Assessment of efficacy and safety of endoscopic lung volume reduction with one-way valves in patients with a very low FEV1.

Introduction: Endoscopic lung volume reduction (ELVR) with one-way valves produces beneficial outcomes in patients with severe emphysema. Evidence on the efficacy remains unclear in patients with a very low forced expiratory volume in 1 s (FEV1) (≤20% predicted). We aim to compare clinical outcomes of ELVR, in relation to the FEV1 restriction. Methods: All data originated from the German Lung Emphysema Registry (Lungenemphysem Register), which is a prospective multicentric observational study for patients with severe emphysema after lung volume reduction. Two groups were formed at baseline: FEV1 ≤20% pred and FEV1 21-45% pred. Pulmonary function tests (FEV1, residual volume, partial pressure of carbon dioxide), training capacity (6-min walk distance (6MWD)), quality of life (modified Medical Research Council dyspnoea scale (mMRC), COPD Assessment Test (CAT), St George's Respiratory Questionnaire (SGRQ)) and adverse events were assessed and compared at baseline and after 3 and 6 months. Results: 33 patients with FEV1 ≤20% pred and 265 patients with FEV1 21-45% pred were analysed. After ELVR, an increase in FEV1 was observed in both groups (both p<0.001). The mMRC and CAT scores, and 6MWD improved in both groups (all p<0.05). The SGRQ score improved significantly in the FEV1 21-45% pred group, and by trend in the FEV1 ≤20% pred group. Pneumothorax was the most frequent complication within the first 90 days in both groups (FEV1 ≤20% pred: 7.7% versus FEV1 21-45% pred: 22.1%; p=0.624). No deaths occurred in the FEV1 ≤20% pred group up to 6 months. Conclusion: Our study highlights the potential efficacy of one-way valves, even in patients with very low FEV1, as these patients experienced significant improvements in FEV1, 6MWD and quality of life. No death was reported, suggesting a good safety profile, even in these high-risk patients.

Three-dimensional assessment of bronchiectasis in a mouse model of mucociliary clearance disorder.

Synchrotron-based imaging allows for detection of bronchiectasis-like phenotypes in mice with mucociliary clearance disorders https://bit.ly/3gXGdP3.

[Contract of the German Health Insurance AOK Hessen Concerning Prolonged Weaning-Methods and First Experiences]. / Vertrag zur prolongierten Beatmungsentwöhnung der AOK Hessen-Methodik und erste Erfahrungen.

INTRODUCTION: In recent years, the number of patients requiring mechanical ventilation has increased steadily. In some cases, weaning is not successful. These patients depend on home mechanical ventilation and intensive outpatient care. Surprisingly, most of these patients were never treated in a weaning center. Thus, weaning might still be possible in at least some of them. Health insurance companies have recognized this problem. METHODS: AOK Hessen, a major health insurance company in the German federal state of Hesse, identified some starting points for improvement after having surveyed their patients in ambulant intensive care. Principal points for future measures are expertise of the treating medical center (weaning experience, weaning center), establishment of new centers for homecare ventilation for long term therapy of these patients and a coordinated follow up. RESULTS: Centers for homecare ventilation are wards with a non-hospital atmosphere affiliated to a weaning center. The main focus here is not weaning itself but daily physical and speech therapy. Patients in home care ventilation centers have time (up to 6 months) to improve their physical and mental strength. Afterwards, depending to their development, they can be transferred to the weaning center again. DISCUSSION: In this paper, we introduce the concept of the home care ventilation centers. Initial data suggests that home care ventilation centers can contribute to successful weaning.

Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study.

OBJECTIVES: To inform health-technology assessments of new adjuvant treatments, we describe treatment patterns in patients with complete resection of stage IB-IIIA non-small cell lung cancer (NSCLC) in France, Germany, and the United Kingdom (UK). MATERIALS AND METHODS: Data were collected via medical record abstraction. Patients were aged ≥18 years with completely resected stage IB-IIIA NSCLC, diagnosed between 01 January 2009 and 31 December 2011. Median follow-up was 26 months. Adjuvant treatment patterns and clinical outcomes were summarized descriptively. RESULTS: Among the 831 patients studied, 239 (29%) had stage IB disease, 179 (22%) had stage IIA disease, 165 (20%) had stage IIB disease, and 248 (30%) had stage IIIA disease. Adjuvant systemic therapy was received by 402 patients (48.4%), (France, 61.8%; Germany, 51.9%; UK, 33.4%). Use of adjuvant therapy increased with increasing stage of disease. Cisplatin/vinorelbine and carboplatin/vinorelbine were the most frequently prescribed adjuvant regimens. Median disease-free survival was 48.0 months (95% confidence interval [CI] 42.3-not estimable); the 25th percentile was 13.2 months (95% CI, 11.0-15.3). 204 patients (24%) died during the follow-up period. The median overall survival was not reached, the 25th percentile was 31.2 months (95% CI 26.8-36.0 months). 272 patients (33%) had disease recurrence during the follow-up period. For 86 of those patients, the first recurrence was local or regional with no distant metastasis and 14 had further progression to metastatic disease during the follow-up time. For the other 186 patients, the first recurrence involved distant metastases. A total of 200 patients had metastatic disease at any time during study follow-up. CONCLUSIONS: Less than half the patients with stage IB-IIIA NSCLC in this observational study received adjuvant systemic therapy. A high rate of first recurrence with distant metastatic disease was observed, emphasising the need for more effective systemic adjuvant therapies in this population.

Economic burden of resected (stage IB-IIIA) non-small cell lung cancer in France, Germany and the United Kingdom: A retrospective observational study (LuCaBIS).

OBJECTIVES: New adjuvant treatments are being developed for patients with resected non-small cell lung cancer (NSCLC). Due to scarcity of real-world data available for treatment costs and resource utilization, health technology and cost-effectiveness assessments can be limited. We estimated the burden and cost-of-illness associated with completely resected stage IB-IIIA NSCLC in France, Germany and the United Kingdom (UK). MATERIALS AND METHODS: Eligible patients were aged ≥18 years with completely resected stage IB-IIIA NSCLC between August 2009 and July 2012. Patients (living or deceased) were enrolled at clinical sites by a systematic sampling method. Data were obtained from medical records and patient surveys. Direct, indirect and patient out-of-pocket expenses were estimated by multiplying resource use by country-specific unit costs. National annual costs were estimated based on disease prevalence data available from published sources. RESULTS: 39 centers provided data from 831 patients of whom patient surveys were evaluable in 306 patients. Median follow-up was 26 months. The mean total direct costs per patient during follow-up were: €19,057 (France), €14,185 (Germany), and €8377 (UK). The largest cost drivers were associated with therapies received (€12,375 France; €3694 UK), and hospitalization/emergency costs (€7706 Germany). Monthly direct costs per patient were the highest during the distant metastasis/terminal illness phase in France (€15,562) and Germany (€6047) and during the adjuvant treatment period in the UK (€2790). Estimated mean total indirect costs per patient were: €696 (France), €2476 (Germany), and €1414 (UK). Estimates for the annual national direct cost were €478.4 million (France), €574.6 million (Germany) and €325.8 million (UK). CONCLUSION: To our knowledge, this is the first comprehensive study describing the burden of illness for patients with completely resected stage IB-IIIA NSCLC. The economic burden was substantial in all three countries. Treatment of NSCLC is associated with large annual national costs, mainly incurred during disease progression.

ERCC1 assessment in upfront treatment with and without cisplatin-based chemotherapy in stage IIIB/IV non-squamous non-small cell lung cancer.

Prior studies have demonstrated an association between excision repair cross-complementation group 1 (ERCC1) expression level and outcomes in patients with advanced non-small cell lung cancer (NSCLC) treated with platinum-based chemotherapy. The aim of this study was to assess the impact of ERCC1 on survival for patients with stage IIIB/IV non-squamous NSCLC (NS-NSCLC) enrolled in the INNOVATIONS trial, thus receiving as treatment either erlotinib/bevacizumab (EB) or cisplatin/gemcitabine/bevacizumab (PGB). We retrospectively analyzed tumor tissue of 72 patients using immunohistochemistry to assess the expression of ERCC1. The distribution between treatment arms was equal (36 patients each). Two different H scores were calculated and correlated with survival. In ERCC1-positive patients, no significant difference in terms of progression-free survival (PFS) between treatment arms has been detected. ERCC1-negative patients benefited from PGB compared to EB arm (H score: HR = 0.377, 95% CI [0.167-0.849], p = 0.0151; modified H score: HR = 0.484, 95% CI [0.234-1.004], p = 0.0468). With respect to the scoring system, in the EB-arm, a significant superior PFS turned out in ERCC1-positive patients when employing the H-score (HR = 0.430, 95% CI [0.188-0.981], p = 0.0397; median 4.9 vs. 3.9 months), but not with the modified H-score. Our findings support the hypothesis that NS-NSCLC displaying a low ERCC1 expression might benefit from cisplatin-based chemotherapy. High expression indicated better PFS in the EB arm supporting the prognostic impact. However, as impact of ERCC1-assessment even might depend on scoring systems differences, the need in standardization of assessment methodology is emphasized.

The German Critical Incident Reporting System for Anesthesiology: CIRSains.

BACKGROUND: In June 2010, the Helsinki Declaration was passed. As a result, an online nationwide critical incident reporting system named CIRSmedical Anaesthesiology (CIRSains) was implemented in Germany. The aim of the article is to evaluate CIRSains for practicability and to provide solutions to the problems detected during evaluation. METHODS: Every medical staff member could take part voluntarily. Data were deidentified. All reports for anesthesiology (1548) were taken into account. Data collection lasted from April 2010 to February 2011. Incident report forms were classified according to World Health Organization and National Patient Safety Agency taxonomy. RESULTS: Most reports (1347; 87.0%) contained American Society of Anaesthesiologists (ASA) classification, stratifying the severity of patients' underlying disease. Only some mentioned patients' age, even less sex. Physicians filed more reports than nurses. Staff-related factors constituted 794 (51.3%) choices, with attention issues (433; 28.0%) and routine violations (143; 9.2%) leading. Clinical processes (443; 28.6%), medication (347; 22.4%), and medical devices (530; 34.2%) were the leading incident category types. Most consequences ranged in low (398; 25.7%) and moderate (826; 53.4%) risk categories. Mitigating factors were barely mentioned. CONCLUSION: CIRSains displays the German effort to establish the Helsinki declaration. Easy accessibility, anonymity, medicolegal safety, and high flexibility resulted in high usage. The study shows a sufficient practicability of the database, but the data input has to be improved for better scientific use, for example, by implementation of more multiple-choice questions. Given the high magnitude and importance of patient safety problems, improving CIRSains remains a priority for the future.