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Pulmonary Medicine

UCLA now offering IBV lung valve under humanitarian-use device guidelines

08/24/2010

CU-IBV Lung ValveTemporary air leaks of the lung commonly occur following lung surgery or trauma when portions of the lung have been cut, removed or punctured. Surgical staples and glues used in lobectomies, segmentectomies and lung volume reduction surgery (LVRS) often do not completely close and seal damaged lung tissue. While most air leaks heal themselves within a few days, some patients develop a prolonged or severe air leak, usually defined as a persistent leak that lasts at least five days.

Prolonged air leaks make recovery from surgery difficult and are typically treated by insertion of chest tubes to help the lung re-expand. Because chest tubes are connected to a drainage system such as a water bottle, patients encumbered with them often experience difficulty moving around, which puts them at risk for developing venous thrombosis and a loss of muscle strength. Patients with chest tubes usually require more pain medication and spend more time in the hospital, where they have a higher chance of getting hospital-acquired infections.

Patients suffering from prolonged air leaks typically have two treatment options: a surgical attempt to repair the leak or more aggressive surgical pleurodesis, in which the surface lining of the lung is purposely removed or scarred to plug up the air leaks. UCLA is one of only a handful of institutions that now offers a third solution to control prolonged air leaks of the lung using the minimally invasive IBV valve.

The IBV valve

CU-IBV ValveIBV valves are tiny, umbrella-shaped medical devices between 5 and 7 mm in diameter that are placed into the lung’s airways to stop leaks. Physicians use a bronchoscope equipped with a balloon catheter to determine the location of the leak. They choose the correct size valve after establishing how much balloon inflation is needed to occlude a particular airway. Both the bronchoscope and catheter that delivers the valve are inserted through the mouth or nose in a minimally invasive procedure performed under sedation. The procedure takes between 30 and 60 minutes and most patients can be discharged from the hospital within 24 hours.

Benefits and risks

While there are some risks associated with both the IBV valve and the insertion procedure, the potential benefits of the device are significant. Patients who receive the valves tend to experience less discomfort, take less pain medication and have shorter hospital stays. They also may avoid additional surgery to control or stop air leaks.

Humanitarian Use Device

The U.S. Food and Drug Administration (FDA) recently authorized the use of the IBV valve as a Humanitarian Use Device (HUD). Under federal guidelines, the device can be used only for the control of prolonged air leaks, or leaks that are likely to become prolonged, following lobectomy, segmentectomy or LVRS. Patients who receive Humanitarian Use Devices such as IBV valves are asked to carry patient information cards, which include their doctor’s contact information, with them at all times. The cards provide useful information to physicians who later treat these patients and who may, for example, see the valves on a chest X-ray.

Previous research using IBV valves

UCLA became a designated site for the humanitarian use of the valve after participating in a research program that tested the device on patients suffering from emphysema. UCLA is one of 30 sites nationwide that is conducting a randomized research program in which half of a group of emphysema patients receive IBV lung valves while the other half do not. The six UCLA patients who have so far received valves have had no serious adverse reactions and five of the six UCLA patients who did not receive valves requested them after six months. Overall, the emphysema patients who received the devices are doing well, according to the study’s principal investigator.

UCLA among few centers authorized for new device

UCLA is one of just a handful of centers nationwide offering the IBV valve as a Humanitarian Use Device for patients with prolonged air leaks of the lungs.

UCLA physicians started using the IBV valve when they began participating in a nationwide research program that has tested the device in approximately 200 patients with emphysema.

“This is one of the advantages of working at an institution like UCLA,” says Christopher B. Cooper, M.D., a pulmonary and critical care medicine specialist, who served as the study’s princi-pal investigator. “Teaching hospitals can often offer medical therapies that are not available elsewhere in the community.”

Patients who receive the minimally invasive device suffer fewer compli-cations, need less pain medication and spend fewer days in the hospital than those who undergo other treatments to stop air leaks.

“The valve allows patients with air leaks — some of whom have been languishing on the intensive care unit — to go home without chest tubes,” says Dr. Cooper. “It actually fixes the problem.”

Participating Physicians

Christopher B. Cooper, M.D.
Professor of Medicine and Physiology
Pulmonary and Critical Care Medicine
Medical Director, Chronic Obstructive
Pulmonary Disease Program
Director, Exercise Physiology
Research Laboratory
Division of Pulmonary and
Critical Care Medicine

Irawan Susanto, M.D.
Clinical Professor of Medicine
Director, Interventional Pulmonolog
Santa Monica-UCLA Medical Center
and Orthopaedic Hospital
Division of Pulmonary and
Critical Care Medicine

Patricia Eshaghian, M.D.
Clinical Instructor of Medicine
Santa Monica-UCLA Medical Center
and Orthopaedic Hospital
Division of Pulmonary and
Critical Care Medicine

Robert B. Cameron, M.D.,
F.A.C.S., F.I.C.S.
Professor of Cardiothoracic Surgery
and Surgical Oncology
Surgical Director, LVRS Program
David Geffen School of Medicine at UCLA
Chief, Division of Thoracic Surgery
West Los Angeles VA Medical Center

Contact Information
Westwood practice:
UCLA Medical Subspecialty
Suite-Pulmonary
200 UCLA Medical Plaza Suite 365B
Los Angeles, CA 90095-1690
(310) 825-8061
(310) 794-6553

Santa Monica practice:
UCLA-Santa Monica
Pulmonary Clinic
1245 16th Street, Suite 204
Santa Monica, CA 90404
(310) 449-0939 Appointment
(310) 449-0977 Fax





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