Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry.

BACKGROUND: Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the postmarketing evaluation of coronary stents, but their scientific relevance remains debated. METHODS: We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n = 551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n = 35,389). All major events were adjudicated by an independent clinical event committee in both studies. Propensity weighted analysis was used to balance baseline and procedural differences between the 2 populations. RESULTS: Coronary artery disease was more complex in e-UM compared to CII-UM, including more acute coronary syndromes, multivessel disease, left main, arterial, or venous grafts, and chronic total occlusions (P < .005 for all). At one-year follow-up and after excluding periprocedural myocardial infarction (MI) there was no statistically significant difference between CII-UM and e-UM regarding all-cause death (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.26-1.20, P = .14), cardiac death (HR 0.71, 95% CI 0.29-1.72, P = .45), target lesion failure (HR 1.18, 95% CI 0.78-1.78, P = .44), and target vessel MI (HR 0.76, 95% CI 0.24-2.38, P = .63). However, target vessel revascularization rate was significantly higher in CII-UM than in e-UM, HR 1.78, 95% CI 1.23-2.56, P = .002. CONCLUSIONS: A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the postmarket performance of new coronary stents, across a wider range of uses and various geographic areas.

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.

Técnica minimalista para valvuloplastía aórtica percutánea / Minimally invasive balloon aortic valve valvuloplastyBackground

RESUMEN: ANTECEDENTES: La valvuloplastía aórtica es un procedimiento paliativo o como puente al reemplazo aórtico percutáneo o quirúrgico. Nuestro abordaje incluye una técnica minimalista y la utilización de balones de mayor tamaño que lo estándar. OBJETIVO: Evaluar los resultados clínicos inmediatos y alejados de pacientes tratados mediante esta técnica modificada. MÉTODOS: Se incluyó a todos los pacientes sometidos a balonplastía aórtica entre Julio del 2012 y Agosto del 2019 en nuestro centro. El procedimiento se realizó bajo sedación consciente mediante un único acceso femoral y sin instalación de un marcapasos transitorio. El éxito de la intervención se definió como caída de gradiente basal en 50% o más en ausencia de complicación mayor. RESULTADOS: Se realizaron un total de 52 procedimientos en 49 pacientes. La edad promedio fue 76 ± 9,9 años. Un tercio de los pacientes tenía una fracción de eyección del ventrículo izquierdo ≤35% y similar proporción tenía un perfil de riesgo STS score > 10 puntos. La duración total promedio fue de 31,1 + 10,0 min. Se utilizó un balón #28 en el 84.6% de los casos. El éxito del procedimiento se alcanzó en 94,2% de los casos. Ocurrieron 2 muertes intraoperatorias (3,9%), ambas en pacientes de muy alto riesgo y 2 (3,9%) complicaciones vasculares mayores. La sobreviva en el seguimiento alejado fue 32,7%. CONCLUSIÓN: La valvuloplastia aórtica percutánea con técnica modificada, utilizando balones de mayor tamaño que lo habitual, es una técnica segura que logra óptimos resultados hemodinámicos.

ABSTRACT: Aortic balloon valvuloplasty (ABV) is a palliative procedure or a bridge to percutaneous or surgical aortic valve replacement. Our group proposes a minimalist approach that reduces the use of resources and also stands out for using larger balloons. AIM: To assess the safety and the immediate results of patients undergoing aortic balloon valvuloplasty using a minimally invasive procedure. METHODS: All patients who underwent ballon aortic valvuloplasty (BAV) between July 2012 and Au- gust 2019 were included. The procedure was performed under conscious sedation using a single femoral access and without the installation of a temporary pacemaker. Success was defined as a 50% drop in the mean aortic gradient plus the absence of major complications. RESULTS: 52 procedures in 49 patients were performed; the average age was 76 ± 9,9 years. A third of patients included had a left ventricular ejection fraction ≤35% and a similar proportion had a high risk profile with an STS score> 10 points. A 28 mm balloon was used in 84.6% of cases. The procedure was successful in 94,2% of cases. There were 2 (3,85%) intraoperative deaths in very high-risk patients and 2 (3,85%) major vascular complications. The survival rate at late follow up was 32,7%. CONCLUSION: Aortic balloon valvuloplasty with a minimally invasive technique using larger than usual balloons is a safe technique that achieves optimal hemodynamic results.

Outcomes and regional differences in practice in a worldwide coronary stent registry.

OBJECTIVE: The primary objective was to assess the performance of a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer in an all comer population. The secondary objective was to detail differences in contemporary percutaneous coronary intervention (PCI) practice worldwide. METHODS: e-Ultimaster was an all-comer, prospective, global registry (NCT02188355) with independent event adjudication enrolling patients undergoing PCI with the study stent. The primary outcome measure was target lesion failure (TLF) at 1 year, defined as the composite of cardiac death, target vessel myocardial infarction and clinically driven target lesion revascularisation. Data were stratified according to 4 geographical regions. RESULTS: A total of 37 198 patients were enrolled (Europe 69.2%, Asia 17.8%, Africa/Middle East 6.6% and South America/Mexico 6.5%) and 1-year follow-up was available for 35 389 patients (95.1%). One-year TLF occurred in 3.2% of the patients, ranging from 2% (Africa/Middle East) to 4.1% (South America/Mexico). In patients with acute coronary syndrome, potent P2Y12 inhibitors were prescribed in 48% of patients at discharge, while at 1 year 72% were on any dual antiplatelet therapy. Lipid-lowering treatment was administered in 80.9% and 75.5% of patients at discharge and 1 year, respectively. Regional differences in the profile of the treated patients as well as in PCI practice were reported. CONCLUSIONS: In this investigation with worldwide representation, contemporary PCI using a new generation thin-strut sirolimus-eluting coronary stent with abluminal biodegradable polymer was associated with low 1-year TLF across clinical presentations and continents. Suboptimal adherence to current recommendations around antiplatelet and lipid lowering treatments was detected.

PRospective Observational Registry Evaluating the Safety and Effectivenessof Orsiro Stent in Chilean Patients - ROSES Registry.

BACKGROUND: There is little information on the performance of the new generation of stents with bioabsorbable polymers in the Latin American population. This registry aimed to further validate the safety and efficacy of the Orsiro bioresorbable-polymer sirolimus-eluting stent (BPSES) in unselected patients undergoing percutaneous coronary intervention (PCI) in Chilean centers. METHODS: We prospectively enrolled patients undergoing PCI with BPSES in 6 Chilean centers. The primary endpoint was defined as the composite of cardiac death, target vessel-related myocardial infarction (MI), and clinically driven target lesion revascularization at 1-year follow-up. RESULTS: From April 2017 to February 2019, 520 patients were enrolled in the registry, more frequently male (74.6%), with a mean age of 62.7 ± 10.8 years and a high prevalence of diabetes (40.2%). The clinical presentation was stable angina in 41.1% (n = 214), acute MI in 52.5% (n = 167 [32.1%] ST-elevation MI and n = 106 [20.4%] non-ST-elevation MI), and unstable angina in 6.3% (n = 33). Of 610 treated lesions, 425 (69.7%) were American College of Cardiology/American Heart Association type B or C lesions. Device and procedural success were achieved in 99.4% and 98.7% of the patients, respectively. The primary endpoint of the study occurred in 4%, primarily driven by cardiac death. CONCLUSIONS: The results of the ROSES multicenter registry indicated good clinical outcomes of BPSES Orsiro in all-comers Latin Americann patients undergoing PCI, despite the high-risk patients and treated lesions.

Repercusión de la pandemia COVID-19 en la práctica de la cardiología intervencional en Chile: datos aportados por la encuesta del grupo Stent-Save a Life! LATAM working group / Decrease in the activity of interventional cardiology in Chile: a report from the "Stent-Save a Life! LATAM working group"

RESUMEN: Introducción: El Stent-Save a Life! (SSL) LATAM working group diseñó una encuesta para objetivar la reducción de la actividad de los laboratorios de hemodinamia en Latinoamérica durante la pandemia COVID-19. Ante la amenaza de nuevos confinamientos en Chile, nos propusimos objetivar las consecuencias de la primera ola de contagios en nuestra actividad. Objetivos: Discutir la repercusión de la pandemia en la cardiología intervencional en Chile. Métodos: El grupo SSL realizó una encuesta telemática a todos los países de Latinoamérica incluido Chile. Se registraron las coronariografías (CAG), intervenciones coronarias percutáneas (ACTP) e intervenciones estructurales, comparando dos períodos determinados por el confinamiento por la pandemia, cada uno de dos semanas. Pre-COVID-19: período previo al confinamiento, y COVID-19: período durante el confinamiento. Se analizan, a partir de esta encuesta, los resultados aplicados a nuestro país. Resultados: Se obtuvo respuesta de trece centros. Hubo una reducción en el número global de procedimientos entre período Pre-COVID-19 y COVID-19 de un 65,1%. Se reportó una disminución de 67% en las CAG, de un 59,4% en las ACTP y de un 92% en los procedimientos terapéuticos estructurales. Entre ambos períodos se redujo la consulta por Síndrome Coronario Agudo por elevación del segmento ST (SCACEST) en 40,8%. Conclusiones: En nuestro país se objetivó una reducción marcada de la actividad asistencial de la cardiología intervencional durante la pandemia COVID-19 y una disminución significativa en el número de pacientes tratados por SCACEST. Los resultados de nuestro país son similares a los reportados por países de Latinoamérica, Europa y Norteamérica.

ABSTRACT: Background: The Stent-Save a Life! (SSL) LATAM working group designed a survey to demonstrate the reduction in the activity of cardiac catheterization laboratories in Latin America during the COVID-19 pandemic. Considering the risk of a new confinement in Chile, we decided to assess the impact of the first wave of contagions on our activity. Aims: To discuss the repercussion of the COVID-19 pandemic on the activity of interventional cardiology in Chile. Methods: The SSL group conducted a telematic survey in all Latin American countries. Coronary angiography, coronary interventions (PCI) and structural interventions were registered, comparing two periods of two weeks duration each: before and during COVID-19 confinement. Results obtained in Chile are analyzed. Results: Thirteen centers in Chile answered the survey. There was an overall decrease of 65.1% in the number of procedures between the pre and the post COVID-19 periods. Coronary angiographies decreased 67%, PCI 59.4% and therapeutical structural procedures 92%. The reduction in acute coronary syndrome with ST segment elevation (STEMI) was 40,8% between periods. Conclusions: In Chile, a significant reduction in healthcare activity related to interventional cardiology and a significant decrease in the number of patients treated with STEMI was observed during the COVID-19 pandemic. The results are similar to those reported by Latin American, European and North American countries.

Resultados clínicos del reemplazo valvular aórtico percutáneo con dispositivo balón expandible MyVal en estenosis aórtica severa de alto riesgo / Clinical results of percutaneous aortic valve replacement using the MyVal prosthesis in patients with severe aortice stenosis and hisgh surgical risk

INTRODUCCIÓN: El dispositivo MyVal balón-expandible (Meril Life Sciences, India) fue recientemente aprobado en Chile y la Unión Europea para uso comercial. El objetivo del presente estudio fue proveer datos de eficacia y seguridad temprana y de mediano plazo en pacientes portadores de estenosis aórtica (EA) severa de alto riesgo quirúrgico sometidos a reemplazo valvular aórtico percutáneo (RVAP) con dispositivo MyVal. MATERIAL Y MÉTODOS: Se enrolaron retrospectivamente todos los pacientes con EA severa sintomática de alto riesgo según criterio del ´heart team´ local, sometidos a RVAP usando prótesis MyVal en Hospital San Borja Arriarán. RESULTADOS: La población quedó compuesta por 14 sujetos tratados entre Octubre 2018 y Noviembre 2019. La población tuvo una edad media de 82,5±7,8 años y elevado perfil de riesgo (puntaje STS promedio 11,6±5,1% de mortalidad a 30 días). Se logró éxito de dispositivo y procedimiento en 12 pacientes (86%) con caída sustancial de la gradiente aórtica media, persistente a 6 meses de seguimiento sin insuficiencia aórtica más que leve. Ocurrió falla de dispositivo en 2 pacientes, una debida a falla de entrega y otra por embolización a ventrículo, esta última con resultado de muerte. En términos de complicaciones, ocurrió una muerte precoz atribuida a disección/ruptura de aorta y 2 hemorragias mayores. La tasa de marcapasos ascendió a 3 pacientes, 23% considerando todos quienes recibieron implante. CONCLUSIÓN: El presente registro cuestiona la seguridad de MyVal en el tratamiento percutáneo de la EA severa de alto riesgo. Sin embargo, una vez logrado un implante exitoso MyVal muestra adecuados parámetros de funcionamiento, persistentes a un plazo mediano de seguimiento.

BACKGROUND: The recently approved balloon expandable MyVal (Meril Life Sciences, India) transcatheter aortic valve replacement (TAVR) prosthesis is available for commercial use in Chile and the European Union. The aim of this study is to provide early and mid-term data on the safety and efficacy of patients with severe aortic stenosis (AS) at high surgical risk undergoing TAVR using the MyVal device. METHODS: All patients with symptomatic severe AS at high surgical risk undergoing intended TAVR with MyVal prosthesis at San Borja-Arriarán Hospital entered to a retrospective registry. RESULTS: Between October 2018 and November 2019, 14 patients entered to the registry. The mean age was 82.5±7.8 years-old with a high-surgical riskprofile (mean STS score of 11.6±5.1% for 30-day mortality). Device and procedural success were achieved in 12 patients (86%) with substantial decrease in the mean aortic gradient, persistent at 6 months follow-up, all with mild or trace aortic regurgitation. Device failure occurred in 2 patients, one due to failed delivery and other due to device embolization into the left ventricle, which resulted in patient death. There were one death attributed aortic dissection/rupture and two major bleeding episodes. Three patients receiving MyVal implant required the implantation of a permanent pacemaker (23%). CONCLUSION: The present registry rises a question upon the safety of the MyVal TAVR device in high-risk AS. However, once a successfully implant was achieved the MyVal prosthesis showed an adequate performance to mid-term follow-up.

Early Oxidative Stress Response in Patients with Severe Aortic Stenosis Undergoing Transcatheter and Surgical Aortic Valve Replacement: A Transatlantic Study.

Myocardial ischemia/reperfusion-related oxidative stress as a result of cardiopulmonary bypass is thought to contribute to the adverse clinical outcomes following surgical aortic valve replacement (SAVR). Although the acute response following this procedure has been well characterized, much less is known about the nature and extent of oxidative stress induced by the transcatheter aortic valve replacement (TAVR) procedure. We therefore sought to examine and directly compare the oxidative stress response in patients undergoing TAVR and SAVR. A total of 60 patients were prospectively enrolled in this exploratory study, 38 patients undergoing TAVR and 22 patients SAVR. Reduced and oxidized glutathione (GSH, GSSG) in red blood cells as well as the ferric-reducing ability of plasma (FRAP) and plasma concentrations of 8-isoprostanes were measured at baseline (S1), during early reperfusion (S2), and 6-8 hours (S3) following aortic valve replacement (AVR). TAVR and SAVR were successful in all patients. Patients undergoing TAVR were older (79.3 ± 9.5 vs. 74.2 ± 4.1 years; P < 0.01) and had a higher mean STS risk score (6.6 ± 4.8 vs. 3.2 ± 3.0; P < 0.001) than patients undergoing SAVR. At baseline, FRAP and 8-isoprostane plasma concentrations were similar between the two groups, but erythrocytic GSH concentrations were significantly lower in the TAVR group. After AVR, FRAP was markedly higher in the TAVR group, whereas 8-isoprostane concentrations were significantly elevated in the SAVR group. In conclusion, TAVR appears not to cause acute oxidative stress and may even improve the antioxidant capacity in the extracellular compartment.

State of Transcatheter Aortic Valve Implantation in Spain Versus Europe and Non-European Countries.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is now the standard treatment for severe aortic stenosis in high-risk symptomatic patients, and its indications are expanding to lower-risk patients. OBJECTIVES: The objective of this study was to analyze the state of TAVI in Spain vs other European and non-European countries. METHODS: Using an online questionnaire, we analyzed the routine practice of 250 TAVI centers worldwide. The questionnaire included 59 questions on patient selection, technical aspects of the procedure, and postprocedural management. The centers were divided into Spain (n = 41), rest of Europe (n = 105), and rest of the world (n = 104). RESULTS: The cumulative number of procedures (74; range, 40-122) and those performed in the last year (16.5; range, 15-29.5) in Spain, were significantly lower than the rest of Europe (P<.01) and the rest of the world (P<.01). The patient risk profile was higher, with an under-use of functional tests compared to the rest of the world. While the use of computed tomography to analyze the aortic annulus was lower in Spain (P<.001), general anesthesia and transesophageal echocardiography were more frequently used in Spain than in the rest of Europe (P<.001 for both). Dual-antiplatelet therapy is the most common post-TAVI antithrombotic therapy in the absence of an indication for anticoagulation, although its duration is longer in Spain (6 months) compared to European centers (3 months). CONCLUSIONS: Routine TAVI practice in Spain differed in some key aspects of preprocedural, intraprocedural, and postprocedural management. Future studies will help to unify strategies and assess their impact on clinical results.

Transcatheter Tricuspid Valve Implantation of NaviGate Bioprosthesis in a Preclinical Model.

Patients with isolated functional or recurrent tricuspid regurgitation are often denied surgery because they are considered to be at high risk. Transcatheter valve therapy provides a less invasive alternative for tricuspid regurgitation associated with right heart failure. We have evaluated the feasibility of transcatheter tricuspid valve implantation of the NaviGate valved stent in a long-term swine model. The valved stent was successfully implanted through transjugular and transatrial approaches on the beating heart with excellent hemodynamic and valve performance. No conduction disturbance or coronary obstruction was observed. This technology could provide an alternative treatment for patients who are at high surgical risk with severe tricuspid regurgitation and compromised right ventricular function.

Single trans-septal access technique for left atrial intracardiac echocardiography to guide left atrial appendage closure.

OBJECTIVE: This registry aimed to describe the safety and feasibility of a single trans-septal (TS) access technique for left intracardiac echocardiography (ICE) guidance of left-atrial appendage (LAA) closure procedure. BACKGROUND: LAA closure is currently accepted as an alternative to oral anticoagulation (OAC) in patients with non-valvular atrial fibrillation (NVAF) who are at high-risk for bleeding. Currently, LAA closure procedure is typically performed under trans-esophageal echocardiogram (TEE) guidance. Although, ICE has the advantage of not requiring profound sedation/anesthesia, ICE-LAA imaging quality is often limited from the right atrium requiring double TS access. METHODS: Twenty-two patients with NVAF underwent LAA closure using the Amplatzer Amulet™ device (St Jude Medical) under ICE guidance from the left atrium. The ICE AcuNav catheter (Biosense Webster) and the Amulet delivery sheath were advanced into the LA through single TS puncture technique. RESULTS: The population was predominately male (59.1%) with a mean age of 74 ± 9.3 years, at high-risk for stroke (mean CHADS2 score of 3.8 ± 1.1) and bleeding (mean HAS BLED score of 3.5 ± 1.3). The Amplatzer AmuletTM device was successfully implanted in all patients. No procedural related complications including device embolization were noted. No major cardiovascular events occurred and all patients were discharged alive. At 30-day follow-up all patients remained alive, free of ischemic stroke and with no residual leak or device thrombus on TEE. CONCLUSIONS: This initial experience suggests that LAA occlusion with the Amplatzer Amulet device using ICE guidance from the left atrium via a single trans-septal technique is feasible and safe.

Transcatheter mitral valve replacement with the NaviGate stent in a preclinical model.

AIMS: The aim of this study was to test the feasibility of transcatheter mitral valve implantation of the NaviGate device in acute and chronic preclinical models. METHODS AND RESULTS: We evaluated NaviGate valved stent implantation in the mitral position in an acute swine model (n=24, ≤5 days) through three different approaches - transatrial, transapical, and transseptal - and in a chronic swine model (n=12, >10 days) through a transatrial approach. The NaviGate implantation procedures were successful in 83% of the acute model studies (n=20) and 83% of the chronic model studies (n=10). Echocardiographic assessment showed low gradient across the valved stent (mean gradient <3 mmHg) and the left ventricular outflow tract (mean gradient <6 mmHg). Post implantation, there was no mitral regurgitation (MR) in 75% (n=15) of the acute studies and mild MR in 25% (n=5). In the chronic model, there was no MR in 60% (n=6) and mild MR in 40% (n=4). The implantation procedure was aborted in four acute studies due to inferior vena cava injury and in two chronic studies due to prosthesis-annulus mismatch. CONCLUSIONS: In preparation for clinical application, transcatheter mitral implantation of the NaviGate valved stent was proved feasible in acute and chronic preclinical models. The three featured delivery approaches are of particular value for high-risk patients with functional MR and challenging vascular access.

Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial.

OBJECTIVES: The aim of this study was to compare aspirin plus clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve replacement (TAVR) for the prevention of ischemic events, bleeding events, and death. BACKGROUND: Few data exist on the optimal antithrombotic therapy following TAVR. METHODS: This was a randomized controlled trial comparing aspirin (80 to 100 mg/day) plus clopidogrel (75 mg/day) (dual antiplatelet therapy [DAPT]) versus aspirin alone (single-antiplatelet therapy [SAPT]) in patients undergoing TAVR with a balloon-expandable valve. The primary endpoint was the occurrence of death, myocardial infarction (MI), stroke or transient ischemic attack, or major or life-threatening bleeding (according to Valve Academic Research Consortium 2 definitions) within the 3 months following the procedure. The trial was prematurely stopped after the inclusion of 74% of the planned study population. RESULTS: A total of 222 patients were included, 111 allocated to DAPT and 111 to SAPT. The composite of death, MI, stroke or transient ischemic attack, or major or life-threatening bleeding tended to occur more frequently in the DAPT group (15.3% vs. 7.2%, p = 0.065). There were no differences between groups in the occurrence of death (DAPT, 6.3%; SAPT, 3.6%; p = 0.37), MI (DAPT, 3.6%; SAT, 0.9%; p = 0.18), or stroke or transient ischemic attack (DAPT, 2.7%; SAPT, 0.9%; p = 0.31) at 3 months. DAPT was associated with a higher rate of major or life-threatening bleeding events (10.8% vs. 3.6% in the SAPT group, p = 0.038). There were no differences between groups in valve hemodynamic status post-TAVR. CONCLUSIONS: This small trial showed that SAPT (vs. DAPT) tended to reduce the occurrence of major adverse events following TAVR. SAPT reduced the risk for major or life-threatening events while not increasing the risk for MI or stroke. Larger studies are needed to confirm these results. (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation: The ARTE Trial [ARTE], NCT01559298; Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI [ARTE], NCT02640794).

Relationship of mitral valve annulus plane and circumflex-right coronary artery plane: Implications for Transcatheter Mitral Valve Implantation.

AIM: Transcatheter mitral valve implantation (TMVI) is a novel technology for patients with severe mitral valve disease but at high surgical risk. Imaging guidance during the procedure is critical for successful device deployment. Identification of the mitral annular plane (MAP) with fluoroscopy during the procedure is limited by lack of clearly defined landmarks. We hypothesized that a plane defined by left circumflex-right coronary arteries (LCX-RCA) would have a consistent relationship to MAP. METHODS AND RESULTS: We studied 25 patients with gated cardiac computed tomography. We identified the MAP and the LCX-RCA plane in mid systole and diastole. The distance between the two planes in prespecified four points (anterior, posterior, medial, and lateral) in the apical 2 and 3-chamber views. Alignment of the planes was described by cranial/caudal angulation for both planes in RAO 30° and LAO 90° (lateral) angulation. Mean age was 81 ± 9 years, 56% of patients had ≥2+ mitral regurgitation. In mid systole, the distances between the LCX-RCA plane and the MAP in the four points were < 5 mm in 92% of patients. In mid diastole, distances were < 5 mm in 100% of patients. In mid systole, the correlation between the caudal/cranial orientations of the 2 planes was 0.85 and 0.80 in the LAO 90° and RAO 30°, respectively (P = <0.001). In mid diastole, this was 0.92 and 0.92 in the LAO 90° and RAO 30°, respectively (P = <0.001). CONCLUSION: LCX-RCA plane has a close and consistent relationship to the MAP and can be useful to guide TMVI. Accurate imaging of mitral valve annular plane during TMVI procedure is challenging. MAP guided by fluoroscopy might be crucial to guide successful prosthesis deployment. A plane defined by the left circumflex- right coronary arteries in the atrioventricular grove has a consistent relationship with MAP; this can be used aided by pre-procedural MDCT to guide TMVI procedure. © 2016 Wiley Periodicals, Inc.

Evaluation of current practices in transcatheter aortic valve implantation: The WRITTEN (WoRldwIde TAVI ExperieNce) survey.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has been adopted worldwide as the standard treatment for severe aortic stenosis in symptomatic patients at prohibitive or high surgical risk, but there are still several areas where consensus and evidence are lacking. The purpose was to obtain a global view of current practice related to TAVI with the potential to identify the main areas of consensus and divergence between centers. METHODS: An online questionnaire was distributed in centers performing TAVI including a total of 59 questions concerning pre-procedural evaluation, procedural practices and post-procedural management. RESULTS: The survey was completed by 250 centers (with a cumulative experience of nearly 70,000 TAVI) from 38 different countries. Heart team meetings and surgical risk scores were routinely performed in most (>95%) centers, but frailty (44%) and quality of life (28%) assessments were less frequently performed. General anesthesia remained the most frequent type of anesthesia (60% of centers), and significant variability was detected in the examinations for residual aortic regurgitation assessment during the procedure and in post-procedural ECG monitoring and temporary pacemaker implementation (from none to ≥72h post-TAVI). Dual antiplatelet therapy duration post-TAVI was highly variable (1, 3, and ≥6months in 14%, 41% and 32% of centers, respectively) and lack of consensus in antithrombotic regimen was observed in patients with atrial fibrillation requiring anticoagulation therapy (anticoagulation alone, anticoagulation+aspirin, anticoagulation+clopidogrel, and triple therapy in 28%, 37%, 26% and 4% of centers, respectively). CONCLUSIONS: The WRITTEN survey provided extensive data on current TAVI-related practice and identified important differences between centers in key aspects of pre-, intra-, and post-operative management. This highlights the urgent need for further studies and evidence-based data to guide multiple aspects of the TAVI field.

Transfemoral implantation of CoreValve Evolut-R aortic prosthesis in patient with prior ball-cage mechanical mitral valve prosthesis.

Transcatheter aortic valve replacement remains challenge in patients with ball-cage-type mechanical valve in mitral position. Potential under-expansion of the percutaneous valve and interaction between the mitral ball-cage mechanical valve tilted towards the left ventricular outflow tract and the percutaneous valve adds risk during and after implantation. We report a successful implantation of the novel CoreValve Evolut-R self-expanding in a patient with severe aortic stenosis and a mitral Starr-Edwards mechanical valve implanted 28years ago.

Costo-efectividad de reemplazo valvular aórtico percutáneo vs terapia conservadora en la estenosis aórtica de muy alto riesgo en un centro terciario chileno / Cost-effectiveness of trans aortic valve replacement vs. conservative treatment in high-risk patients with severe aortic stenosis in a referral hospital center in Santiago, Chile

Introducción: El objetivo fue evaluar la costo-efectividad del reemplazo valvular aórtico percutáneo (RVAP) contra terapia conservadora (TC) en pacientes con estenosis aórtica (EA) severa de muy alto riesgo, en un centro de derivación. Métodos: Los pacientes derivados entre Enero 2013 y Septiembre 2014, considerados de muy alto riesgo y candidatos a RVAP fueron incluidos. El costo de los recursos usados, de las readmisiones y la sobrevida fueron obtenidos para determinar el tiempo de vida ganado y la relación incremental de costo-efectividad (RICE) del RVAP Resultados: El grupo estudiado quedó compuesto por 39 pacientes, con edad promedio 82±7 años, más frecuentemente mujeres (74.4%), con elevado perfil de riesgo (STS score 11.4±5.6). Diecisiete pacientes (43.6%) fueron sometidos a RVAP y 22 (56.4%) a TC. Durante el seguimiento se registraron 25 rehospitalizaciones en el grupo de TC, a un costo promedio de $4.195.073 por paciente (7,027 dólares). Todos los pacientes sometidos a RAVP recibieron con éxito una prótesis Sapien XT y fueron egresados vivos. El costo promedio estimado del RVAP fue $20.000.000 (33,500 dólares). La sobrevida media fue de 54.5% (10 eventos) en grupo TC contra 94.1% (una muerte) en el grupo RVAP [285±204 días/seguimiento] (p<0.001). Así se pudo estimar que RVAP se asoció a un incremento de vida de al menos un año, lo cual resultó en una RICE de 26,470 dólares/año de vida ganado. Conclusión: El RAVP resultó costo-efectivo comparado con la TC en pacientes portadores de EA severa de muy alto riego tratados en la realidad de un centro de derivación nacional.

Aim: to evaluate cost-effectiveness of Transcatheter Aortic Valve Replacement (TAVR) compared to conservative treatment in patients with very high risk severe aortic stenosis (AS) referred to a tertiary center in Santiago, Chile Methods: Patients with high surgical risk and severe AS referred between January 2013 and September 2014 were included. Cost of resources, readdmissions, life-years gained and incremental cost-effectiveness of TAVI were calculated Results: Thirty-nine patients were finally included. Mean age was 82±7 years old, more commonly women (74%) with a mean STS score of 11.4±5.6 that confirmed their high-risk. Seventeen patients (43.6%) had TAVR and 22 (56.4%) underwent conventional medical therapy. All patients in the TAVR group - treated with Sapien XT® device - survived the procedure and were discharged alive. Mean cost of the procedure was approximately US$ 33,500. After a mean follow-up period of 285±204 days, mean survival rate in the control group was 54.5% (10 deaths) as compared to 94.1% in the TAVR group (1 death, p<0.001). Therefore, a gain of al least one year was obtained with TAVR resulting in an incremental cost effectiveness of US$ 26.470 per year of life gained. Conclusion: TAVR resulted costly-effective compared to conventional therapy in patients with severe AS and high surgical risk in a Chilean referral center.

Correlación entre la ecocardiografìa transesofágica tridimensional y tomografìa cardíaca en la determinación del anillo aórtico previo al reemplazo de válvula aórtica con catéteres (TAVR) / Correlation between 3-D trans-esophageal echocardiography and cardiac computed tomography in the evaluation of the aortic annulus prior to transcatheter aortic valveimplantation (TAVR)

Introducción: Para el reemplazo de válvula aórtica con catéteres (TAVR) es fundamental la adecuada medición del anillo aórtico para elegir el tamaño adecuado de la prótesis y evitar complicaciones graves como la ruptura del anillo aórtico y la insuficiencia paravalvular (IAP). La tomografía computada cardíaca (TC) es el estándar de oro en la medición del anillo aórtico, pero la ecocardiografía transesofágica 3D (ETE3D) parece ser una alternativa atractiva. Objetivo: Evaluar la correlación entre las mediciones del anillo aórtico obtenidas por ETE3D y las encontradas en la TC. Los resultados obtenidos se evaluaron en términos de la prótesis elegida y la presencia de insuficiencia aórtica post TAVR. Métodos: Se realizaron de manera retrospectiva y ciega, las mediciones del anillo aórtico por TC y ETE3D en 18 pacientes consecutivos, edad promedio 82 ± 7,06 años, sometidos a TAVR usando prótesis Sapien XT (Edwards Lifescience). Se comparó el diámetro máximo, diámetro mínimo, diámetro medio, área y perímetro del anillo. Resultados: La ETE3D subvaloró el tamaño del anillo aórtico, pero demostró tener una buena correlación con los diferentes parámetros de la TC, con mejor comportamiento para el perímetro del anillo. ETE3D y TC coincidieron en la elección de la prótesis en 17 pacientes y no hubo IAP de relevancia. Conclusión: La ETE3D tiene buena correlación comparada contra la TC en la valoración del anillo aórtico. La ETE3D parece una atractiva alternativa a la TC para medición del anillo especialmente en casos complejos o cuando la disponibilidad y acceso a la TC puede estar limitada.

In TAVR, the precise measuring of the aortic annulus is essential to determine the size of the prosthesis and to avoid complications like rupture of the annulus of aortic insufficiency. Computed tomography (CT) is the gold standard to achieve these goals. 3-D trans-esophageal echocardiography (3-D TEE) to be a useful alternative method. Aim: to evaluate the correlation of aortic annulus measurements obtained with 3-dTE and CT in the determination of annulus measurements before TAVR. Prosthesis size and presence of aortic insufficiency were related to these measurements. Methods: In a retrospective blinded protocol the measurements of the aortic annulus obtained with CT or 3D-TEE were correlated in 18 consecutive patients (mean age 82 ± 7.1) submitted to TAVR with a Sapien XT (Edwards Lifescience) prosthesis. Maximal, minimal and mean diameters as well as area and annular circumference were evaluated. Results: Compared to CT, 3D-TEE under estimated de size of the aortic annulus but correlated well with other measurements of CT, especially with the annular circumference. Measurements from both methods agreed in the determination of the prosthesis size in 17 of 18 patients. No significant per prosthetic aortic insufficiency was observed in any case. Conclusion: 3DTEE correlates well with CT in evaluating the different parameters of the aortic annulus and is a good alternative to CT in complex cases and when CT is not readily available.