Temporal Trends in Transcatheter Aortic Valve Implantation: 10-Year Analysis of the TAVIDOR Registry. / Tendência Temporal no Implante Percutâneo de Bioprótese Aórtica: Análise de 10 Anos do Registro TAVIDOR.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) has established itself as the preferential strategy to approach severe aortic stenosis. Information on procedural improvements and nationwide results obtained with the technique throughout the past decade are unknown. OBJECTIVES: To assess the temporal variation of the demographic profile, procedural characteristics, and in-hospital outcomes of patients undergoing TAVI procedures at the Rede D'Or São Luiz. METHODS: Observational registry comprising 29 national institutions, comparing the characteristics of the TAVI procedures performed from 2012 to 2017 (Group 1) to those performed from 2018 to 2023 (Group 2). The statistical significance level adopted was p < 0.05. RESULTS: This study assessed 661 patients, 95 in Group 1 and 566 in Group 2, with a mean age of 81.1 years. Group 1 patients had a higher prevalence of New York Heart Association functional class III or IV and STS risk score > 8%. In addition, they more often underwent general anesthesia, transesophageal echocardiographic monitoring, and access through femoral dissection. Group 2 patients had a higher success rate of the TAVI procedure (95.4% versus 89.5%; p = 0.018), lower mortality (3.9% versus 11.6%; p = 0.004), and less often needed permanent pacemaker implantation (8.5% versus 17.9%; p = 0.008). CONCLUSIONS: The 10-year temporal trends analysis of the TAVIDOR Registry shows a reduction in patients' clinical complexity over time. Furthermore, the advance to minimalistic implantation techniques, added to the technological evolution of the devices, may have contributed to the favorable outcomes observed among those whose implantation occurred in the last 5 years studied.

FUNDAMENTO: O implante percutâneo de bioprótese valvar aórtica (TAVI) consolidou-se como opção terapêutica da estenose aórtica de grau importante. Dados sobre as características evolutivas dos procedimentos e dos resultados obtidos com a técnica ao longo da última década, em escala nacional, são desconhecidos. OBJETIVOS: Analisar a tendência temporal referente ao perfil demográfico, características dos procedimentos e desfechos hospitalares de pacientes submetidos a TAVI na Rede D'Or São Luiz. MÉTODOS: Registro observacional envolvendo 29 instituições nacionais. Comparou-se características dos procedimentos realizados de 2012 a 2017 (Grupo 1) e de 2018 a 2023 (Grupo 2). Foram considerados significantes os resultados com valor de p < 0,05. RESULTADOS: Foram analisados 661 casos, 95 pertencentes ao Grupo 1 e 566 ao Grupo 2. A média de idade foi 81,1 anos. Observou-se no Grupo 1 maior prevalência de pacientes em classe funcional III ou IV e escore de risco > 8%. Foi mais frequente o emprego de anestesia geral, monitorização ecocardiográfica transesofágica e via de acesso por dissecção. Maior taxa de sucesso do procedimento (95,4% versus 89,5%; p = 0,018) foi aferida em implantes efetivados a partir de 2018, assim como menor mortalidade (3,9% versus 11,6%; p = 0,004) e necessidade de marcapasso definitivo (8,5% versus 17,9%; p = 0,008). CONCLUSÕES: A análise temporal de 10 anos do Registro TAVIDOR demonstra uma queda na complexidade clínica dos pacientes. Além disso, o avanço para técnicas de implante minimalistas, somadas à evolução tecnológica dos dispositivos, podem ter contribuído para desfechos favoráveis dentre aqueles cujo implante ocorreu no último quinquênio.

Brazilian Registry of Interventional Cardiology during the COVID-19 Pandemic (RBCI-COVID19). / Registro Brasileiro de Cardiologia Intervencionista durante a Pandemia de COVID-19 (RBCI-COVID19).

BACKGROUND: At the beginning of the COVID-19 pandemic, patients with myocardial infarction (MI) took longer to present to hospitals because of fear of contamination and health care access difficulties. OBJECTIVES: To assess interventional cardiology procedures performed during the COVID-19 pandemic and its implications for MI approach. METHODS: Prospective registry of 24 cardiac catheterization laboratories in Brazil, with adult patients undergoing interventional cardiology procedures between May 26 and November 30, 2020. The outcomes were cardiovascular (CV) and non-CV complications, death, and MI. Concomitant COVID-19 was confirmed using RT-PCR. Machine learning techniques were used with nonparametric Classification Trees models, and Simple Correspondence Analysis, with R statistical software package. Significance level adopted of 5%. RESULTS: This study included 1282 patients, 435 of whom (33.9%) had MI as follows: ST-segment elevation MI (STEMI), 239 (54.9%); and non-ST-segment elevation MI (NSTEMI), 196 (45.1%). Of the 1282 patients, 29 had CV complications, 47 had non-CV complications, and 31 died. The diagnosis of COVID-19 was confirmed in 77 patients (6%), with 15.58% mortality and non-CV complications in 6.49%. Most patients had significant coronary artery disease (63%), and an intracoronary thrombus was more often found in the presence of STEMI (3.4%) and COVID-19 (4%). A door-to-table time longer than 12 hours in NSTEMI was associated with 30.8% of complications, 25% in COVID-19 patients. CONCLUSIONS: All deaths were preceded by CV or non-CV complications. The presence of COVID-19 was associated with death and non-fatal complications of patients undergoing interventional cardiology procedures during the pandemic.

FUNDAMENTO: No início da pandemia de COVID-19, os pacientes com infarto do miocárdio (IM) demoraram para procurar um hospital por medo de contágio ou dificuldades no acesso aos serviços de saúde. OBJETIVOS: Avaliar procedimentos de cardiologia intervencionista realizados durante a pandemia de COVID-19 e implicações na abordagem do IM. MÉTODOS: Registro prospectivo de 24 centros de hemodinâmica no Brasil, com pacientes adultos submetidos a procedimentos de cardiologia intervencionista entre 26 de maio e 30 de novembro de 2020. Os desfechos foram complicações cardiovasculares (CV) e não CV, morte e IM. A concomitância de COVID-19 foi confirmada com RT-PCR. Técnicas de machine learning foram usadas com modelos não paramétricos de árvores de classificação. Usou-se análise de correspondência simples com o software R. Adotou-se nível de significância de 5%. RESULTADOS: Este estudo incluiu 1.282 pacientes, 435 dos quais (33,9%) apresentaram IM: IM com supra de ST (IMCSST), 239 (54,9%); e IM sem supra de ST(IMSSST), 196 (45.1%). Dos 1.282 pacientes, 29 tiveram complicações CV, 47 tiveram complicações não CV e 31 morreram. O diagnóstico de COVID-19 foi confirmado em 77 pacientes (6%), com 15,58% de mortalidade e 6,49% de complicações não CV. A maioria dos pacientes apresentou significativa doença arterial coronariana (63%). Trombo intracoronariano foi mais frequente na presença de IMCSST (3,4%) e COVID-19 (4%). Tempo porta-mesa superior a 12 horas no IMSSST associou-se a 30,8% de complicações, 25% em pacientes com COVID-19. CONCLUSÕES: Todos os óbitos foram precedidos por complicações CV ou não CV. A presença de COVID-19 foi associada a óbito e complicações não fatais dos pacientes submetidos a procedimentos de cardiologia intervencionista durante a pandemia.

Registro Brasileiro de Cardiologia Intervencionista durante a Pandemia de COVID-19 (RBCI-COVID19) / Brazilian Registry of Interventional Cardiology during the COVID-19 Pandemic (RBCI-COVID19)

Resumo Fundamento No início da pandemia de COVID-19, os pacientes com infarto do miocárdio (IM) demoraram para procurar um hospital por medo de contágio ou dificuldades no acesso aos serviços de saúde. Objetivos Avaliar procedimentos de cardiologia intervencionista realizados durante a pandemia de COVID-19 e implicações na abordagem do IM. Métodos Registro prospectivo de 24 centros de hemodinâmica no Brasil, com pacientes adultos submetidos a procedimentos de cardiologia intervencionista entre 26 de maio e 30 de novembro de 2020. Os desfechos foram complicações cardiovasculares (CV) e não CV, morte e IM. A concomitância de COVID-19 foi confirmada com RT-PCR. Técnicas de machine learning foram usadas com modelos não paramétricos de árvores de classificação. Usou-se análise de correspondência simples com o software R. Adotou-se nível de significância de 5%. Resultados Este estudo incluiu 1.282 pacientes, 435 dos quais (33,9%) apresentaram IM: IM com supra de ST (IMCSST), 239 (54,9%); e IM sem supra de ST(IMSSST), 196 (45.1%). Dos 1.282 pacientes, 29 tiveram complicações CV, 47 tiveram complicações não CV e 31 morreram. O diagnóstico de COVID-19 foi confirmado em 77 pacientes (6%), com 15,58% de mortalidade e 6,49% de complicações não CV. A maioria dos pacientes apresentou significativa doença arterial coronariana (63%). Trombo intracoronariano foi mais frequente na presença de IMCSST (3,4%) e COVID-19 (4%). Tempo porta-mesa superior a 12 horas no IMSSST associou-se a 30,8% de complicações, 25% em pacientes com COVID-19. Conclusões Todos os óbitos foram precedidos por complicações CV ou não CV. A presença de COVID-19 foi associada a óbito e complicações não fatais dos pacientes submetidos a procedimentos de cardiologia intervencionista durante a pandemia.

Abstract Background At the beginning of the COVID-19 pandemic, patients with myocardial infarction (MI) took longer to present to hospitals because of fear of contamination and health care access difficulties. Objectives To assess interventional cardiology procedures performed during the COVID-19 pandemic and its implications for MI approach. Methods Prospective registry of 24 cardiac catheterization laboratories in Brazil, with adult patients undergoing interventional cardiology procedures between May 26 and November 30, 2020. The outcomes were cardiovascular (CV) and non-CV complications, death, and MI. Concomitant COVID-19 was confirmed using RT-PCR. Machine learning techniques were used with nonparametric Classification Trees models, and Simple Correspondence Analysis, with R statistical software package. Significance level adopted of 5%. Results This study included 1282 patients, 435 of whom (33.9%) had MI as follows: ST-segment elevation MI (STEMI), 239 (54.9%); and non-ST-segment elevation MI (NSTEMI), 196 (45.1%). Of the 1282 patients, 29 had CV complications, 47 had non-CV complications, and 31 died. The diagnosis of COVID-19 was confirmed in 77 patients (6%), with 15.58% mortality and non-CV complications in 6.49%. Most patients had significant coronary artery disease (63%), and an intracoronary thrombus was more often found in the presence of STEMI (3.4%) and COVID-19 (4%). A door-to-table time longer than 12 hours in NSTEMI was associated with 30.8% of complications, 25% in COVID-19 patients. Conclusions All deaths were preceded by CV or non-CV complications. The presence of COVID-19 was associated with death and non-fatal complications of patients undergoing interventional cardiology procedures during the pandemic.

One-Year Clinical Outcome of Inspiron Stent in All-Comers Population (Analysis from 790 Consecutive Patients).

AIMS: The goal of this study was to evaluate the performance of the InspironTM coronary stent (Scitech Medical™, Goiás, Brazil). The InspironTM sirolimus-eluting stent uses an ultrathin L-605 cobalt-chromium alloy with a 75 µm strut thickness platform coated with an abluminal biodegradable polymer. The polymer is eliminated from the body through the tricarboxylic acid cycle in 6-9 months, releasing 80% of the drug within 30 days after its deployment. METHODS: It was a prospective, single-center registry. To represent clinical practice, all patients undergoing percutaneous coronary intervention were included in this registry. There were no exclusion criteria. Clinical follow-ups were performed at twelve months. The endpoints were the occurrence of all-cause death, definite stent thrombosis, and new revascularization. RESULTS: Between November 2017 and May 2019, 790 patients were included (1067 lesions). The mean age was 60.42 ± 14.94 years, and 74.7% presented with acute coronary syndrome. Diabetes mellitus was present in 43.9% of patients, and previous myocardial infarction and previous percutaneous coronary intervention were present in 17.9% and 11.3%, respectively. Angiographic success was achieved in 99.1%. The incidence of all-cause death was 11.5% (6.2% in-hospital and 5.3% in the follow-up) and definitive stent thrombosis was 0.2%. New revascularization was performed in only 5.8% (target lesion revascularization: 2.2%; progression of disease in another lesion: 3.6%). Based on the multivariate regression analysis, only chronic renal failure was an independent predictor of adverse events (OR: 3.3; 95% CI: 1.22-8.92). CONCLUSION: The result of this single-center registry demonstrates the safety and excellent performance of the InspironTM stent in daily clinical practice with a low rate of adverse cardiac events.