Transcatheter Mitral Repair for Functional Mitral Regurgitation According to Left Ventricular Function: A Real-Life Propensity-Score Matched Study.

BACKGROUND: Transcatheter mitral valve repair (TMVR) could improve survival in functional mitral regurgitation (FMR), but it is necessary to consider the influence of left ventricular ejection fraction (LVEF). Therefore, we compare the outcomes after TMVR with Mitraclip® between two groups according to LVEF. METHODS: In an observational registry study, we compared the outcomes in patients with FMR who underwent TMVR with and without LVEF <30%. The primary endpoint was the combined one-year all-cause mortality and unplanned hospital readmissions due to HF. The secondary end-points were New York Heart Association (NYHA) functional class and mitral regurgitation (MR) severity. Propensity-score matching was used to create two groups with the same baseline characteristics, except for baseline LVEF. RESULTS: Among 535 FMR eligible patients, 144 patients with LVEF <30% (group 1) and 144 with LVEF >30% (group 2) had similar propensity scores and were included in the analyses. The primary study endpoint was significantlly higher in group 1 (33.3% vs. 9.4%, p = 0.002). There was a maintained improvement in secondary endpoints without significant differences among groups. CONCLUSION: FMR patients with LVEF <30% treated with MitraClip® had higher mortality and readmissions than patients with LVEF ≥30% treated with the same device. However, both groups improved the NYHA functional class and MR severity.

[Changes in percutaneous coronary intervention over the last 20 years: demographic, epidemiologic and clinical characteristics, techniques, and outcomes]. / Evolución en los últimos 20 años en el perfil demográfico, epidemiológico y clínico, técnica y resultados de los procedimientos coronarios percutáneos.

INTRODUCTION AND OBJECTIVES: The aim of this study was to describe the changes observed in clinical practice in our interventional cardiology unit over the last 20 years. METHODS: Between January 1, 1986 and December 31, 2005, >or=17,204 percutaneous transluminal coronary angioplasties (PTCAs) were performed at our center. They were analyzed in four periods of 5 years each. After each procedure, prospective data on patient, procedural, and outcome variables were recorded. The data were analyzed with regard to when the procedure was performed, and the patients' sex and age (i.e., < or >or=75 years). Data from 2006 were used as a reference, but were not included in the analysis. RESULTS: The number of PTCAs increased significantly. Over the time period, mean patient age increased (from 57[10] years to 62[12] years for males and from 66[10] years to 70[11] years for females), and there were significant increases in the proportions of women (from 16% to 22%) and patients aged >75 years (from 7% to 22%). Among men, the incidence of smoking decreased while that of hypertension, diabetes and hyperlipemia increased. Among women, however, there was no change in risk factors. The numbers of urgent and emergent procedures (17% of PTCAs were for acute myocardial infarction in 2006) increased in both sexes and age groups, more ad hoc procedures were carried out, and more lesions were treated, usually with a stent. Over time, the success rate increased and the complication rate decreased in both sexes and age groups. In-hospital mortality for all procedures, except those for acute myocardial infarction, was 0.7% in males and 1.4% in females (P=.012). CONCLUSIONS: Significant changes were observed over the last 20 years in the baseline characteristics of, the techniques used in, and the outcomes obtained in patients undergoing percutaneous coronary intervention.

Evolución en los últimos 20 años en el perfil demográfico, epidemiológico y clínico, técnica y resultados de los procedimientos coronarios percutáneos / Changes in percutaneous coronary intervention over the last 20 years: demographic, epidemiologic and clinical characteristics, techniques, and outcomes

Introducción y objetivos. Describir los cambios observados en la actividad clínica de nuestra unidad de cardiología intervencionista en los últimos 20 años. Métodos. Desde el 1 de enero de 1986 al 31 de diciembre de 2005 se realizaron en nuestro centro 17.204 angioplastias (ACTP), que se han dividido en 4 períodos de 5 años cada uno. Tras cada intervención y de forma prospectiva se recogieron una serie de variables relacionadas con el paciente, la intervención y su resultado. Se describen estas variables y se analizan de acuerdo con el período de realización de la intervención, el sexo y el grupo de edad (< o ≥ 75 años) del paciente. Como referencia, y sin que forme parte del análisis, se incluyen los datos de 2006. Resultados. El número de ACTP ha aumentado de forma significativa. En este tiempo se ha incrementado la edad de los pacientes (de 57 ± 10 a 62 ± 12 años en los varones y de 66 ± 10 a 70 ± 11 años en las mujeres), con un aumento (del 16 al 22%) en el porcentaje de mujeres y de mayores de 75 años (del 7 al 22%). En los varones se ha observado una reducción del tabaquismo y un aumento de la hipertensión arterial, la diabetes y la hiperlipemia, mientras que en las mujeres no se han modificado los factores de riesgo. Ha aumentado el número de procedimientos urgentes y emergentes (un 17% de ACTP en el infarto agudo de miocardio en 2006) en ambos sexos y grupos de edad, se realizan más ACTP ad hoc y se tratan más lesiones, generalmente con stent. La tasa de éxito se ha incrementado con el tiempo y la de complicaciones ha disminuido para ambos sexos y grupos de edad. La mortalidad intrahospitalaria de los procedimientos fuera del infarto agudo de miocardio fue en 2006 del 0,7% para los varones y del 1,4% para las mujeres (p = 0,012). Conclusiones. Se documentan cambios importantes en las características basales, la técnica realizada y los resultados obtenidos en pacientes con intervencionismo coronario (AU)

Introduction and objectives. The aim of this study was to describe the changes observed in clinical practice in our interventional cardiology unit over the last 20 years. Methods. Between January 1, 1986 and December 31, 2005, é17 204 percutaneous transluminal coronary angioplasties (PTCAs) were performed at our center. They were analyzed in four periods of 5 years each. After each procedure, prospective data on patient, procedural, and outcome variables were recorded. The data were analyzed with regard to when the procedure was performed, and the patients' sex and age (i.e., 75 years (from 7% to 22%). Among men, the incidence of smoking decreased while that of hypertension, diabetes and hyperlipemia increased. Among women, however, there was no change in risk factors. The numbers of urgent and emergent procedures (17% of PTCAs were for acute myocardial infarction in 2006) increased in both sexes and age groups, more ad hoc procedures were carried out, and more lesions were treated, usually with a stent. Over time, the success rate increased and the complication rate decreased in both sexes and age groups. In-hospital mortality for all procedures, except those for acute myocardial infarction, was 0.7% in males and 1.4% in females (P=.012). Conclusions. Significant changes were observed over the last 20 years in the baseline characteristics of, the techniques used in, and the outcomes obtained in patients undergoing percutaneous coronary intervention (AU)

[Effect of sex on revascularization strategy]. / Estrategias de revascularización: importancia del sexo.

Cardiovascular disease and, in particular, ischemic heart disease are major causes of morbidity and mortality in women. Diagnosis of ischemic heart disease in women is made more difficult by the occurrence of atypical symptoms, a perception that the risk is low, the limited accuracy of non-invasive tests, and underuse of coronary angiography. Women with ischemic heart disease, with either stable or unstable angina or non-Q wave or ST-elevation myocardial infarction, benefit as much as men from percutaneous or surgical revascularization. However, hemorrhagic complications occur more often in women and periprocedural mortality is slightly higher with both techniques, though the sex difference has tended to decrease in recent years. Moreover, drug-eluting stents, arterial revascularization, and off-pump procedures are equally beneficial to men and women. Nevertheless, strict control of risk factors is essential following any revascularization procedure. Selecting which of the 2 revascularization procedures is more appropriate depends on the patient's age and comorbid conditions, the number, location and type of coronary lesions, ventricular function, and the patient's preferences, among other factors. Nowadays, a significant number of patients can be revascularized using either technique. Therefore, open discussion of each case and close collaboration between interventional cardiologists and surgeons are essential so that joint decisions about the most appropriate treatment can be made in a consistent manner.

Insuficiencia mitral transitoria asociada a disección coronaria espontánea / Transient mitral insufficiency and espontaneous coronary disease

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Estrategias de revascularización: importancia del sexo / Effect of sex on revascularization strategy

La enfermedad cardiovascular en general y la cardiopatía isquémica en particular constituyen una importante fuente de morbimortalidad en la mujer. La sintomatología más atípica, la baja percepción del riesgo por parte de las mujeres, la menor precisión diagnóstica de las pruebas no invasivas y la menor utilización de la coronariografía dificultan el diagnóstico de la cardiopatía isquémica en la mujer. La mujer con cardiopatía isquémica, tanto en el contexto de la angina estable e inestable como del infarto sin onda Q o con elevación del segmento ST, se beneficia tanto como el varón de la revascularización percutánea o quirúrgica, aunque la tasa de complicaciones hemorrágicas y la mortalidad periprocedimiento son algo más elevadas en la mujer; sin embargo, se observa una tendencia hacia una reducción en las diferencias en los últimos años. Tanto los stents farmacoactivos como la revascularización arterial sin circulación extracorpórea aportan beneficios similares en varones y mujeres. El estricto control de los factores de riesgo es imprescindible tras cualquier procedimiento de revascularización. La selección del método de revascularización más adecuado en cada paciente dependerá de la edad, la comorbilidad, el tipo, el número y la localización de las lesiones coronarias, la función ventricular y las preferencias del paciente, entre otros factores. Hoy día, un número considerable de pacientes puede ser revascularizado por ambas técnicas. Por ello es imprescindible la discusión conjunta de casos y la estrecha colaboración de cardiólogos intervencionistas y cirujanos, que lleve a la toma conjunta de decisiones terapéuticas que puedan ser convenientemente evaluadas y modificadas (AU)

Cardiovascular disease and, in particular, ischemic heart disease are major causes of morbidity and mortality in women. Diagnosis of ischemic heart disease in women is made more difficult by the occurrence of atypical symptoms, a perception that the risk is low, the limited accuracy of non-invasive tests, and underuse of coronary angiography. Women with ischemic heart disease, with either stable or unstable angina or non-Q wave or ST-elevation myocardial infarction, benefit as much as men from percutaneous or surgical revascularization. However, hemorrhagic complications occur more often in women and periprocedural mortality is slightly higher with both techniques, though the sex difference has tended to decrease in recent years. Moreover, drug-eluting stents, arterial revascularization, and off-pump procedures are equally beneficial to men and women. Nevertheless, strict control of risk factors is essential following any revascularization procedure. Selecting which of the 2 revascularization procedures is more appropriate depends on the patient's age and comorbid conditions, the number, location and type of coronary lesions, ventricular function, and the patient's preferences, among other factors. Nowadays, a significant number of patients can be revascularized using either technique. Therefore, open discussion of each case and close collaboration between interventional cardiologists and surgeons are essential so that joint decisions about the most appropriate treatment can be made in a consistent manner (AU)

[Interventional cardiology in 2005]. / Cardiología intervencionista 2005.

Drug-eluting stents have been shown to reduce the rate of restenosis significantly in all types of lesion, patient and clinical context without increasing thrombotic complications. Although their high cost limits the extent to which they can replace bare-metal stents, their use will increase inexorably in coming years. In addition to stents containing sirolimus and paclitaxel, which have already been approved, two additional drug-eluting stents have appeared on the market this year: one elutes tacrolimus and the other, ABT578 (a rapamycin analogue). Now that the restenosis rate has been dramatically reduced, the main limitations on percutaneous coronary intervention (PCI) stem from problematic lesions such as those at bifurcations and chronic total occlusions. Although these lesions can be tackled more often and more successfully than in the past, the results obtained are very different from those achieved with other types of lesion. With improvements in safety and long-term efficacy, the number of indications for PCI has expanded to include patients with multivessel disease, left main coronary artery disease, left ventricular dysfunction, and diabetes, conditions in which surgical revascularization was thought necessary only a few years ago. Acute coronary syndromes now make up an increasing proportion of indications for PCI, both in absolute and relative terms. One future challenge is the early identification and treatment of vulnerable plaques before they manifest clinically in the form of irreversible complications such as sudden death or acute myocardial infarction. The use of multislice computed tomography, such as 64-slice detector systems, has considerably increased the sensitivity, specificity, and positive and negative predictive values of diagnosis to around 90%, though diagnostic accuracy may be considerably less in patients with severe coronary calcification, stents, or cardiac arrhythmias. Although the technique is straightforward for patients, the image reconstruction process is time-consuming, few centers currently offer the technique, and radiation exposure is several times that with conventional invasive coronary angiography. It appears that the main application of the technique is in ruling out coronary disease in low-risk patients rather than being part of the diagnostic work-up in those with a high probability of coronary artery disease.

Cardiología intervencionista 2005 / Interventional Cardiology in 2005

Los stents liberadores de fármacos (DES) reducen de forma importante la tasa de reestenosis en todo tipo de lesiones, pacientes y situaciones clínicas, y todo ello sin aumentar las complicaciones trombóticas. Su alto precio impide la sustitución del stent convencional por los DES, pero su utilización va inexorablemente en aumento (el 38% del consumo total de stents en España en 2004). A los stents ya comercializados de rapamicina y paclitaxel se han unido en 2005 otros 2 DES (uno de tacrolimus y otro de ABT578, fármacos de acción similar a la rapamicina). Paliado (que no resuelto) el problema de la reestenosis, las limitaciones del intervencionismo coronario percutáneo (ICP) se sitúan en torno a determinados tipos de lesión (bifurcación, oclusión total crónica) que, aunque se abordan más frecuentemente y con mayor éxito que en el pasado, sus resultados distan mucho de los obtenidos en otro tipo de lesiones. De la posibilidad de tratar con seguridad y bajo riesgo de reestenosis un mayor número de lesiones surge la ampliación de las indicaciones de ICP a pacientes con enfermedad multivaso, tronco, disfunción ventricular severa y diabetes mellitus, situaciones clínicas que fueron patrimonio de la cirugía hasta hace muy poco. El ICP en los síndromes coronarios agudos (SCA) ha supuesto un incremento en términos absolutos y relativos del número de procedimientos, tras demostrarse que la estrategia invasiva supone un beneficio clínico a corto, medio y largo plazo. El reto de los próximos años será identificar (mediante marcadores séricos o técnicas de imagen) y tratar a los pacientes en etapas subclínicas del SCA antes de que se produzcan complicaciones irreversibles, como muerte súbita o infarto agudo de miocardio (IAM). Las nuevas técnicas de diagnóstico no invasivo (TC multicorte) han mejorado de forma sustancial su capacidad diagnóstica, de forma que con los equipos de 64 detectores, la sensibilidad, la especificidad y los valores predictivos positivo y negativo rondan el 90% para la detección de lesiones que precisan revascularización, aunque estas cifras pueden ser sensiblemente inferiores en pacientes taquicárdicos, arrítmicos, obesos, con calcificación coronaria severa o stents. La técnica es sencilla para el paciente, pero la reconstrucción tridimensional lleva entre 30 y 60 min, la disponibilidad actual es escasa y la dosis de radiación recibida por el paciente cuadruplica la de la coronariografía convencional. Con todos estos elementos en consideración, su indicación principal sería descartar enfermedad coronaria en pacientes con bajo riesgo de experimentarla, reservar la coronariografía convencional para aquellos pacientes en los que los datos clínicos y las pruebas no invasivas apuntaran hacia una alta probabilidad de cardiopatía isquémica y necesidad de revascularización (AU)

Drug-eluting stents have been shown to reduce the rate of restenosis significantly in all types of lesion, patient and clinical context without increasing thrombotic complications. Although their high cost limits the extent to which they can replace bare-metal stents, their use will increase inexorably in coming years. In addition to stents containing sirolimus and paclitaxel, which have already been approved, two additional drug-eluting stents have appeared on the market this year: one elutes tacrolimus and the other, ABT578 (a rapamycin analogue). Now that the restenosis rate has been dramatically reduced, the main limitations on percutaneous coronary intervention (PCI) stem from problematic lesions such as those at bifurcations and chronic total occlusions. Although these lesions can be tackled more often and more successfully than in the past, the results obtained are very different from those achieved with other types of lesion. With improvements in safety and long-term efficacy, the number of indications for PCI has expanded to include patients with multivessel disease, left main coronary artery disease, left ventricular dysfunction, and diabetes, conditions in which surgical revascularization was thought necessary only a few years ago. Acute coronary syndromes now make up an increasing proportion of indications for PCI, both in absolute and relative terms. One future challenge is the early identification and treatment of vulnerable plaques before they manifest clinically in the form of irreversible complications such as sudden death or acute myocardial infarction. The use of multislice computed tomography, such as 64-slice detector systems, has considerably increased the sensitivity, specificity, and positive and negative predictive values of diagnosis to around 90%, though diagnostic accuracy may be considerably less in patients with severe coronary calcification, stents, or cardiac arrhythmias. Although the technique is straightforward for patients, the image reconstruction process is time-consuming, few centers currently offer the technique, and radiation exposure is several times that with conventional invasive coronary angiography. It appears that the main application of the technique is in ruling out coronary disease in low-risk patients rather than being part of the diagnostic work-up in those with a high probability of coronary artery disease (AU)

Actualización en cardiología intervencionista 2004 / Update in Interventional Cardiology (2004)

Los stents liberadores de drogas con su doble efecto mecánico y farmacológico son muy eficaces en prevenir la reestenosis, hecho ya conocido en lesiones favorables y que este año ha quedado confirmado también en lesiones de alto riesgo. El número de angioplastias coronarias sigue aumentando (10% anual) como consecuencia del tratamiento invasivo de los síndromes coronarios agudos, la implantación de programas de angioplastia primaria y el tratamiento de pacientes más complejos. El diagnóstico y eventual tratamiento de las placas vulnerables es ahora un nuevo reto. La medicina regenerativa ha levantado grandes expectativas, y la investigación clínica ha precedido a la experimentación animal. De hecho, aspectos tan básicos como el tipo celular, su preparación, la vía de administración, el momento de aplicación o la medicación coadyuvante no están todavía aclarados; todavía están en discusión si las células aplicadas anidan o no en el tejido miocárdico. Con todo, la terapia celular se está aplicando ya y empiezan a aparecer los resultados de los primeros estudios. Las prótesis aórticas percutáneas están en fase avanzada de investigación clínica. En cuanto a los dispositivos de reducción de la regurgitación mitral, acaban de iniciar su fase de aplicación en humanos por lo que tardarán más en incorporarse a la clínica. Los dispositivos de cierre están ya bien desarrollados técnicamente, pero falta perfilar su indicación en determinadas entidades y su efectividad en otras. En el presente artículo se revisan estos y otros aspectos relevantes que durante este año han supuesto aportaciones de interés en el campo de la cardiología intervencionista (AU)

Drug-eluting stents have both mechanical and pharmacological properties and are very effective in the prevention of restenosis. This feature, already known for favorable lesions, has been confirmed this year for high-risk lesions. The number of percutaneous coronary procedures steadily continues to increase as invasive strategy for acute coronary syndromes and primary angioplasty for acute myocardial infarction are being implemented in more centers, and more complex patients are now considered suitable for angioplasty. Diagnosis and treatment of vulnerable plaques is now a new challenge. Regenerative medicine has raised great expectations, with clinical investigation running well before animal work in this field. Such basic features as cellular type, way of preparation and administration, best timing for application or adjuvant medication, are not still clear while evidence of seeding of implanted cells in myocardial tissue is still lacking. Nevertheless, cellular therapy is being applied in many centers around the world while initial clinical results have not been released yet. Aortic valves for percutaneous implantation are in a well-advanced phase of clinical investigation. The role of devices to treat mitral regurgitation is under preclinical investigation; first human experiences have just started and more time will be required for these new devices to enter the clinical setting. Closure devices are technically well developed but its usefullness and indications in several clinical circunstances are still to be determined. This article is a review of these and other relevant issues that during this year have represented significant advances in the field of interventional cardiology (AU)