Terapia de Contrapulsação

Apresentação em tema: "Terapia de Contrapulsação"— Transcrição da apresentação:

2 Terapia de Contrapulsação
Choque Cardiogênico Terapia de Contrapulsação © Datascope Corp. 2001

3 A Terapia de Contrapulsação
Introduzida na prática clínica no final dos anos 60. O catéter de BIA é posicionado na descendente toráxica da aorta, na parte distal da artéria subclávia esquerda. A Contrapulsação é uma terapia estabelecida em inúmeros tratamentos clínicos e cirúrgicos. O balão é programado para inflar e desinflar em sincronia com o ciclo mecânico cardíaco para aumentar a oxigenação ao miocárdio e reduzir a demanda de oxigênio do miocárdio.

4 Efeitos primários da terapia de contrapulsação
BIA Desinflado Oferta = Demanda Consumo de O2 BIA Inflado

5 Diástole: BIA Inflado Sístole: BIA Desinflado
• Aumento da perfusão coronária • Diminuição do esforço cardíaco • Diminuição do consumo de oxigênio pelo miocárdio • Aumento no débito cardíaco

6 Avaliação da sincronização
Aumento da perfusão da artéria coronária mm Hg C D A B E F Redução da demanda de O2 pelo miocárdio 120 100 80 Inflation and deflation of the IAB change the configuration of the arterial pressure waveform. A properly timed balloon will inflate at the dicrotic notch, which will appear as a sharp “V” configuration between the systolic pressure and the diastolic augmentation. The peak diastolic augmentation represents the maximum pressure in the aorta with balloon inflation during diastole. Deflation of the balloon at the end of diastole is reflected in an assisted aortic end-diastolic pressure lower than the unassisted aortic end-diastolic pressure. Proper deflation will also reduce the systolic pressure that follows balloon deflation. The next systolic beat is called the assisted systole. A = Um ciclo cardíaco completo B = Pressão diastólica final sem assistência C = Pressão sistólica sem assistência D = Aumento diastólico E = Pressão diastólica aórtica final reduzida F = Pressão sistólica reduzida

7 Efeitos fisiológicos da terapia de contrapulsação
Fluxo Sanguíneo coronário Débito cardíaco sanguíneo renal Pressão Aórtica Sistólica Diastólica Cardíaco pós-carga Pré-carga Pressão do VE Sistólico Diastólico final Ventrículo Esquerdo Volume Esforço de ejeção Tensão na parede Maccioli, GA, et al; Journal of Cardiothoracic Anesthesia 1988 June; 2(3):

8 Gerenciamento de choque cardiogênico com avaliação de prognóstico para intervenção precoce

9 “A Chave para um bom resultado é um acesso organizado com um diagnóstico rápido e iniciação imediata de terapia para manter a pressão sanguínea e o rendimento cardíaco.” Hollenberg, et al, Cardiogenic Shock: July 99, Annals of Internal Medicine

10 Incidência Choque cardiogênico apresenta complicações em
7.5% dos pacientes com infarto agudo do miocárdio O choque cardiogênio é a causa principal de óbito em pacientes hospitalizados com infarto agudo do miocárdio [IAM] As taxas de mortalidade variam entre 70 a 80% The incidence of cardiogenic shock has not greatly changed in the last 30 years. The Worcester Heart Attack study, a community wide analysis, found an incidence of cardiogenic shock of 7.5%, this incidence remained stable from 1975 to In the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO-I] trial, , the incidence of cardiogenic shock was 7.2% a rate similar to that found in other multicenter thrombolytic trials and accounted for 58% of all deaths in the entire trial. Mortality rates for cardiogenic shock have remained high 70-80%. However current research into the treatment strategies for cardiogenic shock suggest that early diagnosis and intervention can lead to improved survival.

11 Definições Um estado de perfusão inadequada do tecido devido a disfunção cardíaca, mais comunmente causada por infarto agudo do miocárdio.

12 Choque Cardiogênico Quadro clínico / hemodinâmico
PS Sistólico < 90mmHg para >1 hora que não respondem a administração de fluidos Sinais de hipoperfusão: Índice cardíaco < 2.2L/min/m PCAP(m) > 18mmHg Sinais periféricos: alteração sensorial produção de urina < 30ml/h resfriamento corporal Definition from: Hasdai, et al “Cardiogenic shock complicating acute myocardial infarction: predictors of Death”. American Heart Journal; Volume 138, Number 1 Part 1.

13 Vasoconstrição Tonus Simpático SRA
Disfunção do VE Oclusão Coronária Isquemia Massa Contrátil Vasoconstrição Retensão de Na & H2O Tonus Simpático SRA Pressão Arterial Fluxo Coronário Pathophysiology of Cardiogenic shock due to acute myocardial infarction: The pathophysiology of Cardiogenic Shock involves a downward spiral: ischemia causes myocardial dysfunction, which in turn, worsens ischemia. Left ventricular [LV] dysfunction leads to increased sympathetic tone and activation of the renin-angiotensin system [RAS] causing vasoconstriction and sodium retention, two factors which promote further LV dysfunction. Patients in shock often have obstruction of a major coronary vessel, with resultant extensive loss of contractile mass, which leads to decreased arterial pressure. A significant drop in arterial pressure may be profound enough to cause a decrease in coronary blood flow, aggravating myocardial ischemia and further compromising LV function. Initially, the dysfunction is reversible but persistent hypotension leads to irreversible permanent cellular injury and necrosis, organ dysfunction, and can ultimately lead to death. Isquemia Barry WL, et al, Clin. Cardiol. 21, [1998]

14 A terapia efetiva para o choque cardiogênico é a de
Gerenciamento de choque cardiogênico com avaliação de prognóstico para intervenção precoce A terapia efetiva para o choque cardiogênico é a de incluir a estratégia preventiva. Esta estratégia requer a identificação de pacientes com alto risco para desenvolvimento de choque assim como a seleção de pacientes candidatos a procedimentos de intervenção agressivos. Barry et al, Cardiogenic Shock: Therapy and Prevention Clin. Cardiol. 21, [1998]

15 Predictores do choque cardiogênico após terapia com trombolíticos no infarto agudo do miocárdio
Foco: Desenvolver um modelo como preditor da ocorrência do choque cardiogênico entre pacientes com IAM que recebem terapia com trombolíticos. Cardiogenic shock remains a common and ominous complication of AMI. By identifying patients at risk of developing shock, preventative measures may be implemented to avert its development. Hasdai and colleagues undertook a study to characterize clinical factors predictive of cardiogenic shock developing after thrombolytic therapy for acute myocardial infarction. Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

16 Métodos População estudada: GUSTO I N=37,764 Validação
Choque Cardiogênico N= 1,889 [desenvolveram choque após admissão] Baseline variables associated with the development of shock after thrombolytic therapy in the Global Utilization of Streptokinase and Tissue-Plasminogen Activator for Occluded Coronary Arteries [GUSTO I] trial were analyzed. Patients were excluded who presented with shock or who were missing precise data as to the timing of shock relative to the time of enrollment. The occurrence of shock was also analyzed based on its timing after enrollment: <1 h, >1 to 2 h, >2 to 6 h, >6 to 24 h, >24 to 48 h, >48 h. 41,021 patients were enrolled into GUSTO I, 1,889 patients were eligible for this analysis, based on their development of shock after admission. For verification purposes, the model developed was used in the Global Use of Strategies Open Occluded Arteries [GUSTO III] study population. Of the 15,058 patients enrolled into GUSTO III, 643 patients developed shock after admission and were used to test the GUSTO I shock model. Validação GUSTO III N= 15,058 Choque cardiogênico N= 643 Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

17 Desenvolvimento do Choque
10 20 30 40 50 60 70 39.6% 63.2% Prazo de 6 horas Prazo de 24 horas % Timing of shock; The challenge for the clinician is to promptly and thoroughly identify the patient at risk for developing shock and to avert its complication. Recent data have stressed the earlier occurrence of shock, shock occurred at a median of 9 hours after onset of AMI. In GUSTO-I, it was observed that among patients who did not present in shock and who received thrombolytic therapy, shock developed at a median of 11.6 hours. Shock developed within 6 hours of enrollment in 39.6% of shock patients and within 24 hours in 63.2%. This data indicates that the window of opportunity to attempt to avert the development of shock is very short lived; patients must be identified and measures should be taken within hours of presentation. Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

18 Base independente de preditores no desenvolvimento de choque cardiogênico:
Wald X2 valor-p Idade < 0.001 P/S Sistólica < 0.001 Batimentos cardíacos < 0.001 Classe Killip < 0.001 II vs. I III vs. I In the Cox proportional hazards survival model [above table GUSTO I data], the major factors associated with increased adjusted risk of shock were age, systolic blood pressure, heart rate, Killip class. Together these four variables provided >85% of the information needed to predict the occurrence of shock. The same four variables as in the GUSTO-I model were significant in the GUSTO-III population. These four variables accounted for >95% of the predictive information in the GUSTO-III population. This data demonstrates that certain demographic and clinical parameters are strongly associated with the development of shock after thrombolytic therapy. Older age was the variable most strongly associated with the occurrence of shock, for every 10-year increase in age, the risk of developing shock was greater by 47%. In addition simple parameters derived from the physical examination, such as systolic blood pressure, heart rate and Killip class among patients who did not present with shock, were strong predictors of shock developing subsequently. A Wald X2 [chi square] statistic is used to test the hypothesis “An individual factor has no prognostic value when placed in a model with other factors”. Two questions are asked: 1. Does the data provide strong evidence that this factor has any prognostic value in determining the risk of the event, after adjusting for the other factors in the model. 2. What is the magnitude and direction of this factor’s effect [after adjusting for the other factors in the model]? The test is to prove infact that “An individual factor does have prognostic value when placed in a model with other factors”. Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

19 Fatores preditores • Idade • Bat. cardíacos
• P/S sistólico • P/S diastólico • Peso • Classe Killip • Terapia com trombolíticos • Local do IM • Outros - IM prévio - Cirurgia de revascularização coronária prévia - Sem angioplastia prévia - Sexo feminino - Hipertensão - Localização regional Predictive factors assigned a score are: Age, heart rate, systolic BP, diastolic BP, weight, thrombolytic treatment [TPA, SK-IV etc.], Killip class, MI location [ant,inf,other], miscellaneous [previous MI, previous CABG, No previous PTCA, Female, Hypertension, US] Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

20 Pontuação dos preditores de choque cardiogênico
Probabilidade de choque cardiogênico intra - hospitalar Pontuação total 130 10% 142 20% 149 30% 155 40% 160 50% The results of the model were then converted into a scoring system algorithm. Based on certain categorical clinical features such as prior AMI or gender, as well as the value of continuous variables such as age or systolic blood pressure upon presentation, a composite score was calculated. This composite score can then be used to estimate the risk of developing shock after thrombolytic therapy. The value most closely matching the patient’s risk factors are selected. All values are then calculated to arrive at a sum total. Then based on the total number of points determine the predicted probability risk of cardiogenic shock. Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

21 Probabilidade de choque cardiogênico intra - hospitalar : Exemplo
Paciente de 71 anos, sexo feminino, 60 Kg com histórico de hipertensão, diagnosticado com IAM anterior. Na admissão, HR=123, P/S=126/64 e classe Killip = III Pontos Pontos Idade = 37 HR = 17 P/S sistólico = 39 P/S distólico = 5 Peso = 17 Classe Killip III = 17 Localização do IM = 8 Tratamento = 5 Outros [3+5+2] = 10 The total number of points for this patient is then 155 points. This gives us a 40% probability of this patient developing cardiogenic shock Total = 155 pontos 40% probabilidade de choque Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

22 Predictores do choque cardiogênico após terapia com trombolíticos no infarto agudo do miocárdio
Conclusão: Com o desenvolvimento de um sistema simples de pontuação, baseado primáriamente na idade do paciente e descobertas clinicas na apresentação, é possivel estimar com precisão o risco de choque. The challenge facing the physician attending to a patient with AMI is to promptly identify the patient at risk and to take measures to avert the occurrence of shock. Hasdai, D, et al; J Am Coll Cardiol 2000; 35:136-43

23 Intervenção precoce em IAM complicados por choque cardiogênico
For patients that are diagnosed with cardiogenic shock, available evidence supports the concept that early and definitive restoration of coronary blood flow is the most important intervention when ischemic heart disease is the principal cause of the syndrome.

24 Terapia com BIA Disfunção do VE Inotrópos Revascularização
Oclusão coronária Isquemia Massa contrátil Vasoconstrição com retensão deNa & H2O Tonus Simpático SRA Pressão arterial Fluxo coronário In general, three treatment strategies have been aimed at reversing the vicious cycle of cardiogenic shock. 1. Inotropic and pressor agents have been used to counteract LV dysfunction and hypotension. These agents are generally temporizing measures to stabilize a patient until other therapeutic measures can be instituted. They do not improve survival. 2. The use of intra-aortic balloon counterpulsation therapy to improve coronary blood flow, enhance collateral circulation, and improve hemodynamics by increasing cardiac output. Survival benefits have been demonstrated. 3. Revascularization, which is the ultimate goal. Terapia com BIA Isquemia Barry WL, et al, Clin. Cardiol. 21, [1998]

25 Infarto agudo do miocárdio Revascularizaçãode emergência
Revascularização precoce no IAM complicado por choque cardiogênico - Shock Trial Infarto agudo do miocárdio Choque < 36 Horas Randomização < 12 Horas Revascularizaçãode emergência n = 152 Estabilização médica inicial n = 150 The SHOCK trial was a randomized trial to evaluate early revascularization in patients with cardiogenic shock. Patients with shock due to left ventricular failure complicating myocardial infarction were randomly assigned to emergency revascularization [152 patients] or initial medical stabilization [150 patients]. The onset of shock had to be within 36 hours of infarction, and randomization had to occur no more than 12 hours after diagnosis of shock. For patients assigned to revascularization, angioplasty or bypass surgery had to be performed within 6 hours of randomization, IABP therapy was recommended. Usage was 86% in both groups. For patients assigned to medical stabilization, intensive medical therapy was required. IABP therapy and thrombolytics were recommended. Delayed revascularization at a minimum of 54 hours after randomization was recommended. Primary end point was overall 30-day mortality after randomization. Secondary end points consisted of overall mortality 6 and 12 months after infarction. Hochman, JS, et al: New Eng J Med 1999; 341(9):

26 Shock Trial RE AMI valor -p Idade [anos] 65.5 66.2 .524
Características dos pacientes RE AMI valor -p Idade [anos] Hipertensão 49% 43.5% .354 Diabetes % 27.9% .260 IM prévio % 35.3% .326 IM anterior % IM a Rand ,6horas 25% 23.7% .790 Pre-Rand c/ a menor PS PCAP(m) Indice cardíaco The two treatment groups were well balanced. Median time from onset of infarction to shock was 5.6 hours. Patients in both groups had similar medical history. Hemodynamic measurements were most often obtained while the patients were receiving support, this demonstrated the profound abnormalities confirming cardiogenic shock. Hochman, JS, et al: New Eng J Med 1999; 341(9):

27 Shock Trial Mortalidade geral p= 0.11 p= 0.027 63.1 Percentual 56 50.3
20 40 60 80 30-Dias 6-meses p= 0.11 p= 0.027 63.1 Percentual RE 56 50.3 AMI 46.7 The 30-day mortality rates for the revascularization and medical therapy groups were 46.7% and 56% respectively. This was not statistically significant. Patients assigned to revascularization had a high risk of death on days 1 and 2, whereas those assigned to medical therapy had a relatively constant risk of death over the first week. The 30-day mortality was 45.3% among 75 patients who underwent angioplasty alone and 42.1% among the 57 [9 had angioplasty prior] patients who underwent bypass surgery. At six months overall mortality was 50.3% for the group assigned revascularization and 63.1% for the group assigned medical therapy. This was statistically significant. At one year overall mortality remains lower in the revascularization group compared to the medical therapy group. Hochman, JS, et al: New Eng J Med 1999; 341(9):

28 Shock Trial - Conclusão
A revascularização precoce, resultou na diminuição da mortaldade de todas as causas em 6 meses e 1 ano e devem ser fortemente consideradas em pacientes com IAM complicados por choque cardiogênico. ACC/AHA Guidelines - Recomendação: A revascularização para pacientes que desenvolvem choque cardiogênico, tem como recomendação a classe I*. Contudo terapias adjuntas são necessárias para a redução da alta taxa de mortalidade, alem da revascularização precoce de emergência. At 30 days there was no significant benefit of early revascularization. However, early revascularization resulted in lower mortality from all causes at six months and at one year. Revascularization should be strongly considered for patients with AMI complicated by cardiogenic shock. ACC/AHA Recommendation format: Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is beneficial, useful and effective. *ACC/AHA Guidelines for the management of AMI: 1999 update; Circulation 1999; 100: Hochman, JS, et al: New Eng J Med 1999; 341(9):

29 A sobrevida do choque cardiogênico e o uso da terapia de contrapulsação
Em hospitais sem estrutura para revascularização, devem dispor de terapia de contrapulsação e trombolíticos esta recomendação é associada com a redução de mortalidade conforme demonstrado em vários estudos. Many hospitals do not have cardiac catheterization facilities. For patients presenting to these centers observational studies have demonstrated that the use of thrombolytic therapy and intra-aortic counterpulsation followed by rapid transfer to a tertiary centre for revascularization improves survival. SHOCK trial - Comment: The non-significant mortality difference between the groups at 30-days may have resulted partially from the relatively low 30-day mortality in the IMS group due to high rate of IABP [86%] and Thrombolytic [63.3%] therapy use.

30 Resuldados de mortalidade em perspectiva
TT & BIA TT 20 40 60 80 45% 59% 33% 68% 47% 63% 49% 69% 34% 43% Observacional Randomizado p= 0.59 p<0.001 p= 0.02 p<0.007 p= 0.001 Observational studies have demonstrated increased survival in-hospital and at 1-year. Also a combined analysis from the GUSTO-1& III trials showed that the use of IABP in patients with cardiogenic shock was associated with a lower mortality rate. More recently a report from the SHOCK Trial Registry investigated the potential benefit of TT and IABP on in-hospital mortality, they also concluded a lower in-hospital mortality rate than standard therapy. GUSTO Kovack SHOCK NRMI TACTICS I & III [30-Dias] [1 Ano] [Intra-hospitalar] [Intra-hospitalar] [6 Meses]

31 Choque cardiogênico [7%] N= 3,396
Sobrevida no choque cardiogênico e uso de CBIA: Resultados dos estudos Gusto I & III GUSTO I & GUSTO III N= 56,080 Países > 1000 pacientes N= 48,536 Australia, Belgica, Canada, França, Alemanha, Holanda, Nova Zelândia, UK, EUA Choque cardiogênico [7%] N= 3,396 Data from Gusto I and III trials was analyzed to investigate whether adjunctive intraarotic balloon counterpulsation might improve survival. Nine countries were selected who participated in GUSTO-I and III, where patient enrollment was greater than 1000 between From a pool of 48,536 AMI patients, 3,396 were diagnosed as cardiogenic shock. Cardiogenic shock survival and IABP use were compared across these countries. Only 877 patients [26%] received IABP therapy. BIA [26%] N= 877 S/ BIA [74%] N= 2,496 Hudson, MP, et al, Presented at the American Heart Association 72nd Scientific Sessions, November 1999.

32 Sobrevida no choque cardiogênico e uso de CBIA: Resultados dos estudos Gusto I & III
60 50 59% Percentual 40 45% 30 BIA S/ BIA 20 10 Results: IABP use is associated with significantly improved cardiogenic shock mortality, especially in patients aged <70 years and those undergoing PTCA and/or CABG, and patients from the US. IABP was utilized in the minority of AMI-Cardiogenic Shock patients. Only 26% of patients received IABP. Mortalidade a 30 dias Hudson, MP, et al, Presented at the American Heart Association 72nd Scientific Sessions, November 1999.

33 Uso de BIA vs. Sobrevivência em choque cardiogênico
10 20 30 40 NZ UK Alem Holand Aus Can Belg Fr EUA BIA % 50 60 70 80 Mortalidade a 30 dias % % BIA Mortalidade a 30 d There was marked international variation in cardiogenic shock survival and IABP use. In those countries with the lowest percentage use of IABP in cardiogenic shock, mortality was the highest. i.e. Germany, IABP use was 2% in cardiogenic shock with a mortality of 69% versus the US where IABP use was 36% with a mortality of only 50%. These results support increased utilization of IABP therapy in cardiogenic shock. Hudson, MP, et al, Presented at the American Heart Association 72nd Scientific Sessions, November 1999.

34 Sobrevida no choque cardiogênico e uso de CBIA: Resultados dos estudos Gusto I & III
Conclusão: O aumento no uso de BIA pode ser associado com uma melhora de sobrevida no choque cardiogênico pós IAM. Hudson, MP, et al, Presented at the American Heart Association 72nd Scientific Sessions, November 1999.

35 Registro - Shock Trial Impacto na terapia de trombolíticos e contrapulsação com BIA em choque cardiogênico: • Estudos retrospectivos sugerem uma menor taxa de mortalidade intra-hospitalar • Hipoteses examinadas prospectivamente em registros multi-centricos de IAM apresentaram complicações por choque cardiogênico Retrospective studies suggest that patients suffering from Cardiogenic Shock due to AMI have lower in-hospital mortality when they receive a combination of Thrombolytic and IABP Therapy. The potential benefits of this combined therapy on in-hospital mortality was investigated from patients enrolled in prospective, multi-center Registry of acute myocardial infarction [AMI] complicated by cardiogenic shock. Sanborn et al, J Am Coll Cardiol Vol. 36 No. 3, Suppl A Sept 2000:

36 Registro - Shock Trial Choque cardiogênico N= 856 S/ TT S/ BIA N= 285
Somente BIA N= 279 Somente TT N= 132 TT & BIA N= 160 1,190 Patients with suspected cardiogenic shock complicating AMI, were prospectively registered at 36 SHOCK trial sites. 856 patients were evaluated regarding thrombolytic therapy and IABP utilization. Four groups were compared, No TT, No IABP, TT Alone, TT & IABP. Sanborn et al, J Am Coll Cardiol Vol. 36 No. 3, Suppl A Sept 2000:

37 Registro - Shock Trial 63% % TT & BIA 47% TT Mortalidade a 30 dias
80 p <0.007 60 63% % 40 47% TT & BIA TT 20 As in prior retrospective studies, this prospective Registry demonstrated that patients treated with the combination of IABP support and TT had the lowest observed in-hospital mortality [47% vs. 63% p <0.0001]. Mortalidade a 30 dias Sanborn et al, J Am Coll Cardiol Vol. 36 No. 3, Suppl A Sept 2000:

38 Registro - Shock Trial A terapia inicial com BIA e trombolíticos, devem ser consideradas como apropriadas para hospitais sem estrutura para revascularização, se seguido de transferência imediata a centros de cuidado terciários. The SHOCK trial Registry of 856 patients represents the largest prospectively collected series of patients in cardiogenic shock due to predominant LV failure that examines the outcome of various treatments and combinations of therapeutic options. Revascularization by PTCA/CABG, IABP unloading and, to a lesser extent, TT was associated with lower in-hospital mortality rates than treatment with standard medical therapy. Sanborn et al, J Am Coll Cardiol Vol. 36 No. 3, Suppl A Sept 2000:

39 [receberam tromboliticos < 12 hrs]
Trombolítico mais contrapulsação aórtica: Taxa de sobrevida maior em pacientes admitidos em postos de saúde ou hospitais comunitários com choque cardiogênico Revisão retrospectiva em pacientes com IAM, complicados por choque cardiogênico e tratados com terapia trombilítica [receberam tromboliticos < 12 hrs] 46 Pacientes Objectives: Usually cardiogenic shock in community hospitals is treated with thrombolysis alone. This study sought explore the potential benefit of combining IABP with thrombolysis for acute myocardial infarction complicated by cardiogenic shock. The charts of 335 patients were reviewed from two community hospitals who presented with acute myocardial infarction and had cardiogenic shock between 1985 and 1995. There were 46 patients who had cardiogenic shock confirmed within 12 hours of receiving thrombolytics. 27 underwent IABP therapy and 19 did not. Patient characteristics did not differ between the groups. 27 receberam BIA 19 não receberam BIA Kovack, PJ, et al; J Am Coll Cardiol 1997; 29:

40 Trombolítico mais contrapulsação aórtica: Taxa de sobrevida maior em pacientes admitidos em postos de saúde ou hospitais comunitários com choque cardiogênico Sobrevida p 25 p 0.019 93% p 0.019 20 No. Sobreviventes 67% 67% TT & BIA [N= 27] 15 10 TT [N= 19] Patients treated with IABP had a significantly higher rate of community hospital survival, and more of them were transferred for revascularization. Patients treated with IABP also had a significantly higher overall hospital and 1 year survival rate. 5 37% 32% 32% Postos de saúde 30-Dias 1 Ano Kovack, PJ, et al; J Am Coll Cardiol 1997; 29:

41 Trombolítico mais contrapulsação aórtica: Taxa de sobrevida maior em pacientes admitidos em postos de saúde ou hospitais comunitários com choque cardiogênico Conclusão: A sobrevida é aumentada, assim como a transferência para revascularização é facilitada quando pacientes com IAM com complicações de choque cardiogênico admitidos em postos de saúde ou hospitais comunitários recebem terapia com trombolíticos e BIA. Although the study is limited in that it is a nonrandomized, retrospective analysis and the study population was small, the groups were matched for variables known to predict adverse outcome in patients with cardiogenic shock. This strategy has since undergone prospective, randomized evaluation in the Thrombolysis And Counterpulsation To Improve Cardiogenic Shock survival [TACTICS] trial. Kovack, PJ, et al; J Am Coll Cardiol 1997; 29:

42 Trombolíticos e contrapulsação no aumento de sobrevida de pacientes com choque cardiogênico
Pacientes com IAM • sintomas com < 12 horas • Elevação da ST • Hipotensão ou deficiência cardíaca Randomização N= 57 Background: Non-randomized trials have suggested a lower mortality among patients treated with IABP and thrombolysis. Based on this strategy TACTICS trial was designed. A multi-center prospective, randomized study. Hypothesis / primary endpoint: Treatment with intravenous thrombolysis with IABP will lead to a 30% relative reduction in 6 month all-cause mortality compared with thrombolysis alone, among patients with acute myocardial infarction complicated by heart failure or hypotension, and within 12 hours of symptom onset. Secondary endpoints: 30-day mortality In-hospital severe or life-threatening bleeding or vascular complications In-hospital composite of death, reinfarction or new CHF In-hospital overall stroke and IC bleed. Study Design: Patients with AMI diagnosed with heart failure or hypotension within 12 hours, were randomized to either thrombolysis alone or thrombolysis and IABP. In the thrombolysis and IABP group, 3 [10%] patients did not receive IABP. 2 died before IABP could be placed and 1 was due to inability to place the IABP. In the thrombolysis alone group, 9 [33%] patients did require IABP due to clinical deterioration. Trombolíticos N= 27 Trombolíticos + BIA N= 30 Ohman, M, et al, Presented at the 22nd Congress of the European Society of Cardiology, August 27, 1999

43 Trombolíticos e contrapulsação no aumento de sobrevida de pacientes com choque cardiogênico
Características básicas TT TT & BIA valor-p N= N=30 Idade [anos] Diabetes 11% 30% 0.08 IM prévio % 40% 0.08 IM Anterior 56% 77% 0.09 Classe Killip III/IV 48% 60% 0.37 Patients assigned to TT & IABP had higher baseline risk. Ohman, M, et al, Presented at the 22nd Congress of the European Society of Cardiology, August 27, 1999

44 Trombolíticos e contrapulsação no aumento de sobrevida de pacientes com choque cardiogênico
Resultados clínicos p 0.23* 2 4 6 8 10 12 Líticos Líticos & BIA 33% 27% 43% 34% Mortalidade a 30 dias Mortalidade a 6 meses p 0.30* Número de óbitos Only 57 of the 500 planned patients were enrolled, so the study was underpowered. However, patients treated with both counterpulsation and thrombolytics did show a trend in reduced mortality at 6 months, consistent with that seen from several observational studies. * Ajustado para diferenças de base na classe Killip, local do IM e diabetes Ohman, M, et al, Presented at the 22nd Congress of the European Society of Cardiology, August 27, 1999

45 Trombolíticos e contrapulsação no aumento de sobrevida de pacientes com choque cardiogênico
Conclusão: O estudo foi interrompido prematuramente devido a dificuldade na randomização de pacientes críticos Com um número limitado de pacientes inscritos, os autores concluiram que o uso conjunto de BIA e trombolíticos foi associado com: • Baixo número de complicações vasculares e hemorrágicas • Redução na mortalidade consistente com estudos observacionais utilizando BIA no IAM Ohman, M, et al, Presented at the 22nd Congress of the European Society of Cardiology, August 27, 1999

46 Recomendações do ACC/AHA para contra-pulsação com balão intra-aórtico
Classe I: Choque cardiogênico não revertido rapidamente com terapia farmacológica como medida estabilizadora para angiografia e revascularização primária Classe IIa: Sinais de instabilidade hemodinâmica, função do VE pobre ou isquemia persistente em pacientes com grandes areas do miocárdio em risco. ACC/AHA Recommendation format: Class I: Conditions for which there is evidence and/or general agreement that a given procedure or treatment is beneficial, useful and effective. Class II: Conditions for which there is conflicting evidence and/or divergence of opinion about the usefulness/efficacy of a procedure or treatment. Class IIa: Weight of evidence/opinion is in favor of usefulness/efficacy. ACC/AHA Guidelines for the management of AMI: 1999 update; Circulation 1999; 100:

47 Recomendações do ACC/AHA para contra-pulsação com balão intra-aórtico
“Em todas as estratégias de gerenciamento do choque cardiogênico nas quais a contrapulsação é utilizada atualmente, esta terapia atua como um estabilizador ou ponte para facilitar a angiografia diagnóstica e revascularização.” ACC/AHA Guidelines: JACC Vol. 28, No :