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A New Treatment for Severe COPD: The Zephyr Valve
COPD and emphysema sufferers now have a new treatment option. Dr. Justin Thomas, Interventional Pulmonologist, discusses the new Zephyr Valve.
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Learn more about Justin Thomas, MD
Justin Thomas, MD
Justin Thomas, MD, is a formally trained and Board Certified Interventional Pulmonologist who specializes in minimally invasive procedures for diagnosis and treatment or palliation of lung cancer, benign and malignant airway disease, and diffuse lung diseases. Dr. Thomas is also Board Certified in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine.Learn more about Justin Thomas, MD
Transcription:
Bill Klaproth (Host): COPD and emphysema sufferers, we have good news for you. Eisenhower Health is the first hospital in southern California to offer a new lung valve treatment for patients with severe COPD and or emphysema. It’s called The Zephyr Endobronchial Valve. So, let’s learn more about it with Dr. Justin Thomas an Interventional Pulmonologist at Eisenhower Health. Dr. Thomas, thank you for your time. So, let’s start here. what is the Zephyr Endobronchial Valve?
Justin Thomas, MD (Guest): Well thank you very much for having me on the show here Bill. The Zephyr Endobronchial Valve is a one-way valve that can be implanted in patients’ airways to reduce the lung volume that builds up with congestion called COPD and emphysema. And it works to allow the air to escape out of the lung or the area of interest in the lung and not allow air to go back into that segment or lobe of lung.
Host: So, the problem is the lungs are filled but they can’t get air out of the lungs. Is that correct?
Dr. Thomas: Yeah, so COPD is short for chronic obstructive pulmonary disease. So, the airways are obstructed and that’s due to damage of the airways due to primarily smoking here in the US. There is exposure to air pollutants in the home and workplace, genetic factors, respiratory infections; these all also play a role in the development of COPD. And COPD actually is in fact about the third leading cause of death in the US. These patients can develop what’s called a dynamic hyperinflation.
So, the first thing they experience is the inability to get air out. So, that’s the obstructive part. But then once they get this hyperinflation because of their airways being obstructed; the lungs sort of they lose their elasticity due to the destruction by the tobacco smoke and they develop this emphysema and then the lung is unable to really empty itself of air completely. And so air gets trapped in the lung and what this does over time is cause the diaphragm to become overdistended. And it becomes flat. And it can’t work as well as when it’s relaxed and in its normal sort of some shape position.
And so, it’s like if you and I were to take a really large deep breath and then try and breathe at the top of our lungs; this is what it’s like for these patients to actually breathe on a breath by breath basis. So, the idea behind the valve is that you insert these valves bronchoscopically so, with a small camera and scope under general anesthesia and they are implanted into areas that you identify prior to the test or prior to the bronchoscopy as areas that are overinflated. And so, you put these valves in and those areas sort of collapse in on themselves and allow the better portion of the lung to expand and that diaphragm to get back to a better dome shape position.
Host: Wow. This is fascinating. So, where do you route the air with these valves, back into the airway or somewhere outside of the lung?
Dr. Thomas: No actually they are all just within the airways. So, it’s just a one-way valve. So, we implant anywhere from about three to five or maybe up to six valves in a particular lobe and we only treat one lobe. And so, we go in through the airway so down through the trachea, the major windpipe, up into the – whichever side we go into. There are three lobes on the right, there’s two lobes on the left. And so we target just one single lobe and that’s determined based on patient’s CAT scan and we do a quantitative CT analysis to determine really the best target. We also, at the time of the test, do a balloon test which occludes the airway and we measure airflow because sometimes there could be communication between the different lobes of air so, what we call collateral ventilation and we test for that at the time of the placing the valves. Now because if there is collateral flow, then the valves pretty much won’t work. They won’t work to allow that air to expel out of that lobe. Because the lobe will just fill right back up with air from another lobe.
And so, we test for that at the time. And they just expel air out back into the airway, the main airways and the air just does not get back in. Because it’s a single one-way valve. So, air can escape but it can’t go back in.
Host: So, what are the main benefits of this procedure then?
Dr. Thomas: Yeah, so, as far as benefits, one of the main benefits that we see is and what multiple trials have shown now is anywhere from about an 18-30% improvement in lung function. And that’s measured by – we measure lung function by breathing tests or what we call pulmonary function tests and what we measure is the FEV1 or the forced expiratory volume in one second. So, the amount of air a person can blow out in one second. It is sort of a surrogate for their lung function. And there’s an 18-30% improvement in that number in these patients.
They can also walk farther, so their exercise capacity is increased in some of the studies anywhere from 39 to 79 meters and that’s equivalent to about half to a full football field. And their quality of life is also significantly improved as measured by different what we call the St. George respiratory quality of life questionnaire. In addition, they have improvements in their scores in something called the Bode Index that’s the B-O-D-E index and that’s sort of a measure of a patient’s risk of dying from COPD and actually that also improves with the use of the valves.
And the trials have not shown necessarily an improvement in mortality, but the trials have not be powered for that either. They’ve been fairly small trials, less than 200 patients in these trials. But large enough trials to determine that there is a significant improvement in breathing and walking distance and quality of life. So, these patients actually kind of get a renewed hope on life when it works well.
Host: Right which is really important. So, how about risks of the procedure?
Dr. Thomas: There’s about a quarter of the patients end up having a collapsed lung or what we call a pneumothorax. So, when the lung re-expands, the good portion of the lung re-expands, quickly due to the collapse of the bad lung; that lung can actually pop like a balloon and that happens in about a quarter of patients, 26% in some of the studies. And that typically is treated with a small bore chest tube for a few days potentially. Sometimes longer than that. Sometimes shorter than that, maybe just a day or two. And they do have to be watched in the hospital for the first three days after the procedure because of the risk of that is much higher the first three days. And so the FDA has mandated that we do watch them overnight, three nights in the hospital.
Host: All right, got you. So, how long do these valves last?
Dr. Thomas: Yeah, so hopefully the valves will last forever. They just stay in the patient. Right now, there’s no indication to really take them out on sort of a routine basis. They just stay in there and keep that portion of lung that we targeted collapsed. Unless there of course is some sort of complication in which case we may need to go in and take out a valve or two. But no, they essentially stay in.
Host: That’s great. So, people can’t be active smokers with these valves, right and then who would be a good candidate for this procedure?
Dr. Thomas: Yeah, well that’s correct. Patients who are active smokers are not candidates for the procedure. For a couple of reasons. One of course they are going to continue to have continued lung destruction from the smoking and the benefits they may get from the valves may be outweighed by the fact that they are continuing to smoke. And the potential airway reactivity to the valves when you are continuing to smoke and are current smokers. So, right now, the recommendation is that patients be smoke free for four months prior to consideration of the valves.
And as far as what patients benefit from this. Patients with severe COPD, which is the chronic obstructive pulmonary disease, that’s as measured by that FEV1 we talked about earlier of 45% predicted or less also patients who have evidence on their breathing tests of significant air trapping like we talked about earlier. And also, they have to have severe emphysema and that’s determined by a CAT scan. So, there is quite a bit of criteria that patients have to go through and meet so not everybody with COPD or not everybody with emphysema are candidates. But if they are interested in that, they should certainly talk to their doctor about it and if they have a pulmonologist or just their primary doctor can always give us a call here and we can review the case and see if they may be a candidate.
Host: Right, and then where is the Zephyr valve procedure available?
Dr. Thomas: Well here in the desert, I’m the only one that is doing this here at Eisenhower here in the desert and there are a few other centers here that are looking to start here in Southern California. I was the first to start here in Southern California. But there are others, UCSD, the University of California San Diego, USC, University of Southern California, Loma Linda I believe is looking at starting to do these but have not yet. So, there’s about three maybe four centers in Southern California here who are doing it. So, there’s not many places doing it as of yet. It actually was just approved last year and so there’s a lot of stuff you have to go through to not only just get the training but getting your program set up to be able to support such a program. It does take some time and effort.
Host: Well this is really good news for people suffering from COPD or emphysema. Dr. Thomas, thank you so much for your time today.
Dr. Thomas: Thank you Bill. I appreciate you having me on the show.
Host: That’s Dr. Justin Thomas an Interventional Pulmonologist at Eisenhower Health. And to learn more about the Zephyr procedure, you can speak with your primary care physician or contact the Eisenhower Pulmonary and Critical Care Clinic at 760-834-3564, that’s 760-834-3564. And if you found this podcast helpful, please share it on your social channels and be sure to check the entire podcast library for topics of interest to you. This is Living Well with Eisenhower Health. I’m Bill Klaproth. Thanks for listening.
Bill Klaproth (Host): COPD and emphysema sufferers, we have good news for you. Eisenhower Health is the first hospital in southern California to offer a new lung valve treatment for patients with severe COPD and or emphysema. It’s called The Zephyr Endobronchial Valve. So, let’s learn more about it with Dr. Justin Thomas an Interventional Pulmonologist at Eisenhower Health. Dr. Thomas, thank you for your time. So, let’s start here. what is the Zephyr Endobronchial Valve?
Justin Thomas, MD (Guest): Well thank you very much for having me on the show here Bill. The Zephyr Endobronchial Valve is a one-way valve that can be implanted in patients’ airways to reduce the lung volume that builds up with congestion called COPD and emphysema. And it works to allow the air to escape out of the lung or the area of interest in the lung and not allow air to go back into that segment or lobe of lung.
Host: So, the problem is the lungs are filled but they can’t get air out of the lungs. Is that correct?
Dr. Thomas: Yeah, so COPD is short for chronic obstructive pulmonary disease. So, the airways are obstructed and that’s due to damage of the airways due to primarily smoking here in the US. There is exposure to air pollutants in the home and workplace, genetic factors, respiratory infections; these all also play a role in the development of COPD. And COPD actually is in fact about the third leading cause of death in the US. These patients can develop what’s called a dynamic hyperinflation.
So, the first thing they experience is the inability to get air out. So, that’s the obstructive part. But then once they get this hyperinflation because of their airways being obstructed; the lungs sort of they lose their elasticity due to the destruction by the tobacco smoke and they develop this emphysema and then the lung is unable to really empty itself of air completely. And so air gets trapped in the lung and what this does over time is cause the diaphragm to become overdistended. And it becomes flat. And it can’t work as well as when it’s relaxed and in its normal sort of some shape position.
And so, it’s like if you and I were to take a really large deep breath and then try and breathe at the top of our lungs; this is what it’s like for these patients to actually breathe on a breath by breath basis. So, the idea behind the valve is that you insert these valves bronchoscopically so, with a small camera and scope under general anesthesia and they are implanted into areas that you identify prior to the test or prior to the bronchoscopy as areas that are overinflated. And so, you put these valves in and those areas sort of collapse in on themselves and allow the better portion of the lung to expand and that diaphragm to get back to a better dome shape position.
Host: Wow. This is fascinating. So, where do you route the air with these valves, back into the airway or somewhere outside of the lung?
Dr. Thomas: No actually they are all just within the airways. So, it’s just a one-way valve. So, we implant anywhere from about three to five or maybe up to six valves in a particular lobe and we only treat one lobe. And so, we go in through the airway so down through the trachea, the major windpipe, up into the – whichever side we go into. There are three lobes on the right, there’s two lobes on the left. And so we target just one single lobe and that’s determined based on patient’s CAT scan and we do a quantitative CT analysis to determine really the best target. We also, at the time of the test, do a balloon test which occludes the airway and we measure airflow because sometimes there could be communication between the different lobes of air so, what we call collateral ventilation and we test for that at the time of the placing the valves. Now because if there is collateral flow, then the valves pretty much won’t work. They won’t work to allow that air to expel out of that lobe. Because the lobe will just fill right back up with air from another lobe.
And so, we test for that at the time. And they just expel air out back into the airway, the main airways and the air just does not get back in. Because it’s a single one-way valve. So, air can escape but it can’t go back in.
Host: So, what are the main benefits of this procedure then?
Dr. Thomas: Yeah, so, as far as benefits, one of the main benefits that we see is and what multiple trials have shown now is anywhere from about an 18-30% improvement in lung function. And that’s measured by – we measure lung function by breathing tests or what we call pulmonary function tests and what we measure is the FEV1 or the forced expiratory volume in one second. So, the amount of air a person can blow out in one second. It is sort of a surrogate for their lung function. And there’s an 18-30% improvement in that number in these patients.
They can also walk farther, so their exercise capacity is increased in some of the studies anywhere from 39 to 79 meters and that’s equivalent to about half to a full football field. And their quality of life is also significantly improved as measured by different what we call the St. George respiratory quality of life questionnaire. In addition, they have improvements in their scores in something called the Bode Index that’s the B-O-D-E index and that’s sort of a measure of a patient’s risk of dying from COPD and actually that also improves with the use of the valves.
And the trials have not shown necessarily an improvement in mortality, but the trials have not be powered for that either. They’ve been fairly small trials, less than 200 patients in these trials. But large enough trials to determine that there is a significant improvement in breathing and walking distance and quality of life. So, these patients actually kind of get a renewed hope on life when it works well.
Host: Right which is really important. So, how about risks of the procedure?
Dr. Thomas: There’s about a quarter of the patients end up having a collapsed lung or what we call a pneumothorax. So, when the lung re-expands, the good portion of the lung re-expands, quickly due to the collapse of the bad lung; that lung can actually pop like a balloon and that happens in about a quarter of patients, 26% in some of the studies. And that typically is treated with a small bore chest tube for a few days potentially. Sometimes longer than that. Sometimes shorter than that, maybe just a day or two. And they do have to be watched in the hospital for the first three days after the procedure because of the risk of that is much higher the first three days. And so the FDA has mandated that we do watch them overnight, three nights in the hospital.
Host: All right, got you. So, how long do these valves last?
Dr. Thomas: Yeah, so hopefully the valves will last forever. They just stay in the patient. Right now, there’s no indication to really take them out on sort of a routine basis. They just stay in there and keep that portion of lung that we targeted collapsed. Unless there of course is some sort of complication in which case we may need to go in and take out a valve or two. But no, they essentially stay in.
Host: That’s great. So, people can’t be active smokers with these valves, right and then who would be a good candidate for this procedure?
Dr. Thomas: Yeah, well that’s correct. Patients who are active smokers are not candidates for the procedure. For a couple of reasons. One of course they are going to continue to have continued lung destruction from the smoking and the benefits they may get from the valves may be outweighed by the fact that they are continuing to smoke. And the potential airway reactivity to the valves when you are continuing to smoke and are current smokers. So, right now, the recommendation is that patients be smoke free for four months prior to consideration of the valves.
And as far as what patients benefit from this. Patients with severe COPD, which is the chronic obstructive pulmonary disease, that’s as measured by that FEV1 we talked about earlier of 45% predicted or less also patients who have evidence on their breathing tests of significant air trapping like we talked about earlier. And also, they have to have severe emphysema and that’s determined by a CAT scan. So, there is quite a bit of criteria that patients have to go through and meet so not everybody with COPD or not everybody with emphysema are candidates. But if they are interested in that, they should certainly talk to their doctor about it and if they have a pulmonologist or just their primary doctor can always give us a call here and we can review the case and see if they may be a candidate.
Host: Right, and then where is the Zephyr valve procedure available?
Dr. Thomas: Well here in the desert, I’m the only one that is doing this here at Eisenhower here in the desert and there are a few other centers here that are looking to start here in Southern California. I was the first to start here in Southern California. But there are others, UCSD, the University of California San Diego, USC, University of Southern California, Loma Linda I believe is looking at starting to do these but have not yet. So, there’s about three maybe four centers in Southern California here who are doing it. So, there’s not many places doing it as of yet. It actually was just approved last year and so there’s a lot of stuff you have to go through to not only just get the training but getting your program set up to be able to support such a program. It does take some time and effort.
Host: Well this is really good news for people suffering from COPD or emphysema. Dr. Thomas, thank you so much for your time today.
Dr. Thomas: Thank you Bill. I appreciate you having me on the show.
Host: That’s Dr. Justin Thomas an Interventional Pulmonologist at Eisenhower Health. And to learn more about the Zephyr procedure, you can speak with your primary care physician or contact the Eisenhower Pulmonary and Critical Care Clinic at 760-834-3564, that’s 760-834-3564. And if you found this podcast helpful, please share it on your social channels and be sure to check the entire podcast library for topics of interest to you. This is Living Well with Eisenhower Health. I’m Bill Klaproth. Thanks for listening.