PURPOSE:Bronchoscopic lung volume reduction devices have been developed to provide a minimally invasive alternative to lung volume reduction surgery. Recent reports have described the use of endobronchial occlusion devices as efficient interventions, but they are limited by collateral ventilation. This study was designed to assess the acute safety and effectiveness of a novel, non-valve implant, delivered via bronchoscope into the airway to compress diseased lung parenchyma.
METHODS:In this single center study, 5 patients were treated unilaterally with the Lung Volume Reduction Device (LVRD) [PneumRx, Inc.; Mountain View, CA], a nitinol self actuating coil, at Heidelberg, Germany by 2 operators (AE, FH). Each patient underwent CT evaluation, Pulmonary Function Tests (PFT’s) and exercise tolerance tests prior to and after treatment. The devices were placed via a specially designed delivery catheter guided by a 6mm therapeutic bronchoscope and fluoroscopic imaging. Placement locations were determined based on CT observations and post processing analysis.
RESULTS:Mean age was 62 years with a male/female ratio of 1:4 and Homogeneous to Heterogeneous ratio was 1:4. and 24 devices were implanted. The average patient treatment time was 38 minutes with each implant requiring less than 3 minutes to place and there were no significant complications. At up to 3 months follow up, patients tolerated the devices well. Pulmonary function, exercise capacity, and quality of life data have showed improvement.
CONCLUSION:Placement of these devices in patients with severe emphysema is safe.
CLINICAL IMPLICATIONS:Placement of these devices is safe and the effects should be independent of collateral ventilation. Efficacy and long term safety data will need to be collected.
DISCLOSURE:Armin Ernst, Consultant fee, speaker bureau, advisory committee, etc. A. Ernst - consultant to PneumRx, F. Herth - consultant to PneumRx; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. PneumRx, Inc. is a private entity developing therapies for pulmonary disease. The PneumRx Lung Volume Reduction Device (LVRD) is an investigational device and it is designed to be a minimally invasive device for the treatment of emphysema.