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.

Evaluation of Myocardial Ischemia with iFR (Instantaneous Wave-Free Ratio in the Catheterization Laboratory: A Pilot Study.

BACKGROUND: The Instantaneous Wave-Free Ratio (iFR) is an invasive functional evaluation method that does not require vasoactive drugs to induce maximum hyperemia. OBJECTIVE: To evaluate the contribution of the iFR to the therapeutic decision-making of coronary lesions in the absence of non-invasive diagnostic methods for ischemia, or in case of discordance between these methods and coronary angiography. METHOD: We studied patients older than 18 years, of both sexes, consecutively referred for percutaneous treatment between May 2014 and March 2018. Coronary stenotic lesions were classified by visual estimation of the stenosis diameter into moderate (41-70% stenosis) or severe (71%-90%). An iFR ≤ 0.89 was considered positive for ischemia. Logistic regression was performed using the elastic net, with placement of stents as outcome variable, and age, sex, arterial hypertension, diabetes, dyslipidemia, smoking, family history, obesity and acute myocardial infarction (AMI) as independent variables. Classification trees, ROC curves, and Box Plot graphs were constructed using the R software. A p-value < 0.05 was considered statistically significant. RESULTS: Fifty-two patients with 96 stenotic lesions (56 moderate, 40 severe) were evaluated. The iFR cut-off point of 0.87 showed a sensitivity of 0.57 and 1-specificity of 0.88, demonstrating high accuracy in reclassifying the lesions. Diabetes mellitus, dyslipidemia, and presence of moderate lesions with an iFR < 0.87 were predictors of stent implantation. Stents were used in 32% of lesions in patients with stable coronary artery disease and AMI with or without ST elevation (non-culprit lesions). CONCLUSION: The iFR has an additional value to the therapeutic decision making in moderate and severe coronary stenotic lesions, by contributing to the reclassification of lesions and decreasing the need for stenting.

Evaluation of Myocardial Ischemia with iFR (Instantaneous Wave-Free Ratio in the Catheterization Laboratory: A Pilot Study / Avaliação de Isquemia Miocárdica na Sala de Hemodinâmica com iFR Instantaneous Wave-Free Ratio: Estudo Piloto

Abstract Background: The Instantaneous Wave-Free Ratio (iFR) is an invasive functional evaluation method that does not require vasoactive drugs to induce maximum hyperemia Objective: To evaluate the contribution of the iFR to the therapeutic decision-making of coronary lesions in the absence of non-invasive diagnostic methods for ischemia, or in case of discordance between these methods and coronary angiography. Method: We studied patients older than 18 years, of both sexes, consecutively referred for percutaneous treatment between May 2014 and March 2018. Coronary stenotic lesions were classified by visual estimation of the stenosis diameter into moderate (41-70% stenosis) or severe (71%-90%). An iFR ≤ 0.89 was considered positive for ischemia. Logistic regression was performed using the elastic net, with placement of stents as outcome variable, and age, sex, arterial hypertension, diabetes, dyslipidemia, smoking, family history, obesity and acute myocardial infarction (AMI) as independent variables. Classification trees, ROC curves, and Box Plot graphs were constructed using the R software. A p-value < 0.05 was considered statistically significant. Results: Fifty-two patients with 96 stenotic lesions (56 moderate, 40 severe) were evaluated. The iFR cut-off point of 0.87 showed a sensitivity of 0.57 and 1-specificity of 0.88, demonstrating high accuracy in reclassifying the lesions. Diabetes mellitus, dyslipidemia, and presence of moderate lesions with an iFR < 0.87 were predictors of stent implantation. Stents were used in 32% of lesions in patients with stable coronary artery disease and AMI with or without ST elevation (non-culprit lesions). Conclusion: The iFR has an additional value to the therapeutic decision making in moderate and severe coronary stenotic lesions, by contributing to the reclassification of lesions and decreasing the need for stenting.

Resumo Fundamento: Instantaneous Wave-Free Ratio (iFR) é um método de avaliação funcional invasiva sem necessidade de droga vasoativa para indução de hiperemia máxima. Objetivo: Analisar a contribuição do iFR na terapêutica das lesões coronarianas com ausência ou discrepância entre os métodos diagnósticos não invasivos para isquemia e a angiografia coronária. Método: Foram estudados pacientes consecutivos com 18 anos ou mais, ambos os sexos, no período de maio de 2014 a março de 2018, com lesões coronarianas classificadas, por medição da porcentagem de diâmetro da estenose através de estimativa visual, em estenoses moderadas (41-70%) ou graves (71%-90%). O iFR ≤ 0,89 foi considerado positivo para isquemia. Empregou-se regressão logística com elastic net, tendo como variável desfecho o emprego de stent, e variáveis independentes: idade, sexo, hipertensão arterial, diabetes, dislipidemia, tabagismo, história familiar, obesidade e infarto agudo do miocárdio (IAM) prévio. Foram construídas Árvores de Classificação, Curva Roc, e gráficos Box Plot com o software R. O valor de p < 0,05 foi considerado significativo. Resultados: Foram avaliados 52 pacientes com 96 lesões obstrutivas (56 moderadas, 40 graves). O ponto de corte do iFR de 0,87 apresentou sensibilidade de 0,57 e 1-especificidade de 0,88, demonstrando boa acurácia para a reclassificação das lesões. Diabetes mellitus, dislipidemia, e presença de lesão moderada, com iFR < 0,87 foram preditores do implante de stents. Foram empregados stents em 32% das lesões de portadores de doença arterial coronariana estável e IAM com e sem supra de ST (lesões não culpadas). Conclusão: O iFR contribui para a reclassificação das lesões e diminuição do emprego de stents, auxiliando na abordagem das lesões moderadas e severas.