PMID- 32311695 OWN - NLM STAT- MEDLINE DCOM- 20210422 LR - 20210422 IS - 1423-0356 (Electronic) IS - 0025-7931 (Linking) VI - 99 IP - 4 DP - 2020 TI - Efficacy and Safety of the 9-mm Intrabronchial Valve in Patients with Advanced Emphysema. PG - 333-343 LID - 10.1159/000506521 [doi] AB - BACKGROUND: Endoscopic valve therapy aims at lung volume reduction that is associated with improved lung function, exercise tolerance and quality of life in emphysema patients. The size of intrabronchial valves of the Spiration(R) Valve System (SVS) selected to achieve lobar occlusion may have an influence on treatment outcomes. METHODS: 49 severe emphysema patients (M/F: 24/25, age: 64 +/- 7 years), with complete interlobar fissures on the side intended to be treated, underwent treatment with at least one 9-mm intrabronchial valve implantation at 3 centers and were followed up at 30, 90 and 180 days after intervention. Changes in pulmonary function tests (PFT), 6-min walk test (6MWT), modified Medical Research Council (mMRC) dyspnea scale and chronic obstructive pulmonary disease assessment test scores as well as possible complications were recorded. RESULTS: Forced expiratory volume in 1 s (FEV1) improved significantly over the 6-month period of the study, and the proportion of patients achieving a minimal clinically important difference (MCID) for FEV1 was 46.4% at 6 months. Regarding the remaining PFT values, the changes were not statistically significant at 6 months, but when looking at the MCIDs, 44.4% of the patients achieved the MCID decrease for residual volume. The 6MWT distance also improved statistically significantly, and an MCID increase of >/=26 m was reached by 41.7% of the patients. Furthermore, there was a statistically significant improvement in the mMRC score. The incidence of pneumothoraxes requiring drainage was 26.5% while a valve dislocation rate of 24% was observed but only in the lower lobes. CONCLUSIONS: Endoscopic lung volume reduction with the 9-mm SVS valves was associated with statistically significant but modest improvement of FEV1, mMRC and 6MWT up to 6 months after intervention. These results were accompanied by an anticipated and acceptable risk profile. The relative increased incidence of device dislocation observed needs to be further elucidated. CI - (c) 2020 S. Karger AG, Basel. FAU - Kontogianni, Konstantina AU - Kontogianni K AD - Thoraxklinik, University of Heidelberg, Heidelberg, Germany, kkontogianni@gmail.com. AD - Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research (DZL), Heidelberg, Germany, kkontogianni@gmail.com. FAU - Gompelmann, Daniela AU - Gompelmann D AD - Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research (DZL), Heidelberg, Germany. FAU - Valipour, Arschang AU - Valipour A AD - Department of Respiratory and Critical Care Medicine, North Hospital Vienna, Vienna, Austria. FAU - Gerovasili, Vasiliki AU - Gerovasili V AD - Queen Elizabeth Hospital, University Hospitals Birmingham NHS Trust, Birmingham, United Kingdom. FAU - Schuhmann, Maren AU - Schuhmann M AD - Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research (DZL), Heidelberg, Germany. FAU - Stanzel, Franz AU - Stanzel F AD - Lungenklinik Hemer, Hemer, Germany. FAU - Herth, Felix J F AU - Herth FJF AD - Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research (DZL), Heidelberg, Germany. FAU - Eberhardt, Ralf AU - Eberhardt R AD - Thoraxklinik, University of Heidelberg, Heidelberg, Germany. AD - Translational Lung Research Center Heidelberg (TLRCH), German Center for Lung Research (DZL), Heidelberg, Germany. LA - eng PT - Journal Article DEP - 20200420 PL - Switzerland TA - Respiration JT - Respiration; international review of thoracic diseases JID - 0137356 SB - IM MH - Aged MH - Aged, 80 and over MH - Bronchoscopy MH - Dyspnea/physiopathology MH - Female MH - Forced Expiratory Volume MH - Humans MH - Male MH - Middle Aged MH - Minimal Clinically Important Difference MH - *Pneumonectomy MH - Pneumothorax/epidemiology/therapy MH - Postoperative Complications/epidemiology/therapy MH - Prosthesis Failure MH - *Prosthesis Implantation MH - Pulmonary Emphysema/physiopathology/*surgery MH - Residual Volume MH - *Surgical Instruments MH - Treatment Outcome MH - Walk Test OTO - NOTNLM OT - Bronchoscopy OT - Chronic obstructive pulmonary disease OT - Emphysema OT - Endoscopic lung volume reduction OT - Interventional pneumology OT - Intrabronchial valves EDAT- 2020/04/21 06:00 MHDA- 2021/04/23 06:00 CRDT- 2020/04/21 06:00 PHST- 2019/08/14 00:00 [received] PHST- 2020/02/12 00:00 [accepted] PHST- 2020/04/21 06:00 [pubmed] PHST- 2021/04/23 06:00 [medline] PHST- 2020/04/21 06:00 [entrez] AID - 000506521 [pii] AID - 10.1159/000506521 [doi] PST - ppublish SO - Respiration. 2020;99(4):333-343. doi: 10.1159/000506521. Epub 2020 Apr 20.