Endobronchial valves improve pulmonary function in emphysema

Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.

“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.

©Purestock/thinkstockphotos.com

Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.

During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV₁) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.

The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).

Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV₁ by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).

However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.

Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.

All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.

The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.

Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.

“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.

©Purestock/thinkstockphotos.com

Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.

During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV₁) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.

The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).

Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV₁ by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).

However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.

Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.

All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.

The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.

Endobronchial valves improved pulmonary function, exercise capacity, and quality of life in a prospective randomized controlled trial involving 68 adults with severe emphysema, according to a report published online Dec. 10 in the New England Journal of Medicine.

“The improvements we found were of greater magnitude than those noted with pharmacologic treatment in comparable patients and were similar to improvements with surgical lung-volume reduction, but with significantly less morbidity,” said Karin Klooster of the department of pulmonary diseases, University Medical Center Groningen (the Netherlands) and her associates.

©Purestock/thinkstockphotos.com

Previous research suggested that bronchoscopic lung-volume reduction using one-way endobronchial valves to block inspiratory but not expiratory air flow would be most effective in patients who had a complete rather than an incomplete fissure between the targeted lobe and the adjacent lobe on high-resolution CT. “A complete fissure on HRCT [high-resolution computed tomography] is a surrogate finding for the absence of interlobar collateral ventilation; if there is collateral ventilation, an occluded lobe can be reinflated through its collaterals,” defeating the purpose of the procedure, the researchers wrote.

During a 3-year period, Ms. Klooster and her associates studied emphysema patients who were older than 35 years (mean age, 58-59) and had a postbronchodilator forced expiratory volume in 1 second (FEV₁) less than 60% of predicted volume, a total lung capacity more than 100% of the predicted value, and residual volume more than 150% of predicted volume. On HRCT, all the study participants showed a complete or nearly complete fissure between the targeted lobe and the adjacent lobe. They were randomly assigned to receive endobronchial valves (34 patients) or usual care (34 control subjects) and followed for 6 months. At that time, control subjects were allowed to crossover and receive endobronchial valves as well.

The median procedure time was 18 minutes (range, 6-51 minutes), and the median number of valves placed in each patient was 4 (range, 2-7 valves). The median hospital stay was 1 day (range, 1-13 days).

Compared with the control subjects, patients who received endobronchial valves showed a reduction in target lobar volume of 1,366 mL. This was accompanied by improvements in FEV₁ by 191 mL, in forced vital capacity by 442 mL, in residual lung volume, in longer 6-minute walk distance by 106 meters, in scores on the Clinical COPD Questionnaire measuring daily functioning, and in scores on the St. George’s Respiratory Questionnaire measuring quality of life. The results for the control subjects who crossed over to the active-treatment group were very similar, the investigators said (N Engl J Med. 2015 Dec 10;373:2325-35. doi:10.1056/NEJMoa1507807).

However, several adverse effects occurred, and close monitoring of this patient population is crucial. The most common complication was pneumothorax, which developed in 6 of the 34 patients (18%), usually within 1 day of undergoing the procedure. Pneumothorax resolved spontaneously in one patient but required chest-tube drainage in the other five; it resolved in one patient after temporary removal of the valves to promote healing, and in another after permanent removal of all valves.

Other adverse effects, some of which required repeat bronchoscopy, included torsion of the lower-lobe bronchus after upper-lobe treatment (two patients), pneumonia distal to the valves (one patient), increased dyspnea and sputum production (two patients), valve migration (two patients), valve dislocation because of granulation-tissue formation (one patient), and persistent cough (one patient). Despite these setbacks, “the overall outcome of treatment was positive,” Ms. Klooster and her associates said.

All patients who underwent valve removal recovered without any further adverse effects, indicating that this treatment “is fully reversible and doesn’t preclude further therapeutic options,” they added.

The study was supported by the Netherlands Organization for Health Research and Development and the University Medical Center Groningen. Ms. Klooster reported receiving fees, devices, travel support, and grant support from Pulmonx and PneumRx/BTG; her associates reported ties to numerous industry sponsors. Pulmonx commercially supplied the endobronchial valves for the study.