Percutaneous transluminal angioplasty and stent placement in acute vessel occlusion: evaluation of new methods for interventional stroke treatment

BACKGROUND AND PURPOSE: The major goal of acute ischemic stroke treatment is fast and sufficient recanalization. Percutaneous transluminal balloon angioplasty (PTA) and/or placement of a stent might achieve both by compressing the thrombus at the occlusion site. This study assesses the feasibility, recanalization rate, and complications of the 2 techniques in an animal model. MATERIALS AND METHODS: Thirty cranial vessels of 7 swine were occluded by injection of radiopaque thrombi. Fifteen vessel occlusions were treated by PTA alone and 15, by placement of a stent and postdilation. Recanalization was documented immediately after treatment and after 1, 2, and 3 hours. Thromboembolic events and dissections were documented. RESULTS: PTA was significantly faster to perform (mean, 16.6 minutes versus 33.0 minutes for stent placement; P < .001), but the mean recanalization rate after 1 hour was significantly better after stent placement compared with PTA alone (67.5% versus 14.6%, P < .001). Due to the self-expanding force of the stent, vessel diameter further increased with time, whereas the recanalization result after PTA was prone to reocclusion. Besides thromboembolic events related to the passing maneuvers at the occlusion site, no thrombus fragmentation and embolization occurred during balloon inflation or stent deployment. Flow to side branches could also be restored at the occlusion site because it was possible to direct thrombus compression. CONCLUSIONS: Stent placement and postdilation proved to be much more efficient in terms of acute and short-term vessel recanalization compared with PTA alone.

IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial

BACKGROUND The effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate "patient-centric" outcomes of functional limb preservation, mobility and quality of life (QoL). METHODS/DESIGN IN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI. DISCUSSION This multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014. TRIAL REGISTRATION NCT00941733

Percutaneous transluminal coronary angioplasty and coronary events in a biethnic Texas community, 1985--1990

The relationship between change in myocardial infarction (MI) mortality rate (ICD codes 410, 411) and change in use of percutaneous transluminal coronary angioplasty (PTCA), adjusted for change in hospitalization rates for MI, and for change in use of aortocoronary bypass surgery (ACBS) from 1985 through 1990 at private hospitals was examined in the biethnic community of Nueces County, Texas, site of the Corpus Christi Heart Project, a major coronary heart disease (CHD) surveillance program. Age-adjusted rates (per 100,000 persons) were calculated for each of these CHD events for the population aged 25 through 74 years and for each of the four major sex-ethnic groups: Mexican-American and Non-Hispanic White women and men. Over this six year period, there were 541 MI deaths, 2358 MI hospitalizations, 816 PTCA hospitalizations, and 920 ACBS hospitalizations among Mexican-American and Non-Hispanic White Nueces County residents. Acute MI mortality decreased from 24.7 in the first quarter of 1985 to 12.1 in the fourth quarter of 1990, a 51.2% decrease. All three hospitalization rates increased: The MI hospitalization rates increased from 44.1 to 61.3, a 38.9% increase, PTCA use increased from 7.1 to 23.2, a 228.0% increase, and ACBS use increased from 18.8 to 29.5, a 56.6% increase. In linear regression analyses, the change in MI mortality rate was negatively associated with the change in PTCA use (beta = $-$.266 $\pm$.103, p = 0.017) but was not associated with the changes in MI hospitalization rate and in ACBS use. The results of this ecologic research support the idea that the increasing use of PTCA, but not ACBS, has been associated with decreases in MI mortality. The contrast in associations between these two revascularization procedures and MI mortality highlights the need for research aimed at clarifying the proper roles of these procedures in the treatment of patients with CHD. The association between change in PTCA use and change in MI mortality supports the idea that some changes in medical treatment may be partially responsible for trends in CHD mortality. Differences in the use of therapies such as PTCA may be related to differences between geographical sites in CHD rates and trends. ^

Estudio del flujo sanguíneo para diferentes técnicas de implantación de stents en bifurcaciones coronarias

Las enfermedades arteriales vienen presididas por la aterosclerosis, que es un proceso crónico de degeneración, que evoluciona hacia la obstrucción de la luz arterial. La pared de la arteria se engrosa debido al depósito de elementos grasos tales como el colesterol. Los stents intraluminales son diminutas estructuras tubulares autoexpandibles de malla de metal, que se colocan dentro de la arteria coronaria después de una angioplastia con balón para prevenir el cierre de dicha arteria. A pesar de estar diseñados para ser compatibles con el tejido humano, a menudo se da una reacción en cadena de consecuencias indeseables. La reestenosis intra-stent es un problema creciente debido al importante incremento que se ha producido en la utilización del stent intracoronario como forma de revascularización percutánea. Se habla de una incidencia global del 28%, siendo la causa principal de su aparición la proliferación neointimal a través de una compleja cascada de sucesos que pueden tardar meses en desarrollarse. Una de las reacciones más importantes es la trombosis o la formación de una fina capa de coágulo como respuesta a la presencia de un material extraño. Este proceso es multifactorial, y en él intervienen la regresión de la pared como consecuencia del estiramiento previo, la denudación endotelial, lo que permite la agregación plaquetaria, la proliferación neointimal, lo que facilita a los receptores de membrana desencadenar un proceso de agregación posterior y, por último, el remodelado negativo inadecuado de la pared, lo que produce pérdida de luz arterial. Se ha observado frecuentemente que el depósito de ateroma en la pared arterial está relacionado con el valor de los esfuerzos cortantes en la misma. Hay mayores probabilidades de engrosamiento de la pared en las zonas donde son bajos los esfuerzos cortantes, quizá por el mayor tiempo de residencia de las partículas circulantes por el torrente sanguíneo. Si nos centramos en la afirmación anterior, el siguiente paso sería buscar las zonas susceptibles de presentar un valor bajo de dichos esfuerzos. Las zonas potencialmente peligrosas son los codos y bifurcaciones, entre otras. Nos hemos centrado en una bifurcación coronaria, ya que los patrones de flujo que se suelen presentar, tales como recirculación y desprendimiento de vórtices están íntimamente relacionados con las técnicas de implantación de stents en esta zona. Proyectamos nuestros esfuerzos en el estudio de dos técnicas de implante, utilizando un único stent y una tercera a través de una configuración de culotte con el uso de dos stents. El primer caso trata de una bifurcación con un único stent en la rama principal cuyos struts cierran el orificio lateral que da salida a la rama secundaria de la bifurcación, es decir sería un stent sin orificio. El segundo consiste en un único stent también, pero con la diferencia de que éste presenta un orificio de comunicación con la rama lateral. Todas estas técnicas se aplicaron a bifurcaciones de 45º y de 90º. Introdujimos las geometrías -una vez confeccionadas con el código comercial Gambit- en el programa Ansys-Fluent contemplando régimen estacionario. Los resultados obtenidos fueron cotejados con los experimentales, que se realizaron paralelamente, con el fin de corroborarlos. Una vez validados, el estudio computacional ya contó con la fiabilidad suficiente como para abordar el régimen no estacionario, tanto en la versión de reposo como en la de ejercicio –hiperemia- El comportamiento reológico de la sangre para régimen no estacionario en estado de reposo es otra de las tareas abordadas, realizando una comparativa de los modelos Newtoniano, Carreau y Ley de Potencias. Finalmente, en una última etapa, debido a la reciente incursión de los stents diseñados específicamente frente a los convencionales, se aborda el comportamiento hemodinámico de los mismos. Concretamente, se comparó el patrón de flujo en un modelo de bifurcación coronaria con los nuevos stents (Stentys) y los convencionales. Se estudiaron cuatro modelos, a saber, stent simple en la rama principal, stent simple en la rama secundaria, culotte desplegando el primer stent en la rama principal y culotte desplegando el primer stent en la rama secundaria. La bifurcación estudiada presenta un ángulo de apertura de 45º y la relación de diámetros de las ramas hija se ajustaron de acuerdo a la ley de Finet. Se recogieron resultados experimentales en el laboratorio y se corrieron simulaciones numéricas con Ansys Fluent paralelamente. Las magnitudes que se tuvieron en cuenta con el fin de ubicar las regiones potencialmente ateroscleróticas fueron los esfuerzos cortantes, vorticidad y caída de presión. ABSTRACT Nowadays, restenosis after percutaneous dilation is the major drawback of coronary angioplasty. It represents a special form of atherosclerosis due to the healing process secondary to extensive vessel trauma induced after intracoronary balloon inflation. The use of coronary stents may decrease the incidence of this phenomenon. Unfortunately, intra-stent restenosis still occurs in 20-30% of the cases following the stent implantation. Most experiments suggest a correlation between low wall shear stress and wall thickness. The preferential locations for the atherosclerotic plaque are bifurcations. The objective of this work is to analyze the local hemodynamic changes caused in a coronary bifurcation by three different stenting techniques: simple stenting of the main vessel, simple stenting of the main vessel with kissing balloon in the side branch and culotte. To carry out this study an idealized geometry of a coronary bifurcation is used, and two bifurcation angles, 45º and 90º, are chosen as representative of the wide variety of real configurations. Both numerical simulations and experimental measurements are performed. First, steady simulations are carried out with the commercial code Ansys-Fluent, then, experimental measurements with PIV (Particle Image Velocimetry), obtained in the laboratory, are used to validate the numerical simulations. The steady computational simulations show a good overall agreement with the experimental data. Then, pulsatile flow is considered to take into account the transient effects. The time averaged wall shear stress, oscillatory shear index and pressure drop obtained numerically are used to compare the behavior of the stenting techniques. In a second step, the rheologic behavior of blood was considered comparing Newtonian, Carreau and Power Law models. Finally, as a result of previous investigations with conventional stents and after the recent emergence of several devices specifically designed for coronary bifurcations angioplasty, the hemodynamic performance of these new devices (Stentys) was compared to conventional ones and techniques in a coronary bifurcation model. Four different stenting techniques: simple stenting of the main vessel, simple stenting of the side vessel, culotte deploying the first stent in the main vessel and culotte deploying the first stent in the side vessel have been considered. To carry out this study an idealized geometry of a coronary bifurcation is used. A 45 degrees bifurcation angle is considered and the daughter branches diameters are obtained according to the Finet law. Both experiments in the laboratory and numerical simulations were used , focusing on important factors for the atherosclerosis development, like the wall shear stress, the oscillation shear index, the pressure loss and the vorticity.

Inflamação na aterosclerose : impacto na doença coronária

Trabalho Final do Curso de Mestrado Integrado em Medicina, Faculdade de Medicina, Universidade de Lisboa, 2014