Dooms Christophe, Blondeel Astrid, Ceulemans Laurens J, Coolen Johan, Everaerts Stephanie, Demeyer Heleen, Troosters Thierry, Verleden Geert, Van Raemdonck Dirk, Janssens Wim
Clinical Dept of Respiratory Diseases, University Hospitals Leuven, BREATHE, Dept CHROMETA, KU Leuven, Leuven, Belgium.
These authors contributed equally.
ERJ Open Res. 2021 May 31;7(2). doi: 10.1183/23120541.00877-2020. eCollection 2021 Apr.
Limited guidance exists for the implementation of lung volume reduction interventions in routine clinical care. We designed a pragmatic study to evaluate a strategy including endoscopic lung volume reduction (ELVR) and lung volume reduction surgery (LVRS) in heterogeneous emphysema. This prospective monocentre cohort study evaluated ELVR no-ELVR, followed by a cohort study evaluating LVRS. Primary outcome was the proportion of subjects with a forced expiratory volume in 1 s (FEV) improvement of ⩾100 mL at 3-month follow-up. Changes in FEV, residual volume (RV), 6-min walk distance (6MWD) and quality of life (St George's Respiratory Questionnaire (SGRQ)) were evaluated at 6-month follow-up. Hospital stay and treatment-related serious adverse events were monitored. From 106 subjects screened, 38 subjects were enrolled comparing ELVR (n=20) with no-ELVR (n=18). After 6 months' follow-up, eligible patients were referred for LVRS (n=16) with another 6-month follow-up. At 3-month follow-up, 70% of ELVR compared to 11% of no-ELVR (p<0.001) and 69% of LVRS had an FEV improvement of ⩾100 mL. Between-group differences (mean±sem) for ELVR no-ELVR at 6-month follow-up were FEV +0.21±0.05 L; RV -0.95±0.21 L; 6MWD 58±17 m and SGRQ -18±5 points. At 6-month follow-up, within-group differences (mean±sem) for LVRS showed FEV +0.27±0.06 L; RV -1.49±0.22 L and 6MWD +75±18 m. Serious adverse events in 81% 45% of subjects (p=0.04) and a median hospital stay of 15 5 days (p<0.001) were observed for LVRS ELVR, respectively. This pragmatic prospective cohort study supports a clinical approach with ELVR as a less invasive first option and LVRS as powerful alternative in severe heterogeneous emphysema.
在常规临床护理中,关于实施肺减容干预措施的指导有限。我们设计了一项实用性研究,以评估一种包括内镜下肺减容术(ELVR)和肺减容手术(LVRS)的策略在异质性肺气肿中的应用。这项前瞻性单中心队列研究先评估了ELVR与非ELVR,随后进行了一项评估LVRS的队列研究。主要结局是在3个月随访时,1秒用力呼气容积(FEV)改善≥100 mL的受试者比例。在6个月随访时评估FEV、残气量(RV)、6分钟步行距离(6MWD)和生活质量(圣乔治呼吸问卷(SGRQ))的变化。监测住院时间和与治疗相关的严重不良事件。在106名筛查的受试者中,38名受试者被纳入研究,比较ELVR组(n = 20)和非ELVR组(n = 18)。6个月随访后,符合条件的患者被转诊接受LVRS(n = 16),并进行另外6个月的随访。在3个月随访时,ELVR组70%的受试者FEV改善≥100 mL,而非ELVR组为11%(p<0.001),LVRS组为69%。在6个月随访时,ELVR与非ELVR组之间的组间差异(均值±标准误)为:FEV +0.21±0.05 L;RV -0.95±0.21 L;6MWD 58±17 m;SGRQ -18±5分。在6个月随访时,LVRS组的组内差异(均值±标准误)显示为:FEV +0.27±0.06 L;RV -1.49±0.22 L;6MWD +75±18 m。LVRS组和ELVR组分别有81%和45%的受试者发生严重不良事件(p = 0.04),住院时间中位数分别为15天和5天(p<0.001)。这项实用性前瞻性队列研究支持一种临床方法,即对于严重异质性肺气肿,将ELVR作为侵入性较小的首选方案,将LVRS作为有力的替代方案。