Efeitos de Longo Prazo do Implante Valvar Pulmonar e Evolução da Prótese em Pacientes com Tetralogia de Fallot Corrigida / Long-Term Effects of Pulmonary Valve Implantation and Prosthesis Evolution in Patients with Repaired Tetralogy of Fallot

Resumo Fundamento A regurgitação valvar pulmonar é uma importante complicação de longo prazo em pacientes com tetralogia de Fallot (TF). Objetivo O presente estudo tem como objetivo investigar os efeitos do implante valvar pulmonar (IVP) na anatomia e função do ventrículo direito (VD) e na evolução em longo prazo da prótese implantada em posição pulmonar. Métodos Uma análise de coorte retrospectiva e unicêntrica foi realizada em 56 pacientes consecutivos com TF submetidos a IVP. O estudo incluiu pacientes de ambos os gêneros, com idade ≥ 12 anos e compreendeu avaliação de dados clínicos e cirúrgicos, ressonância magnética cardiovascular pré e pós-operatória e dados ecocardiográficos obtidos mais de 1 ano após IVP. Resultados Após o IVP, houve uma diminuição significativa do volume sistólico final do VD indexado pela área de superfície corpórea (ASC), de 89 mL/ASC para 69 mL/ASC (p < 0,001) e do volume diastólico final indexado do VD, de 157 mL/ASC para 116 mL/ASC (p < 0,001). Além disso, houve aumento da fração de ejeção corrigida do VD [ FEVDc = fluxo pulmonar ajustado (fluxo pulmonar anterógrado − fluxo regurgitante) / volume diastólico final do VD ] de 23% para 35% (p < 0,001) e da fração de ejeção do ventrículo esquerdo de 58% para 60% (p = 0,008). No entanto, foi observado um aumento progressivo no gradiente de pico da válvula pulmonar ao longo do tempo, com 25% dos pacientes apresentando um gradiente superior a 60 mmHg. Próteses menores (tamanhos 19 a 23) foram associadas a um risco 4,3 vezes maior de gradiente > 60 mmHg em comparação com próteses maiores (tamanhos 25 a 27; p = 0,029; intervalo de confiança: 1,18 a 17,8). Conclusão Conforme esperado, o IVP demonstrou melhorias nos volumes e na função do VD. O acompanhamento e a vigilância a longo prazo são cruciais para avaliar a durabilidade da prótese e detectar potenciais complicações. O dimensionamento adequado das próteses é essencial para melhorar a longevidade da prótese.

Abstract Background Pulmonary valve regurgitation is a significant long-term complication in patients with tetralogy of Fallot (TOF). Objective This study aims to investigate the effects of pulmonary valve implantation (PVI) on the anatomy and function of the right ventricle (RV) and the long-term evolution of the implanted prosthesis in the pulmonary position. Methods A single-center retrospective cohort analysis was performed in 56 consecutive patients with TOF who underwent PVI. The study included patients of both sexes, aged ≥ 12 years, and involved assessing clinical and surgical data, pre- and post-operative cardiovascular magnetic resonance imaging, and echocardiogram data more than 1 year after PVI. Results After PVI, there was a significant decrease in RV end-systolic volume indexed by body surface area (BSA), from 89 mL/BSA to 69 mL/BSA (p < 0.001) and indexed RV end-diastolic volume, from 157 mL/BSA to 116 mL/BSA (p < 0.001). Moreover, there was an increase in corrected RV ejection fraction [ RVEFC = net pulmonary flow (pulmonary forward flow − regurgitant flow) / R V end-diastolic volume] from 23% to 35% (p < 0.001) and left ventricular ejection fraction from 58% to 60% (p = 0.008). However, a progressive increase in the peak pulmonary valve gradient was observed over time, with 25% of patients experiencing a gradient exceeding 60 mmHg. Smaller prostheses (sizes 19 to 23) were associated with a 4.3-fold higher risk of a gradient > 60 mmHg compared to larger prostheses (sizes 25 to 27; p = 0.029; confidence interval: 1.18 to 17.8). Conclusion As expected, PVI demonstrated improvements in RV volumes and function. Long-term follow-up and surveillance are crucial for assessing the durability of the prosthesis and detecting potential complications. Proper sizing of prostheses is essential for improved prosthesis longevity.

Challenges of Congenital Heart Surgery in Brazil: It is Time to Designate Pediatric Congenital Heart Surgery Subspecialty

ABSTRACT Congenital heart disease (CHD) affects eight to ten out of every 1,000 births, resulting in approximately 23,057 new cases in Brazil in 2022. About one in four children with CHD requires surgery or other procedures in the first year of life, and it is expected that approximately 81% of these children with CHD will survive until at least 35 years of age. Professionals choosing to specialize in CHD surgery face numerous challenges, not only related to mastering surgical techniques and the complexity of the diseases but also to the lack of recognition by medical societies as a separate subspecialty. Furthermore, families face difficulties when access to services capable of providing treatment for these children. To address these challenges, it is essential to have specialized hospitals, qualified professionals, updated technologies, sustainable industry, appropriate financing, quality assessment systems, and knowledge generation. The path to excellence involves specialization across all involved parties. As we reflect on the importance of Pediatric Cardiovascular Surgery and Congenital Heart Diseases establishing themselves as a subspecialty of Cardiovascular Surgery, it is essential to look beyond our borders to countries like the United States of America and United Kingdom, where this evolution is already a reality. This autonomy has led to significant advancements in research, education, and patient care outcomes, establishing a care model. By following this path in Brazil, we not only align our practice with the highest international standards but also demonstrate our maturity and the ability to meet the specific needs of patients with CHD and those with acquired childhood heart disease.

Performance Evaluation of Geometrically Different Pediatric Arterial Cannulae in a Pediatric Cardiopulmonary Bypass Model

ABSTRACT Objective: To define a reference chart comparing pressure drop vs. flow generated by a set of arterial cannulae currently utilized in cardiopulmonary bypass conditions in pediatric surgery. Methods: Cannulae from two manufacturers were selected considering their design and outer and inner diameters. Cannula performance was evaluated in terms of pressure drop vs. flow during simulated cardiopulmonary bypass conditions. The experimental circuits consisted of a Jostra HL-20 roller pump, a Quadrox-i pediatric oxygenator (Maquet Cardiopulmonary AG, Rastatt, Germany), and a custom pediatric tubing set. The circuit was primed with lactated Ringer's solution only (first condition) and with human packed red blood cells added (second condition) to achieve a hematocrit of 30%. Cannula sizes 8 to 16 Fr were inserted into the cardiopulmonary bypass circuit with a "Y" connector. The flow was adjusted in 100 ml/min increments within typical flow ranges for each cannula. Pre-cannula and post-cannula pressures were measured to calculate the pressure drop. Results: Utilizing a pressure drop limit of 100 mmHg, our results suggest a recommended flow limit of 500, 900, 1400, 2600, and 3100 mL/min for Braile arterial cannulae sizes 8, 10, 12, 14, and 16 Fr, respectively. For Medtronic DLP arterial cannulae sizes 8, 10, 12, 14, and 16 Fr, the recommended flow limit is 600, 1100, 1700, 2700, and 3300 mL/min, respectively. Conclusion: This study reinforces discrepancies in pressure drop between cannulae of the same diameter supplied by different manufacturers and the importance of independent translational research to evaluate components' performance.

A New Dawn for Brazilian Pediatric Cardiac Surgery Is on the Way - Issues Around and Outside the Operating Room

ABSTRACT In some developing countries, congenital heart disease still stands out among the leading causes of death in the first year of life. Therefore, there is a great need to develop programs designed to improve outcomes in the diagnosis and surgical treatment of congenital heart disease in these nations, where children have always been and still are severely underserved. The Brazilian Public Health Care System demands universal access to treatment as a constitutional right. Therefore, an underfunded Pediatric Cardiac Surgery program is unacceptable since it will cost lives and increase the infant mortality rate. Additionally, poor funding decreases providers' interest, impedes technological advances and multidisciplinary engagement, and reduces access to comprehensive care. Unfortunately, in most developing countries, Pediatric Cardiac Surgery progress is still the result of isolated personal efforts, dedication, and individual resilience. This article aims to present the current state of Brazilian pediatric cardiac surgery and discuss the structural and human limitations in developing a quality care system for children with congenital heart disease. Considering such constraints, quality improvement programs via International collaboration with centers of excellence, based on proper data collection and outcomes analysis, have been introduced in the country. Such initiatives should bring a new dawn to Brazilian Pediatric Cardiac Surgery.

Adherence to the cardiac surgery checklist decreased mortality at a teaching hospital: A retrospective cohort study

Abstract Objectives To evaluate the impact of adherence to the cardiac surgical checklist on mortality at the teaching hospital. Methods A retrospective cohort study after the implementation of the cardiac surgical safety checklist in a reference hospital in Latin America. All patients undergoing coronary artery bypass surgery and/or heart valve surgery from 2013 to 2019 were analyzed. After the implementation of the project InCor-Checklist "Five steps to safe cardiac surgery" in 2015, the correlation between adherence and completeness of this instrument with surgical mortality was assessed. The EuroSCORE II was used as a reference to assess the risk of expected mortality for patients. Cross-sectional questionnaires were during the implementation of the InCor-Checklist. To perform the correlation, Pearson's coefficient was calculated using R software. Results Since 2013, data from 8139 patients have been analyzed. The average annual mortality was 5.98%. In 2015, the instrument was used in only 58% of patients; in contrast, it was used in 100% of patients in 2019. There was a decrease in surgical mortality from 8.22% to 3.13% for the same group of procedures. The results indicate that the greater the checklist use, the lower the surgical mortality (r = 88.9%). In addition, the greater the InCor-Checklist completeness, the lower the surgical mortality (r = 94.1%). Conclusion In the formation of the surgical patient safety culture, the implementation and adherence to the InCor-Checklist "Five steps to safe cardiac surgery" was associated with decreased mortality after cardiac surgery. HIGHLIGHTS Checklists avoid human errors and are commonly used in high-reliability industries. The "InCor Checklist" was associated with decreased mortality over time. Adherence, completeness, and sustainability within public policies are necessary.

Preoperative Neutrophil-Lymphocyte Ratio Can Predict Outcomes for Patients Undergoing Tetralogy of Fallot Repair

Abstract Introduction: Elevated neutrophil-lymphocyte ratio (NLR) has been associated with poorer outcomes in cyanotic patients undergoing single ventricle palliation. Little is known about this biomarker on patients with tetralogy of Fallot (TOF), the most common cyanotic congenital heart disease. Our objective is to study the impact of preoperative NLR on outcomes of TOF patients undergoing total repair. Methods: This retrospective study included 116 consecutive patients between January 2014 and December 2018. Preoperative NLR was measured from the last complete blood count test before the surgery. Using the cutoff value of 0.80, according to the receiver-operating characteristic (ROC) curve, the sample was divided into two groups (NLR < 0.80 and ≥ 0.80). The primary endpoint was hospital length of stay (LOS). Results: ROC curves showed that higher preoperative NLR was associated with longer hospital LOS, with an area under the curve of 0.801±0.040 (95% confidence interval 0.722 - 0.879; P<0.001). High preoperative NLR was also associated with long intensive care unit (ICU) LOS (P=0.035). Preoperative NLR predicted longer hospital LOS with a sensitivity of 63% and a specificity of 81.4%. Conclusion: Higher preoperative NLR was associated with long ICU and hospital LOS in patients undergoing TOF repair.

Translation and Validation of the Boston Technical Performance Score in a Developing Country

Abstract Introduction: The Technical Performance Score (TPS) was developed and subsequently refined at the Boston Children's Hospital. Our objective was to translate and validate its application in a developing country. Methods: The score was translated into the Portuguese language and approved by the TPS authors. Subsequently, we studied 1,030 surgeries from June 2018 to October 2020. TPS could not be assigned in 58 surgeries, and these were excluded. Surgical risk score was evaluated using Risk Adjustment in Congenital Heart Surgery (or RACHS-1). The impact of TPS on outcomes was studied using multivariable linear and logistic regression adjusting for important perioperative covariates. Results: Median age and weight were 2.2 (interquartile range [IQR] = 0.5-13) years and 10.8 (IQR = 5.6-40) kilograms, respectively. In-hospital mortality was 6.58% (n=64), and postoperative complications occurred in 19.7% (n=192) of the cases. TPS was categorized as 1 in 359 cases (37%), 2 in 464 (47.7%), and 3 in 149 (15.3%). Multivariable analysis identified TPS class 3 as a predictor of longer hospital stay (coefficient: 6.6; standard error: 2.2; P=0.003), higher number of complications (odds ratio [OR]: 1.84; 95% confidence interval [CI]: 1.1-3; P=0.01), and higher mortality (OR: 3.2; 95% CI: 1.4-7; P=0.004). Conclusion: TPS translated into the Portuguese language was validated and showed to be able to predict higher mortality, complication rate, and prolonged postoperative hospital stay in a high-volume Latin-American congenital heart surgery program. TPS is generalizable and can be used as an outcome assessment tool in resource diverse settings.

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.

Impact of vacuum-assisted venous drainage on forward flow in simulated pediatric cardiopulmonary bypass circuits utilizing a centrifugal arterial pump head

Abstract Objective: To analyze the impact of vacuum-assisted venous drainage (VAVD) on arterial pump flow in a simulated pediatric cardiopulmonary bypass circuit utilizing a centrifugal pump (CP) with an external arterial filter. Methods: The simulation circuit consisted of a Quadrox-I Pediatric oxygenator, a Rotaflow CP (Maquet Cardiopulmonary AG, Rastatt, Germany), and a custom pediatric tubing set primed with Lactated Ringer's solution and packed red blood cells. Venous line pressure, reservoir pressure, and arterial flow were measured with VAVD turned off to record baseline values. Four other conditions were tested with progressively higher vacuum pressures (-20, -40, -60, and -80 mmHg) applied to the baseline cardiotomy pressure. An arterial filter was placed into the circuit and arterial flow was measured with the purge line in both open and closed positions. These trials were repeated at set arterial flow rates of 1500, 2000, and 2500 mL/min. Results: The use of progressively higher vacuum caused a reduction in effective arterial flow from 1490±0.00 to 590±0.00, from 2020±0.01 to 1220±0.00, and from 2490±0.0 to 1830±0.01 mL/min. Effective forward flow decreased with increased levels of VAVD. Conclusion: The use of VAVD reduces arterial flow when a CP is used as the main arterial pump. The reduction in the forward arterial flow increases as the vacuum level increases. The loss of forward flow is further reduced when the arterial filter purge line is kept in the recommended open position. An independent flow probe is essential to monitor pump flow during cardiopulmonary bypass.

Early and long-term outcomes of surgical treatment of ebstein's anomaly

Abstract Objective: This study aimed to evaluate Ebstein's anomaly surgical correction and its early and long-term outcomes. Methods: A retrospective analysis of 62 consecutive patients who underwent surgical repair of Ebstein's anomaly in our institution from January 2000 to July 2016. The following long-term outcomes were evaluated: survival, reoperations, tricuspid regurgitation, and postoperative right ventricular dysfunction. Results: Valve repair was performed in 46 (74.2%) patients - 12 of them using the Da Silva cone reconstruction; tricuspid valve replacement was performed in 11 (17.7%) patients; univentricular palliation in one (1.6%) patient; and the one and a half ventricle repair in four (6.5%) patients. The patients' mean age at the time of surgery was 20.5±14.9 years, and 46.8% of them were male. The mean follow-up time was 8.8±6 years. The 30-day mortality rate was 8.06% and the one and 10-year survival rates were 91.9% both. Eleven (17.7%) of the 62 patients required late reoperation due to tricuspid regurgitation, in an average time of 7.1±4.9 years after the first procedure. Conclusion: In our experience, the long-term results of the surgical treatment of Ebstein's anomaly demonstrate an acceptable survival rate and a low incidence of reinterventions.

Outcomes of the Conversion of the Fontan-Kreutzer Operation to a Total Cavopulmonary Connection for the Failing Univentricular Circulation / Resultados da Conversão da Cirurgia de Fontan-Kreutzer para Cavo-Pulmonar Total Devido Falência da Circulação Univentricular

Abstract Background: The Fontan-Kreutzer procedure (FK) was widely performed in the past, but in the long-term generated many complications resulting in univentricular circulation failure. The conversion to total cavopulmonary connection (TCPC) is one of the options for treatment. Objective: To evaluate the results of conversion from FK to TCPC. Methods: A retrospective review of medical records for patients who underwent the conversion of FK to TCPC in the period of 1985 to 2016. Significance p < 0,05. Results: Fontan-type operations were performed in 420 patients during this period: TCPC was performed in 320, lateral tunnel technique in 82, and FK in 18. Ten cases from the FK group were elected to conversion to TCPC. All patients submitted to Fontan Conversion were included in this study. In nine patients the indication was due to uncontrolled arrhythmia and in one, due to protein-losing enteropathy. Death was observed in the first two cases. The average intensive care unit (ICU) length of stay (LOS) was 13 days, and the average hospital LOS was 37 days. A functional class by New York Heart Association (NYHA) improvement was observed in 80% of the patients in NYHA I or II. Fifty-seven percent of conversions due to arrhythmias had improvement of arrhythmias; four cases are cured. Conclusions: The conversion is a complex procedure and requires an experienced tertiary hospital to be performed. The conversion has improved the NYHA functional class despite an unsatisfactory resolution of the arrhythmia.

Resumo Fundamento: O procedimento de Fontan-Kreutzer (FK) foi amplamente realizado no passado, mas a longo prazo gerou muitas complicações, resultando em falha na circulação univentricular. A conversão para conexão cavopulmonar total (CCPT) é uma das opções de tratamento. Objetivo: Avaliar os resultados da conversão de FK para CCPT. Métodos: Revisão retrospectiva de prontuários de pacientes submetidos à conversão de FK para CCPT no período de 1985 a 2016. Significância p < 0,05. Resultados: Operações do tipo Fontan foram realizadas em 420 pacientes durante este período: CCPT foi realizada em 320, técnica de túnel lateral em 82 e FK em 18. Dez casos do grupo FK foram eleitos para conversão em CCPT. Todos os pacientes submetidos à conversão de Fontan foram incluídos neste estudo. Em nove pacientes, a indicação deveu-se a arritmia não controlada e em um devido à enteropatia perdedora de proteínas. A morte foi observada nos dois primeiros casos. O tempo médio de internação na unidade de terapia intensiva (UTI) foi de 13 dias e o tempo médio de internação hospitalar foi de 37 dias. Uma classe funcional pela melhora da New York Heart Association (NYHA) foi observada em 80% dos pacientes em NYHA I ou II. Cinquenta e sete por cento das conversões devido a arritmias tiveram melhora das arritmias; quatro casos foram curados. Conclusões: A conversão é um procedimento complexo e requer que um hospital terciário experiente seja realizado. A conversão melhorou a classe funcional da NYHA, apesar de uma resolução insatisfatória da arritmia.

Rational use of mechanical circulatory support as a bridge to pediatric and congenital heart transplantation

Abstract Introduction: Donor shortage and organ allocation is the main problem in pediatric heart transplant. Mechanical circulatory support is known to increase waiting list survival, but it is not routinely used in pediatric programs in Latin America. Methods: All patients listed for heart transplant and supported by a mechanical circulatory support between January 2012 and March 2016 were included in this retrospective single-center study. The endpoints were mechanical circulatory support time, complications, heart transplant survival and discharge from the hospital. Results: Twenty-nine patients from our waiting list were assessed. Twelve (45%) patients were initially supported by extracorporeal membrane oxygenation (ECMO) and a centrifugal pump was implanted in 17 (55%) patients. Five patients initially supported by ECMO were bridged to another device. One was bridged to a centrifugal pump and four were bridged to Berlin Heart Excor®. Among the 29 supported patients, 18 (62%) managed to have a heart transplant. Thirty-day survival period after heart transplant was 56% (10 patients). Median support duration was 12 days (interquartile range [IQR] 4 - 26 days) per run and the waiting time for heart transplant was 9.5 days (IQR 2.5-25 days). Acute kidney injury was identified as a mortality predictor (OR=22.6 [CI=1.04-494.6]; P=0.04). Conclusion: Mechanical circulatory support was able to bridge most INTERMACS 1 and 2 pediatric patients to transplant with an acceptable complication rate. Acute renal failure increased mortality after mechanical circulatory support in our experience.

Functional performance of different venous limb options in simulated neonatal/pediatric cardiopulmonary bypass circuits

Abstract Objective: Hemodilution is a concern in cardiopulmonary bypass (CPB). Using a smaller dual tubing rather than a single larger inner diameter (ID) tubing in the venous limb to decrease prime volume has been a standard practice. The purpose of this study is to evaluate these tubing options. Methods: Four different CPB circuits primed with blood (hematocrit 30%) were investigated. Two setups were used with two circuits for each one. In Setup I, a neonatal oxygenator was connected to dual 3/16" ID venous limbs (Circuit A) or to a single 1/4" ID venous limb (Circuit B); and in Setup II, a pediatric oxygenator was connected to dual 1/4" ID venous limbs (Circuit C) or a single 3/8" ID venous limb (Circuit D). Trials were conducted at arterial flow rates of 500 ml/min up to 1500 ml/min (Setup I) and up to 3000 ml/min (Setup II), at 36°C and 28°C. Results: Circuit B exhibited a higher venous flow rate than Circuit A, and Circuit D exhibited a higher venous flow rate than Circuit C, at both temperatures. Flow resistance was significantly higher in Circuits A and C than in Circuits B (P<0.001) and D (P<0.001), respectively. Conclusion: A single 1/4" venous limb is better than dual 3/16" venous limbs at all flow rates, up to 1500 ml/min. Moreover, a single 3/8" venous limb is better than dual 1/4" venous limbs, up to 3000 ml/min. Our findings strongly suggest a revision of perfusion practice to include single venous limb circuits for CPB.

Pre-validation study of the brazilian version of the disruptions in surgery index (disi) as a safety tool in cardiothoracic surgery

Abstract Introduction: Most risk stratification scores used in surgery do not include external and non-technical factors as predictors of morbidity and mortality. Objective: The present study aimed to translate and adapt transculturally the Brazilian version of the Disruptions in Surgery Index (DiSI) questionnaire, which was developed to capture the self-perception of each member of the surgical team regarding the disruptions that may contribute to error and obstruction of safe surgical flow. Methods: A universalist approach was adopted to evaluate the conceptual equivalence of items and semantics, which included the following stages: (1) translation of the questionnaire into Portuguese; (2) back translation into English; (3) panel of experts to draft the preliminary version; and (4) pre-test for evaluation of verbal comprehension by the target population of 43 professionals working in cardiothoracic surgery. Results: The questionnaire was translated into Portuguese and its final version with 29 items obtained 89.6% approval from the panel of experts. The target population evaluated all items as easy to understand. The mean overall clarity and verbal comprehension observed in the pre-test reached 4.48 ± 0.16 out of the maximum value of 5 on the psychometric Likert scale. Conclusion: Based on the methodology used, the experts' analysis and the results of the pre-test, it is concluded that the essential stages of translation and cross-cultural adaptation of DiSI to the Portuguese language were satisfactorily fulfilled in this study.

Collaborative quality improvement in the congenital heart defects: development of the assist consortium and a preliminary surgical outcomes report

Abstract Objective: ASSIST is the first Brazilian initiative in building a collaborative quality improvement program in pediatric cardiology and congenital heart disease. The purposes of this manuscript are: (a) to describe the development of the ASSIST project, including the historical, philosophical, organizational, and infrastructural components that will facilitate collaborative quality improvement in congenital heart disease care; (b) to report past and ongoing challenges faced; and (c) to report the first preliminary data analysis. Methods: A total of 614 operations were prospectively included in a comprehensive online database between September 2014 and December 2015 in two participating centers. Risk Adjustment for Congenital Heart Surgery (RACHS) 1 and Aristotle Basic Complexity (ABC) scores were obtained. Descriptive statistics were provided, and the predictive values of the two scores for mortality were calculated by multivariate logistic regression models. Results: Many barriers and challenges were faced and overcome. Overall mortality was 13.4%. Independent predictors of in-hospital death were: RACHS-1 categories (3, 4, and 5/6), ABC level 4, and age group (≤ 30 days, and 30 days - 1 year). Conclusion: The ASSIST project was successfully created over a solid base of collaborative work. The main challenges faced, and overcome, were lack of institutional support, funding, computational infrastructure, dedicated staff, and trust. RACHS-1 and ABC scores performed well in our case mix. Our preliminary outcome analysis shows opportunities for improvement.

Neonatal and pediatric extracorporeal membrane oxygenation in developing Latin American countries / Oxigenação por membrana extracorpórea neonatal e pediátrica em países emergentes da América Latina

Abstract Objective: To review the principles of neonatal-pediatric extracorporeal membrane oxygenation therapy, prognosis, and its establishment in limited resource-limited countries in Latino America. Sources: The PubMed database was explored from 1985 up to the present, selecting from highly-indexed and leading Latin American journals, and Extracorporeal Life Support Organization reports. Summary of the findings: Extracorporeal membrane oxygenation provides “time” for pulmonary and cardiac rest and for recovery. It is used in the neonatal-pediatric field as a rescue therapy for more than 1300 patients with respiratory failure and around 1000 patients with cardiac diseases per year. The best results in short- and long-term survival are among patients with isolated respiratory diseases, currently established as a standard therapy in referral centers for high-risk patients. The first neonatal/pediatric extracorporeal membrane oxygenation Program in Latin America was established in Chile in 2003, which was also the first program in Latin America to affiliate with the Extracorporeal Life Support Organization. New extracorporeal membrane oxygenation programs have been developed in recent years in referral centers in Argentina, Colombia, Brazil, Mexico, Perú, Costa Rica, and Chile, which are currently funding the Latin American Extracorporeal Life Support Organization chapter. Conclusions: The best results in short- and long-term survival are in patients with isolated respiratory diseases. Today extracorporeal membrane oxygenation therapy is a standard therapy in some Latin American referral centers. It is hoped that these new extracorporeal membrane oxygenation centers will have a positive impact on the survival of newborns and children with respiratory or cardiac failure, and that they will be available for an increasing number of patients from this region in the near future.

Resumo Objetivo: Analisar os fundamentos, o prognóstico e o estabelecimento da terapia de oxigenação por membrana extracorpórea ECMO neonatal-pediátrica em países da América Latina com recursos limitados. Fontes: A base de dados PubMed foi explorada de 1985 até hoje, selecionamos os principais periódicos da América Latina e relatos da Organização de Suporte de Vida Extracorpóreo. Resumo dos achados: A oxigenação por membrana extracorpórea proporciona “tempo” para descanso pulmonar e cardíaco e para recuperação. Ela é usada no campo neonatal-pediátrico como terapia de resgate, com mais de 1.300 pacientes com insuficiência respiratória e cerca de 1.000 pacientes com cardiopatias por ano. Os melhores resultados de sobrevida de curto e longo prazo são de pacientes com doenças respiratórias isoladas, o que estabelece uma terapia padrão em centros de encaminhamento para pacientes de alto risco. O primeiro programa de oxigenação por membrana extracorpórea neonatal/pediátrico na América Latina foi estabelecido no Chile em 2003, que também foi o primeiro programa na América Latina a se afiliar à Organização de Suporte de Vida Extracorpóreo. Novos programas de oxigenação por membrana extracorpórea foram desenvolvidos nos últimos anos em centros de encaminhamento em Argentina, Colômbia, Brasil, México, Peru, Costa Rica e Chile, que atualmente fundam a seção da América Latina da Organização de Suporte de Vida Extracorpóreo. Conclusões: Os melhores resultados de sobrevida de curto e longo prazo são de pacientes com doenças respiratórias isoladas. Atualmente, a terapia de oxigenação por membrana extracorpórea é uma terapia padrão em alguns centros de encaminhamento da América Latina. Esperamos que esses novos centros de oxigenação por membrana extracorpórea tenham um impacto positivo sobre a sobrevida de neonatos e crianças com insuficiência respiratória ou cardíaca e que estejam disponíveis para um número cada vez maior de pacientes de nossa região no futuro próximo.

In-vitro evaluation of two types of neonatal oxygenators in handling gaseous microemboli and maintaining optimal hemodynamic stability during cardiopulmonary bypass

Abstract Objective: Usually only FDA-approved oxygenators are subject of studies by the international scientific community. The objective of this study is to evaluate two types of neonatal membrane oxygenators in terms of transmembrane pressure gradient, hemodynamic energy transmission and gaseous microemboli capture in simulated cardiopulmonary bypass systems. Methods: We investigated the Braile Infant 1500 (Braile Biomédica, São José do Rio Preto, Brazil), an oxygenator commonly used in Brazilian operating rooms, and compared it to the Dideco Kids D100 (Sorin Group, Arvada, CO, USA), that is an FDA-approved and widely used model in the USA. Cardiopulmonary bypass circuits were primed with lactated Ringer's solution and packed red blood cells (Hematocrit 40%). Trials were conducted at flow rates of 500 ml/min and 700 ml/min at 35ºC and 25ºC. Real-time pressure and flow data were recorded using a custom-based data acquisition system. For gaseous microemboli testing, 5cc of air were manually injected into the venous line. Gaseous microemboli were recorded using the Emboli Detection and Classification Quantifier. Results: Braile Infant 1500 had a lower pressure drop (P<0.01) and a higher total hemodynamic energy delivered to the pseudopatient (P<0.01). However, there was a higher raw number of gaseous microemboli seen prior to oxygenator at lower temperatures with the Braile oxygenator compared to the Kids D100 (P<0.01). Conclusion: Braile Infant 1500 oxygenator had a better hemodynamic performance compared to the Dideco Kids D100 oxygenator. Braile had more gaseous microemboli detected at the pre-oxygenator site under hypothermia, but delivered a smaller percentage of air emboli to the pseudopatient than the Dideco oxygenator.