Transcatheter Aortic Valve Replacement Through a Single Femoral Access: A Multicenter Experience.

OBJECTIVES: During the past few years, physicians have optimized transcatheter aortic valve replacement and its periprocedural management, with the minimalist approach becoming popular. We aimed to further simplify the procedure using a single femoral access (the "all-in-one" technique). Here, we report a multicenter experience with TAVR with Acurate neo/neo2 transcatheter heart valves (Boston Scientific) through a single, large-bore, femoral sheath. METHODS: Patients underwent TAVR with the Acurate neo or neo2 through a single femoral access at 4 centers. The large sheath was used for both the delivery catheter and the pigtail used to visualize the aortic root. RESULTS: A total of 157 patients (59% women) with a mean age of 82 ± 6 years underwent TAVR with the Acurate neo (n = 100) or the Acurate neo2 (n = 57). The procedure was successfully performed through a single large sheath in all patients. Median duration of hospitalization stay was 2 days (interquartile range, 1-3 days). On echocardiography before discharge, the mean gradient was 7 ± 3 mm Hg and 7 patients (4.4%) had more than mild paravalvular leak. At 30 days, a major vascular complication had occurred in 2 patients (1.3%), 2 patients (1.3%) had suffered a stroke, and only 4 patients (2.5%) had required new permanent pacemaker implantation. A total of 3 patients (1.9%) had died. CONCLUSIONS: An all-in-one access technique allows safe implantation of Acurate neo and neo2 transcatheter heart valves, with low rates of periprocedural complications and favorable short-term outcomes.

Recent Developments and Current Status of Transcatheter Aortic Valve Replacement Practice in Latin America - the WRITTEN LATAM Study. / Evolução e Estado Atual das Práticas de Implante Transcateter de Válvula Aórtica na América Latina ­ Estudo WRITTEN LATAM.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found. OBJECTIVE: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020. METHODS: A survey was applied to global TAVR centers between March and September 2015, and again to Latin-American centers between July 2019 and January 2020. The survey consisted of questions addressing: i) center's general information; ii) pre-TAVR evaluation; iii) procedural techniques; iv) post-TAVR management; v) follow-up. Answers from the 2015 survey of Latin-American centers (LATAM15) were compared with those of other centers around the world (WORLD15) and with the 2020 updated Latin-American survey (LATAM20). A 5% level of significance was adopted for statistical analysis. RESULTS: 250 centers participated in the 2015 survey (LATAM15=29; WORLD15=221) and 46 in the LATAM20. Combined centers experience accounted for 73 707 procedures, with WORLD15 centers performing, on average, 6- and 3-times more procedures than LATAM15 and LATAM20 centers, respectively. LATAM centers performed less minimalistic TAVR than WORLD15 centers, but there was a significant increase in less invasive procedures after 5 years in Latin-American centers. For postprocedural care, a lower period of telemetry and maintenance of temporary pacing wire, along with less utilization of dual antiplatelet therapy was observed in LATAM20 centers. CONCLUSION: Despite still having a much lower number of procedures, many aspects of TAVR practice in Latin-American centers have evolved in recent years, followingthe trend observed in developed country centers.

FUNDAMENTO: Implante transcateter de valva aórtica (TAVI) é um procedimento adotado em todo o mundo e suas práticas evoluem rapidamente. Variações regionais e temporais são esperadas. OBJETIVO: Comparar a prática de TAVI na América Latina com aquela no resto do mundo e avaliar suas mudanças na América Latina de 2015 a 2020. MÉTODO: A pesquisa foi realizada em centros de TAVI em todo o mundo entre março e setembro de 2015, e novamente nos centros latino-americanos entre julho de 2019 e janeiro de 2020. As seguintes questões foram abordadas: i) informação geral sobre os centros; ii) avaliação pré-TAVI; iii) técnicas do procedimento; iv) conduta pós-TAVI; v) seguimento. As respostas da pesquisa dos centros latino-americanos em 2015 (LATAM15) foram comparadas àquelas dos centros no resto do mundo (WORLD15) e ainda àquelas da pesquisa dos centros latino-americanos de 2020 (LATAM20). Adotou-se o nível de significância de 5% na análise estatística. RESULTADOS: 250 centros participaram da pesquisa em 2015 (LATAM15=29; WORLD15=221) e 46 na avaliação LATAM20. No total, foram 73.707 procedimentos, sendo que os centros WORLD15 realizaram, em média, 6 e 3 vezes mais procedimentos do que os centros LATAM15 e LATAM20, respectivamente. Os centros latino-americanos realizaram menor número de TAVI minimalista do que os do restante do mundo, mas aumentaram significativamente os procedimentos menos invasivos após 5 anos. Quanto à assistência pós-procedimento, observaram-se menor tempo de telemetria e de manutenção do marca-passo temporário, além de menor uso de terapia dupla antiplaquetária nos centros LATAM20. CONCLUSÃO: A despeito do volume de procedimentos ainda significativamente menor, muitos aspectos da prática de TAVI nos centros latino-americanos evoluíram recentemente, acompanhando a tendência dos centros dos países desenvolvidos.

Evolução e Estado Atual das Práticas de Implante Transcateter de Válvula Aórtica na América Latina - Estudo WRITTEN LATAM / Recent Developments and Current Status of Transcatheter Aortic Valve Replacement Practice in Latin America - the WRITTEN LATAM Study

Resumo Fundamento: Implante transcateter de valva aórtica (TAVI) é um procedimento adotado em todo o mundo e suas práticas evoluem rapidamente. Variações regionais e temporais são esperadas. Objetivo: Comparar a prática de TAVI na América Latina com aquela no resto do mundo e avaliar suas mudanças na América Latina de 2015 a 2020. Método: A pesquisa foi realizada em centros de TAVI em todo o mundo entre março e setembro de 2015, e novamente nos centros latino-americanos entre julho de 2019 e janeiro de 2020. As seguintes questões foram abordadas: i) informação geral sobre os centros; ii) avaliação pré-TAVI; iii) técnicas do procedimento; iv) conduta pós-TAVI; v) seguimento. As respostas da pesquisa dos centros latino-americanos em 2015 (LATAM15) foram comparadas àquelas dos centros no resto do mundo (WORLD15) e ainda àquelas da pesquisa dos centros latino-americanos de 2020 (LATAM20). Adotou-se o nível de significância de 5% na análise estatística. Resultados: 250 centros participaram da pesquisa em 2015 (LATAM15=29; WORLD15=221) e 46 na avaliação LATAM20. No total, foram 73.707 procedimentos, sendo que os centros WORLD15 realizaram, em média, 6 e 3 vezes mais procedimentos do que os centros LATAM15 e LATAM20, respectivamente. Os centros latino-americanos realizaram menor número de TAVI minimalista do que os do restante do mundo, mas aumentaram significativamente os procedimentos menos invasivos após 5 anos. Quanto à assistência pós-procedimento, observaram-se menor tempo de telemetria e de manutenção do marca-passo temporário, além de menor uso de terapia dupla antiplaquetária nos centros LATAM20. Conclusão: A despeito do volume de procedimentos ainda significativamente menor, muitos aspectos da prática de TAVI nos centros latino-americanos evoluíram recentemente, acompanhando a tendência dos centros dos países desenvolvidos.

Abstract Background: Transcatheter aortic valve replacement (TAVR) is a worldwide adopted procedure with rapidly evolving practices. Regional and temporal variations are expected to be found. Objective: To compare TAVR practice in Latin America with that around the world and to assess its changes in Latin America from 2015 to 2020. Methods: A survey was applied to global TAVR centers between March and September 2015, and again to Latin-American centers between July 2019 and January 2020. The survey consisted of questions addressing: i) center's general information; ii) pre-TAVR evaluation; iii) procedural techniques; iv) post-TAVR management; v) follow-up. Answers from the 2015 survey of Latin-American centers (LATAM15) were compared with those of other centers around the world (WORLD15) and with the 2020 updated Latin-American survey (LATAM20). A 5% level of significance was adopted for statistical analysis. Results: 250 centers participated in the 2015 survey (LATAM15=29; WORLD15=221) and 46 in the LATAM20. Combined centers experience accounted for 73 707 procedures, with WORLD15 centers performing, on average, 6- and 3-times more procedures than LATAM15 and LATAM20 centers, respectively. LATAM centers performed less minimalistic TAVR than WORLD15 centers, but there was a significant increase in less invasive procedures after 5 years in Latin-American centers. For postprocedural care, a lower period of telemetry and maintenance of temporary pacing wire, along with less utilization of dual antiplatelet therapy was observed in LATAM20 centers. Conclusion: Despite still having a much lower number of procedures, many aspects of TAVR practice in Latin-American centers have evolved in recent years, followingthe trend observed in developed country centers.

Interplay between climate, pollution and COVID-19 on ST-elevation myocardial infarction in a large metropolitan region.

BACKGROUND: Collective risk factors such as climate and pollution impact on the risk of acute cardiovascular events, including ST-elevation myocardial infarction (STEMI). There is limited data however on the precise temporal and independent association between these factors and STEMI, and the potentially interacting role of government policies against Coronavirus disease 2019 (COVID-19), especially for Latin America. METHODS: We retrospectively collected aggregate data on daily STEMI admissions at 10 tertiary care centers in the Buenos Aires metropolitan area, Argentina, from January 1, 2017 to November 30, 2020. Daily measurements for temperature, humidity, atmospheric pressure, wind direction, wind speed, and rainfall, as well as carbon monoxide (CO), nitrogen dioxide, and particulate matter <10 µm (PM10), were retrieved. Exploratory analyses focused on key COVID-19-related periods (e.g. first case, first lockdown), and Stringency Index quantifying the intensity of government policy response against COVID-19. RESULTS: A total of 1498 STEMI occurred over 1430 days, for an average of 0.12 STEMI per center (decreasing from 0.130 in 2018 to 0.102 in 2020, P=0.016). Time series analysis showed that lower temperature and higher concentration of CO and PM10 were all significantly associated with an increased rate of STEMI (all P<0.05), whereas COVID-19 outbreak, lockdown, and stringency of government policies were all inversely associated with STEMI (all P<0.05). Notably, environmental features impacted as early as 28 days before the event (all P<0.05), even if same or prior day associations proved stronger (all P<0.05). Multivariable analysis suggested that maximum temperature (P=0.001) and PM10 (P=0.033) were the strongest predictor of STEMI, even after accounting for COVID-19-related countermeasures (P=0.043). CONCLUSIONS: Lower temperature and higher concentrations of CO and PM10 are associated with significant increases in the rate of STEMI in a large Latin American metropolitan area. The reduction in STEMI cases seen during the COVID-19 pandemic is at least in part mediated by improvements in pollution, especially reductions in PM10.

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.

Impact of Cusp-Overlap View for TAVR with Self-Expandable Valves on 30-Day Conduction Disturbances.

METHODS AND RESULTS: We retrospectively compared 257 consecutive patients undergoing TAVR with self-expandable valves using either CON (n = 101) or COVL (n = 156) in four intermediate/low volume centers. There were no significant differences in baseline characteristics between the groups. The 30-day incidence of new-onset LBBB (12.9% vs. 5.8%; p=0.05) and PPMI rate (17.8% vs. 6.4%; p=0.004) was significantly lower when using the COVL implantation view. There was no difference between the CON and COVL groups in 30-day incidence of death (4.9% vs. 2.6%), any stroke (0% vs. 0.6%), and the need for surgical aortic valve replacement (0% for both groups). CONCLUSION: Using the COVL view for implantation, we achieved a significant reduction of the LBBB and PPMI rate after TAVR in comparison with the traditional CON view, without compromising the TAVR outcomes when using self-expandable prostheses.

Impacto de la técnica de Cusp-Overlap en el requerimiento de marcapasos luego de un implante valvular aórtico percutáneo / Impact of Cusp-Overlap Technique on Pacemaker Requirement after Transcatheter Aortic Valve Implantation

RESUMEN Introducción: Las bradiarritmias persistentes que requieren el implante de un marcapasos definitivo son una complicación frecuente tras el implante valvular aórtico percutáneo (IVAP), pero un implante alto con técnica Cusp-Overlap podría evitar las alteraciones del sistema de conducción. Objetivo: El objetivo fue determinar la tasa de uso de marcapasos en pacientes que recibieron IVAP con la técnica convencional coplanar en comparación con Cusp-Overlap. Material y métodos: Entre 2017 y 2019 se analizaron 65 pacientes consecutivos de dos centros, que recibieron válvulas EvolutR o Evolut-Pro: 50 implante coplanar y 15 Cusp-Overlap. Resultados: La edad promedio era 80 años y no hubo diferencias en el riesgo por puntaje EuroSCORE. Los procedimientos con la técnica de Cusp-Overlap presentaron 0% de requerimiento de marcapasos en comparación con 24,9% en el implante convencional (p = 0,041). También hubo menos complicaciones mayores (6,67% vs 42%; OR = 0,09; IC 95% 0,01-0,8; p = 0,011). Conclusiones: En esta cohorte el IVAP con la técnica de Cusp-Overlap se asoció con una necesidad de marcapasos nula. Dado el potencial impacto a gran escala se necesita validar externamente los resultados obtenidos.

ABSTRACT Background: Persistent bradyarrhythmias requiring permanent pacemaker implantation are a common complication after transcatheter aortic valve implantation (TAVI), but high implantation with cusp-overlap technique could prevent conduction system disturbances. Objective: The aim of this study was to assess the rate of pacemaker use in patients who received TAVI with conventional coplanar technique compared with cusp-overlap technique. Methods: A total of 65 consecutive patients from two centers receiving Evolut-R or Evolut-Pro valve implantation, 50 coplanar and 15 cusp-overlap, were analyzed between 2017 and 2019. Results: Mean age was 80 years, and there were no differences in risk according to the EuroSCORE. The rate of pacemaker requirement was 0% in cusp-overlap procedures compared with 24.9% in those with conventional implantation; p=0.041). In addition, cusp-overlap implants presented lower rate of major complications (6.67% vs. 42%; OR=0.09; 95% CI 0.01-0.8; p=0.011). Conclusions: In this cohort, TAVI procedure with cusp-overlap technique was associated with null pacemaker requirement. Given the potential large-scale impact, external validation of results is needed.

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.

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.

The Ibero-American transcatheter aortic valve implantation registry with the CoreValve prosthesis. Early and long-term results.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is the recommended therapy for patients with severe aortic stenosis who are not suitable candidates for surgery. The aim of this study was to describe early experience and long-term follow-up with the CoreValve self-expanding aortic prosthesis at 42 Ibero-American hospitals. METHODS: Multiple centre observational study including 1220 consecutive patients with symptomatic severe aortic stenosis who are not suitable candidates for surgery and underwent transcatheter aortic valve implantation with the self-expanding Medtronic CoreValve System between December 2007 and May 2012. RESULTS: The registry included 1220 consecutive patients with a mean age of 80.8 ± 6.3 years and a mean logistic euroSCORE of 17.8% ± 13%. The procedural success rate was 96.1%. Hospital mortality was 7.3% and combined end-point was 21.3%. Aortic regurgitation after TAVI was present in 24.5% (Sellers grade ≥ 2). The estimated 1-year and 2-year survival rates were 82.1% and 73.4% respectively. The following issues were significant independent risk factors for hospital mortality: acute kidney failure (odds ratio 3.55); stroke (odds ratio 5.72); major bleeding (odds ratio 2.64) and euroSCORE (odds ratio 1.02). Long-term predictors of mortality were diabetes mellitus (hazard ratio 1.59, 95% confidence interval 1.09-2.31), severe chronic obstructive pulmonary disease (hazard ratio 1.85, 95% confidence interval 1.85-2.88), and functional classes NYHA III-IV (hazard ratio 1.31, 95% confidence interval 1.01-1.70). CONCLUSIONS: Transcatheter aortic valve implantation constitutes a safe and viable therapeutic option for high operative risk patients with severe aortic stenosis. Long-term prognosis is conditioned by associate comorbidities.

Problemas y soluciones en la implementación de un Programa de Implante Valvular Aórtico Percutáneo / Problems and Solutions in the Implementation of a Transcatheter Aortic Valve Implantation Program

Introducción La sobrevida de la estenosis aórtica grave sintomática inoperable es baja. El implante percutáneo de válvula aórtica (IVAP) representa una alternativa para estos pacientes. Es nuestra práctica que los candidatos a IVAP ingresen en un programa de evaluación (Programa de IVAP) para determinar su elegibilidad clínica para, luego, solicitar la aprobación a la cobertura de salud. Objetivos Evaluar las causas de la exclusión de pacientes del procedimiento y su impacto clínico. Material y métodos Desde abril de 2009 hasta agosto de 2011, 37 pacientes ingresaron en el Programa de IVAP. Resultados De los 37 pacientes, 29 recibieron el tratamiento o fueron descartados: 14 fueron sometidos a IVAP (grupo IVAP, 48,3%) y 15 fueron descartados (grupo no IVAP 52,7%). Del grupo no IVAP, seis pacientes (40%) fueron descartados por el Programa y cuatro por la cobertura médica, mientras que otros cinco pacientes fallecieron aguardando la autorización. La mediana de EuroSCORE de la población fue del 22% (rango 10-56%) y el promedio de edad fue de 79 ± 8 años. En un seguimiento de 12 meses, la mortalidad del grupo IVAP y no IVAP fue del 7,1% y del 33,3%, respectivamente (p = 0,082). La mortalidad cardiovascular total fue del 17,2%, en todos los casos del grupo no IVAP. Conclusión En nuestro medio, más de la mitad de los pacientes evaluados en un Programa de IVAP no son intervenidos. Razones médicas y socioeconómicas inciden en la toma de decisiones y en la realización o no del IVAP, observándose una mortalidad importante en los pacientes no tratados.

Background Survival of severe symptomatic aortic valve replacement in patients who are not candidates for cardiac surgery is low. Transcatheter aortic valve implantation (TAVI) represents an alternative for these patients. Candidates for TAVI are evaluated in our TAVI Program, firstly to determine if they are clinically eligible and secondly to request the health medical coverage the authorization of the procedure. Objectives To evaluate the reasons for the exclusion of patients from the procedure and its clinical impact. Methods From April 2009 to August 2011, 37 patients were admitted in the TAVI Program. Results From the original 37 patients, 29 were divided into two groups: TAVI group (14 patients undergoing the procedure, 48.3%) and no TAVI group (15 patients rejected for the procedure, 52.7%). In the no TAVI group, six patients (40%) were rejected by the Program and four by the medical coverage, while other five died waiting for the authorization. Median EuroSCORE was of 22% (range 10-56%) and mean age was 79±8 years. After 12 months of follow-up, mortality in the TAVI group and no TAVI group was 7.1% and 33.3%, respectively (p=0.082). Overall cardiovascular mortality was of 17.2%, in all the cases in the no TAVI group. Conclusion In our environment, more than half of the patients evaluated in a TAVI Program do not undergo the procedure. Medical and social and economic reasons influence the decision-making process and carrying out TAVI, with an important mortality in untreated patients.

Problemas y soluciones en la implementación de un Programa de Implante Valvular Aórtico Percutáneo / Problems and Solutions in the Implementation of a Transcatheter Aortic Valve Implantation Program

Introducción La sobrevida de la estenosis aórtica grave sintomática inoperable es baja. El implante percutáneo de válvula aórtica (IVAP) representa una alternativa para estos pacientes. Es nuestra práctica que los candidatos a IVAP ingresen en un programa de evaluación (Programa de IVAP) para determinar su elegibilidad clínica para, luego, solicitar la aprobación a la cobertura de salud. Objetivos Evaluar las causas de la exclusión de pacientes del procedimiento y su impacto clínico. Material y métodos Desde abril de 2009 hasta agosto de 2011, 37 pacientes ingresaron en el Programa de IVAP. Resultados De los 37 pacientes, 29 recibieron el tratamiento o fueron descartados: 14 fueron sometidos a IVAP (grupo IVAP, 48,3%) y 15 fueron descartados (grupo no IVAP 52,7%). Del grupo no IVAP, seis pacientes (40%) fueron descartados por el Programa y cuatro por la cobertura médica, mientras que otros cinco pacientes fallecieron aguardando la autorización. La mediana de EuroSCORE de la población fue del 22% (rango 10-56%) y el promedio de edad fue de 79 ± 8 años. En un seguimiento de 12 meses, la mortalidad del grupo IVAP y no IVAP fue del 7,1% y del 33,3%, respectivamente (p = 0,082). La mortalidad cardiovascular total fue del 17,2%, en todos los casos del grupo no IVAP. Conclusión En nuestro medio, más de la mitad de los pacientes evaluados en un Programa de IVAP no son intervenidos. Razones médicas y socioeconómicas inciden en la toma de decisiones y en la realización o no del IVAP, observándose una mortalidad importante en los pacientes no tratados.(AU)

Background Survival of severe symptomatic aortic valve replacement in patients who are not candidates for cardiac surgery is low. Transcatheter aortic valve implantation (TAVI) represents an alternative for these patients. Candidates for TAVI are evaluated in our TAVI Program, firstly to determine if they are clinically eligible and secondly to request the health medical coverage the authorization of the procedure. Objectives To evaluate the reasons for the exclusion of patients from the procedure and its clinical impact. Methods From April 2009 to August 2011, 37 patients were admitted in the TAVI Program. Results From the original 37 patients, 29 were divided into two groups: TAVI group (14 patients undergoing the procedure, 48.3%) and no TAVI group (15 patients rejected for the procedure, 52.7%). In the no TAVI group, six patients (40%) were rejected by the Program and four by the medical coverage, while other five died waiting for the authorization. Median EuroSCORE was of 22% (range 10-56%) and mean age was 79±8 years. After 12 months of follow-up, mortality in the TAVI group and no TAVI group was 7.1% and 33.3%, respectively (p=0.082). Overall cardiovascular mortality was of 17.2%, in all the cases in the no TAVI group. Conclusion In our environment, more than half of the patients evaluated in a TAVI Program do not undergo the procedure. Medical and social and economic reasons influence the decision-making process and carrying out TAVI, with an important mortality in untreated patients.(AU)

Curva de aprendizaje en el tratamiento percutáneo de las lesiones carotídeas / Learning curve during percutaneous treatment of carotid lesions

Introducción La angioplastia transluminal percutánea (ATP) carotídea con implante de stent es un procedimiento eficaz en la prevención del accidente cerebrovascular (ACV) de tipo isquémico, pero su morbimortalidad periprocedimiento aún es discutida. Objetivo Comunicar los resultados de una serie prospectiva de pacientes tratados con ATP. Material y métodos Estudio descriptivo, observacional y prospectivo de la base de datos de tres centros de Hemodinamia de la Ciudad de Buenos Aires, en el que se incluyeron todos los pacientes sometidos a ATP carotídea desde enero de 1998 a noviembre de 2010. Se analizaron los resultados de las ATP realizadas por un mismo operador. Resultados La edad media fue de 69 años, el 58% de los pacientes eran hombres, el 58,8% tabaquistas, el 52% dislipidémicos, el 79,1% hipertensos y el 28% diabéticos. El 19,4% y el 11,6% tenían historia previa de infarto y cirugía coronaria, respectivamente. Desde 1998 hasta 2004 (etapa inicial, n = 54) hubo un 72% de pacientes sintomáticos con indicación de revascularización; en esta etapa no se utilizó sistema de protección cerebral. En la etapa más contemporánea (2004-2010, n = 171), sólo el 17,5% fueron sintomáticos y el uso de sistema de protección cerebral fue sistemático. Se observó una tasa similar de éxito angiográfico en las dos etapas (inicial 96% vs. contemporánea 97%), en tanto que la tasa de éxito clínico de la etapa contemporánea fue superior a la obtenida en la etapa inicial (96,1% vs. 87%; p = 0,016). No se observaron complicaciones cardiológicas. La tasa de muerte o ACV intrahospitalario fue del 4%, del 4,3% (3/70) en los sintomáticos y del 3,2% (5/155) en los asintomáticos; esta tasa fue mayor en la etapa inicial que en la contemporánea 11,1% (6/54) vs. 1,7% (2/171); p = 0,0028. Conclusión La ATP representa una alternativa terapéutica de aceptable seguridad, siempre que sea realizada por operadores experimentados.

Learning curve during percutaneous treatment of carotid lesions Background Percutaneous transluminal carotid angioplasty (PTCA) with stent implantation is an effective procedure for the prevention of ischemic stroke (IS) but its periprocedural morbimortality is still subject to debate. Objective The aim of this study is to report the results of a prospective series of patients treated with PTCA. Methods This is a descriptive, observational, prospective study using the database of three Hemodynamic centers in Buenos Aires, which included all patients submitted to PTCA from January 1998 to December 2010. The results of PTCA performed by the same operator were analyzed. Results Mean age was 69 years, 58% of the patients were men, 58.8% were smokers, 52% had dyslipidemia, 79.1% were hypertensive, and 28% had diabetes. Prior history of acute myocardial infarction and coronary surgery was present in 19.4 and 11.6% of the patients, respectively. From 1998 to 2004 (initial stage, n=54) 72% of symptomatic patients had indication of revascularization, which was performed without cerebral protection in all cases. During the most recent stage (2004-2010, n=171), only 17.5% of the patients were symptomatic and revascularization was performed systematically with cerebral protection. Similar angiographic success was obtained in both stages (initial 96% vs. recent 97%), whereas clinical success rate was greater in the recent phase (96.1% vs. 87%, p=0.016). There were no cardiac complications. The death rate or intrahospital stroke was 4%, 4.3% (3/70) in symptomatic and 3.2% (5/155) in asymptomatic patients; moreover, this rate was higher in the initial than in the recent phase (11.1% 6/54 vs. 1.7% 2/171, p=0.0028). Conclusions PTCA represents an acceptably safe therapeutic alternative to surgical revascularization, providing the procedure is performed by experienced operators.

Curva de aprendizaje en el tratamiento percutáneo de las lesiones carotídeas / Learning curve during percutaneous treatment of carotid lesions

Introducción La angioplastia transluminal percutánea (ATP) carotídea con implante de stent es un procedimiento eficaz en la prevención del accidente cerebrovascular (ACV) de tipo isquémico, pero su morbimortalidad periprocedimiento aún es discutida. Objetivo Comunicar los resultados de una serie prospectiva de pacientes tratados con ATP. Material y métodos Estudio descriptivo, observacional y prospectivo de la base de datos de tres centros de Hemodinamia de la Ciudad de Buenos Aires, en el que se incluyeron todos los pacientes sometidos a ATP carotídea desde enero de 1998 a noviembre de 2010. Se analizaron los resultados de las ATP realizadas por un mismo operador. Resultados La edad media fue de 69 años, el 58% de los pacientes eran hombres, el 58,8% tabaquistas, el 52% dislipidémicos, el 79,1% hipertensos y el 28% diabéticos. El 19,4% y el 11,6% tenían historia previa de infarto y cirugía coronaria, respectivamente. Desde 1998 hasta 2004 (etapa inicial, n = 54) hubo un 72% de pacientes sintomáticos con indicación de revascularización; en esta etapa no se utilizó sistema de protección cerebral. En la etapa más contemporánea (2004-2010, n = 171), sólo el 17,5% fueron sintomáticos y el uso de sistema de protección cerebral fue sistemático. Se observó una tasa similar de éxito angiográfico en las dos etapas (inicial 96% vs. contemporánea 97%), en tanto que la tasa de éxito clínico de la etapa contemporánea fue superior a la obtenida en la etapa inicial (96,1% vs. 87%; p = 0,016). No se observaron complicaciones cardiológicas. La tasa de muerte o ACV intrahospitalario fue del 4%, del 4,3% (3/70) en los sintomáticos y del 3,2% (5/155) en los asintomáticos; esta tasa fue mayor en la etapa inicial que en la contemporánea 11,1% (6/54) vs. 1,7% (2/171); p = 0,0028. Conclusión La ATP representa una alternativa terapéutica de aceptable seguridad, siempre que sea realizada por operadores experimentados.(AU)

Learning curve during percutaneous treatment of carotid lesions Background Percutaneous transluminal carotid angioplasty (PTCA) with stent implantation is an effective procedure for the prevention of ischemic stroke (IS) but its periprocedural morbimortality is still subject to debate. Objective The aim of this study is to report the results of a prospective series of patients treated with PTCA. Methods This is a descriptive, observational, prospective study using the database of three Hemodynamic centers in Buenos Aires, which included all patients submitted to PTCA from January 1998 to December 2010. The results of PTCA performed by the same operator were analyzed. Results Mean age was 69 years, 58% of the patients were men, 58.8% were smokers, 52% had dyslipidemia, 79.1% were hypertensive, and 28% had diabetes. Prior history of acute myocardial infarction and coronary surgery was present in 19.4 and 11.6% of the patients, respectively. From 1998 to 2004 (initial stage, n=54) 72% of symptomatic patients had indication of revascularization, which was performed without cerebral protection in all cases. During the most recent stage (2004-2010, n=171), only 17.5% of the patients were symptomatic and revascularization was performed systematically with cerebral protection. Similar angiographic success was obtained in both stages (initial 96% vs. recent 97%), whereas clinical success rate was greater in the recent phase (96.1% vs. 87%, p=0.016). There were no cardiac complications. The death rate or intrahospital stroke was 4%, 4.3% (3/70) in symptomatic and 3.2% (5/155) in asymptomatic patients; moreover, this rate was higher in the initial than in the recent phase (11.1% 6/54 vs. 1.7% 2/171, p=0.0028). Conclusions PTCA represents an acceptably safe therapeutic alternative to surgical revascularization, providing the procedure is performed by experienced operators.(AU)

Evolución alejada de la enfermedad renovascular aterosclerótica en pacientes sometidos a angioplastia / Long-Term Outcome of Atherosclerotic Renovascular Disease in Patients Treated with Angioplasty

Introducción El actual incremento en el diagnóstico de la enfermedad renovascular aterosclerótica (ERA) deviene del progresivo reconocimiento de su impacto clínico. El papel de la angioplastia renal percutánea como tratamiento alternativo ha motivado, y continúa haciéndolo, múltiples ensayos clínicos. Objetivos Analizar una población sometida a angioplastia renal percutánea y evaluar la seguridad del procedimiento y la respuesta clínica alejada. Material y métodos Se incluyeron en forma retrospectiva y consecutiva 100 pacientes intervenidos percutáneamente. Se realizó un seguimiento telefónico o por visitas (mediana 1,7 años; rango intercuartil 25-75, 1,2-2,7 años) durante el cual se recolectaron los datos clínicos y de laboratorio. Resultados Se analizaron 100 pacientes, la mayoría de sexo masculino (72%), edad media de 67,3 ± 9,9 años, con múltiples factores de riesgo cardiovascular (HTA 95%, DLP 74%, TBQ 63%, DM 28%) y amplio compromiso vascular aterosclerótico (enfermedad coronaria 56%, enfermedad vascular periférica 39%). Se realizó angioplastia con stent en el 98% de los casos, el 22% en forma bilateral, con un éxito del 99%. Se observó un descenso significativo de la tensión arterial sistólica (TAS) en el seguimiento alejado (TAS preprocedimiento 139,7 ± 24,2 mm Hg - TAS posprocedimiento 129,7 ± 13,9 mm Hg; p < 0,05), así como una reducción del número de drogas indicadas (2,8 ± 1,03 - 1,7 ± 0,9; p = 0,02). Estos resultados beneficiosos fueron incluso mayores en pacientes con compromiso bilateral. En relación con la función renal, el 49% de los pacientes evidenciaron una mejoría sostenida (depuración de creatinina: 53,6± 18,4 ml/min basal vs. 60,8 ± 19,5 ml/min al seguimiento; p = 0,011), mientras que el 20,4% presentó un deterioro importante en el filtrado glomerular. La mejoría en el filtrado glomerular fue más frecuente en pacientes con deterioro crónico avanzado (70,5% estadios ≥ III vs. 13,5% estadios 0-II; p = 0,01) y con angioplastia renal bilateral (depuración de creatinina: 52,8 ± 25,3 ml/min basal vs. 66,1 ± 15,1 ml/min al seguimiento; p = 0,032). En el análisis multivariado, la enfermedad renal grado ≥ III (OR 29,6, IC 95% 8,3-105,8; p > 0,001) y el sexo masculino (OR 16,2, IC 95% 4,3-105,8; p > 0,001) fueron predictores independientes de mejoría del filtrado glomerular en el seguimiento. Conclusiones El tratamiento percutáneo de la enfermedad renovascular es una alternativa terapéutica complementaria de elevada seguridad y buena evolución alejada en pacientes de riesgo alto. Se destaca asimismo el beneficio de la ATR en pacientes con deterioro renal basal importante, a pesar de una revascularización tardía.

Background The current increase in the diagnosis of atherosclerotic renovascular disease (ARD) results from the progressive recognition of its clinical impact. The role of percutaneous renal angioplasty as alternative therapy has been motivating several clinical trials. Objectives To analyze a population undergoing percutaneous renal angioplasty, and to assess the safety of the procedure and the long-term clinical response. Material and Methods A retrospective study of 100 consecutive patients treated with percutaneous surgery. Follow-up visits or telephone calls (median 1.7 years; interquartile range 25-75, 1.2-2.7 years) were performed, during which clinical and laboratory data were collected. Results A total of 100 patients were analyzed, most of them male subjects (72%), mean age of 67.3±9.9 years, with multiple cardiovascular risk factors (HBP 95%, DLP 74%, smoking 63%, DM 28%) and extensive atherosclerotic vascular involvement (coronary heart disease 56%, peripheral vascular disease 39%). Angioplasty with stent-graft was performed in 98% of the patients, 22% bilaterally, with a success rate of 99%. A significant reduction of systolic blood pressure (SBP) was observed at long-term follow up (preprocedural SBP 139.7±24.2 mm Hg - preprocedural SBP 129.7±13.9 mm Hg; p <0.05), and a reduction in the number of drugs indicated (2.8±1.03 - 1.7±0.9; p=0.02). These beneficial outcomes were even greater in patients with bilateral involvement. Regarding renal function, 49% of the patients showed sustained improvement (creatinine clearance: 53.6±18.4 ml/min basal vs. 60.8±19.5 ml/min at follow up; p=0.011), whereas 20.4% showed significant impairment in glomerular filtration. Improvement in glomerular filtration was more common in patients with advanced chronic impairment (70.5% stages ≥III vs. 13.5% stages 0-II; p=0.01) and with bilateral renal angioplasty (creatinine clearance: 52.8±25.3 ml/min basal vs. 66.1±15.1 ml/min at follow up; p=0.032). In multivariate analysis, renal disease degree ≥III (OR 29.6, CI 95% 8.3-105.8; p >0.001) and male sex (OR 16.2, CI 95% 4.3-105.8; p >0.001) were independent predictors of improved glomerular filtration at follow up. Conclusions Percutaneous treatment of renovascular disease is an additional therapeutic option, highly safe and with positive long-term outcomes in high risk patients. Benefits of the TRA in patients with significant baseline renal impairment should also be pointed out, despite the late revascularization.

Gradientes intraventriculares e qualidade de vida no acompanhamento a longo prazo da redução não-cirúrgica do septo intraventricular na cardiomiopatia hipertrófica obstrutiva / Intraventricular gradients and quality of life in the long-term follow-up of nonsurgical intraventricular septum reduction in patients with hypertrophic cardiomyopathy

Introdução: Cerca de 30% dos pacientes com cardiomiopatia hipertrófica obstrutiva têm uma obstrução dinâmica do trato de saída do ventrículo esquerdo (TSVE). Pacientes sintomáticos são tratados com agentes inotrópicos negativos, entretanto alguns pacientes não respondem à terapia medicamentosa. A miectomia cirúrgica foi, até a década de 1990, o tratamento padrão para esses pacientes. A ablação septal percutânea com álcool (ASA) foi introduzida como terapia alternativa menos invasiva. Este estudo teve como objetivo avaliar a evolução clínica de pacientes submetidos a ASA em nosso centro.Método: Foram incluídos sete pacientes com cardiomiopatia hipertrófica obstrutiva, analisando-se os sintomas, os gradientes intraventriculares e a qualidade de vida antes e depois da ASA. O acompanhamento médio foi de 3,3 + 1,8 anos. Resultados: Houve melhora significativa da classe da New York Heart Association (NYHA) durante o acompanhamento clínico. O gradiente médio do TSVE antes da ASA, em repouso, foi de 67 + 22 mmHg, e com a manobra de Valsalva foi de 131 + 27 mmHg. Na evolução tardia, o gradiente médio do TSVE, em repouso, foi de 33 + 37 mmHg e com a manobra de Valsalva, 37 + 47 mmHg. O consumo máximo de oxigênio foi de 14,7 ml/min antes da ASA e durante o acompanhamento aumentou para 25,4 ml/min. Conclusão: Em nosso estudo, a ASA foi um tratamento seguro e eficaz para a cardiomiopatia hipertrófica obstrutiva, propiciando alívio substancial dos sintomas e da obstrução do trato de saída, e melhora da capacidade de exercício e da qualidade de vida, com baixas taxas de complicações.

Background: About 30% of patients with hypertrophic obstructive cardiomyopathy (HOCM) have dynamic obstruction of the left ventricular outflow tract (LVOT). Symptomaticpatients are treated with negative inotropic agents, however, some patients do not respond to medical therapy. Surgical myectomy was the standard therapy for these patients until the nineties. Percutaneous alcohol septal ablation (ASA) was introduced as a less invasive alternative therapy. This study was aimed at assessing the clinical course of patients undergoing ASA at our center. Method: Seven patients with HOCM were included and intraventricular gradients and quality of life before and after ASA were evaluated. Mean follow-up was 3.3 + 1.8 years. Results: There was a significant improvement in the NewYork Heart Association (NYHA) class during the followup. The mean LVOT gradient before ASA at rest was 67 +22 mmHg and 131 + 27 mmHg with Valsalva maneuver. In the late follow-up, the mean LVOT gradient at rest was33 + 37 mmHg and 37 + 47 mmHg with Valsalva maneuver. Peak oxygen uptake was 14.7 ml/min prior ASA, increasing to 25.4 ml/min during the follow-up. Conclusion: In our study, ASA was a safe and effective treatment for HOCM providing substantial relief of symptoms, outflow tract obstructionand improvement of exercise capacity and quality of life with low complication rates.

Reemplazo valvular aórtico percutáneo en pacientes de alto riesgo quirúrgico / Percutaneous Aortic Valve Replacement in High-Risk Patients

Una proporción importante de pacientes con estenosis aórtica (EAo) grave poseen comorbilidades que incrementan el riesgo de la cirugía de reemplazo valvular aórtico. El implante percutáneo de válvula protésica surge como una alternativa en este grupo de pacientes. Se comunican dos casos de pacientes de edad avanzada portadores de EAo grave a los que se les realizó con éxito el implante percutáneo de una prótesis valvular aórtica CoreValve y se describen los criterios para la selección de pacientes y la técnica de implante percutáneo.

A significant proportion of patients with severe aortic stenosis (AS) have comorbidities that increase the risk of surgical aortic valve replacement. Percutaneous implantation of an aortic valve prosthesis emerges as an alternative in this group of patients. We report two cases of elderly patients with severe aortic stenosis that underwent successful percutaneous implantation of CoreValve aortic valve prostheses; in addition, criteria for patient selection and the technique of the procedure are described.