Custo-Efetividade da Oxigenação por Membrana Extracorpórea Venoarterial no Choque Cardiogênico Refratário: Um Estudo na Perspectiva Brasileira / Cost-Utility of Venoarterial Extracorporeal Membrane Oxygenation in Refractory Cardiogenic Shock: A Brazilian Perspective Study

Resumo Fundamento O choque cardiogênico (CC) refratário está associado com altas taxas de mortalidade, e o uso de oxigenação por membrana extracorpórea venoarterial (VA-ECMO, do inglês venoarterial extracorporeal membrane oxygenation) como uma opção terapêutica tem gerado discussões. Nesse sentido, sua custo-efetividade, principalmente em países de baixa e média renda como o Brasil, continua incerto.Objetivos: Conduzir uma análise de custo-efetividade na perspectiva do Sistema Único de Saúde (SUS) para avaliar a custo-efetividade de VA-ECMO combinado com o tratamento padrão em comparação ao tratamento padrão isolado em pacientes adultos com CC refratário. Métodos Acompanhamos uma coorte de pacientes com CC refratário tratados com VA-ECMO em centros de assistência terciária do sul brasileiro. Coletamos dados de desfechos e custos hospitalares. Realizamos uma revisão sistemática para complementar nossos dados e usamos o modelo de Markov para estimar a razão de custo-efetividade incremental (RCEI) por ano de vida ajustado pela qualidade (QALY) e por ano de vida ganho. Resultados Na análise do caso-base, a VA-ECMO gerou uma RCEI de Int$ 37 491 por QALY. Análises de sensibilidade identificaram o custo de internação, o risco relativo de sobrevida, e a sobrevida do grupo submetido à VA-ECMO como principais variáveis influenciando os resultados. A análise de sensibilidade probabilística mostrou um benefício do uso de VA-ECMO, com uma probabilidade de 78% de custo-efetividade no limiar recomendado de disposição a pagar. Conclusões Nosso estudo sugere que, dentro do SUS, VA-ECMO pode ser uma terapia custo-efetiva para o CC refratário. Contudo, a escassez de dados sobre a eficácia e de ensaios clínicos recentes que abordem seus benefícios em subgrupos específicos de pacientes destaca a necessidade de mais pesquisas. Ensaios clínicos rigorosos, incluindo perfis diversos de pacientes, são essenciais para confirmar a custo-efetividade com uso de VA-ECMO e assegurar acesso igualitário a intervenções médicas avançadas dentro dos sistemas de saúde, especialmente em países com desigualdades socioeconômicas como o Brasil.

Abstract Background Refractory cardiogenic shock (CS) is associated with high mortality rates, and the use of venoarterial extracorporeal membrane oxygenation (VA-ECMO) as a therapeutic option has generated discussions. Therefore, its cost-effectiveness, especially in low- and middle-income countries like Brazil, remains uncertain.Objectives: To conduct a cost-utility analysis from the Brazilian Unified Health System perspective to assess the cost-effectiveness of VA-ECMO combined with standard care compared to standard care alone in adult refractory CS patients. Methods We followed a cohort of refractory CS patients treated with VA-ECMO in tertiary care centers located in Southern Brazilian. We collected data on hospital outcomes and costs. We conducted a systematic review to supplement our data and utilized a Markov model to estimate incremental cost-effectiveness ratios (ICERs) per quality-adjusted life year (QALY) and per life-year gained. Results In the base-case analysis, VA-ECMO yielded an ICER of Int$ 37,491 per QALY. Sensitivity analyses identified hospitalization cost, relative risk of survival, and VA-ECMO group survival as key drivers of results. Probabilistic sensitivity analysis favored VA-ECMO, with a 78% probability of cost-effectiveness at the recommended willingness-to-pay threshold. Conclusions Our study suggests that, within the Brazilian Health System framework, VA-ECMO may be a cost-effective therapy for refractory CS. However, limited efficacy data and recent trials questioning its benefit in specific patient subsets highlight the need for further research. Rigorous clinical trials, encompassing diverse patient profiles, are essential to confirm cost-effectiveness and ensure equitable access to advanced medical interventions within healthcare systems, particularly in socio-economically diverse countries like Brazil.

Extracorporeal Mechanical Circulatory Support after Pulmonary Thromboendarterectomy: Experience of One Center.

PURPOSE: Pulmonary thromboendarterectomy (PTE) is the treatment for patients with chronic thromboembolic disease. In the immediate postoperative period, some patients may still experience life-threatening complications such as reperfusion lung injury, airway bleeding, and persistent pulmonary hypertension with consequent right ventricular dysfunction. These issues may require support with extracorporeal membrane oxygenation (ECMO) as a bridge to recovery or lung transplantation. This study aims to analyze our series of PTEs that require ECMO. METHODS: A descriptive and retrospective analysis of all PTE performed at the Favaloro Foundation University Hospital was conducted between March 2013 and December 2023. RESULTS: A total of 42 patients underwent PTE with a median age of 47 years (interquartile range: 26-76). The incidence of patients with ECMO was 26.6%, of which 53.6% were veno-venous (VV) ECMO. Preoperatively, a low cardiac index (CI), high right and left filling pressures, and high total pulmonary vascular resistances (PVRs) were associated with ECMO with a statistically significant relationship. The hospital mortality was 11.9%, and the mortality in the ECMO group was 45.5%, with a statistically significant relationship. Veno-arterial ECMO has a worse prognosis than VV ECMO. CONCLUSIONS: Preoperatively, a low CI, high right and left filling pressures, and high total PVRs were associated with ECMO after PTE.

Circulatory support with triple cannulation V-PaA ECMO in a patient with acute right ventricular failure and refractory hypoxemia secondary to diffuse alveolar hemorrhage: A case report.

A 48-year-old woman presented to the emergency department with a one-week history of progressive dyspnea. During her hospitalization, the diagnosis of diffuse alveolar hemorrhage was made. She subsequently developed respiratory failure and acute right ventricular failure. Despite medical treatment, she continued to experience distributive shock due to a generalized inflammatory response. Circulatory support with ECMO was needed. We opted for triple cannulation to manage the multiorgan failure as a bridge to recovery. We describe our experience with an uncommon cannulation technique: veno-pulmonary-arterial cannulation, which enabled us to address cardiogenic shock, refractory hypoxemia, and distributive shock, leading to the successful recovery of the patient.

Impact of Extracorporeal Membrane Oxygenation Circuitry on Remdesivir.

OBJECTIVES: This study aimed to determine the oxygenator impact on alterations of remdesivir (RDV) in a contemporary neonatal/pediatric (1/4-inch) and adolescent/adult (3/8-inch) extracorporeal membrane -oxygenation (ECMO) circuit including the Quadrox-i oxygenator. METHODS: One-quarter-inch and a 3/8-inch, simulated closed-loop ECMO circuits were prepared with a Quadrox-i pediatric and Quadrox-i adult oxygenator and blood primed. Additionally, 1/4-inch and 3/8-inch circuits were also prepared without an oxygenator in series. A 1-time dose of RDV was administered into the circuits and serial preoxygenator and postoxygenator concentrations were obtained at 0 to 5 minutes, and 1-, 2-, 3-, 4-, 5-, 6-, 8-, 12-, and 24-hour time points. The RDV was also maintained in a glass vial and samples were taken from the vial at the same time periods for control purposes to assess for spontaneous drug degradation. RESULTS: For the 1/4-inch circuits with an oxygenator, there was a 35% to 60% RDV loss during the study period. For the 1/4-inch circuits without an oxygenator, there was a 5% to 20% RDV loss during the study period. For the 3/8-inch circuit with and without an oxygenator, there was a 60% to 70% RDV loss during the study period. CONCLUSIONS: There was RDV loss within the circuit during the study period and the RDV loss was more pronounced with the larger 3/8-inch circuit when compared with the 1/4-inch circuit. The impact of the -oxygenator on RDV loss appears to be variable and possibly dependent on the size of the circuit and -oxygenator. These preliminary data suggest RDV dosing may need to be adjusted for concern of drug loss via the ECMO circuit. Additional single- and multiple-dose studies are needed to validate these findings.

Veno-arterial ECMO ventricular assistance as a direct bridge to heart transplant: A single center experience in a low-middle income country.

INTRODUCTION: The use of veno-arterial extracorporeal membrane oxygenation (VA-ECMO) as a direct bridge to heart transplantation (BTT) is not common in adults worldwide. BTT with ECMO is associated with increased early/mid-term mortality compared with other interventions. In low- and middle-income countries (LMIC), where no other type of short-term mechanical circulatory support is available, its use is widespread and increasingly used as rescue therapy in patients with cardiogenic shock (CS) as a direct bridge to heart transplantation (HT). OBJECTIVE: To assess the outcomes of adult patients using VA-ECMO as a direct BTT in an LMIC and compare them with international registries. METHODS: We conducted a single-center study analyzing consecutive adult patients requiring VA-ECMO as BTT due to refractory CS or cardiac arrest (CA) in a cardiovascular center in Argentina between January 2014 and December 2022. Survival and adverse clinical events after VA-ECMO implantation were evaluated. RESULTS: Of 86 VA-ECMO, 22 (25.5%) were implanted as initial BTT strategy, and 52.1% of them underwent HT. Mean age was 46 years (SD 12); 59% were male. ECMO was indicated in 81% for CS, and the most common underlying condition was coronary artery disease (31.8%). Overall, in-hospital mortality for VA-ECMO as BTT was 50%. Survival to discharge was 83% in those who underwent HT and 10% in those who did not, p < .001. In those who did not undergo HT, the main cause of death was hemorrhagic complications (44%), followed by thrombotic complications (33%). The median duration of VA-ECMO was 6 days (IQR 3-16). There were no differences in the number of days on ECMO between those who received a transplant and those who did not. In the Spanish registry, in-hospital survival after HT was 66.7%; the United Network of Organ Sharing registry estimated post-transplant survival at 73.1% ± 4.4%, and in the French national registry 1-year posttransplant survival was 70% in the VA-ECMO group. CONCLUSIONS: In adult patients with cardiogenic shock, VA-ECMO as a direct BTT allowed successful HT in half of the patients. HT provided a survival benefit in listed patients on VA-ECMO. We present a single center experience with results comparable to those of international registries.

Analysis of Vancomycin Dosage and Plasma Levels in Critically Ill Adult Patients Requiring Extracorporeal Membrane Oxygenation (ECMO).

Introduction: Critically ill patients undergoing extracorporeal membrane oxygenation (ECMO) exhibit unique pharmacokinetics. This study aimed to assess the achievement of vancomycin therapeutic targets in these patients. Methods: This retrospective cohort study included patients on ECMO treated with vancomycin between January 2010 and December 2018. Ninety patients were analyzed based on ECMO connection modality, baseline creatinine levels, estimated glomerular filtration rate (eGFR), renal replacement therapy (RRT) requirements, and vancomycin loading dose administration. Results: Twenty-three percent of the patients achieved the therapeutic range defined by baseline levels. No significant differences in meeting the therapeutic goal were found in multivariate analysis considering ECMO cannulation modality, initial creatinine level, initial eGFR, RRT requirement, or loading dose use. All trough levels between 15 and 20 mcg/mL achieved an estimated area under the curve/minimum inhibitory concentration (AUC/MIC) between 400 and 600, almost all trough levels over 10 mcg/mL predicted an AUC/MIC >400. Discussion: Achieving therapeutic plasma levels in these patients remains challenging, potentially due to factors such as individual pharmacokinetics and pathophysiology. A trough plasma level between 12 and 20 estimated the therapeutic AUC/MIC for all models, proposing a possible lower target, maintaining exposure, and potentially avoiding adverse effects. Despite being one of the largest cohorts of vancomycin use in ECMO patients studied, its retrospective nature and single-center focus limits its broad applicability.

Use of venovenous (VV) extracorporeal membrane oxygenation (ECMO) in near-fatal asthma: a case series.

Introduction: Status asthmaticus (SA) and near-fatal asthma (NFA) are life-threatening conditions that continue to present a management challenge for physicians. Extracorporeal Membrane Oxygenation (ECMO) has been employed as a last resort in treating these patients. Case presentation: We described six patients who were admitted to the ICU for NFA and received ECMO treatment at a high-complexity institution in Cali, Colombia, between 2015 and 2019. All patients are registered in the ELSO registry. Baseline patient characteristics, arterial blood gases (ABG), ventilatory parameters, and complications were collected as specified in the ELSO registry form. Efficacy was analyzed in terms of the improvement in respiratory acidosis, the number of ventilator-free days (VFD), and a reduction in mechanical power (MP). MP, which refers to the energy associated with the mechanical forces involved in breathing and the functioning of the respiratory system, was calculated using a mathematical formula. Safety was evaluated based on the incidence of complications. After 12 hours of ECMO, we achieved a correction of respiratory acidosis, a significant decrease in all ventilatory parameters, and a reduction in MP ranging from 52.8% to 89%. There was one mortality. Among the five surviving patients, all except one, who required a tracheostomy, had a high VFD score, with a mode of 26 days, demonstrating a reduction in ventilation time. Conclusion: Further randomized controlled trials are needed to fully understand the efficacy and safety profiles of ECMO in SA/NFA. MP is being widely used to achieve safer ventilation, and although more data is required, it appears to be a promising option for evaluating the risk of developing VILI and the success of the therapy.

Lactate and Lactate Clearance Are Predictive Factors for Mortality in Patients with Extracorporeal Membrane Oxygenation.

INTRODUCTION: Findings of inadequate tissue perfusion might be used to predict the risk of mortality. In this study, we evaluated the effects of lactate and lactate clearance on mortality of patients who had undergone extracorporeal membrane oxygenation (ECMO). METHODS: Patients younger than 18 years old and who needed venoarterial ECMO support after surgery for congenital heart defects, from July 2010 to January 2019, were retrospectively analyzed. Patients successfully weaned from ECMO constituted Group 1, and patients who could not be weaned from ECMO were in Group 2. Postoperative clinics and follow-ups of the groups including mortality and discharge rates were evaluated. RESULTS: There were 1,844 congenital heart surgeries during the study period, and 55 patients that required ECMO support were included in the study. There was no statistically significant difference between the groups regarding demographics and operative variables. The sixth-, 12th-, and 24th-hour lactate levels in Group 1 were statistically significantly lower than those in Group 2 (P=0.046, P=0.024, and P<0.001, respectively). There were statistically significant differences regarding lactate clearance between the groups at the 24th hour (P=0.009). The cutoff point for lactate level was found as ≥ 2.9, with 74.07% sensitivity and 78.57% specificity (P<0.001). The cutoff point for lactate clearance was determined as 69.44%, with 59.26% sensitivity and 78.57% specificity (P=0.003). CONCLUSION: Prognostic predictive factors are important to initiate advanced treatment modalities in patients with ECMO support. In this condition, lactate and lactate clearance might be used as a predictive marker.

Lactate and lactate clearance as predictors of one-year survival in extracorporeal cardiopulmonary resuscitation - An international, multicentre cohort study.

AIM: Extracorporeal cardiopulmonary resuscitation (ECPR) can be considered in selected patients with refractory cardiac arrest. Given the risk of patient futility and high resource utilisation, identifying ECPR candidates, who would benefit from this therapy, is crucial. Previous ECPR studies investigating lactate as a potential prognostic marker have been small and inconclusive. In this study, it was hypothesised that the lactate level (immediately prior to initiation of ECPR) and lactate clearance (within 24 hours after ECPR initiation) are predictors of one-year survival in a large, multicentre study cohort of ECPR patients. METHODS: Adult patients with refractory cardiac arrest at three German and four Danish tertiary cardiac care centres between 2011 and 2021 were included. Pre-ECPR lactate and 24-hour lactate clearance were divided into three equally sized tertiles. Multivariable logistic regression analyses and Kaplan-Meier analyses were used to analyse survival outcomes. RESULTS: 297 adult patients with refractory cardiac arrest were included in this study, of which 65 (22%) survived within one year. The pre-ECPR lactate level and 24-hour lactate clearance were level-dependently associated with one-year survival: OR 5.40 [95% CI 2.30-13.60] for lowest versus highest pre-ECPR lactate level and OR 0.25 [95% CI 0.09-0.68] for lowest versus highest 24-hour lactate clearance. Results were confirmed in Kaplan-Meier analyses (each p log rank < 0.001) and subgroup analyses. CONCLUSION: Pre-ECPR lactate levels and 24 hour-lactate clearance after ECPR initiation in patients with refractory cardiac arrest were level-dependently associated with one-year survival. Lactate is an easily accessible and quickly available point-of-care measurement which might be considered as an early prognostic marker when considering initiation or continuation of ECPR treatment.

[Fulminant myocarditis in a patient with a history of autoimmune hepatitis]. / Miocarditis fulminante en paciente con antecedente de hepatitis autoinmune.

Myocarditis is an inflammatory disease of the cardiac tissue of variable etiology, both infectious and non-infectious. Its presentation can range from asymptomatic to fulminant forms. We present the case of a 24-year-old male patient with a history of autoimmune hepatitis in compensated cirrhotic phase. He consulted for dyspnea of 15 days evolution. He had presented gastrointestinal symptoms one month prior to the consultation. Physical examination revealed signs of heart failure. Laboratory examination showed elevated cardiac biomarkers and acute on chronic hepatic insufficiency. A transthoracic echocardiogram showed severe global biventricular dysfunction. The diagnostic hypotheses were cardiac involvement due to reactivation of autoimmune disease versus viral myocarditis. An MRI was performed which confirmed very severe ventricular dysfunction and late gadolinium enhancement suggestive of myocarditis. It was indicated treatment with methylprednisolone pulses. On the first day of hospitalization he evolved with clear signs of cardiogenic shock and ventricular arrhythmia refractory to medical treatment. After an exhaustive multidisciplinary evaluation, which was difficult due to his clinical condition, the possibility of a heart transplant was considered. Extracorporeal membrane oxygenation (ECMO) support was established as a bridge to transplantation. On the seventh day after ECMO, and after great improvement of the hepatogram parameters, the patient received a heart transplant. He had good postoperative evolution. However, he died two months after the transplant due to an opportunistic infection. The results of the biopsy of the explanted organ confirmed the diagnosis of lymphocytic myocarditis.

La miocarditis es una enfermedad inflamatoria del tejido cardíaco de etiología variable, infecciosa o no infecciosa. Su presentación va desde formas asintomáticas hasta fulminantes. Se presenta el caso de un varón de 24 años, con antecedente de hepatitis autoinmune, en fase cirrótica compensada. Consultó por disnea de 15 días de evolución. Presentó cuadro gastrointestinal un mes previo a la consulta. El examen físico reveló signos de sobrecarga hídrica. El laboratorio informó elevación de biomarcadores cardiacos, insuficiencia hepática aguda sobre crónica y graves trastornos de coagulación. Se realizó un ecocardiograma transtorácico que evidenció disfunción biventricular grave global, con adelgazamiento de las paredes. Las hipótesis diagnósticas fueron compromiso cardíaco por reactivación de enfermedad autoinmune versus miocarditis viral. Se realizó una resonancia magnética que confirmó la disfunción ventricular grave en la que se observó realce tardío de gadolinio sugestivo de miocarditis. Se indicó tratamiento con pulsos de metilprednisolona. El primer día de la internación evolucionó con signos de shock cardiogénico y arritmia ventricular refractaria al tratamiento. Posteriormente a una evaluación multidisciplinaria exhaustiva y dificultosa por el estado clínico, se planteó la posibilidad de un trasplante cardiaco. Se instauró soporte con membrana de oxigenación extracorpórea (ECMO) como puente al trasplante. Al séptimo día de colocado el ECMO, y luego de gran mejoría de los parámetros del hepatograma, recibió un trasplante cardíaco. Tuvo buena evolución postoperatoria, sin embargo, a los dos meses falleció por una infección oportunista. Los resultados de la biopsia del órgano explantado confirmaron el diagnóstico de miocarditis linfocítica.

Lung transplant outcomes after acute respiratory distress syndrome requiring extracorporeal life support: Lessons from the COVID-19 pandemic.

OBJECTIVE: Lung transplant for acute respiratory distress syndrome in patients supported with extracorporeal membrane oxygenation was rare before 2020, but was rapidly adopted to rescue patients with COVID-19 with lung failure. This study aims to compare the outcomes of patients who underwent lung transplant for COVID-associated acute respiratory distress syndrome and non-COVID acute respiratory distress syndrome, and to assess the impact of type and duration of extracorporeal membrane oxygenation support on survival. METHODS: Using the United Network for Organ Sharing database, we identified 311 patients with acute respiratory distress syndrome who underwent lung transplant from 2007 to 2022 and performed a retrospective analysis of the patients who required extracorporeal membrane oxygenation preoperatively, stratified by COVID-associated acute respiratory distress syndrome and non-COVID acute respiratory distress syndrome listing diagnoses. The primary outcome was 1-year survival. Secondary outcomes included the effect of type and duration of extracorporeal membrane oxygenation on survival. RESULTS: During the study period, 236 patients with acute respiratory distress syndrome and preoperative extracorporeal membrane oxygenation underwent lung transplant; 181 patients had a listing diagnosis of COVID-associated acute respiratory distress syndrome (77%), and 55 patients had a listing diagnosis of non-COVID acute respiratory distress syndrome (23%). Patients with COVID-associated acute respiratory distress syndrome were older, were more likely to be female, had higher body mass index, and spent longer on the waitlist (all P < .02) than patients with non-COVID acute respiratory distress syndrome. The 2 groups had similar 1-year survival (85.8% vs 81.1%, P = .2) with no differences in postoperative complications. Patients with COVID-associated acute respiratory distress syndrome required longer times on extracorporeal membrane oxygenation pretransplant (P = .02), but duration of extracorporeal membrane oxygenation support was not a predictor of 1-year survival (P = .2). CONCLUSIONS: Despite prolonged periods of pretransplant extracorporeal membrane oxygenation support, selected patients with acute respiratory distress syndrome can undergo lung transplant safely with acceptable short-term outcomes. Appropriate selection criteria and long-term implications require further analysis.

Fulminant Necrotizing Eosinophilic Myocarditis Successfully Treated With Veno-Arterial Extracorporeal Membrane Oxygenation and High-Dose Steroids

Abstract Fulminant necrotizing eosinophilic myocarditis (FNEM) is a rare form of EM characterized by biventricular heart failure with hemodynamic deterioration, often requiring inotropes or mechanical circulatory support. Here, we report a case of a 43-year-old healthy woman with FNEM who was admitted with acute heart failure that rapidly progressed to cardiogenic shock and electrical storm, culminating in cardiac arrest. Early diagnosis and prompt administration of corticosteroids in combination with veno-arterial extracorporeal membrane oxygenation allowed complete recovery of biventricular systolic function.

Lactate and Lactate Clearance Are Predictive Factors for Mortality in Patients with Extracorporeal Membrane Oxygenation

ABSTRACT Introduction: Findings of inadequate tissue perfusion might be used to predict the risk of mortality. In this study, we evaluated the effects of lactate and lactate clearance on mortality of patients who had undergone extracorporeal membrane oxygenation (ECMO). Methods: Patients younger than 18 years old and who needed venoarterial ECMO support after surgery for congenital heart defects, from July 2010 to January 2019, were retrospectively analyzed. Patients successfully weaned from ECMO constituted Group 1, and patients who could not be weaned from ECMO were in Group 2. Postoperative clinics and follow-ups of the groups including mortality and discharge rates were evaluated. Results: There were 1,844 congenital heart surgeries during the study period, and 55 patients that required ECMO support were included in the study. There was no statistically significant difference between the groups regarding demographics and operative variables. The sixth-, 12th-, and 24th-hour lactate levels in Group 1 were statistically significantly lower than those in Group 2 (P=0.046, P=0.024, and P<0.001, respectively). There were statistically significant differences regarding lactate clearance between the groups at the 24th hour (P=0.009). The cutoff point for lactate level was found as ≥ 2.9, with 74.07% sensitivity and 78.57% specificity (P<0.001). The cutoff point for lactate clearance was determined as 69.44%, with 59.26% sensitivity and 78.57% specificity (P=0.003). Conclusion: Prognostic predictive factors are important to initiate advanced treatment modalities in patients with ECMO support. In this condition, lactate and lactate clearance might be used as a predictive marker.

Prospective, randomized, controlled trial assessing the effects of a driving pressure-limiting strategy for patients with acute respiratory distress syndrome due to community-acquired pneumonia (STAMINA trial): protocol and statistical analysis plan / Estudo randomizado prospectivo e controlado de avaliação dos efeitos de uma estratégia de limitação da driving pressure em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade (estudo STAMINA): protocolo e plano de análise estatística

ABSTRACT Background: Driving pressure has been suggested to be the main driver of ventilator-induced lung injury and mortality in observational studies of acute respiratory distress syndrome. Whether a driving pressure-limiting strategy can improve clinical outcomes is unclear. Objective: To describe the protocol and statistical analysis plan that will be used to test whether a driving pressure-limiting strategy including positive end-expiratory pressure titration according to the best respiratory compliance and reduction in tidal volume is superior to a standard strategy involving the use of the ARDSNet low-positive end-expiratory pressure table in terms of increasing the number of ventilator-free days in patients with acute respiratory distress syndrome due to community-acquired pneumonia. Methods: The ventilator STrAtegy for coMmunIty acquired pNeumoniA (STAMINA) study is a randomized, multicenter, open-label trial that compares a driving pressure-limiting strategy to the ARDSnet low-positive end-expiratory pressure table in patients with moderate-to-severe acute respiratory distress syndrome due to community-acquired pneumonia admitted to intensive care units. We expect to recruit 500 patients from 20 Brazilian and 2 Colombian intensive care units. They will be randomized to a driving pressure-limiting strategy group or to a standard strategy using the ARDSNet low-positive end-expiratory pressure table. In the driving pressure-limiting strategy group, positive end-expiratory pressure will be titrated according to the best respiratory system compliance. Outcomes: The primary outcome is the number of ventilator-free days within 28 days. The secondary outcomes are in-hospital and intensive care unit mortality and the need for rescue therapies such as extracorporeal life support, recruitment maneuvers and inhaled nitric oxide. Conclusion: STAMINA is designed to provide evidence on whether a driving pressure-limiting strategy is superior to the ARDSNet low-positive end-expiratory pressure table strategy for increasing the number of ventilator-free days within 28 days in patients with moderate-to-severe acute respiratory distress syndrome. Here, we describe the rationale, design and status of the trial.

RESUMO Contexto: Em estudos observacionais sobre a síndrome do desconforto respiratório agudo, sugeriu-se que a driving pressure é o principal fator de lesão pulmonar induzida por ventilador e de mortalidade. Não está claro se uma estratégia de limitação da driving pressure pode melhorar os desfechos clínicos. Objetivo: Descrever o protocolo e o plano de análise estatística que serão usados para testar se uma estratégia de limitação da driving pressure envolvendo a titulação da pressão positiva expiratória final de acordo com a melhor complacência respiratória e a redução do volume corrente é superior a uma estratégia padrão envolvendo o uso da tabela de pressão positiva expiratória final baixa do protocolo ARDSNet, em termos de aumento do número de dias sem ventilador em pacientes com síndrome do desconforto respiratório agudo devido à pneumonia adquirida na comunidade. Métodos: O estudo STAMINA (ventilator STrAtegy for coMmunIty acquired pNeumoniA) é randomizado, multicêntrico e aberto e compara uma estratégia de limitação da driving pressure com a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet em pacientes com síndrome do desconforto respiratório agudo moderada a grave devido à pneumonia adquirida na comunidade internados em unidades de terapia intensiva. Esperamos recrutar 500 pacientes de 20 unidades de terapia intensiva brasileiras e duas colombianas. Eles serão randomizados para um grupo da estratégia de limitação da driving pressure ou para um grupo de estratégia padrão usando a tabela de pressão positiva expiratória final baixa do protocolo ARDSnet. No grupo da estratégia de limitação da driving pressure, a pressão positiva expiratória final será titulada de acordo com a melhor complacência do sistema respiratório. Desfechos: O desfecho primário é o número de dias sem ventilador em 28 dias. Os desfechos secundários são a mortalidade hospitalar e na unidade de terapia intensiva e a necessidade de terapias de resgate, como suporte de vida extracorpóreo, manobras de recrutamento e óxido nítrico inalado. Conclusão: O STAMINA foi projetado para fornecer evidências sobre se uma estratégia de limitação da driving pressure é superior à estratégia da tabela de pressão positiva expiratória final baixa do protocolo ARDSnet para aumentar o número de dias sem ventilador em 28 dias em pacientes com síndrome do desconforto respiratório agudo moderada a grave. Aqui, descrevemos a justificativa, o desenho e o status do estudo.

Miocarditis fulminante en paciente con antecedente de hepatitis autoinmune / Fulminant myocarditis in a patient with a history of autoimmune hepatitis

Resumen La miocarditis es una enfermedad inflamatoria del tejido cardíaco de etiología variable, infecciosa o no in fecciosa. Su presentación va desde formas asintomáticas hasta fulminantes. Se presenta el caso de un varón de 24 años, con antecedente de hepatitis autoinmune, en fase cirrótica compensada. Consultó por disnea de 15 días de evolu ción. Presentó cuadro gastrointestinal un mes previo a la consulta. El examen físico reveló signos de sobrecarga hídrica. El laboratorio informó elevación de biomar cadores cardiacos, insuficiencia hepática aguda sobre crónica y graves trastornos de coagulación. Se realizó un ecocardiograma transtorácico que evidenció disfunción biventricular grave global, con adelgazamiento de las paredes. Las hipótesis diagnósticas fueron compromiso cardíaco por reactivación de enfermedad autoinmu ne versus miocarditis viral. Se realizó una resonancia magnética que confirmó la disfunción ventricular grave en la que se observó realce tardío de gadolinio suges tivo de miocarditis. Se indicó tratamiento con pulsos de metilprednisolona. El primer día de la internación evolucionó con signos de shock cardiogénico y arritmia ventricular refractaria al tratamiento. Posteriormente a una evaluación multidisciplinaria exhaustiva y dificulto sa por el estado clínico, se planteó la posibilidad de un trasplante cardiaco. Se instauró soporte con membrana de oxigenación extracorpórea (ECMO) como puente al trasplante. Al séptimo día de colocado el ECMO, y luego de gran mejoría de los parámetros del hepatograma, recibió un trasplante cardíaco. Tuvo buena evolución postoperatoria, sin embargo, a los dos meses falleció por una infección oportunista. Los resultados de la biopsia del órgano explantado confirmaron el diagnóstico de miocarditis linfocítica.

Abstract Myocarditis is an inflammatory disease of the cardiac tissue of variable etiology, both infectious and non-in fectious. Its presentation can range from asymptomatic to fulminant forms. We present the case of a 24-year-old male patient with a history of autoimmune hepatitis in compensated cirrhotic phase. He consulted for dyspnea of 15 days evolution. He had presented gastrointestinal symptoms one month prior to the consultation. Physical examina tion revealed signs of heart failure. Laboratory examina tion showed elevated cardiac biomarkers and acute on chronic hepatic insufficiency. A transthoracic echocar diogram showed severe global biventricular dysfunction. The diagnostic hypotheses were cardiac involvement due to reactivation of autoimmune disease versus viral myocarditis. An MRI was performed which confirmed very severe ventricular dysfunction and late gadolinium enhancement suggestive of myocarditis. It was indicated treatment with methylprednisolone pulses. On the first day of hospitalization he evolved with clear signs of car diogenic shock and ventricular arrhythmia refractory to medical treatment. After an exhaustive multidisciplinary evaluation, which was difficult due to his clinical condi tion, the possibility of a heart transplant was considered. Extracorporeal membrane oxygenation (ECMO) support was established as a bridge to transplantation. On the seventh day after ECMO, and after great improvement of the hepatogram parameters, the patient received a heart transplant. He had good postoperative evolution. However, he died two months after the transplant due to an opportunistic infection. The results of the biopsy of the explanted organ confirmed the diagnosis of lym phocytic myocarditis.

Use of Extracorporeal Membrane Oxygenation in Adult Patients During Cardiac Arrest

Abstract Background Integrated extracorporeal membrane oxygenation (ECMO) in the treatment of cardiopulmonary resuscitation (CPR) is described as extracorporeal cardiopulmonary resuscitation (ECPR). It is used to ensure recovery of cardiac output when it is not possible to obtain sustained return of spontaneous circulation (ROSC) through conventional CPR methods. The comparison between ECPR and conventional CPR is a dilemma that has been frequently discussed. Objective To identify in the literature the use of ECMO in adult patients during cardiac arrest (CA) in and pre- and in-hospital settings. Method This is an integrative review using the following guiding question: What is the evidence in the literature on the use of ECMO in adult patients with cardiorespiratory arrest in the pre- and in-hospital setting? It consists of primary studies, published in full and available in Portuguese, English, and Spanish. Results The search identified 559 publications in the literature, of which 13 were articles read in full, after applying the inclusion criteria. Of these, 3 were disregarded due to unavailability in the complete format; 7 did not respond to the guiding question, and 3 studies were included. The studies were analyzed according to the 2020 version of the PRISMA Model. Conclusion ECPR is a practice adopted when CPR is refractory to conventional life support and concomitantly with this management. There are no significant differences in the rate of favorable neurological outcomes when comparing the pre- and in-hospital scenarios. In short, the development of institutional protocols with selection and exclusion criteria for ECPR is considered relevant.

Extracorporeal Membrane Oxygenation Uses in Refractory Cardiogenic Shock After Open-Heart Surgery

ABSTRACT Introduction: Extracorporeal membrane oxygenation (ECMO) is the first-line therapy for temporary mechanical circulatory support allowing cardiac and pulmonary recovery or as a bridge to further therapeutic alternatives. The aim of this study was to report clinical outcomes in adult patients with refractory cardiac failure after open-heart surgery undergoing ECMO in a single center with an ECMO unit in Chile. Methods: We retrospectively analyzed adults with refractory cardiac failure after open-heart surgery who required a venoarterial (VA) ECMO between 2016 and 2021. Results: Of 16 patients with VA ECMO, 60% were men (n=10), 90% had hypertension (n=14), 69% had < 30% of left ventricular ejection fraction (n=11), and the mean European System for Cardiac Operative Risk Evaluation II score was 12 ± 11%. ECMO support with central cannulation accounts for 81% (n=13), and an intra-aortic balloon pump was used in nine patients (56%). The mean time of support was 4.7 ± 2.6 days (1.5 - 12 days). ECMO weaning was achieved in 88% of patients, and in-hospital mortality was 44% (n=7) after discharge. The freedom from all-cause mortality at one year of follow-up of the entire cohort was 38% (n=6). Conclusion: VA ECMO is now a well-known life-saving therapeutic option, but mortality and morbidity remain high. Implementation of an ECMO program with educational training is mandatory in order to find the proper balance between patient benefits, ethical considerations, and public health financial input in South America.

Ações de cuidado e diagnósticos de enfermagem ao paciente com oxigenação por membrana extracorpórea: translação do conhecimento / Acciones de cuidado y diagnósticos de enfermería para pacientes con oxigenación por membrana extracorpórea: traslación del conocimiento / Care actions and nursing diagnoses for patients with extracorporeal membrane oxygenation: knowledge translation

Resumo Objetivo mapear diagnósticos e ações de enfermagem para o cuidado ao paciente adulto com oxigenação por membrana extracorpórea, considerando um protocolo e um sistema informatizado de prescrição e a inclusão de novas ações de cuidados, em um processo de translação do conhecimento à prática clínica. Métodos estudo descritivo e exploratório, com mapeamento cruzado entre um protocolo assistencial e sistema informatizado de um hospital universitário, no período de 2014 a 2018. Foram realizados dois encontros com a chefia de enfermagem e membros do time de oxigenação por membrana extracorpórea para validar as ações. Resultados diagnósticos mais comuns utilizados nos 45 prontuários dos pacientes com oxigenação por membrana extracorpórea foram: Risco de infecção (100%); Ventilação espontânea prejudicada (93,33%); Síndrome do déficit de autocuidado (93,33%). Conclusão e implicações para a prática o mapeamento incluiu 25 novas ações associadas a 14 diagnósticos de enfermagem no sistema informatizado, visando a disseminação do conhecimento e sua aplicação em cuidados reais a pacientes com oxigenação por membrana extracorpórea.

Resumen Objetivo mapear diagnósticos y acciones de enfermería para el cuidado de pacientes adultos con oxigenación por membrana extracorpórea, considerando un protocolo y un sistema de prescripción computarizado y la inclusión de nuevas acciones de cuidado, en un proceso de traslación del conocimiento a la práctica clínica. Métodos estudio descriptivo, exploratorio, con mapeo cruzado entre un protocolo de atención y un sistema informatizado en un hospital universitario, de 2014 a 2018. Posteriormente se realizaron dos reuniones con la gerente de enfermería y miembros del equipo de oxigenación por membrana extracorpórea para validar acciones. Resultados los diagnósticos más frecuentes utilizados en los 45 prontuarios de pacientes con oxigenación por membrana extracorpórea fueron: Riesgo de infección (100%); Deterioro de la ventilación espontánea (93,33%); Síndrome de déficit de autocuidado (93,33%). Conclusión e implicaciones para la práctica el mapeo incluyó 25 nuevas acciones asociadas a 14 diagnósticos de enfermería en el sistema informatizado, con el objetivo de difundir el conocimiento y su aplicación en la atención real al paciente con oxigenación por membrana extracorpórea.

Abstract Objective to map diagnoses and nursing actions for the care of adult patients with extracorporeal oxygenation membrane, considering a protocol and a computerized prescription system and the inclusion of new care actions, in a process of translating knowledge to clinical practice. Methods descriptive and exploratory study, with cross-mapping between a care protocol and a computerized system of at a university hospital, from 2014 to 2018. Two meetings were held with the nursing manager and members of the extracorporeal oxygenation membrane team to validate the actions. Results most common diagnoses used in the 45 medical records of patients with extracorporeal membrane oxygenation were: Risk of infection (100%); Impaired spontaneous ventilation (93.33%); Self-care deficit syndrome (93.33%). Conclusion and implications for practice The mapping included 25 new actions, associated with 14 nursing diagnoses in the computerized system, aiming to disseminate knowledge and its application in real care for patients with extracorporeal oxygenation membrane.

Slide tracheoplasty for congenital tracheal stenosis with involvement of the carina and bronchi: a case report

ABSTRACT A female newborn presented with respiratory distress at birth and was diagnosed with congenital tracheal stenosis. The stenosis was positioned at the distal trachea and compromised the carina and the right and left bronchi. She underwent surgical treatment using circulatory life support with veno-arterial peripheral extracorporeal membrane oxygenation, and the airway was reconstructed using the slide tracheoplasty technique to build a neocarina. The patient had an excellent postoperative course, was successfully weaned from extracorporeal membrane oxygenation and invasive ventilation, and was discharged.

[5-year experience in short-term mechanical circulatory support in post-myocardial infarction patients: a report from the INCORMACS]. / Experiencia de 5 años en soporte circulatorio mecánico de corta duración en pacientes posinfarto de miocardio: un reporte del registro INCORMACS.

Objective: To determine the clinical and epidemiological characteristics of patients with short-term mechanical circulatory support devices (MCSD) after myocardial infarction (MI) at a national referral hospital. Materials and methods: Descriptive, retrospective study of post-MI patients in whom short-term mechanical circulatory support devices were implanted from 2015 to 2020. Results: Nine mechanical support devices were implanted, in the same number of patients due to cardiogenic shock post MI. All patients were men with ST-elevation myocardial infarction (STEMI). Eight extracorporeal membrane oxygenation devices (ECMO) and one centrifugal flow pump (in LVAD configuration) were implanted. The median time of use of the devices was eight days. The most frequent complications were non-fatal bleeding (55.6%), acute kidney injury (44.4%) and sepsis (44.4%).In-hospital mortality was 55.6 %. Conclusions: The use of short term MCSD after myocardial infarction is still limited in our institution and its main representative is the ECMO post STEMI complicated by cardiogenic shock. Despite the use of these devices, in-hospital mortality is high.