A long-term follow-up investigation of endobronchial valves in emphysema (the LIVE Study)

• Verfasst von: Skowasch, Dirk [VerfasserIn]
• Verfasst von: Herth, Felix [VerfasserIn]
• Titel: A long-term follow-up investigation of endobronchial valves in emphysema (the LIVE Study)
• Titelzusatz: study protocol and six-month interim analysis results of a prospective five-year observational study
• Verf.angabe: Dirk Skowasch, Andreas Fertl, Björn Schwick, Harald Schäfer, Andreas Hellmann, Felix J.F. Herth on behalf of the LIVE Study Investigators
• E-Jahr: 2016
• Jahr: August 24, 2016
• Umfang: 9 S.
• Fussnoten: Gesehen am 08.05.2020
• Titel Quelle: Enthalten in: Respiration
• Ort Quelle: Basel : Karger, 1944
• Jahr Quelle: 2016
• Band/Heft Quelle: 92(2016), 2, Seite 118-126
• ISSN Quelle: 1423-0356
• DOI: doi:10.1159/000448119
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 169772647X

Abstract

Randomized controlled trials indicate that significant lung volume reduction (ELVR) can be obtained with Zephyr® valves by occluding the target lobe in the absence of collateral ventilation, leading to relevant functional benefits in advanced emphysema patients. To observe the long-term effects of endobronchial valve (EBV) implantation in emphysema patients screened by Chartis assessment in the context of daily pulmonology practice. The LIVE Study is a prospective, observational, open-label, single-arm, multicenter trial conducted in Germany. 498 patients included in this interim analysis were enrolled between July 2, 2012, and September 16, 2014. The 6-month follow-up visit data were recorded for 343 patients (safety population), and complete data sets were available for 321 treated patients (efficacy population) - 56.4% male, age: 64.5 years, forced expiratory volume in 1 s (FEV₁) % predicted: 31.3%, residual volume (RV) % predicted: 252%. Efficacy results at 6 months: FEV₁ (l) increased by +100 ml (+11.9%), RV (l) decreased by -0.42 liter, and the COPD Assessment Test score decreased by -3.14 points (each p < 0.0001). Safety outcomes: A total of 66 adverse events (AEs; with 50 serious AEs - SAEs) were reported in 55 patients (16%) during the hospital stay for EBV placement - pneumothorax (35 cases), chronic obstructive pulmonary disease (COPD) exacerbation (5 cases), and pneumonia (4 cases). During the subsequent 6-month follow-up window, 170 SAEs were recorded in 125 patients (36.4%), predominantly COPD exacerbation (53% of the SAEs). The current results of this large-scale German observational study performed in the context of daily practice further demonstrates that ELVR with Zephyr® valves is an effective and well-tolerated treatment option in advanced emphysema.