Fibrinogen/LDL apheresis as successful second-line treatment of sudden hearing loss: a retrospective study on 217 patients.

BACKGROUND: Sudden sensorineural hearing loss (SSHL) may be caused by a reduction of cochlear perfusion. Cholesterol and fibrinogen negatively influence rheological properties of blood thus leading to alteration of microcirculation. Fibrinogen/LDL apheresis improves cochlear blood flow by acutely decreasing plasma cholesterol and fibrinogen. METHODS: Remission rates of 217 patients with SSHL were analysed retrospectively after single apheresis. All patients had been treated otherwise before without any improvement of hearing. We investigated data in regard to frequency of hearing loss and time between onset of symptoms and apheresis. RESULTS: 15% of all patients had complete remissions, whereas partial remissions were seen in 46%. No change of hearing threshold was seen in 33%, 2% worsened. Remission rates decreased from 70% for a time of 2 weeks between onset of SSHL and apheresis to 63% and 21% for 6 weeks and 3 months. CONCLUSION: The present study shows that apheresis was followed by complete or partial remissions in 61% of patients even as second line therapy. The window for good therapeutic success is approximately 6 weeks.

[Fibrinogen/LDL apheresis for treatment of sudden hearing loss: an observational study on 152 patients]. / H.E.L.P.-Apherese bei der Behandlung des Hörsturzes: Eine Anwendungsbeobachtung an 152 Patienten.

Disturbances of cochlear microcirculation are among the most discussed causes of sudden sensorineural hearing loss. Increased levels of cholesterol and fibrinogen seem to act as risk factors for inner ear disorders. Fibrinogen/LDL apheresis greatly reduces the concentration of plasma fibrinogen thus leading to improved cochlear blood flow. In a retrospective case series remission rates of 152 patients suffering from sudden sensorineural hearing loss and resistant to former treatment were investigated after treatment with a single apheresis. Complete remission was reported in 11% of patients, partial remission in 43%. 37% had no change of hearing threshold and 2% reported a decrease in hearing. Rates of complete remissions decreased from 22% within the first 2 weeks after onset of hearing loss to 14% after 6 weeks. In the same period of time rates of partial remissions decreased from 33% to 13%. The present study shows that apheresis achieved complete or partial remission in 54% of patients even after unsuccessful treatment with another therapy and the therapeutic window lies by approximately 6 weeks.

[The incidence of sudden hearing loss is greater than previously assumed]. / Praktische Erfahrung bestätigt. Hörsturz wesentlich häufiger als bisher angenommen.

The global incidence of sudden hearing loss is quoted to be 5-20 new cases/100,000 inhabitants/year. In the opinion of the present authors, the data on which these figures are based, are too old, methodologically questionable and non-transferable. An analysis of data from the compulsory health insurance carriers in Baden-Württemberg and the Nordrhein district suggests that an appreciably higher incidence must be assumed for Germany. Statistical processing of the numerical data of all cost carriers is necessary if we are to obtain an accurate incidence for Germany.

[Treatment of sudden hearing loss through Fibrinogen/LDL-apheresis. A prospective, randomized multicenter trial]. / Behandlung des Hörsturzes durch Fibrinogen-LDL-Apherese. Eine prospektive randomisierte Multizenterstudie.

INTRODUCTION: Sudden sensorineural hearing loss (SSHL) is thought to be of various origins. Disturbances of microcirculation, autoimmune pathology and viral infection are among the most likely causes. Acute reduction of plasma fibrinogen and serum LDL positively influences hemorheology and endothelial function and might thus be an effective therapy for SSHL. OBJECTIVE: To test the hypothesis that fibrinogen/LDL-apheresis is as effective or superior to conventional therapy with plasma expanders and prednisolone in the treatment of SSHL. DESIGN: controlled, prospective, randomized, multicenter trial. SETTING AND PATIENTS: 201 patients were recruited from 01/2000 to 6/2001 at the University Clinics of Munich, Berlin, Hamburg and Bochum. Inclusion criteria was sudden sensorineural hearing loss of unknown origin within 6 days of onset. INTERVENTIONS: Single fibrinogen/ LDL-apheresis infusion of prednisolone (250 mg, tapered by 25 mg daily), hydroxyethyl starch (500 ml, 6%) and pentoxifylin (400 mg/day). MAIN OUTCOMES: Improvement of pure tone thresholds 48 h after onset of therapy. RESULTS: Over all improvement of pure tone thresholds in the fibrinogen/ LDL-apheresis treated patients is slightly but not significantly better than in the standard therapy group. After 48 h, 50% speech perception in the fibrinogen/ LDL-apheresis group (21.6+/-20.1 dB) is significantly (p<0.034) better than in the standard group (29.3+/-29.4 dB). Patients with plasma fibrinogen levels of more than 295 mg/dl have a substantial and significantly (p<0.005) better improvement of speech perception (15.3+/-17.3 dB) than standard treated patients (6.1+/-10.4 dB). CONCLUSIONS: Fibrinogen/LDLapheresis is at least equally effective compared to prednisolone treatment in sudden hearing loss. Selected patients with plasma fibrinogen of more than 295 mg/dl improve significantly better when treated with fibrinogen/LDLapheresis.

[Health care economics evaluation of inpatient treatment of venous thrombosis with unfractionated heparin versus subcutaneous low molecular weight heparin at home]. / Gesundheitsökonomische Evaluation der Behandlung venöser Thrombosen mit intravenösem unfraktioniertem Heparin stationär versus subkutanem niedermolekularem Heparin zu Hause.

BACKGROUND: An intravenous course of unfractionated heparin as initial treatment is the standard method to treat venous thromboembolism. Increasing scientific knowledge indicates that subcutaneous low-moleculare-weight heparin is just as effective and save as unfractionated heparin. A possible advantage of low-moleculare-weight heparin is the cost saving potential in minor hospitalisation days. Both therapies will be continued for at least three months with an oral anticoagulative. Because hospitalisation belongs to the cost-intensivest factors in the German health care system the question of a health economic difference between both initial treatments raises. METHOD: We transformed published empirical evidences to the German health care system, valued them in a cost analysis for a hypothetical cohort of 100 patients and compared the outcome intertherapeutically. RESULT AND CONCLUSION: From perspective of sickness insurance fund as cost unit we estimate that a partial in hospital initial treatment with subcutaneous low-moleculare-weight heparin is more cost-effective than a total in-hospital initial treatment with unfractionated heparin.

[Public health economic evaluation of screening for APC resistance (Leiden mutation) in new oral contraceptive users]. / Gesundheitsökonomische Evaluation des Screenings auf APC-Resistenz (Mutation Leiden) bei Neuanwenderinnen von Ovulationshemmern

BACKGROUND: Thromboembolic events in users of oral contraceptives rank among the most important complications with potential economic consequences. It is well known that a large part of thromboembolic complications correlates with hereditary thrombophilias. The relative high prevalence of the newly described resistance of activated protein C and an easy test for it rise up the question if general screening of new users of oral contraceptives is sensible of health economic view. METHOD: We conducted a cost-effectiveness analysis using decision analytic techniques, analysing the costs and outcomes in a hypothetical cohort of 10,000 women. RESULT AND CONCLUSION: From a third party payer perspective we estimate that screening for APC resistance by new users of oral contraceptives is more cost-effective than many other primary preventive methods. The cost per life-year gained of testing for APC resistance were in the order of DM 1544,--including direct medical cost only. From perspective of sickness insurance fund as cost unit we estimate that screening for APC resistance by new users of oral contraceptives is more cost-effective than many other primary preventive methods.