Vent for Emphysema: A Minimally Invasive Approach to Breathing Easy
 The Emphasys Endobronchial Valve (EBV™) is designed to redirect airflow to healthier lung segments by blocking inhaled air to the diseased portion. Upon exhalation, trapped air is intended to be vented out (as shown in illustration), creating the potential for non-surgical bronchial lung volume reduction. CREDIT: Courtesy of Emphasys Medical, Inc.™ |
For patients with emphysema, a lung disease typically caused by cigarette smoking, the fundamental act of breathing becomes a battle. Approximately two million Americans are affected by emphysema, and the vast majority are over age 50. Emphysema occurs when damage to the air sacs affects the elasticity of the lungs, trapping air in the lungs and enlarging the chest wall. In lung volume reduction surgery (LVRS), those parts of the lung most affected by emphysema are surgically removed in order to improve the function of the rest of the lung. After LVRS, patients typically experience less shortness of breath and improved quality of life. In a new clinical trial, the Endobronchial Valve for Emphysema Palliation Trial (VENT), physician-scientists at Columbia are investigating the potential benefits of a less invasive approach to lung reduction.
The VENT trial builds upon the findings of the five-year, multi-center National Emphysema Treatment Trial (NETT), published in The New England Journal of Medicine in May 2003. This landmark study was administered by the National Institutes of Health (NIH) in cooperation with the Centers for Medicare and Medicaid Services (CMS) and was spearheaded at Columbia by Mark E. Ginsburg, MD, Assistant Clinical Professor of Surgery at Columbia University College of Physicians & Surgeons and Surgical Director of The LeBuhn Center for Chest Disease and Respiratory Failure at NewYork-Presbyterian Hospital/ Columbia University Medical Center, along with Byron M. Thomashow, MD, Associate Professor of Clinical Medicine at Columbia and Medical Director of The Courtesy of Emphasys Medical, Inc.™ LeBuhn Center for Chest Disease and Respiratory Failure.
The objective of the NETT was to compare the best medical treatments available with LVRS in patients with severe emphysema. The study demonstrated that in select patients, LVRS significantly reduced both shortness of breath and mortality as compared to medical management alone. As a result of the NETT, the CMS approved coverage for bilateral LVRS in designated centers of excellence, such as Columbia.
Dr. Ginsburg and his co-investigator of the VENT trial, Roger A. Maxfield, MD, Associate Clinical Professor of Medicine at Columbia University College of Physicians & Surgeons, are now hoping to dig a bit deeper into LVRS and reveal the benefits of the new minimally invasive approach. "With the VENT study, we're testing if the Emphasys Endobronchial Valve (EBV™) procedure can be performed effectively through an airway. The EBV™ is an implantable device—it's essentially a one-way valve designed to allow trapped air to vent from the isolated lung segment during exhalation while preventing air inflow during inhalation," explains Dr. Ginsburg.
The Emphasys Endobronchial Valve (EBV™) is designed to redirect airflow to healthier lung segments by blocking inhaled air to the diseased portion. Upon exhalation, trapped air is intended to be vented out (as shown in illustration), creating the potential for non-surgical bronchial lung volume reduction.
"Right now lung reduction surgery is done as an open-chest operation, and it has fairly significant morbidity associated with it," he continues. "If we could take away the trauma of the procedure, we would gain a lot in terms of patient outcomes. The minimally invasive procedure could provide a much faster recovery time; the hope is that patients will stay in the hospital for less than 48 hours—versus an average stay of 9-10 days after open lung reduction. It would also be a less costly procedure."
VENT is a multi-center, randomized, prospective clinical trial designed to primarily study the safety and effectiveness of the EBV™ procedure. Of the 20 centers participating in the trial, Columbia is the only center based in the tri-state area. To be eligible for the trial, patients must have severe emphysema, with the worst damage prevalent in the upper lungs. All patients will be required to undergo pulmonary rehabilitation before and after surgery, and patients will be followed for 18 months after randomization.
"If our outcomes prove as promising as I suspect, then this would be another step forward beyond the NETT—and a major advancement for treating patients with severe emphysema," adds Dr. Ginsburg.
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