The safety of treatment with recombinant human erythropoietin in clinical use: a review of controlled studies.

Recombinant human erythropoietin (rhEPO) has now been approved for the treatment of renal anemia, anemia of prematurity, cancer-associated anemia, AIDS-associated anemia and as concomitant treatment for patients with or without autologous blood donation awaiting elective surgery. The purpose of this review is to provide an overview, based on the results of controlled studies, of the anticipated safety profile of rhEPO in various indications and to assess whether treatment with rhEPO influences the incidences of certain adverse events in these indications. The anticipated adverse events differ from indication to indication and generally reflect the corresponding underlying illness. With most indications, no relevant differences in the incidences of adverse events are observed between rhEPO and placebo-control/patients. Only in the rhEPO therapy of renal anemia is an increased incidence of hypertensive events observed in the rhEPO groups, a finding that is not reproduced with the other indications. The controlled studies forming the basis of this review provide no evidence of a relevant increase in the risk of thromboembolic events during rhEPO therapy. Overall, it may be stated that rhEPO treatment, where strictly indicated, is a safe form of therapy. As with any other treatment, the risk of side effects in certain predisposed patients must also be weighed against the desired clinical benefits.

The estimation of efficacy of oral iron supplementation during treatment with epoetin beta (recombinant human erythropoietin) in patients undergoing cardiac surgery.

We estimated the efficacy of oral iron therapy during treatment with rhEPO in patients undergoing cardiac surgery who were contraindicated for autologous blood donation. Seventy-six patients were enrolled in this double-blind, placebo-controlled trial and assigned to the 2 treatment groups (5x500 U/kg body weight rhEPO or placebo intravenously over 14 d before surgery). During the treatment period all patients received 300 mg Fe2+ (iron glycine sulfate) orally per day. rhEPO therapy produced significant increases in hemoglobin concentration (Hb), reticulocyte count, hematocrit (Hct) and the hypochromic red blood cells (HRBC), and a decrease in transferrin saturation (41%) compared to the placebo group before surgery. However, the preoperative increase in HRBC was independent of the baseline ferritin and even correlated positively with the preoperative increase in Hct (r=0.47, p<0.01). In rhEPO patients there were inverse correlations between baseline serum iron and the preoperative increases in Hb (r=-0.39, p<0.05), Hct (r=-0.50, p<0.01) and HRBC (r=-0.53, p<0.001). With this treatment regimen the HRBC appear to reflect the degree of erythropoietic stimulation rather than functional iron deficiency. The preoperative increases in reticulocytes, HRBC and Hb/Hct in patients with ferritin <100 mg/l or transferrin saturation <16% showed no significant difference compared to their complementary groups. The preoperative decrease in storage iron and the inverse correlation between the baseline ferritin and the preoperative change in ferritin (r=-0.94, p<0.0001) in the rhEPO group indicate that the iron requirement for hemoglobin synthesis is probably covered by the breakdown of stored iron and an increase in the rate of absorption of orally administered Fe2+. Intravenous rhEPO treatment with 5x500 U/kg body weight in combination with 300 mg oral Fe2+/d given over 14 d before surgery is a suitable regimen to increase Hb by about 1.61 g/dl and Hct by 0.06.

Evaluation of erythropoietic activity on the basis of the red cell and reticulocyte distribution widths during epoetin beta therapy in patients undergoing cardiac surgery.

The changes in the red cell and reticulocyte distribution widths during preoperative treatment with recombinant human erythropoietin (rhEPO) were evaluated in a double-blind, placebo-controlled trial in cardiac surgery patients. The increases in the reticulocyte count, in the hemoglobin and in all distribution widths are the expression of the marked preoperative stimulation of erythropoiesis in the patients treated with rhEPO. Only placebo patients with a hemoglobin < or = 7.5 mmol/l or a transferrin > 4.0 g/l at baseline showed an increase in the red cell distribution width or in the reticulocyte hemoglobin distribution width on oral iron therapy alone. While the reticulocyte count and the distribution widths of red cells in the rhEPO patients decreased postoperatively, only the increases in the distribution widths of reticulocytes after the second postoperative day indicate that stimulation oferythropoiesis had taken place. In patients with a low hemoglobin or a high transferrin the rhEPO therapy should be preceded by iron therapy in order to raise the hemoglobin level and reduce the cost of treatment.

Kinetics of reticulocyte maturity fractions and indices and iron status during therapy with epoetin beta (recombinant human erythropoietin) in cardiac surgery patients.

We evaluated the changes in reticulocyte maturity fractions and indices, as measured by flow cytometry, during preoperative treatment with recombinant human erythropoietin (epoetin beta) in cardiac surgery patients. A total of 72 patients was enrolled in this double-blind, randomized, placebo-controlled clinical trial and assigned to the two treatment groups (5 x 500 U/kg bodyweight epoetin beta or placebo intravenously over 14 days preoperatively). Therapy with epoetin beta produced continuous increases in hematocrit/hemoglobin, in the most mature fraction of reticulocytes (LR), and in reticulocyte count. In the first treatment week there were parallel increases in the fraction of most immature reticulocytes (HR) and in the reticulocyte mean cell volume. During the second week of treatment the reticulocyte mean cell hemoglobin content (CHr) decreased, but CHr was independent of all iron parameters, affecting neither the reticulocyte fractions nor the hematocrit/hemoglobin increase. The total preoperative rise in hematocrit correlated with the rises in LR fraction (P = 0.0270) and reticulocyte count (P = 0.0486) during the first week of treatment. Whereas in the epoetin beta patients the preoperative change in HR fraction showed negative correlations with transferrin saturation at baseline (P = 0.0058) and with the preoperative change in iron (P = 0.0113), the preoperative change in the LR fraction correlated positively with transferrin at baseline (P = 0.0115). Postoperatively, the reticulocyte parameters revealed that the onset of increased stimulation of erythropoiesis did not occur in the placebo patients until the second postoperative day, whereas erythropoietic activity in the epoetin beta patients was much higher during the postoperative period as well, as a result of the preoperative stimulation of erythropoiesis. The reticulocyte parameters measured by flow cytometry permitted an objective analysis of erythropoietic activity during treatment with epoetin beta and in all patients postoperatively. Further studies in various types of epoetin beta therapy are needed in order to clarify the value of these reticulocyte parameters for identification of iron deficiency and optimization of epoetin beta treatment regimen.

The effect of preoperative recombinant human erythropoietin therapy on platelets and hemostasis in patients undergoing cardiac surgery.

In a double-blind, randomized, placebo-controlled trial we evaluated the effects of the administration of recombinant human erythropoietin (5 x 500 U epoetin beta/kg body weight intravenously over a 14-day period before surgery) in patients undergoing cardiac surgery and in whom autologous blood donation was contraindicated on platelet count, platelet distribution width, mean platelet volume (MPV), and certain hemostaseologic parameters. All patients received 3 x 70 IU heparin/kg per day s.c. from 2 days before operation. No thromboembolic events were associated with epoetin beta therapy during the study period. The thrombocytic parameters showed no significant changes in the placebo group before surgery, and the preoperative hematocrit increase in the epoetin beta group was accompanied with an MPV drop (in contrast to the known MPV rise in recombinant human erythropoietin-treated patients with uremia) by a mean of 0.85 fl and a platelet distribution width rise by 3.3% without a significant change in platelet count. In the epoetin beta group the coagulation time (K) of thromboelastogram (TEG) showed an increase from 4.8 to 5.4 minutes by the seventh study day and after the initiation of heparin therapy a further increase to 7.5 minutes. The higher preoperative K increase in the epoetin beta group may partly be a result of the MPV reduction, because smaller platelets are less reactive, a fact underlined by the negative correlation between the preoperative changes of MPV and reaction time of TEG (r = -0.58, p = 0.0148). In contrast, in the placebo group the K of TEG increased only after the start of heparin therapy (from 5.1 to 6.4 minutes). The significant drop in MPV in the epoetin beta group and the higher increase in K of TEG and the other investigated hemostatic parameters do not suggest any increased thromboembolic risk during the preoperative epoetin beta therapy. Therefore this treatment seems to be a safe way for increasing mean hematocrit by approximately 0.06 within the normal range and reducing the homologous blood requirement in patients undergoing elective cardiac surgery.

Evaluation of oxygen availability with oxygen status algorithm in patients undergoing open heart surgery treated with epoetin beta.

We evaluated in a double-blind randomized study the effect of epoetin beta (recombinant human erythropoietin) therapy on oxygen status in patients undergoing cardiac surgery who were contraindicated for autologous blood donation. All 76 patients enrolled in this study were randomized to the two treatment groups (5 x 500 U epoetin beta or placebo/kg body weight intravenously over a 14-day period before surgery) and received 300 mg Fe2+ per day orally before surgery. Before and after surgery the lactate level and the following parameters according to the oxygen status algorithm by Siggaard-Andersen were evaluated: arterial oxygen tension (PaO2), effective hemoglobin concentration (ceHb), arterial oxygen saturation (SaO2), oxygen half saturation tension (p50), red cell 2.3 diphosphoglycerate (2.3 DPG), arterial total oxygen concentration (ctO2), concentration of extractable oxygen (cx), and oxygen compensation factor (Qx). Therapy with epoetin beta led to increases in ceHb, PaO2, ctO2, and cx and to a decrease in Qx before surgery (p < 0.05 for PaO2, p < 0.0001 for the other parameters vs placebo). The cx in patients who received epoetin beta rose by approximately 20%, thus indicating a considerable improvement in O2 delivery. In patients receiving placebo the hemoximetric parameters remained outside the normal limits at all times after surgery, but in the epoetin beta group PaO2, ctO2, cx, and Qx returned almost to their baseline values by the second or fifth postoperative day, even though the frequency of transfusions was significantly higher in the placebo group. Whereas p50 and 2.3 DPG fell in the placebo group after surgery, these two parameters were significantly higher in the epoetin beta group and led to a further increase in cx (from 24% to 38%) versus the placebo group as a result of the right shift in the hemoglobin O2-binding curve. The postoperative incidence and severity of lactic acidosis were higher in the placebo group. Preoperative epoetin beta therapy is a safe way of providing increased extractable O2 (by 24% to 38%) and decreasing the risk of lactic acidosis after surgery. This therapy has a more favorable effect on the O2 binding curve than the transfusion of erythrocyte concentrate and enhances the effect of epoetin beta therapy on the postoperative oxygen status.

Avoidance of allogeneic blood transfusions by treatment with epoetin beta (recombinant human erythropoietin) in patients undergoing open-heart surgery.

In a double-blind, randomized, placebo-controlled trial, we evaluated the ability of epoetin beta (recombinant human erythropoietin) to avoid allogeneic blood transfusions (ABT) and the associated risks in patients undergoing primary elective open-heart surgery and in whom autologous blood donation (ABD) was contraindicated. Seventy-six patients overall were enrolled onto the trial and were randomly assigned to the two treatment groups, 5 x 500 U/kg body weight (BW) epoetin beta or placebo intravenously over 14 days preoperatively. All patients received 300 mg Fe2+ orally per day during the treatment period. Preoperatively, the mean hemoglobin increase was 1.50 g/dL greater in epoetin beta patients than in placebo patients (95% confidence interval, 1.10 to 1.90 g/dL), allowing a rapid return to the baseline value by the seventh postoperative day in most epoetin beta patients. The mean volume of blood collected by intraoperative isovolemic hemodilution was 562 mL (red blood cell mass, 274 mL) in the epoetin beta group and 218 mL (red blood cell mass, 94 mL) in the placebo group, respectively. Only four patients (11%) in the epoetin beta group received an ABT, compared with 19 (53%) in the placebo group (P = .0003). Epoetin beta was most useful in patients with a perioperative blood loss greater than 750 mL, in those with a baseline hematocrit value less than 0.42, and in those aged > or = 60 years. The iron supplementation proved adequate despite the fact that a significant decrease in ferritin (median, 48.1%) and transferrin saturation (median, 40.5%) was observed in epoetin beta patients preoperatively. No influence of epoetin beta therapy on blood pressure, laboratory safety variables, or the frequency of specific adverse events was observed. Intravenous epoetin beta treatment of 5 x 500 U/kg BW in combination with 300 mg Fe2+ orally per day administered over 14 days preoperatively is an adequate therapy for increasing mean hemoglobin levels by approximately 1.50 g/dL and reducing the allogeneic blood requirement in patients undergoing elective open-heart surgery and in whom ABD is contraindicated.

[Operations with a heart-lung machine in adult members of Jehovah's Witnesses]. / Operationen mit der Herz-Lungen-Maschine bei erwachsenen Patienten der Glaubensgemeinschaft "Zeugen Jehovahs".

Members of Jehovah's Witnesses refuse blood transfusions and blood products under any circumstances. Because of an improvement in blood salvage techniques in our centre, they are not excluded from open-heart surgery. In recent years recombinant human erythropoietin (rhEPO) has been applied to correct perioperative anemia in these patients. METHODS. Seventeen members of Jehovah's Witnesses who were more than 18 years of age were operated on using various blood salvage technique, e.g., haemoseparation and a high dose of Aprotinin. We present the first three patients treated with 4 x 500 U of i.v. rhEPO/kg body wt. given within 11 days preoperatively. Thirteen of the patients operated on had elevated preoperative risk factors, for instance poor left ventricle, severe aortic valve stenosis, metabolic syndrome, age older than 70 years, etc. In other centres that perform cardiac operations on members of Jehovah's Witnesses, these risk factors represent contraindications for open-heart surgery in these patients. RESULTS. Patients with rhEPO treatment showed a preoperative hematocrit increase of 7 Vol.% within 10 days and no postoperative complications. At the 6th postoperative hour the hematocrit returned to the starting values; in patients without rhEPO, however, the hematocrit generally had not increased to preoperative values even by the 8th day after operation. In 9 patients with preoperative elevated risk factors and a postoperative relative decrease in hematocrit below 33% we observed an uncomplicated postoperative period. Four patients with these risk factors, a pronounced decrease in hematocrit and blood loss postoperatively had various severe complications. CONCLUSIONS. Preoperative treatment with a high dose of rhEPO to enhance the hematocrit and maturity by precursor red blood cells in patients with a hematocrit below 45 Vol.% is a possibility to compensate for the blood loss perioperatively and to avoid complications from a decrease in oxygen transport capacity. The anaemia and high blood loss postoperatively are the main causes for a slightly elevated operation risk in members of Jehovah's Witnesses in all heart centres that perform cardiac operations on these patients. Nevertheless, Jehovah's Witnesses should be not excluded from cardiac operations, since open-heart surgery without use of homologous blood is becoming a routine procedure.

[Circulatory changes in acute sauna hyperthermia after heart transplantation]. / Kreislaufverhalten bei akuter Saunahyperthermie nach Herztransplantation.

The authors report on the influence of a single sauna-stay of patients following heart transplantation (HTX) during the rehabilitation phase III. Investigations of blood pressure, heart rate, changer in hemodynamics in the small and large vessels in 8 male patients following HTX (medium age: 42 years) showed that sauna-hyperthermia is well tolerated. We watched significant decreases of blood pressure (systolic and diastolic values), an improvement of the microcirculation in the small vessels, an increase of the left ventricular ejection fraction (LVEF) and a decrease of the total peripheric vascular resistance (TPVR). Possibilities and limitations of sauna-therapy for the therapy of risk factors following HTX especially under immunosuppression are discussed. First results are demonstrated.

[Autogenic training in hypertensive dysregulation after aortocoronary venous bypass operation of coronary heart disease]. / Autogenes Training bei hypertonen Regulations-störungen nach aortokoronarer Venenbypass-Operation (ACVB) bei koronarer Herzkrankheit.

The authors report on the influence of autogenous training on blood pressure at rest and under stress conditions in patients with coronary heart disease following coronary bypass operation. We investigated the influence of autogenous training on the microcirculation and the left ventricular ejection fraction (LVEF) as well. The results showed a significant decrease in blood pressure at rest and also an increase of muscle circulation F and of LVEF.

Treatment of tachyarrhythmias in a patient with the long QT syndrome by autotransplantation of the heart and sinus node-triggered atrial pacing.

The case history of a 37-year-old woman with the long QT syndrome and drug-refractory paroxysmal ventricular tachyarrhythmias is reported. She was resuscitated eight times between 1980 and 1987. The duration of these attacks increased from a few minutes to 8 hours and the interval between them decreased from 2 years to 4 weeks. An autotransplantation was performed of the anatomically and hemodynamically normal heart. She has had normal QT intervals and has been free of tachyarrhythmias since the operation in June 1987. Because of a slow escape low atrial rhythm, she was treated with a dual-chamber pacemaker programmed in the VDD mode with a coupling interval of 15 msec. The pacemaker wires were connected to the nontransplanted atrial cuff ("atrial" wire) and the transplanted atrium ("ventricular" wire). The hemodynamic effect of the resultant sinus node-driven low atrial pacing was restoration of normal values. This is the first report of successful autotransplantation of the heart for ventricular tachyarrhythmias caused by the long QT syndrome.

[Potential use of the sauna in the long-term treatment of hypertensive cardiovascular circulation disorders--a comparison with kinesiotherapy]. / Möglichkeiten des Einsatzes der Sauna in der Langzeitbehandlung von hypertonen Herz-Kreislauf-Regulationsstörungen--ein Vergleich zur Kinesiotherapie.

The authors report about the long-term response (one and three years) of blood pressure and heart frequency under rest and load (50 W) in patients with hypertension, coronary heart disease, essential hypertension and after aortocoronary venous-bypass operation (ACVB) (n = 65) under regular visits (twice a week) to the Finnish sauna. In comparison, 68 hypertensive patients who took a regular kinesiotherapy (running and swimming) were studied. Besides the parameters of heart circulation mentioned above, peripheric microcirculation (M. tibialis anterior) by means of xenon-133 muscle clearance and central hemodynamics by means of LVEF (single probe with In 113) were studied in CHD-patients. Cardiac output at rest and under 50 W load was recorded in hypertensive patients. It was shown that regular balneotherapy had a positive effect on regulation of blood pressure and hemodynamics in patients with hypertension or CHD with hypertension, as had kinesiotherapy in hypertensive patients.

Aortocoronary vascular prosthesis made of siliconized homologous vein or bovine sacral artery.

The purpose of our study was to develop and prepare aortocoronary prostheses, test them experimentally in multivascular and coronary reoperations in case of missing autologous grafts and to use them for shunt operations in cardiac surgery. Human vein or bovine sacral artery were used for preparing aortocoronary prostheses. As for metrics of 9-14 Charr. and a length of 20-30 cm were obtained. Aortocoronary prostheses were preformed according to the coronary configuration for left descending artery, circumflex artery and right coronary artery. Aortocoronary prostheses meet the conditions of desantigenicity, sterility, athrombogenicity, tightness and high tensile strength, tear propagation strength, bursting pressure and shrinkage temperature. Experimental testing was performed in dogs in aortofemoral and aortocoronary positions. Infections did not occur. The healing process and structural changes of aortocoronary vascular prostheses (grafts) were examined histologically and evaluated by means of scanning electron microscopic examinations. Athrombogenicity and healing-in without inflammation and calcification were proved.

[Coronary ventricular fistulas in patients with heart transplants]. / Koronarventrikuläre Fisteln bei herztransplantierten Patienten.

In detailed angiographic follow-up examinations in patients after heart transplantation, coronary artery-ventricular fistulas were observed in two of ten patients. In one patient, in the first postoperative year, 19 right ventricular biopsy procedures were performed obtaining a total of 71 tissue specimens and one year after transplantation, additionally, three specimens were obtained from the left ventricle. Coronary angiography demonstrated a fistula from the first anterior ventricular branch of the right coronary artery into the right ventricle (Figure 1) as well as a second smaller fistula between from a septal perforator of the left anterior descending artery into the left ventricle. At follow-up angiography two months later, the fistulas were unchanged in site and extent (Figure 2). Angiographically there was diffuse hypokinesis of the right ventricle and moderate tricuspid regurgitation. In the second patient, in the first year after transplantation, 20 right ventricular biopsy procedures were performed obtaining a total of 80 tissue specimens. One year after transplantation coronary angiography showed a fistula between a septal perforator of the left anterior descending artery into the right ventricle (Figure 3) which, two months later, was unchanged in morphology and, as in the first case, the size of the shunt was small. Angiographically, there was moderate tricuspid regurgitation and apical hypokinesis of the left ventricle. If a relationship between the fistulas and biopsies is postulated, from a total 196 biopsy procedures obtaining 748 tissue specimens, the rate of this complication would be calculated at 1.5%. It cannot be ruled out, however, that the fistulas had been congenitally present in the donor hearts.(ABSTRACT TRUNCATED AT 250 WORDS)

[Treatment of tachyarrhythmia in a patient with long QT syndrome by autologous heart transplantation and atrial stimulation controlled by the sinoatrial node]. / Lechenie takhiaritmii u bolnoi s sindromom udlinennogo intervala Q-T s pomoshch'iu autotransplantatsii serdtsa i stimuliatsii predserdii, upravliaemoi sinusovym uzlom.

The authors described an operation performed in a female patient aged 37 years who was first examined in 1980. That year she experienced the first ventricular fibrillation episode. The duration of the Q-T interval was 600 msec. She was examined by a comprehensive protocol which enabled coronary abnormalities to be excluded. The operation was made in July 1987 in the Charite Hospital by Dr. Warnke. The operation involved dissection of the nerve connections nearest the heart by cutting the pulmonary artery, aorta, both atria and subsequently suturing by the scheme used in cardiac grafting. The patient rapidly recovered after the surgery. She had a normal Q-T interval and no recurrences of ventricular tachycardias. Following the surgery she displayed disturbances of intraatrial conduction and pacemaker displacement into the lower segments of the right atrium, so she was implanted a DDD-mode pacemaker.

[Non-medicinal therapy tachycardiac arrhythmias]. / Nichtmedikamentöse Therapie tachykarder Herzrhythmusstörungen.

The conservative antiarrhythmic treatment was improved by the introduction of the Holter-ECG technique, of the serial electrophysiological testing and by new antiarrhythmic drugs. An essential enhancement of the therapeutic possibilities, particularly when ineffectiveness, proarrhythmic action or intolerance of the medicaments are existing, are increasingly the non-medicamentous techniques of the antiarrhythmic therapy. Thus the treatment of arrhythmia has become by far more effective, but at the same time also more complicated and more expensive. Between 1980 and 1989 altogether 53 patients were treated with anti-tachycardiac pacemakers (25), with an ablation of the bundle of His by means of catheter-mediated DC-shock application (20), with a direct surgical interruption of the bundle of Kent (5) as well as with the implantation of an automatic cardioverter/defibrillator (3). Indications, techniques and results of the individual methods are represented.

[Significance of echocardiography for the diagnosis and strategy in infectious endocarditis]. / Die Bedeutung der Echokardiographie für Diagnostik und Strategie bei infektiöser Endokarditis.

The echocardiographic results of 29 patients--clinically suspected of infective endocarditis--were compared with clinical, intraoperative, histologic, autoptic data and the available outcome of cardiac catheterization. The purpose of this retrospective study was to define the potential valence of echocardiography for planning of therapy and success. Valvular vegetations of different histological ages were established on 35 valves. The sensitivity was 96.3%, the specificity 100% considering this topic. Following visual assessed sonographical intensity of such vegetations echographical floridity was postulated. In 26 vegetations the sensitivity--considering this floridity statement--was 92% and the specificity 86% compared with the results of histology and intraoperative assessment. The type of pathogens and the time interval between beginning of the clinical symptomatic and the echocardiographic procedure were important for the prognosis in this study. In the case of longer latency time prevailed bivalvular vegetations (n = 6) combined with a high mortality. No patient died in the case of univalvular vegetations. The whole group had a mortality of 17.2%. Considering these results using echocardiographic methods an exact identification of vegetations (infective and noninfective) and additional a quantification of subsequent valvular damaging and actual ventricular function is possible. A qualified sonographical technique permits an earlier diagnosis of bacterial endocarditis (especially in the absence of bacteriaemia) and in the followings a more opportune indication for prosthetic valve replacement.

[Nosocomial infections and sternum osteomyelitis]. / Nosokomiale Infektionen und die Sternumosteomyelitis.

A prospective study of the nosocomial infection rate in the Department of Cardiac Surgery of the Surgical Clinic (Charité) was done between January and December 1987. The investigation was performed computer aided. Data were recorded by an infection register. From 474 hospitalized operated patients 66 (14%) had some kind of nosocomial infection: at the first place wound infections with 5.1% (sternum osteomyelitis 2.1%), respiratory infections with 3.8% and infections of the urogenital system with 3.4%. The way of infection, selected predisposing and exposing factors, the microbacterial spectrum of wound infection, the antimicrobacterial chemotherapeutic strategy and surgical therapy are analyzed and demonstrated.

[Percutaneous coronary angioplasty in chronic coronary disease with single and multiple obstructed vessels (analysis of 315 interventions 1978-1988)]. / Die perkutane koronare Angioplastie (PTKA) bei chronischer koronarer Herzkrankheit mit Ein- und Mehrgefässobstruktionen (Analyse von 315 Eingriffen 1978-1988).

315 percutaneous transluminal coronary angioplasties performed during 1978-1988 in 261 patients with ischemic heart disease were analyzed for three different variants according to primary effectiveness, failure rate the most frequent complications and costs of materials as well as duration of intervention and fluoroscopy. Only variant 3 of the proceeding (soft-tip-applicators, flat profile balloon catheter, Kaltenbach long-wire technique, streptokinase rinsing of instruments, permanent infusion of instruments during the procedure) is an applicable routine method. It has a primary effectiveness of 86%. For multiple vessel PTCA this variant however resulted in significantly prolonged investigation and fluoroscopy intervals, so it is advisable only for selected groups of patients.

[Castaneda-de Leval's modified Fontan operation in complex cyanotic defects with subsequent percutaneous transluminal embolization of systemic pulmonary collaterals]. / Modifizierte Fontan-Operation (nach Castaneda-de Leval) bei komplexem zyanotischem Vitium mit nachfolgender perkutaner transluminaler Embolisation von system-pulmonalen Kollateralen (PTE).

The case of a five year old boy with a double-inlet-left-ventricle and the aorta in 1-malposition, large VSD, ASD and pulmonary stenosis is reported, that showed after modified Fontan surgery severe effusions and a severe protein loss syndrome. Aortopulmonary collaterals were detected as the cause of this and successfully treated in several sessions by percutaneous transluminal embolization.