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TEMPLE UNIVERSITY RESEARCHER COLLABORATES ON NATIONAL STUDY TO IMPROVE LUNG FUNCTION
September 30, 2010
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Criner, left, talks with a patient on oxygen therapy, a common treatment for emphysema and COPD. The study that Criner has co-authored has found that tiny valves implanted in the lungs could eliminate the need for oxygen therapy. Photo by Joseph V. Labolito, Temple University
Michael Hollingsworth lived with severe emphysema for years. The disease, which kills more than 12,000 each year in the U.S., results when air sacs in the lungs are no longer able to properly expand and contract.
For Hollingsworth, like thousands of others with the condition, this meant being tethered by a tube to a tank supplying oxygen to his laboring lungs. It did little for his quality of life, and his condition eventually worsened.
“I was in the hospital twice, both times because I stopped breathing,” he said. “It got to the point where the oxygen wasn’t working anymore.”
After that, his doctor suggested he come to Temple to enroll in a clinical trial that was studying less invasive ways to treat chronic emphysema. Doctors inserted tiny one-way valves into the airways leading to the most severely damaged part of Hollingsworth’s lung. The valves block air entry but enable air exit, thereby deflating the most diseased region and shifting ventilation to more healthy areas of the lung. By reducing the size of the diseased parts, the procedure decreased his chest cavity size and improved the function of his chest wall, breathing muscles and heart.
The procedure was part of VENT, or Endobronchial Valve for Emphysema Palliation Trial, a multi-center, national study that looked at whether endobronchial valves (EBVs) could be a viable alternative to surgery.
The study, which published on Sept. 23 in the online version of the New England Journal of Medicine, followed the progress of 321 patients with emphysema – 220 of whom received EBVs, and 101 who received medical therapy. At six months, the patients who received the valves showed measurable improvements in standard tests of lung function. Among those with the most severe forms of emphysema, researchers saw an even more robust improvement in the patients’ lung function and fewer symptoms.
For Hollingsworth, getting the EBVs meant no more oxygen tubes, and an additional four years of working as a crane operator before his retirement.
“This study suggests that endobronchial approaches to lung volume reduction can produce important improvements in physiological and functional outcomes in properly selected individuals with potentially fewer complications than lung volume reduction surgery,” said study co-author Gerard J. Criner, MD, Chief of Pulmonary and Critical Care Medicine at Temple University Hospital, and Professor of Medicine at the School of Medicine.
Lung volume reduction surgery is the standard therapy that is used to treat hyperinflation in select severe emphysema patients for whom other treatments have not worked. The surgery essentially cuts out areas of hyperinflated lungs to make them work less hard so the patient can breathe easier. However, this procedure is costly and carries with it significant risk.
The ultimate goal of VENT was to provide data and information that will fuel more clinical trials with EBVs in the United States. Currently, the valves are only available clinically in Europe.
“Data from VENT should help to focus future prospective controlled trials in patients with sufficient heterogeneous emphysema and intact fissures to determine the effects of EBV on achieving clinically meaningful and durable improvements in lung function and functional status,” said Criner.
The Temple Lung Center and Criner as director have been highly commended for leadership in respiratory disease diagnosis, treatment and research. Temple University Hospital was recently named one of the nation's top hospitals for pulmonology by U.S. News & World Report.
In addition to VENT, the Temple Lung Center currently heads the mid-Atlantic consortium for the Long-Term Oxygen Treatment Trial (LOTT), an NIH-funded, six-year nationwide study of the effectiveness and safety of long-term home oxygen therapy for sufferers of COPD, and also conducts STATCOPE, a prospective study to determine if the drug simvastatin can reduce the frequency of COPD flare-ups or exacerbations and COPD Gene, a study examining the genotypic and phenotypic expressions of exposure to tobacco smoke and development of COPD.
In 2009, Criner authored a study in the American Journal of Respiratory and Critical Care Medicine, which looked at the use of biologic lung volume reduction in patients with emphysema. In this technique, rather than surgically removing the diseased parts of the lung, a medicated gel is inserted into the area, where it hardens and causes the area to whither and retract over time.
The study was funded by Emphasys Medical Inc. and Pulmonx Inc., in Redwood City Calif. Other authors are Frank Sciurba at the University of Pittsburgh Medical Center, Armin Ernst at the Harvard University Medical School, Felix J.F. Herth at the University of Heidelberg, Charlie Strange at the Medical University of South Carolina, Charles H. Marquette at the University Hospital of Nice, Kevin L. Kovitz at the Tulane University Health Sciences Center, Richard P. Chiacchierini of Chiacchierini and Associates, Jonathan Goldin at the David Geffen School of Medicine at UCLA and Geoffrey McLennan at the University of Iowa.
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