Health-related quality of life of patients submitted to correction of heart valve diseases / Qualidade de vida relacionada à saúde de pacientes submetidos à correção de valvopatias

INTRODUCTION: The measurement of the health-related quality of life construct can reveal the positive repercussions on the lives of patients undergoing corrective valve procedures, as well as revealing points that prevent new surgical approaches. OBJECTIVE: To identify the health-related quality of life of valvular heart disease in the perioperative period of conventional valve surgery. METHODS: This is an integrative literature review. Searches were performed independently in four databases using controlled and uncontrolled descriptors. Eligibility criteria were: original articles that addressed the assessment of the health-related quality of life of valvular patients undergoing valve repair and/or valve prosthesis implantation; in Portuguese, English, and Spanish; with a time frame for convenience between 2015 and 2019. RESULTS: 14 studies comprised the final review sample, despite being studies conducted in different countries and with different designs, it was possible to verify the improvement in health-related quality of life when evaluated through generic instruments in valvular patients after valve surgery. However, in studies in which the assessment of the construct occurred through specific instruments, the existence of factors that can interfere with the quality of life of patients undergoing valve implantation was revealed. CONCLUSION: It was noticed that there was generally an improvement in health-related quality of life after the surgical intervention.

INTRODUÇÃO: A mensuração do constructo qualidade de vida relacionada à saúde pode revelar as repercussões positivas na vida dos pacientes submetidos a procedimentos valvares corretivos, bem como revelar pontos que para prevenção de novas abordagens cirúrgica. OBJETIVO: Identificar a qualidade de vida relacionada à saúde de valvopatas no perioperatório de intervenção cirúrgica valvar convencional. MÉTODO: Trata-se de uma revisão integrativa da literatura. As buscas foram realizadas de forma independente, em quatro bases de dados por meio de descritores controlados e não controlados. Os critérios de elegibilidade foram: artigos originais que abordassem a avaliação da qualidade de vida relacionada à saúde de valvopatas submetidos à plastia valvar e/ou implante de prótese valvar; nos idiomas português, inglês e espanhol; com recorte temporal por conveniência entre 2015 e 2019. RESULTADOS: 14 estudos compuseram a amostra final da revisão, apesar de serem estudos realizados em distintos países e com diferentes delineamentos foi possível verificar a melhora da qualidade de vida relacionada à saúde quando avaliada por meio de instrumentos genéricos em valvopatas após a intervenção cirúrgica valvar. Todavia, nos estudos em que a avaliação do constructo ocorreu por meio de instrumentos específicos, foi revelada a existência de fatores que podem interferir na qualidade de vida dos pacientes submetidos aos implantes valvares. CONCLUSÃO: Percebeu-se que geralmente houve melhora da qualidade de vida relacionada à saúde após a intervenção cirúrgica.

Prótesis Starr-Edwards vigente y funcional por más de 40 años / Starr-Edwards prosthesis current and functional for more than 40 years

INTRODUCCIÓN. Las enfermedades valvulares cardíacas han sido un foco de estudio y de evolución continua, pues existen grupos de pacientes seleccionados en quienes el cambio valvular es parte de su terapéutica. En 1960 surgió el modelo de prótesis de válvula en forma de esfera enjaulada de Albert Starr y Lowell Edwards. El diseño fue perfeccionándose y es usado hasta la actualidad ya que muestra resultados clínicos aceptables. OBJETIVO. Describir el caso de un paciente portador, de uno de los primeros prototipos de prótesis valvular cardiaca metálica Starr-Edwards vigente y funcional por más de 40 años. CASO CLÍNICO. Paciente masculino con prótesis Starr-Edwards en posición aórtica, quien hasta la fecha lleva más de 40 años de uso, mantiene la clase funcional II de la New York Heart Association, realizando anticoagulación con Warfarina así como controles estrictos del índice internacional normalizado. DISCUSIÓN. Es primordial la evaluación y seguimiento de portadores de prótesis valvular para analizar anifestaciones clínicas (disnea) y hallazgos en los exámenes de laboratorio o de imagen (ecografía) para el control clínico y hemodinámica del paciente, con la intención de contemplar circunstancias que podrían determinar la nueva intervención valvular. CONCLUSIONES. Las válvulas metálicas, en particular las del tipo de prótesis de Starr-Edwards presentan alto riesgo trombótico por lo que es recomendable mantener anticoagulación plena evitando valores de índice internacional normalizado muy elevados que podrían crear escenarios de eventos hemorrágicos. Varios pacientes portadores de una de las prótesis más antiguas como es el modelo la prótesis Starr-Edwards, pueden llegar a tener una mejor supervivencia y resultados clínicos aceptables.

INTRODUCTION. Cardiac valve diseases have been a focus of study and continuous evolution, since there are selected groups of patients in whom valve replacement is part of their therapy. In 1960, the caged sphere valve prosthesis model of Albert Starr and Lowell Edwards was developed. The design was refined and is still used today because it shows acceptable clinical results. OBJECTIVE. To describe the case of a patient with one of the first prototypes of Starr- Edwards metallic heart valve prosthesis, which has been in use and functional for more than 40 years. CLINICAL CASE. Male patient with Starr-Edwards prosthesis in aortic position, who to date has been used for more than 40 years, maintains functional class II of the New York Heart Association, performing anticoagulation with Warfarin as well as strict controls of the international normalized index. DISCUSSION. The evaluation and follow-up of valve prosthesis carriers is essential to analyze clinical manifestations (dyspnea) and findings in laboratory or imaging tests (ultrasound) for the clinical and hemodynamic control of the patient, with the intention of contemplating circumstances that could determine the new valve intervention. CONCLUSIONS. Metallic valves, particularly those of the Starr-Edwards prosthesis type, present a high thrombotic risk and it is therefore advisable to maintain full anticoagulation, avoiding very high values of the international normalized index that could create scenarios of hemorrhagic events. Several patients carrying one of the older prostheses, such as the Starr-Edwards prosthesis model, may have better survival and acceptable clinical results.

Conhecimento sobre anticoagulação oral de pacientes após correção cirúrgica de valvopatias: revisão integrativa / Conocimiento sobre la anticoagulación oral de los pacientes después de la corrección quirúrgica de valvulopatías: revisión integradora / Knowledge about oral anticoagulation of patients after surgical correction of valve diseases: integrative review

Objetivo: Verificar a existência de evidências científicas na literatura sobre o conhecimento dos pacientes em relação ao uso do anticoagulante oral após o implante de valva cardíaca metálica. Método: Revisão integrativa realizada nas bases de dados Embase, Scopus, Web of Science e Sistema Online de Busca e Análise de Literatura Médica (MEDLINE)/PubMed, utilizando descritores controlados e não controlados, sem delimitação temporal quanto à publicação, nos idiomas português, inglês e espanhol. A busca ocorreu em junho de 2022, por duas pesquisadoras de forma independente. Resultado: Verificou-se a existência de lacunas no conhecimento dos pacientes sobre os efeitos adversos relacionados ao uso dos anticoagulantes orais, às interações medicamentosas, às interações alimentares, aos fatores que interferem nos níveis do international normalized ratio e ao que deve ser feito em aso de esquecimento das doses diárias. Conclusão: A síntese elaborada enfatiza a necessidade de maior enfoque nas orientações aos pacientes sobre os anticoagulantes e suas implicações relacionadas aos hábitos de vida diária (AU)

Objective: To verify the existence of scientific evidence in the literature on patients regarding the use of oral anticoagulants after implantation of a metallic heart valve. Method: Integrative review carried out in the Embase, Scopus, Web of Science, and Online Medical Literature Search and Analysis System (MEDLINE)/PubMed databases, using controlled and uncontrolled descriptors, without temporal delimitation regarding publication, in Portuguese, English, and Spanish. The search took place in June 2022, by two researchers independently. Result: There were gaps in patients' knowledge about adverse effects related to the use of oral anticoagulants, drug interactions, food interactions, factors that interfere with international normalized ratio levels and what should be done in case of forgetting the daily doses. Conclusion: The synthesis elaborated emphasizes the need for greater focus on patient guidance on anticoagulants and their implications related to daily life habits (AU)

Objetivo: Verificar la existencia de evidencia científica en la literatura sobre el conocimiento de los pacientes sobre el uso de anticoagulantes orales después del implante de una válvula cardíaca metálica. Método: Revisión integradora realizada en las bases de datos Embase, Scopus, Web of Science y MEDLINE/PubMed, utilizando descriptores controlados y no controlados, sin delimitación temporal con respecto a la publicación, en portugués, inglés y español. La búsqueda tuvo lugar en junio de 2022, por dos investigadores de forma independiente. Resultado: Hubo lagunas en el conocimiento de los pacientes sobre los efectos adversos relacionados con el uso de anticoagulantes orales, interacciones medicamentosas, interacciones alimentarias, factores que interfieren con los niveles de la razón internacional normalizada y qué se debe hacer en caso de olvido de las dosis diarias. Conclusión: La síntesis elaborada enfatiza la necesidad de un mayor enfoque en la orientación del paciente sobre los anticoagulantes y sus implicaciones relacionadas con los hábitos de la vida diaria (AU)

Preliminary clinical experience of the novel transcatheter aortic valve system Prizvalve® for the treatment of severe aortic stenosis / 中华心血管病杂志

Objective: To evaluate the safety and efficacy of transcatheter aortic valve implantation (TAVI) with the novel Prizvalve® system in treating severe aortic stenosis. Methods: This is a single-center, prospective, single-arm, observational study. A total of 11 patients with severe aortic stenosis with high risk or inappropriate for conventional surgical aortic valve replacement (SAVR) were included, and TAVI was achieved with the Prizvalve® system between March 2021 and May 2021 in West China Hospital. Transthoracic echocardiography (TTE) was performed immediately after prosthesis implantation to evaluate mean transaortic gradient and maximal transaortic velocity. The device success rate was calculated, which was defined as (1) the device being delivered via the access, deployed, implanted and withdrawn, (2) mean transaortic gradient<20 mmHg (1 mmHg=0.133 kPa) or a maximal transaortic velocity<3 m/s post TAVI, and without severe aortic regurgitation or paravalvular leak post TAVI. TTE was performed at 30 days after the surgery, and all-cause mortality as well as the major cardiovascular adverse events (including acute myocardial infarction, disabling hemorrhagic or ischemic stroke) up to 30 days post TAVI were analyzed. Results: The age of 11 included patients were (78.1±6.3) years, with 8 males. A total of 10 patients were with NYHA functional class Ⅲ or Ⅳ. Devices were delivered via the access, deployed, implanted and withdrawn successfully in all patients. Post-implant mean transaortic gradient was (7.55±4.08) mmHg and maximal transaortic velocity was (1.78±0.44) m/s, and both decreased significantly as compared to baseline levels (both P<0.05). No severe aortic regurgitation or paravalvular leak was observed post TAVI. Device success was achieved in all the 11 patients. No patient died or experienced major cardiovascular adverse events up to 30 days post TAVI. Mean transaortic gradient was (9.45±5.07) mmHg and maximal transaortic velocity was (2.05±0.42) m/s at 30 days post TAVI, which were similar as the values measured immediately post TAVI (both P>0.05). Conclusions: TAVI with the Prizvalve® system is a feasible and relatively safe procedure for patients with severe aortic stenosis and at high risk or inappropriate for SAVR. Further clinical studies could be launched to obtain more clinical experience with Prizvalve® system.

Hand-sewn expanded polytetrafluoroethylene valved conduit for right ventricular outflow tract reconstruction / 中南大学学报(医学版)

OBJECTIVES@#Due to the lack of large-sized pulmonary valved conduit products in clinical practice, hand-sewn expanded polytetrafluoroethylene (ePTFE) valved conduit has been used for right ventricular outflow tract (RVOT) reconstruction in many heart centers around the world. This study aims to summarize the early results of the ePTFE valved conduit and the sewing technology of the conduit in combination with the latest progress, and to provide a reference for the application of ePTFE valved conduit.@*METHODS@#A total of 21 patients using ePTFE valved conduit for RVOT reconstruction in the Second Xiangya Hospital, Central South University from October 2018 to October 2020 were prospectively enrolled in this study. The age at the implantation of the conduit was 4.3 to 43.8 (median 15.1) years old, with weight of (38.9±4.1) kg. In this cohort, 14 patients underwent re-reconstruction of RVOT, including 12 patients with pulmonary regurgitation at 6.3 to 31.0 (median 13.8) years after tetralogy of Fallot (TOF) repair, and 2 patients with failed bovine jugular vein conduit (BJVC). Seven patients underwent Ross operations. Among them, 3 were for aortic valve stenosis, 2 were for aortic regurgitation, and 2 were for both stenosis and regurgitation. The ePTFE valved conduits were standard hand-sewn during the surgery. The 3 leaflets were equal in size with arc-shaped lower edge of the valve sinus. The free edge of the valve leaflets was straight with the length of about 1 mm longer than the diameter. The height of the valve sinus was 4/5 of the diameter. The junction of the valve leaflet was 3/4 of the height of the sinus. The designed leaflets were then continuous non-penetrating sutured into the inner surface of Gore-Tex vessel to make a valved conduit. Valved conduits with diameter of 18, 20, and 22 mm were used in 2, 9, and 10 cases, respectively. The surgical results, postoperative recovery time, and serious complications were summarized, and the changes of postoperative cardiac function status and hemodynamic status of the conduits were investigated.@*RESULTS@#During the implantation of ePTFE valved conduit for RVOT reconstruction, 2 patients underwent mechanical mitral valve replacement with Ross operation, 2 patients with pulmonary regurgitation with repaired TOF underwent left and right pulmonary artery angioplasty, and 1 patient with failed BJVC underwent tricuspid valvuloplasty. The cardiopulmonary bypassing time for patients underwent re-reconstruction of RVOT was (130.9±16.9) min, with aorta clamping for 1 patient to repair the residual defect of the ventricular septum. The cardiopulmonary bypassing and aorta clamping time for Ross operation were (242.7±20.6) min and (145.6±10.5) min, respectively. The duration of postoperative ventilator assistance, intensive care unit stay, and hospital stay were 3.5 h to 7.7 d (median 17.1 h),11.2 h to 29.5 d (median 1.9 d), and 6.0 to 56.0 (median 13.0) d, respectively. All patients survived after discharge from hospital. The follow-up rate after discharge was 100% with median time at 15.0 (13.0 to 39.0) months. No death happened during the follow-up. One patient underwent stent implantation due to right coronary stenosis 2 months after Ross operation. One patient underwent balloon dilation due to right pulmonary artery ostium stenosis 1 year after re-reconstruction of RVOT. The cardiac function of all patients recovered to NYHA class I 6 months after operation. The peak pressure gradient across the valve measured by transthoracic echocardiography before discharge was (9.4±2.6) mmHg (1 mmHg=0.133 kPa), and (18.3±6.1) mmHg at the last follow-up. There was no significant increase in the gradient during the follow-up (P=0.134). No patient suffered from mild or more pulmonary regurgitation.@*CONCLUSIONS@#Hand-sewn ePTFE valved conduit is feasible for RVOT reconstruction. It is a promising material for RVOT reconstruction which can effectively meet clinical need. In our experience, the ePTFE valved conduit is simple to manufacture with satisfactory early outcomes.In the application of ePTFE valved conduit, attention should be paid to implantation indications and postoperative anticoagulation management, especially to the preparation details of the valved conduit, to obtain better function and durability of the conduit after implantation.

Mitral valve-in-valve: defining the indication limits by in vitro hydrodynamic tests in a brazilian transcatheter prosthesis

Abstract Introduction: Reoperations in cardiac surgery represent a clinical challenge, particularly because of the higher rate of perioperative morbidity and mortality. Mitral valve reoperation owing to bioprosthesis dysfunction, transcatheter treatment with a prosthesis implantation over the prosthesis has emerged as an alternative, especially for patients with a previous approach. In this study, we analyzed the hydrodynamic behavior of transcatheter prosthesis implantation in conventional mitral bioprostheses through hydrodynamic tests and produced a recommendation for the size of transcatheter valve most adequate for valve-in-valve procedure. Methods: Mitral bioprostheses were attached to a flow duplicator and different combinations of transcatheter prostheses were implanted inside. The equipment simulates the hydrodynamic behavior of the valves submitted in vitro and determines transvalvular pressures and flow parameters. Results: All tests could be performed. Better hydrodynamic performance occurred for transcatheter prostheses 1 mm smaller than bioprostheses, except for the 27-mm bioprostheses. Effective valve areas (cm²) and transvalvular gradients (mmHg) were, respectively: Bioprosthesis × Inovare: 27 × 28 mm: 1.65 and 5.95/29 × 28 mm and 31 × 30 mm: 2.15 and 3.6. Conclusion: The mitral valve-in-valve implantation proved to be feasible in vitro. The use of 27-mm bioprostheses should be judicious, with preference for a 26-mm transcatheter valve. In the 29 and 31-mm bioprostheses, the implantation was very satisfactory, with good effective valve areas and transvalvular gradients, with preference for smaller transcatheter valves.

Traversing the Learning Curve Associated with a New Minimal Access Aortic Valve Replacement Service

Abstract Objective: Isolated aortic valve replacement is a safe and frequently performed cardiac surgical procedure. Although minimal access approaches including right anterior thoracotomy and partial sternotomy have been adopted by some surgeons in recent years, concerns about additional procedural morbidity and mortality during the early phase of the learning curve persist. The aim of this study was to assess the impact of the learning curve on outcomes for a single surgeon implementing a new minimal access aortic valve replacement service. Methods: Ninety-three patients undergoing minimal access aortic valve replacement performed by a single surgeon in our institution between October 2014 and March 2019 were analysed. Patients were divided into tertiles according to procedure order. Endpoints included peri-operative mortality and post-operative complications, and these were compared across tertiles to assess the impact of the learning curve on procedural outcomes. Results: Overall in-hospital mortality was 2.15% (n=2). Despite significantly longer cardiopulmonary bypass and cross-clamp duration in the early tertile, there was no significant difference in the rate of post-operative complications, post-operative length of stay or in-hospital mortality between tertiles. Conclusions: Although our results have demonstrated a significant learning curve effect associated with the introduction of this minimally invasive approach to aortic valve replacement, as demonstrated by the significant reduction in cardiopulmonary bypass and cross-clamp duration over time, our findings suggest that a minimal access aortic valve replacement service can be safely commenced by an experienced surgeon without concerns about the learning curve significantly affecting post-operative morbidity and mortality.

Open Transcatheter Multivalve Replacement in Degenerated Valve Prostheses in High-Risk Patients with Endocarditis

Abstract Multivalve redo procedures carry a high surgical risk. We describe an alternative surgical treatment for patients presenting with severely degenerated aortic and mitral valve prostheses who have to undergo open surgery due to endocarditis. Open transcatheter multivalve implantation is a feasible bailout strategy in high-risk patients to save cross-clamp and procedural times to reduce morbidity and mortality.

Aortic Root Replacement for Destructive Endocarditis - Clinic and Microbiology

Abstract Introduction: Destructive aortic root endocarditis is associated with high mortality rates. The objective of this article was to characterize the clinical and microbiological profiles of these patients, especially concerning an already implanted aortic valve prosthesis. We also focused on prognostic factors. Methods: Eighty patients underwent aortic root replacement due to destructive endocarditis from 1999 to 2018 in our institution. We analyzed their pre, intra, and postoperative data, outcomes, and predictors of mortality. Results: Thirty-one patients had native valve endocarditis (NVE), eight patients had early-onset prosthetic valve endocarditis (PVE), and 41 patients had late-onset PVE. Streptococcus was found in 19.4% of NVE cases and no PVE case. Coagulase-negative Staphylococcus was responsible for 62.5% of the cases of early-onset PVE. Thirty-four (42.5%) patients had received inappropriate antibiotics before admission. No microorganism was associated with higher risk of mortality. Aortoventricular dehiscence was identified as an independent risk factor of mortality along with PVE, concomitant bypass surgery, and delayed diagnosis. The incidence of postoperative complications was similar in all three groups. Rates of long-term survival (P=0.044) and freedom from the composite endpoint (P=0.024) defined as death, stroke, aortic valve reinfection, and aortic valve reoperation were the lowest within the NVE group and the highest among the PVE patients. Conclusion: In endocarditis, prolonged diagnostics, inadequate antimicrobial treatment, and late surgery led to destructive local complications and worsened the prognosis. PVE is associated with higher mortality than NVE.

Valvuloplasty Without Prosthetic Ring or Band in Patients with Degenerative Mitral Regurgitation: Long-Term Results and Predictive Factors for Outcomes

Abstract Introduction: Mitral valvuloplasty including ring/band support is widely performed despite potential drawbacks of rings. Unsupported valvuloplasty is performed in only a few centers. This study aimed to report long-term outcomes of patients undergoing unsupported valvuloplasty for degenerative mitral regurgitation (MR) and to identify predictive factors for outcomes. Methods: This is a retrospective cohort including patients undergoing mitral valve repair for degenerative MR from 2000 to 2018. The main techniques were Wooler annuloplasty and quadrangular resection. Kaplan-Meier curves and Cox regression models were used for statistical analysis. Results: One hundred fifty-eight patients were included (median age: 64.0 years). In-hospital mortality was 2.5%. Maximum follow-up was 19.6 years, with a median of 4.7 years (992 patient-years). Overall survival at 5, 10, and 15 years was 91.0% (95% confidence interval [CI]: 85.7-96.3), 87.6% (95% CI: 80.7-94.5), and 78.1% (95% CI: 65.9-90.3), respectively. The European System for Cardiac Operative Risk Evaluation (EuroSCORE) II was an independent predictor of late death (hazard ratio [HR] 1.42; P=0.016). Freedom from mitral reoperation at 5, 10, and 15 years was 88.1% (95% CI: 82.0-94.2), 82.4% (95% CI: 74.6-90.2), and 75.7% (95% CI: 64.1-87.3), respectively. Left atrial diameter > 56 mm was associated with late reintervention in univariate analysis (HR 1.06; P=0.049). Conclusion: Degenerative MR can be successfully treated with repair techniques without annular support, thus avoiding the technical and logistical drawbacks of ring/band implantation while maintaining good long-term results. EuroSCORE II was a risk factor for late death, and larger left atrium was associated with late reoperation.

Step-by-Step Minimally Invasive Aortic Valve Replacement: the RAT Approach

Abstract In the growing era of transcatheter aortic valve implantation, it is crucial to develop minimally invasive surgical techniques. These methods enable easier recovery from surgical trauma, especially in elderly and frail patients. Minimally invasive aortic valve replacement (MIAVR) is frequently performed via upper hemisternotomy. We describe MIAVR via right anterior thoracotomy, which is associated with less trauma, rapid mobilization, lower blood transfusion rates, and lower risk of postoperative wound infections. As minimally invasive procedures tend to take longer operative times, we suggest using rapid-deployment valve prostheses to overcome this limitation. This description focuses on the technical aspects and preoperative assessment.

Implante percutâneo de válvula aórtica (TAVI) para tratamento da estenose aórtica grave em pacientes inoperáveis / Percutaneous aortic valve implantation (TAVI) for treatment of severe aortic stenosis in patients inoperable

INTRODUÇÃO: A estenose aórtica é relacionada a fatores de risco para aterosclerose, principalmente ao envelhecimento. A prevalência na faixa etária entre 65 e 74 anos é de 1,3%, e acima de 75 anos, 2,8%. Pacientes com estenose aórtica têm risco aumentado de morte cardiovascular (HR 2,14; IC 95% 1,21-3,76). As manifestações clínicas são relacionadas à insuficiência cardíaca, podendo também estarem presentes dor no peito (angina) e síncope. O prognóstico, após início dos sintomas, é de 50% de mortalidade em dois anos, sendo recomendada a cirurgia de troca valvar aórtica, mas cerca de 30% dos idosos têm a cirurgia contraindicada pelo alto risco cirúrgico. O TAVI é uma opção de tratamento percutâneo (transapical ou transfemoral), com troca valvar sem necessidade de toracotomia e circulação extracorpórea. Apresenta benefícios em relação ao tratamento clínico tais como maior sobrevida e qualidade de vida, reduzindo sintomas relacionados à insuficiência cardíaca e o número de internações hospitalares, porém, associa-se com riscos imediatos como necessidade de implante de marcapasso, hemotransfusões, insuficiência renal, diálise, acidente vascular cerebral, lesões vasculares, tamponamento cardíaco e morte. Como os resultados de eficácia são distintos de acordo com a via de acesso à valva aórtica, este relatório contempla apenas TAVI por via transfemoral. TECNOLOGIA: Implante percutâneo transfemoral de válvula aórtica (TAVI). PERGUNTA DE PESQUISA: Em pacientes com estenose aórtica grave considerados inoperáveis, o TAVI, em comparação com o tratamento clínico, é seguro e custo-efetivo? EVIDÊNCIAS CLÍNICAS: Um ensaio randomizado (PARTNER B), além de registros e estudos observacionais, apresentaram ganhos em sobrevida e na qualidade de vida com o TAVI. Resultados de 5 anos do PARTNER B, com 179 pacientes em cada braço de intervenção, revelam menor mortalidade (71,8% versus 93,6%), HR 0,50 (IC95% 0,39-0,65), menor chance de hospitalização (47,6% versus 87,3%; p < 0,0001) e maior chance de estar em classe funcional NYHA I e II (New York Heart Association) (86% versus 60%) nos pacientes do grupo TAVI. Acidente vascular cerebral foi mais frequente até o seguimento de três anos do TAVI (14,4% TAVI versus 4,12% braço clínico; p = 0,0007). AVALIAÇÃO ECONÔMICA: Avaliação do tipo custo-utilidade em modelo de Markov, com ciclos mensais, horizonte temporal de 5 anos, perspectiva do SUS, revela razão de custo-utilidade incremental (RCUI) de R$189.920,69/QALY. Na análise de sensibilidade determinística, observou-se que o custo do TAVI é o parâmetro com maior impacto na RCUI. Considerando um limiar de 3 PIB per capita por ano de vida ajustado por qualidade (QALY) e analisando separadamente os componentes do custo TAVI como o custo do procedimento (considerado fixo e equivalente a R$ 28.244,41) e o custo da prótese (variável), estimou-se que, para o TAVI ser considerado custo-efetivo, o custo máximo do procedimento TAVI deve ser de R$ 57.292,1 e consequentemente, o custo máximo isolado da prótese equivalente a R$ 29.047,69. AVALIAÇÃO DE IMPACTO ORÇAMENTÁRIO: O impacto orçamentário é proporcional à quantidade de procedimentos de TAVI realizados. Baseado no pressuposto de realização de um máximo de 80 procedimentos por mês no Brasil, foi estimado um impacto em torno de 78 milhões de reais no primeiro ano e um impacto total, em 5 anos, de aproximadamente 467 milhões de reais. MONITORAMENTO DO HORIZONTE TECNOLÓGICO: Foram realizadas pesquisas nos bancos de dados de ensaios clínicos e patentes Clinical Trials , Cortellis , ECRI, Espacenet e Patentscope e no site do FDA. Para isto, foram utilizados os descritores "severe aortic stenosis" e "aortic stenosis". Dentre os resultados obtidos foram desconsiderados os implantes que já são comercializados no mercado do brasileiro, de modo a proporcionar uma melhor prospecção de mercado. Foi identificado um TAVI registrado no FDA e quatro pedidos patentários internacionais que possuem depósito brasileiro, contudo devido a sua recente inclusão internacional ainda não possui pedido em fase nacional. CONSIDERAÇÕES FINAIS: A principal vantagem do TAVI é permitir a troca valvar aórtica sem a necessidade de toracotomia ou circulação extracorpórea, o que o coloca como opção terapêutica para pacientes com estenose aórtica inoperáveis. Demanda expertise médica e estrutura hospitalar com suporte de sala de hemodinâmica e cirurgia cardíaca. O controle na qualidade do atendimento e no impacto orçamentário estão diretamente relacionados a quantidade de centros e de procedimentos por centro que poderão ser autorizados para realização do TAVI. RECOMENDAÇÃO PRELIMINAR DA CONITEC: Pelo exposto, os membros da Conitec, em sua 95ª reunião ordinária, no dia 04 de março de 2021, recomendaram por unanimidade, a não incorporação no SUS do TAVI para tratamento de pacientes com estenose aórtica grave inoperáveis. Considerou-se que, apesar das evidências que suportam o benefício clínico da intervenção, os dados econômicos de relação de custo-utilidade incremental e impacto orçamentário são desfavoráveis. A matéria foi disponibilizada em consulta pública. CONSULTA PÚBLICA: A Consulta Pública nº 15/2021 foi realizada entre os dias 18/03/2021 e 06/04/2021. Foram recebidas 17 contribuições, sendo 12 pelo formulário para contribuições técnico-científicas e cinco pelo formulário para contribuições sobre experiência ou opinião de pacientes, familiares, amigos ou cuidadores de pacientes, profissionais de saúde ou pessoas interessadas no tema. RECOMENDAÇÃO FINAL: Pelo exposto, o Plenário da Conitec, em sua 96ª Reunião Ordinária, no dia 05 de maio de 2021, deliberou por unanimidade recomendar a incorporação do implante percutâneo da válvula aórtica (TAVI) para tratamento da estenose aórtica grave em pacientes com estenose aórtica grave sintomática inoperáveis. Os membros da Conitec consideraram o benefício clínico com ganhos em sobrevida e qualidade de vida dos pacientes para recomendar a incorporação desta tecnologia que está condicionada, no máximo, ao valor considerado custo-efetivo na análise para o Sistema Único de Saúde (SUS). Assim, foi assinado o Registro de Deliberação nº 606/2021. DECISÃO: Incorporar o implante percutâneo de válvula aórtica (TAVI) para tratamento da estenose aórtica grave em pacientes inoperáveisno âmbito do Sistema Único de Saúde ­ SUS, conforme Portaria nº 32, republicada no Diário Oficial da União nº 123, Seção 1, página 195, em 02 de julho de 2021.

The role of the axillary artery as a second access choice in TAVI procedures

Abstract With transcatheter aortic valve implantation (TAVI) technology expanding its indications for low-risk patients, the number of TAVI-eligible patients will globally grow, requiring a better understanding about the second-best access choice. Regarding the potential access sites, the transfemoral retrograde route is recognized as the standard approach and first choice according to current guidelines. However, this approach is not suitable in up to 10-15% of patients, for whom an alternative non-femoral access is required. Among the alternative non-femoral routes, the transaxillary approach has received increasing recognition due to its proximity and relatively straight course from the axillary artery to the aortic annulus, which provides a more accurate device deployment. Here we discuss some particular aspects of the transaxillary access, either percutaneously performed or by cutdown dissection.

Morbidity and mortality in patients undergoing mitral valve replacement at a cardiovascular surgery referral service: a retrospective analysis

Abstract Introduction: We aimed to identify predictors of morbidity and mortality in patients undergoing isolated mitral valve replacement. Methods: This is a retrospective cohort study with 164 patients who underwent isolated mitral valve replacement at a referral hospital for cardiovascular diseases, which were performed from January 2011 to December 2016. Data were obtained from medical records, including preoperative, intraoperative, and postoperative information. Statistical analysis was performed to calculate odds ratio (OR), unpaired Student's t-test, and binary logistic regression. P-values < 0.05 were considered significant. Results: A total of 69.5% (n=114) of the patients had a diagnosis of rheumatic disease prior to surgery. Mortality rate was 6.7% (n=11). The most observed complication was the occurrence of postoperative arrhythmias (19.5%). On average, patients remained 5.34 days in the intensive care unit. There was a statistically significant enhanced risk of death among patients with previous diagnosis of endocarditis (OR 5.22, 95% confidence interval [CI] 1,368-19,915; P=0.008), reduced ejection fraction (EF) (< 50%) (OR 9.46, 95% CI 2,61-34,35; P<0.001), and mitral regurgitation (MR) (OR 7.7, 95% CI 1.576-37.545; P=0.004). Patients who died were older than those who survived surgery (P<0.001) and had lower preoperative serum hemoglobin levels (P=0.018). Logistic regression showed age and reduced EF at preoperative evaluation as predictors of death. Conclusion: Older age, reduced serum hemoglobin levels, preoperative diagnosis of endocarditis, reduced EF, and MR were associated with postoperative mortality. Age and reduced EF were predictors of death.

Comparison between different tricuspid valve procedures through postoperative inflammation and myocardial enzymes

Abstract Introduction: The thoracoscopic procedure for tricuspid valve (TV) diseases is a minimally invasive method of treatment. This study focuses on comparing the changes in postoperative inflammatory reaction and myocardial injury markers after thoracoscopic and sternotomy/thoracotomy TV procedures. Methods: We retrospectively analyzed 88 patients (53 males, aged 50.9±16.2 years) with TV diseases (single-valve disease) (72 cases of TV plasty) between January 2018 and April 2019. A total of 56 patients underwent thoracoscopic procedure (50 cases of TV plasty). The leukocyte and C-reactive protein (CRP) levels were monitored as indicators of systemic inflammatory reaction. The lactate dehydrogenase, creatine kinase, creatine kinase myocardial band, aspartate aminotransferase, and troponin-T levels were recorded as markers of myocardial injury. Results: The CRP and white blood cells levels of patients in the sternotomy approach group were continuously higher than those in patients in the thoracoscopic approach group. And the levels of myocardial enzymes in patients in the thoracoscopic approach group were significantly lower than those in patients in the sternotomy approach group. Conclusion: Compared with sternotomy/thoracotomy procedures on TV, the thoracoscopic procedure can reduce postoperative myocardial injury significantly and systemic inflammatory reaction to a certain extent. It is technically feasible, safe, effective, and worthy of widespread adoption in clinical practice.