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K L Neuhaus

Publications and source records attributed to K L Neuhaus.

At least 37 records · Page 2Linked to original sources
PubMed1999

Comparison of the predictive value of ST segment elevation resolution at 90 and 180 min after start of streptokinase in acute myocardial infarction. A substudy of the hirudin for improvement of thrombolysis (HIT)-4 study.

AIMS: Previous studies revealed that >/=70% or <30% ST segment elevation resolution 180 min after the start of thrombolysis is a strong predictor of either favourable or poor outcome. The aim of this study was to compare the prognostic value of ST segment elevation resolution at 90 and 180 min after the start of streptokinase infusion. METHODS AND RESULTS: The Hirudin for Improvement of Thrombolysis (HIT)-4 study of 1208 patients compared streptokinase therapy in conjunction with either r-hirudin or heparin. Complete ST segment elevation resolution (>/=70%) at 90 and 180 min identified 25% and 50%, respectively, of all patients with a 30 day cardiac mortality of less than 2%. Forty-four percent of patients had no ST segment elevation resolution (<30%) at 90 min and the 30 day cardiac mortality was 7.3%. At 180 min, the no ST segment elevation resolution group decreased to 15% of all patients while the mortality risk increased to 13.6%. CONCLUSIONS: ST segment elevation resolution is a useful tool for early risk stratification and the strategy of rescue angioplasty. Complete ST segment elevation resolution within 180 min of the start of streptokinase therapy indicates excellent survival prospects in 50% of patients. A half of these low risk patients can be identified at 90 min. A high risk group appears to be best characterized by no ST segment elevation resolution at 180 min rather than at 90 min.

Double-Blind Method↗
PubMed1999

Clinical trials in acute myocardial infarction.

Long-term follow-up of placebo-controlled thrombolysis trials has proven that the survival benefit from thrombolysis in acute myocardial infarction (AMI) is maintained for up to 10 years. Ongoing research is being conducted with the aim to further improve early restoration of blood flow in the infarct vessel and, thus, reperfusion of the infarcted myocardium in patients with AMI, with the ultimate goal to improve survival. In two recent mega-trials, two new single-bolus fibrinolytics (lanoteplase and TNK-tissue plasminogen activator) were shown to be equivalent to front-loaded alteplase in reducing infarct mortality. The ease of application of these agents might help reduce the time from symptom onset to start of therapy. More potent thrombin inhibitors such as hirudin and hirulog seem to speed up thrombolysis with streptokinase and reduce the rate of reinfarctions. Very promising results are derived from angiographic trials combining reduced doses of thrombolytics with glycoprotein IIb/IIIa inhibitors. Advances in mechanical revascularization can be achieved with the use of stents and better conjunctive therapies. All of these developments are expected to further improve clinical outcome of patients with AMI in the near future.

Fibrinolytic Agents↗
PubMed1999

The German experience with primary angioplasty.

From July 1994 to October 1998, 4280 primary PTCA procedures were entered into the registry of the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte. The success rate of PTCA, as defined by TIMI-3 perfusion of the infarct-related artery was 87.1%, in-hospital mortality was 10.2% and 2.6% had reinfarction. The most powerful predictors of death were cardiogenic shock present in 14.6% of whom 47% died, and failed PTCA with a mortality of 32%. Stents were used in 4.1% in 1994 increasing to 64.5% in 1998 without significant changes in success rates, but associated with a slight decrease in mortality and reinfarction rates.

Age Distribution↗
PubMed1999

[Quality assurance in the clinic--an example of interventional cardiology].

Beginning in October 1992, all PTCAs from more than 70 German hospitals were gathered in a central registry of the Working Group of the Leading Hospital Physicians in Cardiology in an intention to treat analysis. Each centre was visited twice a year and the local records were compared with the procedures entered into the registry to ensure completeness of the data. In selected patients, a quality control was performed by expert rating regarding the technical performance and the indication for the intervention. Additional registries about primary PTCA in patients with acute myocardial infarction and stent implantations were initiated in 1994 and 1995. Completeness of the registries was more than 98% and more than 150,000 PTCA procedures, more than 5,000 PTCAs in acute myocardial infarction and more than 35,000 stent implantations were entered into the specific registries until April 1998. These data demonstrate that a complete registration and monitoring of procedural outcome is feasible even in high volume procedures such as PTCA. A still unresolved problem is the determination of the appropriateness of the indication for an intervention. However, this part of quality control is very important in interventional cardiology and therefore methods to assess the quality of indications have to be elaborated.

Angioplasty, Balloon, Coronary↗
PubMed1998

Effect of reteplase on hemostasis variables: analysis of fibrin specificity, relation to bleeding complications and coronary patency.

UNLABELLED: The first aim of the present study was to characterize the systemic and fibrin-specific lytic effect of reteplase in the treatment of patients with acute myocardial infarction. The second aim was to investigate the relation of hemostasis variables to risk of bleeding complications and to coronary patency. The present study is a hemostatic substudy of the German Recombinant Activator Study. Forty two patients have been treated with 10 MU of reteplase (Group A) and 100 patients with 15 MU of reteplase (Group B), given as a single bolus. Blood samples for assessment of fibrinogen, plasminogen, alpha-2-antiplasmin, fibrinogen degradation products (FDP) and D-dimers were obtained before and at 2, 4, 8, and 24 h after thrombolytic therapy. The median fibrinogen concentration was decreased from 279 to 169 mg/dl in Group A and from 254 to 92 mg/dl in Group B four hours after administration of reteplase. The decrease in fibrinogen was significantly more pronounced in Group B (P=0.0004). The median plasminogen concentration was decreased to 53% in Group A and to 33% in Group B two hours after administration of reteplase (P=0.0001). Alpha-2-antiplasmin was reduced to 27% and 17,5%, respectively (P=0.0007). D-Dimer levels were increased to 5.2 microg/ml in Group A and 11,6 microg/ml in Group B (P=0.02) and FDP levels to 3.0 microg/ml in Group A and 12,6 microg/ml in Group B (P=0.04). Patients with bleeding complications revealed significant lower nadir levels of fibrinogen than patients without bleeding complications (54 mg/dl versus 125.5 mg/dl, P=0.02). There was no significant difference in any hemostatic parameter between patients with patent and nonpatent infarct related arteries. CONCLUSIONS: Reteplase causes a moderate systemic lytic effect comparable with other relative fibrin specific thrombolytic agents. An increase in the dose from 10 to 15 MU is associated with a marked increase in both fibrin specific and systemic lytic effect. Patients with bleeding complications reveal significant lower nadir levels of fibrinogen than patients without bleeding complications. Determination of any hemostatic parameter seems to be no useful method to predict efficacy of thrombolysis in terms of coronary patency in the individual patient.

Clinical Trials, Phase II as Topic↗
PubMed1998

Effects of thrombolytic therapy in acute inferior myocardial infarction with or without right ventricular involvement. HIT-4 Trial Group. Hirudin for Improvement of Thrombolysis.

OBJECTIVES: This study assessed the prognostic impact of right ventricular involvement (RVI) in streptokinase-treated patients with inferior acute myocardial infarction (AMI) stratified for small or large AMI. BACKGROUND: Only scant data exist from small studies about the impact of reperfusion therapy on survival in patients with RVI during inferior AMI. METHODS: Right ventricular involvement was assessed by ST-segment elevation > or =0.1 mV in lead V4R and infarct size by the extent of ST-segment deviation on the baseline electrocardiogram: small AMI=sum ST-segment elevation < or =0.8 mV and no precordial ST-segment depression (small ST); large AMI=presence of precordial ST-segment depression or sum ST-segment elevation >0.8 mV (large ST) in 522 inferior AMI patients of the Hirudin for Improvement of Thrombolysis (HIT-4) Trial. In 187 patients, 90-min coronary angiography was performed. RESULTS: Right ventricular involvement was present in 169 patients (32%). Higher 30-day cardiac mortality rates with RVI (5.9% vs. 2.5%) were related to larger infarct size rather than to RVI. For large ST, a proximal right coronary artery lesion was observed in 52% with and in 23% without RVI. Patency rates at 90 min were similar (54% vs. 52%). In the 28% of patients who had small ST, cardiac mortality was less than 1% irrespective of the presence of RVI. Coronary artery lesions were mostly located distally. Patency rates were 27% with and 80% without RVI. CONCLUSIONS: ST-segment elevation of > or =0.1 mV in V4R in inferior AMI patients is associated with larger infarct size and higher 30-day mortality rates. Right ventricular involvement is not an independent predictor of survival. In patients with small ST, cardiac mortality is low, even if ST V4R is > or =0.1 mV.

Coronary Angiography↗
PubMed1998

Direct percutaneous transluminal coronary angioplasty in acute myocardial infarction. Predictors of short-term outcome and the impact of coronary stenting. Study Group of The Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK).

BACKGROUND: Direct percutaneous transluminal coronary angioplasty (PTCA) is widely accepted in the treatment of acute myocardial infarction since excellent results had been reported from several small randomized trials. Less favourable results were observed in large-scale registries. In particular, the use of stents in acute myocardial infarction has become common practice without documented evidence of clinical efficacy. METHODS: Data were analysed from a registry of all consecutive percutaneous transluminal coronary angioplasty procedures from 62 centres in Germany, including 2331 direct percutaneous transluminal coronary angioplasty in acute myocardial infarction from July 1994 to April 1997. RESULTS: The overall angiographic success rate of percutaneous transluminal coronary angioplasty, defined as complete antegrade perfusion of the infarct vessel, was 87%. In-hospital mortality was 11.2%. The most important predictor of death was the presence of cardiogenic shock in 15% of patients, of whom 52% died. Mortality in patients without shock was 3.9%. Failed percutaneous transluminal coronary angioplasty was associated with a mortality of 36%. Further independent predictors of death were older age, multivessel disease, and anterior myocardial infarction. Stents were used in 4.1% of the procedures in 1994, increasing to 53% in 1997. However, this was not accompanied by improved clinical outcome. Mortality with coronary stenting was 9.9% vs 11.6% without stents (ns). CONCLUSIONS: Direct percutaneous transluminal coronary angioplasty is a valuable treatment strategy in acute myocardial infarction, although the results are less exceptional than reported from some highly specialized centres. Failed percutaneous transluminal coronary angioplasty seems to be harmful, thus outweighing much of the benefit from successful procedures. Stents did not improve the clinical outcome significantly, despite technically successful placement in 98%. Mortality from cardiogenic shock continues to be excessively high despite direct PTCA.

Adult↗
PubMed1998

HBW 023 (recombinant hirudin) for the acceleration of thrombolysis and prevention of coronary reocclusion in acute myocardial infarction: results of a dose-finding study (HIT-II) by the Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte.

OBJECTIVE: To define an optimal dose of hirudin that would improve early coronary artery Thrombolysis in Myocardial Infarction grade 3 (TIMI 3) patency and prevent reocclusions in patients with acute myocardial infarction treated with front-loaded recombinant tissue-type plasminogen activator (rt-PA). METHODS: Recombinant hirudin (HBW 023) was tested in a sequential dose-escalating study as adjunct to front-loaded rt-PA in 143 patients with acute myocardial infarction. The sequential model was assigned two 'decision boundaries': it triggered an increase in dosage if the 60-min TIMI 3 flow rate in a dosage group was statistically not consistent with a target patency rate of 75%, or if the deterioration in coronary blood flow (of at least one TIMI grade, from TIMI 2 or 3, from one angiography to the next) exceeded 5%. RESULTS: The decision boundary for TIMI 3 flow grade at 60 min was crossed when 18 patients were treated with 0.1/0.06 mg/kg (bolus/infusion per hour over 48 h) r-hirudin (dosage group I), 42 patients treated with 0.2/0.1 mg/kg (dosage group II), and 83 patients with 0.4/0.15 mg/kg (dosage group III). TIMI 3 flow at 60 min was 50%, 58%, and 63% in dosage groups I-III, respectively (P = 0.15). Early, complete, and sustained patency (TIMI 3 flow at 60 min, 90 min and 48 h) were 44%, 55% and 64% (P = 0.07). Reocclusion between 90-min and 48-h angiograms or reinfarction occurred in 0 to 15, two of 36, and one of 72 patients, respectively (P = 0.5). Four patients (2.8%) died in hospital and 14 patients suffered a major bleeding event, but no intracranial bleeding was encountered. CONCLUSIONS: With increasing doses of hirudin, there was a trend towards greater early and complete patency, but no clear dose--response relationship was observed. A borderline significant effect was observed with respect to early, complete, and sustained patencies. In all groups, reocclusions or reinfarctions were rare. Neither clinical nor laboratory data predicted the imbalance in haemorrhagic events observed in a subsequent, prematurely terminated, phase III trial with hirudin and rt-PA.

Adult↗
PubMed1997

Influence of the global utilization of streptokinase and tissue plasminogen activator for occluded coronary arteries (GUSTO-1) trial on the use of thrombolytics in Germany. ALKK Study Group. Arbeitsgemeinschaft der Leitenden Kardiologischen Krankenhausärtze.

Our results show significant and independent influence of the GUSTO-1 trial on the use of recombinant tissue plasminogen activator in acute myocardial infarction in Germany. This influence started soon after the publication of the trial and was not restricted to subgroups who benefitted most from recombinant tissue plasminogen activator.

Aged↗
PubMed1997

Primary angioplasty versus thrombolysis in the treatment of acute myocardial infarction. ALKK Study Group.

This study investigates the hypothesis if primary angioplasty is superior to intravenous thrombolysis in the treatment of acute myocardial infarction (AMI). Small prospective randomized studies did not demonstrate a significant benefit regarding total mortality. A total of 14,980 patients with AMI were registered by "The 60-Minutes Myocardial Infarction Project," a prospective multicenter observational study: 210 of these patients were treated with primary angioplasty. A matched pair analysis comparing 1 primary angioplasty patient with 3 intravenous thrombolysis patients could be performed in 156 primary angioplasty patients. Criteria for matching were age, sex, location of AMI, systolic blood pressure, previous AMI, and prehospital delay. Patients with a bundle branch block or requiring resuscitation were excluded from analysis. Because of matching, both groups showed similar baseline characteristics. Patients with primary angioplasty had more relative contraindications for thrombolysis (ulcers: 10.3% vs 2.3%, recent intramuscular injections: 6.4% vs 1.6%, recent surgical interventions: 5.1% vs 1.1%, central punctures: 9% vs 3.9%). There was a tendency toward less combined adverse events in the primary angioplasty group (3.2% vs 5.7%, odds ratio [OR] = 0.55, 95% confidence interval [CI] = 0.21 to 1.44). In-hospital mortality rates in the primary angioplasty group and thrombolysis group were 4.3% and 10.3%, respectively (OR = 0.39, 95% CI = 0.17 to 0.92). The difference in mortality could already be demonstrated within the first 48 hours with 1.9% versus 5.3% deaths (OR = 0.35, 95% CI = 0.11 to 1.14). Thus this study indicates a superiority of primary angioplasty in comparison to intravenous thrombolysis in AMI even in a clinical routine setting, with a reduction of hospital mortality of about 60%.

Aged↗
PubMed1997

PTCA registry of German community hospitals. Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausärzte (ALKK) Study Group.

BACKGROUND: Percutaneous transluminal coronary angioplasty (PTCA) is widely used, but no quality control has been systematically performed as yet. METHODS: A registry of all PTCA procedures has been established since October 1992 for the majority of the German community hospitals performing PTCA, representing about one third of all PTCA activity in Germany. Baseline demographic data, indication for PTCA, primary success and in-hospital clinical events were recorded. Each centre was visited at regular intervals to assure completeness and reliability of the data. RESULTS: Of 52453 procedures performed from October 1992 to December 1994 the catheter laboratory and discharge forms were 99.7% and 98.1% complete, respectively. In 85.9% a single lesion was dilated per procedure, but 48.7% of the patients had multivessel disease. The success rate was 66.5% in complete occlusions (residual stenosis < 70%) and 91.2% in non-occluded vessels (residual stenosis < 50%). Abrupt vessel closure occurred in 3.4%, of which 77.5% could be recanalized by repeat intervention. In procedures not done for acute myocardial infarction, the in-hospital mortality was 0.52%, the procedure-related mortality 0.37%. In 3.02% of all patients a severe complication occurred (procedure-related death, myocardial infarction or emergency bypass surgery). CONCLUSION: Complete recording of all PTCA procedures is feasible even on a nationwide basis. This is a pre-requisite for continuous quality control. The reporting of the procedures by itself very probably, has an impact on the quality which is, however, not measurable quantitatively.

Aged↗
PubMed1997

The 60 minutes myocardial infarction project. Treatment and clinical outcome of patients with acute myocardial infarction in Germany.

AIMS: To describe patient characteristics, pre-hospital delay, treatment, complications and outcome in patients with acute myocardial infarction admitted to hospitals in Germany. METHODS AND RESULTS: The study was of prospective observational multicentre design. Those involved were consecutive patients with acute Q-wave myocardial infarction admitted within 96 h of onset of symptoms to 136 German hospitals between July 1992 and September 1994 (n = 14980, median age 66 (quartiles 57, 74) years, 68% male, 48% anterior wall infarction). Median pre-hospital delay was 170 (90, 475) min, with 17% arriving within the first hour and 61% within 4 h of onset of symptoms. The following patient groups had a short pre-hospital delay: males, those aged less than 65 years, those admitted at night or the weekend, those with a previous myocardial infarction, those in need of cardiopulmonary resuscitation, and those with a diagnostic first ECG. The first ECG was diagnostic in 67.6% of cases. Reperfusion therapy was used in 53%, with thrombolytic therapy in 51.6%. Median time from admission to initiation of treatment was 30 (20, 55) min. Respective rates of treatment with aspirin, nitrates, and beta-blockers were 81%, 83%, and 16%. Major complications were cerebral bleeding (0.4%), bleeding requiring transfusions (0.9%), left ventricular rupture (0.6%) and anaphylactic shock (0.1%). Median hospital stay was 20 (13, 26) days. In-hospital death rate was 17.2%. Increased hospital mortality was observed with female gender, an unknown or long pre-hospital delay, a diagnostic first ECG, anterior wall infarction, trauma or major operation within the last 14 days, renal insufficiency and malignoma. CONCLUSIONS: 'Real-life' hospital mortality is much higher than previously reported in clinical trials. To reduce hospital mortality, the efficacy of thrombolysis should be increased by shortening the pre-hospital delay, and the use of concomitant therapy, especially beta-blockers, should be increased.

Aged↗
PubMed1997

Significance of initial ST segment changes for thrombolytic treatment in first inferior myocardial infarction.

OBJECTIVE: To evaluate the benefit to risk ratio of thrombolytic treatment in patients with small inferior acute myocardial infarction (AMI). Controlled studies relating the benefit from thrombolysis with initial electrocardiographic features are scarce and of limited sample size. DESIGN: Retrospective study of 728 patients with a first inferior AMI of six hours' duration from the Intravenous Streptokinase in Acute Myocardial Infarction (ISAM) study comparing streptokinase with placebo stratified by the initial sum ST segment elevation (sigma ST) of 0.8 mV or less and greater than 0.8 mV, and 636 patients from the International Joint Efficacy Comparison of Thrombolytics (INJECT) trial comparing double blind streptokinase with reteplase stratified by either sigma ST or the presence of precordial ST segment depression. RESULTS: ISAM study patients with an sigma ST of greater than 0.8 mV had a significant mortality benefit from streptokinase throughout six years, while those with an sigma ST of 0.8 mV or less showed a trend to higher mortality at six months (6.3% streptokinase v 5.1% placebo). Despite significantly smaller infarcts and fewer clinical complications in patients with an sigma ST of 0.8 mV or less (ISAM and INJECT) or the absence of precordial ST segment depression (INJECT) thrombolytic treatment was associated with higher early mortality than in those with initially larger ST segment deviations. CONCLUSION: Thrombolytic treatment in patients with inferior AMI presenting with larger ST segment deviations is associated with improved survival throughout six years. The risk to benefit ratio, however, in terms of early mortality in patients who have an sigma ST of 0.8 mV or less and no precordial ST segment depression may be unfavourable.

Electrocardiography↗
PubMed1996

Cardioversion of atrial fibrillation in the elderly. ALKK-Study Group. Arbeitsgemeinschaft Leitender Kardiologischer Krankenhausaerzte.

The purpose of this investigation was to define cardioversion success rates, frequency of complications of cardioversion, and current treatment practices in elderly patients (aged > or = 65 years) with atrial fibrillation (AF). The results were compared with those in younger patients (aged < 65 years). The investigation was a prospective multicenter observational study with 61 participating cardiology clinics. Consecutive patients in whom cardioversion of AF was planned had to be prospectively registered. Of 1,152 patients registered, 570 (49.5%) were < 65 years old (group 1) and 582 (50.5%) were > or = 65 years (group 2). The overall success rate of cardioversion on an intention-to-treat basis was 76.1% in group 1 and 72.7% in group 2 (p = 0.18). In multivariate analysis, left atrial size and New York Heart Association functional class before cardioversion were identified as predictors of success (p < 0.001, respectively; p = 0.025). These clinical factors were not equally distributed between the age groups: Left atrial size was larger in the elderly than in younger patients (44.0 +/- 6.4 mm vs 42.8 +/- 6.4 mm; p = 0.006) and a New York Heart Association functional class > or = II was more prevalent in group 2 than in group 1 (48.6% vs 29.6%; p < 0.001). The overall complication rates were not significantly different between the 2 groups (4.2% in group 1 vs 5.3% in group 2; p = 0.37). The frequency of patients who were adequately anticoagulated for cardioversion was 56.9% in age group 1 and 39.6% in age group 2 (p < 0.001). In chronic AF the same trend for age-dependent underuse of anticoagulation was observed. Age itself was not a predictor of cardioversion success and did not predispose to higher complication rates. Therefore, cardioversion should be considered in older patients with the same criteria and emphasis as in younger patients. Anticoagulation and antithrombotic medication is underused for cardioversion and in treating chronic AF, especially in elderly patients.

Adult↗