Design of the randomized, controlled sequential staged treatment of emphysema with upper lobe predominance (STEP-UP) study

Valipour, Arschang; Herth, Felix; Eberhardt, Ralf; Shah, Pallav L.; Gupta, Avina; Barry, Robert; Henne, Erik; Bandyopadhyay, Sourish; Snell, Gregory I

doi:10.1186/1471-2466-14-190

Cited by 21 publications

(13 citation statements)

References 24 publications

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“…Full details of the STEP-UP study design and results have been previously reported [5,11,12]. In brief, adult patients with upper lobe-predominant heterogeneous emphysema were enrolled from 13 multinational hospital sites.…”

Section: Methodsmentioning

confidence: 99%

Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study

et al. 2016

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Background: Emphysema patients with collateral ventilation (CV) will not benefit from valve therapy, the most common endoscopic lung volume reduction procedure. A recent randomized controlled trial (STEP-UP) of the alternative bronchoscopic thermal vapor ablation (BTVA) included patients with (CV+) and without interlobar CV (CV-). Objectives: This analysis evaluated the efficacy and safety of the CV+ population following BTVA. Method: A post hoc fissure analysis of the baseline computed tomography of all treatment and control patients was performed with the VIDA Diagnostics Apollo software. A patient was considered to be CV+ if either of the treated upper lobes was adjacent to a fissure that was <90% complete. The primary endpoints, forced expiratory volume in 1 s (FEV₁) and St. George's Respiratory Questionnaire (SGRQ-C), were calculated for these CV+ patients following BTVA and safety results summarized. Results: 78% (35/45) of the patients in the treatment arm and 79% (19/24) of the patients in the control arm were found to be CV+. At 12 months, the FEV₁ improvement of the treatment arm was 9.2%, as compared with a decrease of 5.4% in the control group, resulting in a mean between-group difference of 14.6% (p = 0.0137). The improvement in SGRQ-C of the treatment arm as compared to the control arm was 8.4 points (p = 0.0712). An increase in respiratory related serious adverse events was observed immediately following treatment, but most resolved with routine care. Conclusion: BTVA can achieve safe and clinically meaningful improvement in pulmonary function and quality of life in patients with CV. These randomized controlled trial subgroup results offer proof of a viable solution for CV+ patients.

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Section: Methodsmentioning

confidence: 99%

Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study

et al. 2016

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“…In this study, air volume and tissue mass volumes were quantitatively assessed to compute an air volume to tissue mass ratio, a measure of hyperinflation and tissue destruction. The air volume to tissue mass ratio is the inverse of the previously published measure of lung density, the tissue to air ratio, and is directly correlated with disease severity [5, 14]. During HRCT analysis, the right lung and left lung were each divided into three lobar regions, and each lobar region was divided into bronchopulmonary segments as follows: right upper lobe (RB1, RB2, RB3), right middle lobe (RB4, RB5), and right lower lobe (RB6, RB7, RB8, RB9, RB10); left upper lobe (LB1, LB2, LB3), lingula (LB4, LB5), and left lower lobe (LB6, LB8, LB9, LB10).…”

Section: Methodsmentioning

confidence: 99%

“…Once quantified, the most diseased portions of the lung can potentially be selectively reduced as part of a lung volume reduction (LVR) procedure with the aim of improving patient quality of life. There is some evidence that the degree of disease heterogeneity correlates with clinical efficacy after LVR [3–5]. …”

Section: Introductionmentioning

confidence: 99%

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Patterns of Emphysema Heterogeneity

et al. 2015

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Background: Although lobar patterns of emphysema heterogeneity are indicative of optimal target sites for lung volume reduction (LVR) strategies, the presence of segmental, or sublobar, heterogeneity is often underappreciated. Objective: The aim of this study was to understand lobar and segmental patterns of emphysema heterogeneity, which may more precisely indicate optimal target sites for LVR procedures. Methods: Patterns of emphysema heterogeneity were evaluated in a representative cohort of 150 severe (GOLD stage III/IV) chronic obstructive pulmonary disease (COPD) patients from the COPDGene study. High-resolution computerized tomography analysis software was used to measure tissue destruction throughout the lungs to compute heterogeneity (≥15% difference in tissue destruction) between (inter-) and within (intra-) lobes for each patient. Emphysema tissue destruction was characterized segmentally to define patterns of heterogeneity. Results: Segmental tissue destruction revealed interlobar heterogeneity in the left lung (57%) and right lung (52%). Intralobar heterogeneity was observed in at least one lobe of all patients. No patient presented true homogeneity at a segmental level. There was true homogeneity across both lungs in 3% of the cohort when defining heterogeneity as ≥30% difference in tissue destruction. Conclusion: Many LVR technologies for treatment of emphysema have focused on interlobar heterogeneity and target an entire lobe per procedure. Our observations suggest that a high proportion of patients with emphysema are affected by interlobar as well as intralobar heterogeneity. These findings prompt the need for a segmental approach to LVR in the majority of patients to treat only the most diseased segments and preserve healthier ones.

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“…In a post hoc analysis, the occurrence and severity of serious adverse events increased with the volume of the treated lobe, with an inflection point identified at 1,700 mL target lobar volume [4]. Given the potential for improving the risk-benefit relationship on the basis of the above, an alternative approach was sought to limit the volume treated in a BTVA session, which has resulted in the design of the STEP-UP study [5]. The STEP-UP study was a randomized, controlled open-label trial using BTVA in a sequential (stepwise) bilateral treatment to target individual segments based on their disease state [6].…”

Section: Clinical Evidence For Btvamentioning

confidence: 99%

Bronchoscopic Thermal Vapor Ablation: Best Practice Recommendations from an Expert Panel on Endoscopic Lung Volume Reduction

et al. 2018

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Bronchoscopic thermal vapor ablation (BTVA) represents one of the endoscopic lung volume reduction (ELVR) techniques that aims at hyperinflation reduction in patients with advanced emphysema to improve respiratory mechanics. By targeted segmental vapor ablation, an inflammatory response leads to tissue and volume reduction of the most diseased emphysematous segments. So far, BTVA has been demonstrated in several single-arm trials and 1 multinational randomized controlled trial to improve lung function, exercise capacity, and quality of life in patients with upper lobe-predominant emphysema irrespective of the collateral ventilation. In this review, we emphasize the practical aspects of this ELVR method. Patients with upper lobe-predominant emphysema, forced expiratory volume in 1 second (FEV₁) between 20 and 45% of predicted, residual volume (RV) > 175% of predicted, and carbon monoxide diffusing capacity (DLCO) ≥20% of predicted can be considered for BTVA treatment. Prior to the procedure, a special software assists in identifying the target segments with the highest emphysema index, volume and the highest heterogeneity index to the untreated ipsilateral lung lobes. The procedure may be performed under deep sedation or preferably under general anesthesia. After positioning of the BTVA catheter and occlusion of the target segment by the occlusion balloon, heated water vapor is delivered in a predetermined specified time according to the vapor dose. After the procedure, patients should be strictly monitored to proactively detect symptoms of localized inflammatory reaction that may temporarily worsen the clinical status of the patient and to detect complications. As the data are still very limited, BTVA should be performed within clinical trials or comprehensive registries where the product is commercially available.

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Design of the randomized, controlled sequential staged treatment of emphysema with upper lobe predominance (STEP-UP) study

Cited by 21 publications

References 24 publications

Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study

Lung Volume Reduction with Vapor Ablation in the Presence of Incomplete Fissures: 12-Month Results from the STEP-UP Randomized Controlled Study

Patterns of Emphysema Heterogeneity

Bronchoscopic Thermal Vapor Ablation: Best Practice Recommendations from an Expert Panel on Endoscopic Lung Volume Reduction

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