Breathing Easier: Emphysema Coils
PHILADELPHIA, Pa. (Ivanhoe Newswire) - Two million people suffer with emphysema in this country, a debilitating disease that causes irreversible damage to the lungs, making it hard to breathe for patients and difficult to engage in normal activities. Now, a new therapy could help folks breathe easier without surgery.
Keeping up with her grandson Justin has not been easy for Linda Creighton.
"I would be completely out of breath," Linda told Ivanhoe.
The ex-3 pack-a-day smoker developed severe emphysema a few years ago and was told a lung transplant was her only option.
"I guess I went into denial because I know I'm not ready to take that kind of a step," Linda said.
Now, Dr. Gerard Criner is testing a new non-invasive treatment.
"It has the potential to be huge," Dr. Gerard Criner, Director, Pulmonary and Critical Care Medicine, Director, Temple Lung Center, Temple University School of Medicine, told Ivanhoe.
Doctors use a bronchoscope to deliver ten tiny coils into the diseased lung. The coils work by compressing the lungs to help restore elasticity.
"When it compresses the lung tissue, it actually re-tensions the lung. That increases the recoil of the lung to expand the small airways," Dr. Criner said.
Patients feel a difference just one hour after the coils are placed; studies done in Europe show an average 18-percent improvement in lung function.
After just one month, Linda could walk 60 percent more than before.
"It really has changed my life. It has given me back a comfortable lifestyle of doing things that I normally wanted to do like taking care of my grandson," Linda said.
Patients in the renew study receive two sets of coils placed four months apart. The multi-center study is currently enrolling patients all over the country. For more information on enrolling, go to:http://clinicaltrials.gov/show/NCT01608490.
BACKGROUND: Emphysema occurs when air sacs in the lungs are destroyed gradually, which will make a patient progressively short of breath. It is one of the many diseases known collectively as chronic obstructive pulmonary disease (COPD). As emphysema worsens, it turns the spherical air sacs, which look like a cluster of grapes, into large pockets with gaping holes in their inner walls. This results in the reduction of the surface area of the lungs and the amount of oxygen that reaches the bloodstream. The elastic fibers that open the small airways leading to the air sacs slowly get destroyed as well. (Source:http://www.mayoclinic.org/diseases-conditions/emphysema/basics/definition/CON-20014218)
SIGNS: A patient can have emphysema for years without knowing it. Shortness of breath will begin gradually. Then, patients may start avoiding activities that can cause them to get winded. Eventually, emphysema will cause shortness of breath even while resting. Immediate medical attention is needed if a patient is so short of breath that they can't speak, their lips or fingernails turn gray or blue, their heartbeat is usually fast, or if they're not mentally alert. Smoking is the leading cause of emphysema and treatment can only slow the progression, not reverse the damage. Long-term exposure to airborne irritants, including tobacco smoke, marijuana smoke, air pollution, coal and silica dust, or manufacturing fumes, can cause emphysema too. (Source:http://www.webmd.com/lung/copd/emphysema-symptoms)
NEW TECHNOLOGY: Researchers at Temple University are part of a worldwide, multi-site study examining the effects of lung coils on lung tissue. The RePneu Lung Volume Reduction Coils are small, titanium implants which can be put into the lung with a bronchoscope. Generally ten are put into each lung. The coils are straightened out as they are put into the lung, but once inserted they recoil, compressing the diseased lung tissue around it. This compression allows the lung to regain some of the elasticity lost from emphysema. Patients who underwent early trials in Europe had increased breathing ability, decreased breathlessness, and improved quality of life. (Source: http://www.pneumrx.com/wp-content/uploads/2013/03/LIT0053.A-PatientBrochure-web.pdf)
Dr. Gerard Criner, Director, Pulmonary and Critical Care Medicine, Director, Temple Lung Center, Temple University School of Medicine, talks about a new breakthrough for emphysema.
Can you talk about just how big of a problem emphysema is in this country?
Dr. Criner: Well, emphysema is part of the disease category called chronic obstructive pulmonary disease, or COPD. There are approximately 12 million people that are diagnosed with COPD and it's believed that about 12 million additional patients are not diagnosed and have the disease. About 150,000 patients die from COPD in the U.S. each year, so about one patient dies every four minutes. It's a serious medical problem; it's the third leading cause of death in the United States and in the world right now. Patients that have COPD have severe symptoms like breathlessness, cough, and mucus production, and these limit their ability to do their daily activities and actually can affect their survival. The patients that suffer the most from COPD are probably those with emphysema. That's estimated to be about three to four million patients in the U.S. And emphysema is significant because it causes severe hyperinflation, or big lungs, which impairs how the lung, the heart, the chest wall, and the breathing muscles work. So, it contributes a lot to the patient's sense of shortness of breath and their exercise limitation.
So, bronchoscope lung reduction is possibly an alternative to surgery?
Dr. Criner: Yes. About 20 years ago, lung volume reduction surgery was promoted as a way to surgically treat hyperinflation, by making the lung and chest cavity smaller so breathing muscles and the chest wall could work better. In the National Emphysema Treatment Trial, which was sponsored by the NIH as well as the Center for Medicare and Medicaid Services, they showed in certain patients with certain anatomy had improvement in survival that could be durable up to 17 years in follow-up. Surgery is surgery; there's morbidity, and there is mortality associated with that. So over the last decade or so investigators have looked for less invasive ways to make the lungs smaller that doesn't require surgery.
Can you talk about coils?
Dr. Criner: The different bronchoscopic techniques that are under investigation now in the U.S. all try to accomplish the same thing: they try to make the lung smaller, but they just do it in different ways. The coil works by compressing emphysematous lung tissue. When it compresses the lung tissue it actually re-tensions the lung; it increases the recoil of the lung to expand the small airways and facilitates emptying of the lung that way. It actually is a coil that is deployed it's delivered straight through the bronchoscope and as we unfurl a catheter in the proper area of placement, it assumes its regular tension and coils like the seams of a baseball to compress the lung tissue within that. And then we place 10 of these coils in each lung, in targeted areas based on a CAT scan. In studies done in Europe that have looked at this, there's about an 18 percent improvement in lung function, and there's an improvement in the ability to walk on six minute walk tests about 35 to 50 meters overall.
So then we also have the valve?
Dr. Criner: So the first therapy ever used bronchoscopically to try to reduce lung volume was an endobronchial valve called the Zephyr valve. These are one-way valves, made out of nitinol rings. There's a smaller one, and a larger one. And these are deployed bronchoscopically, they're seated below the orifice of the valve and it blocks the air going in but let's the airs go out. So the emphysematous lung segment that you place it in deflates over a period of time and the air is blocked from going in to that portion of the lung to re-inflate it and it's directed to other, more viable areas of the lung. So it should improve ventilation and decrease lung volume.
What are the side effects from these other two?
Dr. Criner: all of them have the increased risk of having a flare-up after the procedure because they all involve a bronchoscopy. The coil has some blood streaked sputum after, but no flu-like illness associated with it. Then the endobronchial valve may also have some blood streaked sputum. That also carries the risk of the lung collapsing acutely.
How big of a breakthrough would you say each of these are?
Dr. Criner: What we've learned from lung volume reduction surgery is it is a disease modifying therapy, which means in carefully selected patients it not only improves their outcome but it can improve their survival. And in emphysema we only have two other therapies that have been able to improve survival. One is smoking cessation, and the other is oxygen use in people that are severely hypoxemic. Lung volume reduction surgery is the third therapy that can improve survival. If these therapies can prove to be as successful as lung volume reduction surgery in carefully selected patients with less risk then that truly would be a breakthrough where more people could be treated, more people could benefit.
So it has the potential to be huge?
Dr. Criner: It has the potential to be huge.
FOR MORE INFORMATION, PLEASE CONTACT:
Dr. Gerard Criner
Director, Pulmonary and Critical Care Medicine
Director, Temple Lung Center
Temple University School of Medicine