Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study.

AIMS: Chest pain is a major cause of medical evaluation at emergency department (ED) and demands observation to exclude the diagnosis of acute myocardial infarction (AMI). High-sensitivity cardiac troponin assays used as isolated measure and by 0- and 1-h algorithms are accepted as a rule-in/rule-out strategy, but there is a lack of validation in specific populations. METHODS AND RESULTS: The IN-HOspital Program to systematizE Chest Pain Protocol (IN-HOPE study) is a multicentre study that prospectively included patients admitted to the ED due to suspected symptoms of AMI at 16 sites in Brazil. Medical decisions of all patients followed the standard approach of 0 h/3 h protocol, but, in addition, blood samples were also collected at 0 and 1 h and sent to a central laboratory (core lab) to measure high-sensitivity cardiac troponin T (hs-cTnT). To assess the theoretical performance of 0 h/1 h algorithm, troponin < 12 ng/L with a delta < 3 was considered rule-out while a value ≥ 52 or a delta ≥ 5 was considered a rule-in criterion (the remaining were considered as observation group). The main objective of the study was to assess, in a population managed by the 0 h/3 h protocol, the accuracy of 0 h/1 h algorithm overall and in groups with a higher probability of AMI. All patients were followed up for 30 days, and potential events were adjudicated. In addition to the prospective cohort, a retrospective analysis was performed assessing all patients with hs-cTnT measured during the year of 2021 but not included in the prospective cohort, regardless of the indication of the test. A total of 5.497 patients were included (583 in the prospective and 4.914 in the retrospective analysis). The prospective cohort had a mean age of 57.3 (± 14.8) and 45.6% of females with a mean HEART score of 4.0 ± 2.2. By the core lab analysis, 74.4% would be eligible for a rule-out approach (45.3% of them with a HEART score > 3) while 7.3% would fit the rule-in criteria. In this rule-out group, the negative predictive value for index AMI was 100% (99.1-100) overall and regardless of clinical scores. At 30 days, no death or AMI occurred in the rule-out group of both 0/1 and 0/3 h algorithms while 52.4% of the patients in the rule-in group (0 h/1 h) were considered as AMI by adjudication. In the observation group (grey zone) of 0 h/1 h algorithm, GRACE discriminated the risk of these patients better than HEART score. In the retrospective analysis, 1.091 patients had a troponin value of <5 ng/L and there were no cardiovascular deaths at 30 days in this group. Among all 4.914 patients, the 30-day risk of AMI or cardiovascular death increased according to the level of troponin: 0% in the group < 5 ng/L, 0.6% between 5 and 14 ng/L, 2.2% between 14 and 42 ng/L, 6.3% between 42 and 90 ng/L, and 7.7% in the level ≥ 90 ng/L. CONCLUSION: In this large multicentre study, a 0 h/1 h algorithm had the potential to classify as rule-in or rule-out in almost 80% of the patients. The rule-out protocol had high negative predictive value regardless of clinical risk scores. Categories of levels of hs-cTn T also showed good accuracy in discriminating risk of the patients with a very favourable prognosis for cardiovascular death in the group with value < 5 ng/L. CLINICALTRIALS.GOV: NCT04756362.

Potential performance of a 0 h/1 h algorithm and a single cut-off measure of high-sensitivity troponin T in a diverse population: main results of the IN-HOPE study

BACKGROUND: Chest pain is a major cause of medical evaluation at emergency department (ED) and demands observation to exclude the diagnosis of acute myocardial infarction (AMI). High-sensitivity cardiac troponin assays used as isolated measure and by 0 h and 1 h algorithms are accepted as a rule-in/rule-out strategy but there is a lack of validation in specific populations. METHODS: The IN-HOspital Program to systematizE chest pain protocol (In Hope study) is a multicentre study that prospectively included patients admitted to the ED due to suspected symptoms of AMI at 16 sites in Brazil. Medical decisions of all patients followed the standard approach of 0/3-h protocol but, in addition, blood samples were also collected at 0 and 1 hour and sent to a central laboratory (core lab) to measure high-sensitivity troponin T (hs-cTnT). To assess the theoretical performance of 0/1-h algorithm, troponin < 12 ng/L with a delta <--- 3 was considered rule out while a value ≥ 52 and/or a delta ≥ 5 was considered a rule in criteria (the remaining were considered as observation group). The main objective of the study was to assess, in a population managed by the 0/3-h protocol, the accuracy of 0/1-h algorithm overall and in groups with higher probability of AMI. All patients were followed for 30 days, and potential events were adjudicated. In addition to the prospective cohort, a retrospective analysis was performed assessing all patients with hs-cTnT measured during the year of 2021 but not included in the prospective cohort, regardless the indication of the test. RESULTS: A total of 5.497 patients were included (583 in the prospective and 4.914 in the retrospective analysis). The prospective cohort had a mean age of 57.3 (± 14.8) and 45.6% of females with a mean HEART score of 4.0 ± 2.2. By the core lab analysis, 74.4% would be eligible for a rule-out approach (45.3% of HEART score > 3) while 7.3% would fit the rule-in criteria. In this rule-out group, the negative predictive value for index AMI was 100% (99.1-100) overall and regardless clinical scores. At 30 days, no death or AMI occurred in the rule-out group of both 0/1 and 0/3-hour while 52.4% of the patients in the rule-in group (0/1-hour) were considered as AMI by adjudication. In the observation group (grey zone) of 0/1- hour algorithm, GRACE discriminated the risk of these patients better than HEART score. In the retrospective analysis, 1.091 patients had a troponin value < 5 ng/L and there were no cardiovascular deaths at 30 days in this group. Among all 4.914 patients, the 30-day risk of AMI or cardiovascular death increased according to the level of troponin: 0% in the group < 5 ng/L, 0.6% between 5 and 14 ng/L, 2.2% between 14 and 42 ng/L, 6.3% between 42 and 90 ng/L and 7.7% in the level ≥ 90 ng/L. CONCLUSIONS: In this large multicentre study, a 0/1-h algorithm had the potential to classify as rule in or out almost 80% of the patients. The rule-out protocol had high negative predictive value regardless of clinical risk scores. Categories of levels of hs-cTn T also showed good accuracy in discriminating risk of the patients with a very favourable prognosis for cardiovascular death in the group with values < 5 ng/L.

Correlação da capacidade funcional com força muscular respiratória em pacientes na fila de espera do transplante cardíaco / Correlation of functional capacity with respiratory muscle strength in cardiac transplant waiting list patients

INTRODUÇÃO: Estudos mostram que pacientes com insuficiência cardíaca apresentam fraqueza muscular respiratória e que quase sempre está associado com capacidade funcional reduzida, piora na qualidade de vida e mau prognóstico. Identificar a correlação da capacidade funcional com a força muscular respiratória é importante para melhor tratamento dos pacientes que aguardam transplante cardíaco. OBJETIVO: Avaliar a correlação da capacidade funcional com força muscular respiratória em pacientes na fila de espera do transplante cardíaco. MÉTODOS: Foi realizado um estudo observacional com pacientes que estavam ativos na fila do transplante cardíaco, não hospitalizados. Para verificar capacidade funcional foi realizado o teste de caminhada de seis minutos. Para mensuração da força muscular respiratória foi utilizado o manovacuômetro analógico e os valores obtidos foram a pressão inspiratória máxima (PImáx), e a pressão expiratória máxima (PEmáx). Para a análise estatística dos dados, as variáveis quantitativas foram apresentadas pela média e desvio padrão ou mediana e intervalo interquartil. As variáveis categóricas foram apresentadas por números absolutos e porcentagens. Para verificar a correlação entre as variáveis quantitativas e qualitativas foi utilizado o teste de Spearman. O nível de significância adotado foi de 5%. RESULTADOS: Dos 16 pacientes que estavam ativos na fila do transplante cardíaco, 10 foram selecionados pois preenchiam os critérios de inclusão do estudo. A idade variou de 18 a 65 anos, média de 42,5 ± 17,85, 60% de homens, 80% com hipertensão arterial sistêmica, 40% com diabetes melitus e 70% com dislipidemia. O IMC apresentou uma mediana de 28,52 (20,80-31,30) kg/m². Os dados do teste de caminhada de seis minutos, os pacientes andaram em mediana 387 (240 ­ 457) metros. Para as variáveis da manovacuometria, os pacientes tiveram uma mediana de 48,50 cmH2O (29,75 ­ 91,25) da PImáx e os valores de PEmáx 51 cmH2O (31,25 ­ 81,50). Houve correlação significativa da distância percorrida no teste de caminhada de seis minutos com PImáx de [0,778 (p=0,008)] e com PEmáx de [0,771 (p=0,021)], sendo que quanto menor a distância percorrida no teste de caminhada, menor os valores de força muscular respiratória. CONCLUSÃO: Existe possivelmente uma correlação da distância percorrida no teste de caminhada com os valores de força muscular respiratória em pacientes pré-transplante. As hipóteses devem ser confirmadas por estudos longitudinais. (AU)

Pacientes na fila de espera do transplante cardíaco com capacidade funcional reduzida apresentam piora da função muscular na dinamometria / Patients in the heart transplant waiting list with reduced functional capacity show worsening of muscle function on dynamometry

INTRODUÇÃO: Estudos mostram que pacientes com insuficiência cardíaca apresentam fraqueza muscular periférica e que quase sempre está associado com capacidade funcional reduzida. Identificar a correlação da capacidade funcional com a força muscular periférica é importante para melhor tratamento dos pacientes que aguardam transplante cardíaco. OBJETIVO: Avaliar a correlação da capacidade funcional com força muscular periférica em pacientes na fila de espera do transplante cardíaco. MÉTODOS: Foi realizado um estudo observacional com pacientes que estavam ativos na fila do transplante cardíaco, não hospitalizados. Para verificar capacidade funcional foi realizado o teste de caminhada de seis minutos. Para mensurar a função muscular utilizamos um dinamômetro de preensão palmar da marca SAEHAN. O protocolo utilizado para aplicação do teste foi baseado na recomendação da American Society of Hand Therapists. Para a análise estatística dos dados, as variáveis quantitativas foram apresentadas pela média e desvio padrão ou mediana e intervalo interquartil. As variáveis categóricas foram apresentadas por números absolutos e porcentagens. Para verificar a correlação entre as variáveis quantitativas e qualitativas foi utilizado o teste de Spearman. O nível de significância adotado foi de 5%. RESULTADOS: Dos 16 pacientes que estavam ativos na fila do transplante cardíaco, 10 foram selecionados pois preenchiam os critérios de inclusão do estudo. A idade variou de 18 a 65 anos, média de 42,5 ± 17,85, 60% de homens, 80% com hipertensão arterial sistêmica (HAS), 40% com diabetes melitus (DM) e 70% com dislipidemia (DLP). O IMC apresentou uma mediana de 28,52 (20,80-31,30) kg/m². Os dados do teste de caminhada de seis minutos (TC6'), os pacientes andaram em mediana 387 (240 ­ 457) metros. O membro direito foi considerado dominante (100%), a mediana da preensão palmar do membro direito foi 24,65 (21,75 ­ 43,07) e o de membro superior esquerdo foi de 23,45 (16,37 ­ 34,45). Houve correlação da distância percorrida no teste de caminhada de seis minutos com força de preensão palmar [0,821 (p=0,004)] sendo que quanto menor a distância percorrida no teste de caminhada, menor o valor de força muscular periférica. CONCLUSÃO: Existe possivelmente uma correlação da distância percorrida no teste de caminhada com os valores de força muscular periférica em pacientes que estão na fila de espera do transplante cardíaco. As hipóteses devem ser confirmadas por estudos longitudinais. (AU)