Lung volume reduction with vapor ablation in the presence of incomplete fissures: 12-month results from the STEP-UP randomized controlled study

<b><i>Background:</i></b> 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 ablatio...

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Main Authors: Gompelmann, Daniela (Author) , Eberhardt, Ralf (Author) , Schuhmann, Maren (Author) , Valipour, Arschang (Author) , Shah, Pallav (Author) , Herth, Felix (Author) , Kontogianni, Konstantina (Author)
Format: Article (Journal)
Language:English
Published: November 12, 2016
In: Respiration
Year: 2016, Volume: 92, Issue: 6, Pages: 397-403
ISSN:1423-0356
DOI:10.1159/000452424
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1159/000452424
Verlag, lizenzpflichtig, Volltext: https://www.karger.com/Article/FullText/452424
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Author Notes:Daniela Gompelmann, Ralf Eberhardt, Maren Schuhmann, Arschang Valipour, Pallav L. Shah, Felix J.F. Herth, Konstantina Kontogianni
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Summary:<b><i>Background:</i></b> 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-). <b><i>Objectives:</i></b> This analysis evaluated the efficacy and safety of the CV+ population following BTVA. <b><i>Method:</i></b> 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 (FEV<sub>1</sub>) and St. George's Respiratory Questionnaire (SGRQ-C), were calculated for these CV+ patients following BTVA and safety results summarized. <b><i>Results:</i></b> 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 FEV<sub>1</sub> 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% (<i>p</i> = 0.0137). The improvement in SGRQ-C of the treatment arm as compared to the control arm was 8.4 points (<i>p</i> = 0.0712). An increase in respiratory related serious adverse events was observed immediately following treatment, but most resolved with routine care. <b><i>Conclusion:</i></b> 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.
Item Description:Gesehen am 03.07.2020
Physical Description:Online Resource
ISSN:1423-0356
DOI:10.1159/000452424