Learning Curve for In-Hospital Mortality of Transcatheter Aortic Valve Replacement: Insights from the Brazilian National Registry. / Curva de Aprendizagem da Mortalidade Hospitalar da Substituição da Válvula Aórtica Transcateter: Insights do Registro Nacional Brasileiro.

BACKGROUND: Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. OBJECTIVE: To assess TAVR's LC in Brazil over time. METHODS: We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. RESULTS: A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. CONCLUSION: A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.

Curva de Aprendizagem da Mortalidade Hospitalar da Substituição da Válvula Aórtica Transcateter: Insights do Registro Nacional Brasileiro / Learning Curve for In-Hospital Mortality of Transcatheter Aortic Valve Replacement: Insights from the Brazilian National Registry

Resumo Fundamento Dados robustos sobre a curva de aprendizagem (LC) da substituição da válvula aórtica transcateter (TAVR) são escassos nos países em desenvolvimento. Objetivo Avaliar a LC da TAVR no Brasil ao longo do tempo. Métodos Analisamos dados do registro brasileiro de TAVR de 2008 a 2023. Pacientes de cada centro foram numerados cronologicamente em número sequencial de caso (NSC). A LC foi realizada usando um spline cúbico restrito ajustado para o EuroSCORE-II e o uso de próteses de nova geração. Ainda, os desfechos hospitalares foram comparados entre grupos definidos de acordo com o nível de experiência, com base no NSC: 1º ao 40º caso (experiência inicial), 41º ao 80º caso (experiência básica), 81º ao 120º caso (experiência intermediária) e 121º caso em diante (experiência alta). Análises adicionais foram conduzidas de acordo com o número de casos tratados antes de 2014 (>40 e ≤40 procedimentos). O nível de significância adotado foi p <0,05. Resultados Foram incluídos 3194 pacientes de 25 centros. A idade média foi 80,7±8,1 anos e o EuroSCORE II médio foi 7±7,1. A análise da LC demonstrou uma queda na mortalidade hospitalar ajustada após o tratamento de 40 pacientes. Um patamar de nivelamento na curva foi observado após o caso 118. A mortalidade hospitalar entre os grupos foi 8,6%, 7,7%, 5,9%, e 3,7% para experiência inicial, básica, intermediária e alta, respectivamente (p<0,001). A experiência alta foi preditora independente de mortalidade mais baixa (OR 0,57, p=0,013 vs. experiência inicial). Centros com baixo volume de casos antes de 2014 não mostraram uma redução significativa na probabilidade de morte com o ganho de experiência, enquanto centros com alto volume de casos antes de 2014 apresentaram uma melhora contínua após o caso de número 10. Conclusão Observou-se um fenômeno de LC para a mortalidade hospitalar do TAVR no Brasil. Esse efeito foi mais pronunciado em centros que trataram seus 40 primeiros casos antes de 2014 que naqueles que o fizeram após 2014.

Abstract Background Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. Objective To assess TAVR's LC in Brazil over time. Methods We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. Results A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. Conclusion A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.

Impacto clínico da diferença entre os sexos e local de realização de procedimento no implante transcateter de válvula aórtica: dados do registro RIBAC-NT / Clinical impact of the difference between sexes and location of procedure in transcatheter aortic valve implantation: data from the RIBAC-NT registry

INTRODUÇÃO: Implante transcateter de válvula aórtica (TAVI) é o tratamento de escolha para pacientes com estenose aórtica acima de 70 anos de idade com anatomia favorável. No entanto, o impacto das diferenças de entre os sexos e local de realização do procedimento (público versus privado) nos desfechos de TAVI no Brasil permanecem ainda indefinidos. MÉTODOS: O banco de dados RIBAC-NT (Registro de Implante de Bioprotese Aórtica por Cateter) incluiu 3,194 pacientes submetidos a TAVI de 2009 a 2021. Esta análise retrospectiva explorou as características basais, de procedimento e dos desfechosintra-hospitalares, estratificando os pacientes porsexo e local da realização do procedimento. Tendênciastemporaistambém foram avaliadas. RESULTADOS: Foram incluídos 1551 (49%) mulheres e 1.643 (51%) homens. As mulheres eram mais velhas(83 [78-87] vs. 81 [75-85] anos; p<0,01), porém apresentavam menor prevalência de diabetes mellitus (30,2% vs. 36,3%, p<0,01) e doença arterial coronariana (39,0% vs. 52,2%, p<0,01). Com respeito às complicações periprocedimento, as mulheres apresentaram risco 3 vezes maior de sangramento com risco de vida (6,1% vs. 2,4%, p<0,01), bem como maiores taxas de mortalidade de procedimento e intra-hospitalar (4,4% vs. 2,5% e 7,7% vs. 4,5%, respectivamente; p<0,01). A maioria dos procedimentos foi realizada em hospitais privados (66,2%), sendo que pacientes de hospitais públicos apresentaram maistaxas de complicações vasculares maiores(7,2% vs. 3,3%), implante de marcapasso (12,3% vs. 8,9%), mortalidade do procedimento (5,0% vs. 2,7%) e intra-hospitalar (7,5% vs. 5,3%; todos com p<0,01) em relação aos hospitais privados. Ao longo do tempo, as taxas de mortalidade intra-hospitalar diminuíram tanto em hospitais públicos quanto privados, principalmente no grupo de mulheres(p<0,01). CONCLUSÕES: Mulheres apresentaram maiores taxas de mortalidade de procedimento e intra- -hospitalares após TAVI em comparação aos homens, assim como taxas mais altas de sangramento com risco de vida e eventos adversos. Hospitais públicos foram associados a maiores taxas de mortalidade do que centros privados. Nos últimos anos, as mulheres experimentaram reduções mais significativas nas taxas de mortalidade, tanto em hospitais públicos quanto privados.

TAVI com próteses balão-expansíveis de nova geração versus auto-expansíveis de nova geração: análise do registro brasileiro de TAVI - RIBAC-NT / TAVI with new generation balloon-expandable prostheses versus new generation self-expandable prostheses: analysis of the Brazilian TAVI registry - RIBAC-NT

INTRODUÇÃO: Não existem estudos comparando os desfechos clínicos do implante de válvula aórtica transcateter (TAVI) com próteses balão-expansíveis (BE) versus auto-expansíveis (AE) de nova geração na realidade brasileira. OBJETIVO: Comparar os resultados clínicos intra-hospitalares de TAVI realizados com próteses BE de nova geração contra próteses AE de nova geração em centros brasileiros participantes do RIBAC-NT. MÉTODOS: Foram utilizados dados de centros ativamente participantes do registro brasileiro de TAVI. Critério de inclusão: todos os procedimentos de TAVI em válvula nativa tricúspide com utilização de próteses de nova geração. Critério de exclusão principal: procedimentos pela via transapical. Os casos foram separados conforme a prótese utilizada em grupo BE (Sapien S3, S3 Ultra e Myval) e AE (Evolut R, Evolut PRO, Acurate Neo, Acurate Neo2 e Portico). Desfecho primário analisado foi morte intra-hospitalar. Desfechos secundários: complicação vascular maior, sangramento maior, sangramento com risco de vida, qualquer acidente vascular encefálico (AVE) e novo implante de marcapasso. RESULTADOS: Ao todo 1703 pacientes de 25 centros foram incluídos na análise, sendo 887 no grupo BE e 819 no grupo AE. A idade média da população foi 80,7±7,2 anos e 48,9% eram mulheres. O grupo AE teve uma maior proporção de pacientes do sexo feminino (53,5% vs. 44,6%, P=<0,001), maior prevalência de doença arterial periférica (16,2% vs. 11%, P=0,002) e de doença pulmonar obstrutiva crônica (16,8% vs. 11,5%, P=0,002), além de Euroscore 2 maior (6,2 vs. 5,5, P=0,03). Tabela 1 estão demonstradas a comparação das características do procedimento entre os grupos. Pacientes do grupo BE realizaram mais procedimentos com anestesia geral, mais por via transfemoral e também com maior proporção de acessos totalmente percutâneos. No grupo AE houve maior necessidade de pré e pós-dilatação e discreta maior incidência de embolização e necessidade de uma segunda prótese, assim como maior incidência de oclusão coronariana. Tabela 2 sumariza o comparativo dos desfechos clínicos. Não houve diferença significativa para a mortalidade intra-hospitalar entre os grupos. Também não se observou diferença entre complicações vasculares, sangramentos, AVE e necessidade de novo marcapasso. Regressão logístico multivariada ajustando para diferenças entre os grupos não indicou diferença de mortalidade entre utilização de prótese BE vs. AE (OR 0,95, P=0,8). Preditores independentes de mortalidade foram sexo feminino (OR 0,49, P=0,009) e Euroscore 2 (OR 1,04, P=0,006). CONCLUSÃO: Em estudo de vida real de pacientes submetidos a TAVI no Brasil, não houve diferença da mortalidade intra-hospitalar entra a utilização de próteses BE de nova geração em comparação a utilização de próteses AE de nova geração.

Overview of Percutaneous Coronary Interventions for Chronic Total Occlusions Treated at Brazilian Centers Participating in the LATAM CTO Registry. / Panorama das Intervenções Coronárias Percutâneas em Oclusões Totais Crônicas em Centros Participantes do LATAM CTO Registry no Brasil.

BACKGROUND: Major advances have been seen in techniques and devices for performing percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs), but there are limited real-world practice data from developing countries. OBJECTIVES: To report clinical and angiographic characteristics, procedural aspects, and clinical outcomes of CTO PCI performed at dedicated centers in Brazil. METHODS: Included patients underwent CTO PCI at centers participating in the LATAM CTO Registry, a Latin American multicenter registry dedicated to prospective collection of these data. Inclusion criteria were procedures performed in Brazil, age 18 years or over, and presence of CTO with PCI attempt. CTO was defined as a 100% lesion in an epicardial coronary artery, known or estimated to have lasted at least 3 months. RESULTS: Data on 1196 CTO PCIs were included. Procedures were performed primarily for angina control (85%) and/or treatment of moderate/severe ischemia (24%). Technical success rate was 84%, being achieved with antegrade wire approaches in 81% of procedures, antegrade dissection and re-entry in 9%, and retrograde approaches in 10%. In-hospital adverse cardiovascular events occurred in 2.3% of cases, with a mortality rate of 0.75%. CONCLUSIONS: CTOs can be treated effectively in Brazil by using PCI, with low complication rates. The scientific and technological development observed in this area in the past decade is reflected in the clinical practice of dedicated Brazilian centers.

FUNDAMENTO: Tem sido observado um grande avanço nas técnicas e nos dispositivos para a realização de intervenções coronárias percutâneas (ICP) em oclusões totais coronarianas crônicas (OTC), mas existem poucos dados da prática do mundo real em países em desenvolvimento. OBJETIVOS: Relatar as características clínicas e angiográficas, os aspectos dos procedimentos e os resultados clínicos da ICP de OTC em centros dedicados a esse procedimento no Brasil. MÉTODOS: Os pacientes incluídos foram submetidos à ICP de OTC em centros participantes do LATAM CTO Registry, um registro multicêntrico latino-americano dedicado à coleta prospectiva desses dados. Os critérios de inclusão foram procedimentos realizados no Brasil, idade acima de 18 anos e presença de OTC com tentativa de ICP. A definição de OTC foi lesão de 100% em uma artéria coronária epicárdica, conhecida ou estimada como tendo pelo menos 3 meses de evolução. RESULTADOS: Foram incluídos dados de 1.196 ICPs de OTC. Os procedimentos foram realizados principalmente para controle da angina (85%) e/ou tratamento de uma grande área isquêmica (24%). A taxa de sucesso técnico foi de 84% e foi alcançada com técnicas de fios anterógrados em 81%, dissecção/reentrada anterógrada em 9% e retrógrada em 10% dos procedimentos. Os eventos cardiovasculares adversos intra-hospitalares ocorreram em 2,3% dos casos, sendo a mortalidade de 0,75%. CONCLUSÕES: As OTC podem ser tratadas no Brasil por intervenção coronária percutânea de forma efetiva e com baixas taxas de complicações. O desenvolvimento científico e tecnológico observado nessa área na última década reflete-se na prática clínica de centros brasileiros dedicados a essa técnica.

Pure Aortic Regurgitation Complicated by Membranous Interventricular Septum Aneurysm Treated With Transcatheter Aortic Valve Replacement.

An 89-year-old woman with severe aortic regurgitation and an aneurysmal interventricular membranous septum extending into the aortic annulus underwent successful transcatheter aortic valve replacement. A challenging case because of the risk of valve mispositioning complications attributed to the co-occurrence of pure aortic regurgitation (very low calcium burden) with an aneurysmal interventricular membranous septum. (Level of Difficulty: Intermediate.).

Panorama das Intervenções Coronárias Percutâneas em Oclusões Totais Crônicas em Centros Participantes do LATAM CTO Registry no Brasil / Overview of Percutaneous Coronary Interventions for Chronic Total Occlusions Treated at Brazilian Centers Participating in the LATAM CTO Registry

Resumo Fundamento Tem sido observado um grande avanço nas técnicas e nos dispositivos para a realização de intervenções coronárias percutâneas (ICP) em oclusões totais coronarianas crônicas (OTC), mas existem poucos dados da prática do mundo real em países em desenvolvimento. Objetivos Relatar as características clínicas e angiográficas, os aspectos dos procedimentos e os resultados clínicos da ICP de OTC em centros dedicados a esse procedimento no Brasil. Métodos Os pacientes incluídos foram submetidos à ICP de OTC em centros participantes do LATAM CTO Registry, um registro multicêntrico latino-americano dedicado à coleta prospectiva desses dados. Os critérios de inclusão foram procedimentos realizados no Brasil, idade acima de 18 anos e presença de OTC com tentativa de ICP. A definição de OTC foi lesão de 100% em uma artéria coronária epicárdica, conhecida ou estimada como tendo pelo menos 3 meses de evolução. Resultados Foram incluídos dados de 1.196 ICPs de OTC. Os procedimentos foram realizados principalmente para controle da angina (85%) e/ou tratamento de uma grande área isquêmica (24%). A taxa de sucesso técnico foi de 84% e foi alcançada com técnicas de fios anterógrados em 81%, dissecção/reentrada anterógrada em 9% e retrógrada em 10% dos procedimentos. Os eventos cardiovasculares adversos intra-hospitalares ocorreram em 2,3% dos casos, sendo a mortalidade de 0,75%. Conclusões As OTC podem ser tratadas no Brasil por intervenção coronária percutânea de forma efetiva e com baixas taxas de complicações. O desenvolvimento científico e tecnológico observado nessa área na última década reflete-se na prática clínica de centros brasileiros dedicados a essa técnica.

Abstract Background Major advances have been seen in techniques and devices for performing percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs), but there are limited real-world practice data from developing countries. Objectives To report clinical and angiographic characteristics, procedural aspects, and clinical outcomes of CTO PCI performed at dedicated centers in Brazil. Methods Included patients underwent CTO PCI at centers participating in the LATAM CTO Registry, a Latin American multicenter registry dedicated to prospective collection of these data. Inclusion criteria were procedures performed in Brazil, age 18 years or over, and presence of CTO with PCI attempt. CTO was defined as a 100% lesion in an epicardial coronary artery, known or estimated to have lasted at least 3 months. Results Data on 1196 CTO PCIs were included. Procedures were performed primarily for angina control (85%) and/or treatment of moderate/severe ischemia (24%). Technical success rate was 84%, being achieved with antegrade wire approaches in 81% of procedures, antegrade dissection and re-entry in 9%, and retrograde approaches in 10%. In-hospital adverse cardiovascular events occurred in 2.3% of cases, with a mortality rate of 0.75%. Conclusions CTOs can be treated effectively in Brazil by using PCI, with low complication rates. The scientific and technological development observed in this area in the past decade is reflected in the clinical practice of dedicated Brazilian centers.

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.

Mitral Valve Infective Endocarditis after Trans-Catheter Aortic Valve Implantation.

Scarce data exist on mitral valve (MV) infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI). This multicenter study included a total of 579 patients with a diagnosis of definite IE after TAVI from the IE after TAVI International Registry and aimed to evaluate the incidence, characteristics, management, and outcomes of MV-IE after TAVI. A total of 86 patients (14.9%) had MV-IE. These patients were compared with 284 patients (49.1%) with involvement of the transcatheter heart valve (THV) only. Two factors were found to be associated with MV-IE: the use of self-expanding valves (adjusted odds ratio 2.49, 95% confidence interval [CI] 1.23 to 5.07, p = 0.012), and the presence of an aortic regurgitation ≥2 at discharge (adjusted odds ratio 3.33; 95% CI 1.43 to 7.73, p <0.01). There were no differences in IE timing and causative microorganisms between groups, but surgical management was significantly lower in patients with MV-IE (6.0%, vs 21.6% in patients with THV-IE, p = 0.001). All-cause mortality rates at 2-year follow-up were high and similar between patients with MV-IE (51.4%, 95% CI 39.8 to 64.1) and patients with THV-IE (51.5%, 95% CI 45.4 to 58.0) (log-rank p = 0.295). The factors independently associated with increased mortality risk in patients with MV-IE were the occurrence of heart failure (adjusted p <0.001) and septic shock (adjusted p <0.01) during the index hospitalization. One of 6 IE episodes after TAVI is localized on the MV. The implantation of a self-expanding THV and the presence of an aortic regurgitation ≥2 at discharge were associated with MV-IE. Patients with MV-IE were rarely operated on and had a poor prognosis at 2-year follow-up.

Surgical Treatment of Patients With Infective Endocarditis After Transcatheter Aortic Valve Implantation.

BACKGROUND: The optimal treatment of patients developing infective endocarditis (IE) after transcatheter aortic valve implantation (TAVI) is uncertain. OBJECTIVES: The goal of this study was to investigate the clinical characteristics and outcomes of patients with TAVI-IE treated with cardiac surgery and antibiotics (IE-CS) compared with patients treated with antibiotics alone (IE-AB). METHODS: Crude and inverse probability of treatment weighting analyses were applied for the treatment effect of cardiac surgery vs medical therapy on 1-year all-cause mortality in patients with definite TAVI-IE. The study used data from the Infectious Endocarditis after TAVI International Registry. RESULTS: Among 584 patients, 111 patients (19%) were treated with IE-CS and 473 patients (81%) with IE-AB. Compared with IE-AB, IE-CS was not associated with a lower in-hospital mortality (HRunadj: 0.85; 95% CI: 0.58-1.25) and 1-year all-cause mortality (HRunadj: 0.88; 95% CI: 0.64-1.22) in the crude cohort. After adjusting for selection and immortal time bias, IE-CS compared with IE-AB was also not associated with lower mortality rates for in-hospital mortality (HRadj: 0.92; 95% CI: 0.80-1.05) and 1-year all-cause mortality (HRadj: 0.95; 95% CI: 0.84-1.07). Results remained similar when patients with and without TAVI prosthesis involvement were analyzed separately. Predictors for in-hospital and 1-year all-cause mortality included logistic EuroSCORE I, Staphylococcus aureus, acute renal failure, persistent bacteremia, and septic shock. CONCLUSIONS: In this registry, the majority of patients with TAVI-IE were treated with antibiotics alone. Cardiac surgery was not associated with an improved all-cause in-hospital or 1-year mortality. The high mortality of patients with TAVI-IE was strongly linked to patients' characteristics, pathogen, and IE-related complications.

Infective Endocarditis Caused by Staphylococcus aureus After Transcatheter Aortic Valve Replacement.

BACKGROUND: Staphylococcus aureus (SA) has been extensively studied as causative microorganism of surgical prosthetic-valve infective endocarditis (IE). However, scarce evidence exists on SA IE after transcatheter aortic valve replacement (TAVR). METHODS: Data were obtained from the Infectious Endocarditis After TAVR International Registry, including patients with definite IE after TAVR from 59 centres in 11 countries. Patients were divided into 2 groups according to microbiologic etiology: non-SA IE vs SA IE. RESULTS: SA IE was identified in 141 patients out of 573 (24.6%), methicillin-sensitive SA in most cases (115/141, 81.6%). Self-expanding valves were more common than balloon-expandable valves in patients presenting with early SA IE. Major bleeding and sepsis complicating TAVR, neurologic symptoms or systemic embolism at admission, and IE with cardiac device involvement (other than the TAVR prosthesis) were associated with SA IE (P < 0.05 for all). Among patients with IE after TAVR, the likelihood of SA IE increased from 19% in the absence of those risk factors to 84.6% if ≥ 3 risk factors were present. In-hospital (47.8% vs 26.9%; P < 0.001) and 2-year (71.5% vs 49.6%; P < 0.001) mortality rates were higher among patients with SA IE vs non-SA IE. Surgery at the time of index SA IE episode was associated with lower mortality at follow-up compared with medical therapy alone (adjusted hazard ratio 0.46, 95% CI 0.22-0.96; P = 0.038). CONCLUSIONS: SA IE represented approximately 25% of IE cases after TAVR and was associated with very high in-hospital and late mortality. The presence of some features determined a higher likelihood of SA IE and could help to orientate early antibiotic regimen selection. Surgery at index SA IE was associated with improved outcomes, and its role should be evaluated in future studies.

Perivalvular Extension of Infective Endocarditis After Transcatheter Aortic Valve Replacement.

BACKGROUND: Infective endocarditis (IE) following transcatheter aortic valve replacement (TAVR) has been associated with a dismal prognosis. However, scarce data exist on IE perivalvular extension (PEE) in such patients. METHODS: This multicenter study included 579 patients who had the diagnosis of definite IE at a median of 171 (53-421) days following TAVR. PEE was defined as the presence of an intracardiac abscess, pseudoaneurysm, or fistula. RESULTS: A total of 105 patients (18.1%) were diagnosed with PEE (perivalvular abscess, pseudoaneurysm, fistula, or a combination in 87, 7, 7, and 4 patients, respectively). A history of chronic kidney disease (adjusted odds ratio [ORadj], 2.08; 95% confidence interval [CI]: 1.27-3.41; P = .003) and IE secondary to coagulase-negative staphylococci (ORadj, 2.71; 95% CI: 1.57-4.69; P < .001) were associated with an increased risk of PEE. Surgery was performed at index IE episode in 34 patients (32.4%) with PEE (vs 15.2% in patients without PEE, P < .001). In-hospital and 2-year mortality rates among PEE-IE patients were 36.5% and 69.4%, respectively. Factors independently associated with an increased mortality were the occurrence of other complications (stroke post-TAVR, acute renal failure, septic shock) and the lack of surgery at index IE hospitalization (padj < 0.05 for all). CONCLUSIONS: PEE occurred in about one-fifth of IE post-TAVR patients, with the presence of coagulase-negative staphylococci and chronic kidney disease determining an increased risk. Patients with PEE-IE exhibited high early and late mortality rates, and surgery during IE hospitalization seemed to be associated with better outcomes.

Temporal Trends, Characteristics, and Outcomes of Infective Endocarditis After Transcatheter Aortic Valve Replacement

BACKGROUND: Procedural improvements combined with the contemporary clinical profile of patients undergoing transcatheter aortic valve replacement (TAVR) may have influenced the incidence and outcomes of infective endocarditis (IE) following TAVR. We aimed to determine the temporal trends, characteristics, and outcomes of IE post-TAVR. METHODS: Observational study including 552 patients presenting definite IE post-TAVR. Patients were divided in 2 groups according to the timing of TAVR (historical cohort [HC]: before 2014; contemporary cohort [CC]: after 2014). RESULTS: Overall incidence rates of IE were similar in both cohorts (CC vs HC: 5.45 vs 6.52 per 1000 person-years; P = .12), but the rate of early IE was lower in the CC (2.29‰ vs 4.89‰, P < .001). Enterococci were the most frequent microorganism. Most patients presented complicated IE (CC: 67.7%; HC: 69.6%; P = .66), but the rate of surgical treatment remained low (CC: 20.7%; HC: 17.3%; P = .32). The CC exhibited lower rates of in-hospital acute kidney injury (35.1% vs 44.6%; P = .036) and in-hospital (26.6% vs 36.4%; P = .016) and 1-year (37.8% vs 53.5%; P < .001) mortality. Higher logistic EuroScore, Staphylococcus aureus etiology, and complications (stroke, heart failure, and acute renal failure) were associated with in-hospital mortality in multivariable analyses (P < .05 for all). CONCLUSIONS: Although overall IE incidence has remained stable, the incidence of early IE has declined in recent years. The microorganism, high rate of complications, and very low rate of surgical treatment remained similar. In-hospital and 1-year mortality rates were high but progressively decreased over time.

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

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

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

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

Performance of Prediction Models for Contrast-Induced Acute Kidney Injury after Transcutaneous Aortic Valve Replacement.

BACKGROUND: Acute kidney injury (AKI) has shown to adversely affect outcomes in patients undergoing transcutaneous aortic valve replacement (TAVR), and its correct risk estimation may interfere in procedural planning and strategies. The aim of the study was to test and compare 6 scores in predicting AKI after TAVR. METHODS: We tested 6 scores (the contrast material limit score, volume-to-creatinine clearance ratio, ACEF, CR4EATME3AD3, Mehran model A, and Mehran model B) in a total of 559 consecutive patients included in the Brazilian TAVR registry. RESULTS: All scores had a poor accuracy and calibration to predict the occurrence of AKI grade 1 or 2. All scores improved the accuracy of AKI risk prediction when stratified for AKI grade 2/3 and AKI grade 3 for all scores. The CR4EATME3AD3 was the best predictor of AKI stage 2/3 (AUC: 0.62; OR: 1.12; 95% CI 1.01-1.26; p = 0.04) and AKI stage 3 (AUC: 0.64; OR: 1.16; 95% CI 1.02-1.32; p = 0.02). Mehran models A and B were both good models for AKI stage 3 (AUC: 0.63; OR: 1.10; 95% CI 1.01-1.22; p = 0.05; and AUC: 0.62; OR: 1.10; 95% CI 1.00-1.21; p = 0.05, respectively). CONCLUSIONS: None of the current models demonstrated validity in detecting AKI when its lower grades were evaluated. CR4EATME3AD3 was the best score in predicting moderate to severe AKI after TAVR. These findings suggest that contrast-induced AKI may not be the only factor related to kidney injury after TAVR.

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

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