Este estudo avalia mortalidade, eventos hemorrágicos e reoperação em pacientes submetidos à cirurgia para troca valvar aórtica utilizando substituto biológico ou mecânico, com poder de relevância na seleção do tipo da prótese. Foram selecionados, randomicamente, 301 pacientes submetidos à cirurgia para troca valvar aórtica entre 1990 e 2005, com seguimento máximo de 20 anos. A sobrevivência em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 83,9%, 75,4% e 60,2% e, para substituto biológico, foi de 89,3%, 70,4% e 58,4%, respectivamente (p=0,939). Os fatores associados com o óbito foram: idade, obesidade, doença pulmonar, arritmias, eventos hemorrágicos e insuficiência valvar aórtica. A probabilidade livre de reoperação desses pacientes em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 97,9%, 95,8% e 95,8% e, para bioprótese, foi de 94,6%, 91,0% e 83,3%, respectivamente (p=0,057). Os fatores associados com reoperação foram: insuficiência renal, endocardite de prótese e idade. A probabilidade livre de eventos hemorrágicos em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 94,5%, 91,7% e 91,7% e, para bioprótese, foi de 98,6%, 97,8% e 97,8%, respectivamente (p=0,047). Os fatores associados com eventos hemorrágicos foram: insuficiência renal e prótese mecânica. Os autores concluíram que: 1) a mortalidade foi estatisticamente semelhante entre os grupos; 2) as características basais dos pacientes foram os maiores determinantes de mortalidade tardia após a cirurgia; 3) houve uma tendência à reoperação para o grupo com bioprótese; 4) pacientes com prótese mecânica tiveram mais eventos hemorrágicos ao longo do tempo; 5) os dados encontrados no presente estudo são concordantes com a literatura atual. / This paper evaluates mortality, bleeding events and reoperation in patients subjected to surgery for replacement of the aortic valve using a biological or a mechanical substitute, where selection of the type of prosthesis is relevant. Three hundred and one patients who had been subjected to aortic valve replacement surgery between 1990 and 2005, with a maximum follow-up period of 20 years, have been randomly selected. Survival at 5, 10 and 15 years after surgery using a mechanical substitute was 83.9%, 75.4% and 60.2% and, for a biological substitute, was 89.3%, 70.4% and 58.4%, respectively (p=0.939). Factors associated with death were: age, obesity, pulmonary disease, arrhythmia, bleeding and aortic valve failure. The probability free of reoperation for these patients at 5, 10 and 15 years after surgery using a mechanical substitute was 97.9%, 95.8% and 95.8% and, for those using bioprostheses, was 94.6%, 91.0% and 83.3%, respectively (p=0.057). Factors associated with reoperation were: renal failure, prosthesis endocarditis and age. The probability free of bleeding events at 5, 10 and 15 years after surgery using the mechanical substitute was 94.5%, 91.7% and 91.7% and, for bioprostheses, was 98.6%, 97.8% and 97.8%, respectively (p=0.047). Factors associated with bleeding events were: renal failure and mechanical prostheses. The authors have concluded that: 1) mortality was statistically similar in the groups; 2) patient characteristics at baseline were a major determinant of late mortality after surgery; 3) there was a tendency toward reoperation in the bioprostheses group; 4) patients using a mechanical prosthesis had more bleeding events as time passed; 5) the data presented in this paper is in accordance with current literature.

Este estudo avalia mortalidade, eventos hemorrágicos e reoperação em pacientes submetidos à cirurgia para troca valvar aórtica utilizando substituto biológico ou mecânico, com poder de relevância na seleção do tipo da prótese. Foram selecionados, randomicamente, 301 pacientes submetidos à cirurgia para troca valvar aórtica entre 1990 e 2005, com seguimento máximo de 20 anos. A sobrevivência em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 83,9%, 75,4% e 60,2% e, para substituto biológico, foi de 89,3%, 70,4% e 58,4%, respectivamente (p=0,939). Os fatores associados com o óbito foram: idade, obesidade, doença pulmonar, arritmias, eventos hemorrágicos e insuficiência valvar aórtica. A probabilidade livre de reoperação desses pacientes em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 97,9%, 95,8% e 95,8% e, para bioprótese, foi de 94,6%, 91,0% e 83,3%, respectivamente (p=0,057). Os fatores associados com reoperação foram: insuficiência renal, endocardite de prótese e idade. A probabilidade livre de eventos hemorrágicos em 5, 10 e 15 anos após cirurgia utilizando substituto mecânico foi de 94,5%, 91,7% e 91,7% e, para bioprótese, foi de 98,6%, 97,8% e 97,8%, respectivamente (p=0,047). Os fatores associados com eventos hemorrágicos foram: insuficiência renal e prótese mecânica. Os autores concluíram que: 1) a mortalidade foi estatisticamente semelhante entre os grupos; 2) as características basais dos pacientes foram os maiores determinantes de mortalidade tardia após a cirurgia; 3) houve uma tendência à reoperação para o grupo com bioprótese; 4) pacientes com prótese mecânica tiveram mais eventos hemorrágicos ao longo do tempo; 5) os dados encontrados no presente estudo são concordantes com a literatura atual. / This paper evaluates mortality, bleeding events and reoperation in patients subjected to surgery for replacement of the aortic valve using a biological or a mechanical substitute, where selection of the type of prosthesis is relevant. Three hundred and one patients who had been subjected to aortic valve replacement surgery between 1990 and 2005, with a maximum follow-up period of 20 years, have been randomly selected. Survival at 5, 10 and 15 years after surgery using a mechanical substitute was 83.9%, 75.4% and 60.2% and, for a biological substitute, was 89.3%, 70.4% and 58.4%, respectively (p=0.939). Factors associated with death were: age, obesity, pulmonary disease, arrhythmia, bleeding and aortic valve failure. The probability free of reoperation for these patients at 5, 10 and 15 years after surgery using a mechanical substitute was 97.9%, 95.8% and 95.8% and, for those using bioprostheses, was 94.6%, 91.0% and 83.3%, respectively (p=0.057). Factors associated with reoperation were: renal failure, prosthesis endocarditis and age. The probability free of bleeding events at 5, 10 and 15 years after surgery using the mechanical substitute was 94.5%, 91.7% and 91.7% and, for bioprostheses, was 98.6%, 97.8% and 97.8%, respectively (p=0.047). Factors associated with bleeding events were: renal failure and mechanical prostheses. The authors have concluded that: 1) mortality was statistically similar in the groups; 2) patient characteristics at baseline were a major determinant of late mortality after surgery; 3) there was a tendency toward reoperation in the bioprostheses group; 4) patients using a mechanical prosthesis had more bleeding events as time passed; 5) the data presented in this paper is in accordance with current literature.

INTRODUÇÃO: O implante transcateter de prótese valvar aórtica (TAVI) surge nos dias atuais como uma opção terapêutica para os pacientes sintomáticos portadores de estenose aórtica grave. Cerca de 200 mil pacientes em todo o mundo já foram submetidos ao TAVI. Não há grandes estudos que tenham avaliado a correlação prognóstica entre parâmetros ecocardiográficos antes do TAVI e eventos cardiovasculares a longo prazo. É relevante analisar se o strain pré-procedimento e outros parâmetros se comportam como fatores preditores independentes de eventos após o procedimento. MÉTODOS: Foram avaliados, de novembro de 2009 a outubro de 2016, 86 pacientes, submetidos a avaliação ecocardiográfica antes do TAVI e 30 dias após o procedimento, com análise do strain do ventrículo esquerdo pelo speckle tracking bidimensional e outros parâmetros ecocardiográficos. Esses pacientes foram acompanhados clinicamente e avaliados quanto aos desfechos: mortalidade global, mortalidade cardiovascular, classe funcional de insuficiência cardíaca e necessidade de reinternação cardiovascular. RESULTADOS: O strain global longitudinal pré-TAVI reduzido (valor absoluto) aumentou a chance de reinternação cardiovascular (OR: 0,87; 0,77 ±0,99; P= 0,038). A redução da relação E/e´ em 30 dias após o TAVI associou-se à queda da mortalidade global (OR: 0,97; 0,95 ±0,99; P = 0,006), bem como valores elevados pré procedimento dessa relação se associaram a maiores taxas de insuficiência cardíaca classe funcional III ou IV da New York Heart Association após a intervenção (OR: 1,08; 1±1,18; P = 0,049). CONCLUSÃO: Os resultados deste trabalho indicam que o strain global longitudinal pré-procedimento demonstrou ser um preditor de reinternação cardiovascular pós-intervenção a longo prazo. A relação E/e´ pré-procedimento apresentou correlação diretamente proporcional com o desenvolvimento de insuficiência cardíaca classe funcional III ou IV a longo prazo, assim como sua queda acentuada 30 dias após o procedimento correlacionou-se com menor mortalidade global. / INTRODUCTION: Transcatheter aortic valve replacement (TAVR) is a therapeutic option for symptomatic patients with severe aortic stenosis. Approximately 200,000 patients around the world have already undergone TAVR. No large studies have evaluated prognostic correlation between echocardiographic parameters before TAVR and long-term cardiovascular events. It is relevant to analyze strain before procedure and how other parameters work as independent predictors of events after the procedure. METHODS: A total of 86 patients were evaluated from November 2009 to October 2016. They underwent echocardiographic evaluation before TAVR and 30 days after the procedure with analysis of strain of the left ventricle by bidimensional speckle tracking and other echocardiographic parameters. Patients were followed clinically and evaluated in relation to outcomes: global mortality, cardiovascular mortality, functional class of heart failure and need for cardiovascular readmissions. RESULTS: Global longitudinal strain before reduced TAVR (absolute value) increased the chance of cardiovascular readmission (odds ratio: 0.87; 0.77 ± 0.99; p = 0.038). Reduction of E/e´ relationship 30 days after TAVI was associated with a drop in global mortality (odds ratio: 0.97; 0.95 ± 0.99; p = 0.006). In addition, high values for this relation before the procedure were associated with higher rates of New York Heart Association functional class III or IV heart failure after the intervention (odds ratio: 1.08; 1.00 ± 1.18; p = 0.049). CONCLUSIONS: Results of this study indicate that global longitudinal strain before the procedure is a predictor of cardiovascular readmission after TAVR. The E/e´relationship before the procedure presented a correlation directly proportional to the development of long-term functional class III or IV heart failure as well as its accentuated drop 30 days after the procedure was correlated with lower global mortality.

Introdução: Uma nova alternativa de tratamento foi desenvolvida, o Implante por Cateter de Bioprótese Valvar Aórtica (TAVI, em inglês, Transcatheter Aortic Valve Implantation), indicado para os pacientes portadores de estenose aórtica grave com várias comorbidades, considerados inoperáveis pelo tratamento cirúrgico convencional. O TAVI ainda não foi incorporado ao rol de políticas de saúde do Brasil pelo Sistema Único de Saúde (SUS), tampouco pela Agência Nacional de Saúde Suplementar (ANS), pois há escassez de evidências científicas fundamentadas em análise econômica do procedimento que relatem os resultados e o custo a longo prazo em comparação à cirurgia convencional. Objetivo: Identificar o custo direto médio do implante por cateter de bioprótese valvar aórtica, verificar se há alteração significativa de custo nas diferentes vias de acesso utilizadas e identificar os fatores preditores que possam elevar o custo do procedimento. Método: Trata-se de uma pesquisa com abordagens quantitativa, exploratória, descritiva, transversal, retrospectiva e documental, realizada em um hospital da Secretaria de Estado de Saúde de São Paulo (SES-SP), da Administração Direta, especializado no tratamento de doenças cardiovasculares de alta complexidade. A população do estudo correspondeu aos procedimentos eletivos do TAVI, desde a inauguração da sala híbrida, em março de 2012, até agosto de 2015, totalizando 108 procedimentos, sendo 92 por via transfemoral, 8 por via transapical e 8 por via transaórtica. Resultados: O custo direto médio dos procedimentos TAVI nas três vias totalizou R$ 82.230,94. Por via transfemoral, esse custo médio foi de R$ 82.826,38; por via transaórtica, R$ 79.440,91; e por via transapical, R$ 78.173,41. O total de material e medicamento/solução representou, por via transfemoral, 91,89% do total do custo direto médio do procedimento TAVI; por via transapical, 91,81%; e por via transaórtica, 90,69%, e o custo fixo com a válvula transcateter, no valor de R$ 65 mil, representou 78,47% sobre o custo total do procedimento TAVI, por via transfemoral; 83,14%, por via transapical; e 81,82%, por via transaórtica. O Teste Kruskal-Wallis Teste das Variáveis Contínuas apresentou diferença estatisticamente significativa entre as vias de acesso. No custo total do procedimento TAVI, o Teste de Bonferroni mostrou diferença na associação entre as vias transfemoral e transapical. No entanto, na associação com a via transaórtica, não apresentou diferença estatisticamente significativa. Os fatores preditores que elevaram o custo do procedimento TAVI foram: vias de acesso, duração do procedimento, material de hemodinâmica, medicamento/solução, material de consumo, material de perfusão, total de material e medicamento/solução, recursos humanos, gases medicinais, depreciação e energia. A segunda válvula foi a única variável referente às intercorrências no Centro Cirúrgico que elevou o custo do procedimento. A média de idade dos pacientes com indicação ao TAVI foi de 81,50 ±6,96 anos. Conclusão: O TAVI é um avanço a ser discutido e acompanhado, havendo a necessidade de reforçar novas pesquisas que avaliem os benefícios do tratamento com base nos resultados e custos, a fim de auxiliar na tomada de decisão para incorporação desse tratamento para o público-alvo, melhorando a qualidade de vida dos pacientes e proporcionando a integração destes novamente às atividades diárias. / Introduction: A new treatment alternative has been developed, the Transcatheter Aortic Valve Implantation (TAVI), indicated for patients with severe aortic stenosis with various comorbidities deemed inoperable by conventional surgical treatment. TAVI has not yet been incorporated into the Brazilian health policies by the Public Health System (SUS), or by the National Supplementary Health Agency (ANS), because there is a shortage of scientific evidence based on an economic analysis of the procedure that reports the results and the long-term costs compared to conventional surgery. Objective: To identify the average direct cost of the transcatheter aortic valve implantation, to verify if there is significant change of cost in the different access routes used, and to identify predictive factors that could increase the cost of the procedure. Method: This is a study with quantitative, exploratory, descriptive, transversal, retrospective, and documentary approaches, carried out in a hospital of the State Department of Health of São Paulo (SES-SP), of the Direct Administration, specialized in the treatment of high-complexity cardiovascular diseases. The study population corresponded to TAVI elective procedures, from the inauguration of the hybrid room, in March 2012, up to August 2015, totaling 108 procedures, of which 92 were transfemoral, 8 were transapical, and 8 were transaortic. Results: The average direct cost of the TAVI procedures in the three routes totaled R$ 82,230.94. Transfemorally, this average cost was R$ 82,826.38; through the transaortic route, R$ 79,440.91; and through the transapical route, R$ 78,173.41. The total material and medication / solution represented 91.89% of the total average direct cost of the TAVI procedure through the transfemoral route; 91.81% through the transapical route; and 90.69% through the transaortic route, and the fixed cost with the transcatheter valve, in the amount of R$ 65,000.00, represented 78.47% of the total cost of the TAVI procedure through the transfemoral route; 83.14%, through the transapical route; and 81.82% through the transaortic route. The Kruskal-Wallis Test Continuous Variables Test showed a statistically significant difference among the access routes. In the total cost of the TAVI procedure, the Bonferroni Test showed a difference in the association between the transfemoral and transapical routes. However, in the association with the transaortic route, there was no statistically significant difference. Predictive factors that increased the cost of the TAVI procedure were: access routes, length of procedure, hemodynamic material, drug / solution, consumption material, infusion material, total material and medicine/solution, human resources, medical gas, depreciation and energy. The second valve was the only variable related to the complications in the or that increased the cost of the procedure. The mean age of patients with TAVI was 81.50 ± 6.96 years. Conclusion: TAVI is an advance to be discussed and monitored, and there is a need to encourage new studies that evaluate the benefits of treatment based on the results and costs, in order to assist in the decision making for the incorporation of this treatment into its population, improving the quality of life of patients and providing once again their integration into daily activities.

Risk assessment models developed from administrative and clinical databases are used for clinical decision making. Since these models are derived from a database, they have an inherent limitation of being as good as the data they are derived from. Many of these models under or overestimate certain clinical outcomes particularly mortality in certain group of patients. Undeniably, there is significant variability in all these models on account of patient population studied, the statistical analysis used to develop the model and the period during which these models were developed. This review aims to shed light on development and application of risk assessment models for cardiac surgery with special emphasis on risk stratification in severe aortic stenosis to select patients for transcatheter aortic valve replacement.

Unicuspid aortic valve (UAV), which is a rare congenital anomaly, usually presents as aortic stenosis and/or aortic regurgitation. Here we present a case of UAV co-existent with an ascending aortic aneurysm. A 26-year-old male with no significant past medical history presented to the hospital after two episodes of syncope. Transthoracic echocardiogram showed an ejection fraction of 62%, severely stenotic aortic valve, and moderate aortic regurgitation. Computed tomography revealed calcification of the aortic valve, compatible with aortic stenosis and aneurysm of the ascending aorta measuring 4.3 cm in diameter. He underwent successful aortic valve replacement and repair of ascending aortic aneurysm. He recovered well without any complications. This case suggests that any young patient who presents with syncope, aortic stenosis would be a differential and further workup by any available non-invasive modality needs to be performed.

Transcatheter aortic valve replacement is a well-established alternative to surgical aortic valve replacement in high-risk patients with severe symptomatic aortic stenosis. Currently, this technique is shifting towards younger patient groups with intermediate- and low-risk profile, which raises the question about long-term durability. Despite acceptable results up to 5 years, little is currently known about valve performance beyond 5 years. Since valve deterioration, thrombosis and endocarditis seem to be the main factors affecting valve durability, precise and widely accepted definitions of these parameters were stated by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) in 2017, followed by the Valve in Valve International Data (VIVID) group definitions in 2018 and the Valve Academic Research Consortium 3 (VARC-3) definitions in 2021. Until the introduction of these definitions, interstudy comparisons were difficult due to missing uniformity. Since the release of these recommendations, an increasing number of studies have reported their data on long-term durability using these new criteria. The aim of the present article is to discuss the current definitions on bioprosthetic valve durability, and to summarize the available data on long-term durability of transcatheter aortic valves.

Background: Systemic inflammation can occur after transcatheter aortic valve replacement (TAVR) and correlates with adverse outcome. The impact of remote ischemic preconditioning (RIPC) on TAVR associated systemic inflammation is unknown and was focus of this study. Methods: We performed a prospective controlled trial at a single center and included 66 patients treated with remote ischemic preconditioning (RIPC) prior to TAVR, who were matched to a control group by propensity score. RIPC was applied to the upper extremity using a conventional tourniquet. Definition of systemic inflammation was based on leucocyte count, C-reactive protein (CRP), procalcitonin (PCT) and interleukin-6 (IL-6), assessed in the first 5 days following the TAVR procedure. Mortality was determined within 6 months after TAVR. RIPC group and matched control group showed comparable baseline characteristics. Results: Systemic inflammation occurred in 66% of all patients after TAVR. Overall, survival after 6 months was significantly reduced in patients with systemic inflammation. RIPC, in comparison to control, did not significantly alter the plasma levels of leucocyte count, CRP, PCT or IL-6 within the first 5 days after TAVR. Furthermore, inflammation associated survival after 6 months was not improved by RIPC. Of all peri-interventional variables assessed, only the amount of the applied contrast agent was connected to the occurrence of systemic inflammation. Conclusions: Systemic inflammation frequently occurs after TAVR and leads to increased mortality after 6 months. RIPC neither reduces the incidence of systemic inflammation nor improves inflammation associated patient survival within 6 months.

<p>Aortic stenosis is the most common valvular disease in the adult population. A significant aortic stenosis is a serious condition, and if a symptomatic patient is not operated on, it may in most cases cause death. We have examined how many aortic stenoses that were diagnosed during one year, and a follow-up of the patients was also performed. We found 77 patients with significant aortic stenosis with a mean age of 76±13 years. At the time of follow-up 30 (39%) patients, aged between 29-85 years, had been surgically treated with implantation of a valve prosthesis within 2-23 months after the initial examination. At this initial examination 14 of the 30 patients who later underwent surgery had no symptoms. A coronary bypass operation was also performed on seven patients. Postoperative complications were observed in six patients, but none of them was fatal. At the initial examinations there were 26 (34%) patients with a significant aortic stenosis and symptoms who were not treated surgically. The main reason why these patients were not operated was high age, unwillingness, or severe left ventricular dysfunction. This study indicates the importance of repeated clinical and echocardiograpic examinations in patients with aortic stenosis. Almost half of the patients, that later underwent surgery, had no symptoms at the initial examination, but later developed symptoms which made surgery necessary. In one third of the patients no surgery was performed in spite of clinical symptoms.</p>

The overall aim of this thesis is to explore experiences and self-reported outcomes from Transcatheter Aortic Valve Implantation, TAVI, among people with severe aortic stenosis. The thesis includes four studies. Study I-II are based on interviews performed the day before TAVI and Qualitative Concept Analysis was used for analysis. Study III is based on interviews at six months’ follow-up and Grounded Theory was used for analysis. Study IV is quantitative and based on questionnaires at baseline and at six months’ follow-up. Nonparametric, descriptive statistics were used for the analysis. Study I described the vulnerable situation for patients with severe aortic stenosis before TAVI. They were facing death and at the same time struggling to cope with their symptoms and to maintain independent. TAVI offered hope but also caused uncertainty about the new method. Study II focused on the patients’ decision-making process. Three patterns were identified; ambivalent, obedient, and reconciled. The ambivalent patient is unsure of the value of treatment and aware of the risks; the obedient patient is unsure of the value of one's own decision and wants to leave the decision to others; the reconciled patient has reached a point where there is no choice anymore and is always sure that the decision to undergo TAVI is right. Study III offered a deeper understanding of the TAVI trajectory. A journey of balancing between hope and life-struggle was the core category of the analysis. Before TAVI patients felt threatened, but also experienced hope. The rehabilitation phase was described as demanding and depressing or surprisingly simple. At the six months’ followup patients described being pleased to return to life, however, many were still struggling with limitations. Study IV focused on quantifying the symptom burden, function and health related quality of life before and after TAVI. The results were reflected against that of patients treated with open surgery. Self-rated function and health related quality of life increased and symptoms were reduced at follow-up, but breathlessness and fatigue were still common. Conclusively, TAVI patients are struggling with limitations, both because of their comorbidities and because of their valve disease which also poses a threat to their lives. TAVI gives an opportunity to survive, to stay independent and to increase quality of life. To feel and preserve hope is essential for patients’ wellbeing, both before and during the recovery process.