Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (The BeLieVeR-HIFi trial): study design and rationale

Davey, Claire; Zoumot, Zaid; Jordan, Simon; Carr, Denis H.; Polkey, Michael I.; Shah, Pallav L.; Hopkinson, Nicholas S

doi:10.1136/thoraxjnl-2014-205127

Cited by 55 publications

(42 citation statements)

References 5 publications

(8 reference statements)

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“…23,24 Indeed, the BeLiever HiFi RCT, when completed, would help us understand whether an approach treating only the subgroup of patients with intact fissures and the most heterogeneous pattern of emphysema would lead to a better and long-term improvement in FEV 1 and exercise capacity. 25 Our meta-analysis has a few strengths. First, our meta-analysis incorporated all studies that analyzed endobronchial Zephyr valves.…”

Section: Discussionmentioning

confidence: 99%

Predictors of efficacy for endobronchial valves in bronchoscopic lung volume reduction

2014

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Over the last several years, numerous trials have been carried out to check the efficacy of one-way valves in the management of advanced emphysema. While the design of the valves has not altered much, by selectively studying these valves in a select group of participants, such as those with and without intact fissures (FIþ and FIÀ), and by using different procedural techniques, our understanding of the valves has evolved. In this metaanalysis, we sought to study the effect of these factors on the efficacy of one-way valves. From PubMed and Embase, we included only those studies that provided separate data on fissure integrity or collateral ventilation. Our study outcomes included the mean change in forced expiratory volume in first second (FEV 1 ), 6-minute walk distance (6MWD) and the St George's Respiratory Questionnaire (SGRQ). In the FIþ subgroup of participants, the pooled standardized mean difference in FEV 1 , 6MWD, and SGRQ were 0.50 (95% confidence interval (CI): 0.34 to 0.67), p 0.001, 0.29 (95% CI: 0.13 to 0.45), p 0.001 and À6.02 (95% CI: À12.12 to 0.06), p ¼ 0.05, respectively. In comparison, these results were superior to the FIÀ subgroup of participants. A separate analysis of the FIþ subgroup based on lobar occlusion versus nonlobar occlusion favored the former for superior efficacy. The preliminary findings of our meta-analysis confirm that one-way valves perform better in a select group of patients who show intact fissures on lung imaging pretreatment and in those who achieve lobar occlusion.

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Section: Discussionmentioning

confidence: 99%

Predictors of efficacy for endobronchial valves in bronchoscopic lung volume reduction

2014

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“…For example, the placebo procedure involved laparoscopy but without ablation 36 , endoscopy without radiofrequency energy delivery 37 , bronchoscopy without radiofrequency energy delivery 38 , or bronchoscopy without valve placement 39 . Therefore, most of the studies required a small incision to mimic the portals created during the laparoscopy or arthroscopy, or to mimic the incision through which an intravascular catheter was inserted 40 .…”

Section: Strategies Used To Maintain Blinding In Interventional Placementioning

confidence: 99%

Blinding in trials of interventional procedures is possible and worthwhile

2017

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In this paper, we have used evidence from our earlier review of surgical randomised controlled trials with a placebo arm to show that blinding in trials of interventional procedures is feasible, and that many creative methods can be used to make the active and the placebo procedure as similar as possible. We give examples of ingenious strategies used to simulate the active procedure and make the placebo control indistinguishable from the active treatment. We discuss why it is important to blind of patients, assessors, and caregivers and the types of bias that may occur in interventional trials. Finally, we describe the benefits of blinding, from the obvious ones such as avoiding bias, as well as less evident benefits such as avoiding patient drop out in the control arm.

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“…A reduction of lung volume can be forecast with an accuracy of approximately 75 % using the Chartis ® evaluation system. However, this method does not replace CT. A prospective study is currently being conducted to determine whether the clinical benefit can be predicted when a homogenous emphysema with intact fissure is diagnosed using CT [60]. Overall, fissure analysis using CT must be viewed cautiously for the time being.…”

Section: Fissure Analysis: the Interlobular Fissuresmentioning

confidence: 99%

Emphysema: Imaging for Endoscopic Lung Volume Reduction

Storbeck

Schröder

Oldigs

et al. 2015

Fortschr Röntgenstr

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!Chronic obstructive pulmonary disease (COPD) is characterized by two entities, the more airway-predominant type ("bronchitis") on the one hand, and emphysema-predominant type on the other. Imaging via high-resolution computed tomography plays an important role in phenotyping COPD. For patients with advanced lung emphysema, new endoscopic lung volume reduction therapies (ELVR) have been developed. Proper selection of suitable patients requires thinsection reconstruction of volumetric CT image data sets also in coronal and sagittal orientation are required. In the current manuscript we will describe emphysema subtypes (centrilobular, paraseptal, panlobular), options for quantifying emphysema and this importance of regional distribution (homogeneous or heterogeneous, target area) as this is crucial for patient selection. Analysis of the interlobular fissures is obligatory despite the lack of standardization, as incomplete fissures indicate collateral ventilation (CV) via parenchymal bridges, which is an important criterion in choosing endoscopic methods of LVR. Every radiologist should be familiar with modern LVR therapies such as valves and coils, and furthermore should know what a lung doctor expects from radiologic evaluation (before and after ELVR). Finally we present a checklist as a quick reference for all steps concerning imaging for ELVR.

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Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (The BeLieVeR-HIFi trial): study design and rationale

Cited by 55 publications

References 5 publications

Predictors of efficacy for endobronchial valves in bronchoscopic lung volume reduction

Predictors of efficacy for endobronchial valves in bronchoscopic lung volume reduction

Blinding in trials of interventional procedures is possible and worthwhile

Emphysema: Imaging for Endoscopic Lung Volume Reduction

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