP, na proporção de 1:2, com seguimento clínico de 12 meses. Foram avaliados reestenose intrastent (RIS), revascularização da lesão-alvo (RLA), eventos adversos maiores e custo-efetividade (CE) de cada grupo. Os valores de p < 0,05 foram considerados significativos. Resultados No grupo SF, dos 74 pacientes (96,1%) que completaram o acompanhamento, ocorreu RIS em 1(1,4%), RLA em 1 (1,4%), óbito em 1 (1,4%), sem trombose. No grupo SNF, dos 141 pacientes (91,5%),ocorreu RIS em 14 (10,1%), RLA em 10 (7,3%), óbito em 3 (2,1%) e trombose em 1 (0,74%). Na análise econômica, o custo do procedimento foi de R$ 5.722,21 no grupo SF e de R$4.085,21 no grupo SNF. A diferença de efetividade a favor do grupo SF por RIS e RLA foi 8,7% e 5,9%, respectivamente, com RCEI de R$ 18.816,09 e R$ 27.745,76. Conclusões No SUS, o SF foi custo-efetivo, em concordância com o limiar de CE preconizado pela Organização Mundial da Saúde. (Arq Bras Cardiol. 2020; 115(1):80-89)

Abstract Background The use of drug-eluting stents (DESs), compared with bare-metal stents (BMSs), in percutaneous coronary intervention (PCI) has reduced the rate of restenosis, without an impact on mortality but with an increase in costs. Medical literature lacks randomized studies that economically compare these 2 stent types within the reality of the Brazilian Unified Public Health System (SUS). Objective To estimate the incremental cost-effectiveness ratio (ICER) between DES and BMS in SUS patients with single-vessel coronary artery disease. Methods Over a 3-year period, patients with symptomatic single-vessel coronary artery disease were randomized in a 1:2 ratio to receive a DES or BMS during PCI, with a 1-year clinical follow-up. The evaluation included in-stent restenosis (ISR), target lesion revascularization (TLR), major adverse events, and cost-effectiveness for each group. P-values <0.05 were considered significant. Results In the DES group, of 74 patients (96.1%) who completed the follow-up, 1 developed ISR (1.4%), 1 had TLR (1.4%), and 1 died (1.4%), with no cases of thrombosis. In the BMS group, of 141 patients (91.5%), ISR occurred in 14 (10.1%), TLR in 10 (7.3%), death in 3 (2.1%), and thrombosis in 1 (0.74%). In the economic analysis, the cost of the procedure was R$ 5,722.21 in the DES group and R$ 4,085.21 in the BMS group. The effectiveness by ISR and TLR was 8.7% for DES and 5.9% for BMS, with an ICER of R$ 18,816.09 and R$ 27,745.76, respectively. Conclusions In the SUS, DESs were cost-effective in accordance with the cost-effectiveness threshold recommended by the World Health Organization (Arq Bras Cardiol. 2020; 115(1):80-89)

Humans , Brazil , Cost-Benefit Analysis , Percutaneous Coronary Intervention , Prosthesis Design , Stents/adverse effects , Public Health , Risk Factors , Treatment Outcome , Coronary Restenosis/prevention & control , Drug-Eluting Stents/adverse effects