Terapia do controle da temperatura pós-parada cardiorrespiratório / Temperature control therapy after cardiorespiratory

O processo fisiopatológico secundário à parada cardiorrespiratória (PCR) com retorno da circulação espontânea (RCE), determina a síndrome pós-PCR, com lesão cerebral, disfunção miocárdica e reperfusão, em resposta à isquemia orgânica. A terapia do controle da temperatura (TCT) oferece mecanismos neuroprotetores, limitação da lesão miocárdica e redução da resposta inflamatória sistêmica. Dúvidas existem em relação aos benefícios, início e duração da TCT, porém, há evidências que apoiam a melhora da sobrevida e do prognóstico neurológico em populações selecionadas. Recomenda-se a TCT por 24 horas, com controle da temperatura na faixa de 32 °C a 36 °C para adultos que sobrevivem à PCR extra-hospitalar e permanecem em coma com ritmos iniciais de fibrilação/taquicardia ventricular, o que também é sugerido para os sobreviventes de PCR extra-hospitalar com ritmo inicial não chocável e de PCR intra-hospitalar em qualquer ritmo inicial. O início do resfriamento deve ser feito o mais precocemente possível, depreferência, até 12 horas após o RCE. O controle da temperatura corpórea deve ser incorporado aos cuidados dos pacientes críticos pós-PCR, a fim de reduzir as taxas de mortalidade e de sequelas neurológicas...

The secondary pathophysiological process to cardiorespiratory arrest (CRA) with return of spontaneous circulation (ROSC), determines the post-cardiorespiratory arrest syndrome with brain injury, myocardial reperfusion and dysfunction in response to systemic ischemia. The temperature control therapy (TCT) provides neuroprotective mechanisms, limitation of myocardial injury and reduction of systemic inflammatory response. There are still some questions regarding the benefits, timing and duration of TCT, however, there is evidence supporting improved survival and neurological outcome in selected populations. TCT is recommended for 24 hours, with temperature control in the range of 32 to 36 °C for comatose adults who survive after out-of-hospital cardiorespiratory arrest with initial rates of fibrillation/ ventricular tachycardia, which is also suggested for extra-hospital cardiorespiratory arrest survivors with early pace not shockable and intra-hospital cardiorespiratory arrest in any initial rate. The beginning of the cooling should be done as early as possible, ideally up to12 hours after ROSC. The control of body temperature should be incorporated into the careof the post-CRA critically ill patients in order to reduce mortality and neurological sequelae...

Atualização no manejo clínico do choque cardiogênico / Update on clinical management of cardiogenic shock

O choque cardiogênico é uma síndrome clínica caracterizada por hipoperfusão tecidual secundária à disfunção cardíaca, na ausência de hipovolemia. A etiologia principal é o infarto agudo do miocárdio com falência de ventrículo esquerdo, embora existam outras causas relevantes, como complicações mecânicas do infarto, miocardites, evolução de cardiomiopatias, valvopatias agudas não isquêmicas e cardiomiopatia induzida pelo estresse, por exemplo. Apesar dos avanços terapêuticos, persiste como uma afecção de elevada mortalidade e sua incidência não se modificou significativamente nas últimas décadas. A instalação do choque em pacientes com síndromes coronarianasagudas ocorre mais frequentemente após a internação hospitalar, ressaltandoa importância da identificação de preditores e da monitorização de sinais precoces de hipoperfusão tecidual para pronta intervenção. O diagnóstico é essencialmente clínico e alguns exames subsidiários, como eletrocardiograma, marcadores de necrose miocárdica,ecocardiograma e cineangiocoronariografia, que são importantes para a definição da etiologia, estratificação da gravidade e do prognóstico. O manejo adequado dos pacientes requer avaliação dos parâmetros de macro e micro-hemodinâmica. Os principais objetivos terapêuticos incluem a restauração precoce da perfusão tecidual sistêmica ea recuperação da função ventricular. O tratamento inclui medidas gerais para pacientes com choque como ajuste de volemia e adequação da perfusão tecidual com uso de inotrópicos, vasopressores e dispositivos de assistência ventricular, além de medidasespecíficas, direcionadas para a etiologia do choque, como a revascularização precoce nas síndromes coronarianas agudas...

Cardiogenic shock is a clinical syndrome characterized by tissue hypoperfusionsecondary to cardiac dysfunction, in the absence of hypovolemia. Left ventricular failure complicating acute myocardial infarction is the main cause, although other relevant causes include mechanical complications of infarction, myocarditis, progression of cardiomyopathies, acute non-ischemic valvular heart disease, and stress-induced cardiomyopathies, for example. Despite therapeutic advances, it persists as a condition of high mortality, and its incidence has not changed significantly in the last decades.The onset of cardiogenic shock in patients with acute coronary syndromes frequently occurs after hospital admission, reinforcing the importance of identifying predictors and monitoring early signs of tissue hypoperfusion for prompt intervention. The diagnosisis essentially clinical plus some additional tests such as electrocardiogram, myocardial necrosis markers, echocardiogram, and coronary angiography, which are important fordefining the etiology, stratification of severity and prognosis. Proper management of patients requires assessment of macro- and micro-hemodynamic parameters. The maintherapeutic goals include early restoration of tissue perfusion and recovery of ventricular function. Treatment includes general medical care for patients with shock as optimizingvolemia and adjusting of tissue perfusion with inotropic agents, vasopressors and ventricular assist devices, as well as specific interventions focused on the shock etiology, like early revascularization in acute coronary syndromes...

Choque cardiogênico: avaliação clínico-laboratorial e estratégia medicamentosa / Cardiogenic shock: clinical-laboratorial and therapeutic evaluation

O choque cardiogênico é uma síndrome clínica caracterizada por hiperfluxo tecidual secundária à disfunção cardíaca, na ausência de hipovolemia. A etiologia principal é o infarto agudo do miocárdio com falência de ventrículo esquerdo, embora existam outras causas relevantes, como complicações mecânicas do infarto, miocardites, evolução de cardiomiopatias, valvopatias agudas não isquêmicas e cardiomiopatia induzida pelo estresse, por exemplo. Apesar dos avanços terapêuticos, persiste como uma condição de elevada mortalidade e sua incidência não se modificou significativamente nas últimas décadas. A instalação do choque em pacientes com síndromes coronárias agudas ocorre mais frequentemente após a admissão hospitalar, ressaltando a importância da identificação de preditores e da monitorização de sinais precoces de hipoperfusão incidual para pronta intervenção. O diagnóstico é essencialmente clínico e alguns exames subsidiários, como eletrocardiograma, marcadores de necrose miocárdica, ecocardiograma e cineangiocoronariografia, são importantes para a definição da etiologia, estratificação da gravidade e do prognóstico. O manejo adequado dos pacientes requer avaliação dos parâmetros de macro e micro-hemodinâmica. Os principais objetivos terapêuticos incluem a restauração precoce da perfusão tecidual sistêmica e a recuperação da função ventricular. O tratamento inclui medidas gerais para pacientes com choque como ajuste de volemia e adequação da perfusão tecidual com uso de inotrópicos, vasodilatadores e dispositivos de assistência ventricular, além de medidas específicas, direcionadas para etiologia do choque, como a resvascularização precoce nas síndromes coronárias agudas.

Cardiogenic shock is a clinical syndrome characterized by systemic hypoperfusion secondary to cardiac dysfunction, in the absence of hypovolemia. Left ventricular failure complicating massive acute myocardial infarction persists as the most common etiology, although other relevant causes include mechanical complications of acute myocardial infarction, acute myocarditis, non-ischemic valvular heart disease, cardiomyopathies progression and stress induced cardiomyopathies. Despite therapeutic advances the incidence of cardiogenic shock persists almost the same as in the last decades and mortality rate remains very high. the onset of cardiogenic shock, in patients presenting with acute coronary syndromes, frequently accurs after hospital admission, reinforcing the importance of identifying predictors and monitoring early stages of systemic hypoperfusion for early intervention. The diagnosis is established by findings. Diagnostic tests like electrocardiogram, cardiac biomakers, echocardiogram, and coronary angiography, in specific scenarios, can be helpful to confirm the diagnosis, define the etiology, stratify the risk, and provide prognostic information.

Metformin, but not glimepiride, improves carotid artery diameter and blood flow in patients with type 2 diabetes mellitus.

OBJECTIVE: To compare the effects of glimepiride and metformin on vascular reactivity, hemostatic factors and glucose and lipid profiles in patients with type 2 diabetes. METHODS: A prospective study was performed in 16 uncontrolled patients with diabetes previously treated with dietary intervention. The participants were randomized into metformin or glimepiride therapy groups. After four months, the patients were crossed over with no washout period to the alternative treatment for an additional four-month period on similar dosage schedules. The following variables were assessed before and after four months of each treatment: 1) fasting glycemia, insulin, catecholamines, lipid profiles and HbA1 levels; 2) t-PA and PAI-1 (antigen and activity), platelet aggregation and fibrinogen and plasminogen levels; and 3) the flow indices of the carotid and brachial arteries. In addition, at the end of each period, a 12-hour metabolic profile was obtained after fasting and every 2 hours thereafter. RESULTS: Both therapies resulted in similar decreases in fasting glucose, triglyceride and norepinephrine levels, and they increased the fibrinolytic factor plasminogen but decreased t-PA activity. Metformin caused lower insulin and pro-insulin levels and higher glucagon levels and increased systolic carotid diameter and blood flow. Neither metformin nor glimepiride affected endothelial-dependent or endothelial-independent vasodilation of the brachial artery. CONCLUSIONS: Glimepiride and metformin were effective in improving glucose and lipid profiles and norepinephrine levels. Metformin afforded more protection against macrovascular diabetes complications, increased systolic carotid artery diameter and total and systolic blood flow, and decreased insulin levels. As both therapies increased plasminogen levels but reduced t-PA activity, a coagulation process was likely still ongoing.

Metformin, but not glimepiride, improves carotid artery diameter and blood flow in patients with type 2 diabetes mellitus

OBJECTIVE: To compare the effects of glimepiride and metformin on vascular reactivity, hemostatic factors and glucose and lipid profiles in patients with type 2 diabetes. METHODS: A prospective study was performed in 16 uncontrolled patients with diabetes previously treated with dietary intervention. The participants were randomized into metformin or glimepiride therapy groups. After four months, the patients were crossed over with no washout period to the alternative treatment for an additional four-month period on similar dosage schedules. The following variables were assessed before and after four months of each treatment: 1) fasting glycemia, insulin, catecholamines, lipid profiles and HbA1 levels; 2) t-PA and PAI-1 (antigen and activity), platelet aggregation and fibrinogen and plasminogen levels; and 3) the flow indices of the carotid and brachial arteries. In addition, at the end of each period, a 12-hour metabolic profile was obtained after fasting and every 2 hours thereafter. RESULTS: Both therapies resulted in similar decreases in fasting glucose, triglyceride and norepinephrine levels, and they increased the fibrinolytic factor plasminogen but decreased t-PA activity. Metformin caused lower insulin and pro-insulin levels and higher glucagon levels and increased systolic carotid diameter and blood flow. Neither metformin nor glimepiride affected endothelial-dependent or endothelial-independent vasodilation of the brachial artery. CONCLUSIONS: Glimepiride and metformin were effective in improving glucose and lipid profiles and norepinephrine levels. Metformin afforded more protection against macrovascular diabetes complications, increased systolic carotid artery diameter and total and systolic blood flow, and decreased insulin levels. As both therapies increased plasminogen levels but reduced t-PA activity, a coagulation process was likely still ongoing.

Dilated cardiomyopathy in a case of Shwachman-Diamond syndrome.

The Shwachman-Diamond syndrome is an autosomal recessive bone marrow failure syndrome with exocrine pancreatic insufficiency. Additional organ systems, such as the liver, heart and bone, may also be affected. We report a patient with a long history of cardiac failure and diagnosis of dilated cardiomyopathy with intermittent neutropenia. Periodic follow-up revealed progressive cardiac failure and pulmonary hypertension. A diagnosis of Shwachman-Diamond syndrome was made at the autopsy.

The effect of dobutamine without and with L-arginine on arterial compliance in heart failure patients.

The effect of dobutamine on carotid and brachial arteries compliance and the association of L-arginine as a potential nitric oxide pathway restorer were evaluated in patients with heart failure. Twenty-seven outpatients participated. Drugs used for the treatment of heart failure were withheld at least 24 hours before the study. The carotid and brachial artery diameters and hemodynamic variables were evaluated by ultrasonography and Doppler in baseline conditions, with dobutamine, with flow-mediated dilatation (FMD), and with placebo or L-arginine alone and associated with dobutamine. There was a significant increase in carotid peak blood flow with dobutamine when compared with that at baseline (P = 0.0001) or with L-arginine or placebo (P = 0.0001 and P = 0.0001, respectively), with increase of the cardiac index (P = 0.0001). Dobutamine did not increase carotid arterial compliance. FMD significantly increased the brachial peak blood flow (P = 0.0022) and the artery diameter (P = 0.0001). Dobutamine did not change the brachial artery diameter. Brachial peak blood flow was increased with dobutamine alone or associated with placebo or L-arginine comparing with L-arginine or placebo alone (P = 0.0168 and P = 0.0140, respectively), but was not increased compared with that at baseline. L-arginine infusion was not associated with changes in carotid, brachial, or in the cardiac index. We concluded that dobutamine increased carotid peak blood flow in patients with heart failure, although without changing the arterial compliance. The FMD of brachial artery was maintained, while brachial artery response to dobutamine infusion was less reliable. The carotid artery may be under the direct influence of the heart, while the brachial artery may be under predominant local control.

Emergência de infecção por Trichosporon Asahii em pacientes portadores de insuficiência cardíaca em unidade de terapia intensiva cardiológica: relato de caso e revisão da literatura / Trichosporon asahii an emerging etiologic agent of fungal infection and colonization in heart failure patients in intensive care unit: case report and literature review

JUSTIFICATIVA E OBJETIVOS: As infecções fúngicas por Trichosporon Asahii têm sido cada vez mais freqüentes nas últimas duas décadas. Quadros graves com alta mortalidade são tradicionalmente descritos em pacientes neutropênicos com câncer. Recentemente, a infecção tem ocorrido também em outros grupos de pacientes. O objetivo deste estudo foi descrever a crescente prevalência de Trichosporon asahii em unidade de terapia intensiva cardiológica (UTIC), com perfil de pacientes habitualmente não susceptíveis a tal infecção fúngica, relatar um caso clínico e revisão da literatura. RELATO DO CASO: Paciente do sexo feminino, 85 anos, com antecedentes de hipertensão arterial sistêmica, insuficiência cardíaca (fração de ejeção = 30 por cento) e embolia pulmonar, admitida na UTI depois de parada cardiorrespiratória em fibrilação ventricular durante consulta de rotina. Evoluiu sem seqüela neurológica. O ecocardiograma não revelou alterações em relação ao exame anterior. Não houve alteração dos indicadores de necrose miocárdica. A paciente apresentou falha na extubação traqueal e desmame difícil, necessitando ventilação mecânica prolongada mesmo após traqueostomia. Houve complicações por insuficiência renal aguda e infecções recorrentes (respiratória, urinária e sistêmica), com boa resposta ao tratamento com antibióticos de amplo espectro. Após sete meses de internação na UTI, evoluiu com choque séptico, associado à infecção urinária por Trichosporon asahii, com hemoculturas identificadas pelo mesmo fungo. Iniciado tratamento com anfotericina B lipossomal (5 mg/kg/dia). Apesar do uso associado de vancomicina e imipenem, houve piora clínica progressiva. Hemoculturas colhidas no sétimo dia de uso de antifúngico revelaram-se negativas, porém a urocultura ainda revelou o crescimento de T. asahii. Evoluiu com óbito após 18 dias de tratamento, por falência de múltiplos órgãos. CONCLUSÕES: O aumento da gravidade dos pacientes internados nas UTI e o uso disseminado...

BACKGROUND AND OBJECTIVES: Infection with the non-Candida yeast species Trichosporon have been recognized with increasing frequency over the last two decades. Invasive disease due to trichosporonosis has been reported from neutropenic patients with cancer and the mortality is high. Recently, others groups of patients have become susceptible to this rare fungi. We report the emerging of infection with pathogenic Trichosporon asahii in severely ill heart failure patients in a tertiary cardiological intensive care unit (CICU). We describe our data, and report a fatal case of disseminated trichosporonosis in a patient with heart failure. We also review literature pertaining to T. asahii infections. CASE REPORT: An 85 year-old woman with a history of hypertension, heart failure (ejection fraction (EJ): 30 percent) and pulmonary embolism was admitted to a medical cardiological ICU after cardiac arrest (ventricular fibrillation) resuscitated during a routine consultation. There were no neurological sequelae and the echocardiogram revels no changes, neither the cardiac biomarkers. Ventricular fibrillation was considered secondary to heart failure. The patient had extubation failure and difficult weaning needing long term mechanical ventilation even after tracheostomy. Her hospital course was complicated by acute renal failure and recurrent respiratory, urinary and systemic bacterial infections, which responded to broad-spectrum antibiotics. After a temporary improvement she developed urinary infection and subsequent septic shock. Cultures of urine and blood specimens grew T. asahii. Treatment with liposome amphotericin B (5 mg/kg/day) was started. Despite receiving vancomycin and imipenem, the clinical condition of the patient deteriorates. Blood taken for culture on the seventh day of amphotericin B therapy were negative but urine specimen still grew T. asahii. On the eighteenth day of antifungal therapy, the patient died with multiorgan...

[Trichosporon asahii an emerging etiologic agent of fungal infection and colonization in heart failure patients in intensive care unit: case report and literature review]. / Emergência de infecção por Trichosporon Asahii em pacientes portadores de insuficiência cardíaca em unidade de terapia intensiva cardiológica: relato de caso e revisão da literatura.

BACKGROUND AND OBJECTIVES: Infection with the non-Candida yeast species Trichosporon have been recognized with increasing frequency over the last two decades. Invasive disease due to trichosporonosis has been reported from neutropenic patients with cancer and the mortality is high. Recently, others groups of patients have become susceptible to this rare fungi. We report the emerging of infection with pathogenic Trichosporon asahii in severely ill heart failure patients in a tertiary cardiological intensive care unit (CICU). We describe our data, and report a fatal case of disseminated trichosporonosis in a patient with heart failure. We also review literature pertaining to T. asahii infections. CASE REPORT: An 85 year-old woman with a history of hypertension, heart failure (ejection fraction (EJ): 30%) and pulmonary embolism was admitted to a medical cardiological ICU after cardiac arrest (ventricular fibrillation) resuscitated during a routine consultation. There were no neurological sequelae and the echocardiogram revels no changes, neither the cardiac biomarkers. Ventricular fibrillation was considered secondary to heart failure. The patient had extubation failure and difficult weaning needing long term mechanical ventilation even after tracheostomy. Her hospital course was complicated by acute renal failure and recurrent respiratory, urinary and systemic bacterial infections, which responded to broad-spectrum antibiotics. After a temporary improvement she developed urinary infection and subsequent septic shock. Cultures of urine and blood specimens grew T. asahii. Treatment with liposome amphotericin B (5 mg/kg/day) was started. Despite receiving vancomycin and imipenem, the clinical condition of the patient deteriorates. Blood taken for culture on the seventh day of amphotericin B therapy were negative but urine specimen still grew T. asahii. On the eighteenth day of antifungal therapy, the patient died with multiorgan failure. CONCLUSIONS: The increasing of severely ill patients, and the use of broad spectrum antibiotics, has predisposed the emerging of invasive infections by rare and new opportunistic fungal pathogens. Severe infection related to T. asahii, until recently restricted to neutropenic patients with cancer, has been frequently identified in heart failure patients with advanced age. The mortality is high. These data highlights the importance of considering this group of patients as a risk group for T. asahii infection.

Impact of body mass index on blood pressure levels in patients with polycystic ovary syndrome.

As there is controversy about the prevalence of hypertension in patients with polycystic ovary syndrome (PCOS) and, up to the present moment, no studies have evaluated the impact of body mass index (BMI) on blood pressure levels (BP) in these patients, we studied retrospectively sixty-nine patients with PCOS, with BMI of 29.0 +/- 6.7 kg/m(2) and aged 25.6 +/-5.6 yr, subdivided into three groups according to BMI (normal, overweight and obese) and evaluated regarding BP (mercury sphygmomanometer), basal hormonal profile, fasting glucose, and insulin sensitivity (HOMA-IR). Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were normal (118.1 +/- 17.0 and 74.7+/- 11.5 mmHg, respectively), with a hypertension prevalence of 20.3%. Of these patients, 78.6% were obese and 21.4% were overweight. When the groups were compared according to BMI, a significant increase in SBP and DBP was observed (higher in overweight and obese patients for SBP and higher in obese for DBP), as well as a significant progressive increase in glucose, insulin, homeostatic model assessment, and a significant progressive decline in LH levels. When the patients were subdivided as normotensive or hypertensive, a significant difference was observed only for BMI (28.2 +/- 6.1 and 34.7 +/- 8.6 kg/m(2), respectively; p = 0.007). In conclusion, we observed a significant and progressive impact of BMI on blood pressure levels in our patients with polycystic ovary syndrome.

Impact of body mass index on blood pressure levels in patients with polycystic ovary syndrome

As there is controversy about the prevalence of hypertension in patients with polycystic ovary syndrome (PCOS) and, up to the present moment, no studies have evaluated the impact of body mass index (BMI) on blood pressure levels (BP) in these patients, we studied retrospectively sixty-nine patients with PCOS, with BMI of 29.0 ± 6.7 kg/m² and aged 25.6 ± 5.6 yr, subdivided into three groups according to BMI (normal, overweight and obese) and evaluated regarding BP (mercury sphygmomanometer), basal hormonal profile, fasting glucose, and insulin sensitivity (HOMA-IR). Mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) were normal (118.1 ± 17.0 and 74.7 ± 11.5 mmHg, respectively), with a hypertension prevalence of 20.3 percent. Of these patients, 78.6 percent were obese and 21.4 percent were overweight. When the groups were compared according to BMI, a significant increase in SBP and DBP was observed (higher in overweight and obese patients for SBP and higher in obese for DBP), as well as a significant progressive increase in glucose, insulin, homeostatic model assessment, and a significant progressive decline in LH levels. When the patients were subdivided as normotensive or hypertensive, a significant difference was observed only for BMI (28.2 ± 6.1 and 34.7 ± 8.6 kg/m², respectively; p = 0.007). In conclusion, we observed a significant and progressive impact of BMI on blood pressure levels in our patients with polycystic ovary syndrome.

Como há controvérsia sobre a prevalência de hipertensão arterial em pacientes com a síndrome dos ovários policísticos (SOP) e, até o momento, nenhum estudo avaliou o impacto do índice de massa corporal (IMC) sobre a pressão arterial (PA), foram estudados retrospectivamente 69 pacientes com a SOP, com IMC de 29,0 ± 6,7 kg/m² e idade de 25,6 ± 5,6 anos, subdivididos em 3 grupos de acordo com o IMC (normal, sobrepeso e obesos) e avaliados com relação à PA, perfil hormonal basal, glicemia de jejum e sensibilidade à insulina (HOMA-IR). As médias das pressões arteriais sistólica (PAS) e diastólica (PAD) foram normais (118,1 ± 17,0 e 74,7 ± 11,5 mmHg, respectivamente), com uma prevalência de hipertensão de 20,3 por cento. Das pacientes hipertensas, 78,6 por cento eram obesas e 21,4 por cento apresentavam sobrepeso. Quando os grupos, subdivididos de acordo com o IMC, foram comparados, aumento significativo da PAS e PAD foi observado (PAS maior nas pacientes com sobrepeso e obesas e PAD maior nas pacientes obesas), assim como um aumento progressivo da glicemia, insulina e HOMA-IR, e um decréscimo significante e progressivo de LH. Quando as pacientes foram subdivididas em normotensas e hipertensas, diferença significativa foi observada somente para IMC (28,2 ± 6,1 e 34,7 ± 8,6 kg/m², respectivamente; p = 0,007). Em conclusão, observamos um impacto significativo e progressivo do IMC sobre os níveis pressóricos em nossas pacientes com a síndrome dos ovários policísticos.

Estudo de segurança e eficácia da enoxaparina sódica na profilaxia e terapêutica antitrombótica / Safety and efficacy of sodium enoxaparin in anti-thrombotic prophylaxis and treatment

JUSTIFICATIVA E OBJETIVOS: O uso de heparina de baixo peso molecular (HBPM) na profilaxia ou terapêutica de diversas doenças ou síndromes é de grande importância na prática clínica. O objetivo deste estudo foi avaliar a segurança e a eficácia da enoxaparina sódica, teste (ENOX-T) comparada ao medicamento de referência (ENOX-R). MÉTODO: Foi realizado estudo prospectivo, aleatório, comparativo, unicêntrico e aberto envolvendo pacientes com indicação de profilaxia ou tratamento antitrombótico. Foram incluídos 100 pacientes divididos em 2 braços: profilático (n = 50) e terapêutico (n = 50) divididos em 2 grupos para cada braço (grupo 1: ENOX-R e grupo 2: ENOX-T). Analisou-se em cada segmento os dados clínicos e laboratoriais. A atividade do anti-fator Xa foi aferida em três momentos: basal (1ª avaliação); 1º ou 2º dia (2ª avaliação) e 5º a 7º dia (3ª avaliação). O ultra-som Doppler dos membros inferiores foi realizado na 2ª ou 3ª avaliação do braço profilático. RESULTADOS: Os resultados demonstraram homogeneidade dos grupos nos 2 braços (profilático e terapêutico) quanto a sexo, idade, índice de massa corpórea, creatinina sérica e Apache II. Os valores do anti-fator Xa nos braços profilático e terapêutico demonstraram eficácia adequada dos medicamentos, sem diferença clínica ou estatística entre ambos. A ocorrência de eventos adversos não mostrou diferença clínica ou estatística entre os medicamentos. No braço profilático o ultra-som de membros inferiores acrescentou informações úteis sobre a eficácia dos fármacos estudados. CONCLUSÕES: A enoxaparina sódica teste (ENOX-T) foi segura e eficaz nos pacientes analisados e equivalente ao medicamento de referência (ENOX-R).

BACKGROUND AND OBJECTIVES: Use of low molecular weight heparins (LMWH), either prophylactic or therapeutic, is of most importance in several syndromes and diseases in daily clinical practice. Our objective in this clinical trial was to evaluate safety and efficacy of test sodium enoxaparin (ENOX-T) compared to the reference drug (ENOX-R). METHODS: We conducted a prospective, randomized, comparative, unicentric and open-labeled trial including patients with either prophylactic or therapeutic anti-thrombotic indications. A total of 100 patients were enrolled in two branches: prophylactic (n=50) and therapeutic (n=50) and two groups for each branch (group 1: ENOX-R and group 2: ENOX-T). We analyzed clinical and laboratory data in each segment. Anti-factor Xa was measured in three different moments: baseline (1st evaluation); 1st or 2nd day (2nd evaluation) and 5th to 7th day (3rd evaluation). Doppler-sonography of inferior limbs was performed on all patients in prophylactic group on 2nd or 3rd evaluation. RESULTS: The data showed that both branches (prophylactic and therapeutic) were homogenous in regard of sex, age, body mass index (BMI), serum creatinine and APACHE II severity score at admission. Anti-factor Xa results, in both prophylactic and therapeutic branches, showed expected efficacy to both drugs, without any clinical or statistical difference between them. Adverse events incurred in both groups in a similar way, without any clinical or statistical difference between them. In prophylactic branch, Doppler-sonography of inferior limbs added useful information on drugs efficacy. CONCLUSIONS: We conclude that test sodium enoxaparin (ENOX-T) was effective and safe in our patient's cohort and equivalent to reference drug (ENOX-R).

[Safety and efficacy of sodium enoxaparin in anti-thrombotic prophylaxis and treatment]. / Estudo de segurança e eficácia da enoxaparina sódica na profilaxia e terapêutica antitrombótica.

BACKGROUND AND OBJECTIVES: Use of low molecular weight heparins (LMWH), either prophylactic or therapeutic, is of most importance in several syndromes and diseases in daily clinical practice. Our objective in this clinical trial was to evaluate safety and efficacy of test sodium enoxaparin (ENOX-T) compared to the reference drug (ENOX-R). METHODS: We conducted a prospective, randomized, comparative, unicentric and open-labeled trial including patients with either prophylactic or therapeutic anti-thrombotic indications. A total of 100 patients were enrolled in two branches: prophylactic (n=50) and therapeutic (n=50) and two groups for each branch (group 1: ENOX-R and group 2: ENOX-T). We analyzed clinical and laboratory data in each segment. Anti-factor Xa was measured in three different moments: baseline (1st evaluation); 1st or 2nd day (2nd evaluation) and 5th to 7th day (3rd evaluation). Doppler-sonography of inferior limbs was performed on all patients in prophylactic group on 2nd or 3rd evaluation. RESULTS: The data showed that both branches (prophylactic and therapeutic) were homogenous in regard of sex, age, body mass index (BMI), serum creatinine and APACHE II severity score at admission. Anti-factor Xa results, in both prophylactic and therapeutic branches, showed expected efficacy to both drugs, without any clinical or statistical difference between them. Adverse events incurred in both groups in a similar way, without any clinical or statistical difference between them. In prophylactic branch, Doppler-sonography of inferior limbs added useful information on drugs efficacy. CONCLUSIONS: We conclude that test sodium enoxaparin (ENOX-T) was effective and safe in our patient's cohort and equivalent to reference drug (ENOX-R).

Severe heart failure at intensive therapy unit--is there an ideal prognostic index?

OBJECTIVE: To assess the applicability of three prognostic indexes--APACHE II, SAPS II and UNICAMP II--in a subgroup of critical heart failure (HF) patients. METHODS: Ninety patients were studied, being 12 females and 78 males. Mean age was 56 (18-83). Patients were ranked in functional class IV (NYHA) or cardiogenic shock secondary to cardiomyopathies: dilated (44%), chagasic (25.5%), ischemic (18%), hypertensive (1.1%), hypertrophic (1.1%), alcoholic (1.1%), and secondary to valvopathies after surgical correction (7.7%). Tables with frequency of categorical variables and descriptive statistics of continuous variables were created in order to describe sample profile for the different variables under study. In order to analyze the relationship between prognostic indexes levels and course towards death, an analysis of the ROC curve, as well as Hosmer and Lemeshow Test of Goodness of Fit calculated, and Standardized Mortality Ratio (SMR) were carried out. RESULTS: The statistical analysis showed low sensitivity, specificity, and accuracy of the three prognostic indexes for HF patients. Mortality was underestimated in this group. Pulmonary thromboembolism (PTE) was a major factor of mortality rate in severe HF. CONCLUSION: The three prognostic indexes under study did not prove to be appropriate for the assessment of cardiopathy patients at Intensive Care Unit (ICU). For HF patients, PTE played a major role in mortality of heart failure. Specific prognostic indexes for cardiopathy patients with severe HF should be proposed, and the discussion on anticoagulation on those patients should be expanded.

Insuficiência cardíaca grave em unidade de terapia intensiva: existe um índice prognóstico ideal? / Severe heart failure at intensive therapy unit: is there an ideal prognostic index? / Severe heart failure at intensive therapy unit: is there an ideal prognostic index?

OBJETIVO: Avaliar a aplicabilidade de três índices prognósticos - APACHE II, SAPS II e Unicamp II, em um subgrupo de pacientes críticos, portadores de insuficiência cardíaca (IC). MÉTODOS: Foram estudados 90 pacientes, sendo 12 do sexo feminino e 78, do sexo masculino, com idade média de 56 (18-83) anos. Os pacientes encontravam-se em classe funcional IV (NYHA) ou choque cardiogênico secundário às cardiomiopatias: dilatada (44 por cento), chagásica (25,5 por cento), isquêmica (18 por cento), hipertensiva (1,1 por cento), hipertrófica (1,1 por cento), alcoólica (1,1 por cento), e secundário às valvopatias já submetidas à correção cirúrgica (7,7 por cento). Para descrever o perfil da amostra, segundo as diversas variáveis em estudo, foram feitas tabelas de freqüência das variáveis categóricas e estatísticas descritivas das variáveis contínuas. Para analisar a relação entre os valores dos índices prognósticos e a evolução para o óbito, foi realizada a análise da curva ROC, calculadas as estatísticas de bondade do ajuste de Hosmer e Lemeshow, assim como a SMR (Standardized Mortality Ratio). RESULTADOS: A análise estatística mostrou baixa sensibilidade, especificidade e acurácia dos três índices prognósticos para os pacientes com IC, tendo sido subestimada a mortalidade nesse grupo. Na IC refratária, a ocorrência de tromboembolismo pulmonar (TEP) foi um fator importante em relação à mortalidade. CONCLUSÃO: Os três índices prognósticos estudados não foram adequados para avaliação dos cardiopatas internados na Unidades de Terapia Intensiva (UTI). Nos pacientes com IC, o fator TEP foi importante para a descompensação aguda da IC e para a alta mortalidade do grupo. índices prognósticos para cardiopatas com IC refratária deverão ser propostos, e a discussão sobre anticoagulação nestes pacientes deve ser ampliada.

OBJECTIVE: To assess the applicability of three prognostic indexes - APACHE II, SAPS II and UNICAMP II - in a subgroup of critical heart failure (HF) patients. METHODS: Ninety patients were studied, being 12 females and 78 males. Mean age was 56 (18-83). Patients were ranked in functional class IV (NYHA) or cardiogenic shock secondary to cardiomyopathies: dilated (44 percent), chagasic (25.5 percent), ischemic (18 percent), hypertensive (1.1 percent), hypertrophic (1.1 percent), alcoholic (1.1 percent), and secondary to valvopathies after surgical correction (7.7 percent). Tables with frequency of categorical variables and descriptive statistics of continuous variables were created in order to describe sample profile for the different variables under study. In order to analyze the relationship between prognostic indexes levels and course towards death, an analysis of the ROC curve, as well as Hosmer and Lemeshow Test of Goodness of Fit calculated, and Standardized Mortality Ratio (SMR) were carried out. RESULTS: The statistical analysis showed low sensitivity, specificity, and accuracy of the three prognostic indexes for HF patients. Mortality was underestimated in this group. Pulmonary thromboembolism (PTE) was a major factor of mortality rate in severe HF. CONCLUSION: The three prognostic indexes under study did not prove to be appropriate for the assessment of cardiopathy patients at Intensive Care Unit (ICU). For HF patients, PTE played a major role in mortality of heart failure. Specific prognostic indexes for cardiopathy patients with severe HF should be proposed, and the discussion on anticoagulation on those patients should be expanded.

[Resistive exercise in the evaluation of endothelial dysfunction in heart failure]. / Exercício resistido na avaliação da disfunção endotelial na insuficiência cardíaca.

OBJECTIVE: To evaluate the use of resistive exercise in the study of endothelial dysfunction in heart failure (HF) comparatively to reactive hyperemia (RH). METHODS: Eighteen patients with heart failure and 15 normal volunteers were submitted to intermittent handgrip exercise in a pneumatic bag, at an intensity that corresponds to 75% of the previously assessed maximum load. Patients underwent high-resolution vascular ultrasonography for brachial artery diameter and flow evaluation as well as cardiac output determination at rest, RH and after exercise. The systolic flow index in the brachial artery and cardiac index were calculated. RESULTS: Systolic flow index increase in the brachial artery was observed after RH and physical exercise, with the latter presenting the highest increase. There was an increase in the cardiac index after the study conditions in comparison to resting conditions. CONCLUSION: Resistive exercise, performed at the assessed load, increases blood flow more intensively than RH, constituting a physiological option for the evaluation of endothelial function in HF.

Exercício resistido na avaliação da disfunção endotelial na insuficiência cardíaca / Resistive exercise in the evaluation of endothelial dysfunction in heart failure

OBJETIVO: Avaliar o uso de exercício físico resistido no estudo da disfunção endotelial na insuficiência cardíaca comparativamente à hiperemia reativa (HR). MÉTODOS: Dezoito portadores de insuficiência cardíaca (IC) e 15 voluntários realizaram esforço físico manual de preensão intermitente em bolsa pneumática com intensidade correspondente a 75 por cento da carga máxima previamente avaliada. Foram avaliados por ultra-sonografia vascular de alta resolução para análise dos diâmetros da artéria braquial e fluxos bem como determinação do débito cardíaco em repouso, após HR e após exercício. Foram calculados o índice de fluxo sistólico na artéria braquial e o índice cardíaco. RESULTADOS: Houve aumento do índice de fluxo sistólico na artéria braquial nas condições HR e exercício físico sendo maior nessa última. Houve aumento do índice cardíaco nas condições de estudo comparativamente ao repouso. CONCLUSÃO: O exercício físico resistido, na carga avaliada, aumenta o fluxo sanguíneo local de forma mais intensa que a HR, constituindo-se numa opção fisiológica à avaliação da disfunção endotelial na IC .

Coronary flow reserve impairment predicts cardiac events in heart transplant patients with preserved left ventricular function.

BACKGROUND: The impact of allograft vasculopathy on the coronary circulation and consequently on cardiac outcome may be expressed by coronary flow reserve (CFR) impairment. Therefore, we aimed to evaluate CFR and its relation to cardiac events in heart transplant patients. METHODS: Twenty-three patients, 2 female, with left ventricular ejection fraction >45% were studied 76+/-30 months after heart transplantation. They were divided into 2 groups according to coronary angiography: Group A, 10 patients with significant coronary artery disease (stenosis> or =50%) and group B, 13 patients without significant stenosis. Twenty healthy subjects, 13 female, served as controls. Coronary flow velocity reserve (CFVR) was assessed by transesophageal echocardiography and calculated as the ratio of maximal (i.v. adenosine, 140 microg/kg/min) to baseline coronary velocities. Patients were followed for a mean of 25 months for cardiac events. RESULTS: Compared to controls, heart transplant groups showed significantly higher baseline coronary flow velocities (51+/-27, 38+/-12 and 32+/-12 cm/s, respectively) and lower maximal coronary velocities (90+/-52, 112+/-33 and 118+/-24 cm/s), resulting in a reduced CFVR (1.9+/-1.0, 3.0+/-0.5 and 3.8+/-1.2). Multivariate analysis identified heart transplantation and epicardial coronary artery disease as the only variables independently related to CFVR. Hypertension was positively related to baseline while diabetes inversely related to maximal coronary flow velocities. A CFVR <2.3 was a marker for cardiac events (4 deaths, 1 heart failure). CONCLUSION: CFVR impairment, particularly in the presence of epicardial coronary artery disease, follows heart transplantation and is associated with a worse outcome.