Documento de posición para la mejora en la reperfusión del infarto agudo de miocardio con elevación del ST en Latinoamérica / Position statement for improvement in reperfusion of ST-elevation myocardial infarction in Latin America

Resumen El tratamiento del infarto agudo de miocardio con elevación del segmento ST tiene barreras dependiendo de la región geográfica. La angioplastia coronaria primaria es el tratamiento de elección, siempre y cuando sea realizada dentro de tiempo y por operadores experimentados. Sin embargo, cuando no está disponible, la administración de fibrinólisis y el envío para angioplastia de rescate, en caso de reperfusión negativa, es la mejor estrategia. De la misma manera, la angioplastia coronaria, como parte de una estrategia farmacoinvasiva, es la mejor alternativa cuando hay reperfusión positiva. El desarrollo de redes de tratamiento del infarto aumenta el número de pacientes reperfundidos dentro de los tiempos recomendados y mejora los desenlaces. En América Latina, los programas nacionales para el tratamiento del infarto deben centrarse en mejorar los resultados y el éxito a largo plazo depende de trabajar hacia objetivos definidos y obtener métricas de rendimiento, por lo tanto, estos deben desarrollar métricas para cuantificar su desempeño. El siguiente documento discute todas estas alternativas y sugiere oportunidades de mejora.

Abstract The treatment of ST-segment elevation myocardial infarction has barriers depending on the geographic region. Primary coronary angioplasty is the treatment of choice, if it is performed on time and by experienced operators. However, when it is not available, the administration of fibrinolysis and referral for rescue angioplasty, in case of negative reperfusion, is the best strategy. In the same way, coronary angioplasty, as part of a pharmacoinvasive strategy, is the best alternative when there is positive reperfusion. The development of infarct treatment networks increases the number of patients reperfused within the recommended times and improves outcomes. In Latin America, national myocardial infarction treatment programs should focus on improving outcomes, and long-term success depends on working toward defined goals and enhancing functionality, therefore programs should develop capacity to measure their performance. The following document discusses all of these alternatives and suggests opportunities for improvement.

[Position statement for improvement in reperfusion of ST-elevation myocardial infarction in Latin America]. / Documento de posición para la mejora en la reperfusión del infarto agudo de miocardio con elevación del ST en Latinoamérica.

The treatment of ST-segment elevation myocardial infarction has barriers depending on the geographic region. Primary coronary angioplasty is the treatment of choice, if it is performed on time and by experienced operators. However, when it is not available, the administration of fibrinolysis and referral for rescue angioplasty, in case of negative reperfusion, is the best strategy. In the same way, coronary angioplasty, as part of a pharmacoinvasive strategy, is the best alternative when there is positive reperfusion. The development of infarct treatment networks increases the number of patients reperfused within the recommended times and improves outcomes. In Latin America, national myocardial infarction treatment programs should focus on improving outcomes, and long-term success depends on working toward defined goals and enhancing functionality, therefore programs should develop capacity to measure their performance. The following document discusses all of these alternatives and suggests opportunities for improvement.

El tratamiento del infarto agudo de miocardio con elevación del segmento ST tiene barreras dependiendo de la región geográfica. La angioplastia coronaria primaria es el tratamiento de elección, siempre y cuando sea realizada dentro de tiempo y por operadores experimentados. Sin embargo, cuando no está disponible, la administración de fibrinólisis y el envío para angioplastia de rescate, en caso de reperfusión negativa, es la mejor estrategia. De la misma manera, la angioplastia coronaria, como parte de una estrategia farmacoinvasiva, es la mejor alternativa cuando hay reperfusión positiva. El desarrollo de redes de tratamiento del infarto aumenta el número de pacientes reperfundidos dentro de los tiempos recomendados y mejora los desenlaces. En América Latina, los programas nacionales para el tratamiento del infarto deben centrarse en mejorar los resultados y el éxito a largo plazo depende de trabajar hacia objetivos definidos y obtener métricas de rendimiento, por lo tanto, estos deben desarrollar métricas para cuantificar su desempeño. El siguiente documento discute todas estas alternativas y sugiere oportunidades de mejora.

Impacto de un Heart Team en pacientes con estenosis aórtica candidatos a reemplazo percutáneo / Impact of a Heart Team in patients with aortic stenosis who are candidates for transcatheter aortic valve replacement

RESUMEN La difusión del reemplazo valvular aórtico percutáneo (TAVI) en la estenosis aórtica (EAo) generó la creación de un Heart Team (HT), para elegir el mejor tratamiento. Existen pocos reportes sobre su utilidad. Objetivos: analizar los resultados del tratamiento de los pacientes con EAo evaluados por un HT durante 10 años Material y métodos: Inclusión consecutiva de todos los pacientes con EAo candidatos a TAVI entre enero del 2012 y julio del 2021 para seleccionar el mejor tratamiento, incluyendo además Cirugía de reemplazo valvular aórtico (CRVA) y Tratamiento médico conservador (TMC). Resultados: De 841 pacientes, se asignaron a TAVI 455 (53%), CRVA 213 (24%) y TMC 183 (23%). El porcentaje asignado a TAVI aumentó con el tiempo de 48 a 62% (p < 0,05). Los pacientes que fueron a TAVI, con respecto a los enviados a CRVA, eran mayores (86 ± 7 vs 83 ± 7 años), con mayor EUROSCORE II (6,2, IC95% 5,7-6,6 vs 5,6, IC95% 4,4-6,5) y más frágiles (1,62 ± 1 vs 0,91 ± 1), en todos los casos p <0,01. La sobrevida actuarial (IC 95%) a 1 y a 2 años fue, para TAVI 88% (84-91%) y 82% (77-86%), para CRVA 83% (76-88%) y 78% (70-84%) y para TMC 70% (60-87%) y 59% (48-68%) respectivamente (p <0,001). Conclusiones: Durante los primeros 10 años de establecido un Heart Team para la toma de decisiones en EAo, se asignaron a TAVI aproximadamente la mitad y el resto se asignó por mitades a cirugía u observación. La sobrevida de los pacientes intervenidos fue similar a 2 años y mayor que la de los no intervenidos.

ABSTRACT As transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) became widespread, the need for a Heart Team (HT) arose to choose the best treatment. There are few reports regarding its usefulness. Objectives: To analyze treatment outcomes in patients with AS evaluated by a HT for 10 years. Methods: Consecutive enrollment of all patients with AS who were candidates for TAVI between January 2012 and July 2021 to choose the best treatment, including surgical aortic valve replacement (SAVR) and conservative medical management (CMM). Results: Out of 841 patients, 455 were assigned to TAVI (53%), 213 to SAVR (24%), and 183 to CMM (23%). The percentage assigned to TAVI has increased from 48% to 62% over time (p <0.05). Patients who underwent TAVI versus those who underwent SAVR were older (86 ± 7 vs. 83 ± 7 years), had a higher EUROSCORE II (6.2, 95% CI 5.7-6.6 vs. 5.6; 95% CI 4.4-6.5) and were frailer (1.62 ± 1 vs. 0.91 ± 1), in all cases p <0.01. Actuarial survival (95% CI) at 1 and 2 years was 88% (84-91%) and 82% (77-86%) for TAVI, 83% (76-88%) and 78% (70-84%) for SAVR, and 70% (60-87%) and 59% (48-68%) for CMM, respectively (p <0.001). Conclusions: For the first 10 years after a Heart Team was established for AS decision-making, approximately half of the patients were assigned to TAVI, and the rest were equally assigned in halves to either surgery or observation. Survival for patients who received interventions was similar at 2 years and higher than in those who did not.

Optimización del tiempo puerta-balón mediante la implementación de un programa de mejora de procesos. Resultados a 5 años de funcionamiento / Optimization of Door-to-Balloon Time Implementing a Process Improvement Program. Results after 5 Years

RESUMEN Introducción : de estar disponible, la angioplastia primaria (ATCp), en tiempos adecuados y en centros con experiencia, es la mejor estrategia de reperfusión para el infarto agudo de miocardio con supradesnivel del segmento ST (IAMCEST). El tiempo puerta-balón (TPB) es una expresión de eficiencia operativa de la institución que realiza la ATCp, con impacto en la evolución del paciente. El objetivo de este trabajo fue analizar los resultados a largo plazo de un programa de mejora continua del proceso TPB. Material y métodos : se incluyeron en forma prospectiva y consecutiva pacientes con diagnóstico de IAMCEST sometidos a ATCp desde enero de 2015 a mayo de 2022. La población se dividió en dos períodos: período de implementación inmediata y período de seguimiento a largo plazo. Resultados : se ingresaron 671 pacientes en forma prospectiva y consecutiva. En el primer período, de implementación, (P1), se incluyeron 91 pacientes, y en el segundo período, de seguimiento del programa, (P2), 580 pacientes. La mediana (rango intercuartilo, RIC) de TPB fue de 46 min (29-59) en P1 vs 42 min(25-52) en el P2, p = 0,055. En el segundo período se evi denció una reducción de las preactivaciones (P1 54,1% vs P2 30%,p = 0,02) y los procedimientos on hours (42% en p1 vs 30% en P2, p = 0,029). Conclusión : el registro mostró el mantenimiento de los buenos resultados a largo plazo a pesar de una reducción de las preactivaciones y los procedimientos on hours.

ABSTRACT Background : If available, primary transluminal coronary angioplasty (PTCA), performed timely and in experienced sites, is the best reperfusion strategy for ST elevation myocardial infarction (STEMI). The door-to-balloon (DTB) time expresses operational efficiency of the site in charge of the PTCA, with an impact on patient's progress. The aim of this study was to analyze the long-term results of a continuous improvement program for the DTB time process. Methods : Patients diagnosed with STEMI who had undergone PTCA from January 2015 to May 2022 were prospectively and consecutively enrolled. The population was divided in two periods: an immediate implementation period and a long-term follow-up period. Results : 671 patients were prospectively and consecutively enrolled. During the implementation period (P1) 91 patients were enrolled, and 580 during the program follow-up (P2). The median (interquartile range, IQR) DTB time was 46 min (29-59) for P1 vs 42 min(25-52) for P2, p=0.055). The second period showed a reduction in pre-activations (P1 54,1% vs P2 30% p=0.02) and on-hour procedures (42% for P1 versus 30% for P2, p=0.029). Conclusion : The registry showed long-term maintenance of good results, despite reduced reactivations and on-hour procedures.

ORBI Score Validation as Predictor of Cardiogenic Shock in Patients With St Elevation Myocardial Infarction in Two Medical Centers in Argentina.

Cardiogenic shock(CS) after ST-segment elevation myocardial infarction(STEMI) has an in-hospital mortality of 50%. The ORBI score identifies patients at risk of CS after primary angioplasty. We aim to validate the score in an Argentinian cohort. A retrospective validation analysis was carried out from a cohort of patients with STEMI in 2 centers in Buenos Aires Metropolitan Area. The predictive value of the score were estimated through its discrimination power by AUC-ROC and calibration with the Hosmer Lemeshow (HL) goodness of fit test. Four hundred and twenty-four patients were analyzed. The incidence of CS was 8.5%. The median ORBI score was 10 (IQR 7-13) vs 5 in those without CS (IQR 3-7) (P < 0.0001). The performance of the test showed an AUC-ROC of 0.80 (95%CI 0.73-0.87; P < 0.0001); and a HL X² of 4.26 (P = 0.74). The ORBI score presented an adequate predictive capacity and calibration, suggesting its possible application in this population.

How to set up regional STEMI networks: a "Stent - Save a life!" initiative.

Clinical guidelines recommend the development of ST-elevation myocardial infarction (STEMI) networks at community, regional and/or national level to ideally offer primary coronary angioplasty, or at least the best available STEMI care to all patients. However, there is a discrepancy between this clinical recommendation and daily practice, with no coordinated care for STEMI patients in many regions of the world. While this can be a consequence of lack of resources, in reality it is more frequently a lack of organisational power. In this paper, the Stent - Save a Life! Initiative (www.stentsavealife.com) proposes a practical methodology to set up a STEMI network effectively in any region of the world with existing resources, and to develop the STEMI network continuously once it has been established.

Impacto de un sistema de evaluación de tiempos a la reperfusión en infarto agudo de miocardio con elevación del ST / Impact of an Evaluation System of Times to Reperfusion in ST-segment Elevation Acute Myocardial Infarction

RESUMEN • Introducción: El tratamiento del infarto con supradesnivel del ST (IAMCEST) es tiempo-dependiente, por lo que los centros con angioplastia primaria (ATCp) deben estar organizados para asegurar una rápida reperfusión. Objetivos: Evaluar el impacto de un sistema de evaluación sistemática de los tiempos de reperfusión y feedback de resultados en la reducción de las demoras. Material y métodos: Estudio observacional, prospectivo, realizado en 46 centros con ATCp 24/7 de la Iniciativa Stent-Save a Life! Argentina. Se incluyeron pacientes con IAMCEST sometidos a ATCp antes de las 12 h desde el inicio de los síntomas, asistidos entre marzo de 2016 y febrero de 2019. La población se dividió en tres etapas consecutivas de 1 año cada una desde la inclusión de cada centro. Resultados: Se incluyeron 3492 pacientes consecutivos (primer año: 1482; segundo año: 1166; tercer año: 844). Se observó una reducción significativa del tiempo puerta-balón (TPB) (68, 60 y 50 min; p < 0,0001) a lo largo de los años considerados, independientemente de dónde haya sido el primer contacto médico (PCM) y del tiempo desde el primer contacto médico (PCM) al balón (115, 112 y 98 min; p < 0,0001), sin diferencias en el tiempo desde el inicio de los síntomas al PCM ni en el tiempo total de isquemia (TTI). Asimismo, en aquellos pacientes que tuvieron su PCM en centros sin hemodinamia y fueron derivados para la realización de ATCp, se observó una disminución del TTI (274, 260 y 235 min; p < 0,001). Conclusiones: La implementación de un programa puerta-balón (PPB) en centros con ATCp permitió reducir los tiempos al tratamiento.

ABSTRACT • Background: Treatment of patients with ST-elevation myocardial infarction (STEMI) is time-dependent; therefore centers with primary percutaneous coronary intervention (pPCI) capability should be organized to achieve rapid reperfusion. Objectives: The aim of this study was to assess the impact of a systematic evaluation of reperfusion times with periodic feed-back of results in reducing delays to treatment. Methods: This was an observational, prospective study conducted in 46 centers with 24/7 pPCI capability participating in the Stent-Save a Life! Argentina Initiative. Patients with STEMI who underwent pPCI within 12 hours from the onset of symptoms were included from March 2016 to February 2019. The population was divided into three consecutive stages lasting one year each since the inclusion of each center in the Stent-Save a Life! Initiative. Results: A total of 3,492 patients were included (1st year: 1,482, 2nd year: 1,166, 3rd year: 844). There was a significant reduction in door-to-balloon (DTB) time (68, 60 and 50 min; p <0.0001), regardless of the type of first medical contact (FMC), and of the time from FMC to reperfusion (115, 112 and 98 min; p<0.0001), without differences in time from the onset of symptoms to FMC or total ischemic time (TIT). In addition, patients with FMC in centers without PCI capability who were referred for pPCI also evidenced a significant reduction of TIT (274, 260 and 235 min; p<0.001). Conclusion: The implementation of a DTB program in centers with pPCI capability resulted in a significant reduction of treatment times.

Telehealth in Heart Failure Care during COVID-19 Pandemic Lockdown in Argentina.

Background and Objectives: During the coronavirus disease 2019 (COVID-19) pandemic, virtual visits (VVs) were recommended as an innovative and necessary alternative for patients with heart failure (HF). To assess the feasibility and acceptability of VVs in patients with HF, pulmonary hypertension (PH), and heart transplant (HT). Methods: We designed a single-centre cohort study. Consecutive VVs performed in our HF unit were analysed. The period comprehended between January 1st and March 19th (before COVID-19) and March 20th and June 30th (during COVID-19) was compared. We assessed acceptability, feasibility and the need for diagnostic studies, in-person medical evaluation, and hospitalization at 30 days. Results: HF unit medical doctors conducted 22 VVs in the pre-COVID period and 416 VVs during the COVID period. The VV was able to be performed in all patients scheduled for it and 44% answered the survey. Ninety percent of the patients who answered the survey strongly agreed that VVs were easy to be carried out. All the patients "strongly agreed" or "agreed" that their health problem could be resolved. Most patients (95%) rated the global experience as very good or excellent, with an overall average rate of 9.76±0.5 out of 10. We found no differences regarding the requirement of diagnostic studies, in-person medical evaluation and hospitalization during the first month after VVs between the 2 periods. Conclusions: VVs were feasible, presented high acceptability, and the overall experience was positive in patients with HF, PH, and HT, being this modality a valuable tool that complements in-person care.

Impacto de la diabetes mellitus en pacientes tratados con angioplastia coronaria / Impact diabetes mellitus in patients undergoing percutaneous coronary intervention

RESUMEN Introducción: La diabetes mellitus (DM) se ha asociado a un incremento en los resultados adversos en pacientes tratados con angioplastia coronaria (ATC), en comparación con los pacientes no diabéticos. Objetivos: Evaluar el riesgo de eventos cardiovasculares mayores en los pacientes diabéticos, estratificados según el tratamiento recibido (no insulinorrequirientes o insulinorrequirientes), en una población de pacientes no seleccionada tratados con angioplastia coronaria. Material y métodos: Análisis de registro, unicéntrico y retrospectivo de pacientes con enfermedad coronaria tratados con ATC desde marzo 2009 a junio 2018, según la presencia de DM estratificada de acuerdo con el tratamiento establecido para el control del desorden metabólico en: DM insulino-requirientes (DM-IR) y DM no insulino-requirientes (DM-NIR). Se aplicó un modelo de regresión de Cox ajustado para evaluar la relación entre la presencia de diabetes y el riesgo de eventos cardiovasculares mayores. Resultados: Se incluyeron 6.313 pacientes (seguimiento promedio 4,1 ± 1,8 años), con una prevalencia global de DM del 22,8% (DM-NIR 19,1%; DM-IR 3,8%). Los pacientes diabéticos presentaron un perfil de riesgo elevado, particularmente los DM-IR. Al seguimiento promedio, el riesgo ajustado de eventos cardiovasculares mayores fue similar entre los pacientes No-DM y los DM-NIR (HR 1,02 [0,81-1,27], p 0,85). En relación con los pacientes DM-IR, se observó un riesgo elevado comparados con los No-DM (HR 1,73 [1,20-2,49], p 0,003) y con los DM-NIR (HR 1,65 [1,10-2,48], p 0,015). Se observó una interacción significativa entre el estado diabético y el riesgo de eventos según la indicación de la angioplastia coronaria al ingreso (pint 0,045). Conclusiones: En nuestra serie de pacientes tratados con angioplastia coronaria y con seguimiento a largo plazo, los pacientes diabéticos presentaron alto riesgo de eventos cardiovasculares mayores. Este riesgo se observó particularmente incrementado en pacientes DM-IR. Sin embargo, no se evidenciaron diferencias significativas en el riesgo de eventos entre los pacientes DM-NIR y los No-DM.

ABSTRACT Background: Diabetes mellitus (DM) has been associated with an increase in adverse outcomes in patients treated with coronary angioplasty, compared to non-diabetic patients. Objective: To evaluate the risk of major adverse cardiovascular events in diabetic patients, stratified according to the treatment (non-insulin dependent or insulin-dependent), in a population of unselected patients treated with coronary angioplasty. Methods: Registry-based analysis of patients with coronary artery disease undergoing percutaneous coronary intervention from March 2009 to June 2018, according presence of DM stratified according to the established treatment for the metabolic disorder: insulin-dependent DM (ID -DM) and non-insulin dependent DM (NID -DM). An adjusted Cox regression model was applied to evaluate the relationship between the diabetic status and the risk of major adverse cardiovascular events. Results: A total of 6313 patients were included (mean follow-up 4.1 ± 1.8 years), with a global prevalence of DM of 22,8% (non-insulin dependent DM 19,1%, insulin-dependent DM 3,8%). Diabetic patients showed a higher risk profile, particularly those with ID-DM. At the average follow-up, the adjusted risk of MACE was similar between Non-DM patients and the NIR-DM patients (HR 1,02 [0,81-1,27], p 0.85). In relation to DM-IR patients, it was observed a higher risk of MACE in comparison to Non-DM (HR 1,73 [1,20-2,49], p 0.003) and NIR-DM (HR 1,65 [1,10-2,48], p 0.015). A significant interaction was observed between the diabetic status and the risk of MACE according to the indication of the percutaneous coronary artery intervention (pint 0.045). Conclusions: In our registry of patients undergoing PCI, with long-term follow-up, DM patients had a higher risk of MACE. The risk of MACE was particularly increased in ID-DM patients. However, there were no significant differences in the risk of MACE between DM-NIR and non-DM patients.

Iniciativa Stent-Save a Life! Argentina / Stent-Save a Life! Argentina Initiative

RESUMEN 31. Introducción: La iniciativa Stent-Save a Life! (SSL) es un programa europeo que busca mejorar el acceso de pacientes con infarto agudo de miocardio con elevación del ST (IAMCEST) a un tratamiento de reperfusión basado en las recomendaciones de las guías clínicas, reduciendo así su morbimortalidad. Objetivo: Describir los resultados de los primeros tres años de la iniciativa SSL Argentina Material y métodos: Se realizó inicialmente un mapeo para analizar la situación local y luego se desarrolló el Programa Puerta-Balón (PPB) como un proceso de mejora continua para centros con capacidad de realizar angioplastia primaria (ATCp). Resultados: Desde marzo de 2016 hasta marzo de 2018 se trataron 3041 pacientes con IAMCEST en 38 centros participantes del citado programa. El 20% (n = 610) de esos pacientes tuvo su primer contacto médico (PCM) con el servicio de emergencias médicas. Excluyendo los 184 pacientes sin lesiones coronarias (6% del total), el 93% fue reperfundido, principalmente con ATCp (95%). El tiempo global de isquemia fue de 117 minutos, variando según el momento del PCM. La mortalidad global intrahospitalaria fue del 7%. Conclusiones: La falta de una "cultura de reperfusión" fue la barrera en común de centros públicos y privados que motivó el desarrollo del PPB. La identificación de los puntos críticos que impiden un tratamiento a tiempo, junto con la organización de los centros puertas adentro, representan el primer paso para mejorar la atención de estos pacientes. Es necesario el trabajo integrado de todos los actores involucrados a partir de la organización de redes de atención, adaptadas a la realidad local de cada centro y región.

ABSTRACT 39. Introduction: The Stent-Save a Life! (SSL) initiative is a European program that seeks to improve the access of patients with ST-segment elevation acute myocardial infarction (STEMI) to reperfusion therapies based on clinical guideline recommendations, thus reducing morbidity and mortality. Objective: The aim of this study was to describe the results of the first three years of the SSL Argentina initiative. Methods: Initially, a mapping was carried out to analyze the local situation and then the Door-to- Balloon Program (DBP) was developed as a continuous improvement process for centers with primary percutaneous coronary intervention (pPCI) capability. Results: From March 2016 to March 2018, 3,041 patients with STEMI were treated in 38 centers participating in this program. In 20% of cases (n=610) patients had their first medical contact with the emergency medical services. After excluding 184 patients (6%) without coronary lesions, reperfusion therapy was performed in 93% of cases, mainly by pPCI (95%). Total ischemic time was 117 minutes, with differences according to the time of first medical contact. Overall in-hospital mortality was 7%. Conclusions: The lack of a "reperfusion culture" was the common barrier of public and private centers that motivated the development of the DBP. The identification of critical points that prevent treatment on time, together with enhancement of in-hospital organization, represent the first step to improve the care of these patients. The integrated work of all the involved parties is necessary to develop care networks adapted to the local reality of each center and region.

Eficiencia y seguridad del acceso radial versus el acceso femoral en la angioplastia coronaria / Efficiency and Safety of Radial Access versus Femoral Access in Percutaneous Coronary Intervention

RESUMEN Introducción: El acceso radial se ha asociado a numerosos beneficios en angioplastia coronaria en comparación con el acceso femoral. Sin embargo, múltiples registros internacionales han reportado una escasa adherencia a esta técnica. Objetivos: Evaluar la seguridad, la eficacia y la eficiencia operativa de la angioplastia coronaria según la vía de acceso utilizada y el cuadro clínico del paciente. Métodos: Análisis de registro, unicéntrico y retrospectivo de los pacientes con enfermedad coronaria tratados con angioplastia coronaria desde marzo de 2009 a junio de 2018, según el acceso vascular. Se aplicó un modelo de regresión de Cox ajustado para evaluar la relación entre la vía de acceso y el riesgo de eventos cardiovasculares mayores y un modelo de regresión logística para evaluar la relación con el sangrado mayor y las complicaciones del acceso vascular. La eficiencia operativa se evaluó mediante la medición del tiempo de internación total y los costos totales asociados a esta. Resultados: Se incluyeron 8155 angioplastias coronarias (seguimiento promedio 1448,6 ± 714,1 días), mediante acceso radial (n = 5706) o acceso femoral (n = 2449). A los 30 días, el riesgo de eventos cardiovasculares mayores se redujo significativamente con el acceso radial (HR 0,66 [0,5-0,88], p = 0,004), a expensas de una reducción de la mortalidad total. A su vez, el acceso radial redujo significativamente el riesgo de sangrado mayor (HR 0,33 [0,16- 0,67], p = 0,002) y de complicaciones del acceso vascular (HR 0,72 [0,53-0,98], p = 0,038). Se observó una interacción significativa entre la vía de acceso y el riesgo de eventos según el cuadro clínico al ingreso. Se observó una reducción significativa del tiempo total de internación (≈30%) y de sus costos totales (≈15%) mediante el uso del acceso radial. Conclusiones: El uso del acceso radial en angioplastia coronaria es seguro y eficaz en comparación con el acceso femoral, con menores tasas de eventos cardiovasculares mayores a los 30 días, como, así también, un menor riesgo de sangrado mayor y complicaciones del acceso vascular. Asimismo, el acceso radial se asoció con una mayor eficiencia operativa durante la internación.

ABSTRACT Background: Radial access has been associated with many advantages in percutaneous coronary intervention compared with femoral access. However, many international registries have reported poor adherence to this technique. Objectives: The aim of this study was to evaluate the safety, efficacy and operational efficiency of percutaneous coronary intervention according to the access site and the clinical presentation of the patient. Methods: A single-center, retrospective registry of patientis with coronary artery disease undergoing percutaneous coronary intervention was conducted from March 2009 to June 2018 according to the vascular access. A Cox proportional-hazards model was used to analyze the association between vascular access and risk of major cardiovascular eventis, and a logistic regression model was applied to assess the relationship between major bleeding and access site complications. Total hospital stay and total hospitalization costis were measured to evaluate the operational efficiency. Resultis: A total of 8,155 percutaneous coronary interventions (mean follow-up of 1,448.6±714.1 days), via radial access (n=5,706) or femoral access (n=2,449), were included in the study. At 30 days, the risk of major cardiovascular eventis was significantly lower with the radial access (HR 0.66 [0.5-0.88], p=0.004), at the expense of a reduction in all-cause mortal-ity In addition, radial access significantly reduced the risk of major bleeding (HR 0.33 [0.16-0.67], p=0.002) and access site complications (HR 0.72 [0.53-0.98], p=0.038). A significant interaction was observed between the vascular access site and the risk of eventis according to the clinical presentation at admission. Use of radial access was associated with a significant reduction in the length of total hospital stay (≈30%) and total hospitalization costis (≈15%). Conclusions: The use of radial access in percutaneous coronary intervention was safe and effective compared with the femoral access, with lower rates of major cardiovascular eventis at 30 days, lower risk of major bleeding and of access site complications. Moreover, radial access was associated with greater operational efficiency during hospitalization.

Clinical outcome in nonagenarians undergoing transcatheter valve replacement.

BACKGROUND: Nonagenarians are mostly denied from different therapeutic strategies due to high preoperative risk. We present the results of nonagenarians with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). METHODS: Our retrospective analysis include baseline and procedural data along with clinical outcome. Clinical follow-up was performed in all patients after TAVR. RESULTS: Out of 689 patients, 33 nonagenarians with a mean age of 90.9±1.4years suffering from severe AS and elevated comorbidity index (logistic EuroSCORE of 16.3±9.6%, STS score 11.1±9.9%) underwent TAVR between September 2009 and July 2016 using self-expanding prosthesis. Baseline transthoracic echocardiography reported a mean aortic valve area (AVA) of 0.64±0.12cm2 with a mean pressure gradient of 56.1±16.1mmHg. Five (16.2%) patients had postprocedural moderate/severe aortic regurgitation. One patient died intraoperally due to ventricular perforation during predilatation, while two patients died within the first 30days, one due to cardiogenic shock and the other due to pneumonia. No patient experienced a myocardial infarction or a stroke, while ten (30.3%) required permanent pacemaker placement. At follow-up (mean 20.3 months, range 1-78 months), all cause and cardiovascular mortality was 24.2% and 15.1%, respectively. Two patients presented heart failure and 12 (40%) had exertional dyspnea. By echo, mean valve area was 1.72±0.12cm2 and mean gradient 11.2±1.4mmHg. Two patients (16.7%) presented moderate aortic regurgitation. CONCLUSION: Our case series demonstrate that even with elevated comorbidity index, clinical endpoints and valve-associated results are relatively favorable in nonagenarians treated with TAVR.

Percutaneous coronary interventions in diabetics: The never-ending challenge.

Diabetes mellitus (DM) is a multisystem disorder and a recognized risk factor for coronary artery disease (CAD) and DM patient are particularly challenging for revascularization. In this "real world" retrospective study post-PCI DM patients showed a high risk profile compared to the non-DM group, given by the higher prevalence of cardiovascular risk factors, multiple vessel disease, and renal dysfunction, with the highest rates seen in the ITDM. Only ITDM patients present higher 30-day mortality compared to non-DM patients in the urgent and primary PCI setting. Also ITDM, but not those NITDM patients, had an increased long-term mortality in the overall cohort and in all PCI setting.

Tratamiento del seudoaneurisma femoral mediante la inyección local de trombina / Femoral Pseudoaneurysm Treatment by Local Thrombin Injection

Introducción: El seudoaneurisma es una complicación ocasional (0,05-0,5%) de los procedimientos intervencionistas cuando se utiliza el acceso femoral. El cierre con inyección local de trombina como alternativa al tratamiento quirúrgico luego de compresión manual fallida cuenta con escasos registros. Objetivo: Evaluar la seguridad y eficacia del cierre del seudoaneurisma femoral iatrogénico mediante la inyección local de trombina guiada por ecografía Doppler. Material y métodos: Entre marzo de 2007 y junio de 2016 se incluyeron 32 pacientes para tratamiento con inyección de trombina. Resultados: La edad media fue de 64,3 ± 10,2 años. La mayoría de los seudoaneurismas estuvieron asociados con la realización de cateterismos coronarios diagnósticos o terapéuticos (59,3%). Siete pacientes habían recibido tratamiento anticoagulante y 21 doble antiagregación plaquetaria. En todos los casos se intentó previamente el cierre por compresión manual. La media del diámetro mayor de los seudoaneurismas fue de 38 mm. Luego del tratamiento, la trombosis inmediata del saco ocurrió en 28 pacientes (87,5%), mientras que 4 pacientes requirieron una segunda inyección, lo que determinó un éxito del 96,8%. En un solo paciente este tratamiento no fue efectivo, con posterior conversión a reparación quirúrgica programada. La dosis media de trombina fue de 450 unidades. Un único paciente presentó complicación trombótica venosa que requirió terapia anticoagulante, con buena evolución clínica. Conclusión: El tratamiento del seudoaneurisma con inyección local de trombina guiada con eco-Doppler fue una alternativa terapéutica segura y eficaz para pacientes con seudoaneurisma femoral refractarios a la compresión manual.

Background: Pseudoaneurysm is a rare complication (0.05-0.5%) after interventional procedures using femoral access. There are few registries of local thrombin injection for pseudoaneurysm closure as an alternative treatment to surgery after failed manual compression. Objective: The aim of this study was to evaluate the safety and efficacy of iatrogenic femoral pseudoaneurysm closure with Doppler ultrasound-guided local thrombin injection. Methods: Thirty-two patients were included for thrombin injection treatment between March 2007 and June 2016. Results: Mean age was 64.3±10.2 years. Most pseudoaneurysms were associated with diagnostic or therapeutic cardiac cath-eterizations (59.3%). Seven patients had received anticoagulant treatment and 21, double antiplatelet therapy. In all cases, prior closure was attempted by manual compression. Mean pseudoaneurysm major diameter was 38 mm. Following treatment, immediate pseudoaneurysm sac thrombosis occurred in 28 patients (87.5%), while 4 patients required a second injection, resulting in 96.8% success rate. Treatment was not effective in only one patient, with subsequent conversion to programmed surgical repair. Mean thrombin dose was 450 units. Only one patient presented with venous thrombosis complication requir-ing anticoagulant therapy, with good clinical outcome. Conclusion: Doppler ultrasound-guided local thrombin injection was a safe and effective therapeutic alternative for pseudoa-neurysm treatment in patients with femoral pseudoaneurysm refractory to manual compression.

Optimización del tiempo puerta-balón mediante la implementación de un programa de mejora de procesos / Optimization of Door-to-Balloon Time Implementing a Process Improvement Program

es

Sobrevivência a médio prazo e estado funcional de pacientes com estenose valvar aórtica grave submetidos a implante transcateter da válvula aórtica / Medium-term survival and functional status of patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation

INTRODUÇÃO: O procedimento de implante transcateter da válvula aórtica (TAVI, do inglês transcatheter aortic valve implantation) representa opção de tratamento em pacientes com estenose valvar aórtica (EA) com risco cirúrgico elevado ou proibitivo. Relatamos nossa experiência usando o sistema autoexpansível Medtronic CoreValve®. MÉTODOS: No período de 2009 a 2013, 51 pacientes consecutivos com EA grave sintomática e risco cirúrgico alto ou proibitivo foram submetidos ao TAVI. Os resultados foram analisados de acordo com os critérios Valve Academic Research Consortium (VARC) -2. RESULTADOS: A média de idades dos pacientes foi 82 ± 6 anos, 49% eram do sexo feminino, 19% diabéticos, 21% tinham insuficiência renal e o EuroSCORE logístico foi 17,4 ± 11,4%. O sucesso do dispositivo foi alcançado em 84,3%. Todos os pacientes tiveram diminuição significativa dos gradientes transaórticos, que foi mantida ao longo do tempo. A internação hospitalar foi de 6 dias (intervalo interquartil: 5-8,8). A mortalidade intra-hospitalar e aos 30 dias foi 7,8% e 9,8%, respectivamente. Implante de marca-passo permanente foi necessário em 32,6% dos casos; acidente cerebrovascular isquêmico ocorreu em 3,9%; e complicações vasculares maiores em 6% dos pacientes. A sobrevivência aos 6 meses e em 1 ano foi 86,3% e 84,4%, respectivamente. A classe funcional NYHA melhorou significativamente após o TAVI e permaneceu baixa no seguimento de médio prazo. CONCLUSÕES: Nesta experiência preliminar, o tratamento de pacientes com EA e risco cirúrgico alto ou proibitivo com TAVI, usando o sistema autoexpansível CoreValve®, foi considerado viável e seguro, e levou à melhoria sustentável dos sintomas cardíacos. Após a superação dos riscos iniciais de morte e de acidente cerebrovascular, o procedimento garantiu um bom resultado clínico, no longo prazo.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a treatment option for patients with aortic valve stenosis (AS) and high or prohibitive surgical risk. We report our experience using the Medtronic CoreValveTM self-expending system. METHODS: From 2009 to 2013, 51 consecutive patients with severe symptomatic AS and high or prohibitive surgical risk were submitted to TAVI. Results were analyzed according to the criteria of the Valve Academic Research Consortium (VARC) -2. RESULTS: Mean age was 82 ± 6 years, 49% were female, 19% were diabetic, 21% had renal failure and the logistic EuroScore was 17.4 ± 11.4%. The success rate of the device was 84.3%. All of the patients had a significant decrease of transaortic gradients, which was maintained over time. Hospitalization time was 6 days (interquartile range: 5-8,8). In-hospital mortality at 30 days was 7.8% and 9.8%, respectively. Permanent pacemaker implantation was required in 32.6% of the cases, ischemic stroke was observed in 3.9% and major vascular complications in 6% of the patients. Survival at 6 months and 1 year was 86.3% and 84.4%, respectively. NYHA functional class improved significantly after TAVI and remained low in the medium-term follow-up. CONCLUSIONS: In this preliminary experience, the treatment of patients with AS and high or prohibitive surgical risk with TAVI, using the CoreValveTM self-expanding system was feasible and safe and led to sustained improvement of cardiac symptoms. After overcoming the initial risks of death and stroke, the procedure guaranteed good long-term clinical outcomes.

Tratamiento antiagregante guiado por pruebas de función plaquetaria en pacientes sometidos a angioplastia coronaria exitosa / Antiplatelet Therapy Guided by Platelet Function Testing after Successful Percutaneous Coronary Intervention / Antiplatelet Therapy Guided by Platelet Function testing after Successful Percutaneous Coronary Intervention Background

Introducción El tratamiento antiagregante dual con aspirina y clopidogrel constituye un tratamiento esencial para la prevención de eventos isquémicos en pacientes sometidos a angioplastia transluminal coronaria (ATC). Sin embargo, existe alta variabilidad interpaciente en la respuesta al clopidogrel, condicionando la falla en su efecto terapéutico, que se manifiesta como hiperreactividad plaquetaria residual (HPR). El prasugrel podría reducir este estado protrombótico. Objetivos 1) Estudiar la respuesta antiagregante en pacientes sometidos a ATC exitosa pretratados con clopidogrel o prasugrel y 2) evaluar la respuesta a una carga de prasugrel en pacientes con HPR bajo tratamiento con clopidogrel. Material y métodos Se incluyeron en forma prospectiva y consecutiva 83 pacientes sin riesgo hemorrágico alto sometidos a ATC exitosa bajo tratamiento antiagregante dual: aspirina más clopidogrel (600 mg de carga o mantenimiento de 75 mg/día por más de 7 días; n = 42) o prasugrel (60 mg de carga o mantenimiento de 10 mg/día por más de 7 días, n = 41). La selección de la tienopiridina quedó a cargo del médico tratante. La función plaquetaria se evaluó a las 12-24 horas pos-ATC con el método VerifyNow«. Se definió HPR a la presencia de ≥ 230 unidades de reactividad plaquetaria (URP). Los pacientes con HPR recibieron una dosis de carga de prasugrel de 60 mg y se repitió la evaluación de la función plaquetaria a las 2 horas. Resultados No hubo diferencias significativas en las características basales de ambos grupos. A las 12-24 horas pos-ATC, los pacientes tratados con prasugrel presentaron menos URP en comparación con el grupo clopidogrel [mediana 49 (9-78) vs. 160 (82-224); p < 0,001]. Se observó HPR en el 24% de los pacientes del grupo clopidogrel y cero en el grupo prasugrel (p < 0,001). Todos los pacientes con HPR bajo tratamiento con clopidogrel lograron corregirla luego de la carga de prasugrel. Conclusiones En pacientes sometidos a ATC exitosa, el tratamiento con prasugrel logró una mayor inhibición de la agregación plaquetaria (IAP) en comparación con la administración de clopidogrel. Por su parte, los pacientes con HPR bajo tratamiento con clopidogrel lograron alcanzar una IAP óptima con la administración adicional de prasugrel.(AU)

Dual antiplatelet therapy with aspirin and clopidogrel is an essential treatment to prevent ischemic events in patients undergoing percutaneous coronary intervention (PCI). However, a significant interindividual variability exists in response to clopidogrel treatment, which is responsible for failure in the therapeutic effect and in the development of high residual platelet reactivity (HRPR). Prasugrel could reduce this prothrombotic state. Objectives To evaluate: 1) the antiaggregant response in clopidogrel or prasugrel pretreated patients undergoing successful PCI, and 2) the response to prasugrel loading in patients with low residual platelet reactivity on clopidogrel therapy. Material and Methods Eighty three patients were prospectively included in the study. They underwent successful PCI under dual antiplatelet therapy: aspirin plus clopidogrel (600 mg loading dose or a maintenance dose of 75 mg for more than 7 days; n=42) or prasugrel (60 mg loading dose or a maintenance dose of 10 mg for more than 7 days; n=41). The selection of thienopyridine was left at the discretion of the treating physician. Patients with high hemorrhagic risk were excluded. Platelet function was tested 12-24 hours after PCI with the VerifyNowTM P2Y12 Assay. High residual platelet reactivity (HRPR) was defined as P2Y12-reaction units (PRU) ≥ 230. In case of HRPR, patients received a loading dose of prasugrel 60 mg and platelet function was reassessed 2 hours later. Results Baseline characteristics did not differ in patients who initially received clopidogrel or prasugrel. At 12-24 hours post PCI, patients treated with prasugrel presented significantly less PRU compared with the clopidogrel cohort (median 49 (9-78) vs. 160 (82-224); p < 0.001). HRPR was observed in 24% of patients in the clopidogrel group and in no patients in the prasugrel cohort (p < 0.001). All patients with HRPR on clopidogrel treatment corrected this value after the loading dose of prasugrel. Conclusions After successful PCI, prasugrel administration achieved greater platelet inhibition compared to clopidogrel. Moreover, in patients with high-on treatment platelet reactivity with clopidogrel, optimal platelet inhibition was accomplished by additional prasugrel administration.(AU)

Tratamiento antiagregante guiado por pruebas de función plaquetaria en pacientes sometidos a angioplastia coronaria exitosa / Antiplatelet Therapy Guided by Platelet Function Testing after Successful Percutaneous Coronary Intervention / Antiplatelet Therapy Guided by Platelet Function testing after Successful Percutaneous Coronary Intervention Background

Introducción El tratamiento antiagregante dual con aspirina y clopidogrel constituye un tratamiento esencial para la prevención de eventos isquémicos en pacientes sometidos a angioplastia transluminal coronaria (ATC). Sin embargo, existe alta variabilidad interpaciente en la respuesta al clopidogrel, condicionando la falla en su efecto terapéutico, que se manifiesta como hiperreactividad plaquetaria residual (HPR). El prasugrel podría reducir este estado protrombótico. Objetivos 1) Estudiar la respuesta antiagregante en pacientes sometidos a ATC exitosa pretratados con clopidogrel o prasugrel y 2) evaluar la respuesta a una carga de prasugrel en pacientes con HPR bajo tratamiento con clopidogrel. Material y métodos Se incluyeron en forma prospectiva y consecutiva 83 pacientes sin riesgo hemorrágico alto sometidos a ATC exitosa bajo tratamiento antiagregante dual: aspirina más clopidogrel (600 mg de carga o mantenimiento de 75 mg/día por más de 7 días; n = 42) o prasugrel (60 mg de carga o mantenimiento de 10 mg/día por más de 7 días, n = 41). La selección de la tienopiridina quedó a cargo del médico tratante. La función plaquetaria se evaluó a las 12-24 horas pos-ATC con el método VerifyNow®. Se definió HPR a la presencia de ≥ 230 unidades de reactividad plaquetaria (URP). Los pacientes con HPR recibieron una dosis de carga de prasugrel de 60 mg y se repitió la evaluación de la función plaquetaria a las 2 horas. Resultados No hubo diferencias significativas en las características basales de ambos grupos. A las 12-24 horas pos-ATC, los pacientes tratados con prasugrel presentaron menos URP en comparación con el grupo clopidogrel [mediana 49 (9-78) vs. 160 (82-224); p < 0,001]. Se observó HPR en el 24% de los pacientes del grupo clopidogrel y cero en el grupo prasugrel (p < 0,001). Todos los pacientes con HPR bajo tratamiento con clopidogrel lograron corregirla luego de la carga de prasugrel. Conclusiones En pacientes sometidos a ATC exitosa, el tratamiento con prasugrel logró una mayor inhibición de la agregación plaquetaria (IAP) en comparación con la administración de clopidogrel. Por su parte, los pacientes con HPR bajo tratamiento con clopidogrel lograron alcanzar una IAP óptima con la administración adicional de prasugrel.

Dual antiplatelet therapy with aspirin and clopidogrel is an essential treatment to prevent ischemic events in patients undergoing percutaneous coronary intervention (PCI). However, a significant interindividual variability exists in response to clopidogrel treatment, which is responsible for failure in the therapeutic effect and in the development of high residual platelet reactivity (HRPR). Prasugrel could reduce this prothrombotic state. Objectives To evaluate: 1) the antiaggregant response in clopidogrel or prasugrel pretreated patients undergoing successful PCI, and 2) the response to prasugrel loading in patients with low residual platelet reactivity on clopidogrel therapy. Material and Methods Eighty three patients were prospectively included in the study. They underwent successful PCI under dual antiplatelet therapy: aspirin plus clopidogrel (600 mg loading dose or a maintenance dose of 75 mg for more than 7 days; n=42) or prasugrel (60 mg loading dose or a maintenance dose of 10 mg for more than 7 days; n=41). The selection of thienopyridine was left at the discretion of the treating physician. Patients with high hemorrhagic risk were excluded. Platelet function was tested 12-24 hours after PCI with the VerifyNowTM P2Y12 Assay. High residual platelet reactivity (HRPR) was defined as P2Y12-reaction units (PRU) ≥ 230. In case of HRPR, patients received a loading dose of prasugrel 60 mg and platelet function was reassessed 2 hours later. Results Baseline characteristics did not differ in patients who initially received clopidogrel or prasugrel. At 12-24 hours post PCI, patients treated with prasugrel presented significantly less PRU compared with the clopidogrel cohort (median 49 (9-78) vs. 160 (82-224); p < 0.001). HRPR was observed in 24% of patients in the clopidogrel group and in no patients in the prasugrel cohort (p < 0.001). All patients with HRPR on clopidogrel treatment corrected this value after the loading dose of prasugrel. Conclusions After successful PCI, prasugrel administration achieved greater platelet inhibition compared to clopidogrel. Moreover, in patients with high-on treatment platelet reactivity with clopidogrel, optimal platelet inhibition was accomplished by additional prasugrel administration.