Carotid artery stenting in clinical practice results from the Carotid Artery Stenting (CAS)-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK).

BACKGROUND: Carotid artery stenting (CAS) for symptomatic and asymptomatic carotid stenosis seems to be on the doorstep of more widespread use. However, its feasibility and safety in clinical practice at a broad spectrum of hospitals needs to be determined. METHODS: We analyzed data of the prospective multi-centre Carotid Artery Stenting (CAS) Registry of the German Arbeitsgemeinschaft Leitende Kardiologische Krankenhausarzte (ALKK). RESULTS: From 7/1996 to 5/2004 1888 patients from 28 hospitals were included in the CAS Registry. The median hospital stay from CAS until hospital discharge was 3 days (quartiles: 2-6 days). Median patients age was 70 years (quartiles: 64-76 years) with 72.1% males. CAS for symptomatic stenosis was performed in 55% of cases. Patients treated with CAS suffered from coronary artery disease in 66.5%, had arterial hypertension in 91.7%, hyperlipidemia in 86.3% and 34.2% were diabetics. The intended CAS procedure was completed in 98.1% of cases. A stent was implanted in 97.3% of completed cases. The median intervention time was 43 min (quartiles: 30-60 min). During the hospital stay death rate was 0.3% (5/1888) and the rate of ipsilateral stroke 3.2% (58/1840). A contralateral ischemic event occurred in 1.4% (26/ 1840) of patients. The combined rate of all death or strokes was 3.8% (70/1841). Between 1996 and 2004 there was a steady increase in the use of protection devices during CAS (0% in 1996 and 97.9% in 2004; p for trend <0.0001). There was also an increase in the proportion of patients treated for asymptomatic stenoses (p for trend <0.0001). We observed a decrease of the combined endpoint of death or stroke from 6.3% in 1996 to 1.9% in 2004 (p for trend=0.021). CONCLUSION: The multi-centre ALKK CAS Registry data confirm the feasibility and shot-term safety of CAS even in daily clinical practice. There was a rapid penetration of the use of embolic protection devices, an increase in treatment of asymptomatic carotid stenoses and a decrease in acute complication rates from 1996 to 2004.

[Efficacy and safety of treatment of acute ischemic stroke with glycoprotein IIb/IIIa receptor blocker in routine clinical practice]. / Wirksamkeit und Sicherheit einer Akuttherapie mit GPIIb/IIIa-Rezeptorblockern bei ischämischem zerebralem Insult in der klinisch-internistischen Routine.

BACKGROUND: Platelet aggregation plays an important pathophysiological role in the incidence of myocardial infarction and ischemic stroke. The expression of glycoprotein IIb/IIIa receptors on the surface of activated platelets is the final common pathway of platelet aggregation. PATIENTS AND METHODS: Encouraged by the favorable outcome in acute coronary syndromes and by preliminary results, which substantiate the efficacy and safety of GP IIa/III antagonists (GP) in ischemic stroke, we treated 21 cases/20 patients (13 male, 7 female, age 39-79 y.) and conducted a retrospective study using a clinical graduation scale (Modified Rankin Scale MRS). Patients received tirofiban (n = 18) or eptifibatide (n = 3) in the usual cardiological dose 3 h (0.5-8 h) after beginning of symptoms together with "full dose " heparin (n = 8) or "low dose" heparin (n = 12) in the acute phase, with aspirin 100 mg (n = 4), Clopidrogel 75 mg (n = 5), aspirin + clopidogrel (n = 4) in the chronic phase. All patients had a cranial CT, 95% an echocardiography and Doppler sonography of the carotid artery system and some cranial MRI (43%). RESULTS: There was no significant clinical deterioration. All except one patient showed a rapid and impressive improvement during the first 24 h after initiation of treatment (median MRS pre/post 3/1). CONCLUSION: The results with GP in acute ischemic stroke are promising and further studies should be initiated using especially tirofiban, but with monitoring by cerebral diffusion-weighted MRI before and after treatment.

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.

Comparison of saruplase and alteplase in acute myocardial infarction. SESAM Study Group. The Study in Europe with Saruplase and Alteplase in Myocardial Infarction.

Four hundred seventy-three patients with acute myocardial infarction (AMI) were treated with either saruplase (80 mg/hour, n = 236) or alteplase (100 mg every 3 hours, n = 237). Comedication included heparin and acetylsalicylic acid. Angiography was performed at 45 and 60 minutes after the start of thrombolytic therapy. When flow was insufficient, angiography was repeated at 90 minutes. Coronary angioplasty was then performed if Thrombolysis In Myocardial Infarction (TIMI) trial 0 to 1 flow was seen. Control angiography was at 24 to 40 hours. Baseline characteristics were similar. Angiography showed comparable and remarkably high early patency rates (TIMI 2 or 3 flow) in both treatment groups: at 45 minutes, 74.6% versus 68.9% (p = 0.22); and at 60 minutes 79.9% versus 75.3% (p = 0.26). Patency rates at 90 minutes before additional interventions were also comparable (79.9% and 81.4%). Angiographic reocclusion rates were not significantly different: 1.2% versus 2.4% (p = 0.68). After rescue angioplasty, angiographic reocclusion rates of 22.0% and 15.0% were observed. Safety data were similar for both groups. Thus, (1) early patency rates were high for saruplase and alteplase treatment, (2) reocclusion rates for both drugs were remarkably low, and (3) complication rates were similar. Thus, saruplase seems to be as safe and effective as alteplase.

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.

Ventricular late potentials and inducible ventricular tachyarrhythmias as a marker for ventricular tachycardia after myocardial infarction.

To assess the predictive value of ventricular late potentials and programmed ventricular stimulation, 379 patients without a history of sustained ventricular tachycardia, dizziness or syncope were studied prospectively. Group I included patients referred for coronary angiography. Group II consisted of patients who survived an episode of acute myocardial infarction and who were studied within 6 weeks after onset. During follow-up (mean 13 months), 16 patients died. Six of these patients died suddenly within one hour. The prevalence of sudden cardiac death was lower (0.8%) in group I compared to group II (3.0%). There was no correlation between results of both methods and the subsequent occurrence of sudden cardiac death. Symptomatic sustained ventricular tachycardia was documented in 10 patients (2.6%). Only one patient in group I later developed symptomatic sustained ventricular tachycardia in contrast to nine cases in group II. Symptomatic sustained ventricular tachycardia could be predicted in patients in the early postmyocardial infarction period (group II). By using various combinations of parameters, the highest predictive value for subsequent sustained ventricular tachycardia was reached by the following combination: Late potentials of 40 ms duration or more, induction of monomorphic sustained ventricular tachycardia at rates below 270 beats min-1 and interval after myocardial infarction less than 6 weeks. In conclusion, both techniques seemed to be promising for the identification of patients at risk of ventricular tachycardia after myocardial infarction.

[Prognostic significance of programmed ventricular stimulation in the noninvasive registration of ventricular late potentials in the postinfarct period]. / Prognostische Bedeutung der programmierten Ventrikelstimulation und der nichtinvasiven Registrierung ventrikulärer Spätpotentiale in der Postinfarktperiode.

The prognostic significance of programmed ventricular stimulation for assessing ventricular vulnerability and of signal averaging for detection of ventricular late potentials was assessed prospectively in 132 survivors of acute myocardial infarction. The median day of these studies was the 22nd. Programmed ventricular stimulation (PVS) included single and double premature stimuli during sinus rhythm and paced ventricular rhythms at rates of 120, 140, 160 and 180 bpm. The endpoint for stimulation was the induction of 4 or more consecutive echo beats. 59 of 132 patients (45%) had late potentials in their body surface signal-averaged ECG. The prevalence was 35% in those with anterior wall infarction and 54% in those with inferior wall infarction (chi 2 = 3.9; p less than 0.05). In 61 patients (46%), 4 or more consecutive echo beats were induced. In 28 of these patients, sustained ventricular tachycardia or fibrillation were initiated. During follow-up (15 +/- 11 months; mean +/- S.D.), there were 4 sudden deaths. Neither PVS nor signal averaging were able to predict these events. Spontaneous symptomatic sustained ventricular tachycardia occurred in a total of 9 patients, all of whom had an abnormal PVS result (sensitivity 100%); 7 of these patients also had late potentials (sensitivity 78%). Stepwise analysis revealed that the combination of late potentials (duration greater than or equal to 40 ms), and of induction of sustained ventricular tachycardia at rates less than 270 bpm had the highest predictive value (50%). In contrast, the prevalence of sustained ventricular tachycardia was as low as 3% in those without late potentials.(ABSTRACT TRUNCATED AT 250 WORDS)

[Incidence and prognostic significance of inducible ventricular arrhythmias in the early post-infarction phase]. / Häufigkeit und prognostische Bedeutung auslösbarer ventrikulärer Arrhythmien im frühen Postinfarktstadium.

To identify patients at risk of sudden cardiac death or sustained ventricular tachycardia (VT) after recent acute myocardial infarction, 100 patients younger than 70 years (80 male, 20 female; 47 anterior wall infarction, 53 inferior wall infarction) were studied prospectively. 25 days (mean) after onset of myocardial infarction, programmed ventricular stimulation was performed, including the introduction of single (S2) and double (S2-S3) ventricular extrastimuli both during sinus rhythm and at paced ventricular cycle lengths (S1-S1) of 500, 430, 370, and 330 ms. The end of the protocol was reached as soon as 4 or more consecutive ventricular echo beats (VE) were initiated. Four or more VE were initiated in 46% of patients, 4 to 9 VE in 21%, greater than or equal to 10 VE or sustained VT in 25%. During follow-up (15 +/- 8 months), 5 patients died suddenly (less than or equal to 1 h), and 5 further patients developed spontaneous sustained ventricular tachycardia. In 3 patients who died suddenly and 4 with spontaneous sustained VT, greater than or equal to 4 VE had been induced by programmed ventricular stimulation (sensitivity 60% and 80% respectively). With regard to sudden cardiac death and spontaneous ventricular tachycardia, the predictive value of a positive test was 15%, that of a negative (normal) test 94%. False negative results occurred in 6%, whereas 85% of all abnormal results had to be regarded as false positive, as these patients did not develop an arrhythmic event during follow-up. Thus patients after recent myocardial infarction frequently have signs of increased ventricular vulnerability during programmed ventricular stimulation.(ABSTRACT TRUNCATED AT 250 WORDS)

Prevalence and clinical significance of the repetitive ventricular response during sinus rhythm in coronary disease patients.

The prevalence of the repetitive ventricular response (RVR) after single and double premature stimulation during sinus rhythm or a paced supraventricular rhythm at a rate of 85 bpm was assessed in 343 patients (group 1: 237 patients studied prospectively who were referred for coronary arteriography and ventriculography; group 2: 44 patients after recent acute myocardial infarction; group 3: 61 patients with documented ventricular tachycardia and/or fibrillation). In group 1 patients, RVR testing was performed from both the right ventricular apex (n = 237) and outflow tract (n = 190), whereas in the remaining patients only the apex was stimulated. In group 1, RVR after a single premature stimulus occurred in 21.9% and after two stimuli in 63.2%. In patients with normal left ventricular (LV) function (n = 63) the prevalence of RVR after a single stimulus was significantly less (9.5%) than in those with LV dysfunction (n = 174;26.4%,p less than 0.01). However, after double stimulation, there was no longer any difference. In group 2, the prevalence of RVR was 25% after one and 34.1% after two premature stimuli. In group 3 patients, RVR was observed in only 14.8% after one and in 41% of patients after two premature stimuli. Ventricular tachycardia (greater than or equal to 10 QRS) was induced in nine patients during a supraventricular rhythm. Two hundred thirty-seven patients of group 1, who were prospectively studied in order to assess the prognostic significance of the RVR, were followed for a mean period of 27.2 +/- 10.7 months.(ABSTRACT TRUNCATED AT 250 WORDS)