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)

Central hemodynamics at rest and during exercise after mitral valve replacement with different prostheses.

To compare the hemodynamic features of different prosthetic heart valves that have equal tissue anulus diameter (29 mm or comparable), 75 patients with isolated mitral valve replacement (19 with Björk-Shiley Standard [BS], five with Hall-Kaster [HK], seven with Ionescu-Shiley [IS], 12 with Lillehei-Kaster [LK], 12 with Starr-Edwards [type 6120, SE], and 20 with St. Jude Medical [SJ] prostheses) were reexamined approximately 1 year after operation by right and left heart catheterization while they were at rest and during bicycle exercise. Mean pulmonary artery and mean left atrial pressure were reduced significantly in all the groups postoperatively. However, pulmonary artery and left atrial pressure were somewhat lower after BS and SJ implantation than the comparable pressures in the other groups. Normal values were reached only in a small number of patients, and the cardiac index remained at the lower limit of normal. Average diastolic pressure gradients in patients at rest were 2.3 +/- 0.6 mm Hg after SJ, 4.5 +/- 1.6 after BS, 5.2 +/- 3.3 after HK, 5.3 +/- 1.6 after IS, 7.1 +/- 1.3 after LK, and 6.3 +/- 2.0 after SE implantation. Effective valve orifice areas were calculated to be 3.1 +/- 0.8 cm2 in the SJ group and 2.2 +/- 0.5 cm2 in the BS group and even smaller in the other groups. Total volume loss does not seem to be significantly different among the valve types reexamined as determined by left ventricular angiography. For hemodynamic reasons, of all those prosthetic valves we compared, the SJ prosthesis appears to perform best in terms of lowest pressure gradients and largest effective orifice areas.

[Late complications following Björk-Shiley and St. Jude Medical heart valve replacement]. / Spätkomplikationen nach Björk-Shiley- und St.-Jude-Medical-Herzklappenersatz.

Valve-related complications after Björk-Shiley mitral (n = 475), aortic (n = 424), or mitral-aortic implantation (n = 119) were compared to complications after St. Jude mitral (n = 173), aortic (n = 152), and St. Jude mitral and aortic (n = 63) replacements. The 1,018 consecutive patients with Björk-Shiley valves had been operated upon between 1974 and 1982, those with St. Jude valves between 1978 and 1982. All patients were placed on anticoagulant therapy with phenprocoumon early after operation and no significant intergroup differences in the effectiveness of the anticoagulant therapy were found. At a comparable follow-up time of approximately 23 months, 24 major thromboembolic episodes were observed after Björk-Shiley mitral (BSM) and 3 after St. Jude mitral valve implantation (SJM), corresponding to a thromboembolic rate of 2.82/100 patient years with BSM and 0.93/100 patient years with SJM. After aortic valve replacements, 1.93 events in 100 patient years occurred after Björk-Shiley aortic (BSA) and 0.73 after St. Jude aortic implantation (SJA). In patients with double valve replacements, these rates were 3.2 (BSM + BSA) and 0.88 (SJM + SJA), respectively. The cerebral vessels were involved in 52% and the arteries of the extremities in 22% of these major events. Six Björk-Shiley prostheses had to be replaced because of valve thrombosis. The overall incidence of severe hemorrhagic complications was 2.94/100 patient years in BSM and 1.79 in SJM. After aortic valve replacement, we found rates of 1.80/100 patient years (BSA) and 2.57/100 patient years (SJA), respectively. Intravascular hemolysis no longer seems to be a significant clinical problem. However, indications of red cell damage after heart valve replacement were significantly greater in patients with perivalvular leakage, valve thrombosis, or dysfunction than in those with normally functioning prostheses. Reoperations were necessary because of valve thrombosis (0.46%), perivalvular leakage (2.2%), or prosthetic valve endocarditis with concomitant perivalvular regurgitation (0.46%). One valve had to be replaced because of fracture of the outlet strut of a BSM prosthesis. Hemorrhage due to the anticoagulant treatment was thus the most frequent complication, without significant intergroup differences, while thromboembolic complications were significantly more frequent after Björk-Shiley mitral, aortic, and double valve replacements than after St. Jude implantation. This may lead to the consideration of a change in the prophylaxis of thrombus formations with the St. Jude valve, especially in aortic valve replacements with sinus rhythm.

Preliminary results in mitral valve replacement with St. Jude medical prosthesis: comparison with the Björk-Shiley valve.

The clinical improvement and the hemodynamic performance at rest and during bicycle exercise in 22 patients 1 year after implantation of a St. Jude Medical mitral valve (SJMM) were compared with the results of 40 patients after implantation of a Björk-Shiley mitral valve (BSM). In both subjective and functional improvement were significant. In the SJMM group no thromboembolic event occurred, while five patients in the BSM group suffered from embolism during the first year postoperative year (12.5%). Hemolysis was significantly lower in the BSM group but remained subclinical in the SJMM group. This may be explained by a premature backward movement of the posterior leaflet of the SJMM prosthesis in the late diastole, which resulted in a change of flow pattern. Low resistance to blood flow in the SJMM prosthesis could be verified by a small diastolic transvalvular gradient. In valves with equal tissue annulus diameters (29 mm), the calculated effective valve orifices were significantly different (3.07 +/- 1.36 cm2 in SJMM, 1.85 +/- 0.53 cm2 in BSM). In both groups, the mean pulmonary artery pressure was significantly reduced at the time of reinvestigation but increased during exercise. Durability may become a problem because of the two moving parts of SJMM, but we have observed no malfunction. The SJMM appears to be a good alternative in mitral valve replacement.

Preliminary clinical and hemodynamic results after mitral valve replacement using St. Jude Medical prostheses in comparison with the Björk-Shiley valve.

The clinical improvement and the hemodynamic performance at rest and during bicycle exercise in 12 patients one year after St. Jude Medical mitral valve (SJMM) replacement were compared to the results of 40 patients after Björk-Shiley mitral valve (BSM) implantation. In both groups subjective and functional improvement was significant. In the SJMM-group no thromboembolic event had occurred, while 5 patients suffered from embolism during the first postoperative year after BSM (12.5%). Hemolysis was significantly lower in BSM but remained subclinical in SJMM. This may be explained by a premature backward movement of the posterior leaflet of the SJMM-prosthesis in late diastole resulting in a change of flow pattern. Low resistance to blood flow in the SJMM-prosthesis could be verified by a smaller diastolic transvalvular gradient (SJMM: 2.8 +/- 1.1; BSM: 5.3 +/- 2.6 mmHg). In valves with equal tissue annulus diameters (29 mm) the calculated effective valve orifices were significantly different (SJMM: 2.83 +/- 1.3 cm2; BSM: 1.85 +/- 0.53 cm2). In both groups the mean pulmonary artery pressure was significantly reduced at the time of reinvestigation but increased under exercise. Durability may become a problem because of the 2 moving parts of SJMM but until now we have observed no malfunction. St. Jude Medical mitral valve seems to be a good alternative in heart valve replacement with prostheses of small sizes, both for the mitral and tricuspid valve.

[Natural history of patients with severe aortic valve disease under medical therapy (author's transl)]. / Natürlicher Verlauf operationswürdiger Aortenklappenvitien bei konservativer Therapie.

65 patients out of 420 with aortic valve lesions (class III and IV NYHA) who underwent cardiac catheterization in 1967-1976 were not operated upon for different reasons. The fate of these 65 patients was analyzed retrospectively to elucidate the natural history of severe aortic valve disease. The five years survival rate was 26% (aortic stenosis 17%, aortic incompetence 37%). Patients with angina pectoris and congestive heart failure, ventricular ectopic beats, mean pulmonary artery pressure greater than 30 mm Hg, mean left atrial pressure greater than 16 mm Hg and left ventricular enddiastolic pressure greater than 20 mm Hg had a significant worse prognosis than those without these parameters. Otherwise patients who refused the operation by personal reasons had a high survival rate. The results of the study indicate that patients with aortic valve disease class III or IV (NYHA) have a serious prognosis when treated medically. In comparison with our patients who underwent aortic valve replacement surgery has proven to be a life-prolonging procedure in these highly endangered cases.