Impact of a dedicated radial lounge on same-day discharge percutaneous coronary intervention.

BACKGROUND: The same-day discharge (SDD) program after elective percutaneous coronary intervention (PCI) is a safe strategy that allows for the optimization of hospital resources. However, the lack of adequate infrastructure and a specially targeted care model may limit its implementation. Our center developed an outpatient care model based on an area designed for percutaneous procedures called radial lounge (RL). AIMS: Evaluate the efficacy and safety of the RL care model: (1) SDD rate, (2) patient experience, (3) major adverse cardiac events (MACEs) (in-hospital, 30-day, and 1-year mortality and intervention), and (4) vascular access complication. SECONDARY OBJECTIVE:  Impact of RL SDD rate on total elective SDD-PCI volume. METHODS: We conducted a retrospective observational cohort study at a cardiovascular hospital, including consecutive patients undergoing elective PCI between 2015 and 2022 who were admitted to the conventional hospitalization area (CHA) or the RL about the stated objectives. Patient experience was assessed using the Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. RESULTS: A total of 5466 elective PCI procedures were included: 2102 in the RL and 3364 in the CHA. The SDD rate was 85.2% in the RL group and 54% in the CHA. After the implementation of RL, a significant increase in the volume of elective SDD-PCI was observed and patient satisfaction improved significantly (p < 0.005) with CHA. Finally, a greater amount of MACEs were not observed in the RL. CONCLUSIONS: The PCI program in RL proved to be safe and effective. It showed a higher rate of SDD and a significant improvement in patient experience was observed without affecting safety.

Impacto de un modelo asistencial específicamente diseñado en un programa de angioplastia coronaria ambulatoria / Impact of a Specifically Designed Model of Care in an Outpatient Coronary Angioplasty Program

RESUMEN Introducción: Desarrollamos en nuestro centro un modelo asistencial ambulatorio para procedimientos coronarios percutáneos denominado Radial Lounge (RL). Los pacientes visten su propia ropa durante toda la estadía, sin restricciones de movilidad y sin necesidad de ayuno. Antes y después del procedimiento permanecen en un sillón acompañados por un familiar hasta el alta, sin monitoreo continuo y controlados por un enfermero dedicado exclusivamente a esta área. Objetivos: Evaluar la seguridad y eficacia del modelo asistencial del RL, la tasa de alta el mismo día (AMD), experiencia del paciente y eventos cardiovasculares adversos mayores (ECAM): mortalidad intrahospitalaria, mortalidad y rehospitalización a 30 días. Material y métodos: Se realizó un estudio observacional de cohorte retrospectiva en un centro cardiovascular, en que se incluyeron consecutivamente pacientes sometidos a una angioplastia transluminal coronaria (ATC) electiva en el RL. Resultados: Se incluyeron 2102 procedimientos de ATC electivas realizadas bajo el modelo RL. La tasa de AMD fue del 85,3% en el primer año de su implementación (2018) y alcanzó un 89% en 2022. Al evaluar la experiencia de los pacientes, el puntaje promedio obtenido a través de la encuesta de Consumer Assessment of Healthcare Providers and Systems (HCAHPS) fue 9,61/10. La tasa de ECAM no fue mayor que la reportada en la literatura. Conclusiones: El programa de ATC en RL demostró ser un modelo seguro y efectivo en nuestra experiencia.

ABSTRACT Introduction: An outpatient model of care for percutaneous coronary procedures called Radial Lounge (RL) was designed at our center. Patients wear their own clothes throughout their stay, with no mobility restrictions and without fasting. Before and after the procedure, they remain in an armchair accompanied by a family member until discharge, without continuous monitoring, under the supervision of a nurse dedicated exclusively to this area. Objectives: The aim of this study was to evaluate the safety and efficacy of the RL model of care, the same-day discharge (SDD) rate, patient experience, and major adverse cardiovascular events (MACE): in-hospital mortality, overall mortality, and re-hospitalization at 30 days Methods: A retrospective observational cohort study was conducted at a cardiovascular center, including consecutively enrolled patients undergoing elective percutaneous coronary intervention (PCI) in the RL. Results: A total of 2102 elective PCI procedures were included under the RL model. The SDD rate was 85.3% in the first year of its implementation (2018) and reached 89% in 2022. Assessing patient experience, the average score obtained through the Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey was 9.61/10. The rate of MACE was not higher than that reported in the literature. Conclusion: The PCI program in the RL proved to be a safe and effective model in our experience.

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.

Incidence, Predictor, and Clinical Outcomes of Multiple Resheathing With Self-Expanding Valves During Transcatheter Aortic Valve Replacement.

Background No study has evaluated the impact of the additional manipulation demanded by multiple resheathing (MR) in patients undergoing transcatheter aortic valve replacement with repositionable self-expanding valves. Methods and Results This study included a real-world, multicenter registry involving 16 centers from Canada, Germany, Latin America, and Spain. All consecutive patients who underwent transcatheter aortic valve replacement with the Evolut R, Evolut PRO, and Portico valves were included. Patients were divided according to the number of resheathing: no resheathing, single resheathing (SR), and MR. The primary end point was device success. Secondary outcomes included procedural complications, early safety events, and 1-year mortality. In 1026 patients, the proportion who required SR and MR was 23.9% and 9.3%, respectively. MR was predicted by the use of Portico and moderate/severe aortic regurgitation at baseline (both with P<0.01). Patients undergoing MR had less device success (no resheathing=89.9%, SR=89.8%, and MR=80%; P=0.01), driven by more need for a second prosthesis and device embolization. At 30 days, there were no differences in safety events. At 1 year, more deaths occurred with MR (no resheathing=10.5%, SR=8.0%, and MR=18.8%; P=0.014). After adjusting for baseline differences and center experience by annual volume, MR associated with less device success (odds ratio, 0.42; P=0.003) and increased 1-year mortality (hazard ratio, 2.06; P=0.01). When including only the Evolut R/PRO cases (N=837), MR continued to have less device success (P<0.001) and a trend toward increased mortality (P=0.05). Conclusions Repositioning a self-expanding valve is used in a third of patients, being multiple in ≈10%. MR, but not SR, was associated with more device failure and higher 1-year mortality, regardless of the type of valve implanted.

Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence. This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold. The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

Clinical practice guideline for transcatheter versus surgical valve replacement in patients with severe aortic stenosis in Latin America.

In elderly (75 years or older) patients living in Latin America with severe symptomatic aortic stenosis candidates for transfemoral approach, the panel suggests the use of transcatheter aortic valve implant (TAVI) over surgical aortic valve replacement (SAVR). This is a conditional recommendation, based on moderate certainty in the evidence (⨁⨁⨁Ο).This recommendation does not apply to patients in which there is a standard of care, like TAVI for patients at very high risk for cardiac surgery or inoperable patients, or SAVR for non-elderly patients (eg, under 65 years old) at low risk for cardiac surgery. The suggested age threshold of 75 years old is based on judgement of limited available literature and should be used as a guide rather than a determinant threshold.The conditional nature of this recommendation means that the majority of patients in this situation would want a transfemoral TAVI over SAVR, but some may prefer SAVR. For clinicians, this means that they must be familiar with the evidence supporting this recommendation and help each patient to arrive at a management decision integrating a multidisciplinary team discussion (Heart Team), patient's values and preferences through shared decision-making, and available resources. Policymakers will require substantial debate and the involvement of various stakeholders to implement this recommendation.

Surgical Risk Scoring in TAVR: Still Needed? A Metaregression Analysis.

Several randomized controlled trials evaluating the effectiveness of transcatheter aortic valve replacement (TAVR) against surgical aortic valve replacement have been published to date. The fact that higher risk populations were implemented first does not necessarily mean that they benefit more from a TAVR procedure. We performed meta-analysis of the 8 randomized clinical trials performing TAVR for both mortality and stroke outcomes. Meta-regression was used to evaluate the association between mean surgical risk using the Society of Thoracic Surgeons (STS) score and hazard ratio observed in each of the trials. Overall, TAVR was associated with a significant reduction of both mortality and stroke across the whole spectrum of patients enrolled, with no evidence of significant heterogeneity. Metaregression analysis does not suggest a statistically significant association between STS score and hazard ratio for both mortality and stroke. This observation suggests reconsidering the use of risk scores to prioritize TAVR utilization in higher risk patients, while more focus should be done on patient's life expectancy related to TAVR durability.

Experiencia multicéntrica de implante valvular aórtico percutáneo discriminada por riesgo en centros de Latinoamérica / Multicenter Experience of Transcatheter Aortic Valve Implantation Stratified by Risk in Latin American Centers

RESUMEN Introducción: El implante valvular aórtico percutáneo ha sido valorado en diferentes escenarios del amplio espectro de la población portadora de estenosis aórtica grave sintomática. La elección del tipo de tratamiento parte de una evaluación del riesgo de un equipo multidisciplinario. Objetivos: El objetivo de este estudio fue analizar las características y conocer los resultados de los pacientes sometidos a IVAP en Latinoamérica según el riesgo. Material y métodos: Se incluyeron a partir de marzo de 2009 a diciembre de 2018 pacientes en forma continua del registro multicéntrico latinoamericano de implante valvular aórtico percutáneo. La indicación de implante valvular aórtico percutáneo fue realizada en cada caso por un equipo multidisciplinario local. Se estratifica la población en función del riesgo quirúrgico evaluado por el puntaje STS-PROM. Se definieron tres grupos en función de los puntos de corte del STS -PROM establecidos: riesgo alto (RA, mayor del 8%), riesgo intermedio (RI, entre el 4% y el 8%) y riesgo bajo (RB, menordel 4%). Resultados: Se incluyeron en el análisis 770 pacientes; la mitad era de sexo femenino (50,2%) con una mediana de edad de 81 años (RIC 75,6-85,7). Del total, 230 pacientes (29,8%) fueron incluidos en el grupo AR (STS-PROM medio 11 [9,3-16,7]); 339 pacientes (44%), al riesgo intermedio (STS-PROM medio 6 [4,8-6,71]); y los restantes 201 (26,1%), al bajo riesgo (STS-PROM medio 2,7 [2-3,24]). La proporción de pacientes de bajo riesgo se incrementó a lo largo del período del registro (ptrend 0,011). Se utilizó acceso femoral (95%), y fue percutáneo en el 69% de los pacientes. Se implantaron en el 80% válvulas autoexpandibles. Del total de válvulas implantadas, el 23% (n = 177) resultaron ser reposicionables sin diferencias a través de los grupos. No se evidenciaron diferencias en mortalidad a los 30 días (RA 10,4%, RI 6,48%, RB 5,9%, p: 0,154) Tanto en el RA como en el de RB se observó una reducción de la mortalidad (RA 13,7%-4,1%, p: 0,001; RB 11,7%-0%; p: 0,0023). Conclusiones: La estratificación de riesgo mediante puntajes quirúrgicos continúa representando una guía de gran utilidad, sin embargo la indicación de implante valvular percutáneo en el mundo real incorpora otros factores no contemplados en la puntuación clásica, que modifica nuestras decisiones en la práctica diaria.

SUMMARY Introduction: Transcatheter aortic valve implantation (TAVI) has been evaluated in different scenarios of the broad spectrum of patients with severe symptomatic aortic stenosis. The choice of treatment starts through a risk assessment guided by a multidisciplinary team. Purpose: The aim of this study was to analyze the population undergoing TAVI in Latin America according to their risk. Methods: From March 2009 to December 2018, consecutive TAVI procedures registered in the Latin American multicenter registry were included. The indication of TAVI was made in each case by a multidisciplinary team set up by each center. The population is stratified according to the surgical risk evaluated by the STS-PROM score. Three groups were defined, based on the established STS-PROM cut-off points: high risk (RA, higher 8%), intermediate risk (IR, between 4%-8%) and low risk (RB, lower 4%). Results: 770 patients were included in the analysis, resulting 50,2% female, with a mean age of 81 y/o (IQR 75.6-85.7). 29.8% were included in the AR group (STS-PROM 11 (9.3-16.7), 44% at intermediate risk (STS-PROM 6 (4.8-6.71) and 26.1% at low risk (STS-PROM 2.7 (2-3.24). The proportion of low-risk patients has increased significantly over the period of inclusion (ptrend 0.011). Femoral access (95%), being percutaneous in 69% of patients. Self-expanding valves were implanted in 80%. 23% of the valves were repositionable without differences across the groups. There was no differences in 30-day mortality (RA 10.4%, IR 6.48%, RB 5.9%, p 0.154). Reduction in mortality were observed (RA 13, 7-4.1%, p0.001; RB 11.7-0%; p 0.0023) during the analyzed period. Conclusions: Risk stratification through surgical "scores" continues to represent a very useful guide, however the indication of TAVI in the real world incorporates other factors not contemplated in the classical score, which modifies our decisions in daily practice.

Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.

BACKGROUND: The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS: Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS: Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; Pinteraction=0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; Pinteraction=0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups (Pinteraction=0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; Pinteraction=0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization (Pinteraction=0.787) and death and ischemic events (Pinteraction=0.710). CONCLUSIONS: An antithrombotic regimen consisting of apixaban and a P2Y12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.

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.

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.

Implementación de un programa de angioplastia coronaria ambulatoria en pacientes con riesgo incrementado / Implementation of an Ambulatory Percutaneous Coronary Intervention Program in Higher Risk Patients

RESUMEN: Introducción: La hipercolesterolemia familiar es una hiperlipidemia primaria. Se trata de un trastorno genético autosómico dominante del metabolismo de las lipoproteínas, caracterizado por concentraciones plasmáticas elevadas de colesterol unido a lipoproteínas de baja densidad y presencia de xantomas tendinosos, y está asociado con el desarrollo prematuro de enfermedad cardiovascular. Objetivos: Investigar la presencia de mutaciones en el principal gen asociado al desarrollo de hipercolesterolemia familiar (LDLR) en un grupo de pacientes identificados como "casos índices", de entre aquellos que concurren al Servicio de Lípidos del Hospital Universitario Fundación Favaloro con diagnóstico clínico de hipercolesterolemia familiar. Determinar la composición ancestral de la población estudiada. Material y métodos: Se estudió una población de 38 pacientes con diagnóstico clínico de hipercolesterolemia familiar. La región codificante y las zonas intrónicas adyacentes del gen LDLR se secuenciaron automáticamente por el método de Sanger. Se investigó el componente ancestral de la población estudiada a partir del análisis de 46 marcadores informativos de ancestralidad (AIM-Indel). Resultados: Se identificaron 50 variantes diferentes, de las cuales el 48% se consideraron patogénicas. Se logró establecer una correlación genotipo-gravedad del fenotipo en el 60,5% de los pacientes estudiados. El componente ancestral de la población estudiada fue predominantemente europeo, seguido de un componente nativo-americano y, en menor proporción, africano. Conclusiones: El análisis genético por secuenciación del gen LDLR en pacientes identificados como "casos índices" con diagnóstico clínico de hipercolesterolemia familiar permite correlacionar el dato genético con la gravedad del fenotipo observado clínicamente y efectuar un diagnóstico en cascada en los miembros de la familia que presentan los criterios de inclusión considerados.

ABSTRACT: Background: Familial hypercholesterolemia is a primary hyperlipidemia. It is an autosomal dominant genetic disorder of lipoprotein metabolism, characterized by elevated plasma low-density lipoprotein cholesterol and presence of tendon xanthomas, and is associated with early cardiovascular disease. Objectives: The aim of this study was to investigate the presence of mutations in the main gene associated with the development of familial hypercholesterolemia (LDLR) in a group of patients identified as "index cases" attending the Lipid Clinic of the Hospital Universitario Fundación Favaloro with clinical diagnosis of familial hypercholesterolemia. The ancestral composition of the study population was determined. Methods: We evaluated 38 patients with clinical diagnosis of familial hypercholesterolemia. Mutation screening of the LDLR gene coding regions and adjacent intronic areas was performed using Sanger sequencing. The ancestral component of the study population was investigated using 46 ancestry inference markers (AIM-Indel). Results: Fifty different variants were identified, 48% of which were considered pathogenic. A genotype-phenotype severity correlation was established in 60.5% of the patients evaluated. The ancestral component of the study population was predominantly European, followed by native-American and African in lower proportion. Conclusions: Genetic testing by LDLR gene sequencing in patients identified as "index cases" with clinical diagnosis of familial hypercholesterolemia allows the correlation between the genetic information and the severity of the clinical phenotype to a cascade testing of the family members presenting the inclusion criteria considered.

Eficacia y seguridad del implante valvular aórtico percutáneo por vía transfemoral bajo anestesia general vs. anestesia local más sedación consciente / Efficacy and Safety of Transfemoral Transcatheter Aortic Valve Replacement under General Anesthesia versus Local Anesthesia with Conscious Sedation

RESUMEN: Introducción: Actualmente no hay consenso sobre el manejo anestésico más adecuado en el implante valvular aórtico percutáneo por vía transfemoral. Aunque se ha demostrado la factibilidad de concretar el procedimiento bajo anestesia local con sedación consciente o sin esta, los resultados clínicos reportados son controvertidos. Objetivos: Evaluar la seguridad y eficacia del implante valvular aórtico percutáneo por vía transfemoral realizado bajo anestesia general versus anestesia local con sedación consciente. Material y métodos: Análisis unicéntrico y retrospectivo de los pacientes con estenosis aórtica grave sintomática con alto riesgo quirúrgico sometidos a un implante valvular aórtico percutáneo por vía transfemoral desde marzo de 2009 a diciembre de 2016, según el manejo anestésico. Los desenlaces de seguridad y eficacia fueron evaluados a 30 días según las definiciones del Valve Academic Research Consortium-2. Además, se evaluaron los principales tiempos durante la internación. Resultados: Se incluyeron 121 pacientes (Edad 83,2 ± 5,7 años, hombres 48,8%), tratados con un implante valvular aórtico percutáneo por vía transfemoral bajo anestesia general (n = 55, 45,5%) o anestesia local con sedación consciente (n = 66, 54,5%). No se observaron diferencias significativas en los resultados intraprocedimiento ni en los desenlaces de seguridad y eficacia a 30 días. La mortalidad a 30 días fue del 7,3% en el grupo AG y del 3% en el grupo anestesia local con sedación consciente 3%, p log-rank 0,28 (mortalidad global 5%). La necesidad de conversión a anestesia general se presentó en 2 pacientes (3%), por complicaciones vasculares mayores durante el procedimiento. El grupo anestesia local con sedación consciente presentó menor tiempo total de procedimiento, internación en unidad de cuidados intensivos e internación total. Conclusión: El implante valvular aórtico percutáneo por vía transfemoral realizado bajo anestesia local con sedación consciente, parece ser una alternativa segura y eficaz al uso de anestesia general.

Abstract: Background: Currently, there is no consensus about the most adequate anesthetic management in transfemoral transcatheter aortic valve replacement. Although it has been shown that local anesthesia (LA) with or without conscious sedation is feasible, clinical results are controversial. Objective: The aim of this study was to evaluate the safety and efficacy of transfemoral transcatheter aortic valve replacement performed under general anesthesia versus local anesthesia with conscious sedation. Methods: This was a single-center, retrospective study of high risk patients with severe aortic stenosis undergoing transfemoral transcatheter aortic valve replacement between March 2009 and December 2016. The population was divided according to anesthetic management. Safety and efficacy outcomes were evaluated at 30-days and were classified according to definitions of the Valve Academic Research Consortium-2. In addition, key times during hospitalization were evaluated. Results: A total of 121 patients undergoing transfemoral transcatheter aortic valve replacement under general anesthesia (n=55, 45.5%) or local anesthesia with conscious sedation (n=66, 54.5%). were included in this analysis. Mean age was 83.2±5.7 years and 48.8% were men. There were no differences in either the procedural result or in the 30-day efficacy and safety outcomes. The rate of death at 30-days was 7.3% in the group with general anesthesia and 3% in the local anesthesia with conscious sedation group (log-rank p 0.28). The need of conversion to general anesthesia was 3% (2 patients), in all cases due to major vascular complications during the procedure. In the local anesthesia with conscious sedation group shorter procedural time, intensive care unit and hospital length of stay were observed. Conclusions: Transfemoral transcatheter aortic valve replacement performed under local anesthesia with conscious sedation seems to be a safe and effective alternative to the use of general anesthesia.

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.

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

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Evolución a largo plazo de pacientes con miocardiopatía hipertrófica / Long-term Outcome of Patients with Hypertrophic Cardiomyopathy

Introducción: La miocardiopatía hipertrófica es una enfermedad compleja que se ha asociado durante años con tasas altas de morbimortalidad. Sin embargo, mucha de la información que tenemos en relación con su evolución proviene de centros en los que se incluyeron pacientes seleccionados, principalmente de riesgo alto. Objetivo: Evaluar los eventos en el seguimiento de pacientes con miocardiopatía hipertrófica en nuestro medio. Material y métodos: Se evaluó una cohorte retrospectiva de pacientes con diagnóstico de miocardiopatía hipertrófica. Se analizó la evolución de la clase funcional junto con la ocurrencia de eventos clínicos. Se recabaron datos del ecocardiograma y de la resonancia magnética cardíaca. Resultados: Se incluyeron 259 pacientes, con una mediana de seguimiento de 3,5 años (2-10). La edad promedio fue de 56 ± 16,8 años y el 38,2% de los pacientes tenían formas obstructivas de la enfermedad. Al inicio del seguimiento, el 67% se encontraban en clase funcional I. En la evolución, la mortalidad global fue del 1,6%, con el 1,1% de muerte súbita o choque apropiado de desfibrilador y el 6,6% de los pacientes presentaron fibrilación auricular. La tasa de internación por insuficiencia cardíaca resultó del 5,8% y en el 14,3% de los pacientes empeoró la clase funcional. Se realizaron 22 procedimientos de ablación septal y 15 miectomías, con mejoría significativa de la sintomatología. Conclusiones: El trabajo muestra que en el seguimiento de esta cohorte de pacientes con miocardiopatía hipertrófica la tasa de morbimortalidad fue baja; el principal evento adverso fue el empeoramiento de la clase funcional, seguido por el desarrollo de fibrilación auricular y la insuficiencia cardíaca, con una tasa baja de muerte súbita.