Clinical impact of sex differences and procedural setting in transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic patients with aortic stenosis. Yet, the impact of sex differences and public vs. private procedural setting on TAVI outcomes remain uncertain. METHODS: The RIBAC-NT (Brazilian Registry for Evaluation of Transcatheter Aortic Valve Replacement Outcomes) dataset included 3194 TAVI patients from 2009 to 2021. This retrospective analysis explored disparities in baseline characteristics, procedural and in-hospital outcomes stratifying patients by sex and procedural setting. Temporal trends were also investigated. RESULTS: We included 1551 (49 %) female and 1643 (51 %) male patients. Women were older (83 [78-87] vs. 81 [75-85] years; p < 0.01) but had a lower prevalence of diabetes mellitus (30.2 % vs. 36.3 %, p < 0.01) and coronary artery disease (39.0 % vs. 52.2 %, p < 0.01). However, women had a 3-fold higher higher risk of life-threatening bleeding (6.1 % vs. 2.4 %, p < 0.01). Women presented higher procedural and in-hospital mortality rates (4.4 % vs. 2.5 % and 7.7 % vs. 4.5 %, all p < 0.01, respectively). Although public hospitals presented ~2-fold higher procedural mortality rate compared with private settings (5.0 % vs. 2.7 %, p < 0.01), after multivariable analysis procedural setting was not independently associated with in-hospital mortality. CONCLUSIONS: Women had higher procedural and in-hospital mortality rates after TAVI as compared with men, while facing higher life-threatening bleeding and adverse events rates. Although public hospitals exhibited higher mortality rates than private centers, procedural setting was not independently associated with in-hospital mortality.

Clinical impact of sex differences and procedural setting in transcatheter aortic valve implantation

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a well-established treatment for symptomatic patients with aortic stenosis. Yet, the impact of sex differences and public vs. private procedural setting on TAVI outcomes remain uncertain. METHODS: The RIBAC-NT (Brazilian Registry for Evaluation of Transcatheter Aortic Valve Replacement Outcomes) dataset included 3194 TAVI patients from 2009 to 2021. This retrospective analysis explored disparities in baseline characteristics, procedural and in-hospital outcomes stratifying patients by sex and procedural setting. Temporal trends were also investigated. RESULTS: We included 1551 (49 %) female and 1643 (51 %) male patients. Women were older (83 [78-87] vs. 81 [75-85] years; p < 0.01) but had a lower prevalence of diabetes mellitus (30.2 % vs. 36.3 %, p < 0.01) and coronary artery disease (39.0 % vs. 52.2 %, p < 0.01). However, women had a 3-fold higher higher risk of life-threatening bleeding (6.1 % vs. 2.4 %, p < 0.01). Women presented higher procedural and in-hospital mortality rates (4.4 % vs. 2.5 % and 7.7 % vs. 4.5 %, all p < 0.01, respectively). Although public hospitals presented ~2-fold higher procedural mortality rate compared with private settings (5.0 % vs. 2.7 %, p < 0.01), after multivariable analysis procedural setting was not independently associated with in-hospital mortality. CONCLUSIONS: Women had higher procedural and in-hospital mortality rates after TAVI as compared with men, while facing higher life-threatening bleeding and adverse events rates. Although public hospitals exhibited higher mortality rates than private centers, procedural setting was not independently associated with in-hospital mortality.

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.

Reversible Tricuspid Regurgitation Due to Beriberi.

We report a case of cardiac beriberi in a 76-year-old man who was hospitalized with a congestive condition of subacute onset, diagnosed as high-output heart failure associated with severe tricuspid regurgitation and indication for caval valve implantation, which, after thiamine replacement, resulted in improvement of all conditions. (Level of Difficulty: Beginner.).

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.

Avaliação dos efeitos do curativo compressivo após procedimentos intervencionistas por via radial / Evaluation of the effects of compressive dressing after interventional procedures via radial approach

Introdução: Dispositivos externos compressivos após a punção radial para cateterismo cardíaco e intervenção coronária percutânea visam à hemostasia, ao conforto para o paciente e à segurança. O estudo objetivou avaliar pacientes submetidos a procedimentos coronários invasivos por via radial, nos quais se utilizou um curativo compressivo e de baixo custo, desenvolvido no serviço, avaliando a segurança dele e a ocorrência de complicações. Métodos: Indivíduos submetidos à coronariografia e à intervenção coronária percutânea, avaliados no momento de retirada do curativo compressivo e após 7 dias, por meio de questionário abrangendo comorbidades, quadro clínico, tempo do procedimento e de compressão, avaliação física de hematoma e dor, e Doppler vascular sonoro para avaliação de oclusão da artéria radial. Resultados: Foram avaliados 144 pacientes, sendo 138 com seguimento em 7 dias. Os eventos não diferiram entre procedimentos diagnósticos e terapêuticos. Na avaliação imediata à retirada do curativo, revelou-se incidência de 4,2% de oclusão da artéria radial, com dor referida em 23,6% dos pacientes, graduada em 2,9±1,7 pela Escala Visual Analógica (intensidade de zero a dez) e sem sangramentos graves. Hematoma ocorreu em um paciente (0,9%), com classificação III pelo critério EASY. Na avaliação de 7 dias, a incidência de oclusão da artéria radial foi de 2,2%, a dor foi referida em 11,1% da amostra (intensidade 1,8±0,8), e o hematoma foi evidenciado em 3,5%. Conclusão: O curativo compressivo mostrou-se um procedimento seguro, com baixa taxa de complicações e baixa taxa de dor local nos pacientes submetidos a procedimentos coronários invasivos pela via radial.

Background: External compressive devices after radial puncture for cardiac catheterization and percutaneous coronary intervention aim at hemostasis, patient comfort, and safety. The objective of the study was to evaluate patients undergoing invasive coronary procedures by radial approach, in which a low-cost compressive dressing developed at the service was used, assessing its safety and the occurrence of complications. Methods: Patients undergoing coronary angiography and percutaneous coronary intervention, evaluated at the time of removal of compressive dressing and after 7 days, by means of a questionnaire addressing comorbidities, clinical picture, procedure and compression time, physical assessment of hematoma and pain, and a vascular Doppler ultrasound to evaluate radial artery occlusion. Results: A total of 144 patients were evaluated, 138 of whom were followed up within 7 days. Events did not differ among diagnostic and therapeutic procedures. In the immediate evaluation after removal of dressing, an incidence of 4.2% of radial artery occlusion was observed, with pain reported by 23.6% of patients, graded at 2.9±1.7 points in the Visual Analogue Scale (intensity of zero to ten), and no major bleeding. Hematoma occurred in one patient (0.9%), classified as type III according to the EASY criteria. In the 7-day evaluation, the incidence of radial artery occlusion was 2.2%, pain was reported in 11.1% of sample (intensity 1.8±0.8), and hematoma was evident in 3.5%. Conclusion: The compressive dressing proved to be a safe procedure, with a low rate of complications and a low rate of local pain in patients undergoing invasive coronary procedures via radial approach.

Tratamento percutâneo de origem anômala de coronária direita com trajeto maligno em paciente com morte súbita abortada / Percutaneous treatment of anomalous origin of the right coronary artery with malignant course in a patient with aborted sudden death

Anomalias coronarianas são menos frequentes em relação às doenças coronarianas adquiridas, como a aterosclerose, e têm sido implicadas como causa de eventos cardiovasculares. Este relato de caso descreve um achado incidental por angiografia de coronária direita anômala com origem no seio coronariano esquerdo e trajeto intra-arterial, após episódio de morte súbita abortada. A análise do Heart Team indicou como melhor tratamento a abordagem percutânea com implante de stent farmacológico em origem de coronária direita, procedimento este que foi realizado com sucesso. Este relato de caso e estudos recentes têm demonstrado que o tratamento percutâneo de anomalias coronarianas é uma opção segura para pacientes selecionados, levando em consideração quadro clínico, estudo anatômico e capacitação da equipe de hemodinâmica

Coronary anomalies are less frequent than acquired coronary diseases, such as atherosclerosis, and have been implicated as a cause of cardiovascular events. This case report describes an incidental finding on angiography of an anomalous right coronary artery with origin in the left coronary sinus and an intra-arterial course, after an episode of aborted sudden death. The Heart Team analysis indicated a percutaneous approach with drug-eluting stent implantation at the origin of the right coronary artery as the best treatment, and the procedure was successfully performed. This case report and recent studies have demonstrated percutaneous treatment of coronary anomalies is a safe option for selected patients, considering clinical presentation, anatomy study, and training of the cath lab team

Embolização percutânea de fístulas arteriovenosas pulmonares / Percutaneous embolization of pulmonary arteriovenous fistulas

Malformações arteriovenosas pulmonares são uma comunicação anormal entre uma artéria e uma veia, causando manifestações clínicas, como hipoxemia crônica e eventos embólicos. As malformações arteriovenosas eram tratadas cirurgicamente, com taxa expressiva de complicações. Na década de 1970, a primeira embolização percutânea por cateter foi realizada com molas. Descrevemos três casos nos quais técnicas de embolização percutânea foram efetivas em prevenir eventos embólicos, hemorrágicos e hipoxêmicos no seguimento dos pacientes.

Pulmonary arteriovenous malformation is an abnormal communication between an artery and a vein, causing clinical manifestations, such as chronic hypoxemia and embolic events. Arteriovenous malformations were treated surgically, with a significant rate of complications. In the 1970 ́s, the first percutaneous catheter embolization was performed with coils. We describe three cases in which percutaneous embolization techniques were effective to prevent embolic, hemorrhagic, and hypoxemic events in the follow-up of patients.

Uso de aterectomia rotacional para tratamento de reestenose intra-stent com subexpansão de dupla malha de stents coronarianos. Relato de caso / Use of rotational atherectomy for treatment of in-stent restenosis with coronary double-mesh stent underexpansion. Case report

O tratamento de lesões reestenóticas intra-stent, principalmente as calcificadas, com subexpansão do stent, geralmente requer o uso de técnicas mais complexas para sua execução, como a aterectomia rotacional. O caso se trata de um paciente do sexo masculino com lesão reestenótica focal intra-stent de 99% na origem do primeiro ramo diagonal, local onde foram implantados dois stents há 14 anos. Após falha da angioplastia apenas com balões, realizou-se a ablação da placa e de parte das hastes dos stents pela técnica de aterectomia rotacional, o que possibilitou o implante de novo stent com sua expansão total.

Treatment of in-stent restenosis lesions, especially calcified lesions, with stent underexpansion, generally requires more complex techniques, such as rotational atherectomy. The case reported is a male patient with a 99% in-stent focal restenosis lesion at the origin of the first diagonal branch, where two stents were implanted 14 years ago. After failure of balloon angioplasty alone, ablation of the plaque and part of the stent struts was performed using the rotational atherectomy technique, which allowed the implantation of a new stent which was totally expanded.

Análise dos desfechos em intervenção coronária percutânea de tronco de coronária esquerda não protegido / Analysis of percutaneous coronary intervention outcomes in unprotected left main coronary artery lesions

Introdução: Lesões significativas no tronco de coronária esquerda são encontradas em aproximadamente 5% dos pacientes submetidos à coronariografia, sendo a maioria dos casos multiarteriais e com envolvimento do tronco distal. A cirurgia de revascularização do miocárdio é considerada o tratamento preferencial para lesões de tronco de coronária esquerda não protegido. No entanto, com o avanço de técnicas e a introdução dos novos stents liberadores de fármacos, a intervenção coronariana percutânea tem sido considerada estratégia viável, apresentando resultados favoráveis. O objetivo deste estudo foi analisar os desfechos em pacientes com lesões de tronco de coronária esquerda não protegido submetidos à intervenção coronariana percutânea. Métodos: Foram analisados dados eletrônicos de pacientes submetidos à intervenção coronariana percutânea entre dezembro de 2017 e janeiro de 2020 em um único centro, com o objetivo de avaliar características clínicas, angiográficas e os desfechos clínicos. Resultados: Foram incluídos 103 pacientes portadores de lesões significativas de tronco não protegido, 66% eram do sexo masculino, 88,3% eram hipertensos, e 87,4% possuíam função ventricular normal. Lesões envolvendo a bifurcação foram identificadas em 73,8% dos pacientes, 36,9% apresentavam lesões concomitantes nos três grandes vasos epicárdicos e 42,7% com escore SYNTAX intermediário (23 a 32 pontos). O sucesso angiográfico foi obtido em 100% dos casos, com quatro (3,9%) eventos cardíacos e cerebrovasculares adversos, sendo 2,9% de mortalidade. Conclusão: Os resultados hospitalares sustentam a intervenção coronariana percutânea como um procedimento seguro, de excelente resultado angiográfico e eventos cardíacos e cerebrovasculares adversos comparáveis aos da cirurgia de revascularização do miocárdio, configurando opção bastante viável em relação ao tratamento cirúrgico.

Background: Significant lesions in the left main coronary artery are found in approximately 5% of patients undergoing coronary angiography, with most cases involving multiple vessels and affecting the distal bifurcation. A coronary artery bypass graft surgery is considered the preferred treatment for unprotected left main coronary artery lesions. However, with the advancement of techniques and the introduction of new drug-eluting stents, percutaneous coronary intervention has been considered a viable strategy, with favorable results. The objective of this study was to analyze the outcomes in patients with unprotected left main coronary artery lesions undergoing percutaneous coronary intervention. Methods: Electronic data from patients undergoing percutaneous coronary intervention between December 2017 and January 2020 at a single center were analyzed to assess clinical and angiographic characteristics and clinical outcomes. Results: A total of 103 patients with significant unprotected left main coronary artery lesions were included; in that, 66% were male, 88.3% were hypertensive, and 87.4% had normal ventricular function. Lesions involving the bifurcation were identified in 73.8% of patients, 36.9% had concomitant lesions in the three major epicardial vessels, and 42.7% had an intermediate SYNTAX score (23 to 32 points). Angiographic success was achieved in 100% of cases, with four (3.9%) adverse cardiac and cerebrovascular events, with 2.9% mortality. Conclusion: Hospital results support percutaneous coronary intervention as a safe procedure, with excellent angiographic results and low rates of adverse cardiac and cerebrovascular events. We concluded that percutaneous coronary intervention is an option to coronary artery bypass graft surgery and is a very viable option for surgical treatment of unprotected left main coronary artery lesions.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial

Resumo Introdução e objetivos: Stents Coated with the Biodegradable Polymer on their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions (Destiny Trial) é um estudo randomizado de não inferioridade que comparou o stent farmacológico eluído com Sirolimus Inspiron® (SES) ao controle o stent Biomatrix® Flex eluído com biolimus (BES). Relatórios dentro do primeiro ano mostraram resultados semelhantes para ambos os stents, em seguimento clínico, angiográfico e também em análise de tomografia de coerência ótica e ultrassom intracoronário. A presente análise tem como objetivo comparar o desempenho clínico desses dois stents farmacológicos com polímeros biodegradáveis após cinco anos do procedimento índice. Métodos: Foram randomizados 170 pacientes (194 lesões) em uma proporção de 2:1 para trata mento com SES ou BES, respetivamente. O desfecho primário para o presente estudo foi a taxa em cinco anos de eventos cardíacos adversos maiores combinados, definida como morte cardíaca, infarto do miocárdio ou revascularização da lesão-alvo. Resultados: Em cinco anos, o desfecho primário ocorreu em 12,5% e 17,9% para o grupo SES e BES, respectivamente (p=0,4). Não houve trombose de stent definitiva ou provável entre os pacientes tratados com o novo SES durante os cinco anos de seguimento e ausência de trombose de stent após o primeiro ano no grupo BES. Conclusões: O novo stent Inspiron® apresentou uma boa e semelhante performance clínica no seguimento em longo prazo, quando comparado com o controle o stent de última geração Biomatrix® Flex.

Spinal anesthesia increases the frequency of extubation in the operating room and decreases the time of mechanical ventilation after cardiac surgery

Abstract Introduction: The delayed extubation of patients undergoing mechanical ventilation (MV) in the postoperative period of cardiac surgery (CS) is associated with mortality. The adoption of spinal anesthesia (SA) combined with general anesthesia in CS influences the orotracheal intubation time (OIT). This study aims to verify if the adoption of SA reduces the time of MV after CS, compared to general anesthesia (GA) alone. Methods: Two hundred and seventeen CS patients were divided into two groups. The GA group included 108 patients (age: 56±1 years, 66 males) and the SA group included 109 patients (age: 60±13 years, 55 males). Patients were weaned from MV and, after clinical evaluation, extubated. Results: In the SA group, considering a 13-month period, 24% of the patients were extubated in the operating room (OR), compared to 10% in the GA group (P=0.00). The OIT was lower in the SA group than in the GA group (SA: 4.4±5.9 hours vs. GA: 6.0±5.6 hours, P=0.04). In July/2017, where all surgeries were performed in the GA regimen, only 7.1% of the patients were extubated in the OR. In July/2018, 94% of the surgeries were performed under SA, and 64.7% of the patients were extubated in the OR (P=0.00). The OIT on arrival at the intensive care unit to extubation, comparing July/2017 to July/2018, was 5.3±5.3 hours in the GA group vs. 1.7±3.9 hours in the SA group (P=0.04). Conclusion: The adoption of SA in CS increased the frequency of extubations in the OR and decreased OIT and MV time.

Comparative clinical performance of two types of drug-eluting stents with abluminal biodegradable polymer coating: Five-year results of the DESTINY randomized trial.

INTRODUCTION AND OBJECTIVES: The Stents Coated With the Biodegradable Polymer on Their Abluminal Faces and Elution of Sirolimus Versus Biolimus Elution for the Treatment of de Novo Coronary Lesions - DESTINY Trial is a non-inferiority randomized study that compared the Inspiron™ sirolimus-eluting stent (SES) with the control Biomatrix™ Flex biolimus-eluting stent (BES). Previous reports in the first year showed similar outcomes for both stents, in clinical, angiographic, optical coherence tomography, and intravascular ultrasound assessments. The present analysis aims to compare the clinical performance of these two biodegradable polymer drug-eluting stents five years after the index procedure. METHODS: A total of 170 patients (194 lesions) were randomized in a 2:1 ratio for treatment with SES or BES, respectively. The primary endpoint for the present study was the five-year rate of combined major adverse cardiac events, defined as cardiac death, myocardial infarction, or target lesion revascularization. RESULTS: At five years, the primary endpoint occurred in 12.5% and 17.9% of the SES and BES groups, respectively (p=0.4). There was no definite or probable stent thrombosis among patients treated with the novel SES stent during the five years of follow-up, and no stent thrombosis after the first year in the BES group. CONCLUSIONS: The novel Inspiron™ stent had similar good clinical performance in long-term follow-up when compared head-to-head with the control latest-generation Biomatrix™ Flex biolimus-eluting stent.

Spinal Anesthesia Increases the Frequency of Extubation in the Operating Room and Decreases the Time of Mechanical Ventilation after Cardiac Surgery.

INTRODUCTION: The delayed extubation of patients undergoing mechanical ventilation (MV) in the postoperative period of cardiac surgery (CS) is associated with mortality. The adoption of spinal anesthesia (SA) combined with general anesthesia in CS influences the orotracheal intubation time (OIT). This study aims to verify if the adoption of SA reduces the time of MV after CS, compared to general anesthesia (GA) alone. METHODS: Two hundred and seventeen CS patients were divided into two groups. The GA group included 108 patients (age: 56±1 years, 66 males) and the SA group included 109 patients (age: 60±13 years, 55 males). Patients were weaned from MV and, after clinical evaluation, extubated. RESULTS: In the SA group, considering a 13-month period, 24% of the patients were extubated in the operating room (OR), compared to 10% in the GA group (P=0.00). The OIT was lower in the SA group than in the GA group (SA: 4.4±5.9 hours vs. GA: 6.0±5.6 hours, P=0.04). In July/2017, where all surgeries were performed in the GA regimen, only 7.1% of the patients were extubated in the OR. In July/2018, 94% of the surgeries were performed under SA, and 64.7% of the patients were extubated in the OR (P=0.00). The OIT on arrival at the intensive care unit to extubation, comparing July/2017 to July/2018, was 5.3±5.3 hours in the GA group vs. 1.7±3.9 hours in the SA group (P=0.04). CONCLUSION: The adoption of SA in CS increased the frequency of extubations in the OR and decreased OIT and MV time.

Implante Percutâneo Transeptal de Bioprótese em Disfunção de Prótese Valvar Cirúrgica Mitral - Experiência Multicêntrica Brasileira / Percutaneous Transseptal Bioprosthetic Implantation in Failed Prosthetic Surgical Mitral Valve - Brazilian Multicenter Experience

Resumo Fundamento A intervenção percutânea em pacientes com disfunção de prótese biológica mitral apresenta-se como uma alternativa ao tratamento cirúrgico convencional. Objetivo Relatar a primeira experiência brasileira de implante transcateter de bioprótese valve-in-valve mitral via transeptal (TMVIV-via transeptal). Métodos Foram incluídos pacientes portadores de disfunção de bioprótese cirúrgica submetidos ao TMVIV-transeptal em 12 hospitais brasileiros. Foram considerados estatisticamente significativos valores de p<0,05. Resultados Entre junho/2016 e fevereiro/2019, 17 pacientes foram submetidos ao TMVIV-via transeptal. A mediana de idade foi 77 anos (IIQ,70-82), a mediana do escore STS-PROM foi 8,7% (IIQ,7,2-17,8). Todos os pacientes tinham sintomas limitantes de insuficiência cardíaca (CF≥III), tendo 5 (29,4%) sido submetidos a mais de uma toracotomia prévia. Obteve-se sucesso do TMVIV-via transeptal em todos os pacientes. A avaliação ecocardiográfica demonstrou redução significativa do gradiente médio (pré-intervenção, 12±3,8 mmHg; pós-intervenção, 5,3±2,6 mmHg; p<0,001), assim como aumento da área valvar mitral (pré-intervenção, 1,06±0,59 cm2; pós-intervenção, 2,18±0,36 cm2; p<0,001) sustentados em 30 dias. Houve redução significativa e imediata da pressão sistólica de artéria pulmonar, com redução adicional em 30 dias (pré-intervenção, 68,9±16,4 mmHg; pós-intervenção, 57,7±16,5 mmHg; 30 dias, 50,9±18,7 mmHg; p<0,001). Durante o seguimento, com mediana de 162 dias (IIQ, 102-411), observou-se marcada melhora clínica (CF≤II) em 87,5%. Um paciente (5,9%) apresentou obstrução de via de saída de ventrículo esquerdo (VSVE), evoluindo para óbito logo após o procedimento, e outro morreu aos 161 dias de seguimento.Conclusão: A primeira experiência brasileira de TMVIV-transeptal demonstra a segurança e a efetividade dessa nova técnica. A obstrução da VSVE é uma complicação potencialmente fatal, reforçando a importância da seleção dos pacientes e do planejamento do procedimento. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Abstract Background Percutaneous intervention in patients with bioprosthetic mitral valve dysfunction is an alternative to conventional surgical treatment. Objectives To report the first Brazilian experience with transseptal transcatheter bioprosthetic mitral valve-in-valve implantation (transseptal-TMVIV). Methods Patients with surgical bioprosthetic dysfunction submitted to transseptal-TMVIV in 12 Brazilian hospitals were included. The significance level adopted was p<0.05. Results From June/2016 to February/2019, 17 patients underwent transseptal-TMVIV. Their median age was 77 years (IQR,70-82) and median Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) score was 8.7% (IQR,7.2-17.8). All patients had limiting symptoms of heart failure (FC≥III) and 5 (29.4%) had undergone more than one previous thoracotomy. Transseptal-TMVIV was successful in all patients. Echocardiographic assessment showed a significant reduction in mean mitral valve gradient (pre-intervention, 12±3.8 mmHg; post-intervention, 5.3±2.6 mmHg; p<0.001), in addition to an increase in mitral valve area (pre-intervention, 1.06±0.59 cm2; post-intervention, 2.18±0.36 cm2; p<0.001) sustained for 30 days. There was a significant and immediate reduction in the pulmonary artery systolic pressure, with an additional reduction in 30 days (pre-intervention, 68.9±16.4 mmHg; post-intervention, 57.7±16.5 mmHg; 30 days, 50.9±18.7 mmHg; p<0.001). During follow-up (median, 162 days; IQR, 102-411), significant clinical improvement (FC≤II) was observed in 87.5% of the patients. One patient (5.9%) had left ventricular outflow tract (LVOT) obstruction and died right after the procedure, and another died at 161 days of follow-up. Conclusion The first Brazilian experience with transseptal-TMVIV shows the safety and effectivity of the new technique. The LVOT obstruction is a potentially fatal complication, reinforcing the importance of patients' selection and of procedural planning. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0)

Percutaneous Transseptal Bioprosthetic Implantation in Failed Prosthetic Surgical Mitral Valve - Brazilian Multicenter Experience. / Implante Percutâneo Transeptal de Bioprótese em Disfunção de Prótese Valvar Cirúrgica Mitral ­ Experiência Multicêntrica Brasileira.

BACKGROUND: Percutaneous intervention in patients with bioprosthetic mitral valve dysfunction is an alternative to conventional surgical treatment. OBJECTIVES: To report the first Brazilian experience with transseptal transcatheter bioprosthetic mitral valve-in-valve implantation (transseptal-TMVIV). METHODS: Patients with surgical bioprosthetic dysfunction submitted to transseptal-TMVIV in 12 Brazilian hospitals were included. The significance level adopted was p<0.05. RESULTS: From June/2016 to February/2019, 17 patients underwent transseptal-TMVIV. Their median age was 77 years (IQR,70-82) and median Society of Thoracic Surgeons predicted risk of mortality (STS-PROM) score was 8.7% (IQR,7.2-17.8). All patients had limiting symptoms of heart failure (FC≥III) and 5 (29.4%) had undergone more than one previous thoracotomy. Transseptal-TMVIV was successful in all patients. Echocardiographic assessment showed a significant reduction in mean mitral valve gradient (pre-intervention, 12±3.8 mmHg; post-intervention, 5.3±2.6 mmHg; p<0.001), in addition to an increase in mitral valve area (pre-intervention, 1.06±0.59 cm2; post-intervention, 2.18±0.36 cm2; p<0.001) sustained for 30 days. There was a significant and immediate reduction in the pulmonary artery systolic pressure, with an additional reduction in 30 days (pre-intervention, 68.9±16.4 mmHg; post-intervention, 57.7±16.5 mmHg; 30 days, 50.9±18.7 mmHg; p<0.001). During follow-up (median, 162 days; IQR, 102-411), significant clinical improvement (FC≤II) was observed in 87.5% of the patients. One patient (5.9%) had left ventricular outflow tract (LVOT) obstruction and died right after the procedure, and another died at 161 days of follow-up. CONCLUSION: The first Brazilian experience with transseptal-TMVIV shows the safety and effectivity of the new technique. The LVOT obstruction is a potentially fatal complication, reinforcing the importance of patients' selection and of procedural planning. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0).

FUNDAMENTO: A intervenção percutânea em pacientes com disfunção de prótese biológica mitral apresenta-se como uma alternativa ao tratamento cirúrgico convencional. OBJETIVO: Relatar a primeira experiência brasileira de implante transcateter de bioprótese valve-in-valve mitral via transeptal (TMVIV-via transeptal). MÉTODOS: Foram incluídos pacientes portadores de disfunção de bioprótese cirúrgica submetidos ao TMVIV-transeptal em 12 hospitais brasileiros. Foram considerados estatisticamente significativos valores de p<0,05. RESULTADOS: Entre junho/2016 e fevereiro/2019, 17 pacientes foram submetidos ao TMVIV-via transeptal. A mediana de idade foi 77 anos (IIQ,70-82), a mediana do escore STS-PROM foi 8,7% (IIQ,7,2-17,8). Todos os pacientes tinham sintomas limitantes de insuficiência cardíaca (CF≥III), tendo 5 (29,4%) sido submetidos a mais de uma toracotomia prévia. Obteve-se sucesso do TMVIV-via transeptal em todos os pacientes. A avaliação ecocardiográfica demonstrou redução significativa do gradiente médio (pré-intervenção, 12±3,8 mmHg; pós-intervenção, 5,3±2,6 mmHg; p<0,001), assim como aumento da área valvar mitral (pré-intervenção, 1,06±0,59 cm2; pós-intervenção, 2,18±0,36 cm2; p<0,001) sustentados em 30 dias. Houve redução significativa e imediata da pressão sistólica de artéria pulmonar, com redução adicional em 30 dias (pré-intervenção, 68,9±16,4 mmHg; pós-intervenção, 57,7±16,5 mmHg; 30 dias, 50,9±18,7 mmHg; p<0,001). Durante o seguimento, com mediana de 162 dias (IIQ, 102-411), observou-se marcada melhora clínica (CF≤II) em 87,5%. Um paciente (5,9%) apresentou obstrução de via de saída de ventrículo esquerdo (VSVE), evoluindo para óbito logo após o procedimento, e outro morreu aos 161 dias de seguimento.Conclusão: A primeira experiência brasileira de TMVIV-transeptal demonstra a segurança e a efetividade dessa nova técnica. A obstrução da VSVE é uma complicação potencialmente fatal, reforçando a importância da seleção dos pacientes e do planejamento do procedimento. (Arq Bras Cardiol. 2020; [online].ahead print, PP.0-0).

Deambulação precoce após angioplastia transluminal coronária por acesso femoral - Relato de dois casos / Early ambulation after femoral percutaneous transluminal angioplasty - Report of 02 cases

INTRODUÇÃO: No Brasil e no mundo ainda é abundante o número de serviços hospitalares que restringe a realização de exercício nos indivíduos submetidos à angioplastia transluminal coronária (ATC), no período pós-operatório imediato, por receio de complicações. É importante demonstrar que a Fisioterapia cardiovascular pode ser realizada nessa população. OBJETIVO: Verificar os efeitos adversos no desempenho da deambulação precoce após ATC, com o uso de um dispositivo mecânico de oclusão arterial na punção femoral. POPULAÇÃO E MÉTODOS: Relato de dois casos (um homem de 68 anos e uma mulher de 57 anos) submetidos à ATC de um único vaso (artéria coronária direita e ramo diagonal, respectivamente) que tiveram sua punção realizada por via femoral, associada ao dispositivo de fechamento arterial Angio-Seal- St. Jude Medical®, que receberam alta do hospital após seis horas do término da intervenção. Os pacientes apresentavam, antes da ATC, angina estável e fatores de risco cardiovascular (dislipidemia, hipertensão e outros). Após a ATC, os pacientes foram avaliados pela equipe, que monitorava intercorrências durante a internação (dor no peito, desconforto ventilatório, eletrocardiograma, enzimas cardíacas e outras). A marcha dos indivíduos era verificada, no sentido de se avaliar a tolerância dos indivíduos à mesma, após cinco horas da realização da ATC. Os indivíduos eram orientados a caminhar em ritmo leve (Borg modificado entre 1-3) por cinco minutos em um corredor de aproximadamente 15 metros, em movimentos de ida e volta, sendo avaliados após a deambulação quanto ao surgimento de hematoma no sítio da punção, dores ou quaisquer complicações que surgissem. No primeiro dia de pós-operatório foi realizado um telefonema para segunda checagem de complicações. RESULTADOS: Ambos toleraram a realização dos cinco minutos de marcha e foram liberados do hospital após seis horas, deambulando sem intercorrências. Um dos pacientes referiu cefaleia de baixa intensidade durante a internação. A mesma paciente referiu dor de baixa intensidade no local da punção arterial no dia seguinte. Não se verificaram alterações clinicamente relevantes nos parâmetros cardiovasculares ou ventilatórios durante as seis horas de internação pós-operatória ou durante a deambulação. CONCLUSÃO: A realização de deambulação precoce dentro de seis horas após a ATC foi bem tolerada nos dois casos estudados, mesmo com o sítio de acesso arterial femoral. O uso de dispositivo mecânico de fechamento arterial foi importante para que se pudesse realizar a deambulação nessa população.

INTRODUCTION: In Brazil and around the world, there is still an abundance of hospital services that restrict exercise in individuals undergoing percutaneous coronary interventions (PCI), in the immediate postoperative period, for fear of complications. It is important to demonstrate that cardiovascular physical therapy can be performed in this population. OBJECTIVE: To verify the adverse effects in the performance of early ambulation after PCI, with the use of a mechanical device of arterial closure in the femoral puncture. POPULATION AND METHODS: Two cases (68-years-old man and 57-years-old woman) submitted to a single-vessel coronary artery (right coronary artery and diagonal branch, respectively) that had their femoral puncture associated with the device Angio-Seal - St. Jude Medical©, who were discharged from the hospital six hours after the intervention. Before PCI, patients had stable angina and cardiovascular risk factors (dyslipidemia, hypertension, and others). After the PCI, the patients were evaluated by the Heart Team, who monitored intercurrences during hospitalization (chest pain, ventilatory discomfort, electrocardiogram, cardiac enzymes and others). The gait of the individuals was verified, in order to evaluate the tolerance of the individuals to the same, after five hours of the PCI. Individuals were advised to walk in a light rhythm (modified Borg 1-3) for five minutes in a corridor of approximately 15 meters, in round-trip movements, and were evaluated after ambulation for hematoma at the puncture site, pain or any complications that might arise. On the first postoperative day, a telephone call was made for a second complication check. RESULTS: Both patients tolerated the five-minute walk and were released from the hospital after six hours, wandering uneventfully. One of the patients reported low-intensity headache during hospitalization. The same patient reported low-intensity pain at the puncture site the next day. There were no clinically relevant changes in cardiovascular or ventilatory parameters during the six hours postoperative hospitalization or during ambulation. CONCLUSION: Early ambulation within six hours after PCI was well tolerated in the two cases studied, even with the femoral artery access site. The use of a mechanical device for arterial closure was important so that the ambulation could be carried out in this population.

Intravascular imaging comparison of two metallic limus-eluting stents abluminally coated with biodegradable polymers: IVUS and OCT results of the DESTINY trial.

We sought to compare, by means of IVUS and OCT imaging, the performance of a novel sirolimus-eluting drug-eluting stent (DES) with biodegradable polymer (Inspiron™) to the Biomatrix™ DES. From the DESTINY trial, a total of 70 randomized patients (2:1) were enrolled in the IVUS substudy (Inspiron™, n = 46; Biomatrix™: n = 20) while 25 patients were evaluated with OCT (Inspiron™, n = 19; Biomatrix™: n = 06) at 9-month follow-up. The main endpoints were % of neointimal tissue obstruction (IVUS) and neointimal stut coverage (OCT) at 9 months. Patients treated with both DES had very little NIH formation at 9 months either by IVUS (% of NIH obstruction of 4.9 ± 4.1 % with Inspiron™ vs. 2.7 ± 2.9 % with Biomatrix™, p = 0.03) or by OCT (neointimal thickness of 144.2 ± 72.5 µm Inspiron™ vs. 115.0 ± 53.9 µm with Biomatrix™, p = 0.45). Regarding OCT strut-level assessment, again both devices showed excellent 9-month performance, with high rates of strut coverage (99.49 ± 1.01 % with Inspiron™ vs. 97.62 ± 2.21 % with Biomatrix™, p < 0.001) and very rare malapposition (0.29 ± 1.06 % with Inspiron™ vs. 0.53 ± 0.82 % with Biomatrix™, p = 0.44). Patients with any uncovered struts were more frequently identified in the Biomatrix™ group (9.78 ± 7.13 vs. 2.29 ± 3.91 %, p < 0.001). In the present study, midterm IVUS and OCT evaluations showed that both new generation DES with biodegradable polymer were effective in terms of suppressing excessive neointimal response, with very high rates of apposed and covered struts, suggesting a consistent and benign healing pattern.