The randomised-controlled EMPROVE trial demonstrated long-term added clinical benefits of bronchoscopic placement of endobronchial one-way valves with the Spiration® Valve System (SVS) over medical management alone in treating hyperinflation in patients with severe heterogenous emphysema.
Minimally-invasive, bronchoscopic placement of endobronchial one-way valves has been demonstrated to improve pulmonary function, reduce hyperinflation, and improve dyspnoea severity in patients with COPD and emphysema . However, it is not established whether this treatment is superior to ‘no intervention’ in the long term. The EMPROVE trial (NCT01812447) randomised 174 patients with severe, heterogenous emphysema 2:1 to active treatment with the SVS on top of medical management or to medical management alone. Assessed were several quality-of-life endpoints to compare the 2 arms of the trial. The positive primary results of the trial were published in 2019 . Prof. Gerard Criner (Temple University, PA, USA) presented the results after 24 months of follow-up .
The results displayed significant benefits of the intervention arm over the control arm in terms of severe dyspnoea (P<0.01), St. George’s Respiratory Questionnaire (SGRQ) total score (P<0.05), the COPD assessment test score (P<0.05), and forced expiratory volume in 1 second (FEV1) (P<0.05). Although the intervention arm was associated with a higher rate of serious adverse events in the short term (0–6 months; 28.3% vs 8.5%; P=0.003), this pattern was no longer significant in the long term (12–24 months; 29.6% vs 20.5%; P=0.309), indicating durability of the procedure.
“The EMPROVE trial demonstrated that SVS treatment provides a long-term clinical benefit in disease-specific, health-related quality-of-life, dyspnoea, and lung function in patients with severe heterogenous emphysema,” concluded Prof. Criner.
- Hartman JE, et al. Eur Respir Rev.2019;28(152):180121.
- Criner GJ, et al. Am J Respir Crit Care Med. 2019; 200(11):1354–1362.
- Criner GJ, et al. Sustained health-related quality of life in patients with severe heterogenous emphysema treated with spiration valve system at 24-month follow-up (EMPROVE). ALERT 4, RCT4449, ERS International Congress 2022, Barcelona, Spain, 4–6 September.
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Table of Contents: ERS 2022
Letter from the Editor
ERS 2022 Highlights Podcast
COVID-19: What Is New?
Does vilobelimab reduce mortality in severe COVID-19?
Awake proning not positive in COVID-19
Favipiravir may help patients over 60 years with COVID-19 to recover
Brensocatib fails in severe COVID-19
Inhaled agent under investigation for COVID-19
Accurate voice-based COVID-19 diagnostic test in development
Novel scoring tool for post-COVID syndrome aids clinicians and researchers
COPD: Therapies and Innovations
Icenticaftor achieves results on top of triple inhalation therapy in COPD
STARR2: A new approach for treating COPD exacerbations
COPD medication not effective in symptomatic smokers with preserved spirometry
Do digital tools improve physical activity in COPD?
Hyperpolarised gas MRI ready for clinical use
All About Asthma
Tezepelumab in asthma: mucus plugging down, lung function up
Digital asthma intervention improves health and reduces costs
Digitally enhanced therapy lowers treatment burden and costs in severe asthma
Mepolizumab beneficial for patients with severe eosinophilic asthma
Progress in Paediatrics
Antibiotics cause increased risk of wheezing in severe RSV bronchiolitis
Inhaled corticosteroids useful in preterms with decreased lung function
Fish oil or vitamin D during pregnancy can prevent croup
Encouraging results of nintedanib in children with fibrosing ILD
Focus on Interventional Pulmonology
Head-to-head: lung volume reduction surgery vs endobronchial valves
Durable effect of endobronchial valves in severe emphysema
Cone beam CT-guided ENB improves detection of pulmonary nodules
Confirmatory mediastinoscopy not needed in resectable NSCLC
Sleep and Breathing Disorders
In the spotlight: Cancer trends in obstructive sleep apnoea
Impact of CPAP on cardiac endpoints in OSA
Sustained hypoxaemia predicts unprovoked VTE in OSA
CPAP therapy in the prevention of cardiovascular risk in patients with OSA
Other Remarkable Research
Excellent results for high-flow nasal cannula oxygen therapy in acute respiratory failure
Antifibrotic therapy may slow down FVC decline in RAILD
Intravenous N-acetylcysteine performs well in hospitalised patients
Men and women respond differently to diesel exhaust
New trends in cystic lung diseases
Oral cannabinoid drugs may worsen COPD outcomes