None — D. Kyle Hogarth, M.D., from the University of Chicago Medical Center, is helping emphysema patients breathe easier.
Who would you consider a candidate for this valve?
Dr. Hogarth: These valves are for people with advanced emphysema. People that are still suffering lots of symptoms despite being on a current drug regimen, and have done pulmonary rehabilitation and things like that. There are specific criteria that besides a degree of just how bad your lung function is, you also have to have your emphysema distributed to the top of your lungs, and not at the bottom to be a candidate for this valve.
What is the standard treatment for someone with severe emphysema?
Dr. Hogarth: People with severe emphysema are obviously told to quit smoking. They get vaccinated, if they need oxygen, they're put on oxygen, they do pulmonary rehabilitation, try to maintain good nutrition, and then they get the standard various inhalers that are prescribed on the market that have been shown to improve lung function, and for some people, that's all you need. But there are people whose emphysema is advanced enough that despite all of that they still continue to do poorly. Traditionally, the two other things available then are either lung transplant, which has obviously lots of issues, and a surgery called lung volume reduction surgery, where we literally cut out these dysfunctional regions of the lungs so that the remaining good lung at the bottom can do more work. Except that it's a massive surgery, and so the two kind of last ditch options clearly have their limits.
What do the Valves do exactly?
Dr. Hogarth: The idea behind the valve was to sort of mimic the idea of the lung volume reduction surgery. Instead of cutting out the regions of the lungs that don't work, what if you could just block them off so that they work so poorly that they actually kind of hinder the remaining good lung. If you could sort of shut those regions down, it would allow the good lungs, good regions of the lungs to do more work, that's the idea behind it, and it's clearly a lot easier to put a little device in the airway than it is to have your chest cut open. If this works, it's going to revolutionize how we take care of advanced emphysema.
What's an umbrella? Dr. Hogarth: When it's put inside the airways, it expands open, and sort of seals the airway to prevent more air from going into this bad region of the lung, but during, when people are breathing out, it closes down a little bit, so that air can come out and so that secretions and other stuff in the lung can come out still. That's why they can be placed so safely, people don't get pneumonias and things like that, because they just sit there, and they re-direct the air, if you will, towards the good regions of the lung.
Does it need to be replaced after sometime or is it permanent?
Dr. Hogarth: they've been stress-tested to last at least twelve years. They're made of titanium, so we think that you'll get them put in and really not have to have them re-done. I believe the person who's had them in the longest now is four or five years out and doing fine, so it hasn't been an issue there mechanically. Yeah, they're designed to more or less stay put.
After someone has it put in, is it an outpatient procedure or is this an overnight?
Dr. Hogarth: Right now, the protocol of the research trial, we do it and then they stay the night, more as a precaution. I can tell you that the people that we've had in the trial here are very bored during the night, and they're pretty much ready to leave first thing in the morning, so I envision that if this becomes approved and becomes a standard protocol, people will be done as an outpatient.
Do they feel relief immediately?
Dr. Hogarth: Some people do, some people don't, and of course that's part of the trial, because of course, some people wake up and don't feel anything, but they also might not have gotten anything done. There's also the possibility, as logical as these things are, and as exciting as the initial data is, they might not work. That's why we're doing the trial here, to see if they work or not. The nice thing is they are removable because if people are having problems with it, or if we find out they don't work and the person says, yeah, I want them out, we can remove them.
Do they still need to be on other treatments in terms of oxygen and things like that?
Dr. Hogarth: Absolutely. If you are taking inhalers, you still need to take them. This is an additive to what you're already doing for your emphysema, this isn't replacing it, so yeah, don't stop your inhalers, keep using your oxygen, keep exercising, don't smoke, eat properly, get your vaccinations, and you're not off the hook.
Could this revolutionize how we treat end-stage emphysema?
Dr. Hogarth: It gives us another tool right away. The drug development is always a long-term process, and in the end, so much of what is influencing emphysema, what influences people's difficulty breathing from emphysema in some ways is mechanical, so you can inhaler all you want, you're not going to fix the mechanical problem, that's where the idea of the surgery came in. As crazy as it sounds, the surgery works, and so the surgery is part of the repertoire, to cut out the non-functioning part of the lungs, so it's going to revolutionize it, because you can imagine there are people who are candidates for the surgery. Everyone in the trial is actually a candidate for the surgery, who, for one reason or another say, I don't want a big surgery, it's a big risk, it's a bronchoscopy with a little device left behind doesn't even sound that bad, and it isn't.
How long is someone in the hospital when they undergo this surgical reduction procedure?
Dr. Hogarth: Many days, if it goes smooth. Then of course, there can be complications; surgery is always a big deal. The surgeons who do it are incredible. There's very limited centers that can do lung volume reduction surgery. We do lung volume reduction surgery and our surgeon is fantastic. Even in the best hands it's still many days, it's still a big risk, it's still fraught with complications, even in the most expert hands. I am hoping this works, and if it doesn't, that's fine. I don't want to be doing something to someone that doesn't work, that's a waste of money, that's a waste of effort, and harmful, potentially, but if this works, what a great tool, what an amazing ability to help somebody.
How big is the problem of emphysema?
Dr. Hogarth: Emphysema is a component of COPD, but by various estimates there's 24 million Americans with COPD, only about 10 million are diagnosed, so there's a lot of people with disease out there that they ascribe to. I got older, or I can't breathe because I'm fatter, or whatever. Pure emphysema, with all the holes and destruction in the lung, by various estimates, four to six million people and just the pure emphysema, not so much of the air flow obstruction of the mucus and so forth, but no matter how you want to slice and dice it, it affects a lot of people.
What is life like for someone with severe emphysema?
Dr. Hogarth: There were surveys done of people with COPD and emphysema. Roughly 90% of them say that on any given day, they have trouble breathing, so pretty much all of them. Life with COPD actually has to cut back on what you do, because you're afraid that if you walk too far away from your home, how are you going to get back. Patients tell me that when we start to treat their COPD, whether it's with medications or something like this, the mundane activities they can do again, stuff that you and I take for granted; going to the grocery store, walking up and down the aisles, carrying the laundry, playing with your children or your grandchildren, dancing with your spouse, pick something, that's why this is so important to me. The doctors are always looking for ways to make people live longer, and that's clearly important, but living better is I think actually more important because COPD robs you of your life even while you're still alive, and being able to give someone their life back is unbelievable, and the patients are so appreciative for it because nobody knows how much they suffer, but they do.
How long do you think the trial would take?
Dr. Hogarth: It's phase 3 pivotal trial. People are randomized to a sham bronchoscopy, we size the airways, we get ready to put them in, we open the envelope and it says, oh, no valves, we spend the next half an hour twiddling our thumbs, because we need the bronch to last as long. If we put valves in, we spend the next half an hour putting valves in, that's the only way to know that this is going to make a difference. Then they're followed for six months. Those that get the sham bronch, they don't get the valves. What they signed up for when we six months later say, yeah, you didn't get them, would you like them? There's an open label extension where you come back, we do it again, and you're definitely getting valves. We did two ladies yesterday who were in our trial, who were randomized to sham, spent the last six months not having valves in, they got them yesterday.
Who is Pam?
Dr. Hogarth: Pam is a great example of what the valves can do and why this trial is occurring. Studies don't get to this size and magnitude unless there's obviously been data to show that they're safe, and there's a reason to believe that they can help people. She's a great example of the type of patient who had, despite doing all the right things, was being robbed of the quality of life that she deserves, and as I'm sure she said to you, simple little things. I remember her commenting once that vacuuming got easy. Who wants to vacuum? Until you realize that vacuuming might be all you got done that day because it wiped you out, and now it just goes back to being the annoyance for the rest of the world. People don't recognize how this disease robs you of the mundane aspects of life, let alone the great sides of life. She is, in my opinion, the great example of what this device can do, and why we hope so desperately that it works universally so that it will get approved and so forth.
What is the time frame for the trial?
Dr. Hogarth: The clinical trial is still ongoing. There is a recruitment goal. We'll probably have it within the year, from now, you never know. We still need more patients, the data, once it's closed, then you have to have the follow up from recruitment and so forth, and then you apply to the FDA. Realistically, it's probably two years from now, the company may have a different answer but I'm not affiliated with them.
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