The study was presented at the ATS 2012 International Conference in San Francisco, demonstrating that the wire can easily be implanted, and potentially replace more invasive procedures to improving lung function in these patients.
Leading author Dirk-Jan Slebos, MD, a pulmonary physician at the Groningen University's Medical Center (UMCG) in The Netherlands explains:
"Our results indicate that LVRC treatment is technically feasible in both upper and lower regions of the lung in patients with severe heterogeneous emphysema, and results in significant improvements in pulmonary function, exercise capacity and quality of life, with an acceptable safety profile."
To help improve emphysema patients' breathing and functioning, they often undergo a lung volume reduction in order to isolate diseased lung tissue, allowing healthy lung tissue to expand and improve function.
However, surgery can be difficult and extensive given that heterogeneous emphysema involves different areas, or lobes of the lung, which makes
using the wire coils more effective and safer for these patients as they can be implanted in relatively noninvasive bronchoscopic procedures. During the implantation, the coils are compressed and expand to their original shape once they are located in the lung tissue.
LVRC has previously been deemed as safe and effective in patients with severe upper-lobe emphysema in a single center trial. However this study involved 53 patients who underwent 101 LVRC procedures, including 46 bilateral (both lungs) procedures and nine unilateral procedures at 11 different healthcare centers in France, Germany and The Netherlands, assessing LVRCs safety, efficacy and feasibility in both upper and lower lobes. The clinicians implanted between eight to fourteen coils in each procedure, with a total number of 1,070 coils being implanted in the study.
All recorded adverse events that occurred within the first 30 days after treatment and those that occurred between 30 days and six months after the procedure were examined, in addition to various tests being performed six months following treatment, which included pulmonary function and exercise tests, as well as measuring the procedures' efficacy by using quality-of-life questionnaires. The adverse events consisted of exacerbation of chronic obstructive pulmonary disease (COPD), collapsed lung, pneumonia, chest pain and mild hemoptysis, as well as coughing up blood that could be managed with standard care.
At six months, the researchers noted a significant improvement in respiratory measurements, in particular in those whose lungs were severely hyperinflated. Those with severely hyperinflated lungs experienced a substantial improvement in lung function, together with hyperinflation, exercise capacity and quality of life.
Dr. Slebos notes that these severe hyperinflation at the start of the study seemed to suggest a better outcome, saying: "Hyperinflation of lung tissue is one of the key pathophysiological features of emphysema that is responsible for shortness of breath, and its magnitude seems to be a good indicator of successful LVRC treatment."
The trial is continuing with new data being collected.
Dr. Slebos concludes:
"The results so far indicate that the LVRC is a safe and effective choice for treating patients with severe heterogeneous emphysema where current medical treatment fails, and as we continue to collect follow-up data, we hopefully will have a more complete profile of its applications in this patient population."
Written By Petra Rattue