Das neue Bewertungsverfahren zur Erstattung digitaler Gesundheitsanwendungen (DiGA) aus Sicht der gesetzlichen Krankenversicherung

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz - Seit Herbst 2020 stehen die ersten digitalen Gesundheitsanwendungen (DiGA) flächendeckend als Leistung der gesetzlichen...     

Intramyocardial Oxygen Monitoring in Coronary Artery Bypass Surgery

OBJECTIVE: In coronary artery bypass surgery various parameters have been used to monitor patients clinical status. Direct monitoring of myocardial oxygenation can be performed by measuring intramyocardial partial oxygen tension pressure (p ti O2). This study was performed to determine the perioperative time course of this parameter in correlation to standard monitoring parameters. METHODS: Twenty-three patients underwent standard coronary artery bypass grafting (CABG). A special polarographic microprobes was inserted into the myocardium in the distribution zone of the left anterior descending artery which was one of the target vessels of myocardial revascularization. Intramyocardial p ti O2 was monitored intra- and up to 12 hours postoperatively. Values were correlated to hemodynamic, oxygenation and procedure associated parameters. RESULTS: Myocardial oxygenation during CABG is characterized by a significant decrease of p ti O2 during cross-clamping and a significant increase after removal of the cross-clamp. The postoperative time course of p ti O2 shows a steady increase of p ti O2 in the first 12 postoperative hours investigated. Preoperative ejection fraction as well as cardio-pulmonary bypass time does not seem to have an influence on the postoperative p ti O2 in these patients. Various standard monitoring parameters show complex influence on intramyocardial p ti O2- CONCLUSIONS: Determination of intramyocardial partial oxygen pressure in patients undergoing bypass surgery shows characteristic changes. Changes in p ti O2 as a direct online parameter of myocardial oxygenation occur immediately after procedures that influence myocardial perfusion and therefore, may help to detect potential complications earlier than standard monitoring parameters in cardiac surgery.     

Beitrag zur Pharmakologie der anorganischen Rhodanide

Ohne ZusammenfassungAus dem Physiologisch-Pharmakologischen Laboratorium des ReichsgesundheitsamtesMit 2 Textabbildungen.     

Ouabain-like compound changes rapidly on physical exercise in humans and dogs: effects of beta-blockade and angiotensin-converting enzyme inhibition

Ouabain, an inhibitor of the sodium pump, has been identified as a constituent of bovine adrenal glands. We were interested whether the release of this cardiotonic steroid is stimulated by physical exercise. Hence, athletes and healthy dogs were subjected to ergometry. Ouabain-like compound (OLC) was measured in venous blood by enzyme-linked immunosorbent assay as well as by (86)Rb+ uptake inhibition (as ouabain equivalents). OLC increased in venous blood of athletes after 15 minutes of ergometry from 2.5+/-0.5 to 86.0+/-27.2 nmol/L (n=51; P<0.001), as did the concentration of a circulating inhibitor of the sodium pump from 7.3+/-1.7 to 129.8+/-51 nmol/L (ouabain equivalents, P<0.05). Half-maximal increase in heart rate and systolic blood pressure occurred at 5.1+/-1.2 nmol/L and at 30+/-1 nmol/L OLC, respectively. On rest, OLC decreased in humans and dogs with a half-life of 3 to 5 minutes. In beagles exposed to moderate exercise on a treadmill for 13 minutes, levels of OLC increased 46-fold (from 3.7+/-0.8 to 166.9+/-91.8 nmol/L; n=6; P<0.005). This effect was suppressed when the dogs had been treated for 3 weeks with the beta1-adrenergic receptor blocker atenolol or the angiotensin-converting enzyme inhibitor benazepril. We conclude that OLC changes rapidly during exercise and is under the control of norepinephrine and angiotensin II.     

Health economic evaluations comparing insulin glargine with NPH insulin in patients with type 1 diabetes: a systematic review

Background

Compared to conventional human basal insulin (neutral protamine Hagedorn; NPH) the long-acting analogue insulin glargine (GLA) is associated with a number of advantages regarding metabolic control, hypoglycaemic events and convenience. However, the unit costs of GLA exceed those of NPH. This study aims to systematically review the economic evidence comparing GLA with NPH in basal-bolus treatment (intensified conventional therapy; ICT) of type 1 diabetes in order to facilitate informed decision making in clinical practice and health policy.

Methods

A systematic literature search was performed for the period of January 1st 2000 to December 1st 2009 via Embase, Medline, the Cochrane Library, the databases GMS (German Medical Science) and DAHTA (Deutsche Agentur für Health Technology Assessment), and the abstract books of relevant international scientific congresses. Retrieved studies were reviewed based on predefined inclusion criteria, methodological and quality aspects. In order to allow comparison between studies, currencies were converted using purchasing power parities (PPP).

Results

A total of 7 health economic evaluations from 4 different countries fulfilled the predefined criteria: 6 modelling studies, all of them cost-utility analyses, and one claims data analysis with a cost-minimisation design. One cost-utility analysis showed dominance of GLA over NPH. The other 5 cost-utility analyses resulted in additional costs per quality adjusted life year (QALY) gained for GLA, ranging from ?3,859 to ?57,002 (incremental cost effectiveness ratio; ICER). The cost-minimisation analysis revealed lower annual diabetes-specific costs in favour of NPH from the perspective of the German Statutory Health Insurance (SHI).

Conclusions

The incremental cost-utility-ratios (ICER) show favourable values for GLA with considerable variation. If a willingness-to-pay threshold of £ 30,000 (National Institute of Clinical Excellence, UK) is adopted, GLA is cost-effective in 4 of 6 cost utility analyses (CUA) included. Thus insulin glargine (GLA) seems to offer good value for money. Comparability between studies is limited because of methodological and country specific aspects. The results of this review underline that evaluation of insulin therapy should use evidence on efficacy of therapy from information synthesis. The concept of relating utility decrements to fear of hypoglycaemia is a plausible approach but needs further investigation. Also future evaluations of basal-bolus insulin therapy should include costs of consumables such as needles for insulin injection as well as test strips and lancets for blood glucose self monitoring.     

Über klinisch-experimentelle Untersuchungen mit Eiweißhydrolysaten bei Rachitis

Zusammenfassung Das Rachitisproblem ist durch die Entdeckung des Vitamin D nicht voll gelöst worden. Die Bedeutung der Eiweißstoffe für den Mineralstoffwechsel ist erheblich größer, als bisher beachtet wurde. Vor allem scheint der ultrafiltrable, komplexgebundene Anteil des Calcium im Serum die Fraktion zu sein, die den Calciumstoffwechsel beherrscht und sie ist es, die die größte Beziehung zu den Eiweißabbauprodukten (Peptone, Peptide, Aminosäuren) hat. Auch der Verkalkungsprozeß steht mit den Eiweißkörpern in direktem Zusammenhang.Aus diesen Gründen wurde mit einem Caseinhydrolysat Aminotrat (Nordmarkwerke) versucht, auf die Rachitis bei Ratten, Frühgeburten und Reifgeborenen einen Einfluß auszuüben, ohne daß ein Erfolg erzielt werden konnte. Auch mit dem 24% Peptide enthaltenden fermentativen Caseinhydrolysat Aminosol (Vitrum) wurde ein gleich negatives Ergebnis erhalten.Untersuchungen an Neugeborenen ergaben einen Anstieg des kindlichen Weichschädels auf 22,3% bei Reifgeborenen. Aus diesem Grunde werden Beziehungen zu der Eiweiß- und Calciumresorption werdender Mütter erörtert.In der Annahme, daß neben der Vigantolwirkung ein richtiges Zusammenspiel aller Nährstoffe ebenso wichtig ist für die Behebung wie die Verhütung der Rachitis, wird besonders auf die Zusammenhänge von Calcium- und Mineralstoffwechsel hingewiesen und sowohl für die werdenden wie stillenden Mütter eine genügende Eiweiß- und Kalkzufuhr in physiologischer Form gefordert. Bei der Frühgeburt besteht neben der Störung der Resorption wahrscheinlich auch eine Verwertungsstörung, durch die auch in aufbereiteter Form zugeführte Nährstoffe nicht voll zur Wirkung kommen können. Es muß daher versucht werden, in den Mineralstoffwechsel auch in einer für die Frühgeburt verwertbaren Form einzugreifen.     

Intramyocardial partial oxygen pressure in patients undergoing transmyocardial laser revascularization and bypass surgery

OBJECTIVE: Numerous investigations could not clarify the exact mechanism of transmyocardial laser revascularization (TMLR). The aim of this study was to investigate, whether TMLR leads to an increase of myocardial oxygenation in comparison to patients undergoing coronary artery bypass grafting (CABG). DESIGN: Twelve patients (TMLR group) underwent TMLR alone with an 800 W CO2 laser through a left anterior thoracotomy. Seventeen patients (CABG group) underwent standard CABG. Myocardial oxygenation was determined by measuring intramyocardial partial oxygen pressure (ptiO2 ). PtiO2 was measured online and mean values at 1, 24, 32, and 48 h postoperatively were compared with baseline before intervention. Parameters influencing ptiO2 (arterial pO2, hemodynamic parameters, hemoglobin) were recorded. RESULTS: Mean baseline ptiO2 was significantly lower in the TMLR group compared with the CABG group (p < 0.05). In both groups ptiO2 increased significantly in the postoperative course, whereby ptiO2 in the TMLR group was significantly lower compared with the CABG group. CONCLUSION: Although the exact mechanism of action of TMLR remains unclear, ptiO2 and thus oxygen supply in the myocardium increased in patients undergoing TMLR at least in the early postoperative course. However, ptiO2 increased to a lesser extent compared with CABG.     

Transcatheter aortic valve implantation in patients with severely reduced left ventricular systolic function: a single-center experience

Aims

Current guidelines consider severe systolic left ventricular dysfunction [ejection fraction (EF) ≤20 %; left ventricular dysfunction (LVD)] a contraindication for transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the efficacy and safety of TAVI in this extreme risk subset of patients.

Methods and Results

The study population (253 patients) was divided into two groups; the LVD group [21 patients with left ventricular ejection fraction (LVEF) ≤20 %] and the control group (232 patients with LVEF >20 %). TAVI was generally performed transfemorally under analgosedation without mechanical circulatory support. Clinical and hemodynamic variables, as well as procedural and follow-up outcomes, were compared, and all events were defined according to the Valve Academic Research Consortium criteria for event definition. Mean EF in the LVD group was 18.3 ± 2.9 % compared to 50.9 ± 11.3 % in the control group. Patients in the LVD group were younger, more commonly males, had higher logistic EuroSCORE and lower mean aortic pressure gradients. Immediate procedural mortality was low and similar in both groups (0 vs. 2.2 % in the LVD and control group, respectively, p = 0.49). At 30 days, post-procedural vascular and bleeding complications as well as strokes were similar, but all-cause mortality was higher in the LVD group (14.3 vs. 3.4 %, p = 0.05). In the survivors of the LVD group, New York Heart Association functional class and LVEF significantly improved at 30 days and 6 months. Survival at 1 and 2 years was 70.2 vs. 86.0 % and 56.1 vs. 78.3 % in the LVD and control group, respectively (log-rank p = 0.03).

Conclusions

TAVI without mechanical circulatory support appears feasible, safe and effective in patients with severe aortic stenosis and severe LVD, but short- and long-term mortality remain high. TAVI should be considered a viable treatment option in this subset of extremely compromised patients.     

Resource use and treatment costs after kidney transplantation: impact of demographic factors, comorbidities, and complications

BACKGROUND: Our goal was to quantify outcomes, resource use, and treatment costs for the first 2 years after renal transplantation in a "real-life" European setting and to assess the impact of preoperative risk factors and postoperative complications on treatment costs. METHODS: Inpatient and outpatient records of all patients who received a renal transplant at Medizinische Hochschule Hannover, Germany, between January 1998 and July 2000, were evaluated. Key clinical events were recorded. Direct costs were calculated for primary hospitalization, the remainder of year 1, and year 2 after transplantation. Cost of organ procurement, pretransplant care, and transplant surgery were excluded. Cost consequences for key clinical events were determined. RESULTS: Of 204 patients undergoing transplantation, 195 and 149 completed 1 year and 2 years of follow-up, respectively. The outcomes of years 1 and 2, respectively, were as follows: graft failure, 5.4%, 0.7%; acute rejection, 35.9%, 5.4%; cytomegalovirus (CMV) infection, 29.2%, 2.0%; and delayed graft function, 30.9%. Costs for primary hospitalization, the remainder of year 1, and year 2 averaged Euro 15,380, Euro 18,636, and Euro 14,484, respectively. Cost-driving events included graft failure Euro 36,228), acute rejection (Euro 9,638), delayed graft function (Euro7,359), and CMV infection (Euro 4,149). Graft failure and acute rejection for year 1 also added significantly to the costs for year 2. CONCLUSIONS: These results show that posttransplant clinical outcomes result in a significant increase in treatment costs. Because the economic impact of primary causes of chronic rejection (acute rejection and CMV) and delayed graft function is substantial, careful selection of the most appropriate immunosuppressive regimen is essential.     

Time-trends in the epidemiology of peptic ulcer bleeding

OBJECTIVE: Despite the introduction of effective medical treatment of peptic ulcer disease, bleeding is still a frequent complication. The aim of this study was to investigate whether the incidence and the risk profile of peptic ulcer haemorrhage have changed within a 10-year period. MATERIAL AND METHODS: In a prospective epidemiological and observational study the incidence and risk profile of peptic ulcer haemorrhage in Düsseldorf, Germany were compared between two time periods (period A: 1.3.89-28.2.90 and period B: 1.4.99-31.3.2000), involving nine hospitals with both surgical and medical departments. Patients with proven peptic ulcer haemorrhage at endoscopy or operation were included in the study; those with bleeding under defined severe stress conditions were excluded. RESULTS: No differences in bleeding ulcer incidence were observed between periods A and B (51.4 per 100,000 person-years versus 48.7), or for duodenal ulcer (24.9 versus 25.7) or for gastric ulcer bleeding (26.5 versus 23.0). A marked increase in incidence rates was observed with increasing age. In period B, patients with bleeding ulcers were older (56% versus 41% 70 years or older), were usually taking non-steroidal anti-inflammatory drugs (NSAIDs) (45% versus 27%) and were less likely to have a history of ulcer (25% versus 59%) compared with patients in period A. CONCLUSIONS: The persisting high incidence of peptic ulcer disease is a superimposing of two trends: a higher incidence in the growing population of elderly patient with a higher intake of NSAIDs and a lower incidence among younger patients due to a decrease in incidence and improved medical treatment.