Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): A randomised controlled trial
ABSTRACT Background: Few treatment options exist for patients with severe emphysema. We assessed the clinical benefits and safety of lung volume reduction coils (LVRCs) for the treatment of patients with severe emphysema with hyperinflation. Methods: In a randomised study, we recruited patients with severe emphysema (aged ≥35 years) from three centres in the UK. Using a computer-generated randomisation sequence, we randomly allocated patients in a one-to-one ratio (block sizes of four and stratified by centre) to either LVRC treatment (treatment group) or best medical care (usual care group). The primary endpoint was the difference in response in the St George's Respiratory Questionnaire (SGRQ) between treatment and usual care groups at 90 days after final treatment (by intention-to-treat analysis). The trial is registered with ClinicalTrials.gov, number NCT01334307. Findings: Between Jan 27, 2010, to Oct 25, 2011, we recruited and randomly allocated 47 patients: 23 to treatment and 24 to usual care (23 patients in each group were included in the intention-to-treat analysis). SGRQ response at 90 days after final treatment was greater in the treatment group than it was in the usual care group (between-group difference in change from baseline -8·36 points [95% CI -16·24 to -0·47]; p=0·04). We detected no between-group difference in serious adverse events. Interpretation: Our findings suggest that treatment with endobronchial coils can improve quality of life for patients with severe emphysema and hyperinflation. Funding: PneumRx. © 2013 Elsevier Ltd.
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ABSTRACT: Endoscopic lung volume reduction (ELVR) offers a novel therapeutic approach for patients with severe pulmonary emphysema. In Europe, several types of ELVR are available. The choice of ELVR technique depends both on the distribution of emphysema and the presence or absence of interlobar collateral ventilation (CV). For this reason, accurate patient selection is crucial. Bronchial valve implantation is the technique that has been most widely studied and represents an effective treatment option for patients with severe heterogeneous upper- or lower-lobe-predominant emphysema. Lobar occlusion and low interlobar CV are predictive factors for positive outcomes. Lung volume reduction coil implantation is an effective option for patients with upper- and lower-lobe-predominant emphysema, and the efficacy is not influenced by CV; however, the technique should be regarded as mainly irreversible. Polymeric lung volume reduction relies on irreversible scarring and fibrosis and is especially effective in patients with chronic obstructive pulmonary disease classified as Global Initiative for Chronic Obstructive Lung Disease stage III; it also offers benefits to patients with upper-lobe-predominant emphysema and those with homogeneous emphysema. Like polymeric lung volume reduction, bronchoscopic thermal vapor ablation is also not influenced by CV and represents a good option for patients with upper-lobe-predominant emphysema. Exhale airway stents for emphysema-"airway bypass"-appeared to be a promising technique but proved ineffective in randomized clinical trials, likely in part due to long-term occlusion of the drug-eluting stents. Although European physicians are able to choose from a host of approved bronchoscopic interventions for emphysema, future studies for techniques in use are needed to further clarify patient selection criteria.12/2013; 10(6):657-66. DOI:10.1513/AnnalsATS.201301-003FR
- Respiration 01/2014; 87(6):452-5. DOI:10.1159/000360643 · 2.92 Impact Factor
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ABSTRACT: As parenchymal lung disease in chronic obstructive pulmonary disease becomes increasingly severe there is a diminishing prospect of drug therapies conferring clinically useful benefit. Lung volume reduction surgery is effective in patients with heterogenous upper zone emphysema and reduced exercise tolerance, and is probably underused. Rapid progress is being made in nonsurgical approaches to lung volume reduction, but use outside specialized centers cannot be recommended presently. Noninvasive ventilation given to patients with acute hypercapnic exacerbation of chronic obstructive pulmonary disease reduces mortality and morbidity, but the place of chronic non-invasive ventilatory support remains more controversial.Clinics in chest medicine 03/2014; 35(1):251-269. DOI:10.1016/j.ccm.2013.10.011 · 2.17 Impact Factor