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New Treatment For Leaky Lungs

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TAMPA, FL - We depend on our lungs every day for every breath, but there are 12 million people in the United States who suffer from lung diseases ranging from bronchitis to emphysema, and many more.

Medications and therapies can help those patients breathe easier and feel better, but what if you had those chronic problems, plus a hole in one of your lungs? For one man, new technology came to the rescue when nothing else could help.

Everywhere James Austin goes; his oxygen unit goes with him. After a lung injury, several surgeries, emphysema and heart problems left him with a deep hole in his back. The large hole, called a bronchopleural fistula, was the drain for a hole in his lung.

"It wasn't very pleasant," James said.

"A bronchopleural fistula is nothing more than an air pipe that doesn't heal after surgery, and you can imagine that's not a simple problem to deal with," Eric Sommers, M.D., a cardiothoracic surgeon at Tampa General Hospital, explained.

"Every two to four months, I had to be in the hospital, sometimes with chronic infection," James said

 "I couldn't sleep at night because I was afraid he wouldn't wake up. It was pretty stressful," Mary Austin, James's wife said.

Austin was too sick for open surgery, but a new procedure allowed doctors to repair his lung from the inside.

"Oh yeah. I was ready," James said.

The procedure involved introducing through a bronchoscope, a balloon catheter which provided information on the size and location of the hole. Then, a flexible, umbrella-shaped valve, about the size of a small spider, is deployed to close the leak.

"It is used to create a block to the segment of the lung where the air is leaking from," Dr. Sommers said.

Three months after surgery, the hole is gone. One little valve made a big difference.

"It's like night and day," James said.

Now, he and his wife are enjoying the simple pleasures of retirement and appreciating every single day.

"We do have a whole new life," Mary said.

The device that helped James Austin, called the IBV Spiration valve, is still under FDA investigation. The FDA has approved it only for humanitarian use. Clinical trials are now underway to explore the possibility of using the device in patients with emphysema as well.

 


RESEARCH SUMMARY:

 

BACKGROUND: Millions of people around the world are living with lung diseases like emphysema. According to the American Lung Association, more than 3.1 million people in the United States have been diagnosed with it. As a result of the disease, the tiny air sacs that make up the lungs are either enlarged or destroyed, and the exchange of oxygen and carbon dioxide with the blood is impaired. This leads to difficulty breathing, coughing and shortness of breath. The most common cause of emphysema is smoking.  (SOURCE: American Lung Association)

TREATMENT OPTIONS: Many people with emphysema do not respond well to medical treatments and are not eligible for major surgeries. Available treatments for emphysema are generally palliative (they alleviate pain without curing) and include medications, home oxygen therapy, pulmonary rehabilitation, lung volume reduction surgery and lung transplantation. The IBV Valve System is under investigation in the U.S. as a new treatment option for patients who have severe emphysema. It is also an investigational device in Canada. (SOURCE: National Center for Biotechnology Information)

HOW IT WORKS: The IBV Spiration Valve is a minimally invasive treatment that is designed to redirect airflow from diseased portions of the lung to healthier areas.

The main goal of the device is to block the entrance of air into diseased regions of the lungs and also prevent air from escaping from air leaks. Air leaks are a common complication of surgery.

The leaks are caused by lung tissue that has not completely closed and sealed, resulting in an accumulation of air in the chest that can cause difficulty breathing. They can occur after lung surgery or as a consequence of certain serious lung diseases.

During the procedure, a catheter is passed through a flexible tube that is passed into the bronchial tubes through the nose or mouth. It deploys small umbrella-shaped valves into the airways of the most diseased upper parts of the lungs. The valves are designed to be permanent but can be removed if necessary. In Europe, the system has already received market clearance for the treatment of emphysema and to resolve air leaks. (SOURCE: www.spiration.com)

 


 

In-Depth Doctor's Interview:

What is leaky lung and how does this happen?

Dr. Eric Sommers:  Leaky lung is a general term that we use for what happens to some patients following lung surgery. As you can imagine, any operation on the lung comes with risk and potential problems just as it does with any other type of surgery. The lung, by its nature, as it heals, will leak varying amount of fluid or air and the leaky lung that we are talking about is really a natural consequence of any operation on the lungs. In the vast majority of patients the leak heals as any tissue would heal and as the lung heals the air leak resolves and the patient goes home and lives their life naturally. In a small percentage of patients after lung surgery the air leak actually persists and becomes a more serious problem and can leave the patient staying several more days in the hospital than normal and, in some instances, very rarely, would require the patient to go back to the operating room and have another surgery to repair the leak.

Is this essentially a hole in their lung?

Dr. Eric Sommers:  In some cases yes. It's that simple:  it's a hole in the lung. It could be due to several different reasons. One would be an air pipe, or air tube, that's been cut or stapled during the surgery that doesn't heal normally, or it could be the lung tissue itself that is leaking air.

And what does that mean for the patient?  Do they have trouble breathing?

Dr. Eric Sommers:  Normally, the patient feels very little in the way of symptoms from this because the air that leaks out of the lung is normally drained through a tube that all patients get after surgery, but the problem is, of course, we can't remove that tube until the air leak resolves and so they spend time in the hospital waiting for that air leak to heal with a tube in their side.

In Mr. Austin's case, I guess the hole didn't heal itself and he couldn't handle another surgery. Can you tell me about that?

Dr. Eric Sommers:  Mr. Austin's case is a very unique case in that he had a very severe heart problem that prevented the usual approach to his complication, which would have been another extensive operation. So, in lieu of that, they had been managing his leak by actually packing the hole in his side, which would prevent him from becoming gravely ill, but, of course, that is not something someone wants to live with permanently.

How big was the hole in his lung?

Dr. Eric Sommers: His problem was technically known as a broncho-pleural fistula, which is nothing more than an air pipe that doesn't heal right after surgery. You can imagine that is not a simple problem to deal with. In his instance, the leak was coming directly off one of the air pipes that went to the lobe that was removed, but which did not heal normally.

 Is the leaky lung a fairly common experience after lung surgery?

Dr. Eric Sommers: Virtually, everyone will have an air leak after surgery to some degree. For the majority of the patients it is taken care of in the operating room, or resolves in the first 24 to 48 hours. In a small percentage of patients the air leak will persist and take longer to heal.

What is this new Endobronchial Valve do?

Dr. Eric Sommers:  The Endobronchial Valve is an ingenious device that is used to create a block to the segment of the lung where the air is leaking. The ingenious part of this technology is that it's removable. So, it can be placed so that the leak is resolved and the chest tube is removed and the patient can go home and once final healing occurs they can come back and have the valve removed. All done without any additional surgery.

So this looks like an umbrella doesn't it?

Dr. Eric Sommers:  Yes, it does. It looks like a cocktail umbrella. It's turned upside down so that the concave portion of the umbrella catches the air and prevents the patient from filling that specific part of the lung. This is a very small device and so the amount of lung that is affected is minimized, so it has virtually no effect on the patient's gas exchange, or the ability of the patient to maintain their oxygen level. It is specific enough in the area of the lung so that the affected part that is leaking is defunctionalized, so that the air no longer has access to the hole and therefore, the hole will heal faster and easier.

So will Mr. Austin's lung close itself, or is this a permanent fixture?

Dr. Eric Sommers:  Mr. Austin has a unique situation. I would anticipate that we would be removing his valve, but it would be a lot longer than what we would do typically after lung surgery. Of course, we will evaluate him on a regular basis and once it is obvious that his fistula is healed permanently then, of course, we will remove the valve.

How do you put this IBV in?

Dr. Eric Sommers:  It's placed using a lighted tube called a bronchoscope. A bronchoscope is nothing more than placing the tube into the patient's lung through the patient's mouth and airway and using a very sophisticated set of rules about sizing. We identify the area where the leak is coming from inside and once that is positively identified then we deploy the valve in that specific area. Of course, it is a very specific area of the lung and relatively small area of the total lung capacity.

And then once it is in there it just settles into place?

Dr. Eric Sommers:  It has an anchoring system and the anchoring system ensures that it doesn't move with respiration. Obviously, the lungs go up and down and move back and forth during normal respiration so the anchoring system allows for it to stay in place so the umbrella portion of the device or valve stays where it is intended to be.

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