Assessment of efficacy and safety of endoscopic lung volume reduction with one-way valves in patients with a very low FEV₁

Abstract

IntroductionEndoscopic 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 one second (FEV1≤ 20%). We aim to compare clinical outcomes of ELVR, in relation to the FEV1restriction.MethodsAll data originated from the German Lung Emphysema Registry (Lungenemphysem Register e.V.), which is a prospective multicentric observational study for patients with severe emphysema after lung volume reduction. Two groups were formed at baseline: FEV1≤ 20% and FEV121–45%. Pulmonary function tests (FEV1, RV, pCO2), training capacity (6-MWD), quality of life (mMRC, CAT, SGRQ) and adverse events were assessed and compared at baseline and after three and six months.Results33 patients with FEV1≤ 20% and 265 patients with FEV121–45% were analyzed. After ELVR, an increase in FEV1was observed in both groups (both p<0.001). The mMRC- and CAT-Score, and 6-MWD improved in both groups (all p<0.05). The SGRQ-Score improved significantly in FEV121–45% group, and by trend in the FEV1≤ 20% group. Pneumothorax was the most frequent complication within the first 90 days in both groups (FEV1≤ 20%: 7.7% versus FEV121–45%: 22.1%; p=0.624). No deaths occurred in the FEV1≤ 20% group up to six months.ConclusionOur study highlights the potential efficacy of one-way valves even in patients with very low FEV1as these patients experienced significant improvements in FEV1, 6-MWD and quality of life. No death was reported, suggesting a good safety profile even in these high-risk patients.

Is It Time to Expand the Criteria for Bronchoscopic Lung Volume Reduction in Very Low FEV1 and DLCO Emphysema

“…In patients with FEV1 ≤ 20%, there were statistically significant improvements in FEV1 with a weighted pooled mean ± standard deviation (WPM) of 0.15 ± 0.27 L, 13.45 ± 23.76%, and reduction in residual volume (RV) (WPM 1.01 ± 1.72 L, 31.1 ± 71.8%) [4][5][6] (Table 1). In patients with DLCO, ≤ 20% there was an improvement of FEV1 (WPM 0.13 ± 0.28 L, 8.6 ± 16.3%) and a reduction in RV (WPM 0.66 ± 1.16 L, 31 ± 87%) (Table 1).…”

“…Ten articles were retrieved for full-text review, from which 6 articles were selected. [4][5][6][7][8][9] These included 5 studies on valve placements, 4-8 and 1 on coil placement. 9 The inclusion criteria for heterogeneous/ FIGURE 1.…”

“…In patients with DLCO, ≤ 20% there was an improvement of FEV1 (WPM 0.13 ± 0.28 L, 8.6 ± 16.3%) and a reduction in RV (WPM 0.66 ± 1.16 L, 31 ± 87%) (Table 1). 4,7,8 St George's Respiratory Questionnaire (SGRQ) score was reduced by 9.3 (FEV1 ≤ 20%) 6 and a WPM of 12.3 ± 15.6 (DLCO ≤ 20%) 7,8 (Table 1). Six-minute walk test (6MWT) improved by a WPM of 50.8 ± 72.4 m (FEV1 ≤ 20%) [4][5][6] and a WPM of 42.1 ± 69.8 m (DLCO ≤ 20%) 4,7,8 (Table 1).…”

“…4,7,8 St George's Respiratory Questionnaire (SGRQ) score was reduced by 9.3 (FEV1 ≤ 20%) 6 and a WPM of 12.3 ± 15.6 (DLCO ≤ 20%) 7,8 (Table 1). Six-minute walk test (6MWT) improved by a WPM of 50.8 ± 72.4 m (FEV1 ≤ 20%) [4][5][6] and a WPM of 42.1 ± 69.8 m (DLCO ≤ 20%) 4,7,8 (Table 1). Despite no deaths among patients with FEV1 and/or DLCO ≤ 20%, 2 fatalities were reported in the FEV1 > 20% subgroup by Sgarbossa et al, 6 with 1 due to acute respiratory failure linked to BLVR and the other due to myocardial infarction, unrelated to BLVR.…”

“…homogeneous emphysema, FEV1, and/or DLCO of each study are shown in Table 1. The total sample size of patients with FEV1 and/or DLCO ≤ 20% was 157 (106 patients with FEV1 ≤ 20% [4][5][6]9 and 71 patients with DLCO ≤ 20% 4,7,8 ).…”