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. (LC (TAVR countries TAVRs s time 200 2023 CSNs. CSNs . (CSNs) EuroSCOREII newgeneration new generation prostheses Also inhospital hospital CSN st th initialexperience, initialexperience , (initial-experience) earlyexperience, earlyexperience early (early-experience) intermediateexperience, intermediateexperience intermediate (intermediate-experience) highexperience. highexperience high (high-experience) 201 >40 (>4 ≤4 procedures. procedures procedures) 005 0 05 <0.05 3194 3 194 3,19 2 included 80781 80 7 8 1 80.7±8. 771 7±7.1 4 118 #118 Inhospital In 86 6 8.6% 77 7.7% 59 5 9 5.9% 37 3.7 initial, initial- early, early- intermediate, intermediate- highexperience, high-experience p<0.001. p0001 p p<0.001 001 (p<0.001) OR 057 57 0.57 p0013 013 p=0.01 vs experience. experience) Lowvolume Low volume highvolume 10 #10 20 202 (CSNs (initial-experience (early-experience (intermediate-experience (high-experience >4 (> ≤ 00 <0.0 319 19 3,1 8078 80.7±8 7±7. 11 #11 8.6 7.7 5.9 3. p000 p<0.00 (p<0.001 0.5 p001 01 p=0.0 #1 > ( <0. 31 3, 807 80.7± 7±7 8. 7. 5. p00 p<0.0 (p<0.00 0. p=0. # <0 80.7 7± p0 p<0. (p<0.0 p=0 < 80. p<0 (p<0. p= p< (p<0 (p< (p

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. (LC (TAVR desenvolvimento tempo 200 2023 NSC. NSC . (NSC) EuroSCOREII geração Ainda º inicial , inicial) básica básica) alta. alta) 201 >40 (>4 ≤4 procedimentos. procedimentos procedimentos) 005 0 05 <0,05 319 2 80781 80 7 8 1 80,7±8, 771 7±7,1 4 118 86 6 8,6% 77 7,7% 59 5 9 5,9% 37 3 3,7 p<0,001. p0001 p<0,001 001 (p<0,001) OR 057 57 0,57 p0013 013 p=0,01 vs inicial. 10 Observouse Observou se 20 202 (NSC >4 (> ≤ 00 <0,0 31 8078 80,7±8 7±7, 11 8,6 7,7 5,9 3, p000 p<0,00 (p<0,001 0,5 p001 01 p=0,0 > ( <0, 807 80,7± 7±7 8, 7, 5, p00 p<0,0 (p<0,00 0, p=0, <0 80,7 7± p0 p<0, (p<0,0 p=0 < 80, p<0 (p<0, p= p< (p<0 (p< (p

Abstract Background: The treatment for symptomatic severe aortic stenosis (AS) is the correction of valve stenosis by surgical valve replacement and more recently by transcatheter aortic valve implant (TAVI). However, in some high risk surgical patients, TAVI is not possible for technical or clinical reasons or due to the unavailability of the endoprosthesis. Objective: The aim of this study was to evaluate a mid-term follow-up of symptomatic severe AS patients who are not eligible for TAVI trials, as well as to identify the clinical features of these patients. Methods: This was an observational, retrospective study conducted with 475 symptomatic severe AS patients, evaluated by the Heart Team between 2000 and 2017. Inclusion criterias were: patients considered not to be eligible for TAVI. The Shapiro-Wilk test was applied to evaluate normality. Non-paired t and Mann-Whitney tests were applied for continuous variables, while the chi-squared and Fischer exact tests were applied for categorical variables, with a level of significance of p<0,05. Results: The heart team evaluated 475 patients: 25 (5.26%) died before any intervention could be proposed; 326 (68.3%) were submitted to TAVI, so the study population consisted of 124 patients not eligible for TAVI. Of these, 31 (25%) underwent surgery and 93 (75%) remained in clinical treatment. In a mean 56 months- follow-up the mortality in clinical group was 46.2%. In the surgical group the mortality was 23.9% (in-hospital 12.9% and late mortality 11% in a mean 47.4 months follow-up). The patients that died presented a significantly lower left ventricle ejection fraction (LVEF), a smaller valve area, and a larger end-systolic diameter of the LV. Conclusion: The mortality of the clinical group's patients was significantly higher than the surgical mortality (46.2% vs. 12.9%; p=0.021). The patients of the clinical group were older, weighed less, and had a higher incidence of renal failure and a higher STS score.