Bronchoscopic nitinol coils improve severe emphysema

Bronchoscopically placed nitinol coils to reduce lung volume markedly improved quality of life and modestly improved walk distance and lung function in a preliminary study of patients with severe emphysema, which was published online Jan. 12 in JAMA.

The magnitude and severity of serious and nonserious adverse effects were far less than has been reported for more invasive lung volume reduction surgery in this patient population. However, the short-term financial costs of coil placement were substantial, said Dr. Gaetan Deslee of University of Reims (France) Hospital and his associates.

Nitinol coils are shape-memory devices delivered into subsegmental airways to reduce regional parenchymal volume, which increases expansion of adjacent nontargeted lung. This increases the nontargeted tissue’s elastic recoil and reestablishes small-airway tethering, which improves expiratory flow and reduces air trapping.

The investigators compared this procedure against usual care in 100 patients with severe emphysema who were treated and followed for 1 year at 10 university hospitals across France. Both groups underwent pretreatment pulmonary rehabilitation and received inhaled bronchodilators with or without inhaled corticosteroids and with or without supplemental oxygen at the discretion of their treating physicians. Then patients were randomly assigned – 50 to receive the coils and 50 to receive usual care.

The coils were inserted under general anesthesia, and approximately 10 coils were placed per targeted lobe. Most patients later underwent the procedure on the opposite side, so that 47 patients received bilateral and 3 received unilateral coils during 97 bronchoscopies. The mean procedure time was 54 minutes, and the treatment significantly decreased lung hyperinflation.

The primary efficacy endpoint, improvement in 6-minute walk test scores after 6 months, was evaluable for 44 patients in each study group. A total of 18 patients (36%) who underwent coil placement and 9 (18%) who received usual care improved their scores by at least 54 m, which was a significant difference, the investigators said (JAMA. 2016 Jan 12. doi: 10.1001/jama.2015.17821).

In addition, all secondary endpoints were significantly better after coil placement than after usual care at both 6 months and 12 months. This included forced expiratory volume in 1 second, forced vital capacity, residual volume, and residual volume/total lung capacity, scores on the Medical Research Council dyspnea scale, and scores on a measure of health-related quality of life.

A cost-benefit analysis at 1 year showed that the mean increase in expenditures was $47,908 per person in the coil group, compared with the usual-care group. The 1-year incremental cost-effectiveness ratio was $782,598 per quality-adjusted life year (QALY). Assuming that the quality of life gains would be maintained over 3 years and that the costs of follow-up care would be identically low in both study groups, this ratio would decrease to $270,000 per QALY at 3 years.

However, neither of these cost-effectiveness ratios would be considered economical enough to warrant adopting this technology in most countries, Dr. Deslee and his associates noted.

At least one serious adverse event developed in 52% of the coil group and in 38% of the usual-care group, and there were four deaths (8%) in the coil group and three deaths (6%) in the usual-care group. The most frequent adverse event was pneumonia, which resolved with medical care in all cases. “The mechanism involved in pneumonia may result from local airway irritation, subsegmental airway closure, tension-induced inflammation, or local ischemia rather than from an infectious mechanism,” the researchers said.

This study was limited in that coil placement was not compared with either a sham or control procedure, patients were not blinded to treatment assignment, the sample size was relatively small, and follow-up was short. Larger studies using more rigorous statistical methods are needed “to draw a definitive conclusion regarding the long-term efficacy of coil treatment,” they added.

Bronchoscopically placed nitinol coils to reduce lung volume markedly improved quality of life and modestly improved walk distance and lung function in a preliminary study of patients with severe emphysema, which was published online Jan. 12 in JAMA.

The magnitude and severity of serious and nonserious adverse effects were far less than has been reported for more invasive lung volume reduction surgery in this patient population. However, the short-term financial costs of coil placement were substantial, said Dr. Gaetan Deslee of University of Reims (France) Hospital and his associates.

Nitinol coils are shape-memory devices delivered into subsegmental airways to reduce regional parenchymal volume, which increases expansion of adjacent nontargeted lung. This increases the nontargeted tissue’s elastic recoil and reestablishes small-airway tethering, which improves expiratory flow and reduces air trapping.

The investigators compared this procedure against usual care in 100 patients with severe emphysema who were treated and followed for 1 year at 10 university hospitals across France. Both groups underwent pretreatment pulmonary rehabilitation and received inhaled bronchodilators with or without inhaled corticosteroids and with or without supplemental oxygen at the discretion of their treating physicians. Then patients were randomly assigned – 50 to receive the coils and 50 to receive usual care.

The coils were inserted under general anesthesia, and approximately 10 coils were placed per targeted lobe. Most patients later underwent the procedure on the opposite side, so that 47 patients received bilateral and 3 received unilateral coils during 97 bronchoscopies. The mean procedure time was 54 minutes, and the treatment significantly decreased lung hyperinflation.

The primary efficacy endpoint, improvement in 6-minute walk test scores after 6 months, was evaluable for 44 patients in each study group. A total of 18 patients (36%) who underwent coil placement and 9 (18%) who received usual care improved their scores by at least 54 m, which was a significant difference, the investigators said (JAMA. 2016 Jan 12. doi: 10.1001/jama.2015.17821).

In addition, all secondary endpoints were significantly better after coil placement than after usual care at both 6 months and 12 months. This included forced expiratory volume in 1 second, forced vital capacity, residual volume, and residual volume/total lung capacity, scores on the Medical Research Council dyspnea scale, and scores on a measure of health-related quality of life.

A cost-benefit analysis at 1 year showed that the mean increase in expenditures was $47,908 per person in the coil group, compared with the usual-care group. The 1-year incremental cost-effectiveness ratio was $782,598 per quality-adjusted life year (QALY). Assuming that the quality of life gains would be maintained over 3 years and that the costs of follow-up care would be identically low in both study groups, this ratio would decrease to $270,000 per QALY at 3 years.

However, neither of these cost-effectiveness ratios would be considered economical enough to warrant adopting this technology in most countries, Dr. Deslee and his associates noted.

At least one serious adverse event developed in 52% of the coil group and in 38% of the usual-care group, and there were four deaths (8%) in the coil group and three deaths (6%) in the usual-care group. The most frequent adverse event was pneumonia, which resolved with medical care in all cases. “The mechanism involved in pneumonia may result from local airway irritation, subsegmental airway closure, tension-induced inflammation, or local ischemia rather than from an infectious mechanism,” the researchers said.

This study was limited in that coil placement was not compared with either a sham or control procedure, patients were not blinded to treatment assignment, the sample size was relatively small, and follow-up was short. Larger studies using more rigorous statistical methods are needed “to draw a definitive conclusion regarding the long-term efficacy of coil treatment,” they added.

Bronchoscopically placed nitinol coils to reduce lung volume markedly improved quality of life and modestly improved walk distance and lung function in a preliminary study of patients with severe emphysema, which was published online Jan. 12 in JAMA.

The magnitude and severity of serious and nonserious adverse effects were far less than has been reported for more invasive lung volume reduction surgery in this patient population. However, the short-term financial costs of coil placement were substantial, said Dr. Gaetan Deslee of University of Reims (France) Hospital and his associates.

Nitinol coils are shape-memory devices delivered into subsegmental airways to reduce regional parenchymal volume, which increases expansion of adjacent nontargeted lung. This increases the nontargeted tissue’s elastic recoil and reestablishes small-airway tethering, which improves expiratory flow and reduces air trapping.

The investigators compared this procedure against usual care in 100 patients with severe emphysema who were treated and followed for 1 year at 10 university hospitals across France. Both groups underwent pretreatment pulmonary rehabilitation and received inhaled bronchodilators with or without inhaled corticosteroids and with or without supplemental oxygen at the discretion of their treating physicians. Then patients were randomly assigned – 50 to receive the coils and 50 to receive usual care.

The coils were inserted under general anesthesia, and approximately 10 coils were placed per targeted lobe. Most patients later underwent the procedure on the opposite side, so that 47 patients received bilateral and 3 received unilateral coils during 97 bronchoscopies. The mean procedure time was 54 minutes, and the treatment significantly decreased lung hyperinflation.

The primary efficacy endpoint, improvement in 6-minute walk test scores after 6 months, was evaluable for 44 patients in each study group. A total of 18 patients (36%) who underwent coil placement and 9 (18%) who received usual care improved their scores by at least 54 m, which was a significant difference, the investigators said (JAMA. 2016 Jan 12. doi: 10.1001/jama.2015.17821).

In addition, all secondary endpoints were significantly better after coil placement than after usual care at both 6 months and 12 months. This included forced expiratory volume in 1 second, forced vital capacity, residual volume, and residual volume/total lung capacity, scores on the Medical Research Council dyspnea scale, and scores on a measure of health-related quality of life.

A cost-benefit analysis at 1 year showed that the mean increase in expenditures was $47,908 per person in the coil group, compared with the usual-care group. The 1-year incremental cost-effectiveness ratio was $782,598 per quality-adjusted life year (QALY). Assuming that the quality of life gains would be maintained over 3 years and that the costs of follow-up care would be identically low in both study groups, this ratio would decrease to $270,000 per QALY at 3 years.

However, neither of these cost-effectiveness ratios would be considered economical enough to warrant adopting this technology in most countries, Dr. Deslee and his associates noted.

At least one serious adverse event developed in 52% of the coil group and in 38% of the usual-care group, and there were four deaths (8%) in the coil group and three deaths (6%) in the usual-care group. The most frequent adverse event was pneumonia, which resolved with medical care in all cases. “The mechanism involved in pneumonia may result from local airway irritation, subsegmental airway closure, tension-induced inflammation, or local ischemia rather than from an infectious mechanism,” the researchers said.

This study was limited in that coil placement was not compared with either a sham or control procedure, patients were not blinded to treatment assignment, the sample size was relatively small, and follow-up was short. Larger studies using more rigorous statistical methods are needed “to draw a definitive conclusion regarding the long-term efficacy of coil treatment,” they added.