Endobronchial valve therapy for patients with advanced emphysema. A report from a tertiary care center in China

Hang Yu; Zhen Yang; Minghui Zhu; Zhixin Liang; Wei Zhao; Qiang Zhu; Liang-an Chen

doi:10.15537/smj.2022.43.12.20220527

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Table 1

- Demographics and clinical characteristics of subjects in baseline assessment.

Characteristics	mean±SD
Gender (male)	38 (100%)
Age (years)	62.2 ± 6.9
BMI (kg/m²)	20.7 [19.2, 23.9]
Smoking history (pack years)	40.0 [30.0, 60.0]
Duration of smoking abstinence (years)	4.0 [0.5, 6.0]
COPD history (years)	8.0 [6.0, 10.5]
GOLD stage	Stage III: 18 (47.4%) Stage IV: 20 (52.6%)
PaO₂ (mmHg)	72.28 ± 8.06
PaCO₂ (mmHg)	49.00 ± 8.50
SaO₂ (%)	93.23 ± 2.26
Potential of hydrogen	7.37 ± 0.04
HCO₃- (mmcl/L)	27.29 ± 4.05
Post-BD FEV1 (L)	0.85 ± 0.28
Post-BD FEV1 (% of predicted)	30.78 ± 10.22
Post-BD FVC (L)	2.27 ± 0.76
Post-BD FVC (% of predicted)	63.53 ± 20.28
Post-BD FEV1/FVC (%)	38.17 ± 9.30
Post-BD RV (L)	6.12 ± 1.43
Post-BD RV (% of predicted)	263.78 ± 62.75
Post-BD TLC (L)	8.75 ± 1.54
Post-BD TLC (% of predicted)	138.99 ± 23.81
Post-BD RV/TLC (%)	69.76 ± 9.21
6MWD (m)	287.06 ± 98.54
mMRC (points)	3.0 [2.0, 3.0]

Values are presented as mean ± standard deviation (SD) or median (interquartile range). COPD: chronic obstructive pulmonary disease, GOLD: Global Initiative for Chronic Obstructive Lung Disease, BMI: body mass index, post-BD: post-bronchodilator, FEV1: forced expiratory volume in 1 second, FVC: forced vital capacity, RV: residual volume, TLC: total lung capacity, 6MWD: 6-minute walk distance, mMRC: modified Medical Research Council, HCO₃: bicarbonate

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Table 2

- Clinical changes of subjects prior to and 3 months after EBV implantation.

Outcome	Baseline	3 months	Change from baseline to 3 months	P-value
Post-BD FEV1 (L)	0.85 ± 0.28	0.97 ± 0.28	0.12 ± 0.20	<0.001^†
Post-BD FEV1 (% predicted)	30.78 ± 10.22	35.36 ± 11.06	4.59 ± 7.87	0.001^†
Post-BD FVC (L)	2.27 ± 0.76	2.54 ± 0.72	0.27 ± 0.61	0.009^†
Post-BD FVC (% predicted)	63.53 ± 20.28	72.29 ± 20.13	8.76 ± 17.86	0.005^†
Post-BD FEV1/FVC (%)	38.17 ± 9.30	39.06 ± 9.27	0.89 ± 4.37	0.231
Post-BD RV (L)	6.12 ± 1.43	5.56 ± 1.65	-0.56 ± 1.05	0.008^†
Post-BD RV (% predicted)	263.78 ± 62.75	236.71 ± 62.65	-27.07 ± 49.58	0.007^†
Post-BD TLC (L)	8.75 ± 1.54	8.47 ± 1.73	-0.29 ± 0.92	0.107
Post-BD TLC (% predicted)	138.99 ± 23.81	134.88 ± 23.95	-4.11 ± 17.12	0.207
Post-BD RV/TLC (%)	69.76 ± 9.21	64.68 ± 9.13	-5.08 ± 11.25	0.022*
6MWD (m)	287.06 ± 98.54	351.92 ± 99.22	64.86 ± 60.45	<0.001^†
mMRC (points)	3.0 [2.0, 3.0]	2.0 [2.0, 2.8]	-0.5 [-1.0, 0.0]	0.007^†
Target lobe volume (ml)	1693 ± 790	1127 ± 676	-566 ± 741	<0.001^†
Percentage of Subjects with Post-BD FEV1 (L) improvement of ≥15%	-	55.3% (21/38)	-	-
Percentage of Subjects with 6MWD improvement of ≥25 m	-	65.8% (25/38)	-	-
Percentage of subjects with TLVR ≥563ml	-	42.1% (16/38)	-	-
Percentage of subjects with RV reduction ≥430ml	-	57.9% (22/38)	-	-

Values are presented as mean ± standard deviation or median (interquartile range). post-BD: post-bronchodilator, FEV1: forced expiratory volume in 1 second, FVC: forced vital capacity, RV: residual volume;, TLC: total lung capacity, 6MWD: 6-minute walk distance, mMRC: modified Medical Research Council, ^*p<0.05, ^†p<0.01

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Table 3

- Adverse events occurred during 3 months after endobronchial valve treatment.

Adverse events	From the day of the procedure to 45 days afterward	Between the 45 days after the procedure and the 3-month follow-up date
Respiratory
Cough	12 (31.6)	8 (21.1)
Increase in sputum production	10 (26.3)	6 (15.8)
Chest discomfort	7 (18.4)	4 (10.5)
Chest pain	1 (2.6)	0 (0.0)
Upper respiratory tract infection	1 (2.6)	0 (0.0)
Fever	0 (0.0)	1 (2.6)
Pneumonia	0 (0.0)	1 (2.6)
Non-Respiratory
Acute urinary retention	2 (5.3)	0 (0.0)
Atrial fibrillation	1 (2.6)	0 (0.0)
Hiatus hernia	0 (0.0)	1 (2.6)