Fractional flow reserve use in coronary artery revascularization: A systematic review and meta-analysis.

Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) is recommended in revascularization guidelines for intermediate lesions. However, recent studies comparing FFR-guided PCI with non-physiology-guided revascularization have reported conflicting results. PubMed and Embase were searched for studies comparing FFR-guided PCI with non-physiology-guided revascularization strategies (angiography-guided, intracoronary imaging-guided, coronary artery bypass grafting). Data were pooled by meta-analysis using random-effects model. 26 studies enrolling 78,897 patients were included. FFR-guided PCI as compared to non-physiology-guided coronary revascularization had lower risk of all-cause mortality (odds ratio [OR] 0.79 95% confidence interval [CI] 0.64-0.99, I2 = 53%) and myocardial infarction (MI) (OR 0.74 95% CI 0.59-0.93, I2 = 44.7%). However, no differences between groups were found in terms of major adverse cardiac events (MACEs) (OR 0.86 95% CI 0.72-1.03, I2 = 72.3%) and repeat revascularization (OR 1 95% CI 0.82-1.20, I2 = 43.2%). Among patients with coronary artery disease (CAD), FFR-guided PCI as compared to non-physiology-guided revascularization was associated with a lower risk of all-cause mortality and MI.

Vieussens' ring fistula to pulmonary artery: embolization with grandmother-mother-child technique / Fístula del anillo de Vieussens a arteria pulmonar: embolización con técnica abuela-madre-hijo

Abstract A 53-year-old man with an asymptomatic fistula from the Vieussens ring to the pulmonary artery presented with progressive respiratory distress. Coil embolization of this type of fistula has been described by femoral access. The advanced transradial "grandmother-mother-son" technique for high active support safely allows successful embolization of this type of coronary fistulae.

Resumen Un hombre de 53 años con una fístula asintomática del anillo de Vieussens a la arteria pulmonar comenzó con dificultad respiratoria progresiva. La embolización con coils de este tipo de fístulas ha sido descrita por acceso femoral. La técnica transradial avanzada "abuela-madre-hijo" para un alto soporte activo permite de manera segura la embolización exitosa de este tipo fístulas coronarias.

Seguridad y eficacia de la bioprótesis de válvula cardiaca INC en humanos / Safety and efficacy of the INC bioprosthetic heart valve in humans

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.

Safety and efficacy of the INC bioprosthetic heart valve in humans.

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.

Design, manufacture and initial tests of a drug-eluting coronary stent / Diseño, fabricación y pruebas iniciales de una endoprótesis coronaria liberadora de fármaco

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.

Design and manufacture of a coronary stent INC-1 and initial tests in experimental animal model / Diseño y fabricación del stent coronario INC-1y pruebas iniciales en animales de experimentación

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.

Human pilot study of bare-metal stent: INC-01

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.

Left main-like bifurcation primary percutaneous coronary intervention case report: anomalous right coronary artery ostium from the left anterior descending.

BACKGROUND: A single coronary artery ostium (SCAO) is estimated to be present in 0.066% of the general population. The proximal coronary course and the relationship with surrounding structures are related to malignant vs. benign prognoses. We present a case of SCAO with the right coronary artery (RCA) arising from the mid-left anterior descending (LAD), complicated by anterior and inferior STEMI because of acute thrombotic occlusion at the bifurcation and its percutaneous management. CASE SUMMARY: A 56-year-old male was admitted with sudden onset of resting chest pain. His ECG showed an anterior, inferior, and right ventricular STEMI. Via trans-radial access, coronary angiography showed significant stenoses at the left main and the circumflex but also a thrombotic occlusion at the proximal segment of the LAD while no RCA was seen. After crossing the LAD occlusion, the dominant RCA appeared from the mid-LAD. A provisional stent technique was performed achieving good results. Coronary computed tomography angiography showed an SCAO congenital anomaly with a patent stent in the bifurcation accompanied by diffuse coronary artery disease causing mild stenosis of the left main, proximal, and distal circumflex. DISCUSSION: The RCA arising from the mid-LAD with pre-pulmonic course has been described in only 37 cases. One reported an LAD/RCA bifurcation treatment with two stents technique in a stable scenario. The present is the first case reported of an acute thrombotic occlusion of an LAD/RCA bifurcation clinically resulting in a left main equivalent STEMI treated successfully with primary percutaneous coronary intervention using a bifurcation technique.