Contact: Ellen Bank
843.792.2626
May 20, 2004
CHARLESTON, SC -- Barbara Hasenzahl of Myrtle Beach is the first
patient in the Southeast and eighth in the nation to have a valve implanted
in her lung to assist her breathing which has been severely compromised for
many years because of emphysema.
On Tuesday, Charlie Strange, M.D., a Medical University of South Carolina (MUSC)
pulmonologist, implanted the miniature Emphasys Endobronchial Valve (EBV) with
a bronchosope in order to isolate the diseased portion of the lung and restore
airflow to the healthier portions. The procedure was done as part of a nationwide
multi-center clinical trial known as VENT (Endobronchial Valve for Emphysema
Palliation Trial), involving 20 medical centers across the United States and
Europe.
Emphysema is a debilitating disease that afflicts more than three million
Americans. It is caused primarily by smoking and leads to a progressive, irreversible
breakdown of lung tissue. This reduces the amount of lung tissue available for
gas exchange and also impairs the lung’s ability to inflate and deflate
normally. As the disease advances, the most damaged areas of the lung overinflate
within the chest cavity, trapping air and preventing the healthier lung areas
from functioning normally.
Patients with advanced emphysema have difficulty breathing and constantly feel
out-of-breath. Advanced emphysema patients become dependent on oxygen support
and must carry supplemental oxygen with them wherever they go. Their activities
are severely restricted.
There is currently no cure for the condition, and, for the majority of patients,
few available treatment options. For some patients, lung volume reduction surgery
is used to reduce the size of the over-expanded lung, thereby allowing the breathing
muscles to function more normally. “Major surgery poses a number of risks
and may even cause life-threatening complications,” said Strange. “The
new bronchoscopy procedure avoids surgery and promises to achieve similar results
with a significant reduction in risk and complications.”
The procedure is done using a flexible bronchoscope passed through the mouth.
It is minimally invasive and involves the implantation of small valves in the
patient’s lung to vent out the trapped air in diseased portions of the
lung, redirecting inspired air to healthier portions of lung. The result is
a shrinking of the most diseased lung areas, creating more space for the healthier
parts of the lung to function.
The multi-center, randomized study will enroll 270 participants across the United States and Europe. The study will have two arms: the control arm will receive standard optimal medical management, and the treatment arm will receive the valve. Patients in both arms will undergo pulmonary rehabilitation prior to randomization. The study’s primary efficacy endpoints are improvement in lung function and exercise tolerance. The study will also measure improvement in quality of life and assess cost effectiveness.
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