A small, easily implantable device called the Lung Volume Reduction Coil (LVRC) may play a key role in the treatment of two types of emphysema, according to a study conducted in Europe. Results of the study indicate the beneficial effects of the device persist more than a year after initial treatment.
The study was presented at the ATS 2013 International Conference.
“LVRC treatment results in significant and clinically relevant improvements in lung function, ability to exercise and quality of life for patients with emphysema,” said Gaetan Deslee, MD, PhD, professor of respiratory medicine at the University Hospital of Reims, France. “Our study shows the device is effective in treating both homogeneous disease, where emphysema is distributed evenly throughout the lungs, and heterogeneous disease, where emphysema is isolated to specific areas of the lungs.”
The coil works by gathering and compressing diseased lung tissue, allowing healthy tissue to function more efficiently. The device is implanted in a simple procedure which does not require a surgical incision. Patients typically are implanted with multiple devices in each affected lung, with each lung being treated in a separate procedure.
The study’s researchers gathered and analyzed data from three nearly identical multicenter European studies that analyzed the safety and efficacy of LVRC treatment in 109 patients with severe emphysema who had received two separate coil treatments. In total, 2081 devices were implanted in 218 procedures. In addition, computed tomography (CT) scans were used to determine whether these patients had homogeneous or heterogeneous disease.
Follow-up data were gathered from each patient at six months and 12 months following the procedure on the second lung. To evaluate the effectiveness of the LVRC device, the studies used a validated quality of life survey designed for patients with obstructive airways disease and three other standard measures: the forced expiratory volume or FEV1, which measures the maximum amount of air that can be exhaled in one second; the residual volume or RV, which measures the volume of air remaining in the lungs after a maximal exhalation; and six-minute walking distance or 6WMD, which estimates a person’s ability or capacity to exercise.
The study authors found that, at both six months and 12 months following the procedure, values for all four measurements were significantly improved.
“The results clearly demonstrate that a broad population of emphysema patients can achieve clinically and statistically significant improvements in quality of life, exercise capacity and lung function from treatment with LVRC, and that these improvements are sustained at one year from treatment,” Dr. Deslee said.
There were few adverse events. Following 218 procedures, there were 13 exacerbations of chronic obstructive pulmonary disease (COPD), nine incidents of pneumonia and nine cases of pneumothorax (deflated lung); in addition, one patient developed a cough containing significant amounts of blood (haemoptysis). All of these events resolved with standard care.
A post-hoc analysis of 53 patients identified as having either homogeneous or heterogeneous disease showed the improvements from LVRC treatment were similar between the groups, an important finding since other minimally-invasive treatment methods have not shown sustained efficacy in the many patients who have diffuse patterns of emphysema, Dr. Deslee noted.
Emphysema and chronic bronchitis are the two primary forms of COPD, recognized worldwide as a major public health concern.
“Emphysema is a progressive disease and there is no known cure,” Dr. Deslee said. “Because available drug and behavior-based therapies have only limited effectiveness in relieving the symptoms of the disease, researchers have pinned much hope on the emergence of new medical implants which seek to provide significant and lasting improvements in patients’ lung function and ability to perform activities of daily living. To date, many of these technologies have come up short, and data on the sustained effectiveness of new technologies is scarce.”
The U.S. Food and Drug Administration (FDA) recently gave its approval for a clinical study evaluating the LVRC in emphysema patients, the first step in making the technology available to emphysema patients in the United States. The LVRC has also been selected by the French Ministry of Health for a national cost-effectiveness study, expected to lead to reimbursement of the treatment for emphysema patients in France.
“A minimally-invasive technology which proves to be effective in treating a large population of emphysema patients could potentially help patients to live healthier lives despite their emphysema,” Dr. Deslee said. “Because the disease imposes such an enormous economic and social burden, rapid adoption of such a technology could change the paradigm of emphysema management, evolving the standard of care from today’s drug and behavior-based methods to include routine use of treatment procedures to optimize and prolong a patient’s overall health.”
American Thoracic Society International Conference May 17-22, 2013 Philadelphia, Pennsylvania
* Please note that numbers in this release may differ slightly from those in the abstract. Many of these investigations are ongoing; the release represents the most up-to-date data available at press time.
Lung Volume Reduction Coil (LVRC) Sustained Treatment Effectiveness In Heterogeneous And Homogenous Emphysema
Type: Scientific Abstract
Category: 09.08 – COPD: Non-Pharmacological Treatment (CP)
Authors: G. Deslee1, S. Blaas2, W. Gesierich3, F.J. Herth4, J. Hetzel5, R. Kessler6, C.H. Marquette7, M. Pfeifer2, F. Stanzel8, C. Witt9, D.-J. Slebos10; 1University Hospital of Reims – Reims/FR, 2Klinikum Donaustauf – Donaustauf/DE, 3Asklepios – Gauting – Gauting/DE, 4Thorax Klinik – Heidelberg/DE, 5UKT University Hospital – Tuebingen/DE, 6University Hospital Strasbourg – Strasbourg/FR, 7University Hospital Nice – Nice/FR, 8Lungenklinik – Hemer/DE, 9Charité Universitätsmedizin Berlin – Berlin/DE, 10University Medical Center Groningen – Groningen/NL
Rationale: The Lung Volume Reduction Coil (LVRC, PneumRx Inc.) is a bronchoscopic device for the treatment of severe emphysema. Three multicenter European studies with nearly identical protocols have analyzed the safety and efficacy of LVRC treatment in severe emphysema. The results of these studies out to 15 months post-treatment, including sub-group efficacy analysis, will be presented.
Methods: To date, 109 patients (mean age: 61 years, mean FEV1: 29%, mean RV: 242%) were treated by bilateral LVRC performed in two separate procedures in two contralateral lobes, with follow-up beyond one year. Data was analyzed at 6-months and 12-months post treatment. A post-hoc blinded CT analysis was performed on a subset of data i) by a digital lobar CT emphysema score assessing the percentage destruction below -950HU with a <25% difference between ipsilateral lobes defining homogenous emphysema, and ii) by a visual pattern approach grading from 0 (no damage) to 4 (bullous disease) with a difference of ≤1 point defining homogenous emphysema.
Results: 2081 LVRC were placed in 218 procedures (mean 9.5 per lobe). Serious adverse events (SAE) in the 30 days following treatment were 13 COPD exacerbations (6%), 1 haemoptysis (0,5%), 9 pneumonia (5%), 9 pneumothorax (4%), no death or acute respiratory failure. All SAE resolved with standard care. Effects of LVRC treatment at 6 and 12 months after the second procedure showed sustained efficacy: FEV1 : +15.4% and +15.2%; RV: -10% and -10.3%; 6MWD: +47.5m and +53.6m; and an improvement in quality of life (SGRQ): -10.9 pts and -11.4 pts (p<0.0001 all but 360 day FEV1 p<0.0004). Post-hoc analysis at 6 months was performed on 53 patients to compare homogenous and heterogeneous response. Digital CT analyses identified 15 homogenous and 38 heterogeneous cases; the visual approach identified 24 homogeneous and 29 heterogeneous. RV, 6MWT and SGRQ responses were similar between the two groups, regardless of the calculation method. Only FEV1 response differed significantly between the heterogeneous/homogeneous groups.
Conclusion: LVRC treatment results in significant and clinically relevant improvements in lung function, exercise capacity and quality of life for patients with homogenous and heterogeneous emphysema. These improvements are sustained beyond one year from treatment.