Sgarbossa Thomas, Lenga Pavlina, Stanzel Franz, Holland Angelique, Grah Christian, Gesierich Wolfgang, Gebhardt Andreas, Ficker Joachim, Eggeling Stephan, Andreas Stefan, Schmidt Bernd, Eisenmann Stephan, Schwick Björn, Franke Karl-Josef, Fertl Andreas, Witzenrath Martin, Hübner Ralf-Harto
Department of Infectious Diseases, Respiratory Medicine and Critical Care, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
These authors contributed equally.
ERJ Open Res. 2023 Aug 21;9(4). doi: 10.1183/23120541.00190-2023. eCollection 2023 Jul.
Endoscopic lung volume reduction (ELVR) with one-way valves produces beneficial outcomes in patients with severe emphysema. Evidence on the efficacy remains unclear in patients with a very low forced expiratory volume in 1 s (FEV) (≤20% predicted). We aim to compare clinical outcomes of ELVR, in relation to the FEV restriction.
All data originated from the German Lung Emphysema Registry (Lungenemphysem Register), which is a prospective multicentric observational study for patients with severe emphysema after lung volume reduction. Two groups were formed at baseline: FEV ≤20% pred and FEV 21-45% pred. Pulmonary function tests (FEV, residual volume, partial pressure of carbon dioxide), training capacity (6-min walk distance (6MWD)), quality of life (modified Medical Research Council dyspnoea scale (mMRC), COPD Assessment Test (CAT), St George's Respiratory Questionnaire (SGRQ)) and adverse events were assessed and compared at baseline and after 3 and 6 months.
33 patients with FEV ≤20% pred and 265 patients with FEV 21-45% pred were analysed. After ELVR, an increase in FEV was observed in both groups (both p<0.001). The mMRC and CAT scores, and 6MWD improved in both groups (all p<0.05). The SGRQ score improved significantly in the FEV 21-45% pred group, and by trend in the FEV ≤20% pred group. Pneumothorax was the most frequent complication within the first 90 days in both groups (FEV ≤20% pred: 7.7% FEV 21-45% pred: 22.1%; p=0.624). No deaths occurred in the FEV ≤20% pred group up to 6 months.
Our study highlights the potential efficacy of one-way valves, even in patients with very low FEV, as these patients experienced significant improvements in FEV, 6MWD and quality of life. No death was reported, suggesting a good safety profile, even in these high-risk patients.
单向阀内镜下肺减容术（ELVR）在重度肺气肿患者中产生了有益的结果。对于1秒用力呼气容积（FEV）非常低（≤预测值的20%）的患者，其疗效证据仍不明确。我们旨在比较ELVR与FEV限制相关的临床结果。
所有数据均来自德国肺气肿登记处（Lungenemphysem Register），这是一项针对肺减容术后重度肺气肿患者的前瞻性多中心观察性研究。在基线时形成两组：FEV≤预测值的20%和FEV为预测值的21 - 45%。在基线以及3个月和6个月后评估并比较肺功能测试（FEV、残气量、二氧化碳分压）、训练能力（6分钟步行距离（6MWD））、生活质量（改良医学研究委员会呼吸困难量表（mMRC）、慢性阻塞性肺疾病评估测试（CAT）、圣乔治呼吸问卷（SGRQ））和不良事件。
分析了33例FEV≤预测值的20%的患者和265例FEV为预测值的21 - 45%的患者。ELVR后，两组的FEV均增加（均p<0.001）。两组的mMRC和CAT评分以及6MWD均有所改善（均p<0.05）。FEV为预测值的21 - 45%的组中SGRQ评分显著改善，FEV≤预测值的20%的组有改善趋势。气胸是两组在前90天内最常见的并发症（FEV≤预测值的20%：7.7%；FEV为预测值的21 - 45%：22.1%；p = 0.624）。FEV≤预测值的20%的组在6个月内无死亡病例。
我们的研究强调了单向阀的潜在疗效，即使在FEV非常低的患者中也是如此，因为这些患者的FEV、6MWD和生活质量有显著改善。未报告死亡病例，表明即使在这些高危患者中安全性也良好。
