Showing papers by "Manel Sabaté published in 2011"

Integración entre cardiología y atención primaria: impacto sobre la práctica clínica

Abstract: Introduction and objectives: To assess the impact of a program integrating cardiology and primary care in clinical practice, compared with usual care. The integrated care consists of a hospital cardiologist in each primary care clinic, shared clinical history, joint practice guidelines, consultation sessions, and other coordinating tools. Methods: Observational, cross-sectional study of 2 series of chronic outpatients: conventional and integrated care. We analyzed patient distribution and the impact on good clinical practice indicators in patients with ischemic heart disease, heart failure and atrial fibrillation, along with primary care practitioner satisfaction and use of resources. Results: We included 3194 patients (1572 usual care, 1622 integrated care). Integrated care changed the patient distribution, allowing the cardiologist to focus on serious pathologies while cardiovascular risk factors and stable patients were monitored in primary care. In ischemic heart disease, improvement was observed in cholesterol management and blood pressure control; optimal medical treatment was more frequently prescribed and ventricular function evaluated more often. In heart failure, b-blockers treatment increased and functional class was assessed more often. In atrial fibrillation, an increase in anticoagulation prescription and echocardiography evaluation was observed. Satisfaction parameters improved with integrated care. The use of resources was not increased. Conclusions: Using our integration model, follow-up and chronic treatment of patients with ischemic heart disease, heart failure, and atrial fibrillation were improved. Monitoring of chronic patients was

Registro Español de Hemodinámica y Cardiología Intervencionista. XX Informe Oficial de la Sección de Hemodinámica y Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2010)

Abstract: Resumen Introduccion y objetivos La Seccion de Hemodinamica y Cardiologia Intervencionista presenta su informe anual con los datos del registro de actividad nacional correspondientes a 2010. Esta informacion permite conocer la distribucion nacional del intervencionismo cardiaco y ofrece datos para compararlo con el de otros paises. Metodos Los centros proporcionan sus datos de forma voluntaria. La informacion se introduce online y la analiza la Junta Directiva de la Seccion de Hemodinamica. Resultados Enviaron sus datos 113 hospitales (71 publicos y 42 privados) que realizan su actividad predominantemente en adultos. Se realizaron 135.486 estudios diagnosticos; las 119.118 coronariografias suponen una ligera reduccion respecto al ano anterior, con una tasa de 2.945 coronariografias/millon de habitantes. Los procedimientos intervencionistas coronarios aumentaron ligeramente, hasta alcanzar los 64.331 (1.398 intervenciones/millon de habitantes). Se implantaron 100.371 stents, de los cuales el 61,3% fueron farmacoactivos. Se llevaron a cabo 14.248 procedimientos en el infarto agudo de miocardio, lo que supone un incremento del 6% respecto a 2009 y representa el 22% del total de intervenciones coronarias percutaneas. El intervencionismo mas frecuente (295 procedimientos) en las cardiopatias congenitas del adulto es el cierre de la comunicacion interauricular. La valvuloplastia mitral sigue en descenso, con 326 casos. El implante de valvulas aorticas percutaneas crece exponencialmente, con 655 unidades implantadas en 2010. Conclusiones El aumento mas importante en la actividad fue en relacion con el infarto agudo de miocardio con elevacion de ST y el implante percutaneo de valvulas; los demas procedimientos diagnosticos y terapeuticos se mantienen en fase de meseta.

Rationale and design of the EXAMINATION trial: A randomised comparison between everolimus-eluting stents and cobalt-chromium bare-metal stents in ST-elevation myocardial infarction

Abstract: Aims: To assess the performance of the everolimus-eluting stent (EES) versus cobalt chromium bare-metal stent (BMS) in the setting of primary percutaneous coronary intervention for treatment of patients presenting with ST-segment elevation myocardial infarction (STEMI). The implantation of a drug-eluting stent in the setting of an acute myocardial infarction is still controversial. In several registries this clinical scenario has been associated with the development of stent thrombosis. The EES has demonstrated to reduce the stent thrombosis rate as compared to paclitaxel-eluting stent in randomised controlled trials, mainly performed in patients in stable clinical conditions. There are however few data regarding the effectiveness of EES in the context of STEMI. Methods and results: This is an investigator-driven, prospective, multicentre, multinational, randomised, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT00828087). This trial, with an all comer design, randomises approximately 1,500 patients 1:1 to EES or BMS. Overall, any patient presenting with STEMI up to 48 hours who requires emergent percutaneous coronary intervention can be included. The primary endpoint is the patient-oriented combined endpoint of all-cause death, any myocardial infarction and any revascularisation at 1-year according to the Academic Research Consortium. Clinical follow-up will be scheduled at 30 days, six months, one year and yearly up to five years. No angiographic follow-up is mandated per protocol. Conclusions: This trial with broad inclusion and few exclusion criteria will shed light on the performance of the second generation EES in the complex scenario of STEMI.

Long-term outcome after sirolimus-eluting stents versus bare metal stents in patients with Diabetes mellitus: a patient-level meta-analysis of randomized trials

Abstract: Background Although it is widely believed that patients with diabetes mellitus obtain the greatest benefit from drug-eluting stents, convincing evidence on long-term efficacy and safety of these stents is lacking.

Spanish Cardiac Catheterization and Coronary Intervention Registry. 20th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2010)

Abstract: Introduction and objectives The Working Group on Cardiac Catheterization and Interventional Cardiology presents on a yearly basis a report on the data collected for the national registry. This information displays how procedures are distributed throughout Spain and makes comparisons with other countries feasible. Methods Institutions render their data voluntarily (online) and they are analyzed by the Working Group's steering committee. Results Data was sent by 113 hospitals (71 public and 41 private) that treat mainly adults, reporting 135 486 diagnostic procedures, 119 118 of them coronary angiograms, slightly less than the year before, and with a rate of 2945 coronary angiograms per million inhabitants. Percutaneous coronary interventions increased a bit, to 64 331 procedures and a rate of 1398 interventions per million. Of 100 371 stents implanted, 61.3% were drug-eluting stents. In the acute phase of myocardial infarction, 14 248 coronary interventions were carried out, 6% more than in 2009 and 22% of the total number of coronary interventions. The most frequent intervention for adult congenital heart disease was closure of an atrial septal defect (295 procedures). Percutaneous mitral valvuloplasty continues to decrease (326 procedures) and percutaneous aortic valve implantations are growing rapidly, with 655 units implanted in 2010. Conclusions The greatest increase in activity has occurred in the field of myocardial infarction and percutaneous aortic valve implantation. The other procedures, both diagnostic and therapeutic, remain stable.

Commentary: The risk of over-regulation

Abstract: Regulatory bodies are expected to protect the public from the danger of inappropriately tested treatments—a shield against the vested interest of drug and device companies to sell products irrespective of their safety and effectiveness. The idea of the greedy industrialist focused on short term advantage and endangering lives with low quality components used to save manufacturing costs is familiar to the public and seems to justify stringent regulatory processes. But one person is forgotten in this equation—the doctor. The doctor is directly accountable to the patient and is expected to have the competency and motivation to select appropriate devices and drugs. The personal ethical responsibility of every doctor towards his or her patient may get diluted in the impersonal setting of large hospitals run by governments or private health providers. Doctors have largely ceased to be independent professionals and became employees forced to follow rules aimed at maximising profit and containment of expenses. The medical industry is the main source of sponsorship for clinical trials and the main supporter of postgraduate medical education. This creates links with industry that have been overemphasised, depicting doctors like car dealers with a vested interest to “sell” products. The net result has been a shift of power in the decision making process about providing and regulating healthcare from the medical profession to …

Endothelial progenitor cell capturing stent and short dual antiplatelet therapy in patients on chronic anti-vitamin k regimen undergoing percutaneous coronary interventions: long-term outcomes of a single centre registry.

Abstract: Aims: To evaluate outcomes of the endothelial progenitor cell (EPC) capture stent in patients on chronic anti-vitamin K (AVK) regimen, requiring percutaneous coronary intervention (PCI). Methods and results: Between February 2007 and February 2008, 78 consecutive patients under chronic AVK treatment undergoing PCI were enrolled in the registry and received an EPC capture stent. The incidence of comorbid conditions was analysed by the Charlson index. Dual antiplatelet therapy (DAT, aspirin and clopidogrel) was prescribed for one month only together with the AVK treatment, after PCI. Major adverse clinical events (MACE) rate, included death, acute myocardial infarction (MI) or target lesion revascularisation (TLR), incidence of stent thrombosis and rate of haemorrhagic events were collected. A Charlson index >3 was present in 89% of patients. At 14±8 months the cumulative rate of MACE was 22%: 10 deaths (six cardiac deaths), and six TLR. No MI or definitive/probable stent thromboses occurred during follow-up. Four major haemorrhagic episodes occurred during follow-up, all of them after the first month. Conclusions: Patients on AVK treatment represent a highly comorbid population with a high event rate after PCI. The strategy of PCI with an EPC capture stent and short duration of DAT may be used in patients who need a short-term DAT.

[Integration between cardiology and primary care: impact on clinical practice].

Abstract: Introduction and objectives: To assess the impact of a program integrating cardiology and primary care in clinical practice, compared with usual care. The integrated care consists of a hospital cardiologist in each primary care clinic, shared clinical history, joint practice guidelines, consultation sessions, and other coordinating tools. Methods: Observational, cross-sectional study of 2 series of chronic outpatients: conventional and integrated care. We analyzed patient distribution and the impact on good clinical practice indicators in patients with ischemic heart disease, heart failure and atrial fibrillation, along with primary care practitioner satisfaction and use of resources. Results: We included 3194 patients (1572 usual care, 1622 integrated care). Integrated care changed the patient distribution, allowing the cardiologist to focus on serious pathologies while cardiovascular risk factors and stable patients were monitored in primary care. In ischemic heart disease, improvement was observed in cholesterol management and blood pressure control; optimal medical treatment was more frequently prescribed and ventricular function evaluated more often. In heart failure, b-blockers treatment increased and functional class was assessed more often. In atrial fibrillation, an increase in anticoagulation prescription and echocardiography evaluation was observed. Satisfaction parameters improved with integrated care. The use of resources was not increased. Conclusions: Using our integration model, follow-up and chronic treatment of patients with ischemic heart disease, heart failure, and atrial fibrillation were improved. Monitoring of chronic patients was redistributed between primary care and cardiology, and family physicians’ satisfaction levels improved. There was no increase in use of resources.

Evaluación de los cambios dinámicos de las placas coronarias y sus consecuencias clínicas en pacientes con diabetes mellitus tipo 2: un estudio de ecografía intracoronaria seriada

Abstract: Introduction and objectives: One of the aims of secondary prevention is to achieve plaque stabilization. This study sought to investigate the clinical consequences and predictive factors of the change in the type of plaque (CTP) as assessed by serial intracoronary ultrasound in type II diabetic patients with known coronary artery disease. Methods: 237 segments (45 patients) from the DIABETES I, II, and III trials were included. Intracoronary ultrasound from motorized pullbacks (0.5 mm/s) after index procedure and at 9-month angiographic follow-up was performed in the same coronary segment. Nontreated mild lesions (angiographic stenosis <25%) with 0.5 mm plaque thickening and 5 mm of length assessed by intracoronary ultrasound were included. As different types of plaques may be encountered throughout a given coronary lesion,

[Assessment of dynamic coronary plaque changes and the clinical consequences in type-II diabetic patients: a serial intracoronary ultrasound study]

Abstract: Introduction and objectives: One of the aims of secondary prevention is to achieve plaque stabilization. This study sought to investigate the clinical consequences and predictive factors of the change in the type of plaque (CTP) as assessed by serial intracoronary ultrasound in type II diabetic patients with known coronary artery disease. Methods: 237 segments (45 patients) from the DIABETES I, II, and III trials were included. Intracoronary ultrasound from motorized pullbacks (0.5 mm/s) after index procedure and at 9-month angiographic follow-up was performed in the same coronary segment. Nontreated mild lesions (angiographic stenosis < 25%) with 0.5 mm plaque thickening and 5 mm of length assessed by intracoronary ultrasound were included. As different types of plaques may be encountered throughout a given coronary lesion, each study lesion was divided into 3 segments for serial quantitative and qualitative analyses. Statistical adjustment by multiple lesion segments per patient (generalized estimating equations method) was performed. A CTP was defined as any qualitative change in plaque type at followup. At 1-year follow-up, major adverse cardiac events – death, myocardial infarction and target vessel revascularization) – were recorded. Results: A CTP was observed in 48 lesions (20.2%) and occurred more frequently (52.1%) in mixed plaques. Independent predictors of CTP were glycated hemoglobin levels (odds ratio [OR] 1.2; 95% confidence interval [CI] 1.01-1.5; P = .04); glycoprotein IIb-IIIa inhibitors (OR 0.3; 95% CI 0.1-0.7; P = .004) and statin administration (OR 0.3; 95% CI 0.1-0.8; P = .02). At 1-year follow-up CTP was associated with an increase in major adverse cardiac events rate (CTP 20.8% vs non-CTP 13.8%, P = .008; hazard ratio = 1.9, 95% CI 1.3-1.9, P = .01). Conclusions: Qualitative changes in mild stenosis documented by intracoronary ultrasound in type II diabetics are associated with suboptimal secondary prevention and may have clinical consequences.

Emergent versus elective percutaneous stent implantation in the unprotected left main: long-term outcomes from a single-center registry.

Abstract: Background: Unprotected left main (ULM) coronary disease is considered by contemporary guidelines a class I indication for surgery. However, percutaneous coronary intervention (PCI) is often carried out in the ULM in either emergent or high-risk elective procedures. The aim of this study was to evaluate ULM-PCI as a feasible and safe procedure in the emergent setting, and to analyze outcomes in both scenarios. Methods: Angiographic and clinical data were collected retrospectively for all patients who underwent emergent or elective PCI on ULM at our center from January 2006 to June 2009. All patients were followed up with a clinical visit or telephone interview. Main outcomes included major adverse cardiac events (MACE) and its individual components: cardiac death, myocardial infarction (MI) and target lesion revascularization. These were analyzed at the longest follow-up available. Results: A total of 98 consecutive patients with significant LM disease were included. Fifty-seven of them were treated as a planned procedure (elective group) and 41 as an emergent procedure (emergent group). Procedural success was achieved in 100% of cases in the elective group and in 88% of the emergent group (p ≤ 0.011). Higher use of drug-eluting stents (DES) was recorded in the elective group (75% versus 45% in the emergent group; p <0.002). The emergent group presented a higher in-hospital mortality (24% versus 2% in the elective group; p <0.001). At a mean follow-up of 626 ± 380 days, the overall MACE rate was similar betweeen the two groups (23% in the emergent group versus 17% in the elective group; p ≤ 0.52). Independent predictors of MACE after discharge follow-up were postprocedure minimal diameter and DES use. Conclusions: Emergent PCI of the ULM exhibits worse in-hospital outcomes as compared to elective procedures. However, after discharge, long-term outcomes remain comparably good between groups.

Introducción: Iniciativa Stent for Life en España o la necesidad imperiosa de pasar de la evidencia a la asistencia integrada y transversal

Abstract: doi: 84.1416/j.cardio.2011.11.001 Cuando hace 2 anos iniciamos, por encargo de la Sociedad Europea de Cardiologia y con el apoyo de la Sociedad Espanola de Cardiologia, la andadura de Stent for Life en Espana, poco podiamos imaginar el reto que teniamos delante. Espana estaba en el elenco de paises europeos con tasas bajas de reperfusion en el infarto agudo de miocardio con elevacion del segmento ST (IAMCEST). Desde Europa se nos mandaba un mensaje claro: no se puede justificar hoy en dia en un pais desarrollado como el nuestro no ofrecer a la mayoria de los pacientes el mejor tratamiento que existe para el IAMCEST, que es la intervencion coronaria percutanea primaria (ICPp). Y es que la evidencia existe desde hace anos, y paises con menor renta per capita han sido capaces de organizar una asistencia al IAMCEST de mayor cobertura y mejor calidad que la existente en Espana. La ICPp, cuando la lleva a cabo personal experimentado, en centros de excelencia y con un retraso minimo desde el inicio de los sintomas, es un tratamiento cuyo objetivo primario es salvar vidas; ademas, y mas importante, mejora otras variables como la estancia media hospitalaria, la tasa de complicaciones y de reingresos y la funcion ventricular, entre otras. Con todo ello, en 2008 la tasa general de ICPp en Espana era de solo 169/millon de habitantes, cuando desde Stent for Life se preconizaba que la tasa necesaria para tratar a la mayoria de los pacientes con IAMCEST debia ser de 600/millon de habitantes o al menos un 70% de los pacientes con IAMCEST (cifra que puede ser mas realista segun la diferente prevalencia de la enfermedad en cada pais). Ademas, esta cifra precaria de ICPp no se compensaba por una mayor tasa de trombolisis. De hecho, se consideraba que hasta una tercera parte de nuestros pacientes no recibian tratamiento alguno de reperfusion en el IAMCEST. Sin embargo, cuando se analiza la situacion dentro de Espana, en primer lugar uno se da cuenta de la gran falta de homogeneidad que existe tambien entre comunidades autonomas. Asi, como pasa en Europa, hay comunidades que cuentan desde hace anos con un programa regional de tratamiento del IAMCEST. Galicia, Navarra, Murcia, Baleares y, recientemente, Cataluna y Castilla-La Mancha son las comunidades que han sido capaces de organizar este tipo de programa adaptandose a su geografia, situacion de los sistemas de emergencias medicas y de los hospitales con permanente capacidad de tratamiento y de la ubicacion de la poblacion receptora del programa. Aqui, como en Europa, no se puede justificar la inequidad del tratamiento del paciente con IAMCEST entre unas comunidades y otras. Ni el numero de hospitales ni la renta per capita de las distintas comunidades se correlacionan con el tipo de tratamiento que reciben los pacientes con IAMCEST. Este suplemento va dirigido no solo a los profesionales que tratan a los pacientes con IAMCEST, sino tambien a los gestores y responsables de planificacion de las comunidades autonomas y del Gobierno de Espana para que inicien las acciones que sean necesarias para organizar el tratamiento de esta enfermedad tan prevalente y mortal. Nunca una evidencia tan consistente, consolidada, demostrada y solida ha sido seguida por una asistencia tan precaria, desorganizada, incoherente y arbitraria como la que actualmente se lleva a cabo en muchas comunidades autonomas. Por lo tanto, desde Stent for Life queremos llamar la atencion de todos los profesionales y gestores para que busquen las estrategias organizativas integradas y transversales que puedan hacer llegar de manera equitativa este tratamiento a la mayor parte de la poblacion en riesgo. En la primera parte de esta monografia, describimos especificamente los objetivos de Stent for Life desde la vision europea, la evidencia actual del tratamiento del IAMCEST y la situacion actual de la ICPp, con las principales barreras que existen en Espana. Seguidamente, se presentan los seis programas de tratamiento que actualmente existen en nuestro pais, haciendo hincapie en su parte mas organizativa. Finalmente, se exponen los objetivos de Stent for Life-Espana para el proximo trienio. Esta monografia pretende divulgar la evidencia cientifica, exponer los programas que ya se estan llevando a cabo con el objeto de evitar la repeticion de errores y no tener que reinventar la rueda constantemente y, en definitiva, concienciar a los diferentes actores de la necesidad imperiosa de pasar a la accion en el tratamiento de esta grave enfermedad.

Usefulness of the Tornus ® Catheter in Nondilatable Coronary Chronic Total Occlusion

Abstract: The treatment of coronary chronic total occlusions (CTO) remains a challenge for the interventional cardiologist. Failure of balloon angioplasty is the second more common cause of an unsuccessful procedure. We describe our experience with the use of the new Tornus ® catheter (Asahi Intecc, Aichi, Japan) designed specifically for the treatment of “nondilatable” CTO. Between November 2008 and March 2010, 17 patients (age 62 years, 88% men, 82% dyslipidemia, 52% hypertension, 29% diabetes) were treated in whom balloon dilatation had failed after crossing the lesion with the guide. The use of Tornus ® catheter was successful without complications in 15. All patients underwent clinical follow-up (median, 573 days) with no documented major adverse events. The use of the Tornus ® catheter is safe and feasible in those patients with CTO lesions in whom balloon angioplasty has been unsuccessful.

Adequate antiplatelet regimen in patients on chronic anti-vitamin K treatment undergoing percutaneous coronary intervention.

Abstract: AIM: To investigate the impact of dual antiplatelet therapy (DAT) in patients on anti-vitamin K (AVK) regimen requiring percutaneous coronary intervention (PCI). METHODS: Between February 2006 and February 2008, 138 consecutive patients under chronic AVK treatment were enrolled in this registry. Of them, 122 received bare metal stent implantation and 16 received drug eluting stent implantation. The duration of DAT, on top of AVK treatment, was decided at the discretion of the clinician. Adequate duration of DAT was defined according to type of stent implanted and to its clinical indication. RESULTS: The baseline clinical characteristics of patients reflect their high risk, with high incidence of comorbid conditions (Charlson score ≥ 3 in 89% of the patients). At a mean follow-up of 17 ± 11 mo, 22.9% of patients developed a major adverse cardiac event (MACE): 12.6% died from cardiovascular disease and almost 6% had an acute myocardial infarction. Major hemorrhagic events were observed in 7.4%. Adequate DAT was obtained in only 44% of patients. In the multivariate analysis, no adequate DAT and Charlson score were the only independent predictors of MACE (both P = 0.02). CONCLUSION: Patients on chronic AVK therapy represent a high risk population and suffer from a high MACE rate after PCI. An adequate DAT regimen and absence of comorbid conditions are strongly associated with better clinical outcomes.

Utilidad del catéter Tornus® en las oclusiones coronarias crónicas no dilatables

Abstract: Resumen El tratamiento percutaneo de las oclusiones coronarias cronicas (OCC) representa un desafio. La segunda causa del fracaso de la tecnica es la imposibilidad de dilatarlas con un balon. Describimos nuestra experiencia con el nuevo cateter Tornus ® (Asahi Intecc; Aichi, Japon), disenado especificamente para facilitar el tratamiento de OCC «no dilatables». Desde noviembre de 2008 hasta marzo de 2010, hemos tratado a 17 pacientes (media de edad, 62 anos; el 88% varones, el 82% dislipemicos, el 52% hipertensos, el 29% diabeticos) en los que no se consiguio dilatar la lesion con ningun cateter balon tras haber cruzado la lesion con una guia de angioplastia. El cateter se utilizo con exito en 15 casos, sin complicaciones, y se consiguio finalizar la revascularizacion del vaso. Durante el seguimiento clinico (mediana, 573 dias), no se registraron eventos de importancia. El uso del cateter Tornus ® es seguro y factible en las OCC de lesiones previamente no dilatables de manera convencional.

Letter by Brugaletta et al Regarding Article, “Vascular Reactivity and Flow Characteristics of Radial Artery and Long Saphenous Vein Coronary Bypass Grafts: A 5-Year Follow-Up”

Abstract: To the Editor: We read with interest the article by Webb et al,1 demonstrating that, 5 years after coronary surgery, radial artery (RA) grafts have a preserved flow-mediated vasodilatation, whereas saphenous vein (SV) grafts have not. We agree with the authors that these results may provide insight into the more favorable patency of the RA graft over the SV graft, because the RA grafts preserved their ability to autoregulate their diameter in response to changes in myocardial flow physiology. However, some considerations about the SV graft should be highlighted. First, although the results represent a situation 5 years after the surgery, it is important to know the …