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Unilateral lobar treatment with endobronchial valves produces modest improvements in lung function, exercise tolerance, and symptoms in patients with advanced, heterogenous, hyperinflated emphysema, according to a report in the Sept. 23 issue of the New England Journal of Medicine.
However, these benefits come with substantial costs in the months following implantation: more frequent exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia distal to the valves in more than 4% of cases, hemoptysis related to oozing from granulation tissue, and pneumothorax, said Dr. Frank C. Sciurba of the University of Pittsburgh and his associates.
They assessed the safety and efficacy of endobronchial valves, compared with standard medical care, in what they described as the first randomized, prospective, multicenter study of the devices, the Endobronchial Valve for Emphysema Palliation Trial (VENT).
The study involved 321 patients (aged 40-75 years) who were randomly assigned to receive either the unidirectional valves (220 subjects), which block regional inflation while allowing exhalation, or standard medical therapy (101 controls).
The valves are designed to reduce the volume (hyperinflation) of the most severely damaged lobe, allowing expansion of the more viable adjacent lobe.
A mean of 3.8 valves was placed in each patient via bronchoscopy. The valves were placed in only one lung (in the lobar, segmental, or subsegmental bronchi, depending on the patient’s anatomy) to completely isolate the targeted lobe. Moderate sedation was used in 71% of patients and general anesthesia in 29%. The mean duration of the procedure was 34 minutes.
The composite efficacy end point was the percent change in FEV1 and distance achieved in the 6-minute walk test at the 6-month follow-up. The primary safety end point was a composite of six major complications arising within 6 months: death, empyema, massive hemoptysis, pneumonia distal to the valves, pneumothorax or air leak of more than 7 days’ duration, or ventilator-dependent respiratory failure of more than 24 hours’ duration.
Quality of life, exercise capacity, dyspnea, and daily oxygen use also were assessed as secondary end points.
At 6 months, FEV1 increased by 4.3% in the valve group and decreased by 2.5% in control group, for a mean between-group difference of 6.8%. Similarly, distance traveled in the 6-minute walk test increased by 2.5% in the valve group and decreased by 3.2% in the control group, for a mean between-group difference of 5.8%, Dr. Sciurba and his colleagues reported (N. Engl. J. Med. 2010;363:1233-44).
Patients who received the valves also showed modest changes in all secondary end points.
However, the 6-month rate of composite complications was 6.1% in the valve group, compared with 1.2% in the control group. This included six deaths in the valve group and none in the control group. At 1 year, the complication rates were 10.3% and 4.6%, respectively.
The most common adverse event related to valve placement was pneumonia distal to the valve, which developed in 4.2% of patients within 1 year of the procedure. Hemoptysis requiring bronchoscopic inspection was significantly more common in the valve group (approximately 12%) than in controls (0%). Similarly, pneumothorax developed more often in the valve group (5.2%) than in controls (2.4%), as did COPD exacerbations requiring hospitalization (7.9% and 1.1%, respectively).
“In 12 months of follow-up, valves were removed in 31 patients for reasons including retrieval of a migrated valve (in 8 patients), the patient’s request for an unspecified reason (in 7), pneumonia management (in 3), COPD exacerbations (in 2), hemoptysis (in 1), and other reasons (in 7),” the researchers said. In addition, further bronchoscopies were required in 23% of the valve group, compared with only 1% of the control group.
After the trial was completed in 2007, an additional eight patients underwent elective removal of the valves because of adverse events, and three others experienced spontaneous expectoration of a valve, the investigators said.
The VENT study was funded by Emphasys Medical (now Pulmonx) and a grant to Dr. Sciurba from the National Institutes of Health. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.
It would be premature to recommend the routine use of endobronchial valves in patients with COPD based on the results of this study, which had several limitations, said Dr. Antonio Anzueto.
First, concomitant medical therapy was not standardized in the two study groups, and “in my opinion, the patients with severe or very severe COPD received suboptimal medical therapy,” Dr. Anzueto said. For example, fewer than 60% were taking the recommended bronchodilators at baseline.
Second, patients were given prophylactic antibiotics for 1 week following implantation, but the investigators did not cite any rationale for doing so, and did not describe any preliminary microbiologic data to guide the antibiotic therapy. The antibiotics did nothing to prevent pneumonia, which developed several weeks later.
“I believe that exhaustive microbiologic assessments should have been made in these patients with severe lung disease, because they are at high risk for lung infection by resistant pathogens,” Dr. Anzueto said.
Finally, lung volumes (as measured by body plethysmography) did not change significantly in either group. “Thus, changes in lung function seen in patients with endobronchial valves may not be due to decreased hyperinflation but to other unknown mechanisms,” he noted.
Antonio Anzueto, M.D., is at the University of Texas Health Science Center and the South Texas Veterans Health Care Center, both in San Antonio. He is cochair of the U.S. COPD Coalition and a member of the executive and scientific committee of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which issues disease management guidelines. He reported serving on boards and speakers bureaus for a number of pharmaceutical companies. His comments here were taken from an editorial (N. Engl. J. Med. 2010;363:1280-1) that accompanied the report by Dr. Sciurba and colleagues.
It would be premature to recommend the routine use of endobronchial valves in patients with COPD based on the results of this study, which had several limitations, said Dr. Antonio Anzueto.
First, concomitant medical therapy was not standardized in the two study groups, and “in my opinion, the patients with severe or very severe COPD received suboptimal medical therapy,” Dr. Anzueto said. For example, fewer than 60% were taking the recommended bronchodilators at baseline.
Second, patients were given prophylactic antibiotics for 1 week following implantation, but the investigators did not cite any rationale for doing so, and did not describe any preliminary microbiologic data to guide the antibiotic therapy. The antibiotics did nothing to prevent pneumonia, which developed several weeks later.
“I believe that exhaustive microbiologic assessments should have been made in these patients with severe lung disease, because they are at high risk for lung infection by resistant pathogens,” Dr. Anzueto said.
Finally, lung volumes (as measured by body plethysmography) did not change significantly in either group. “Thus, changes in lung function seen in patients with endobronchial valves may not be due to decreased hyperinflation but to other unknown mechanisms,” he noted.
Antonio Anzueto, M.D., is at the University of Texas Health Science Center and the South Texas Veterans Health Care Center, both in San Antonio. He is cochair of the U.S. COPD Coalition and a member of the executive and scientific committee of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which issues disease management guidelines. He reported serving on boards and speakers bureaus for a number of pharmaceutical companies. His comments here were taken from an editorial (N. Engl. J. Med. 2010;363:1280-1) that accompanied the report by Dr. Sciurba and colleagues.
It would be premature to recommend the routine use of endobronchial valves in patients with COPD based on the results of this study, which had several limitations, said Dr. Antonio Anzueto.
First, concomitant medical therapy was not standardized in the two study groups, and “in my opinion, the patients with severe or very severe COPD received suboptimal medical therapy,” Dr. Anzueto said. For example, fewer than 60% were taking the recommended bronchodilators at baseline.
Second, patients were given prophylactic antibiotics for 1 week following implantation, but the investigators did not cite any rationale for doing so, and did not describe any preliminary microbiologic data to guide the antibiotic therapy. The antibiotics did nothing to prevent pneumonia, which developed several weeks later.
“I believe that exhaustive microbiologic assessments should have been made in these patients with severe lung disease, because they are at high risk for lung infection by resistant pathogens,” Dr. Anzueto said.
Finally, lung volumes (as measured by body plethysmography) did not change significantly in either group. “Thus, changes in lung function seen in patients with endobronchial valves may not be due to decreased hyperinflation but to other unknown mechanisms,” he noted.
Antonio Anzueto, M.D., is at the University of Texas Health Science Center and the South Texas Veterans Health Care Center, both in San Antonio. He is cochair of the U.S. COPD Coalition and a member of the executive and scientific committee of the Global Initiative for Chronic Obstructive Lung Disease (GOLD), which issues disease management guidelines. He reported serving on boards and speakers bureaus for a number of pharmaceutical companies. His comments here were taken from an editorial (N. Engl. J. Med. 2010;363:1280-1) that accompanied the report by Dr. Sciurba and colleagues.
Unilateral lobar treatment with endobronchial valves produces modest improvements in lung function, exercise tolerance, and symptoms in patients with advanced, heterogenous, hyperinflated emphysema, according to a report in the Sept. 23 issue of the New England Journal of Medicine.
However, these benefits come with substantial costs in the months following implantation: more frequent exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia distal to the valves in more than 4% of cases, hemoptysis related to oozing from granulation tissue, and pneumothorax, said Dr. Frank C. Sciurba of the University of Pittsburgh and his associates.
They assessed the safety and efficacy of endobronchial valves, compared with standard medical care, in what they described as the first randomized, prospective, multicenter study of the devices, the Endobronchial Valve for Emphysema Palliation Trial (VENT).
The study involved 321 patients (aged 40-75 years) who were randomly assigned to receive either the unidirectional valves (220 subjects), which block regional inflation while allowing exhalation, or standard medical therapy (101 controls).
The valves are designed to reduce the volume (hyperinflation) of the most severely damaged lobe, allowing expansion of the more viable adjacent lobe.
A mean of 3.8 valves was placed in each patient via bronchoscopy. The valves were placed in only one lung (in the lobar, segmental, or subsegmental bronchi, depending on the patient’s anatomy) to completely isolate the targeted lobe. Moderate sedation was used in 71% of patients and general anesthesia in 29%. The mean duration of the procedure was 34 minutes.
The composite efficacy end point was the percent change in FEV1 and distance achieved in the 6-minute walk test at the 6-month follow-up. The primary safety end point was a composite of six major complications arising within 6 months: death, empyema, massive hemoptysis, pneumonia distal to the valves, pneumothorax or air leak of more than 7 days’ duration, or ventilator-dependent respiratory failure of more than 24 hours’ duration.
Quality of life, exercise capacity, dyspnea, and daily oxygen use also were assessed as secondary end points.
At 6 months, FEV1 increased by 4.3% in the valve group and decreased by 2.5% in control group, for a mean between-group difference of 6.8%. Similarly, distance traveled in the 6-minute walk test increased by 2.5% in the valve group and decreased by 3.2% in the control group, for a mean between-group difference of 5.8%, Dr. Sciurba and his colleagues reported (N. Engl. J. Med. 2010;363:1233-44).
Patients who received the valves also showed modest changes in all secondary end points.
However, the 6-month rate of composite complications was 6.1% in the valve group, compared with 1.2% in the control group. This included six deaths in the valve group and none in the control group. At 1 year, the complication rates were 10.3% and 4.6%, respectively.
The most common adverse event related to valve placement was pneumonia distal to the valve, which developed in 4.2% of patients within 1 year of the procedure. Hemoptysis requiring bronchoscopic inspection was significantly more common in the valve group (approximately 12%) than in controls (0%). Similarly, pneumothorax developed more often in the valve group (5.2%) than in controls (2.4%), as did COPD exacerbations requiring hospitalization (7.9% and 1.1%, respectively).
“In 12 months of follow-up, valves were removed in 31 patients for reasons including retrieval of a migrated valve (in 8 patients), the patient’s request for an unspecified reason (in 7), pneumonia management (in 3), COPD exacerbations (in 2), hemoptysis (in 1), and other reasons (in 7),” the researchers said. In addition, further bronchoscopies were required in 23% of the valve group, compared with only 1% of the control group.
After the trial was completed in 2007, an additional eight patients underwent elective removal of the valves because of adverse events, and three others experienced spontaneous expectoration of a valve, the investigators said.
The VENT study was funded by Emphasys Medical (now Pulmonx) and a grant to Dr. Sciurba from the National Institutes of Health. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.
Unilateral lobar treatment with endobronchial valves produces modest improvements in lung function, exercise tolerance, and symptoms in patients with advanced, heterogenous, hyperinflated emphysema, according to a report in the Sept. 23 issue of the New England Journal of Medicine.
However, these benefits come with substantial costs in the months following implantation: more frequent exacerbations of chronic obstructive pulmonary disease (COPD), pneumonia distal to the valves in more than 4% of cases, hemoptysis related to oozing from granulation tissue, and pneumothorax, said Dr. Frank C. Sciurba of the University of Pittsburgh and his associates.
They assessed the safety and efficacy of endobronchial valves, compared with standard medical care, in what they described as the first randomized, prospective, multicenter study of the devices, the Endobronchial Valve for Emphysema Palliation Trial (VENT).
The study involved 321 patients (aged 40-75 years) who were randomly assigned to receive either the unidirectional valves (220 subjects), which block regional inflation while allowing exhalation, or standard medical therapy (101 controls).
The valves are designed to reduce the volume (hyperinflation) of the most severely damaged lobe, allowing expansion of the more viable adjacent lobe.
A mean of 3.8 valves was placed in each patient via bronchoscopy. The valves were placed in only one lung (in the lobar, segmental, or subsegmental bronchi, depending on the patient’s anatomy) to completely isolate the targeted lobe. Moderate sedation was used in 71% of patients and general anesthesia in 29%. The mean duration of the procedure was 34 minutes.
The composite efficacy end point was the percent change in FEV1 and distance achieved in the 6-minute walk test at the 6-month follow-up. The primary safety end point was a composite of six major complications arising within 6 months: death, empyema, massive hemoptysis, pneumonia distal to the valves, pneumothorax or air leak of more than 7 days’ duration, or ventilator-dependent respiratory failure of more than 24 hours’ duration.
Quality of life, exercise capacity, dyspnea, and daily oxygen use also were assessed as secondary end points.
At 6 months, FEV1 increased by 4.3% in the valve group and decreased by 2.5% in control group, for a mean between-group difference of 6.8%. Similarly, distance traveled in the 6-minute walk test increased by 2.5% in the valve group and decreased by 3.2% in the control group, for a mean between-group difference of 5.8%, Dr. Sciurba and his colleagues reported (N. Engl. J. Med. 2010;363:1233-44).
Patients who received the valves also showed modest changes in all secondary end points.
However, the 6-month rate of composite complications was 6.1% in the valve group, compared with 1.2% in the control group. This included six deaths in the valve group and none in the control group. At 1 year, the complication rates were 10.3% and 4.6%, respectively.
The most common adverse event related to valve placement was pneumonia distal to the valve, which developed in 4.2% of patients within 1 year of the procedure. Hemoptysis requiring bronchoscopic inspection was significantly more common in the valve group (approximately 12%) than in controls (0%). Similarly, pneumothorax developed more often in the valve group (5.2%) than in controls (2.4%), as did COPD exacerbations requiring hospitalization (7.9% and 1.1%, respectively).
“In 12 months of follow-up, valves were removed in 31 patients for reasons including retrieval of a migrated valve (in 8 patients), the patient’s request for an unspecified reason (in 7), pneumonia management (in 3), COPD exacerbations (in 2), hemoptysis (in 1), and other reasons (in 7),” the researchers said. In addition, further bronchoscopies were required in 23% of the valve group, compared with only 1% of the control group.
After the trial was completed in 2007, an additional eight patients underwent elective removal of the valves because of adverse events, and three others experienced spontaneous expectoration of a valve, the investigators said.
The VENT study was funded by Emphasys Medical (now Pulmonx) and a grant to Dr. Sciurba from the National Institutes of Health. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.
Major Finding: At 6 months, FEV1 increased by 4.3% in patients who received endobronchial valves, but decreased by 2.5% in the control subjects; timed walking distance increased by 2.5% in the valve group, but decreased by 3.2% in the control group. However, adverse events including pneumonia, exacerbations of COPD, hemoptysis, and pneumothorax were significantly more common in the valve group.
Data Source: A randomized, prospective, multicenter clinical trial involving 321 patients with advanced, heterogenous emphysema who were followed for 1 year.
Disclosures: The VENT study was funded by Emphasys Medical (now Pulmonx) and an NIH grant to Dr. Sciurba. Dr. Sciurba and several associates reported ties to numerous drug and device manufacturers.