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.

[Complicated hematomediastinum in a 76-year-old patient after performing an endosonographically guided transbronchial cryobiopsy (EBUS-TBCB) with suspected lymphoma]. / Komplikatives Hämatomediastinum einer 76-jährigen Patientin nach Durchführung einer endosonografisch gesteuerten transbronchialen Kryobiopsie (EBUS-TBKB) bei Verdacht einer Lymphomerkrankung.

We present the case of a patient with severe complications from mediastinal bleeding after endosonographically guided transbronchial cryobiopsy (EBUS-TBKB) with suspected advanced lymphoma. The EBUS-TBKB is a new effective examination method in interventional pneumology for the diagnosis of diseases with mediastinal lymph node enlargement and intrathoracic tumors, with which large tissue cylinders in the mediastinum can be obtained. Due to the high diagnostic value of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) for the clarification of lymphadenopathy, the examination should not be carried out as a routine application. Indications for a primary EBUS-TBKB arise when there is a suspicion of intrathoracic malignant lymphomas or other rare tumors in which extensive unfragmented tissue material is required for diagnosis. A rare complication that has not yet been described in the literature is a hematomediastinum, so that a careful risk assessment of possible bleeding complications should be carried out before intervention and the more invasive mediastinoscopy can be a safer examination method.

[The Importance of Electromagnetic Navigation Bronchoscopy in the Clarification of Pulmonary Nodules]. / Stellenwert der elektromagnetischen Navigationsbronchoskopie bei der Abklärung pulmonaler Rundherde.

Electromagnetic navigation bronchoscopy (ENB) is a very helpful examination for clarifying pulmonary nodules (PDs). The advantages are the low complication rate, avoiding the dangers of punctures in several areas of the lungs during an examination under general anesthesia and no radiation exposure. If malignancy is confirmed, PDs are curatively treatable as they are often early-stage cancers and, in case the disease is benign, it is treatable as other infectious diseases. With experience and routine use, the ENB procedure can contribute to the successful diagnosis of peripheral lesions (at least 1.5 cm in size) in about 75 % of cases. Due to the increase in CT chest examinations and the aging population, clarification of patients with PD is becoming increasingly important in lung clinics. The ENB should therefore develop into a routine examination procedure in interventional pulmonology in addition to the now indispensable endobronchial ultrasound examination. Unfortunately, the ENB is not yet mapped in the DRG system in a cost-relevant manner.

A Long-Term Follow-Up Investigation of Endobronchial Valves in Emphysema (the LIVE Study): Study Protocol and Six-Month Interim Analysis Results of a Prospective Five-Year Observational Study.

BACKGROUND: Randomized controlled trials indicate that significant lung volume reduction (ELVR) can be obtained with Zephyr® valves by occluding the target lobe in the absence of collateral ventilation, leading to relevant functional benefits in advanced emphysema patients. OBJECTIVES: To observe the long-term effects of endobronchial valve (EBV) implantation in emphysema patients screened by Chartis assessment in the context of daily pulmonology practice. METHODS: The LIVE Study is a prospective, observational, open-label, single-arm, multicenter trial conducted in Germany. 498 patients included in this interim analysis were enrolled between July 2, 2012, and September 16, 2014. The 6-month follow-up visit data were recorded for 343 patients (safety population), and complete data sets were available for 321 treated patients (efficacy population) - 56.4% male, age: 64.5 years, forced expiratory volume in 1 s (FEV1) % predicted: 31.3%, residual volume (RV) % predicted: 252%. RESULTS: Efficacy results at 6 months: FEV1 (l) increased by +100 ml (+11.9%), RV (l) decreased by -0.42 liter, and the COPD Assessment Test score decreased by -3.14 points (each p < 0.0001). Safety outcomes: A total of 66 adverse events (AEs; with 50 serious AEs - SAEs) were reported in 55 patients (16%) during the hospital stay for EBV placement - pneumothorax (35 cases), chronic obstructive pulmonary disease (COPD) exacerbation (5 cases), and pneumonia (4 cases). During the subsequent 6-month follow-up window, 170 SAEs were recorded in 125 patients (36.4%), predominantly COPD exacerbation (53% of the SAEs). CONCLUSION: The current results of this large-scale German observational study performed in the context of daily practice further demonstrates that ELVR with Zephyr® valves is an effective and well-tolerated treatment option in advanced emphysema.