Supplementary Material for: Efficacy of the Spiration Valve System in Patients with Severe Heterogeneous Emphysema: A Systematic Review and Meta-Analysis

<b><i>Background:</i></b> Spiration Valve System (SVS) is an alternative for patients with severe heterogeneous emphysema; however, data about efficacy from randomized controlled trials (RCT) are unclear. <b><i>Objectives:</i></b> To explore both efficacy and safety of SVS in patients with severe emphysema and hyperinflation. <b><i>Methods:</i></b> We included PubMed, EMBASE, Coch­rane database. All searches were performed until August 2019. Only RCTs were included for analysis. Risk of bias was assessed using Cochrane risk of bias tool. A meta-analysis evaluated change in forced expiratory volume in 1 s (FEV₁), 6-min walking test (6MWT), residual volume, modified medical research council (mMRC) and Saint George respiratory questionnaire (SGRQ), all-cause mortality, risk of pneumothorax, and risk of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Quality of the evidence was rated using GRADE approach. <b><i>Results:</i></b> Four RCTs including 629 subjects were included. SVS showed an overall change of 0.03 L (–0.07 to 0.13, <i>I</i>² = 90%) in the in FEV₁ (L) and a 2.03% (–2.50 to 6.57, <i>I</i>² = 96%) in the predicted FEV₁ (%) compared to baseline; however, studies without collateral ventilation (CV) showed an improvement of 0.12 L (95% CI 0.09–0.015, <i>I</i>² = 0%), This subgroup also reported better results in SGRQ –12.27 points (95% CI –15.84 to –8.70, <i>I</i>² = 0%) and mMRC –0.54 (95% CI –0.74 to –0.33, <i>I</i>² = 0%). We found no benefit in 6MWT mean difference = 4.56 m (95% CI –21.88 to 31.00, <i>I</i>² = 73%). Relative risk of mortality was 2.54 (95% CI 0.81–7.96, <i>I</i>² = 0%), for pneumothorax 3.3 (95% CI 0.61–18.12, <i>I</i>² = 0%) and AECOPD 1.68 (95% CI 1.04–2.70, <i>I</i>² = 0%). <b><i>Conclusion:</i></b> In patients with severe heterogeneous emphysema and hyperinflation without CV, SVS is an alternative that showed an improvement in pulmonary function, quality of life, and dyspnea score with an acceptable risk profile.

**背景：** 螺旋阀系统（Spiration Valve System, SVS）是重度异质性肺气肿患者的替代治疗方案，但目前来自随机对照试验（randomized controlled trials, RCT）的疗效数据尚不明确。**研究目的：** 探讨SVS用于重度肺气肿伴肺过度充气患者的疗效与安全性。**研究方法：** 本研究检索了PubMed、EMBASE、Cochrane数据库，检索时限截至2019年8月，仅纳入随机对照试验进行分析。采用Cochrane偏倚风险工具评估偏倚风险。通过荟萃分析评估1秒用力呼气容积（forced expiratory volume in 1 s, FEV₁）、6分钟步行试验（6-min walking test, 6MWT）、残气量、改良医学研究委员会评分（modified medical research council, mMRC）、圣乔治呼吸问卷（Saint George respiratory questionnaire, SGRQ）、全因死亡率、气胸发生风险以及慢性阻塞性肺疾病急性加重（acute exacerbation of chronic obstructive pulmonary disease, AECOPD）的发生风险变化情况。采用GRADE方法对证据质量进行评级。**研究结果：** 本研究共纳入4项随机对照试验，涉及629名受试者。与基线相比，SVS组的1秒用力呼气容积（FEV₁，单位：L）总体变化量为0.03 L（95%置信区间：-0.07~0.13，I²=90%），预测FEV₁百分比变化量为2.03%（95%置信区间：-2.50~6.57，I²=96%）；但在无侧支通气（collateral ventilation, CV）的亚组中，FEV₁提升了0.12 L（95%置信区间：0.09~0.015，I²=0%），该亚组同时在SGRQ评分中显示出更优结果，评分降低12.27分（95%置信区间：-15.84~-8.70，I²=0%），mMRC评分降低0.54分（95%置信区间：-0.74~-0.33，I²=0%）。本研究未观察到6MWT存在显著获益，其平均差值为4.56 m（95%置信区间：-21.88~31.00，I²=73%）。全因死亡率相对风险为2.54（95%置信区间：0.81~7.96，I²=0%），气胸发生风险相对风险为3.3（95%置信区间：0.61~18.12，I²=0%），AECOPD发生风险相对风险为1.68（95%置信区间：1.04~2.70，I²=0%）。**研究结论：** 对于无侧支通气的重度异质性肺气肿伴肺过度充气患者，SVS是一种可行的替代治疗方案，可改善肺功能、生活质量及呼吸困难评分，且整体风险可接受。