A Randomized Study of Endobronchial Valves for Advanced Emphysema

Sciurba, Frank C.; Ernst, Armin; Herth, Felix J.F.; Strange, Charlie; Criner, Gerard J.; Marquette, Charles-Hugo; Kovitz, Kevin L.; Chiacchierini, Richard P.; Goldin, Jonathan G.; McLennan, Geoffrey

doi:10.1056/nejmoa0900928

Cited by 715 publications

(859 citation statements)

References 36 publications

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“…Despite these promising findings, such bronchoscopic lung volume reduction (BLVR) has important limitations: valve placement may induce granuloma formation and localized inflammation, with subsequent mucus hypersecretion, which can increase the risk of infection and contribute to worsening of clinical status in these patients 2.…”

Section: Introductionmentioning

confidence: 99%

Combined Bone Marrow-Derived Mesenchymal Stromal Cell Therapy and One-Way Endobronchial Valve Placement in Patients with Pulmonary Emphysema: A Phase I Clinical Trial

Oliveira

Cruz

Antunes

et al. 2016

Stem Cells Translational Medicine

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One‐way endobronchial valves (EBV) insertion to reduce pulmonary air trapping has been used as therapy for chronic obstructive pulmonary disease (COPD) patients. However, local inflammation may result and can contribute to worsening of clinical status in these patients. We hypothesized that combined EBV insertion and intrabronchial administration of mesenchymal stromal cells (MSCs) would decrease the inflammatory process, thus mitigating EBV complications in severe COPD patients. This initial study sought to investigate the safety of this approach. For this purpose, a phase I, prospective, patient‐blinded, randomized, placebo‐controlled design was used. Heterogeneous advanced emphysema (Global Initiative for Chronic Lung Disease [GOLD] III or IV) patients randomly received either allogeneic bone marrow‐derived MSCs (108 cells, EBV+MSC) or 0.9% saline solution (EBV) (n = 5 per group), bronchoscopically, just before insertion of one‐way EBVs. Patients were evaluated 1, 7, 30, and 90 days after therapy. All patients completed the study protocol and 90‐day follow‐up. MSC delivery did not result in acute administration‐related toxicity, serious adverse events, or death. No significant between‐group differences were observed in overall number of adverse events, frequency of COPD exacerbations, or worsening of disease. Additionally, there were no significant differences in blood tests, lung function, or radiological outcomes. However, quality‐of‐life indicators were higher in EBV + MSC compared with EBV. EBV + MSC patients presented decreased levels of circulating C‐reactive protein at 30 and 90 days, as well as BODE (Body mass index, airway Obstruction, Dyspnea, and Exercise index) and MMRC (Modified Medical Research Council) scores. Thus, combined use of EBV and MSCs appears to be safe in patients with severe COPD, providing a basis for subsequent investigations using MSCs as concomitant therapy. Stem Cells Translational Medicine 2017;6:962–969

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Section: Introductionmentioning

confidence: 99%

Combined Bone Marrow-Derived Mesenchymal Stromal Cell Therapy and One-Way Endobronchial Valve Placement in Patients with Pulmonary Emphysema: A Phase I Clinical Trial

Oliveira

Cruz

Antunes

et al. 2016

Stem Cells Translational Medicine

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“…In US VENT study by Sciurba et al, an EBV was implanted in 214 patients with emphysema, and results indicated that the forced expiratory volume in 1 second (FEV 1 ) increased by 4.3% over the previous procedure in 6 months, compared to a decrease of 2.5% in the control group (p = 0.005). Similar differences were observed in the 6-minute walk test (6MWT) and health-related quality of life measured with the St. George's Respiratory Questionnaire (SGRQ), and the modified Medical Research Council (mMRC) Dyspnea scale (18). In the implantation need to be developed for the technique to be effective.…”

Section: Endobronchial Valves and Intrabronchial Valvesmentioning

confidence: 60%

“…The Endobronchial Valve for Emphysema Palliation Trial, or VENT, was the first and largest randomized controlled trial (RCT) of valve implantation to treat emphysema; the trial was conducted separately in the US and Europe (18,19). In US VENT study by Sciurba et al, an EBV was implanted in 214 patients with emphysema, and results indicated that the forced expiratory volume in 1 second (FEV 1 ) increased by 4.3% over the previous procedure in 6 months, compared to a decrease of 2.5% in the control group (p = 0.005).…”

Section: Endobronchial Valves and Intrabronchial Valvesmentioning

confidence: 99%

“…Current methods for the assessment of fissure integrity are mainly based on visual assessment by imaging experts using high-resolution reconstructed CT images (18,19,31). The assessments are heavily influenced by the level of experience of the experts and they are highly subjective, and often there is disagreement between imaging experts (32).…”

Section: Direct Measurement Of Collateral Ventilationmentioning

confidence: 99%

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Status of and prospects for bronchoscopic lung volume reduction for patients with severe emphysema

Wang

et al. 2016

BST

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“…4) aimed at collapsing or shrinking the emphysematous lung tissue have been developed These methods are an option only for patients with advanced stages of the disease and require an exhaustive diagnosis of lung function. Derived from the VENT-study [19], the inclusion criteria comprises, among other factors, stage 3 (through 4) COPD according to GOLD with high-grade pulmonary hyperinflation (residual volumes over 200 %). In principle, distinction must be made between blocking and non-blocking as well as between reversible and irreversible procedures.…”

Section: Endoscopic Lung Volume Reduction (Elvr)mentioning

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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A Randomized Study of Endobronchial Valves for Advanced Emphysema

Cited by 715 publications

References 36 publications

Combined Bone Marrow-Derived Mesenchymal Stromal Cell Therapy and One-Way Endobronchial Valve Placement in Patients with Pulmonary Emphysema: A Phase I Clinical Trial

Combined Bone Marrow-Derived Mesenchymal Stromal Cell Therapy and One-Way Endobronchial Valve Placement in Patients with Pulmonary Emphysema: A Phase I Clinical Trial

Status of and prospects for bronchoscopic lung volume reduction for patients with severe emphysema

Emphysema: Imaging for Endoscopic Lung Volume Reduction

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