ResMed (Australia)

Advanced emphysema is marked by progressive airflow obstruction and hyperinflation, significantly reducing patients’ quality of life. Bronchoscopic lung volume reduction (BLVR) with endobronchial one-way valves (EBVs) has been shown to improve lung function and relieve dyspnea. However, the effectiveness of EBVs depends on achieving lung collapse, which can be hindered by collateral ventilation (CV) resulting from incomplete lobar fissures. This study explores the potential of advanced imaging software to deliver more accurate assessments of CV. In this prospective study at Temple University Hospital, 30 participants (aged 40 and older) were recruited. All underwent a Chartis assessment to determine their CV status. Paired inspiratory-expiratory CT scans were used to generate advanced ventilation images (CT LVAS, 4DMedical) and density/emphysema-scored images (LDAf, IMBIO). Ventilation and emphysema distribution within the fissure region were measured and used as predictors of CV in a weighted factor model. The results were further validated using a k-folds cross-validation approach. The weighted model demonstrates that a combination of LDAf density scoring and assessment of ventilation in the fissure region predicted CV with accuracy of 0.97, AUC of 0.94, sensitivity of 0.9 and specificity of 1. Repeated stratified k-folds yielded a mean accuracy of 94%. This study demonstrates that the novel method for CV detection is highly accurate. By providing a more efficient and less invasive alternative, this method has the potential to improve diagnostic accuracy and patient outcomes.

Abstract In vivo models that replicate and reproduce human lung cancer and its response to therapy are necessary for the development of new therapeutic strategies and understanding drug resistance. Imaging lung tumors in live animals to monitor tumor growth and response to therapy is challenging due to the location of the lungs and their constant movement during breathing. Additionally, methods such as computed tomography (CT) only provide structural information and not functional information about how well the lungs are working. X-ray velocimetry (XV) is a novel functional lung imaging technique that generates 3D maps of regional lung expansion during breathing. In other lung diseases it has been shown to provide spatial information on where ventilation changes occur. The aim of this pilot study was to use XV and flexiVent lung mechanics assessments to determine the effect of tumor growth on lung function in mice at 2- or 3-weeks post tumor induction, and to evaluate the efficacy of these two tools. Histological analysis showed that tumour growth was not uniform between animals. At 3-weeks post tumor induction, some XV ventilation and flexiVent lung mechanics parameters were significantly different from baseline metrics. In addition, the forced expiratory volume, small-scale ventilation heterogeneity, and the average CT gray value correlated with the tumour counts from the histology. In some mice XV revealed localised regions with altered expansion rates. This pilot study demonstrated that changes in lung function can be identified following tumor induction, and that the model and techniques could be used in the future to determine response to anti-tumor drugs.

BACKGROUNDThere are no guidelines for obstructive sleep apnea (OSA) assessment in patients with chronic obstructive pulmonary disease (COPD). Home non-invasive ventilation (NIV) studies have excluded patients with comorbid OSA. Thus, it is unclear whether home NIV is associated with reduced exacerbation risk in patients with overlap syndrome (COPD-OSA). RESEARCH QUESTIONDoes home NIV impact the rate of severe exacerbations in patients with overlap syndrome 1 year post therapy initiation? STUDY DESIGN AND METHODSA retrospective analysis was performed on administrative claims data from patients with COPD and OSA who received a NIV device claim between 2015 and 2020. Patients were characterized 1 year before NIV initiation and 1 year after NIV initiation. A modified Poisson regression model was built to identify predictors for severe exacerbation occurrence during follow-up. RESULTSA total of 23,992 patients were included in the analysis (mean age 61.3±10.1 years, 44.9% female). The proportion of patients with ≥1 severe exacerbation was 10.2% in the year before NIV initiation and 5.9% in the year after NIV initiation (χ2 440.5, P < 0.0001). Occurrence of a severe exacerbation in the year prior to NIV was associated with a nearly 5-fold higher risk of severe exacerbation during follow-up [risk ratio 4.91; 95% confidence interval 4.39–5.48; P < 0.0001]. Heart failure, pneumonia, and anxiety were the comorbidities most associated with increased severe exacerbation risk. INTERPRETATIONThis is the first study to describe risk factors for severe exacerbations and to examine home NIV claims in this specific population. Results may be informative for overlap syndrome management, especially for preventing a first severe exacerbation and to treat OSA as part of COPD management. Additional information is needed to optimize the access, timing, and benefits of NIV treatment in patients with overlap syndrome.

BackgroundA post hoc analysis of the MERGE trial was conducted, to investigate whether sex differences are evident at the mildest end of the disease spectrum, for symptoms associated with obstructive sleep apnoea (OSA) and the response to continuous positive airway pressure (CPAP) treatment.MethodsMERGE participants with mild OSA (apnoea–hypopnoea index 5–15 events·h−1; American Academy of Sleep Medicine 2012 criteria) were randomised to either CPAP plus standard care (sleep hygiene counselling) or standard care alone for 3 months. Quality of life (QoL) was measured by questionnaires completed before and after the 3 months. This post hoc analysis of participants of the MERGE trial compared the symptom presentation, and response to CPAP, between the sexes.Results233 patients were included; 71 (30%) were female. Females were more symptomatic at baseline in all QoL questionnaires. Specifically, females had lower 36-item Short-Form Health Survey (SF-36) Vitality scores (mean±sd 39.1±10.1 versus 44.8±10.3) and higher Epworth Sleepiness Scale (ESS) scores (mean±sd 11.0±4.2 versus 9.5±4.4). Both sexes experienced snoring, but more females reported fatigue and more males reported witnessed apnoeas. All symptoms improved with CPAP for both sexes; however, females had larger improvements in SF-36 Vitality scores, which was the primary outcome of the MERGE trial (mean change 9.4 (95% CI 6.8–12.0) versus 6.0 (95% CI 4.3–7.7); p=0.034), and ESS (mean change −4.1 (95% CI −5.1– −3.0) versus −2.5 (95% CI −3.1– −1.8); p=0.015), after adjustment for baseline scores and CPAP usage.ConclusionsSex differences are apparent in patients with mild OSA. Females experience worse QoL symptoms than males at presentation to the sleep clinic; however, these improve significantly with CPAP treatment.

<b>Introduction:</b> Chronic Obstructive Pulmonary Disease (COPD) is responsive to bronchodilator (BD). However, it is unclear how BD alters ventilation distribution. <b>Aims:</b> To determine the effect of BD on the extent and distribution of ventilation in COPD measured by Single Photon Emission Computed Tomography (SPECT)/Computed Tomography (CT). <b>Methods:</b> 10 participants (6M) with physician diagnosed COPD underwent baseline spirometry and a SPECT/CT pre and post BD. A significant BD response was an increase of 200mL and 12% in FEV1 or FVC. Both lungs were segmented into outer, middle, and inner shells, from the CT which were 40%, 30%, and 30% of each lungs’ volume respectively. From fused SPECT/CT, we calculated ventilation as; 1) percentage of total CT lung volume (Vent_Total), 2) percentage in each shell (Vent_Shell) and 3) each shell’s ventilation as a proportion of total ventilation (Shell_Total). <b>Results:</b> 3/10 participants had significant BD responses. Vent_Total did not change following BD (p=0.13). Vent_Shell decreased in the inner shell exclusively (p=0.004). Shell_Total significantly increased in the outer shells (Shell_Total Δ=1.19, p=0.003) and decreased in the inner shells (Shell_Total Δ =-1.31, p=0.001). Shell_Total did not undergo significant change in the middle shells (Shell_Total Δ = 0.06, p=0.8). % change in Shell_Total in the middle shells correlated significantly with % change in FEV1 (p=0.003, r=-0.86) and FVC (p=0.02, r=-0.74). <b>Conclusion:</b> SPECT imaging is sensitive to changes in the pattern of ventilation following BD in COPD, showing that ventilation is redistributed from the central to the peripheral areas of the lungs.

RationalePositive airway pressure (PAP) is the first-choice treatment for obstructive sleep apnea (OSA). However, its real-world effectiveness is often questioned because of usage issues. The relationship between patient sleepiness and PAP usage has been assessed in relatively small and selected populations within the research context.ObjectivesTo assess the impact of patient-reported sleep outcomes, particularly self-reported sleepiness and its change during therapy, on PAP usage in the real-world setting.MethodsDeidentified data for U.S.-based patients receiving PAP therapy were examined. Eligible patients were registered in the myAir app and provided self-reported sleepiness at baseline and after 7, 14, 21, and 28 days of PAP between November 2019 and April 2020.ResultsA total of 95,397 registered patients met all eligibility criteria and were included in the analysis (mean age, 49.6 ± 13.0 yr; 61.6% male). Daytime sleepiness was the most common reason for PAP therapy initiation (57.1% of patients), and 42.2% of all patients had self-reported moderate to severe OSA. Self-reported sleepiness improved with PAP therapy in most patients over the assessment period, with 62.1% of patients reporting “no” or “slight” sleepiness at Day 28. There was a dose-dependent association between improvement in self-reported sleepiness at Day 28 and PAP usage, and this finding was maintained at Day 360. Self-reported sleepiness at Day 28 was associated with achieving U.S. Centers for Medicare & Medicaid Services compliance at 90 days (approximately 90% for those with no or slight sleepiness vs. <70% for those with residual very or extreme sleepiness); average daily PAP usage over 360 days was ⩾5.0 and ⩽3.7 hours, respectively, for those with no or slight versus very or extreme sleepiness.ConclusionsThis study demonstrates the feasibility of capturing patient-reported outcomes via a digital platform. Patient-reported outcomes appear to be associated with PAP usage, especially self-reported sleepiness and its response to therapy. Capturing patient-reported outcomes using digital solutions during the course of treatment has the potential to enhance patient outcomes by providing actionable insights.

BackgroundAlthough adaptive servo-ventilation (ASV) effectively supresses central sleep apnoea (CSA), little is known about real-world indications of ASV therapy and its effects on quality of life (QoL).MethodsThis report details the design, baseline characteristics, indications for ASV and symptom burden in patients enrolled in the Registry on the Treatment of Central and Complex Sleep-Disordered Breathing with Adaptive Servo-Ventilation (READ-ASV). This multicentre, European, non-interventional trial enrolled participants prescribed ASV in clinical practice between September 2017 and March 2021. An expert review board assigned participants to ASV indications using a guideline-based semi-automated algorithm. The primary end-point was change in disease-specific QoL based on the Functional Outcomes of Sleep Questionnaire (FOSQ) from baseline to 12-month follow-up.ResultsThe registry population includes 801 participants (age 67±12 years, 14% female). Indications for ASV were treatment-emergent or persistent CSA (56%), CSA in cardiovascular disease (31%), unclassified CSA (2%), coexisting obstructive sleep apnoea and CSA (4%), obstructive sleep apnoea (3%), CSA in stroke (2%) and opioid-induced CSA (1%). Baseline mean apnoea­–hypopnoea index was 48±23 events·h−1 (≥30 events·h−1 in 78%), FOSQ score was 16.7±3.0 (<17.9 in 54%) and Epworth Sleepiness Scale (ESS) score was 8.8±4.9 (>10 in 34%); 62% of patients were symptomatic (FOSQ score <17.9 or ESS score >10).ConclusionThe most common indications for ASV were treatment-emergent or persistent CSA or CSA in cardiovascular disease (excluding systolic heart failure). Patients using ASV in clinical practice had severe sleep-disordered breathing and were often symptomatic. One-year follow-up will provide data on the effects of ASV on QoL, respiratory parameters and clinical outcomes in these patients.