Search

Objectives: We sought to assess the effect of clopidogrel on one-year ischemic events in unselected patients with NSTEMI., Methods: We analysed data of consecutive patients with acute NSTEMI treated with aspirin or aspirin plus clopidogrel, who were prospectively enrolled in the ACOS registry., Results: A total of 4290 patients were included, 2171 were treated with aspirin and 2119 with aspirin plus clopidogrel. In the univariate analysis in-hospital (13.7% versus 6.3%, P<0.001) and one-year (28.1% versus 15.6 %, P<0.001) mortality and the combined endpoint of death, non-fatal myocardial infarction and non-fatal stroke was significantly lower in the clopidogrel group. There was a significant increase in in-hospital bleeding complications with clopidogrel (5.4 % versus 3.3 %, P<0.05). In the multivariable propensity score analysis adjusted for baseline variables the odds ratio for the one-year combined endpoint was significantly reduced (odds ratio 0.69, 95% CI: 0.64-0.74) in the aspirin plus clopidogrel group., Conclusion: In clinical practice, early therapy with clopidogrel, in addition, to aspirin in patients with NSTEMI is associated with a significant reduction of the combined endpoint of death, non-fatal reinfarction and non-fatal stroke after one year. This advantage was associated with an increase in major in-hospital bleeding complications.

The prognostic effect of beta-blocker treatment on ST-elevation acute myocardial infarction (STEMI) is controversially discussed in the era of reperfusion therapy. From the German multicenter registry Maximal Individual Therapy of Acute Myocardial Infarction PLUS (MITRA PLUS), 17,809 consecutive patients with STEMI treated with a guideline-recommended therapy with aspirin and an angiotensin-converting enzyme inhibitor were investigated; the prognostic effect of additional acute beta-blocker treatment was analyzed. Patients with cardiogenic shock were excluded. Of included patients, 77.6% received additional acute beta-blocker treatment and 22.4% did not. Patients with beta-blocker treatment were younger and more often received reperfusion therapy. Acute beta-blocker treatment was associated with a lower hospital mortality (univariate analysis 4.9% vs 10.8%, p <0.001; multivariate analysis odds ratio [OR] 0.70, 95% confidence interval [CI] 0.61 to 0.81). Acute beta blockade was significantly associated with a lower hospital mortality in patients without (OR 0.66, 95% CI 0.56 to 0.79) and with (OR 0.76, 95% CI 0.60 to 0.98) reperfusion therapy. The greatest benefit of acute beta-blocker treatment, measured by the number needed to treat to save 1 life, was found in patients with anterior MI, a heart rate > or =80 beats/min, no reperfusion therapy, female gender, and age > or =65 years. In conclusion, acute beta-blocker therapy in the clinical practice of treating patients with STEMI, in addition to aspirin and angiotensin-converting enzyme inhibitor therapy, was independently associated with a significant decrease in hospital mortality in patients with and without reperfusion therapy. High-risk patients with STEMI, such as elderly patients and patients without reperfusion therapy, showed a greater benefit of acute beta-blocker therapy than low-risk patients with STEMI.

Aims: We sought to assess the effect of clopidogrel on clinical events 1 year after discharge in survivors of ST-elevation myocardial infarction (STEMI) in clinical practice., Methods and Results: We analysed data of consecutive survivors of acute STEMI and either concomitant therapy with aspirin or aspirin plus clopidogrel at discharge, who were prospectively enrolled in the Acute Coronary Syndromes (ACOS) registry between July 2000 and November 2002. A total of 5886 (3795 with and 2091 without clopidogrel) patients were included into this analysis. Patients were divided into three groups according to the initial reperfusion therapy: no reperfusion therapy (n=1445), fibrinolysis (n=1734), or primary PCI (n=2707). The multivariable analysis for 12+2 month mortality after discharge using the propenstiy score with adjustment for baseline characteristics and treatments (age, sex, diabetes mellitus, hypertension, prior MI, hyperlipidaemia, renal insufficiency, cardiogenic shock, heart rate, systolic blood pressure, anterior infarct location, reduced left ventricular function, elective revascularization, beta-blockers, statins, ACE-inhibitors) showed that mortality was significantly lower in the aspirin plus clopidogrel group compared with the aspirin group in the total group and patients with reperfusion therapy [total group odds ratio (OR) 0.48, 95% confidence interval (CI) 0.48-0.61; no reperfusion therapy OR 0.96, 95% CI 0.65-1.45; fibrinolysis OR 0.53, 95% CI 0.32-0.87; primary percutaneous coronary intervention OR 0.38, 95% CI 0.23-0.62]., Conclusion: In clinical practice, adjunctive therapy with clopidogrel, in addition to aspirin, in survivors after STEMI is associated with a reduction in 1-year mortality in patients treated with early reperfusion therapy.

Aims: Statins provide effective secondary prevention in cardiovascular disease. However, it remains uncertain how soon statins should be started after an acute coronary syndrome (ACS). Recently published trials suggest starting before discharge. We hypothesize that statins should be initiated without delay., Methods and Results: Data from a large cohort of 10,484 consecutive patients with an ACS were analysed. Of this cohort, 1426 first-time statin receivers and survivors of the first 24 h were compared with 6771 first-day survivors not receiving statin therapy. A propensity score for the likelihood of receiving statin therapy within 24 h was developed and used with other established risk factors in a multivariable analysis. There was a significantly reduced all-cause 7-day mortality in patients receiving early statin therapy [0.4 vs. 2.6%, unadjusted hazard ratio (HR) 0.16, 95% confidence interval (CI) 0.08-0.37, adjusted HR 0.34, 95% CI 0.15-0.79]. Statistical significance was observed in patients presenting with STE-ACS (adjusted HR 0.17, 95% CI 0.04-0.70) and not in NSTE-ACS patients. However, no statistical evidence of heterogeneity in treatment effect was observed between these groups., Conclusion: These data suggest that very early statin therapy is associated with reduced mortality in patients presenting with STE-ACS; however, these findings have to be confirmed by prospective, randomized controlled trials before firm treatment recommendations can be given.

Aims: Age is one of the most powerful determinants of prognosis in myocardial infarction, but there is comparatively little recent data across the whole spectrum of acute coronary syndromes (ACS). We examined the impact of increasing age on clinical presentation and hospital outcome in a large sample of patients with ACS., Methods and Results: Patients (n = 10 253) from the Euroheart ACS survey in 103 hospitals in 25 countries were investigated. There was a significant inverse association between the age and the likelihood of presenting with ST-elevation. For each decade of life, the odds of presenting with ST-elevation decreased by 0.82 [95% confidence interval (CI) 0.79-0.84]; P < 0.0001. Elderly patients were considerably less often treated by cardiologists, less extensively investigated, and, when presenting with ST-elevation ACS, less likely to be treated with reperfusion. Compared with patients <55 years, the odds ratios of hospital mortality were 1.87 (1.21-2.88) at age 55-64, 3.70 (2.51-5.44) at age 65-74, 6.23 (4.25-9.14) at age 75-84, and 14.5 (9.47-22.1) among patients > or =85 years, with no major differences across different types of admission or discharge diagnoses., Conclusion: Elderly ACS patients were less likely to present with ST-elevation but had substantial in-hospital mortality, yet they were markedly less intensively treated and investigated.

Background/aims: A large proportion of patients with a ST-elevation acute coronary syndrome do not receive reperfusion therapy. In order to contribute to a better understanding of the clinical decision making process, we analyzed which factors are associated with the application of reperfusion therapy., Methods: From the Euro Heart Survey of Acute Coronary Syndromes I, 4,260 patients with ST-elevation acute coronary syndrome were selected for the current analysis, of which 1,539 (36%) patients received fibrinolysis and 904 (21%) primary percutaneous coronary intervention (PCI). The analysis contained 32 variables on demographics, medical history, admission parameters and reperfusion therapy., Results: A short pre-hospital delay, arrival in a hospital with PCI facilities, severe ST-elevation, and participation in a clinical trial were the strongest predictors for receiving reperfusion therapy. Primary PCI was more likely to be performed than fibrinolysis in patients with a long pre-hospital delay, arriving in a hospital with PCI facilities, not participating in a clinical trial, and with at least one previous PCI., Conclusion: Hospital facilities and culture, pre-hospital delay and infarction size play a major role in management decisions regarding reperfusion therapy in ST-elevation acute coronary syndrome. This analysis indicates which factors require special attention when implementing and reviewing the reperfusion guidelines., (Copyright 2006 S. Karger AG, Basel.)

Treatment of acute ST elevation myocardial infarction (STEMI) is based on early reperfusion therapy (primary PCI [percutaneous coronary intervention], thrombolysis) and adjunctive medical therapy. Primary PCI is recommended as the therapy of first choice in the German guidelines, if the delay by a transfer to primary PCI versus thrombolysis is

Objective: To investigate the hypothesis that risk factors may be differently related to severity of acute coronary syndromes (ACS), with ST elevation used as a marker of severe ACS., Design: Cross sectional study of patients with ACS., Setting: 103 hospitals in 25 countries in Europe and the Mediterranean basin., Patients: 10,253 patients with a discharge diagnosis of ACS in the Euro heart survey of ACS., Main Outcome Measures: Presenting with ST elevation ACS., Results: Patients with ACS who were smokers had an increased risk to present with ST elevation (age adjusted odds ratio (OR) 1.84, 95% confidence interval (CI) 1.67 to 2.02). Hypertension (OR 0.65, 95% CI 0.60 to 0.70) and high body mass index (BMI) (p for trend 0.0005) were associated with less ST elevation ACS. Diabetes mellitus was also associated with less ST elevation, but only among men. Prior disease (infarction, chronic angina, revascularisation) and treatment with aspirin, beta blockers, or statins before admission were also associated with less ST elevation. After adjustment for age, sex, prior disease, and prior medication, smoking was still significantly associated with increased risk of ST elevation (OR 1.53, 95% CI 1.38 to 1.69), whereas hypertension was associated with reduced risk (OR 0.75, 95% CI 0.69 to 0.82). Obesity (BMI > 30 kg/m2 versus < 25 kg/m2) was independently associated with less risk of presenting with ST elevation among women, but not among men., Conclusion: Among patients with ACS, presenting with ST elevation is strongly associated with smoking, whereas hypertension and high BMI (in women) are associated with less ST elevation, independently of prior disease and medication.

Objective: To determine the predictors of time between presentation and primary angioplasty and the influence of this delay time on in-hospital mortality in clinical practice., Design: Analysis of data from the registry of percutaneous coronary interventions in acute myocardial infarction of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK)., Patients: Data of 4815 patients registered at 80 hospitals between 1994 and 2000 were analysed., Results: Mean age of the patients was 61.4 (12.5) years. Cardiogenic shock was present in 14.1%. Mean time from admission to primary angioplasty ("door to angiography" time) was 83 (122) minutes. Logistic regression analysis showed the presence of a bundle branch block (odds ratio (OR) 1.95, 95% confidence interval (CI) 1.15 to 3.29), prior coronary artery bypass grafting (OR 1.67, 95% CI 1.08 to 2.59), pre-hospital delay > 3 hours (OR 1.61, 95% CI 1.37 to 1.89), and female sex (OR 1.21, 95% CI 1.01 to 1.45) to be independently associated with longer door to angiography times, whereas a higher hospital volume of performing primary angioplasty (OR 0.53, 95% CI 0.46 to 0.62) and the year of the investigation (OR 0.96, 95% CI 0.92 to 1.00) were independently associated with shorter door to angiography times. Independent predictors of in-hospital mortality were cardiogenic shock (41.6% v 4.0% without cardiogenic shock, p < 0.0001), technical success (29.2% with TIMI (thrombolysis in myocardial infarction) flow < 3 v 6.5% with TIMI flow 3, p < 0.0001), age (16.5% > or = 70 years v 6.6% < 70, p < 0.0001), three vessel disease (16.5% v 6.8% with < 3 vessel disease, p < 0.0001), anterior location of infarction (12% v 7.4% without anterior infarction, p < 0.0001), year of inclusion (adjusted OR 0.92 per year, p = 0.011), and volume of primary angioplasty at the hospital (11% for < 20 angioplasty procedures/year v 8.3% for > or = 20/year, p = 0.027) but not the door to angiography time (adjusted OR 1.14 per tertile, p = 0.397)., Conclusions: In current clinical practice in Germany median door to angiography time is quite short (83 (122) minutes). Some patients and hospital factors are independently associated with a longer door to angiography time. Within the observed short in-hospital delays door to angiography time did not influence in-hospital mortality. However, efforts to keep them as short as possible should be continued.

Aims: Systematic registration of data from clinical practice is important for clinical care, local, national and international registries, and audit. Data to be collected for these different purposes should be harmonized. Therefore, during Ireland's Presidency of the European Union (EU) (January to June 2004), the Department of Health and Children worked with the European Society of Cardiology, the Irish Cardiac Society, and the European Commission to develop data standards for clinical cardiology. The Cardiology Audit and Registration Data Standards (CARDS) Project aimed to agree standards for three modules of cardiovascular health information systems: acute coronary syndromes (ACS), percutaneous coronary interventions (PCI), and clinical electrophysiology (pacemakers, implantable cardioverter defibrillators, and ablation procedures)., Methods and Results: Data items from existing registries and surveys were reviewed to derive draft data standards (variables, coding, and definitions). Variables common to the three modules include demographics, risk factors, medication, and discharge and follow-up data. Modules about a procedure contain variables on the lesion, the device, and medication during the procedure. The ACS module includes presenting symptoms, reperfusion and acute treatments, and procedures in hospital and at follow-up., Conclusions: The data standards were discussed and adopted at a conference involving EU member states in Cork, Ireland, in May 2004. After a pilot study, the standards will be disseminated to stakeholders throughout Europe.

Background: A meta-analysis of randomized trials has shown a significant reduction of mortality rate in patients receiving aspirin for secondary prevention after acute myocardial infarction (AMI). However, a significant number of patients do not receive aspirin after AMI. Little is known about why aspirin is withheld or the long-term outcome of these patients today., Methods: The Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) registry is a multicenter registry of patients with AMI in Germany., Results: Of 4902 patients, 509 (10%) did not receive aspirin at the time of discharge from the hospital. The mean follow-up period for these patients was 17 months. Relative contraindications to aspirin were significantly associated with the withholding of aspirin (in-hospital bleeding: odds ratio [OR], 3.56; 95% CI, 1.86-6.80; history of peptic ulcer: OR, 2.49; 95% CI, 1.62-3.83). Absolute contraindications to aspirin were rare (2.2%). Other medications of proven benefit were also given less often in these patients (beta-blockers: 49.0% vs 61.9%, P <.001; angiotensin-converting enzyme inhibitors: 65.6% vs 70.2%, P =.06; statins: 12.2% vs 15.1%, P =.10). Patients who were not given aspirin were at high risk for vascular events. They were more likely to have a history of prior AMI (OR, 1.34; 95% CI, 1.02-1.79), were in critical clinical condition at admission more often (cardiogenic shock: OR, 1.98; 95% CI, 1.09-3.56; overt heart failure: OR, 1.6; 95% CI, 1.05-2.3), and received acute revascularization less often (OR, 1.32; 95% CI, 1.05-1.67). The 1-year mortality was 2-times higher in patients who did not receive aspirin than in patients who did receive aspirin (16.5% vs 8.3%, P <.001). A significant association of withheld aspirin at discharge with a higher long-term mortality rate was confirmed with multivariate analysis (OR, 1.62; 95% CI, 1.15-2.29)., Conclusions: Ten percent of patients who sustained an AMI did not receive aspirin at the time of hospital discharge. Most of these patients were at high risk for cardiovascular events. Withheld aspirin was significantly associated with higher mortality rate during follow up.

Cardiovascular disease (CVD) is the primary cause of death in women, and women with type 2 diabetes mellitus are at greater risk of CVD compared with nondiabetic women. The increment in risk attributable to diabetes is greater in women than in men. The extent to which hyperglycemia contributes to heart disease risk has been examined in observational studies and clinical trials, although most included only men or did not analyze sex differences. The probable adverse influence of hyperglycemia is potentially mediated by impaired endothelial function, and/or by other mechanisms. Beyond high blood glucose level, a number of other common risk factors for CVD, including hypertension, dyslipidemia, and cigarette smoking, are seen in women with diabetes and require special attention. Presentation and diagnosis of CVD may differ between women and men, regardless of the presence of diabetes. Recognizing the potential for atypical presentation of CVD in women and the limitations of common diagnostic tools are important in preventing unnecessary delay in initiating proper treatment. Based on what we know today, treatment of CVD should be at least as aggressive in women-and especially in those with diabetes-as it is in men. Future trials should generate specific data on CVD in women, either by design of female-only studies or by subgroup analysis by sex.

Patients with diabetes are at high risk for the development of coronary artery disease and have a significantly impaired prognosis after ST-elevation myocardial infarction (STEMI) as compared with non-diabetic patients. The beneficial effect of pharmaceutical treatment for secondary prevention after STEMI is proven also for diabetics, but little is known about its use in clinical practice. Between June 1994 and December 2000, consecutive patients with STEMI, admitted to hospital within 24 h of symptoms onset, were enrolled into the multicenter MITRA registry in 61 hospitals in Germany. We examined whether there were differences in the frequencies of pharmaceutical secondary prevention after STEMI and in long-term outcomes between diabetics and nondiabetics in 8206 patients who had been discharged alive and followed for a mean period of 17 months. The prevalence of diabetes in 8206 patients discharged alive after acute STEMI was 18%. Diabetics were older and more often female, and more often already had prior myocardial infarction (MI) and stroke than non-diabetics. As chronic discharge medication, diabetics received aspirin and betablockers less often, but more often ACE inhibitors than non-diabetics. The mortality rate 17 months after STEMI was nearly twice as high in diabetics than in non-diabetics (19.1% vs. 10.4%, p<0.01 at univariate analysis; OR=1.50 and 95% CI 1.27-1.77 at multivariate analysis). The combined endpoint of death, MI and stroke occurred in 25.8% of diabetics, but only in 15.8% of non-diabetics ( p<0.01). Long-term treatment with aspirin, betablockers and ACE inhibitors in diabetics was associated with a significant reduction of mortality. Diabetics received intensive pharmaceutical therapy for secondary prevention significantly less often than non-diabetics, although the beneficial effects of this treatment were similar or even more pronounced as compared with non-diabetics. Diabetes was an independent predictor of increased mortality in follow-up after acute STEMI. Intensifying secondary prevention by a more frequent use of established pharmaceutical regimes might improve the prognosis of diabetics after STEMI and prevent cardiovascular and cerebrovascular events.

Background: Diabetic patients with acute myocardial infarction (AMI) may have diminished pain or a higher frequency of asymptomatic infarctions. This appears to be a common clinical perception., Methods: Data from two registries of AMI patients presenting in hospital (MITRA PLUS with 18786 patients; North German Registry, NGR, 1042 patients with detailed symptom interviews) were analyzed concerning symptoms of acute myocardial infarction in patients with diabetes mellitus (DM) and without diabetes (non-DM)., Results: DM patients were significantly older and more often female than non-DM. There were no differences in the frequency of pre-infarction angina between DM and non-DM (Mitra Plus). In NGR, severe angina during AMI occurred in 49.8% of DM and 46.3% of non-DM (n. s.). No chest pain was reported in 16.9% of DM and 15.0% of non-DM (n. s.). Extra-thoracic pain, dizziness, nausea, sweating, palpitations, radiation of angina and localization of radiating pain was not different between DM and non-DM patients. Severe dyspnea occurred in 29.5% of DM and 19.5% of non-DM patients (p = 0.003)., Conclusions: Apart from a higher frequency of severe dyspnea in diabetics, there appears to be no difference in the clinical symptoms of AMI patients with and without diabetes mellitus. AMI with little or no angina was also frequently found in non-diabetics. In the hospital, diabetics with suspected AMI do not appear to need a special judgement of symptoms. This could accelerate access of diabetics to standard therapeutic procedures.

Objective: Randomized controlled trials (RCTs) showed that the glycoprotein (GP) IIb/IIIa antagonist abciximab is able to reduce ischemic complications during percutaneous transluminal coronary interventions (PCIs). Its effectiveness in daily clinical practice in unselected patients remains to be determined., Design, Setting and Patients: From 7/1997 until 12/2000, 3310 PCIs were performed at the Heart Center Ludwigshafen. Out of them, 1076 (32.5%) patients were nonrandomly treated with a GP IIb/ IIa antagonist. Patients who were treated with abciximab were matched with patients not treated with abciximab. The matching procedure resulted in 590 pairs of patients., Results: Patients treated with abciximab were more likely to have a history of former PCI (13.7% versus 8.8%, p=0.008) or coronary artery bypass surgery (19.2% versus 12.8%, p=0.003). There were no differences in concomitant diseases, left ventricular function, number of vessels diseased or target vessel. However, patients treated with abciximab had a higher rate of more complex stenosis (> or =B2; 94.4% versus 80.7%, p<0.001) and a longer x-ray exposition (median 486 s versus 422 s, p<0.001). Treatment with abciximab was associated with a significantly lower incidence of the combined endpoint of death, reinfarction or stroke during the hospital stay (2.4% versus 4.4%, p=0.039). This was confirmed after adjustment for confounding parameters (p=0.034). There was no increase in the rate of severe bleeding in the abciximab group (p=0.347). After one year the rates for the combined endpoint were 8.5% in the control group and 6.2% in the abciximab group (univariate analysis, p=0.134; multivariate analysis, p=0.143)., Conclusion: Treatment with abciximab during PCI in daily clinical practice at a high volume center in patients with a high rate of acute coronary syndromes seems to be as effective as shown in RCTs.

We examined the impact of treatment with ramipril versus other angiotensin-converting enzyme (ACE) inhibitors on clinical outcome in unselected patients of the prospective multicenter registry Maximal Individual Therapy of Acute Myocardial Infarction PLUS registry (MITRA PLUS). Of 14,608 consecutive patients with ST-elevation acute myocardial infarction, 4.7% received acute therapy with ramipril, 39.0% received other ACE inhibitor therapy, and 56.3% received no ACE inhibitor therapy. In a multivariate analysis, the treatment with ramipril compared with the treatment without ACE inhibitors was associated with a significantly lower hospital mortality and a lower rate of nonfatal major adverse coronary and cerebrovascular events. Compared with other generic ACE inhibitors, ramipril therapy was independently associated with a significantly lower hospital mortality (odds ratio [OR] 0.54, 95% confidence interval [CI] 0.32 to 0.90) and a lower rate of nonfatal major adverse coronary and cerebrovascular events (OR 0.65, 95% CI 0.46 to 0.93), but not with a lower rate of heart failure at discharge (OR 0.79, 95% CI 0.50 to 1.27).

Aims: To better delineate the characteristics, treatments, and outcomes of patients with acute coronary syndromes (ACS) in representative countries across Europe and the Mediterranean basin, and to examine adherence to current guidelines., Methods and Results: We performed a prospective survey (103 hospitals, 25 countries) of 10484 patients with a discharge diagnosis of acute coronary syndromes. The initial diagnosis was ST elevation ACS in 42.3%, non-ST elevation ACS in 51.2%, and undetermined electrocardiogram ACS in 6.5%. The discharge diagnosis was Q wave myocardial infarction in 32.8%, non-Q wave myocardial infarction in 25.3%, and unstable angina in 41.9%. The use of aspirin, beta-blockers, angiotensin converting enzyme inhibitors, and heparins for patients with ST elevation ACS were 93.0%, 77.8%, 62.1%, and 86.8%, respectively, with corresponding rates of 88.5%, 76.6%, 55.8%, and 83.9% for non-ST elevation ACS patients. Coronary angiography, percutaneous coronary interventions, and coronary bypass surgery were performed in 56.3%, 40.4%, and 3.4% of ST elevation ACS patients, respectively, with corresponding rates of 52.0%, 25.4%, and 5.4% for non-ST elevation ACS patients. Among patients with ST elevation ACS, 55.8% received reperfusion treatment; 35.1% fibrinolytic therapy and 20.7% primary percutaneous coronary interventions. The in-hospital mortality of patients with ST elevation ACS was 7.0%, for non-ST elevation ACS 2.4%, and for undetermined electrocardiogram ACS 11.8%. At 30 days, mortality was 8.4%, 3.5%, and 13.3%, respectively., Conclusions: This survey demonstrates the discordance between existing guidelines for ACS and current practice across a broad region in Europe and the Mediterranean basin and more extensively reflects the outcomes of ACS in real practice in this region.

There is conflicting information about gender differences in presentation, treatment, and outcome after acute ST elevation myocardial infarction (STEMI) in the era of thrombolytic therapy and primary percutaneous coronary intervention. From June 1994 to January 1997, we enrolled 6,067 consecutive patients with STEMI admitted to 54 hospitals in southwest Germany in the Maximal Individual TheRapy of Acute myocardial infarction (MITRA), a community-based registry. Women were 9 years older than men, more often had hypertension, diabetes mellitus, and congestive heart failure, and had a history of previous myocardial infarction less often. Women had a longer prehospital delay (45 minutes), had anterior wall infarction more often (odds ratio [OR] 1.21; 95% confidence interval [CI] 1.08 to 1.36), and received reperfusion therapy less often (OR 0.83; 95% CI 0.74 to 0.94). The percentage of patients who were eligible for thrombolysis and received no reperfusion was higher in women (OR 1.7; 95% CI 1.56 to 1.89). Women had recurrent angina (OR 1.45; 95% CI 1.23 to 1.71) and congestive heart failure (OR 1.26; 95% CI 1.01 to 1.56) more often. There was a trend toward a higher hospital mortality in women (age-adjusted OR 1.16, 95% CI 0.99 to 1.35; multivariate OR 1.21, 95% CI 0.96 to 1.51), but there was no gender difference in long-term mortality after multivariate analysis (age-adjusted OR 0.95, 95% CI 0.78 to 1.15; multivariate OR 0.93, 95% CI 0.72 to 1.19). Thus, women with STEMI receive reperfusion therapy less often than men. They experience recurrent angina and congestive heart failure more often during their hospital stay. The age-adjusted long-term mortality is not different between men and women, but there is a trend for a higher short-term mortality in women.

Objective Among other adjunctive medication, heparin is widely used in the therapy of acute myocardial infarction (AMI) today. Large randomized trials, however, have shown inconclusive data on the benefit of adjunctive heparin therapy for patients with AMI. The aim of this study was to describe the use of heparin and complication rates in routine clinical practice today. Methods MITRA and MIR were multicenter registries of AMI patients in Germany. During the years 1994 to 1998, 22697 patients were registered with MITRA and MIR. Of these patients 49.9% received reperfusion therapy. Results 21004 patients (92%) received heparin during acute therapy of AMI. The following factors were associated with withholding heparin: Bleeding at admission (OR 4.7; CI 3.2-6.8), cardiogenic shock (OR 1.8; CI 1.4-2.3) and fibrinolytic therapy with streptokinase (OR 2.1; CI 1.8-2.3). Complication rates of patients with heparin were only slightly higher than among those without heparin: 1.7% strokes and 1.9% bleedings were reported among the patients with fibrinolysis and heparin compared to 1.3% strokes and 1.4% bleedings among patients without heparin (p=ns). Mortality rates were 14.1% for patients with and 27.3% for patients without heparin (p<0.001). Conclusions Of the patients in MITRA and MIR 92% received heparin during AMI. Patients with active bleeding or in critical condition received heparin significantly less often. The selection of critically ill patients may have contributed to the high mortality of patients without heparin for AMI. Bleeding complication rates of patients with adjunctive heparin were only sightly higher than reported in randomized trials.

Objective: Among other adjunctive medication, heparin is widely used in the therapy of acute myocardial infarction (AMI) today. Large randomized trials, however, have shown inconclusive data on the benefit of adjunctive heparin therapy for patients with AMI. The aim of this study was to describe the use of heparin and complication rates in routine clinical practice today., Methods: MITRA and MIR were multicenter registries of AMI patients in Germany. During the years 1994 to 1998, 22,697 patients were registered with MITRA and MIR. Of these patients 49.9% received reperfusion therapy., Results: 21,004 patients (92%) received heparin during acute therapy of AMI. The following factors were associated with withholding heparin: Bleeding at admission (OR 4.7; CI 3.2-6.8), cardiogenic shock (OR 1.8; CI 1.4-2.3) and fibrinolytic therapy with streptokinase (OR 2.1; CI 1.8-2.3). Complication rates of patients with heparin were only slightly higher than among those without heparin: 1.7% strokes and 1.9% bleedings were reported among the patients with fibrinolysis and heparin compared to 1.3% strokes and 1.4% bleedings among patients without heparin (p = ns). Mortality rates were 14.1% for patients with and 27.3% for patients without heparin (p < 0.001)., Conclusions: Of the patients in MITRA and MIR 92% received heparin during AMI. Patients with active bleeding or in critical condition received heparin significantly less often. The selection of critically ill patients may have contributed to the high mortality of patients without heparin for AMI. Bleeding complication rates of patients with adjunctive heparin were only slightly higher than reported in randomized trials.

The pooled data of two German AMI registries: the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study and the Myocardial Infarction Registry (MIR) were analysed in order to 1) describe current clinical practice of primary angioplasty in Germany, 2) compare the results of primary angioplasty with those of thrombolysis in the "real world" and 3) define subgroups of patients profiting probably most from primary angioplasty. Between 1994 and 1998, 20,306 AMI patients were included in the registries. At the 271 participating hospitals angioplasty facilities were available at 18.5%. Thrombolysis was still the most frequently used reperfusion therapy at hospitals without (96%) as well as hospitals with such facilities (55%). Transfer of AMI patients for angiography was performed in 3.6% of AMI patients admitted to hospitals without angioplasty facilities. A total of 9906 lytic eligible AMI patients with a pre-hospital delay of no more than 12 hours were treated with either primary angioplasty (n = 1327) or thrombolysis (n = 8579). Univariate analysis of hospital mortality showed a more favourable course for patients treated with primary angioplasty: 6.4% versus 11.3%, OR = 0.54, 95% CI: 0.43-0.67, p < 0.0001. This was confirmed by logistic regression analysis: multivariate OR = 0.58, 95% CI: 0.44-0.77, p < 0.0001. Primary angioplasty was associated with a lower mortality in all subgroups analysed. There was a significant correlation between mortality and the absolute risk reduction (r = 0.82, p < 0.0001) in the different subgroups, which showed an increasing absolute benefit of primary angioplasty compared to thrombolysis with increasing mortality risk.

Long-term follow-up after treatment with primary angioplasty compared to treatment with thrombolysis in patients with acute myocardial infarction (AMI) remains still to be determined. We therefore analyzed the data of the "Maximal Individual Therapy" in Acute Myocardial Infarction (MITRA-1) Registry. Follow-up data for a median of 17 months after discharge were available in 2090 out of 2195 (95%) AMI patients treated with thrombolysis, as well as 293 out of 312 patients (94%) treated with primary angioplasty. There were only small differences in patient characteristics between the two treatment groups. Compared to patients treated with thrombolysis, those treated with primary angioplasty had a higher prevalence of prior myocardial infarction (16.4% versus 12.2%, p = 0.04), longer prehospital delay: 10 minutes (130 minutes versus 120 minutes, p = 0.002), and a longer door-to-treatment time: 45 minutes (p < 0.001). Primary angioplasty patients were more likely to be treated with beta-blockers (primary angioplasty 79.8% versus thrombolysis 66.2%, p < 0.001) or statins (24.5% versus 16.5%, p < 0.001). There was no difference between the treatment groups for total mortality (p = 0.90) nor for the combined endpoint of death or re-infarction (p = 0.85). However, the combined endpoint of death, re-infarction or percutaneous coronary intervention or coronary bypass surgery was significantly lower in the primary angioplasty group (primary angioplasty 25.6% versus thrombolysis 32.3%, univariate odds ratio 0.72, 95% CI: 0.55-0.95, p = 0.02). This result was confirmed by multivariate analysis after adjusting for confounding parameters (multivariate odds ratio: 0.62, 95% CI: 0.42-0.91). The beneficial effect of primary angioplasty compared to thrombolysis achieved during the hospital stay after an AMI is maintained during a 17 month follow-up. AMI patients treated with thrombolysis were more likely to be treated with either percutaneous coronary intervention or coronary bypass surgery after discharge.

Aims: The specialty of the admitting physician may influence treatment and outcome in patients with acute myocardial infarction., Methods and Results: The pooled data of three German acute myocardial infarction registries: the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) 1+2 studies and the Myocardial Infarction Registry (MIR) were analysed. Patients admitted to hospitals with departments of cardiology were compared to hospitals without such departments. A total of 24 814 acute myocardial infarction patients were included, 9020 (36%) patients at 91 (29.8%) hospitals with departments of cardiology and 15 794 (64%) at 214 (70.2%) hospitals without cardiology departments. There were only minor differences in patient characteristics and prevalence of concomitant diseases between the two types of hospital. The first electrocardiogram was more often diagnostic at hospitals with cardiology departments (71.8% vs 66.5%, P<0.001). Reperfusion therapy and adjunctive medical therapy, such as aspirin, beta-blockers and ACE-inhibitors were used more often at cardiology departments (all P -values <0.001), even after adjustment for confounding parameters. Treatment improved at both types of hospital over time. Admission to a hospital with a department of cardiology was independently associated with a lower hospital mortality (14.2% vs 15.4%, adjusted OR=0.91; 95%CI: 0.83-0.99). Additional logistic regression models showed that the higher use of reperfusion therapy and recommended concomitant medical therapy was responsible for most of the survival benefit at such hospitals., Conclusion: Treatment of acute myocardial infarction patients at hospitals with departments of cardiology was independently associated with a higher use of recommended therapy and a lower hospital mortality compared to hospitals without such departments., (Copyright 2001 The European Society of Cardiology.)

Background: In patients with acute myocardial infarction treated with thrombolysis, longer times to treatment are associated with increasingly worse clinical outcome. This relation may be different for treatment with primary angioplasty., Methods: We analyzed the pooled data of the German acute myocardial infarction registries Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) and Myocardial Infarction Registry (MIR) to determine the influence of prehospital delays on hospital mortality rates. Primary angioplasty was performed in 1063 patients and thrombolysis in 7552 patients., Results: In patients treated with thrombolysis, in-hospital time to treatment was constantly 30 minutes median. In patients treated with primary angioplasty, in-hospital time to treatment increased from 60 minutes median up to 87 minutes median with increasing prehospital delay. Hospital mortality rates slightly decreased with increasing prehospital delays in patients treated with primary angioplasty (P for trend =.02). However, in patients treated with thrombolysis, mortality rate was nonsignificantly increased (P for trend =.11). Logistic regression analysis showed no significant difference in mortality rates between primary angioplasty and thrombolysis for prehospital delays of <3 hours. However, when prehospital delay was >3 hours, thrombolysis was independently associated with a higher mortality rate compared with primary angioplasty., Conclusions: Compared with thrombolysis, primary angioplasty is independently associated with a lower mortality rate in prehospital delays of >3 hours. The reason for this may be a time-dependent loss of efficacy to achieve reperfusion for thrombolysis but not for primary angioplasty.

We investigated the use of statins in clinical practice in patients with acute myocardial infarction in Germany in 17,732 consecutively included patients of the registries MIR-1 and MITRA-1. A clinical follow-up has been performed in the MITRA-1 study after a mean period of 18 months. In total 30% of all patients with acute myocardial infarction received statins at discharge. From 1994 to 1998 the use of statins increased from 6% to 44%; however in 1998 still less than half of the patients with acute myocardial infarction received statins at discharge. In a logistic regression model, concomittant diseases as renal failure (OR 0.7), heart failure (OR 0.7) and diabetes mellitus (OR 0.9) were associated with a lower use of statins. Age > 70 years (OR 0.5) was also associated with a lower use of statins at hospital discharge. Patients with statins at discharge had a lower long-term mortality of 5.8% versus 12.9% in patients without statins. After adjustment to age and comorbidity, use of statins at discharge was associated with a borderline significant reduction of long-term mortality (multivariate OR 0.7, 95% CI 0.4-1.0). In a subgroup analysis of therapeutic benefit, measured by the "number needed to treat" (NNT), the number of patients to treat with statins to save one life, patients with cardiovascular risk factors, as heart failure (NNT 7.5), diabetes mellitus (NNT 7.8) and age > 70 years (NNT 13.8) had a larger therapeutic benefit as patients without these risk factors (NNT 345). However, these high-risk patients received less often statins than patients without risk factors (use of statins 11.8% versus 19.8%).

Objectives: We sought to determine the effectiveness of primary angioplasty compared with thrombolysis in clinical practice., Background: In clinical practice, primary angioplasty for the treatment of acute myocardial infarction (AMI) has not yet been proven more effective than intravenous thrombolysis, nor have subgroups of patients been identified who would perhaps benefit from primary angioplasty., Methods: The pooled data of two AMI registries--the Maximal Individual TheRapy in Acute myocardial infarction (MITRA) study and the Myocardial Infarction Registry (MIR)--were analyzed. A total of 9,906 lytic-eligible patients with AMI, with a pre-hospital delay of < or =12 h, were treated with either primary angioplasty (n = 1,327) or thrombolysis (n = 8,579)., Results: Despite differences in the patients' characteristics and concomitant diseases between the two groups, the prevalence of adverse risk factors was balanced. Univariate analysis of hospital mortality showed a more favorable course for patients treated with primary angioplasty: 6.4% versus 11.3% (odds ratio [OR] 0.54, 95% confidence interval [CI] 0.43 to 0.67). This was confirmed by logistic regression analysis (multivariate OR 0.58, 95% CI 0.44 to 0.77). Primary angioplasty was associated with a lower mortality in all subgroups analyzed. We observed a significant correlation between mortality and absolute risk reduction (r = 0.82, p < 0.0001) in the different subgroups: as mortality increased, there was an increase in absolute benefit of primary angioplasty compared with thrombolysis., Conclusions: These large registry data showed the effect of primary angioplasty to be more favorable than thrombolysis for the treatment of patients with AMI in clinical practice. This effect was not restricted to special subgroups of patients. As mortality increased, the absolute benefit of primary angioplasty also increased.

Objective: In patients with acute myocardial infarction (AMI), treatment with thrombolysis is superior to no reperfusion therapy only up to 12 hours after the onset of symptoms. There are no data addressing whether this time limit is also justified for treatment with primary angioplasty., Design: The pooled data of two German ST-segment elevation AMI registries, the Maximal Individual Therapy in Acute Myocardial Infarction (MITRA) study and the Myocardial Infarction Registry (MIR), were analyzed., Patients: Out of 22,749 patients, eight hundred and forty-eight with a pre-hospital delay of > 12 hours and < or = 24 hours were treated with either primary angioplasty (94/848; 11.1%) or no reperfusion therapy (754/848; 88.9%)., Results: Patients treated with primary angioplasty were 10 years younger (59 years versus 69 years; p = 0.001), more often male [72.3% versus 59.9%; odds ratio (OR) = 0.57; 95% confidence interval (CI) = 0.36-0.92] and less likely to be diabetics (17% versus 27.2%; OR = 0.55; 95% CI = 0.31-0.97). Hospital mortality was 8.5% in patients treated with primary angioplasty compared to 17.1% in patients with no reperfusion therapy (OR = 0.45; 95% CI = 0.21-0.95; p = 0.033) and the combined endpoint (death, reinfarction or stroke) occurred significantly less often (11.7% versus 20.3%; OR = 0.52; 95% CI =0.27-1; p = 0.045). However, multiple logistic regression showed only a non-significant trend for lower mortality (OR = 0.54; 95% CI =0.20-1.23) and the combined endpoint (OR = 0.65; 95% CI = 0.29-1.31) in patients treated with primary angioplasty., Conclusions: These data show the possibility of a benefit of primary angioplasty over conservative treatment in patients with pre-hospital delays of > 12 up to 24 hours, although multiple logistic regression analysis failed to find significant differences between treatments. This might be due to inadequate study power or a selection bias. These findings encourage further investigation of this subject.

The Ludwigshafen myocardial infarction project has demonstrated, that an intense public media campaign can reduce prehospital delays in acute myocardial infarction. With an additional intrahospital improvement, this can lead to a better and more frequent use of recanalization (thrombolysis or percutaneous transluminal coronary angioplasty [PTCA]). Several large multicentric registries (60 minutes myocardial infarction project, MIR, MITRA) with a total of about 40,000 patients at over 300 hospitals in Germany showed, that intrahospital improvement of infarction therapy can also be achieved in other hospitals. Voluntary participation in an infarction registry leads to quality control and improvement. Two factors are especially important: (1) documentation of every infarction patient, and (2) documentation of the reasons why therapy was given or withheld in every single patient. The improvement in early therapy is associated with a 20% reduction of hospital mortality (MITRA-1). The media campaign in Ludwigshafen to reduce pre-hospital patient delay, however, could not yet be carried out in other areas effectively and intensely enough.

In this analysis of ischemic and hemorrhagic strokes after acute myocardial infarction (AMI) in 21,330 consecutively included patients with AMI, we found an incidence of stroke after AMI of 1.2% and a very poor prognosis. Previous stroke, atrial fibrillation, and older age were the strongest predictors of stroke after AMI; thrombolysis was a borderline risk factor and early therapy with aspirin was associated with a reduction in stroke after AMI.

Background: Clinical trials have shown the efficacy of aspirin for acute myocardial infarction (AMI). However, not all patients receive aspirin for AMI. The aim of this study was to provide information on characteristics and clinical course of patients not treated with aspirin for AMI., Methods: We analyzed the data of the Myocardial Infarction Registry (MIR) and the Maximal Individual Therapy of Acute Myocardial Infarction (MITRA) registry. MITRA and MIR were prospective multicenter registries of patients with ST segment elevation myocardial infarction in Germany., Results: Of 22,572 patients registered from 1994 to 1998, 1767 (7.8%) did not receive aspirin within the first 48 hours after admission. Multivariate analysis revealed two main factors associated with withholding aspirin for AMI: relative contraindications to aspirin (gastric ulcer [odds ratio (OR) 4.9, 95% confidence interval (CI) 3.7-5.7], renal insufficiency [OR 1.4, 95% CI 1.1-1.8]), and critical clinical state at admission (cardiogenic shock [OR 1.5, 95% CI 1.2-2.1] and prehospital resuscitation [OR 1.8, 95% CI 1.4-2.2]). In addition, these patients were significantly less likely to receive reperfusion therapy and adjunctive medical therapy such as beta-blockers and angiotensin-converting enzyme inhibitors. In-hospital mortality after adjustment for baseline characteristics was 27.2% in patients without aspirin compared with 11.1% in patients treated with aspirin., Conclusions: Only a minority of AMI patients (7.8%) did not receive aspirin. Relative contraindications to aspirin and a critical clinical state at admission were the main factors associated with withholding aspirin for AMI. Even after adjustment for patient characteristics, the mortality of patients without aspirin was almost three times higher.

Preinfarction angina is associated with better clinical outcome in patients with acute myocardial infarction (AMI) who receive intravenous thrombolysis. This has not been proved in patients with AMI treated with primary angioplasty. We analyzed the data of the prospective multicenter Myocardial Infarction Registry (MIR). Of 14,440 patients with AMI, 774 with a prehospital delay of < or =12 hours were treated with primary angioplasty. Five hundred thirty-two patients (68.7%) had preinfarction angina. Patients with preinfarction angina were slightly older than patients without (63 vs 62 years, p = 0.042), prehospital delay was 1 hour longer (180 vs 120 minutes, p = 0.001), and arterial hypertension was more prevalent (47.6% vs 32.2%, odds ratio [OR] 1.91, 95% confidence intervals [CI] 1.39 to 2.62). There was no significant difference in hospital mortality (5.6% vs 3.3%, OR 1.75, 95% CI 0.79 to 3.87), reinfarction, stroke, or the combined end point of death, reinfarction, or stroke between the 2 groups. Logistic regression analysis showed no association of preinfarction angina with the occurrence of either death (OR 2.21, 95% CI 0.91 to 6.08) or the combined end points (OR 1.10, 95% CI 0.55 to 2.31). There was also no significant difference in mortality (6% vs 5.1%, OR 1.19, 95% CI 0.56 to 2.52), reinfarction, stroke, postinfarction angina, or the combined end points between patients with preinfarction angina within 48 hours compared with patients with preinfarction angina between 49 hours and 4 weeks before the AMI. Thus, the MIR data showed no protective effects of preinfarction angina in patients with AMI treated with primary angioplasty.

Objectives: We investigated changes in the clinical outcome of primary angioplasty and thrombolysis for the treatment of acute myocardial infarction (AMI) from 1994 to 1998., Background: Primary angioplasty for the treatment of AMI is a sophisticated technical procedure that requires experienced personnel and optimized hospital logistics. Growing experience with primary angioplasty in clinical routine and new adjunctive therapies may have improved the outcome over the years., Methods: The pooled data of two German AMI registries: the Maximal Individual Therapy in AMI (MITRA) study and the Myocardial Infarction Registry (MIR) were analyzed., Results: Of 10,118 lytic eligible patients with AMI, 1,385 (13.7%) were treated with primary angioplasty, and 8,733 (86.3%) received intravenous thrombolysis. Patients characteristics were quite balanced between the two treatment groups, but there was a higher proportion of patients with a prehospital delay of >6 h in those treated with primary angioplasty. The proportion of an in-hospital delay of more than 90 min significantly decreased in patients treated with primary angioplasty over the years (p for trend = 0.015, multivariate odds ratio [OR] for each year of the observation period = 0.84, 95% confidence interval [CI]: 0.73-0.96) but did not change significantly in patients treated with thrombolysis. Hospital mortality decreased significantly in the primary angioplasty group (p = 0.003 for trend; multivariate OR for each year = 0.73, 95% CI: 0.58-0.93). However, for patients treated with thrombolysis, hospital mortality did not change significantly (p for trend 0.175, multivariate OR for each year: 1.02, 95% CI: 0.94- 1.11)., Conclusions: Compared with thrombolysis the clinical results of primary angioplasty for the treatment of AMI improved from 1994 to 1998. This indicates a beneficial effect of the growing experience and optimized hospital logistics of this technique over the years.

In patients with acute myocardial infarction (AMI) admitted at hospitals without angioplasty facilities there are some subgroups of patients which seem to profit from a transfer to primary or acute angioplasty. However, current clinical practice at such hospitals is unknown. We analyzed the pooled data of the German acute myocardial infarction registries MITRA and the MIR. Angioplasty was not available at 221/271 hospitals (81.5%). Out of 14,487 patients with acute myocardial infarction admitted to these hospitals, 50.1% (7,259/14,487) received thrombolysis at the initial hospital and 3.6% (523/14,487) were transferred. Out of the transferred patients, 55.3% (289/523) were treated with primary angioplasty and 44.7% (234/523) received a combination of thrombolysis and angioplasty. The proportion of transferred patients increased from 1.1% in 1994 to 5.5% in 1998 (p for trend = 0.001). One hundred and four hospitals (47.1%) never transferred patients. Patients transferred for primary angioplasty (289 patients) were compared to patients treated with thrombolysis at the initial hospitals (7,259 patients). Multivariate analysis showed the following independent predictors for transfer of patients for primary angioplasty: contraindications for thrombolysis (OR = 17.9), a non-diagnostic first ECG (OR = 4.0), pre-hospital delay > 6 hours (OR = 2.5), unknown symptom onset of the acute myocardial infarction (OR = 2.0) and anterior wall acute myocardial infarction (OR = 1.6). Heart failure at admission was the only independent predictor not to transfer patients (OR = 0.40). In Germany only 47.1% of hospitals without angioplasty facilities transfer patients with acute myocardial infarction to primary or acute angioplasty. The proportion of transferred patients increased from 1.1% in 1994 to 5.5% in 1998. Contraindications for thrombolysis were the strongest predictor to transfer patients to primary angioplasty.

Background: Prognostic data on heart failure rely on epidemiological studies or large clinical trials. These data are not to transfer easily on everyday practice., Objective: To assess the prognosis of left ventricular dysfunction under the therapeutic conditions of the 1990s., Setting: Nonuniversity tertiary care hospital., Patients and Methods: Since January 1995 consecutive and complete registry of all inpatients presenting with a left ventricular dysfunction (EF < 45%). No exclusion criteria., Results: n = 512, mean age 64 years, 77% male, mean NYHA class 2.5, left ventricular EF 31%., Etiology: 58% coronary heart disease, 28% dilated cardiomyopathy. Medical treatment consisting of 91% ACE inhibitors, ACE inhibitor dosage 52% of the recommended dose, 42% beta-blockers, 70% diuretics, and 63% digitalis. Follow-up completeness 95.5%. One-year mortality 64/489 patients (13.9%). Determinants of mortality: NYHA III/IV, EF < 30%, malignant disease, age > 75 years., Conclusion: In spite of the aforementioned medical treatment and a proportion of 14.8% implanted defibrillators in 1998, the one-year mortality of ventricular dysfunction is as high as 13.9%. In everyday practice the prognostic effect of ACE inhibition and beta-blockade is not completely utilized.

Cardiopulmonary exercise testing (CPX) allows a non-invasive control of the cardiopulmonary exercise capacity. In this study, we wanted to investigate if the CPX can be securely, practicably, and accurately performed in patients with invasively documented coronary heart disease (CHD). Furthermore, we wanted to find out the clinical value of CPX in CHD diagnosis. The CPX measurements (symptom-limited; ramp program with 20 Watts increase/min; semi-supine position; continuous registration of the cardio-circulatory parameters (HR, RR, ECG), of the gas exchange parameters (O2, CO2) and of the ventilation) in 101 patients have shown that CPX is secure, accurate, and practicable. The day-to-day reproducibility is high (r > 0.8). The respiratory anaerobic threshold can be manually evaluated by means of the PET O2 criterion in 95% of the cases. The CCS-classification of angina pectoris could not accurately describe the cardiopulmonary exercise capacity as compared to the Weber-classification. The disadvantage of the Weber-classification is that it does not respect the age-, sex- and weight-dependent differences of the normal values. Our own data and results from the literature demonstrate that the anaerobic threshold, the maximum VO2 and the maximum O2-pulse are the more reduced the more coronary arteries are involved, the more reduced the left ventricular function is. But, nevertheless, the range of values shows large overlaps so that an exact differentiation, based upon these parameters, is not possible. Patients with similar functional results or degree of reduced exercise capacity have different morphological alterations. Most patients demonstrated typical ischemic cascade with anaerobic threshold, ST-segment alterations, angina pectoris and, finally, reduced max. VO2. In conclusion, CPX does not replace the traditional methods of non-invasive and invasive ischemia detection, but enables secure, practicable, and accurate measurements of the individual cardiopulmonary exercise capacity and the interaction between muscles, heart, circulation, and lungs. Possibly, CPX can be used in the near future for identifying CHD patients with low, medium or high risk.

In this study we wanted to investigate if noninvasive cardiopulmonary exercise testing can be securely, accurately applied in patients with acquired cardiac valve disease pre- and postoperatively with any convenience. Furthermore, we looked if the cardiopulmonary exercise capacity (anaerobic threshold, etc.) was improved postoperatively (3 and 6 months) in 15 patients suffering from severe mitral valve disease as compared to the preoperative condition. The symptom-limited cardiopulmonary exercise testing was performed on a bike in a semi-supine position using a ramp program (+20 W/min). The following parameters were continuously monitored, and the breath-by-breath gas exchange values documented: cardiocirculatory parameters (heart rate; blood pressure; surface ECG; exercise capacity in Watts); gas-exchange parameters (O2-uptake VO2; CO2-production VCO2; respiratory anaerobic threshold VO2 AT; gas-exchange ratio VCO2/VO2; O2-pulse VO2/HR; aerobic capacity delta VO2/delta WR) and ventilatory parameters (respiratory rate; tidal volume Vt; minute ventilation VE; equivalent for O2: VE/VO2 and CO2: VE/VCO2). The 155 cardio-pulmonary exercise tests in 115 patients were practicable, safe (no emergency case) and accurate. In 100 patients late postoperatively (68.3 +/- 53.0 -102.9 +/- 41.2 months) after aortic or mitral valve replacement or both without signs of significant hemolysis or prosthetic valve dysfunction the NYHA classification was too imprecise to characterize the actual exercise capacity of the patients (e.g., NYHA class II: Weber class B to E). Patients with aortic valve prosthesis had a significantly better anaerobic threshold (57.4 +/- 19.1% pred. value max. VO2) as compared to those with mitral valve replacement (mean: 35.9% pred. value max. VO2).(ABSTRACT TRUNCATED AT 250 WORDS)

We analyzed 128 cardiopulmonary exercise tests (CPX), performed in normal subjects (n = 31), in patients with coronary artery disease (n = 41), with chronic heart failure before (n = 14) and after (n = 14) application of oral PDE-inhibitors and in patients with HIV-infection on a bicycle-ergometer in semi-supine position using a ramp-program (dependent on study-population with 15, 20 or 35 Watt/min increases) with respect to the ability to determine the respiratory anaerobic threshold non-invasively, using the main criteria described by Wasserman et al.: the V-slope-method according to Beaver, the increase of the ventilatory equivalent for O2 (VE/VO2), the increase of the end-tidal PO2 (PETO2) and the increase of the respiratory quotient (RQ) during exercise. In the different study-populations we calculated the detection rates of the AT for each criteria separately. The typical changes in the end-tidal PO2 (124/128 = 96.9%) and the V-slope-method (119/128 = 92.9%) were the most reliable parameters to detect the anaerobic threshold. The characteristic changes of the ventilatory equivalent for O2 (VE/VO2) and of the respiratory quotient (RQ) we found in 100/128 (= 78.1%) and in 107/128 (= 83.6%) of the tests respectively. 86/128 tests (67.2%) showed typical changes in all four mentioned criteria. In another 24/128 tests (19.8%) three of four criteria were fulfilled. Therefore, our investigations showed that in 110/128 cases (85.9%) the AT could be determined by typical changes by means of at least three of the four described parameters. In 15/128 (11.7%) tests only two of four criteria were fulfilled.(ABSTRACT TRUNCATED AT 250 WORDS)

The cardiopulmonary exercise testing (CPX) is a non-invasive method for the evaluation of the cardiopulmonary exercise capacity. Based upon the recent technical progress in gas analysers and personal computers today it is possible to perform CPX with acceptable time consumption, high practicability and high reproducibility of the results in many clinical areas. CPX is realized on a bike or on a treadmill. In bicycle CPX a ramp program (increase of x watts per minute) or a constant workload test (p.e. with 75% of the watts at anaerobic threshold) are performed. Furthermore, an estimation of the cardiac output using CO2-rebreathing method can be realized during a ramp program or a constant workload test. In this paper, also the CPX parameters of the ramp program, the constant workload test and the CO2-rebreathing method are defined and explained. The normal values of CPX are dependent of age, sex, body weight and exercise program. This should be kept in mind in interpreting the measured CPX data. Additionally, the performance of a routine CPX will be reported. Furthermore, the accuracy of the CPX parameters and the potential influences on the data will be discussed. Finally, problems during measurements and their analysis will be clarified.

The clinician who uses cardio-pulmonary exercise testing (CPX) systems relies on the technical informations from the device producers. In this paper, the practicability, the accuracy and the safety of four different, available CPX systems are compared in the clinical area, using clinically orientated criteria. The exercise tests were performed in healthy subjects, in patients with cardiac and/or pulmonary disease as well as in young or old people. The comparison study showed, that there were partially large differences in device design and measurement accuracy. Furthermore, our investigation demonstrated that beneath repetitive calibrations of the CPX systems a frequent validation of the devices by means of a metabolic simulator is necessary. Problems in calibration can be caused by an inadequate performance or by unclean calibration gases. Problems in validation can be due to incompatibility of the CPX device and the validator. The comparison study of the four different systems showed that in the future standards for CPX testing should be defined.

Autologous blood donation is an established method for an effective reduction of the blood-transfusion-associated infectious diseases (hepatitis, HIV infections, etc.) in elective surgical procedures. The aim of the study was to investigate the effects of a blood donation of 450 ml on the cardiopulmonary exercise capacity in 16 apparently healthy young subjects. The 24 cardiopulmonary exercise tests were performed on a bicycle ergometer (Ergoline 900) in a semisupine position, using a ramp program (+20 watt/min) 1-7 days before and 2 days after blood donation. By means of continuous breath-by-breath measurements of the gas exchange (VO2, VCO2) and ventilation parameters (minute ventilation VE), as well as of the routine parameters (heart rate, blood pressure, work rate) during incremental exercise the respiratory anaerobic threshold VO2AT, the maximum VO2 (VO2max and the maximal working capacity (max. WR) were determined. Serum hemoglobin concentration was significantly (p < 0.0005) reduced from 14.5 +/- 1.0 to 13.0 +/- 1.4 g/dl after blood donation. The ventilatory anaerobic threshold (before: 68.5 +/- 17.0; after: 52.0 +/- 20.3% pred. max. VO2), the max. VO2 (before: 124.2 +/- 21.3; after: 110.2 +/- 23.2% pred. max. VO2) and max. WR (before: 287.1 +/- 75.6; after 265.5 +/- 76.2 watt) fell significantly (VO2AT: p < 0.0005; max. VO2: p < 0.0005; max. WR: p < 0.025). Heart rate and minute ventilation showed a steeper increase (dHR/dWR: before: 0.31 +/- 0.06; after: 0.34 +/- 0.05 beats/min/watt; dVE/dWR: before: 0.29 +/- 0.05; after: 0.31 +/- 0.05 l/watt) in relation to the increase in WR after blood donation as compared to the test before.(ABSTRACT TRUNCATED AT 250 WORDS)

The purpose of the study was to examine the cardiovascular and cardiopulmonary exercise capacity in patients with symptomatic congestive heart failure more exactly than with conventional investigations, using the simultaneous non-invasive determination of the gas exchange parameters (ergospirometry, CPX) and of the hemodynamic (transthoracic bioimpedance). The reproducibility of the data were measured with each method with repeated tests under the same conditions in healthy subjects and patients with myocardial failure. Therefore we tested 15 patients with documented congestive heart failure repeatedly on a bicycle (semi-supine, +15 watts/min, symptom-limited). The ergospirometric (VO2, VCO2, RER = VCO2/VO2, max. VO2, VO2AT, VE, RR) and the bioimpedance-parameters (CI, SVI, HR) were measured simultaneously during rest and exercise. According to Wasserman et al. we used the VO2AT and the max. VO2 to assign the patients to the different Weber classes: Weber A: greater than 20 ml/min/kg max. VO2, greater than 14 ml/min/kg VO2AT; Weber B: 16 to 20 ml/min/kg max. VO2, 11 to 14 8 to 11 ml/min/kg VO2AT; Weber D: 6 to 10 ml/min/kg max. ml/min/kg VO2AT; Weber C: 10 to 16 ml/min/kg max. VO2, 8 to 11 ml/min/kg VO2AT; Weber D: 6 to 10 ml/min/kg max. VO2, 4 to 8 ml/min/kg VO2AT: Weber E: less than 6 ml/min/kg max. VO2, less than 4 ml/min/kg VO2AT. The V-slope-method according to Beaver et al. allowed for the determination of the anaerobic threshold in 13/15 patients. 2/15 patients didn't reach the anaerobic threshold. Oscillations of the gas exchange parameters due to Cheyne-Stokes-breathing were found in 9/15 patients.(ABSTRACT TRUNCATED AT 250 WORDS)