RESUMO
Abstract Objective: The objectives of this study were to evaluate an automated device for ventilatory support based on AMBU manufactured in March 2020. Methods: The ESSI-1 INC was evaluated through pulmonary mechanics and physiology parameters through compensatory spirometer tests (TISSOTs), and an artificial lung Model5600i Dual Adult PNEU VIEW SYSTEM; it was also compared to the anesthetic ventilatory support equipment (AEONMED 7500) in porcine models, measuring ventilatory, hemodynamic and gasometric parameters. Results: This equipment (ESSI-1 INC) was successfully tested by mechanical and biological models, such as pigs in which its performance was evaluated in terms of variability of tidal volume, ventilation frequency, and I/E relationship versus the manual performance of two medical interns. All the results turned out as expected and were satisfactory. Conclusions: It is safe and effective equipment and should be tested and used in diverse clinical conditions to standardize the ventilatory safety and care of patients who require it.
Resumen Objetivo: Evaluar un dispositivo automatizado para la asistencia ventilatoria basado en un AMBU manufacturado en Marzo del 2020. Métodos: El ESSI-1 INC fue evaluado por medio de parámetros fisiológicos y mecánica pulmonar a través de pruebas de espirómetro compensatorios (TISSOT); pulmón artificial (Modelo 5600i Dual Adult PNEU VIEW SYSTEM); así como su desempeño comparado a la máquina de anestesia (AEONMED 7500) en modelos porcinos, midiendo criterios ventilatorios, hemodinámicos y gasométricos. Resultados: Este equipo (ESSI-1 INC) fue exitosamente probado por modelos mecánicos y biológicos, tales como cerdos donde su desempeño fue evaluado en términos de la variabilidad del volumen tidal, frecuencia ventilatoria, y relación I/E versus el desempeño manual de dos médicos. Todos los resultados finalizaron como se esperaba de forma satisfactoria. Conclusiones: Es un equipo seguro y efectivo, el cual debería ser probado y usado en distintas condiciones clínicas para estandarizar la seguridad ventilatoria y cuidado de pacientes que lo requieran.
RESUMO
OBJECTIVE: The objectives of this study were to evaluate an automated device for ventilatory support based on AMBU manufactured in March 2020. METHODS: The ESSI-1 INC was evaluated through pulmonary mechanics and physiology parameters through compensatory spirometer tests (TISSOTs), and an artificial lung Model5600i Dual Adult PNEU VIEW SYSTEM; it was also compared to the anesthetic ventilatory support equipment (AEONMED 7500) in porcine models, measuring ventilatory, hemodynamic and gasometric parameters. RESULTS: This equipment (ESSI-1 INC) was successfully tested by mechanical and biological models, such as pigs in which its performance was evaluated in terms of variability of tidal volume, ventilation frequency, and I/E relationship versus the manual performance of two medical interns. All the results turned out as expected and were satisfactory. CONCLUSIONS: It is safe and effective equipment and should be tested and used in diverse clinical conditions to standardize the ventilatory safety and care of patients who require it.
OBJETIVO: Evaluar un dispositivo automatizado para la asistencia ventilatoria basado en un AMBU manufacturado en Marzo del 2020. MÉTODOS: El ESSI-1 INC fue evaluado por medio de parámetros fisiológicos y mecánica pulmonar a través de pruebas de espirómetro compensatorios (TISSOT); pulmón artificial (Modelo 5600i Dual Adult PNEU VIEW SYSTEM); así como su desempeño comparado a la máquina de anestesia (AEONMED 7500) en modelos porcinos, midiendo criterios ventilatorios, hemodinámicos y gasométricos. RESULTADOS: Este equipo (ESSI-1 INC) fue exitosamente probado por modelos mecánicos y biológicos, tales como cerdos donde su desempeño fue evaluado en términos de la variabilidad del volumen tidal, frecuencia ventilatoria, y relación I/E versus el desempeño manual de dos médicos. Todos los resultados finalizaron como se esperaba de forma satisfactoria. CONCLUSIONES: Es un equipo seguro y efectivo, el cual debería ser probado y usado en distintas condiciones clínicas para estandarizar la seguridad ventilatoria y cuidado de pacientes que lo requieran.
Assuntos
Cardiologia , Respiração Artificial , Animais , Humanos , Suínos , Espirometria , Respiração Artificial/instrumentaçãoRESUMO
Resumen Introducción: Las bioprótesis de válvulas cardiacas son el estándar de oro para el reemplazo quirúrgico de la válvula aórtica en pacientes seleccionados. Objetivo: Evaluar la seguridad y eficacia de la válvula cardiaca bioprotésica del Instituto Nacional de Cardiología (INC) en humanos. Métodos: Estudio unicéntrico que incluyó 341 pacientes que se sometieron a reemplazo valvular quirúrgico único de válvula aórtica con válvula INC. Resultados: Se realizaron 318 implantes de novo (93 %) y 23 como segunda cirugía (7 %); las puntuaciones STS fueron de 1.4 y 1.8 % y el seguimiento de 42 y 46 meses, respectivamente. No existieron diferencias en las complicaciones ni en la tasa de implantación de marcapasos. Ambos grupos mantuvieron una FEVI normal. Se observó mejoría global en la clase funcional con empeoramiento solo en dos pacientes del grupo de novo. La disfunción de la prótesis INC que ameritó reintervención quirúrgica se observó en ocho pacientes (4.65 %) del grupo de novo versus un paciente (7.69 %) con segunda cirugía. Conclusiones: La válvula cardiaca INC es eficaz y segura, se asocia a baja tasa de complicaciones y mejoría de la clase funcional durante el seguimiento a largo plazo. Se necesitan estudios prospectivos comparativos de esta válvula.
Abstract Introduction: Heart valve bioprostheses are the gold standard for aortic valve surgical replacement in selected patients. Objective: To evaluate the safety and efficacy of the of the National Institute of Cardiology (INC) bioprosthetic heart alve of the National Institute of Cardiology (INC) bioprosthetic heart valve in humans. Methods: Single-center study that ncluded 341 patients who underwent single surgical aortic valve replacement with INC heart valve. Results: 318 implants were performed de novo (93%) and 23 as redo surgery (7%); STS scores were 1.4 and 1.8%, and follow-up was for 42 and 46 months, respectively. There were no differences in clinical complications or pacemaker implantation rate. Both groups maintained a normal LVEF. Overall improvement in functional class was observed, with worsening only in two patients of the de novo group. INC prosthesis dysfunction requiring surgical reintervention was observed in eight patients (4.65%) of the de novo group vs. one patient in the redo group. Conclusions: The INC heart valve is efficacious and safe, and is associated with a The INC heart valve is efficacious and safe, and is associated with a low rate of complications and functional class improvement during long-term follow-up. Prospective, comparative studies of this valve are required.
RESUMO
INTRODUCTION: Heart valve bioprostheses are the gold standard for aortic valve surgical replacement in selected patients. OBJECTIVE: To evaluate the safety and efficacy of the National Institute of Cardiology (INC) bioprosthetic heart valve in humans. METHODS: Single-center study that included 341 patients who underwent single surgical aortic valve replacement with INC heart valve. RESULTS: 318 implants were performed de novo (93%) and 23 as redo surgery (7%); STS scores were 1.4 and 1.8%, and follow-up was for 42 and 46 months, respectively. There were no differences in clinical complications or pacemaker implantation rate. Both groups maintained a normal LVEF. Overall improvement in functional class was observed, with worsening only in two patients of the de novo group. INC prosthesis dysfunction requiring surgical reintervention was observed in eight patients (4.65%) of the de novo group vs. one patient in the redo group. CONCLUSIONS: The INC heart valve is efficacious and safe, and is associated with a low rate of complications and functional class improvement during long-term follow-up. Prospective, comparative studies of this valve are required.
INTRODUCCIÓN: Las bioprótesis de válvulas cardiacas son el estándar de oro para el reemplazo quirúrgico de la válvula aórtica en pacientes seleccionados. OBJETIVO: Evaluar la seguridad y eficacia de la válvula cardiaca bioprotésica del Instituto Nacional de Cardiología (INC) en humanos. MÉTODOS: Estudio unicéntrico que incluyó 341 pacientes que se sometieron a reemplazo valvular quirúrgico único de válvula aórtica con válvula INC. RESULTADOS: Se realizaron 318 implantes de novo (93 %) y 23 como segunda cirugía (7 %); las puntuaciones STS fueron de 1.4 y 1.8 % y el seguimiento de 42 y 46 meses, respectivamente. No existieron diferencias en las complicaciones ni en la tasa de implantación de marcapasos. Ambos grupos mantuvieron una FEVI normal. Se observó mejoría global en la clase funcional con empeoramiento solo en dos pacientes del grupo de novo. La disfunción de la prótesis INC que ameritó reintervención quirúrgica se observó en ocho pacientes (4.65 %) del grupo de novo versus un paciente (7.69 %) con segunda cirugía. CONCLUSIONES: La válvula cardiaca INC es eficaz y segura, se asocia a baja tasa de complicaciones y mejoría de la clase funcional durante el seguimiento a largo plazo. Se necesitan estudios prospectivos comparativos de esta válvula.
Assuntos
Estenose da Valva Aórtica , Cardiologia , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas , Humanos , Implante de Prótese de Valva Cardíaca/efeitos adversos , Estudos Prospectivos , Valva Aórtica/cirurgia , Falha de Prótese , Resultado do Tratamento , Estenose da Valva Aórtica/cirurgia , ReoperaçãoRESUMO
In this paper, we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing, and mechanic trials, we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 µm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion, and safety, as well as endothelial attachment, thrombogenicity, and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion, and complete endothelial attach. Furthermore, we obtained a good post-implant balloon withdrawal, functional integrity, and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.
En esta publicación se describen el diseño y el desarrollo de un stent coronario (INC-1), la forma en que se determinaron las características biofísicas deseadas, el diseño y las pruebas computacionales por elemento finito, su fabricación, así como las pruebas mecánicas a las que se sometió el prototipo y por último las primeras experiencias en modelos animales. La plataforma del stent desarrollado fue de cobalto y cromo L605 (Co-Cr), con struts de 80 µm de grosor, expandido por balón. La colocación del stent coronario INC-1 se realizó en un modelo de conejo y uno canino con el objetivo de evaluar el éxito técnico y de seguridad del stent en relación con las propiedades biomecánicas (capacidad de navegación, maniobrabilidad, expansión simétrica del stent) y de seguridad (fijación a la pared vascular y ausencia de compromiso de ramas secundarias y formación de trombos en el momento de la colocación del stent en el modelo animal). Se obtuvo éxito técnico y de seguridad del stent después del implante guiado por fluoroscopia, lo que demostró adecuada capacidad del sistema liberador, excelente maniobrabilidad, adecuada visualización fluoroscópica, expansión simétrica y fijación completa a la pared vascular, capacidad para retirar el balón desinflado después del implante, e integridad funcional y sin complicaciones vasculares. La evolución clínica fue favorable a tres semanas del seguimiento planeado.
Assuntos
Vasos Coronários/cirurgia , Desenho de Prótese , Stents , Animais , Ligas de Cromo/química , Doença da Artéria Coronariana/cirurgia , Cães , Fluoroscopia , Humanos , Modelos Animais , CoelhosRESUMO
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.
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.
Assuntos
Stents Farmacológicos , Paclitaxel/administração & dosagem , Sirolimo/administração & dosagem , Animais , Modelos Animais de Doenças , Feminino , Seguimentos , Masculino , Microscopia , Desenho de Prótese , Coelhos , Espectrofotometria Infravermelho , SuínosRESUMO
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.
Assuntos
Animais , Masculino , Feminino , Coelhos , Paclitaxel/administração & dosagem , Sirolimo/administração & dosagem , Stents Farmacológicos , Desenho de Prótese , Espectrofotometria Infravermelho , Suínos , Seguimentos , Modelos Animais de Doenças , MicroscopiaRESUMO
Abstract In this paper, we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing, and mechanic trials, we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 μm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion, and safety, as well as endothelial attachment, thrombogenicity, and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion, and complete endothelial attach. Furthermore, we obtained a good post-implant balloon withdrawal, functional integrity, and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.
Resumen En esta publicación se describen el diseño y el desarrollo de un stent coronario (INC-1), la forma en que se determinaron las características biofísicas deseadas, el diseño y las pruebas computacionales por elemento finito, su fabricación, así como las pruebas mecánicas a las que se sometió el prototipo y por último las primeras experiencias en modelos animales. La plataforma del stent desarrollado fue de cobalto y cromo L605 (Co-Cr), con struts de 80 μm de grosor, expandido por balón. La colocación del stent coronario INC-1 se realizó en un modelo de conejo y uno canino con el objetivo de evaluar el éxito técnico y de seguridad del stent en relación con las propiedades biomecánicas (capacidad de navegación, maniobrabilidad, expansión simétrica del stent) y de seguridad (fijación a la pared vascular y ausencia de compromiso de ramas secundarias y formación de trombos en el momento de la colocación del stent en el modelo animal). Se obtuvo éxito técnico y de seguridad del stent después del implante guiado por fluoroscopia, lo que demostró adecuada capacidad del sistema liberador, excelente maniobrabilidad, adecuada visualización fluoroscópica, expansión simétrica y fijación completa a la pared vascular, capacidad para retirar el balón desinflado después del implante, e integridad funcional y sin complicaciones vasculares. La evolución clínica fue favorable a tres semanas del seguimiento planeado.
Assuntos
Humanos , Animais , Cães , Coelhos , Desenho de Prótese , Stents , Vasos Coronários/cirurgia , Doença da Artéria Coronariana/cirurgia , Fluoroscopia , Ligas de Cromo/química , Modelos AnimaisRESUMO
BACKGROUND: PCI is an expensive procedure in our population and it implies a huge cost for the institutions and National Health Service. AIM OF THE STUDY: The main objective was to evaluate the technical and biological success of two stents designed in Mexico. METHODS: Ten York pigs, 4-6 months of age, underwent implantation of the bare metal INC-01 (10 stents) and INC-02 (6 stents) coronary stent in addition to a conventional commercial stent (10 stents). Technical success was evaluated immediately with angiography and Intravascular Ultrasound IVUS, continued by a mean follow-up of 4 month and a final angiographic, IVUS and histological evaluation. RESULTS: Initial technical success, angiography and IVUS between the three stents were not significant. One stent presented restenosis in follow-up (commercial stent), but all other stents presented excellent clinical outcome, satisfactory angiographic and IVUS results. Inflammation, proliferation and endothelialization between the stents had no major differences in histological analysis in a mean of 4 months follow-up. CONCLUSIONS: In this pig model, the INC 01 and INC 02 stents showed the same delivering technical success, angiographic and IVUS features, biological and histological response compared to commercial last generation stents.
Assuntos
Isquemia Miocárdica/cirurgia , Intervenção Coronária Percutânea/métodos , Stents/normas , Animais , Humanos , Metais , Pessoa de Meia-Idade , Suínos , Resultado do TratamentoRESUMO
In this paper we describe our coronary stent (INC-1) design and development, the way that we found the specific characteristics needed for our device including biophysics aspects, design, finite element testing, manufacturing and mechanic trials we submitted and animal models experiences. The stent platform was cobalt-chromium L605 (Co-Cr), with struts thickness of 80 µm, balloon expandable. We placed the coronary stent INC-1 on a rabbit and dog models so we can evaluate efficacy and security of the device in relationship to its biomechanical properties including navigation capacity, traceability, symmetric expansion and safety. As well as endothelial attachment, thrombogenicity and lack of involvement of secondary branches in these models. We succeeded in efficacy and safety of the device after fluoroscopy-guided implant proving excellent capacity of release system, traceability, fluoroscopic visualization, symmetric expansion and complete endothelial attach. Also, we obtained a good post-implant balloon withdrawal, functional integrity and no vascular complications. We observed adequate clinical evolution 3 weeks after the stent implantation.
En esta publicación se describen el diseño y el desarrollo de un stent coronario (INC-1), la forma en que se determinaron las características biofísicas deseadas, el diseño y las pruebas computacionales por elemento finito, su fabricación, así como las pruebas mecánicas a las que se sometió el prototipo y por último las primeras experiencias en modelos animales. La plataforma del stent desarrollado fue de cobalto y cromo L605 (Co-Cr), con struts de 80 µm de grosor, expandido por balón. La colocación del stent coronario INC-1 se realizó en un modelo de conejo y uno canino con el objetivo de evaluar el éxito técnico y de seguridad del stent en relación con las propiedades biomecánicas (capacidad de navegación, maniobrabilidad, expansión simétrica del stent) y de seguridad (fijación a la pared vascular y ausencia de compromiso de ramas secundarias y formación de trombos en el momento de la colocación del stent en el modelo animal). Se obtuvo éxito técnico y de seguridad del stent después del implante guiado por fluoroscopia, lo que demostró adecuada capacidad del sistema liberador, excelente maniobrabilidad, adecuada visualización fluoroscópica, expansión simétrica y fijación completa a la pared vascular, capacidad para retirar el balón desinflado después del implante, e integridad funcional y sin complicaciones vasculares. La evolución clínica fue favorable a tres semanas del seguimiento planeado.
Assuntos
Doença da Artéria Coronariana/cirurgia , Desenho de Prótese , Stents , Animais , Modelos Animais de Doenças , Cães , Fluoroscopia , Humanos , CoelhosRESUMO
BACKGROUND: The cost of performing a percutaneous coronary intervention is considerably high for the patient as well as for health systems, which have promoted the development of local technology to help meet the need for these devices. METHODS: The INC-01 bare-metal stent was developed at the National Institute of Cardiology in Mexico City and was first implanted on porcine models with technical success in 100% of the evaluated parameters. PRESENTATION OF CASES: We present the first three cases of patients with ischemic heart disease, to whom the INC-01 bare-metal stent was implanted. Intracoronary ultrasonography was performed post-stent implantation, showing all the characteristics of implant success during evaluation and clinical follow-up. CONCLUSIONS: Angiography and intracoronary ultrasound were carried out demonstrating that the INC-01 bare-metal stent has physical, biological, and histological characteristics similar to those found in commercial metallic stents.
Assuntos
Isquemia Miocárdica/cirurgia , Desenho de Prótese , Stents , Adulto , Idoso , Seguimentos , Humanos , Masculino , México , Pessoa de Meia-Idade , Isquemia Miocárdica/diagnóstico por imagem , Isquemia Miocárdica/fisiopatologia , Projetos Piloto , Resultado do Tratamento , UltrassonografiaRESUMO
ABSTRACT Background: The cost of performing a percutaneous coronary intervention is considerably high for the patient as well as for health systems, which have promoted the development of local technology to help meet the need for these devices. Methods: The INC-01 bare-metal stent was developed at the National Institute of Cardiology in Mexico City and was first implanted on porcine models with technical success in 100% of the evaluated parameters. Presentation of Cases: We present the first three cases of patients with ischemic heart disease, to whom the INC-01 bare-metal stent was implanted. Intracoronary ultrasonography was performed post-stent implantation, showing all the characteristics of implant success during evaluation and clinical follow-up. Conclusions: Angiography and intracoronary ultrasound were carried out demonstrating that the INC-01 bare-metal stent has physical, biological, and histological characteristics similar to those found in commercial metallic stents.
Assuntos
Humanos , Masculino , Adulto , Pessoa de Meia-Idade , Idoso , Desenho de Prótese , Stents , Isquemia Miocárdica/cirurgia , Projetos Piloto , Seguimentos , Ultrassonografia , Resultado do Tratamento , Isquemia Miocárdica/fisiopatologia , Isquemia Miocárdica/diagnóstico por imagem , MéxicoRESUMO
Resumen Antecedentes: El mejor método para el tratamiento de la revascularización de la lesión del tronco no protegido de la coronaria izquierda es un tema de creciente interés. Método: Se realizaron un total de 2,439 intervenciones coronarias percutáneas (ICP) durante 3 años; se incluyeron los pacientes con lesión del tronco no protegido de la coronaria izquierda (TCI; n = 48) y se compararon con pacientes a los que se realizó cirugía de revascularización coronaria (CRVC; n = 50). Se analizaron los eventos cardiovasculares en fase hospitalaria y extrahospitalaria. El promedio de seguimiento fue de 16 meses. Resultados: El riesgo cardiovascular fue mayor en pacientes con ICP; log EuroSCORE (16 ± 21 vs. 5 ± 6, p = 0.001), Syntax clínico (77 ± 74 vs. 53 ± 39, p = 0.04). Los pacientes del grupo de ICP presentaron al ingreso con más frecuencia infarto con elevación del ST (IMCEST) y con choque cardiogénico. Los eventos hospitalarios fueron similares en ICP y CRVC (14% vs. 18%, p = 0.64). El IMCEST fue menos frecuente en el grupo de ICP (0% vs. 10%, p = 0.03. Los eventos cardiovasculares fueron menores en el grupo de ICP (2.3% vs. 18%, p = 0.01) y hubo una disminución de la muerte general y cardiaca (2.3% vs. 12%, p = 0.08 y 2.3% vs. 8%, p = 0.24), al excluir los pacientes con choque cardiogénico como presentación. En la fase extrahospitalaria los eventos fueron similares en ICP y CRVC (15% vs. 12%, p = 0.46). La supervivencia sin eventos cardiovasculares, muerte general y cardiaca fueron comparables entre los grupos (log rank, p = 0.38, p = 0.44 y p = 0.16). Conclusión: Pese a que los pacientes de ICP mostraron un perfil de riesgo mayor que los de CRVC, la seguridad y eficacia intrahospitalaria y extrahospitalaria fueron similares. © 2016 Instituto Nacional de Cardiología Ignacio Chávez. Publicado por Masson Doyma México S.A. Este es un artículo Open Access bajo la licencia CC BY-NC-ND (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Abstract Background: The best revascularisation method of the unprotected left main artery is a current and evolving topic. Methods: A total of 2439 percutaneous coronary interventions (PCI) were registered during a 3-year period. The study included all the patients with PCI of the unprotected left main coronary (n = 48) and matched with patients who underwent coronary artery bypass graft (CABG) (n = 50). Major adverse cerebral and cardiac events (MACCE) were assessed within the hospital and in outpatients during a 16 month follow up. Results: The cardiovascular risk was greater in the PCI group; logEuroSCORE 16 ± 21 vs. 5 ± 6, P = .001; clinical Syntax 77 ± 74 vs 53 ± 39, P = .04. On admission, the PCI group of patients had a higher frequency of ST segment elevation myocardial infarction (STEMI) and cardiogenic shock. The MACCE were similar in both groups (14% vs. 18%, P = .64). STEMI was less frequent in the PCI group (0% vs. 10%, P = .03). Cardiovascular events were lower in the PCI group (2.3% vs. 18%, P = .01), and there was a decrease in general and cardiac mortality (2.3% vs. 12%, P = .08 y 2.3% vs. 8%, P = .24), on excluding the patients with cardiogenic shock as a presentation. MACCE were similar in both groups in the out-patient phase (15% vs. 12%, P = .46). Survival without MACCE, general and cardiac death were comparable between groups (log rank, P = .38, P = .44 and P = .16, respectively). Conclusion: Even though the clinical and periprocedural risk profile of the PCI patients were higher, the in-hospital and out-hospital efficacy and safety were comparable with CABG. © 2016 Instituto Nacional de Cardiología Ignacio Chávez. Published by Masson Doyma México S.A. This is an open access article under the CC BY-NC-ND license (https://creativecommons.org/licenses/by-nc-nd/4.0/).
Assuntos
Humanos , Masculino , Feminino , Idoso , Doença da Artéria Coronariana/cirurgia , Ponte de Artéria Coronária , Intervenção Coronária Percutânea/métodos , Fatores de Tempo , Estudos de Casos e Controles , Estudos Retrospectivos , Estudos Longitudinais , Resultado do Tratamento , MéxicoRESUMO
BACKGROUND: Reclassification of a large thrombus burden is an independent predictor of major adverse cardiac events and no-reflow in patients with ST- segment elevation myocardial infarction (STEMI). Patients with a greater residual thrombus burden have worse microvascular dysfunction and greater myocardial damage. METHODS: A retrospective analysis was performed on 833 STEMI patients who underwent primary percutaneous coronary intervention. The final residual thrombus burden was reclassified after the lesion was wired, and a thrombus aspiration or balloon dilatation was performed to restore and stabilise a thrombolysis in myocardial infarction (TIMI) 2-3 flow. Deferred stenting (DEI) was compared with immediate stenting (ISI) group, and the primary outcome was the incidence of no-/slow-reflow (TIMI ≤ 2, or TIMI 3 with myocardial blush grade < 2). RESULTS: Overall, 47 patients (6.8%) had a residual large thrombus burden reclassified. The right coronary artery was the culprit vessel in 34 cases. More patients had coronary ectasia in the DSI group (P=.005). Fewer patients in the DSI had no-/slow-reflow (36% vs. 58%), and the myocardial blush grade 3 was more frequent in the DSI group (P=.005). After repeat coronary angiography in the DSI group, stenting was not performed in 56%, and oral anticoagulation was more frequent in the follow-up (P=.031). Major cardiac adverse events were similar between groups. There was a tendency to better left ventricular function in the DSI group (P=.056). CONCLUSIONS: Deferred stenting may be an efficient option in STEMI patients with a residual large thrombus burden reclassified after achieving a stable TIMI 2-3 flow.
Assuntos
Angiografia Coronária/métodos , Trombose Coronária/terapia , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Stents , Adulto , Idoso , Anticoagulantes/administração & dosagem , Trombose Coronária/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Infarto do Miocárdio com Supradesnível do Segmento ST/diagnóstico por imagem , Infarto do Miocárdio com Supradesnível do Segmento ST/fisiopatologia , Fatores de Tempo , Função Ventricular EsquerdaRESUMO
BACKGROUND: The best revascularisation method of the unprotected left main artery is a current and evolving topic. METHODS: A total of 2439 percutaneous coronary interventions (PCI) were registered during a 3-year period. The study included all the patients with PCI of the unprotected left main coronary (n=48) and matched with patients who underwent coronary artery bypass graft (CABG) (n=50). Major adverse cerebral and cardiac events (MACCE) were assessed within the hospital and in outpatients during a 16 month follow up. RESULTS: The cardiovascular risk was greater in the PCI group; logEuroSCORE 16±21 vs. 5±6, P=.001; clinical Syntax 77±74 vs 53±39, P=.04. On admission, the PCI group of patients had a higher frequency of ST segment elevation myocardial infarction (STEMI) and cardiogenic shock. The MACCE were similar in both groups (14% vs. 18%, P=.64). STEMI was less frequent in the PCI group (0% vs. 10%, P=.03). Cardiovascular events were lower in the PCI group (2.3% vs. 18%, P=.01), and there was a decrease in general and cardiac mortality (2.3% vs. 12%, P=.08 y 2.3% vs. 8%, P=.24), on excluding the patients with cardiogenic shock as a presentation. MACCE were similar in both groups in the out-patient phase (15% vs. 12%, P=.46). Survival without MACCE, general and cardiac death were comparable between groups (log rank, P=.38, P=.44 and P=.16, respectively). CONCLUSION: Even though the clinical and peri-procedural risk profile of the PCI patients were higher, the in-hospital and out-hospital efficacy and safety were comparable with CABG.
Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/cirurgia , Intervenção Coronária Percutânea/métodos , Idoso , Estudos de Casos e Controles , Feminino , Humanos , Estudos Longitudinais , Masculino , México , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
Resumen Introducción: Un trombo intracorononario largo reclasificado es un predictor independiente de resultados adversos y no reflujo en el infarto agudo de miocardio con elevación del ST. Pacientes con mayor carga de trombo residual tienen peor disfunción microvascular y mayor daño miocárdico. Métodos: Evaluamos retrospectivamente a 833 pacientes que fueron a angioplastia primaria entre enero del 2011 y junio del 2016. La carga de trombo residual final fue reclasificada tras realizar el cruce de la guía, predilatación con balón o tromboaspiración, para restaurar y estabilizar un flujo TIMI 2-3. Las estrategias de stent diferido vs. stent inmediato fueron comparadas, siendo el objetivo primario la incidencia de no reflujo (TIMI ≤ 2, o TIMI 3 con TMP < 2). Resultados: Cuarenta y siete pacientes (6.8%) presentaron una alta carga trombo residual reclasificado. La coronaria derecha fue la arteria culpable en 34 casos. Hubo mayor frecuencia de ectasia coronaria en el grupo de stent diferido (p = 0.005). Se encontraron menores tasas de no reflujo en el stent diferido (36% vs. 58%), con una mayor frecuencia de un TMP 3 (p = 0.005). Tras la nueva cateterización un 56% quedó libre de stent en el grupo diferido y la anticoagulación oral les fue más frecuentemente indicada (p = 0.031). La tasa de eventos cardiacos adversos mayores fue similar entre los grupos. Hubo una tendencia a una mejor función ventricular izquierda en el grupo diferido (p = 0.056). Conclusiones: El stent diferido puede ser una alternativa eficiente en pacientes con IAM CEST y alta carga de trombo residual reclasificado, después de conseguir un flujo TIMI 2-3 estable.
Abstract Background: Reclassification of a large thrombus burden is an independent predictor of major adverse cardiac events and no-reflow in patients with ST- segment elevation myocardial infarction (STEMI). Patients with a greater residual thrombus burden have worse microvascular dysfunction and greater myocardial damage. Methods: A retrospective analysis was performed on 833 STEMI patients who underwent primary percutaneous coronary intervention. The final residual thrombus burden was reclassified after the lesion was wired, and a thrombus aspiration or balloon dilatation was performed to restore and stabilise a thrombolysis in myocardial infarction (TIMI) 2-3 flow. Deferred stenting (DEI) was compared with immediate stenting (ISI) group, and the primary outcome was the incidence of no-/slow-reflow (TIMI ≤ 2, or TIMI 3 with myocardial blush grade < 2). Results: Overall, 47 patients (6.8%) had a residual large thrombus burden reclassified. The right coronary artery was the culprit vessel in 34 cases. More patients had coronary ectasia in the DSI group (P=.005). Fewer patients in the DSI had no-/slow-reflow (36% vs. 58%), and the myocardial blush grade 3 was more frequent in the DSI group (P=.005). After repeat coronary angiography in the DSI group, stenting was not performed in 56%, and oral anticoagulation was more frequent in the follow-up (P=.031). Major cardiac adverse events were similar between groups. There was a tendency to better left ventricular function in the DSI group (P=.056). Conclusions: Deferred stenting may be an efficient option in STEMI patients with a residual large thrombus burden reclassified after achieving a stable TIMI 2-3 flow.
Assuntos
Humanos , Masculino , Feminino , Adulto , Pessoa de Meia-Idade , Idoso , Trombose Coronária/terapia , Stents , Angiografia Coronária/métodos , Intervenção Coronária Percutânea/métodos , Infarto do Miocárdio com Supradesnível do Segmento ST/terapia , Fatores de Tempo , Trombose Coronária/diagnóstico por imagem , Estudos Retrospectivos , Seguimentos , Estudos Longitudinais , Função Ventricular Esquerda , Anticoagulantes/administração & dosagemRESUMO
BACKGROUND: Nowadays, stenting is the treatment of choice in patients >15 years of age with coarctation of the aorta without hypoplastic aortic isthmus. The platinum/iridium stent manufactured in Mexico may be an affordable alternative with the same benefits as the imported stent. METHODS: This is a series of cases in which we present the immediate results of the first seven patients with coarctation of the aorta treated with the platinum/iridium stent manufactured in Mexico. The first four patients were selected and treated at the Cardiology Hospital of the National Medical Center during the year 2003, two more patients were selected and treated at the National Institute of Cardiology, and another patient was treated at the Military Hospital, Mexico City, in the year 2005. RESULTS: A total of seven patients were successfully treated with the platinum/iridium stent without any complications. Average initial gradient was 56.4 mmHg (range: 30-90 mmHg). In six patients, the final gradient was 0.0 mmHg and in one it was 2 mmHg. In the four patients treated in the Cardiology Hospital of the National Medical Center, mean follow-up time was 17.5 +/- 2.5 months, with a gradient of 0.0 mmHg. All patients are in NYHA Class I. At 12 months follow-up, the gradient remains as 0 mmHg and the patients are still in NYHA Class I functional state. CONCLUSIONS: This stent can be a safe and effective alternative to other stents available on the market for the treatment of coarctation of the aorta.
Assuntos
Coartação Aórtica/terapia , Cateterismo , Irídio , Platina , Stents , Adolescente , Adulto , Coartação Aórtica/diagnóstico , Coartação Aórtica/diagnóstico por imagem , Aortografia , Feminino , Seguimentos , Humanos , Masculino , México , Desenho de Prótese/economia , Estudos Retrospectivos , Fatores de Tempo , Resultado do TratamentoRESUMO
UNLABELLED: We evaluated immediate and mid-term clinical and angiographic results in diabetic patients with percutaneous coronary intervention with deployment of drug eluting stents. METHODS: Between November of 2004 and June of 2005 percutaneous coronary interventions were performed 860 with the deployment of 112 drug eluting stents to 42 diabetic patients. The mean of stents was 2.6 per patient, and the type of drug eluting stent was paclitaxel in 60% and sirolimus in 40%. The average of age was 51.2 +/- 9.6 years old. The gender was male in 25 (60%) of patients and female in 17 (40%). The indication of coronary angiography was unstable angina in 15 (35%) patients and stable angina in 27 (65%). There was history of anterior myocardial infarction in 20 (47%), inferior myocardial infarction in 8 (20%) and multiple vessel disease in 16 (38%). The stenosis severity of the lesion was 85.9% +/- 12.2% and the left ventricular function was (55 +/- 10). The hospital stay was 7 +/- 5.4 days. RESULTS: Both clinical and angiographic immediate success was 100%. The average follow was 7.6 +/- 3.3 months in 34 patients (80.9%). The target lesion revascularization (TLR) was 7.1%. (3 patients). Death, myocardial infarction or reinfarction (0%). COMPLICATIONS: One patient (2.3%) developed contrast induced nephropathy. CONCLUSIONS: These results suggest that the use of drug eluting stents (paclitaxel or sirolimus) in diabetic patients has a high rate of success with good angiographic and clinical results and with a low rate of complications or restenosis in this high risk group of patients.