Introduction
Patients and methods
Study subjects
Inclusion standards
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The patient’s age is forty years or more.
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A high resolution computed tomography (HRCT) indicated the presence of homogenous emphysema.
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According to the most current Medical Research Council, patients have grade 2 dyspnea (mMRC) or more.
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The post-bronchodilator (forced expiratory volume in one second to forced vital capacity ratio) (FEV1/FVC) was 70% or less, and the FEV1 ranged from (30–50%) of the predicted value.
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Total lung capacity (TLC) of 75% or more of the expected value and residual volume (RV) of 150% or more suggest hyperinflation.
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A former smoker who smoked for 20 pack-years.
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Patients who have declined lung volume reduction surgery or who do not qualify for the procedure.
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Patients who might potentially benefit from a bronchoscopy.
Exclusion standards
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Reduction in lung capacity or prior lobectomy; clinically severe bronchitis or asthma.
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The most recent severe chronic obstructive pulmonary disease (COPD) flare-up occurred less than 2 months prior to the procedure.
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Imaging findings that are consistent with a lung nodule bigger than 1 cm in diameter, a huge bullous disease (predominant bulla larger than 10 cm in diameter), significant interstitial lung disease, or pleural disease.
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HIV, serious malignancy, and recent myocardial infarction are examples.
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The incidence of pulmonary hypertension is prevalent and estimated by echocardiography (estimated systolic pulmonary artery pressure > 45 mmHg).
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The BMI ranges between 15 and 35 kg/m2.
The following procedures were applied to all chosen patients
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Baseline values were obtained from the following assessments on admission and at 1-, 3-, and 6-months post-op:
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Chest CT with many detectors (HRCT volumetry).
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Using single-breath helium dilution technology, European manufacturers of medical equipment provide very accurate pulmonary function tests (spirometry; FEV1, FVC, FEV1/FVC lung volumes; RV, TLC, and RV/TLC).
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6 min walk distance (6MWD).
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The dyspnea rating scale was developed by the mMRC.
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Quality of life is evaluated with the use of the COPD Assessment Test (CAT) score.
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High-Resolution Computed Tomography of Large Volumes (HRCT).
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HRCT volumetry was performed using a 128-detector CT scanner (a Philips Ingenuity Core128 scanner from Philips Medical Systems in Best, the Netherlands, which is also capable of helical CT).
Post maneuver follow-up for early and late complications
Outcomes evaluation
Primary outcome
Measures to minimize the risks
Secondary outcome
Statistical analysis
Results
Variable | Range | Mean ± SD |
---|---|---|
Age | 44–71 | 58.40 ± 6.86 |
Smoking index | 20–100 | 51.35 ± 22.56 |
Emphysema distribution (Patients No.= 40) | No | % |
---|---|---|
Right upper lobe | 15 | 37.5% |
Right lower lobe | 5 | 12.5% |
Left upper lobe | 13 | 32.5% |
Left lower lobe | 7 | 17.5% |
mMRC | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 3.35 ± 0.53 | 2.43 ± 0.50 | 2.40 ± 0.50 | 2.38 ± 0.49 | |
F test | 35.395 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.001* | 0.001* | 0.001* | 0.996 | 0.971 | 0.996 |
PaO2/mmHg | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 61.03 ± 3.42 | 71.88 ± 7.33 | 73.15 ± 7.06 | 73.73 ± 6.89 | |
F test | 35.348 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.001* | 0.001* | 0.001* | 0.808 | 0.566 | 0.978 |
FEV1/FVC (%) | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 39.30 ± 8.55 | 49.58 ± 9.49 | 52.75 ± 9.13 | 54.35 ± 9.13 | |
F test | 22.171 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.001* | 0.001* | 0.001* | 0.402 | 0.091 | 0.860 |
FEV1 (%) | Baseline | 1st month | 3rd months | 6th months | |
---|---|---|---|---|---|
Mean ± SD
| 32.73 ± 4.29 | 41.03 ± 6.49 | 43.65 ± 6.47 | 44.28 ± 6.34 | |
F test
| 76.363 | ||||
P value
| 0.001* | ||||
Baseline & 1 m.
|
Baseline & 3 m.
|
Baseline & 6 m.
|
1 m. & 3 m.
|
1 m. & 6 m.
|
3 m. & 6 m.
|
0.001*
| 0.001* | 0.001* | 0.205 | 0.075 | 0.966 |
RV/TLC (%) | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 166.28 ± 11.87 | 126.55 ± 17.28 | 115.85 ± 17.68 | 107.20 ± 18.94 | |
F test | 98.119 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.001* | 0.001* | 0.001* | 0.024* | 0.001* | 0.098 |
HRCT volumetry (ml3) | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 1398.60 ± 585.08 | 1037.50 ± 503.25 | 926.03 ± 451.54 | 860.91 ± 430.50 | |
F test | 9.285 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.008* | 0.001* | 0.001* | 0.747 | 0.393 | 0.937 |
6MWD | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 404.58 ± 73.39 | 453.28 ± 76.87 | 466.53 ± 73.77 | 482.65 ± 77.21 | |
F test | 7.991 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.023* | 0.002* | 0.001* | 0.860 | 0.305 | 0.774 |
CAT | Baseline | 1 month | 3 months | 6 months | |
---|---|---|---|---|---|
Mean ± SD | 34.68 ± 3.58 | 29.58 ± 2.60 | 28.65 ± 1.94 | 27.35 ± 1.55 | |
F test | 64.024 | ||||
P value | 0.001* | ||||
Baseline & 1 m. | Baseline & 3 m. | Baseline & 6 m. | 1 m. & 3 m. | 1 m. & 6 m. | 3 m. & 6 m. |
0.001* | 0.001* | 0.001* | 0.364 | 0.001* | 0.104 |
Complication | No (40) | % |
---|---|---|
COPD excerbation | 3 | 7.5 |
Pneumonia | 1 | 2.5 |
Haemoptysis | 0 | 0 |
Pleuritic chest pain | 0 | 0 |
Discussion
Primary outcome
Secondary outcome
Conclusions
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(Bio LVR) by using locally prepared fibrin glue could be an efficient method in treating advanced homogenous emphysema.
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Regarding safety and cost- effectiveness, the biological agent used was safe and low cost in comparison with synthetic agents.
Limitations of the study
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Inability to perform multicenter study.
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Lack of comparison between the effect of BLVR in homogenous versus heterogenous emphysema.
Recommendations
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Biological agents’ long-term efficacy in reducing lung volume could be assessed through additional clinical trials.
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Under investigation should be the combination of biological agents and other BioLVR techniques utilized in the same procedure.
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It is recommended that future investigations compare the effectiveness of bronchoscopic Bio LVR in cases of upper lobe predominant emphysema versus lower lobe predominant emphysema.