Bronchoscopic lung volume reduction by endobronchial valve in advanced emphysema: the first Asian report

Figures & data

Figure 1 An example of target lobe selection on the basis of dual-source computed tomography.

Notes: (A) Lung setting image. (B) Quantitative perfusion image. The perfusion is presented from red (normal) to black (no perfusion). (C) Quantitative analysis of perfusion and volume for each lobe. In this patient, the left lower lobe was selected as target lobe (as shown by the bold) since it had the lowest fraction of perfusion compared with its volume (0.20/0.33). It means that left lower lobe is the most emphysematous and hyperinflated.

Table 1 Baseline characteristics of the patients

Variables	N=43
Demographic characteristics
Age, years	68.4±7.5
Sex, male	40 (93%)
Body mass index, kg/m^2	18.5±3.1
Smoking, pack years
Has ever smoked	43 (100%)
Number of pack years	45.1±15.8
Receiving long-term oxygen therapy	17 (39.5%)
History of pulmonary tuberculosis	10 (23.3%)
Pulmonary function
FEV1, L	0.68±0.26
FEV1, %predicted	24.5±10.7
FVC, L	2.50±0.75
FVC, %predicted	63.8±17.3
TLC, L	7.51±1.20
TLC, %predicted	126.7±18.8
RV, L	4.98±1.15
RV, %predicted	208.7±47.9
DLCO, mL/min/mmHg	6.1±2.5
DLCO, %predicted	31.6±11.9
DLCO/VA, %predicted	51.02±17.8
Functional assessment
6MWD, m	233.5±114.8
Quality of life and dyspnea
SGRQ total score	65.59±13.07
mMRC dyspnea scale	3.7±0.6

Note: The data are presented as mean ± SD or n (%) unless otherwise stated.

Abbreviations: DL_CO, diffusing capacity for carbon monoxide; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; mMRC, modified Medical Research Council; RV, residual volume; SGRQ, St George’s Respiratory Questionnaire; TLC, total lung capacity; VA, alveolar volume; 6MWD, 6-min walk distance test; SD, standard deviation.

Figure 2 Flow chart indicating patient disposition in the study.

Abbreviations: BLVR, bronchoscopic lung volume reduction; EBV, endobronchial valve; FEV₁, forced expiratory volume in 1 second; SGRQ, St George’s Respiratory Questionnaire; 6MWD, 6-minute walk distance test.

Figure 3 Primary outcomes 3 and 6 months after endobronchial valve therapy relative to baseline.

Abbreviations: FEV₁, forced expiratory volume in 1 second; 6MWD, 6-minute walk distance test; mMrc, modified Medical Research Council dyspnea scale; SGRQ, St George’s Respiratory Questionnaire.

Figure 4 Proportion of patients whose clinical outcomes after endobronchial valve therapy exceed the minimum clinically important differences FEV₁, 6MWD and SGRQ.

Abbreviations: FEV₁, forced expiratory volume in 1 second; 6MWD, 6-minute walk distance; SGRQ, St George’s Respiratory Questionnaire.

Table 2 Primary outcomes relative to baseline in patients who did and did not achieve target lobe volume reduction

	Target lobe volume reduction		P-valuea
	Yes (n=28)	No (n=7)
3 months
ΔFEV1 (L)	0.26±0.22	−0.02±0.17	0.001
Δ6MWD (m)	64.2±84.6	−4.0±131.5	0.298
ΔSGRQ total (score)	−7.0±11.3	−5.2±6.7	0.606
6 months
ΔFEV1 (L)	0.29±0.23	−0.02±0.13	0.002
Δ6MWD (m)	68.2±102.0	−4.8±46.4	0.065
ΔSGRQ total (score)	−8.1±16.5	−7.1±6.2	0.516

Notes: The data are presented as mean ± SD.

a The two groups were compared by using the Mann–Whitney U-test.

Abbreviations: FEV₁, forced expiratory volume in 1 second; SGRQ, St George’s Respiratory Questionnaire; 6MWD, 6-minute walk distance test; SD, standard deviation.

Table 3 Adverse events in the 6 months after bronchoscopic lung volume reduction with endobronchial valve. (n=43)

Events	n
Death, all causes	4 (9.3%)
Related to procedure	1 (2.3%)
Unrelated to procedure	3 (7.0%)
Pneumothorax	10 (23.3%)
Oxygen supply only	2 (4.7%)
Chest tube <7 days	3 (7.0%)
Prolonged air leak ≥7 days	4 (9.3%)
Requiring surgical intervention	2 (4.7%)
Postobstructive pneumonia	1 (2.3%)
Pneumonia in other than target lobe	0 (0%)
Empyema	0 (0%)
Hemoptysis	4 (9.3%)
Nonmassive	4 (9.3%)
Massive	0 (0%)
Valve migration	1 (2.3%)
Intractable pain	1 (2.3%)
Acute exacerbation of COPD	0 (0%)

Note: The data are presented as n (%).

Table 4 Comparison of our study results with those of previous trials in Western countries in terms of pneumothorax frequency and baseline characteristics

	This study	Previous trialsa	P-value
Pneumothorax
Incidence in complete fissure patients, (%)	23.3%	10.6%	0.03
Median time to onset, days (range)	2 (1–26)	2 (0–272)
Baseline characteristics, mean (SE)
Age, years	68.4 (1.14)	62.8 (1.70)	<0.001
Body mass index, kg/m^2	18.5 (0.47)	23.9 (0.61)	<0.001
FEV1, %predicted	24.5 (1.63)	30.0 (0.53)	0.001
RV, %predicted	208.7 (7.31)	232.0 (8.07)	0.002
6MWD	233.5 (17.53)	333.9 (4.77)	<0.001

Notes:

a The previous trials are three prospective multicenter trials: VENT (a US study cohort [NCT0129584] and a European cohort [NCT0129584]) and the multicenter Chartis™ trial (NCT1101958).

Abbreviations: FEV₁, forced expiratory volume in 1 second; RV, residual volume; SE, standard error; 6MWD, 6-minute walk distance test.

Table S1 Pulmonary function test, 6MWD, mMRC dyspnea scale, and SGRQ total score results 3 and 6 months after endobronchial valve therapy

	Baseline	3 months	6 months
Spirometry, subjects n	43	35	27
FEV1, L	0.68±0.26	0.89±0.37***	0.92±0.40***
FEV1, %predicted	24.5±10.7	32.5±16.3***	33.8±17.9***
FVC, L	2.50±0.75	2.95±0.83**	3.06±0.82**
FVC, %predicted	63.8±17.3	74.0±18.4*	78.7±15.9**
TLC, L	7.51±1.20	6.91±1.31*	6.78±1.21*
Lung volume, subjects n	42	32	24
TLC, %predicted	126.7±18.8	117.2±15.1*	116.0±14.7*
RV, L	4.98±1.15	3.91±1.15**	3.67±0.95***
RV, %predicted	208.7±47.9	165.0±47.7***	155.9±42.6***
Diffusing capacity, subjects n	43	31	23
DLCO, mL/min/mmHg	6.1±2.5	6.7±2.3*	6.6±2.3*
DLCO, %predicted	31.6±11.9	34.9±10.7*	34.3±10.7*
Exercise capacity, subjects n	40	31	21
6MWD, m	233.5±114.8	283.7±121.6**	299.6±87.5*
Dyspnea scale, subjects n	43	35	27
mMRC dyspnea scale	3.7±0.6	2.5±1.2***	2.4±1.2***
Quality of life, subjects n	39	27	20
SGRQ total score*	65.59±13.07	55.70±13.79**	53.76±11.40*

Notes: The data are presented as mean ± SD.

* P<0.05,

** P<0.01, and

*** P<0.001 compared to baseline, as determined by using Wilcoxon signed rank test.

Abbreviations: DL_CO, diffusing capacity for carbon monoxide; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; mMRC, modified Medical Research Council; RV, residual volume; SGRQ, St George’s Respiratory Questionnaire; TLC, total lung capacity; 6MWD, 6-minute walk distance; SD, standard deviation.

Table S2 Effect of tuberculosis scar on target lobe volume reduction and pneumothorax

	Tuberculosis scar		P-valuea
	No (n=34)	Yes (n=9)
Target lobe volume reduction
No	5 (14.5%)	2 (22.2%)	0.624
Yes	29 (85.3%)	7 (77.8%)
Pneumothorax
No	26 (76.5%)	7 (77.8%)	1.000
Yes	8 (23.5%)	2 (22.2%)

Notes: The data are presented as n (%).

a The patients with and without a tuberculosis scar were compared by using Pearson’s chi-squared test.