Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis

ABSTRACT Objective: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). Methods: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. Results: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. Conclusion: According to this analysis, BVP meets world standards for safety and clinical efficacy.

Prevalence of Frailty in Patients Undergoing Cardiac Valve Surgery: Comparison of Frailty Tools

Abstract Background There is no consensus among tools for assessing frailty. Objective To evaluate the prevalence of frailty according to different tools in patients referred for elective valve cardiac surgery. Methods This is a cross-sectional study. All patients were ≥ 18 years of age, clinically stable. The following patients were excluded: those unable to perform the tests because of physical, cognitive, or neurological limitations; those requiring non elective/emergency procedures or hemodynamic instability. During the preoperative cardiology visit, frailty was assessed by the Short Physical Performance Battery (SPPB), the Frailty Deficit Index (FDI), handgrip strength, and gait speed 3m. For the entire analysis, the statistical significance was set at 5%. Results Our cohort consisted of 258 subjects. From the total cohort, 201 were ≤ 70 years of age (77.9%), the predominant etiology according to rheumatic disease (50.7% vs 8.8%; p=0.000) with double mitral lesion (24.9% vs 0%; p=0.000). Frailty was present in 32.9% according SPPB, 29.1% with reduced muscular strength. and 8.9% with FDI. Handgrip strength was weaker in elderly patients (26.7 vs 23.6; p=0.051) and gait speed was lower in the younger group, in which 36% were considered frail (36% vs 14%; p=0.002). Variables associated with frailty were age ≥ 70 years, female gender, aortic stenosis, and regurgitation. Conclusion Frailty in adult patients who will have elective heart valve surgery is present even in the younger groups, although the older group with comorbidities are more frail. Frailty was more clearly shown by the SPPB than by the FDI and handgrip tests.

Analysis of >100. 000 Cardiovascular Surgeries Performed at the Heart Institute and a New Era of Outcomes / Análise de >100. 000 Cirurgias Cardiovasculares Realizadas no Instituto do Coração e a Nova Era com Foco nos Resultados

Abstract Background: The current challenge of cardiovascular surgery (CVS) is to improve the outcomes in increasingly severe patients. In this respect, continuous quality improvement (CQI) programs have had an impact on outcomes. Objective: To assess the evolution of the incidence and mortality due to CVS, as well as the current outcomes of the Hospital das Clínicas Heart Institute of the University of São Paulo Medical School (InCor-HCFMUSP). Methods: An outcome analysis of CVSs performed at the InCor, between January 1984 and June 2019. We observed the surgical volume and mortality rates in 5 time periods: 1st (1984-1989), 2nd (1990-1999), 3rd (2000-2007), 4th (2008-2015) and 5th (2016-2019). The CQI program was implemented between 2015 and 2016. The analysis included the total number of surgeries and the evolution of the most frequent procedures. Results: A total of 105,599 CCVs were performed, with an annual mean of 2,964 procedures and mortality of 5,63%. When comparing the 4th and the 5th periods, the average global volume of surgeries was increased from 2,943 to 3,139 (p = 0.368), bypass graft (CABG), from 638 to 597 (p = 0.214), heart valve surgery, from 372 to 465 (p = 0.201), and congenital heart disease surgery, from 530 to 615 (p = 0.125). The average global mortality went from 7.8% to 5% (p < 0.0001); in CABG surgery, from 5.8% to 3.1% (p < 0.0001); in heart valve surgery, from 14% to 7.5% (p < 0.0001) and in congenital heart disease surgery, from 12.1% to 9.6% (p < 0.0001). Conclusion: In spite of a recent trend towards increased surgical volume, there was a significant decrease in operative mortality in the groups studied. After the implementation of the CQI program, the mortality rates were closer to international standards.

Resumo Fundamento: O desafio atual da cirurgia cardiovascular (CCV) é melhorar resultados em pacientes cada vez mais graves. Nesse sentido, Programas de Melhoria Contínua da Qualidade (PMCQ) tem impactado os resultados. Objetivo: Avaliar a evolução da incidência e mortalidade das CCV, assim como os resultados atuais do Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor). Métodos: Análise dos resultados das CCV realizadas no InCor entre jan-1984 e jun-2019. Foram observadas as tendências dos volumes cirúrgicos e da mortalidade em 5 períodos 1º (1984-1989), 2º (1990-1999), 3º (2000-2007), 4º (2008-2015) e 5º (2016-2019). O PMCQ foi estabelecido entre 2015-2016. A análise incluiu o total de cirurgias e a evolução dos procedimentos mais frequentes. Resultados: Foram realizadas 105.599 CCV, com uma média anual de 2.964 procedimentos e mortalidade de 5,63%. Comparando o 4º com o 5º período, o volume global médio de cirurgias foi de 2.943 para 3.139 (p = 0,368), cirurgias de revascularização miocárdica (CRM) de 638 para 597 (p = 0,214), valvas cardíacas de 372 para 465 (p = 0,201) e cardiopatias congênitas de 530 para 615 (p = 0,125). A mortalidade média global passou de 7,8% para 5% (p < 0,0001), nas cirurgias de revascularização miocárdica de 5,8% para 3,1% (p < 0,0001), nas cirurgias valvares de 14% para 7,5% (p < 0,0001) e nas cirurgias de cardiopatias congênitas de 12,1% para 9,6% (p < 0,0001). Conclusão: Embora haja uma tendência recente ao aumento dos volumes cirúrgicos, houve uma diminuição significativa da mortalidade cirúrgica nos grupos analisados. Após o estabelecimento do PMCQ, as taxas de mortalidade se aproximaram a dos padrões internacionais.

Cardiac magnetic resonance analysis of mitral annular dynamics after mitral valve repair

OBJECTIVES: The aim of this study was to analyze mitral annulus (MA) dynamics using cardiac magnetic resonance (CMR) in patients with degenerative mitral insufficiency who underwent mitral valve repair (MVR). METHODS: Mitral valve imaging was performed by CMR in twenty-nine patients with degenerative mitral insufficiency who underwent MVR between July 2014 and August 2016, with quadrangular resection of the posterior leaflet without ring annuloplasty. They were prospectively followed up from the preoperative period up to 2 years postoperatively. RESULTS: We observed a significant reduction in all measurements of the MA after surgery. The mean systolic circumference of the MA was reduced from 13.28±1.95 cm to 11.50±1.59 cm, and the diastolic circumference was reduced from 12.51±2.01 cm to 10.66±2.09 cm in the immediate postoperative period, measures that remained stable 2 years after MVR (p<0.001). The mean maximum area of the MA was significantly reduced from 14.34±4.03 to 10.45±3.17 cm2 when comparing the immediate postoperative period and the 2 year follow-up (p<0.001). The same occurred with the mean minimum area of the MA, which was reduced from 12.53±3.68 cm2 to 9.23±2.84 cm2 in the same period, and this reduction was greater in the antero-posterior diameter than in the mid-lateral diameter. The mobility of the MA was preserved after surgery, ranging between 19.6% and 25.7% at 2-year follow-up. CONCLUSION: We observed a significant reduction in the MA size after MVR, with preservation of the MA mobility at the 2-year follow-up.

Quadricuspid aortic valve: three cases report and literature review

Abstract Quadricuspid aortic valve (QAV) is a rare cardiac malformation. Many cases are incidentally diagnosed in aortic surgeries or autopsies and it usually appears as an isolated anomaly. The most widely classification used is the one by Hurwitz and Roberts[1], which divides 7 alphabetical subtypes based on the cusps size. The aim of this report is to describe three different anatomic presentations of this rare aortic valve anomaly.

Perioperative management of the diabetic patient referred to cardiac surgery

Abstract Currently there is a progressive increase in the prevalence of diabetes in a referred for cardiovascular surgery. Benefits of glycemic management (< 180 mg/dL) in diabetic patients compared to patients without diabetes in perioperative cardiac surgery. The purpose of this study is to present recommendations based on international evidence and adapted to our clinical practice for the perioperative management of hyperglycemia in adult patients with and without diabetes undergoing cardiovascular surgery. This update is based on the latest current literature derived from articles and guidelines regarding perioperative management of diabetic patients to cardiovascular surgery.

Thrombocytopenia after transcatheter valve-in-valve implantation: prognostic marker or mere finding?

Abstract Objective: To analyze the behavior of platelets after transcatheter valve-in-valve implantation for the treatment of degenerated bioprosthesis and how they correlate with adverse events upon follow-up. Methods: Retrospective analysis of 28 patients who received a valve-in-valve implant, 5 in aortic, 18 in mitral and 5 in tricuspid positions. Data were compared with 74 patients submitted to conventional redo valvular replacements during the same period, and both groups' platelet curves were analyzed. Statistical analysis was conducted using the IBM SPSS Statistics(r) 20 for Windows. Results: All patients in the valve-in-valve group developed thrombocytopenia, 25% presenting mild (<150.000/µL), 54% moderate (<100.000/µL) and 21% severe (<50.000/µL) thrombocytopenia. The platelet nadir was on the 4th postoperative day for aortic ViV, 2nd for mitral and 3rd for tricuspid patients, with the majority of patients recovering regular platelet count. However, the aortic subgroup comparison between valve-in-valve and conventional surgery showed a statistically significant difference from the 7th day onwards, where valve-in-valve patients had more severe and longer lasting thrombocytopenia. This, however, did not translate into a higher postoperative risk. In our study population, postoperative thrombocytopenia did not correlate with greater occurrence of adverse outcomes and only normal preoperative platelet count could significantly predict a postoperative drop >50%. Conclusion: Although thrombocytopenia is an extremely common finding after valve-in-valve procedures, the degree of platelet count drop did not correlate with greater incidence of postoperative adverse outcomes in our study population.

Resection of left atrial myxoma in a patient with retrosternal gastric tube: a case report

Abstract The median sternotomy remains the standard approach in cardiovascular surgery but, in some conditions, it can be considered difficult to perform, especially in patients with history of esophagectomy. This case report describes a successful resection of a left atrial myxoma through a right anterolateral thoracotomy approach in a patient with a previous retrosternal gastric tube reconstruction. The decision for the best surgical approach was made after a heart surgery team discussion. Through this surgical access, a safe and excellent exposure of the left atrium was possible, and a complete resection of the myxoma was performed without any injury to the gastric tube.

Do We Need to Personalize Renal Function Assessment in the Stratification of Patients Undergoing Cardiac Surgery? / É Necessário Personalizar a Avaliação da Função Renal na Estratificação de Pacientes Submetidos à Cirurgia Cardíaca?

Abstract Background: Renal dysfunction is an independent predictor of morbidity and mortality in cardiac surgery. For a better assessment of renal function, calculation of creatinine clearance (CC) may be necessary. Objective: To objectively evaluate whether CC is a better risk predictor than serum creatinine (SC) in patients undergoing cardiac surgery. Methods: Analysis of 3,285 patients registered in a prospective, consecutive and mandatory manner in the Sao Paulo Registry of Cardiovascular Surgery (REPLICCAR) between November 2013 and January 2015. Values of SC, CC (Cockcroft-Gault) and EuroSCORE II were obtained. Association analysis of SC and CC with morbidity and mortality was performed by calibration and discrimination tests. Independent multivariate models with SC and CC were generated by multiple logistic regression to predict morbidity and mortality following cardiac surgery. Results: Despite the association between SC and mortality, it did not calibrate properly the risk groups. There was an association between CC and mortality with good calibration of risk groups. In mortality risk prediction, SC was uncalibrated with values > 1.35 mg /dL (p < 0.001). The ROC curve showed that CC is better than SC in predicting both morbidity and mortality risk. In the multivariate model without CC, SC was the only predictor of morbidity, whereas in the model without SC, CC was not only a mortality predictor, but also the only morbidity predictor. Conclusion: Compared with SC, CC is a better parameter of renal function in risk stratification of patients undergoing cardiac surgery.

Resumo Fundamentos: Disfunção renal é preditor independente de morbimortalidade após cirurgia cardíaca. Para uma melhor avaliação da função renal, o cálculo do clearance de creatinina (CC) pode ser necessário. Objetivo: Avaliar objetivamente se o CC é melhor que a creatinina sérica (CS) para predizer risco nos pacientes submetidos à cirurgia cardíaca. Métodos: Análise em 3285 pacientes do Registro Paulista de Cirurgia Cardiovascular (REPLICCAR) incluídos de forma prospectiva, consecutiva e mandatória entre novembro de 2013 e janeiro de 2015. Foram obtidos valores de CS, CC (Cockcroft-Gault) e do EuroSCORE II. Análise de associações da CS e do CC com morbimortalidade foi realizada mediante testes de calibração e discriminação. Por regressão logística múltipla, foram criados modelos multivariados independentes com CS e com CC para predição de risco de morbimortalidade após cirurgia cardíaca. Resultados: Apesar da associação entre a CS e morbimortalidade, essa não calibrou adequadamente os grupos de risco. Houve associação entre o CC e morbimortalidade com boa calibração dos grupos de risco. Na predição do risco de mortalidade, a CS ficou descalibrada com valores >1,35 mg/dL (p < 0,001). A curva ROC revelou que o CC é superior à CS na predição de risco de morbimortalidade. No modelo multivariado sem CC, a CS foi a única preditora de morbidade, enquanto que no modelo sem a CS, o CC foi preditor de mortalidade e o único preditor de morbidade. Conclusão: Para avaliação da função renal, o CC é superior que a CS na estratificação de risco dos pacientes submetidos a cirurgia cardíaca.

EuroSCORE II and STS as mortality predictors in patients undergoing TAVI / EuroSCORE II e STS como preditores de mortalidade em pacientes submetidos ao TAVI

SUMMARY Introduction: the EuroSCORE II and STS are the most used scores for surgical risk stratification and indication of transcatheter aortic valve implantation (TAVI). However, its role as a tool for mortality prediction in patients undergoing TAVI is still unclear. Objective: to evaluate the performance of the EuroSCORE II and STS as predictors of in-hospital and 30-day mortality in patients undergoing TAVI. Methods: we included 59 symptomatic patients with severe aortic stenosis that underwent TAVI between 2010 and 2014. The variables were analyzed using Student's t-test and Fisher's exact test and the discriminative power was evaluated using receiver operating characteristic curve (ROC) and area under the curve (AUC) with a 95% confidence interval. Results: mean age was 81±7.3 years, 42.3% men. The mean EuroSCORE II was 7.6±7.3 % and STS was 20.7±10.3%. Transfemoral procedure was performed in 88.13%, transapical in 3.38% and transaortic in 8.47%. In-hospital mortality was 10.1% and 30-day mortality was 13.5%. Patients who died had EuroSCORE II and STS higher than the survivors (33.7±16.7vs. 18.6±7.3% p=0,0001 for STS and 13.9±16.1 vs. 4.8±3.8% p=0.0007 for EuroSCORE II). The STS showed an AUC of 0.81 and the EuroSCORE II of 0.77 and there were no differences in the discrimination ability using ROC curves (p=0.72). Conclusion: in this cohort, the STS and EuroSCORE II were predictors of in-hospital and 30-days mortality in patients with severe aortic stenosis undergoing TAVI.

RESUMO Introdução: STS e EuroSCORE II são os escores mais utilizados para a estratificação de risco cirúrgico e indicação do implante de válvula aórtica transcateter (TAVI). Entretanto, seu papel como ferramenta para predição de mortalidade em pacientes submetidos ao TAVI ainda é incerto. Objetivo: avaliar o desempenho do EuroSCORE II e STS como preditores de mortalidade intra-hospitalar em 30 dias em pacientes submetidos ao TAVI. Métodos: 59 pacientes com estenose aórtica importante submetidos ao TAVI entre 2010 e 2014. Variáveis foram analisadas por meio do teste t-Student e teste exato de Fisher, e o poder discriminativo foi avaliado pela curva ROC e área sob a curva, acompanhada de intervalo de confiança de 95%. Resultados: a idade média foi de 81±7,3 anos, 42,3% homens. Média do EuroSCORE II foi de 6,07±7,3%, e do STS, 20,7±10,3%. Procedimento transfemoral foi realizado em 88,13%, transapical, em 3,38% e transaórtico, em 8,47%. A mortalidade intra-hospitalar foi 10,1%, e em 30 dias, 13,5%. Os pacientes que evoluíram para óbito apresentavam STS e EuroSCORE II mais elevados que os sobreviventes (33,7±16,7% vs. 18,6±7,3%; p=0,0001 para STS e 13,9±16,1% vs. 4,8±3,8%; p=0,0007 para EuroSCORE II). O STS apresentou AUC de 0,81, e o EuroSCORE II, 0,77. Não houve diferença na capacidade de discriminação pelas curvas ROC (p=0,72). Conclusão: STS e EuroSCORE II foram preditores de mortalidade intra-hospitalar em 30 dias.

Mitral annulus morphologic and functional analysis using real time tridimensional echocardiography in patients submitted to unsupported mitral valve repair / Análise morfológica e funcional do anel mitral com o uso da ecocardiografia tridimensional em tempo real em indivíduos submetidos à plástica mitral sem o uso de anéis protéticos

AbstractIntroduction:Mitral valve repair is the treatment of choice to correct mitral insufficiency, although the literature related to mitral valve annulus behavior after mitral repair without use of prosthetic rings is scarce.Objective:To analyze mitral annulus morphology and function using real time tridimensional echocardiography in individuals submitted to mitral valve repair with Double Teflon technique.Methods:Fourteen patients with mitral valve insufficiency secondary to mixomatous degeneration that were submitted to mitral valve repair with the Double Teflon technique were included. Thirteen patients were in FC III/IV. Patients were evaluated in preoperative period, immediate postoperative period, 6 months and 1 year after mitral repair. Statistical analysis was made by repeated measures ANOVA test and was considered statistically significant P<0.05.Results:There were no deaths, reoperation due to valve dysfunction, thromboembolism or endocarditis during the study. Posterior mitral annulus demonstrated a significant reduction in immediate postoperative period (P<0.001), remaining stable during the study, and presents a mean of reduction of 25.8% comparing with preoperative period. There was a significant reduction in anteroposterior and mediolateral diameters in the immediate postoperative period (P<0.001), although there was a significant increase in mediolateral diameter between immediate postoperative period and 1 year. There was no difference in mitral internal area variation over the cardiac cycle during the study.Conclusion:Segmentar annuloplasty reduced the posterior component of mitral annulus, which remained stable in a 1-year-period. The variation in mitral annulus area during cardiac cycle remained stable during the study.

ResumoIntrodução:A plastia valvar mitral é o tratamento de escolha para a insuficiência mitral, porém, a literatura é escassa em relação ao comportamento do anel mitral após a plástica mitral sem utilização de anéis protéticos.Objetivo:Realizar a análise morfofuncional do anel mitral de indivíduos submetidos à plastia valvar mitral pela Técnica de Duplo Teflon, sem utilização de anel protético, por meio da ecocardiografia tridimensional em tempo real.Métodos:Foram incluídos 14 pacientes com insuficiência mitral mixomatosa submetidos à plástica mitral pela técnica de Duplo Teflon. Treze pacientes encontravam-se em classe III/IV. Os pacientes foram avaliados nos períodos pré-operatório, pós-operatório imediato, 6 meses e 1 ano. Foi utilizado teste de análise de variância de medidas repetidas para o estudo estatístico, sendo considerado estatisticamente significante P<0,05.Resultados:Não houve óbito, reoperação por disfunção valvar, tromboembolismo ou endocardite durante o estudo. A planimetria posterior do anel mitral demostrou uma redução significativa (P<0,001) no pós-operatório imediato, que se manteve estável durante o estudo, apresentando redução média de 25,8% com 1 ano em relação ao pré-operatório. Houve uma redução significativa dos diâmetros ântero-posterior e médio-lateral no pós-operatório imediato (P<0,001), porém, houve um aumento significativo no diâmetro médio-lateral entre pós-operatório imediato e 1 ano. Não houve diferença na variação da área interna mitral ao longo do estudo.Conclusão:A anuloplastia segmentar reduziu significativamente o componente posterior do anel mitral, permanecendo estável no período de um ano. A variação da área valvar durante o ciclo cardíaco permaneceu estável durante o estudo.

Late outcome analysis of the Braile Biomédica® pericardial valve in the aortic position / Avaliação dos resultados tardios da bioprótese de pericárdio bovino Braile Biomédica® em posição aórtica

Objective: Aortic valve replacement with Braile bovine pericardial prosthesis has been routinely done at the Heart Institute of the Universidade de São Paulo Medical School since 2006. The objective of this study is to analyze the results of Braile Biomédica® aortic bioprosthesis in patients with aortic valve disease. Methods: We retrospectively evaluated 196 patients with aortic valve disease submitted to aortic valve replacement with Braile Biomédica® bovine pericardial prosthesis, between 2006 and 2010. Mean age was 59.41±16.34 years and 67.3% were male. Before surgery, 73.4% of patients were in NYHA functional class III or IV. Results: Hospital mortality was 8.16% (16 patients). Linearized rates of mortality, endocarditis, reintervention, and structural dysfunction were 1.065%, 0.91%, 0.68% and 0.075% patients/year, respectively. Actuarial survival was 90.59±2.56% in 88 months. Freedom from reintervention, endocarditis and structural dysfunction was respectively 91.38±2.79%, 89.84±2.92% and 98.57±0.72% in 88 months. Conclusion: The Braile Biomédica® pericardial aortic valve prosthesis demonstrated actuarial survival and durability similar to that described in the literature, but further follow up is required to assess the incidence of prosthetic valve endocarditis and structural dysfunction in the future. .

Objetivo: A troca valvar aórtica por substitutos biológicos de pericárdio bovino Braile é realizada rotineiramente no Instituto do Coração da Faculdade de Medicina da USP desde 2006. O objetivo deste estudo é analisar os resultados da utilização da prótese aórtica Braile Biomédica® em pacientes com doença valvar aórtica. Métodos: Foram analisados, retrospectivamente, 196 pacientes portadores de valvopatia aórtica submetidos à troca valvar aórtica por prótese biológica de pericárdio bovino Braile Biomédica® entre 2006 e 2010. A idade média foi de 59,41±16,34 anos e 67,3% eram do sexo masculino. No pré-operatório, 73,4% dos pacientes estavam em classe funcional III ou IV. Resultados: A mortalidade hospitalar foi 8,16% (16 pacientes). As taxas linearizadas de óbito, endocardite, reoperação e disfunção estrutural foram de 1,065%, 0,91%, 0,68% e 0,075% pacientes/ano, respectivamente. A sobrevida actuarial foi de 90,59±2,56% em 88 meses. A curva livre de reoperação, endocardite e disfunção estrutural foi respectivamente de 91,38±2,79%, 89,84±2,92% e 98,57±0,72% em 88 meses. Conclusão: O implante da prótese aórtica de pericárdio bovino Braile Biomédica® demonstrou sobrevida e durabilidade compatível com a literatura, porém maior seguimento é necessário para avaliar a incidência de endocardite e disfunção estrutural no futuro. .

Novas perspectivas no tratamento cirúrgico da estenose aórtica / New perspectives in the surgical treatment of aortic stenosis

A estenose aórtica degenerativa é a doença valvar adquirida mais comum em adultos, acometendo principalmente os idosos. A cirurgia de substituição da valva aórtica é o tratamento de escolha nos pacientes com estenose aórtica importante sintomática. Seus resultados são reproduzíveis e bem estabelecidos. Porém, cerca de um terço dos pacientes são considerados inoperáveis devido ao risco cirúrgico inaceitável. Em consequência, nos últimos anos, novas alternativas de tratamento intervencionista foram introduzidas na prática clínica, com resultados iniciais favoráveis. Atualmente, as opções englobam a cirurgia de troca da valva aórtica, o implante da valva aórtica transcateter e, mais recentemente, a cirurgia de troca valvar aórtica sem sutura. Técnicas cirúrgicas minimamente invasivas não demonstraram diferença na mortalidade, porém chamam a atenção pelo resultado similar à esternotomia clássica, melhor resultado estético e menor tempo de hospitalização. Além disso, para evitar a utilização de próteses, técnicas de reconstrução valvar têm sido descritas. No implante de valva transcateter, o treinamento de equipe multidisciplinar é mandatório para a criteriosa seleção dos pacientes e da via de acesso. Os acessos transapical e transaórtico evoluíram como opções eficazes e vantajosas nos pacientes não candidatos para a via femoral. A familiaridade dos cirurgiões com essas abordagens tem contribuído para os bons resultados descritos. Um centro que seja capaz de oferecer todas essas alternativas de tratamento poderá selecionar a técnica mais apropriada, considerando a preferência do paciente e avaliando características fundamentais como idade, comorbidades, fragilidade e anatomia. Experiente "Heart Team" será capaz de fazer a escolha mais adequada.

Degenerative aortic stenosis is the most common acquired valvular disease in adults, affecting mainly the elderly. Surgical aortic valve replacement is the treatment of choice in patients with severe symptomatic aortic stenosis. Its results are reproducible and well established. However, about one third of patients are considered inoperable because of unacceptable surgical risk. Therefore, in the past few years, new alternative interventional treatments were introduced in clinical practice, with favorable initial results. Currently, the options include surgical aortic valve replacement, transcatheter aortic valve implantation and more recently, sutureless aortic valve replacement. Minimally invasive surgical techniques showed no difference in mortality, but caIl attention for similar result to the classic sternotomy, better cosmetic effect and shorter length of hospital stay. Furthermore, to avoid the use of prostheses, valve reconstruction techniques have been described. In transcatheter valve implantation, training multidisciplinary team is mandatory for careful selection of patients and access routes. The transapical and transaortic approaches evolved as effective and advantageous options in patients not candidates for transfemoral access. The familiarity of surgeons with these routes has contributed to the good results described. A center that is able to offer ali of these therapeutic alternatives can select the most appropriate technique, considering the patient' s preferences and evaluating crucial characteristics such as age, comorbidities, frailty and anatomy. An experienced "Heart Team" will be able to make the most adequate choice.

EuroSCORE II e a importância de um modelo local, InsCor e o futuro SP-SCORE / EuroSCORE II and the importance of a local model, InsCor and the future SP-SCORE

Introdução: O modelo mais utilizado para predição de mortalidade em cirurgia cardíaca foi recentemente remodelado, mas dúvidas referentes à sua metodologia e desenvolvimento têm sido relatadas. Objetivo: O objetivo deste estudo foi avaliar o desempenho do EuroSCORE II na predição de mortalidade em pacientes submetidos a cirurgia de coronária e/ou valva na instituição. Métodos: Mil pacientes, operados consecutivamente de coronária e/ou valva, entre outubro de 2008 e julho de 2009, foram analisados. O desfecho de interesse foi mortalidade intra-hospitalar. A calibração foi realizada pela correlação entre mortalidade esperada e observada por meio do teste de Hosmer Lemeshow. A discriminação foi calculada pela área abaixo da curva ROC. O desempenho do EuroSCORE II foi comparado com os modelos EuroSCORE e InsCor (modelo local). Resultados: Na calibração, o teste de Hosmer Lemeshow foi inadequado para o EuroSCORE II (P=0,0003) e bom para os modelos EuroSCORE (P=0,593) e InsCor (P=0,184). No entanto, na discriminação, a área abaixo da curva ROC para o EuroSCORE II foi de 0,81 [IC 95% (0,76-0,85), P<0,001]; para o EuroSCORE foi de 0,81 [IC 95% (0,77-0,86), P<0,001] e para o InsCor foi de 0,79 [IC 95% (0,74-0,83), P<0,001], revelando-se adequada para todos. Conclusão: O EuroSCORE II se tornou mais complexo e, à semelhança com a literatura internacional, mal calibrado para predizer mortalidade nos pacientes operados de coronária e/ou valva em nosso meio. Esses dados reforçam a importância do modelo local. .

Introduction: The most widely used model for predicting mortality in cardiac surgery was recently remodeled, but the doubts regarding its methodology and development have been reported. Objective: The aim of this study was to assess the performance of the EuroSCORE II to predict mortality in patients undergoing coronary artery bypass grafts or valve surgery at our institution. Methods: One thousand consecutive patients operated on coronary artery bypass grafts or valve surgery, between October 2008 and July 2009, were analyzed. The outcome of interest was in-hospital mortality. Calibration was performed by correlation between observed and expected mortality by Hosmer Lemeshow. Discrimination was calculated by the area under the ROC curve. The performance of the EuroSCORE II was compared with the EuroSCORE and InsCor (local model). Results: In calibration, the Hosmer Lemeshow test was inappropriate for the EuroSCORE II (P=0.0003) and good for the EuroSCORE (P=0.593) and InsCor (P=0.184). However, the discrimination, the area under the ROC curve for EuroSCORE II was 0.81 [95% CI (0.76 to 0.85), P<0.001], for the EuroSCORE was 0.81 [95% CI (0.77 to 0.86), P<0.001] and for InsCor was 0.79 [95% CI (0.74-0.83), P<0.001] showing up properly for all. Conclusion: The EuroSCORE II became more complex and resemblance to the international literature poorly calibrated to predict mortality in patients undergoing coronary artery bypass grafts or valve surgery at our institution. These data emphasize the importance of the local model. .

Estratificação de risco cirúrgico como instrumento de inovação em programas de cirurgia cardíaca no Sistema Único de Saúde do Estado de São Paulo: ESTUDO SP-SCORE-SUS / Heart surgery programs innovation using surgical risk stratification at the São Paulo State Public Healthcare System: SP-SCORE-SUS STUDY

Doenças cardiovasculares representam a maior carga de morbimortalidade para o sistema de saúde e a cirurgia cardíaca desempenha importante impacto na sua resolutividade. O agrupamento das informações demográficas e clínicas relevantes dos pacientes acometidos, no nível de estratos específicos e em correlação com os conjuntos de recursos requeridos, representa a possibilidade de adaptar, aprimorar e inovar nos programas assistenciais. Este projeto tem por objetivo remodelar o escore de risco "InsCor" para formulação do SP-SCORE (São Paulo System for Cardiac Operative Risk Evaluation), visando refletir melhor a complexidade da assistência cirúrgica cardíaca. Os hospitais participantes integram os Núcleos de Avaliação de Tecnologias da Secretaria de Estado da Saúde de São Paulo (NATSs/SES-SP). Para a elaboração do SP-SCORE, serão utilizadas as 10 variáveis do modelo InsCor e 8 outras com suposta influência no Brasil. Os desfechos primários consistem na morbidade e na mortalidade hospitalar. A técnica de bootstrap junto a procedimentos de seleção automatizada de variáveis "stepwise" será utilizada para desenvolver um modelo parcimonioso por meio da regressão logística múltipla. Este projeto visa subsidiar a sustentabilidade e o financiamento do SUS-SP para as Redes Regionalizadas de Atenção à Saúde (RRAS) de cirurgias de coronária e/ou valva, promovendo alocação equitativa, incremento do acesso e efetividade, bem como caracterizar a magnitude dos recursos disponíveis e seu impacto.

Cardiovascular diseases represent the greatest burden of morbidity and mortality for the health system and cardiac surgery has an important impact on their resolutivity. The association and correlation of patients' demographic and clinical relevant information with the resources required for each stratum represent the possibility to adapt, improve and innovate into the healthcare programs. This project aims to remodel the "InsCor" risk score for the formulation of the SP-SCORE (Sao Paulo System for Cardiac Operative Risk Evaluation) in order to better reflects the complexity of cardiac surgical care. The participating hospitals include the Health Technology Assessment Centers in of the Health Secretariat' HTA Network of São Paulo State (HTA-NATSs / SES-SP). The SP-SCORE will use 10 variables of the InsCor model and others 8 variables with presumed influence in Brazil. The primary endpoints are morbidity and mortality. Bootstrap technique besides automated selection of variables (stepwise) will be used to develop a parsimonious model by multiple logistic regression. This project will contribute for the SUS-SP regionalized health-care (RRAS) sustainability and financing of the CABG and/or heart valve surgery programs promoting equitable allocation, increasing access and effectiveness, as well as characterizing the magnitude of available resources and its impact.