House dust mite SCIT reduces asthma risk and significantly improves long-term rhinitis and asthma control-A RWE study.

BACKGROUND: The German Therapy Allergen Ordinance (TAO) triggered an ongoing upheaval in the market for house dust mite (HDM) allergen immunotherapy (AIT) products. Three HDM subcutaneous AIT (SCIT) products hold approval in Germany and therefore will be available after the scheduled completion of the TAO procedure in 2026. In general, data from clinical trials on the long-term effectiveness of HDM AIT are rare. We evaluated real-world data (RWD) in a retrospective, observational cohort study based on a longitudinal claims database including 60% of all German statutory healthcare prescriptions to show the long-term effectiveness of one of these products in daily life. Aim of this analysis was to provide a per product analysis on effectiveness of mite AIT as it is demanded by international guidelines on AIT. METHODS: Subjects between 5 and 70 years receiving their first (index) prescription of SCIT with a native HDM product (SCIT group) between 2009 and 2013 were included. The exactly 3:1 matched control group received prescriptions for only symptomatic AR medication (non-AIT group); the evaluation period for up to 6 years of follow-up ended in February 2017. Study endpoints were the progression of allergic rhinitis (AR) and asthma, asthma occurrence and time to the onset of asthma after at least 2 treatment years. RESULTS: In total, 892 subjects (608 adults and 284 children/adolescents) were included in the SCIT group and 2676 subjects (1824 adults and 852 children/adolescents) in the non-AIT group. During the follow-up period after at least 2 years of SCIT, the number of prescriptions in the SCIT group was reduced by 62.8% (p < .0001) for AR medication and by 42.4% for asthma medication (p = .0003). New-onset asthma risk was significantly reduced in the SCIT vs non-AIT group by 27.0% (p = .0212). The asthma-preventive effect of SCIT occurred 15 months after start of the treatment. In the SCIT group, the time to onset of asthma was prolonged compared to the non-AIT group (p = .0010). CONCLUSION: In this first product based RWD analysis on SCIT with a native HDM product, patients aged 5 to 70 years benefited from AIT in the long term in terms of reduced progression of AR and asthma after at least 2 years of treatment. The effects seemed to last for up to 6 years after treatment termination. A significantly reduced risk of asthma onset was observed, starting after 15 months of treatment.

Real-world evidence for the long-term effect of allergen immunotherapy: Current status on database-derived European studies.

Randomized controlled trials (RCTs) are the gold-standard for benefit-risk assessments during drug approval processes. Real-word data (RWD) and the resulting real-world evidence (RWE) are becoming increasingly important for assessing the effectiveness of drug products after marketing authorization showing how RCT results are transferred into real life care. The effectiveness of allergen immunotherapy (AIT) has been assessed in several RWE studies based on large prescription databases. We performed a literature search for retrospective cohort assessments of prescription databases in Europe to provide an overview on the methodology, long-term effectiveness outcomes, and adherence to AIT. Thirteen respective publications were selected. AIT was more effective in reducing the progression of allergic rhinitis (AR) compared to a non-AIT control group receiving only symptomatic treatment for AR for up to 6 years. The development and progression of asthma were hampered for most endpoints in patients treated with most preparations compared to the non-AIT group, receiving only anti-asthmatic medication. The results for "time to onset" of asthma were inconsistent. Adherence to AIT decreased during the recommended 3-year treatment period, however, in most studies higher adherence to subcutaneous than to sublingual AIT was shown. The analysis of long-term effectiveness outcomes of the RWE studies based on prescription databases confirms the long-term efficacy of AIT demonstrated in RCTs. Progression of rhinitis and asthma symptoms as well as delayed onset of asthma triggered by different allergens, real life adherence to the treatment shows differences in particular application routes.

Foot and Ankle Surgical Incision Closure With Three Different Materials.

There is no clear recommendation for wound closure material in foot and ankle surgery. Thus, we hypothesized that there was no difference in clinical outcomes among 3 suture materials, namely, absorbable sutures, nonabsorbable sutures, and metallic staples. This study compared the 3 materials for wound closure in foot and ankle surgery. In this prospective randomized study, 124 patients were randomly divided into the nonabsorbable suture group, absorbable suture group, and staple group. ASEPSIS score, Hollander Wound Evaluation Scale, and numerical rating scale (regarding pain and satisfaction) were collected at first dressing changes, suture removal, and 6 weeks after surgery. Suture time and incision length were recorded. No significant differences were detected for the ASEPSIS and Hollander Wound Evaluation Scale scores. There was significantly more pain after 6 weeks in the nonabsorbable suture group. The closure time (13 s/cm) with staples was significantly lower in the nonabsorbable suture group than in the other groups. Regardless of wound closure material, male sex and obesity appeared to be associated with a higher risk for the occurrence of wound complications. The 3 suture materials showed no significant differences regarding the frequency of wound complications. Staples and absorbable sutures should therefore be considered in the repertoire of suture materials used in foot and ankle surgery.

Real-world evidence of subcutaneous allergoid immunotherapy in house dust mite-induced allergic rhinitis and asthma.

BACKGROUND: The objective of this study was to analyze the effectiveness of allergen immunotherapy (AIT) with an allergoid in the treatment of house dust mites (HDM)-induced allergic rhinitis and/or asthma based on recent real-life data. The outcomes were measured using asthma incidence and consumption of corresponding medications as the indicator of persisting symptoms. METHODS: In this retrospective cohort analysis of a German longitudinal prescription database, patients who received at least two relevant mite AIT prescriptions in two different successive seasonal cycles were compared with non-AIT patients who received at least three symptomatic allergic rhinitis (AR) prescriptions in successive mite seasons. Study endpoints included AR progression, asthma progression, asthma occurrence, and therapy adherence. We used multivariate regression analyses to estimate the effects of AIT, adjusting for relevant variables. RESULTS: This study included 2350 patients receiving a mite allergoid and 64 740 control patients. After up to 6 years of follow-up, patients treated with mite allergoid required significantly fewer AR and asthma prescriptions (59.7% vs 10.8%) than the control group, and the probability of asthma development was significantly lower. The adherence of patients receiving allergoid was 63.8% at the end of the second year and 38.6% at the end of the third year. CONCLUSIONS: This real-world evidence confirms the good efficacy of subcutaneous AIT with HDM mite allergoid in the treatment of allergic rhinitis and/or asthma. Up to 6 years of follow-up revealed significant effects in allergic rhinitis by measuring the number of AR medications and demonstrating significant reductions in asthma medications.

Ambulatory screening and decontamination to prevent Staphylococcus aureus complications in patients undergoing elective surgery (STAUfrei): study protocol for a controlled intervention study.

BACKGROUND: Surgical site infections (SSI) are the most common health care associated infections in German acute hospitals and can result in prolonged hospital stays, increased use of antibiotics and utilisation of care. Staphylococcus aureus bacteria (methicillin-resistant S Aureus (MRSA) and methicillin-susceptible S Aureus (MSSA)) are amongst the most prominent causes of SSI. While up to 90% of documented S Aureus colonization is already detectable prior to hospital admission, the majority of hygiene measures in Germany is focused on the hospital setting. It is hypothesized that early detection and decontamination of S Aureus colonization in primary care can prevent health care associated infections and reduce the number of S Aureus isolates in the hospital setting. METHODS: This study is a controlled interventional study (N = 13,260) with a pre-post comparison. The intersectoral intervention (over 2 years) will encompass the following elements: ambulatory detection and decontamination of MRSA and MSSA prior to elective surgery combined with a structured follow-up care. Patients from the control group will be screened in the hospital setting, in accordance with the standard operating procedure (SOP) in routine care. The primary endpoint is the reduction of MRSA and MSSA colonization upon hospital admission. Secondary endpoints are complication rate (SSI), length of stay, recolonization of patients (3 and 6 months after release), patient and provider satisfaction, patient compliance and cost development. DISCUSSION: In case of positive results, the chance of a widespread uptake and implementation in routine care are considered high. The active involvement of primary care providers in the implementation of screening and decontamination as well as follow-up care is a unique feature of this study. The positive resonance of primary care providers during the recruitment phase highlights the relevance of the topic to the participating actors. These efforts are coupled with patient education and specifically trained medical staff, promising a sustained impact. The STAUfrei care pathway can homogenize current practices in routine care and provide a template for further intersectoral cooperation. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), DRKS00016615. Registered on April 1st, 2019.

Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study.

BACKGROUND: Venous thromboembolism (VTE, including deep vein thrombosis [DVT] and pulmonary embolism [PE]) has an annual incidence rate of 104-183 per 100,000 person-years. After a VTE episode, the two-year recurrence rate is about 17%. Consequently, effective and safe anticoagulation is paramount. Edoxaban is a direct oral anticoagulant (DOAC) approved VTE treatment. Current safety and efficacy data are derived from clinical trials, and information about treatment durations beyond 12 months are not available. METHODS: ETNA-VTE-Europe is an 18-month prospective, single-arm, non-interventional, multinational post-authorisation safety study. Approximately 310 sites across eight European countries (Austria, Belgium, Germany, Ireland, Italy, the Netherlands, Switzerland and the United Kingdom) will participate in the study, with the intention to represent the regional distributions of centres, healthcare settings and specialties. An estimated cohort of 2700 patients will be recruited, the only enrolment criteria being acute symptomatic VTE, no participation in an interventional study, and treating physician decision to prescribe edoxaban independently from the registry. Data from patient medical records and/or telephone interviews will be collected at baseline, 1, 3, 6, 12 and 18 months. The primary objective is to evaluate the 18-month rate of symptomatic VTE recurrence in patients with VTE treated with edoxaban outside a clinical trial. The co-primary objective is to evaluate the real-world rates of bleeding and adverse drug reactions. Secondary outcomes include rates of other patient-relevant safety events, adherence to and discontinuation of edoxaban. Furthermore, 12-month ETNA-VTE-Europe data will be considered in the context of those for patients receiving different anticoagulants in the PREFER in VTE registry and Hokusai-VTE clinical trial. CONCLUSIONS: ETNA-VTE-Europe will allow the safety and effectiveness of edoxaban to be evaluated over an extended period in acute symptomatic VTE patients encountered in routine clinical practice. Findings will be informative for European practitioners prescribing edoxaban as part of real-world VTE treatment/prevention. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02943993.

Correction to: Design and rationale of the non-interventional, edoxaban treatment in routiNe clinical prActice in patients with venous ThromboEmbolism in Europe (ETNA-VTE-Europe) study.

[This corrects the article DOI: 10.1186/s12959-018-0163-7.].

Comparison of 'anatomically designed' and 'point-by-point' catheter ablations for human atrial fibrillation in terms of procedure timing and costs in German hospitals.

AIMS: The purpose of the FAST-PVI study was to compare 'traditional' ablation tools based on 'point-by-point' technology with the new 'anatomically designed' technologies in terms of procedure times and related costs for the treatment of paroxysmal atrial fibrillation. METHODS AND RESULTS: Four hundred and fifty-two consecutive ablation procedures (222 'anatomically designed', 136 Arctic Front® and 86 PVAC®) and 230 'point-by-point' ablations (100 CARTO XP and 130 NavX navigation systems) performed by nine university centres across Germany from 2006 to 2010 were evaluated retrospectively. Staffing and resources times for each procedure were documented together with patient morbidities, complications, and pulmonary veins isolations. On the basis of DRG data from 2006 to 2010, human resources use and equipment maintenance costs were assigned to ablation procedure and calendar year. All procedural times were significantly higher in 'point-by-point' technologies compared with 'anatomically designed' ablations [average lab occupancy time 185.30 vs. 280.28 min; physician time 152.21 vs. 238.04 min; support time 183.43 vs. 278.34 min and fluoroscopy time 29.11 vs. 40.72 min; P < 0.001 (95% confidence interval, CI)]. For each ablation procedure human resource use per operating minute resulted in lower costs for 'anatomically designed' ablations [€744.24 per patient; P < 0.001 (95% CI)]. Savings due to reduced duration in 'anatomically designed' technologies accrued to 20% lower human resource costs. Sensitivity analyses did not lead to any significant variations on the outcomes parameter cost per minute. CONCLUSION: FAST-PVI showed reductions in ablation procedural time may lead to increased hospital capacity and non-device-related cost-savings, while maintaining quality.

Impact of public health interventions to curb SARS-CoV-2 spread assessed by an evidence-educated Delphi panel and tailored SEIR model.

Aim: To use a Delphi-panel-based assessment of the effectiveness of different non-pharmaceutical interventions (NPI) in order to retrospectively approximate and to prospectively predict the SARS-CoV-2 pandemic progression via a SEIR model (susceptible, exposed, infectious, removed). Methods: We applied an evidence-educated Delphi-panel approach to elicit the impact of NPIs on the SARS-CoV-2 transmission rate R0 in Germany. Effectiveness was defined as the product of efficacy and compliance. A discrete, deterministic SEIR model with time step of 1 day, a latency period of 1.8 days, duration of infectiousness of 5 days, and a share of the total population of 15% assumed to be protected by immunity was developed in order to estimate the impact of selected NPI measures on the course of the pandemic. The model was populated with the Delphi-panel results and varied in sensitivity analyses. Results: Efficacy and compliance estimates for the three most effective NPIs were as follows: test and isolate 49% (efficacy)/78% (compliance), keeping distance 42%/74%, personal protection masks (cloth masks or other face masks) 33%/79%. Applying all NPI effectiveness estimates to the SEIR model resulted in a valid replication of reported occurrence of the German SARS-CoV-2 pandemic. A combination of four NPIs at consented compliance rates might curb the CoViD-19 pandemic. Conclusion: Employing an evidence-educated Delphi-panel approach can support SARS-CoV-2 modelling. Future curbing scenarios require a combination of NPIs. A Delphi-panel-based NPI assessment and modelling might support public health policy decision making by informing sequence and number of needed public health measures. Supplementary Information: The online version contains supplementary material available at 10.1007/s10389-021-01566-2.

Anticoagulant Treatment Adherence and Persistence in German Patients with Atrial Fibrillation.

INTRODUCTION: Treatment adherence and persistence impact the effectiveness of edoxaban for the prevention of thromboembolism in patients with atrial fibrillation (AF). The objective of this analysis was to assess adherence and persistence of edoxaban vs. other non-vitamin K antagonist oral anticoagulants (NOACs) and vitamin K antagonists (VKAs). METHODS: Utilizing a German claims database, adults with AF with the first pharmacy claim identified for edoxaban, apixaban, dabigatran, rivaroxaban, or VKAs from January 2013 to December 2017 were included in a propensity score-matched analysis. The first pharmacy claim was the index claim. Adherence (i.e., proportion of days covered [PDC]) and persistence (proportion of patients who continued therapy) were compared between edoxaban and other therapies. Patients receiving once-daily (QD) vs. twice-daily (BID) NOAC were also analyzed. RESULTS: Overall, 21,038 patients were included (1236 edoxaban, 6053 apixaban, 1306 dabigatran, 7013 rivaroxaban, and 5430 VKA). After matching, baseline characteristics were well balanced across cohorts. Adherence was significantly higher for edoxaban vs. apixaban, dabigatran, and VKAs (all P < 0.0001). Significantly more edoxaban patients continued therapy vs. rivaroxaban (P = 0.0153), dabigatran (P < 0.0001), and VKAs (P < 0.0001). Time to discontinuation was significantly longer for edoxaban vs. dabigatran, rivaroxaban, and VKAs (all P < 0.0001). More patients receiving NOACs QD had a PDC ≥ 0.8 compared with those receiving NOACs BID (65.3 vs. 49.6%, respectively; P < 0.05); persistence rates were comparable between QD and BID groups. CONCLUSIONS: Patients with AF receiving edoxaban had significantly higher adherence and persistence compared with those receiving VKAs. This trend was also seen in NOAC QD regimens vs. NOAC BID regimens for adherence. These results provide insight into how adherence and persistence may contribute to the effectiveness of edoxaban for stroke prevention in patients with AF in Germany.

Ablation of Left Atrial Tachycardia following Catheter Ablation of Atrial Fibrillation: 12-Month Success Rates.

The treatment of atrial tachycardia following catheter ablation of atrial fibrillation is often challenging. Electrophysiological studies using high-resolution 3D mapping systems have contributed significantly to their understanding, and new ablation approaches have shown high rates of acute terminations with low recurrences for the clinical AT. However, patient populations are very heterogeneous, and long-term data of the freedom from any atrial tachycardia or any arrhythmia are still sparse. To evaluate long-term success, a unified patient population and predefined ablation strategies are preferred. In this study, we present 12-month success and mean 30 month follow-up data of catheter ablation of left atrial tachycardia. All 35 patients had a history of pulmonary vein isolation (PVI), 71% of which had a previous substrate modification. A total of 54 ATs, with a mean cycle length 297 ± 86 ms, 31 macro-reentries, and 4 localized reentries, were targeted. The ablation strategy to be used was given by the study protocol, depending on the type of reentry and the number of critical isthmuses. All available ablation strategies were included: standard (anatomical) lines, individual lines, critical isthmuses, and focal ablation. All ATs were terminated by ablation. A total of 91% terminated upon the first ablation strategy. Freedom from any AT after 12 months was 82%, and from any arrhythmia, it was 77%. The multi-procedure success after 30 months was 65% for any AT and 55% for any arrhythmia. In conclusion, individual ablation strategies based on the reentry mechanism and the number of critical isthmuses seems promising and demonstrates a high long-term clinical success. Tachycardia comprising a single critical isthmus can be ablated by critical isthmus ablation only. These patients present with the highest 12-month and long-term success rates.

The costs of atrial fibrillation in patients with cardiovascular comorbidities--a longitudinal analysis of German health insurance data.

AIMS: Since atrial fibrillation (AFib) is one of the most frequent cardiac disorders, the primary aim of the present study was to assess the disease-related costs as well as the course of costs associated with AFib. The study was focused on a hospitalized patient subgroup with cardiac comorbidities. METHODS AND RESULTS: We undertook a retrospective review of the medical, hospital, and drug claims data in the database of a German statutory health insurance company covering ∼5 million insured persons. The data of patients suffering from AFib were extracted by using documented hospital International Classification of Diseases Revision 10 codes during 2004 and 2005. For these patients we reviewed and summarized all the charges incurred over a 1-year period after the initial index event on the basis of weekly costs and from the third-party payer's perspective. We included 14 798 patients with primary diagnosis of AFib (44.6% male patients, mean age of 72.2 ± 10.1 years). The average weekly total first-year cost after AFib was calculated at ∼148 ± 875 Euro per patient. The cumulative total cost was ∼7688 ± 954 Euro per patient for the first year. Thirty per cent of these total costs were directly associated with Afib (2,234 ± 838 Euro). CONCLUSION: Atrial fibrillation is associated with significant economic costs from the perspective of statutory health insurance. Since the largest part of costs is attributable to inpatient stays and drug usage, an efficient management of inpatient treatment structures as well as a cost-outcome-oriented drug regime seems to be outstandingly important.

Antithrombotic management and outcomes of patients with atrial fibrillation treated with NOACs early at the time of market introduction: Main results from the PREFER in AF Prolongation Registry.

The management of patients with atrial fibrillation (AF) has rapidly changed with increasing use of non-vitamin K antagonist oral anticoagulants (NOACs) and changes in the use of rhythm control therapy. The prevention of thromboembolic events European Registry in Atrial Fibrillation Prolongation Registry (PREFER Prolongation) enrolled consecutive patients with AF on NOACs between 2014 and 2016 in a multicentre, prospective, observational study with one-year follow-up, focusing on the time of introduction of NOACs. Overall, 3783 patients were enrolled, with follow-up information available in 3223 (85%). Mean age was 72.2 ± 9.4 years, 40% were women, mean CHA2DS2VASc score was 3.4 ± 1.6, and 2587 (88.6%) had a CHA2DS2VASc score ≥ 2. Rivaroxaban was used in half of patients, and dabigatran and apixaban were used in about a quarter of patients each; edoxaban was not available for use in Europe at the time. Major cardiovascular event rate was low: serious events occurred in 74 patients (84 events, 2%), including 24 strokes (1%), 62 major bleeds (2%), of which 30 were life-threatening (1%) and 3 intracranial (0.1%), and 28 acute coronary syndromes (1%). Mortality was 2%. Antiarrhythmic drugs were used in about 50% of patients, catheter ablation in 5%. Adverse events were low in this contemporary European cohort of unselected AF patients treated with NOACs already at the time of their first introduction, despite high thromboembolic risk.

Real-World Adherence and Evidence of Subcutaneous and Sublingual Immunotherapy in Grass and Tree Pollen-Induced Allergic Rhinitis and Asthma.

PURPOSE: Allergen immunotherapy (AIT), when continued for 3 years, is the only disease-modifying treatment for AR and asthma. Adherence is a key to ensure effectiveness, and poor adherence is a contraindication for AIT. The objective of this study was to evaluate real-world adherence to AIT with subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) preparations in patients allergic to grass or tree pollen. The impact of AIT on the consumption of asthma and rhinitis medication was also analyzed. PATIENTS AND METHODS: In this retrospective cohort analysis of a German longitudinal prescription database, the adherence of a grass and tree pollen allergoid was examined and compared to two sublingual AIT tablets/drops. Patients receiving grass or tree allergen-specific immunotherapy prescriptions were compared with non-AIT patients receiving symptomatic allergic rhinitis (AR) and asthma prescriptions. The study endpoints included therapy adherence, AR progression, and asthma progression. Multivariate regression analyses were used to estimate the effects of SCIT or SLIT, adjusting for variables related to demographics and prescriptions. RESULTS: SCIT adherence was 60.1-61.8% at 2 years and 35.0-37.5% at 3 years for the two allergens. SLIT adherence was distinctly lower (29.5-36.5% and 9.6-18.2%, respectively). Adherence in children was higher compared to adolescents or adults. All products were highly efficacious at reducing symptomatic AR medication consumption. SCIT also reduced asthma medication use for both allergens, whereas for SLIT these results were significant only for grasses but not trees. CONCLUSION: Subcutaneous AIT in a real-world setting achieved significantly higher adherence rates compared to sublingual administration. SCIT reduced the use of rhinitis and asthma medication significantly for both allergens, while SLIT reduced the use of rhinitis medication for both allergens and the use of asthma medication for grasses only.

ETNA VTE Europe: A contemporary snapshot of patients treated with edoxaban in clinical practice across eight European countries.

INTRODUCTION: Edoxaban has proven its efficacy and safety in the ENGAGE AF-TIMI 48 and HOKUSAI-VTE clinical trials. Clinical practice patients, however, may differ from those enolled in clinical trials. We aimed to compare patients from the HOKUSAI-VTE clinical trial with those treated in clinical practice. MATERIALS AND METHODS: ETNA-VTE-Europe is a prospective, non-interventional post-authorisation safety study conducted in eight European countries. RESULTS: A total of 2,879 patients presenting with acute symptomatic venous thromboembolism (VTE) were enrolled at 339 sites. Of the 2,680 patients with complete data, 23.6% reported prior VTE and 2.8% had a history of bleeding. Patients in ETNA-VTE were older (65vs.57 years), more likely to be female (46.5vs.39.8%) and had a higher prevalence of chronic venous insufficiency (11.1vs.1.6%) than those in the European cohort of the HOKUSAI-VTE trial (n=1,512). Bodyweight and creatinine clearance were substantially lower in clinical practice. Edoxaban dosing was adherent to label in 90% of patients, with higher (60 mg) and lower than recommended doses (30 mg) used in 6.6% and 3.3% of the patients, respectively. Heparin lead-in was used in 84.7% of the patients overall, and was more frequently used in patients with PE than patients with DVT only (91.3% vs. 80.1%; p<0.0001). CONCLUSIONS: These data reinforce the largely appropriate use of edoxaban in routine clinical practice, where the study population differs from those in prior randomised controlled trials. CLINICALTRIALS. GOV IDENTIFIER: NCT02943993.

ETNA-VTE Europe: Benefits and risks of venous thromboembolism treatment using edoxaban in the first 3 months.

INTRODUCTION: Edoxaban had a positive risk-benefit ratio for the treatment of venous thromboembolism (VTE) compared to conventional therapy with warfarin. The objective of this analysis of the ongoing ETNA-VTE Europe study was to assess the real-world benefits and risks of edoxaban during the first 3 months of treatment, the highest risk period for further VTE events. METHODS: ETNA-VTE Europe is a prospective, non-interventional, post-authorization study, conducted in eight European countries. Participants had initial or recurrent acute VTE (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) that occurred ≤2 weeks prior to enrolment and received edoxaban therapy. RESULTS: The analysis set included 2672 patients (PE ± DVT, n = 1117; DVT only, n = 1555); mean age 62.9 ± 16.0 years, bodyweight 81.9 ± 17.4 kg, estimated glomerular filtration rate 95.4 ± 42.8 mL/min; 46.4% were female. Overall, 66.4% of patients (PE ± DVT, 68.5%; DVT-only, 64.8%) received heparin lead-in treatment for at least 5 days. Most patients (87.7%) received edoxaban at a dose of 60 mg once daily. Event rates at 3 months were: recurrent VTE 0.34% (n = 9), major bleeding 0.97% (n = 26), all-cause mortality 0.79% (n = 21). Rates were numerically higher in the PE ± DVT group compared with the DVT-only group (recurrent VTE, 0.45% (n = 5) versus 0.26% (n = 4); major bleeding, 1.34% (n = 15) versus 0.71% (n = 11); and all-cause mortality 1.16% (n = 13) versus 0.51% (n = 8)). CONCLUSIONS: The results support the safety and effectiveness of edoxaban in a general VTE population during the most critical time period, the first 3 months. The outcomes of this study extend the principal efficacy and safety data on edoxaban into the routine clinical practice setting.

The costs of care in atrial fibrillation and the effect of treatment modalities in Germany.

OBJECTIVE: Atrial fibrillation (AF) is an increasing burden on health-care systems because of an aging population. This study aimed to estimate health-care resource use and costs of treating AF in Germany. METHOD: A 6-month multicenter prospective observational cohort study with additional 3-month retrospective clinical data collection was performed in physician practices. AF-related resource use was documented by 3-month retrospective and 6-month prospective clinical data from physician charts and prospectively by patient questionnaires at 3 and 6 months. Cost calculation was from the health-care payer perspective. RESULTS: A total of 361 patients (mean age 71 +/- 9 years, 61% male) were recruited from 45 physician practices. Of 311 (86.1%) patients with complete data, 75% had persistent AF; oral anticoagulation and/or aspirin were prescribed in 98%. A rhythm-control strategy was applied in 27%, rate control in 58%, and 15% received neither antiarrhythmic medication nor cardioversion. A higher proportion of rhythm-control patients had paroxysmal AF (P < 0.001). Mean annual AF-related per-patient cost was 827 Euro +/- 1476 (median 386 Euro). 50% of total costs were incurred by 11% of patients, driven by AF-related hospitalizations (44%). Antiarrhythmics and stroke prophylaxis accounted for 20% and 15% of expenditures, respectively. Mean annualized costs were higher for rhythm-control patients than for rate-control patients or those without antiarrhythmic treatment (1572 vs. 780 vs. 544 Euro, P < 0.001). CONCLUSION: This evaluation provides an overview of current treatment modalities and cost of AF management in Germany. Efforts to reduce the economic burden of AF should focus on avoidance of AF hospital admissions and optimization of stroke prevention and rhythm control.

Economic and human costs of restless legs syndrome.

Restless legs syndrome (RLS) is a common and often underestimated neurological disorder, with a prevalence ranging from approximately 2.5% to 10% in Western industrialized countries. The aim of the present study was to summarize the research findings on the human and economic costs associated with RLS in populations without any co-morbidities or potentially confounding health conditions. A further objective was to identify studies on the cost effectiveness of RLS treatments. A systematic literature search was performed. Two researchers independently assessed the relevance of each publication. Studies published before August 2008 were included if they assessed quality of life in patients suffering from RLS, determined total or patient-related costs attributable to RLS, and/or evaluated the cost effectiveness of treatment options for RLS. A total of 725 references were identified, including 100 full-text articles. Fifteen of these publications met all of the selection criteria and were included in the present review. Seven abstracts that focused on the economic burden of RLS and/or the cost effectiveness of different treatment strategies in RLS patients were also included. RLS was associated, in the included studies, with reductions in quality of life similar to those seen in patients with other chronic conditions. The cost-of-illness studies were heterogeneous but indicated that RLS was associated with a substantial economic burden, resulting in high direct and indirect costs to society. Although effective and cost-effective treatments appear to be available, further research is warranted, especially regarding the economic burden of RLS and the cost effectiveness of available treatment options.

Length of stay after introduction of a new total knee arthroplasty (TKA)-results of a German retrospective database analysis.

BACKGROUND: Although total knee arthroplasty (TKA) procedures are increasing, patient satisfaction is still inferior compared to total hip arthroplasty. The ATTUNE® Knee System was designed to reduce pain and improve function, leading to greater patient satisfaction and decreased resource utilization in TKA. The objective of this study was to compare length of stay (LOS) of TKA with ATTUNE knee versus LCS® knee implants. METHODS: A retrospective chart review analysis in a German center was conducted between 2008 and 2016. All patients without prior ipsilateral knee operation, treated with a cemented LCS or ATTUNE knee were included. Endpoints captured included gender, age, availability of home support, prior contralateral TKA, ASA grade and LOS. Statistical analyses included chi-squared test for differences in patient demographics and Welch two-sample t-test for difference in LOS. RESULTS: Mean LOS in the ATTUNE Knee group (N=85) was 8.3 days (SD: 1.79) compared to 10.4 days (SD: 1.91) in the LCS knee group (N=85). No significant differences in gender, age, availability of home support, prior contralateral TKA, or ASA grade between both cohorts were observed. The 2.1 days reduction was statistically significant (P<0.001; 95%CI: 2.7-1.6). A sensitivity analysis outlined the impact of the study duration: even when assuming that 1.3 days reduction resulted from the observed national LOS decrease, the remaining 0.8 reduction in days LOS reduction was still significant (P<0.01). CONCLUSION: When comparing two cohorts with similar sociodemographic and medical factors, LOS of ATTUNE knee patients was 2.1 days shorter than patients treated with the LCS knee.

Cost-effectiveness of grass pollen subcutaneous immunotherapy (SCIT) compared to sublingual immunotherapy (SLIT) and symptomatic treatment in Austria, Spain, and Switzerland.

BACKGROUND: While specific immunotherapy (SIT) has been proven to be cost-effective for the treatment of allergic rhinitis compared to symptomatic treatment, there is a lack of European studies in which sublingual (SLIT) and subcutaneous (SCIT) immunotherapy were compared. The present analysis is focused on the cost-effectiveness of SCIT compared to SLIT and symptomatic treatment of grass pollen allergy in Austria, Spain, and Switzerland. It will address specific properties of the underlying healthcare systems. METHODS: The investigation is based on a previously published health economic model calculation. This was designed as a Markov model with pre-defined health stages and a duration of 9 years covering specific preparations for SCIT (Allergovit) and SLIT (Oralair). The effectiveness was assessed as symptom-score based quality-adjusted life years (QALYs). Additionally, total cost has been determined as well as the cost-effectiveness of SCIT. The robustness of model results was proved in further sensitivity analyses. RESULTS: With regard to the effectiveness of both SCIT and SLIT, preparations were dominant compared to pharmacological symptomatic therapy. Both strategies were associated with additional cost, but, combined with the results on effectiveness, both have to be regarded as cost-effective. A direct comparison of the SCIT (Allergovit) and SLIT (Oralair) showed lower total costs of SCIT vs SLIT for Austria, Spain, and Switzerland (€1,368 vs €2,012, €2,229 vs €2,547, and €1,901 vs €2,220) and superior effectiveness (SCIT =8.02 QALYs; SLIT =7.98 QALYs; and symptomatic therapy =7.90 QALYs). CONCLUSION: In patients with allergic rhinitis, SIT offers cost-effective treatment options compared to symptomatic treatment. When comparing SCIT (Allergovit) and SLIT (Oralair), SCIT was dominant in terms of QALYs as well as costs, in particular due to a slightly higher patient compliance and lower drug costs.