Hello. Okay, it's 1 p.m. I'm sure people are going to be drifting in, but I was reminded by my German faculty here that we have to stay on time. So I'm going to get us started. We have a fun panel, I think, today. I'm trying something different this year where I'm going to put resources into this shared file. So feel free to scan the QR code with your phones and then it will take you to a file that is on a OneDrive with the University of Chicago. It does expire, like, in a month. It's November 8th or 9th. And so you can get, like, some of the slides. The slides that I think are more helpful for you to have as a resource later, maybe not the entire presentation. And some of the papers that are relevant to the talk. And so if that, I hope it works. If anyone can fact-check that at least you have access to the file. But if not, let me know. That's my email contact information and I'll fix it. I'm a technology challenge. I started to hit my 40s and that's it. Neuroplasticity. So good luck to us with the link. We're going to talk COPD. The issue of mortality always comes up, but I think beyond mortality, disability and quality of life is something that is patient-centric and the patients really care about. And that I actually, I'm going to have your guys come over to this side. Thank you. And that I think it's now the focus is over, you know, mortality is also improving the lives of patients, right? That's what matters to them. It matters to they don't come back to the hospital, that they don't have as many symptoms, they don't have as much dyspnea. So that's part of why we put this talk together. And so regarding high flow nasal cannula, and this is a joint that I put together. But the idea is that you have the high flow can go up to 60. The new Aerovo Fisher & Paykel can actually go to 70 liters. So it's a high flow. You can do it with oxygen and you, we must remember, we can also do it without oxygen, just air and it's heated and humidified. So the way it can help from the physiologic standpoint for COPD is by increasing the inspiratory lung volume. It causes washout of the CO2 off the upper airway. I got a little carried away with the diagram here, but this has been proven on clinical trials where there is a washout of CO2 off the upper airway. And so it creates a more efficient ventilation because by affecting the dead space and there is this pressure generation with the higher flow is never going to be high intensity pressure support, right? Non-invasive ventilation. But it's about three to eight centimeters water pressure that can perhaps support some of these patients with the auto-PEEP and with work of breathing. So that's how we think that high flow nasal cannula can be potentially helpful in chronic stable COPD. We know the literature in acute hypoxic respiratory failure. So that's not the focus of the talk, but the, you know, but obviously there come questions as of, is the level of pressure enough? And that comes from the non-invasive ventilation literature, because we have shown that the low intensity pressure ventilation is not effective to decrease CO2 or improve CO2 levels and affect mortality. So we would really need the high intensity pressure ventilation. So it's not a one mechanism that would help with COPD management. It's kind of a combination of this. The other advantage is it's heated and humidified air and it desiccates desiccations less, right, than high intensity positive pressure ventilation. So if it keeps the airway more moist and warm, the patients have the opportunity to clear secretions, improve the mucociliary clearance, and that also can improve VQ matching. And we can improve with lung recruitment or alveolar recruitment. So that's some of the benefits. The one caveat is it really doesn't support the diaphragm, right? It's not as helpful like NIV to provide the diaphragmatic support. There are previous trials that have evaluated high flow nasal cannula in patients with chronic stable COPD. Some of them are short term and some of them are long term. And you can see the characteristics listed here. They vary in the liters of oxygen used between 15 to 30 liters, the hours of daily use, and then the populations recruited generally have focused on COPD patients that are relatively stable but have had an acute exacerbation within the past few weeks. And that goes from six to 12 weeks. So an exacerbator phenotype. And in those, the other differences, they've enrolled between eukapnic to hypercapnic patients. With the hypercapnic patients, the CO2s in the studies have ranged probably between the 46, 47, call it hyper, so very mild hypercapnia, to mid-50s, so 55, 53, 52. So relatively low CO2 levels. More recently, we have the studies by Dr. Nagata in Japan. This is an initial short term crossover trial where they randomized patients to high flow followed by conventional oxygen therapy and conventional oxygen therapy followed by high flow. So they had the two groups and they demonstrated improved quality of life, which again is going back to that slide, right, that we're working beyond mortality. And it did improve CO2 levels, improve the pH. We think because of the mechanism of the upper airway, CO2 washed out and improved in the ventilation efficiency. And then there was a question about exacerbations. There was a trend. It was not statistically significant. It was a short term, so it was not designed to assess exacerbation. So then they kind of went on and did a longer trial and they enrolled patients that were older than 40 that had daytime hypercapnia stable and COPD goals 2 to 4. And then they had the two arms. So it's a randomized control multicentric study. They did have the patients use seven hours. Mostly they recommend that during the night or during sleep, but they could use it during the day as well as needed. And they followed them for 52 weeks. Once again, the trial demonstrated improvements in quality of life. And this trial didn't show improvement in CO2. And in the past one, even though it had said that the CO2 and the pH improved, the numbers were like three to four millimeters of mercury. So there is like very minimal decreases in CO2. And there was a trend towards improvement in exacerbations, but it was not statistically significant. Was it? Let me see. No, there was. So this is the graphs for that study, the last one. In the initial one, it was questionable. The longer term trial did show a difference in exacerbation. You can see the Kaplan-Meier curve, but there is no difference in overall survival. So, you know, I guess the concerns are, again, we didn't study patients that were significantly hypercapnic. We know that that may be important. This is extrapolated from the positive pressure ventilation studies. There was no clear titration protocols for the high flow nasal cannula. Do you increase the flow to decrease work of breathing, respiratory rate for comfort? And then the care models are honestly unclear, right? Like we are talking high flow nasal cannula for stable COPD, good luck getting approved for that. Anyone knows of any insurance that can approve a high flow nasal cannula device for stable chronic COPD? They're not approving it. So in Japan, there is also, you know, this study was mostly done there. We don't know how much support patients with COPD get at home with the clinical trials, which could have biased the results of this study as well. And so I took this slide from Lisa. And so we did another session on titrations and for sleep disorder breathing, and she touched on the high flow nasal cannula for COPD. And so this, when we're comparing to high intensity positive pressure ventilation, here are some of the like benefits and downsides, right? So we talked about the secretion and the high intensity positive pressure ventilation has a mortality benefit that is proven in hypercapnic patients. But we have the concern about the dryness and the leak and the tolerance. High flow nasal cannula helps with airway clearance. It does reduce some of the CO2, but maybe not as clinically relevant as the positive pressure ventilation. And then the concern of no diaphragmatic rest and accessibility. Now, there in regards to, can we do it? There have been some pilot trials showing that in the US, we can do this high flow nasal cannula for home for patients with acute exacerbation of COPD. This is a study by the Temple group led by Dr. Kreiner that showed that it's well tolerated, at least we know that the patients can use it and they tolerate it well. They saw some trends, but it was not statistically significant, but again, it was a feasibility study. And right now we're enrolling for the high flow study. So it's a multi-center randomized control trial of high flow nasal cannula versus standard of care with oxygen. And we're going to be using the MyAero3 device. There's going to be blood oxygen saturation measurements. There's going to be patient questionnaires. And these are some of the primary objectives and secondary objectives that we're evaluating. And the goal is to recruit 642 gold grade E and stages three to four moderate to severe COPD. This is the overview of the clinical trial. Again, this is in the resources that you have. If you have a center that is academic, that has a high population of patients with COPD, and you were interested in being a site for the high flow COPD study, either reach out to me or to Dr. Kreiner or to the group I put the information because you could potentially, there's still acceptance sites for enrollment. The patients are going to have actually an app where they're going to log daily symptoms and it's very easy to use. And so that's happening kind of on the research world on the clinics. I actually have patients that I have on high flow nasal cannula and those patients are patients that qualify for non-invasive mechanical ventilation. So we have two home ventilators in the market and they're more common that have high flow capabilities. So they go up to 60 liters of high flow and they can use mask ventilation for the night or even during the day as needed. Then they can switch to the high flow circuit with the machine. One of the equipments you can actually give the patient a range where they can adjust the high flow. So if they're doing well, they can do lower liters. If they're struggling, they can increase the liter within a timeframe that you give. So you empower the patient to also use the flow for dyspnea and you can blend oxygen to the high flow to adjust for an SPO2, 88% or above, or even like for FiO2 based on charts that they have of blending oxygen and airflow. The masks, we still use the traditional high flow nasal cannulas like we do in the hospital, is heated and humidified. These ones have also battery operated, so they don't need to be plugged to the wall. So the patients could actually walk around and use their device, let's say they're gardening or they're taking a shower or something that allows them to have more mobility. And then, you know, occasionally I do have patients that come with like this funky setups. This is actually an inpatient BiPAP nasal pillow cannula. It doesn't have a lot of the leak ports. So she liked it, but it's probably not recommended because we still want to have that CO2 washout. So there is, it's not well known, it's happening in the clinical setting with the home ventilators. There are ongoing clinical studies to assess the efficacy, safety, and like patient centric outcomes for patients with COPD. So take-home points, right now we know it's safe, it's well tolerated and improves quality of life and decreases exacerbation potentially. There is a signal. There is no evidence of a mortality benefit, so I don't think it's going to substitute high-intensity positive pressure ventilation. It's not paid, but we can get it these days if they're qualifying for non-invasive ventilation. This is traditionally the patient that comes to the hospital, frequent exacerbator with a CO2 of 52 and or above. And there are ongoing clinical trials. So hopefully in the near future, we are going to be able, if we show a benefit, to prescribe this for patients for home. I want to thank Lisa for her slide and Dr. Kreiner for the support he was going to be here, but he has like three grandkids coming on the way. One was born, so I forgave him for that. I'll have our next speaker. This is the cure code again. I can show it at the end and it's going to be Dr. Lucas Kimmick to discuss successful inpatient to outpatient. COPD transitions. Hi everyone. I'm Lucas Kimmick. I get to talk to you today a little bit about transitions in care and patients with COPD, focusing mostly on the inpatient to outpatient transition. I have no relevant financial disclosures. I'm not sponsored by Big Transition. The goals for today are going to be focused a little bit on why are transitions in care important, why should we care about them, what the perils and pitfalls are of transitions of care. These are generally sort of vulnerable time points and what can go wrong and what data do we have to support some of the interventions that we do to help make that process easier. And then what role sort of an interdisciplinary team can provide, what role an institution can provide to make these processes easier and kind of what the future of that may look like. So why should we care, why should you care about transitions in care and COPD? That's been sort of something that's I think in certainly here in the U.S. has been a big focus for hospitals and for Medicare to reduce readmission. COPD is a third most common cause for readmission and so decreasing that is a significant focus for the health care system to rein in costs for some chronic diseases that have a high financial burden. One of the strongest predictors for readmission is a prior exacerbation or one of the risks like the strongest risk factors for future exacerbations is your prior history of exacerbations. And so by definition based on the new goal guidelines anyone who has had one exacerbation that's been hospitalized is automatically group E so that person is at high risk. So anyone who gets transitioned from an inpatient to outpatient setting who has COPD is at high risk for readmission and exacerbation. And these are vulnerable times and we'll get into sort of what that means and how that looks like. We should care about it not only because it's expensive and because it leads to morbidity but also because COPD is the leading cause of mortality and transitions and interventions to make that process better may also have a mortality benefit. Currently it's a very broad sort of there's a lot of variety in how institutions and individuals manage that process. The ATS came together a few years ago and did sort of a workshop on how to transition patients or what should we look at when transitioning patients. What's important you can see this is a very comprehensive statement because you have to take into account individual factors institutional factors social factors. And so it's not as easy as just going through the med rec with a patient making sure they understand what they're supposed to take and sending them on their way. And in fact when we think about transitions these are just some of the domains that are important to think about as someone transitions from an inpatient to an outpatient setting. Do they know what medications they're supposed to take? Do they know how to use their inhalers? We know that the vast majority of patients with obstructive lung diseases actually don't know how to use their inhalers properly at least the ones that are hospitalized. Can we get those inhalers covered especially in an insurance market like the U.S.? That's not an easy answer or a question that's easy to answer. You may have a sort of variety of inhalers that are covered or not covered by an insurance company. Do they have the financial means to afford their inhalers? Do they know what to do about an exacerbation? Do they know what an exacerbation is? Do they know whom to contact? Do they have oxygen at home? These are all questions that become very important as you send someone on their way because they may be in the hospital because they didn't have some of these things and so ensuring that they have that is is one big component. The other thing is especially in the U.S. we're doing this on sort of a patchwork of you know care that may or may not be in network that is disjointed between hospitals, primary care physicians, and that patients may or may not have ready access to. So what can we do to reduce readmissions? We know that readmissions tend to happen about a quarter of them happen in the first week. The most common day to be readmitted to the hospital is the day after you were discharged which speaks to the fact that probably something went wrong in that transition process. But we know that in the first about 60% of all readmissions for COPD happen in the first two weeks so that's a very very vulnerable time. So we think that providing patients with early follow-up and clinic is one avenue to successfully reduce readmissions. Teaching patients how to use their inhalers properly especially in sort of an intensive teach-to-goal method can reduce 30-day readmissions which is the metric here that the Centers for Medicare Service CMS uses for reimbursement for hospitals. So those are some of the individual things that we know help and what different institutions did is they bundled these and this is one of the results from one of the first meta-analyses that looked at well what what are these trials actually so show that use sort of a bundled transition process that has usually a combination of respiratory therapists teaching the patient how to use their inhalers pharmacists reviewing their medication reconciliation that usually has a COPD action plan and patient education and as well as follow-up visits and they actually found that there's a pretty heterogeneous effect. Some of these reduced readmissions some of them increased readmissions or increased healthcare utilization which was sort of an interesting finding and actually in a more recent study from three years ago out of Hopkins they saw that a similar effect that a bundled intervention to comprehensively provide transition information and care led to increased utilization in the next one to three months for patients with COPD and so even though we think we know what to do during these transitions it turns out that some of these things may actually not have the intended effect and even though after the in the U.S. the hospital started being penalized for frequent readmissions for chronic disease including COPD could actually see that the readmission rate started to decrease even before this was introduced however mortality has actually increased with the implementation of financial penalties for hospitals for frequent readmission so something that was designed to improve care has conversely led for this is not has been shown not just for COPD but has been shown for some other metrics such as heart failure and pneumonia where there's also a CMS penalty that has actually led to increased mortality which leads to the question there's Goodhart's Law when a measure becomes a when outcome becomes a measure it stops being a good out with the other way around when that outcome becomes a measure it's not either way if you start measuring something and then everyone tries to meet that metric and it stops actually reflecting what the underlying process is so this is just all to say really don't have a lot of good hard data what transitions work or what what what concepts are important for transitions and what are we actually trying to target here and and I think that probably readmissions and mortality are both important readmissions are important because chronic diseases do impose a large financial burden on our ever-increasing health care expenditure and that's money that is you know in a fixed pot that we otherwise can't spend on other things such as screening mammograms things that have sort of a high that go a long way and so it is important to be judicious of our health care resources but also mortality should be sort of an important end point I think a very reasonable this is what the British Thoracic Society recommends it's sort of a minimum COPD discharge bundle which are the things that we know that we can do and that that probably work well which is making sure people understand how to use their inhaler what medications to take if they have a self-management plan number to call that you've assessed them for smoking whether or not they smoke and whether or not they are interested in smoking cessation and counsel them on the importance of that and then counseling them on or enrolling them for pulmonary rehabilitation and timely follow-up transitions aren't only just risky this is also a time where you have the attention of the patient and the health care resources together at the same time in the same room in the same place and so it is a I think a area that is potentially very impactful as well the challenge is always that you know we don't see COPD patients in isolation these are not folks who usually have just COPD but these are patients who have complex comorbidity who some of whom are actually hospital dependent that no matter how well you transition them they have several different diseases that will invariably lead to very frequent health care utilization they are often patients of lower socioeconomic status they are often patients who have poor access to health care health inequity and who are often from marginalized communities and so it's very important I think to do interventions for transition and sort of a needs-based assessment too and make sure what does this patient need how can we help what are their unique challenges what we have at the University of Chicago was we have a sort of a multidisciplinary COPD team which consists of a consult team that sees every patient who's admitted with COPD exacerbation who's getting co-existent treatment for a COPD exacerbation during their hospitalization it's led by a team of nurse practitioners we also have a team of pharmacists and respiratory therapists who can meet with the patients who can deliver their discharge medications to the bedside for those who have insurance issues we have sort of a hospital five dollar co-pay list of medications which include at least one of each short-acting bronchodilator ICS LABA and LAMA medications to ensure that patients have access to these medications they do patient education before discharge place referrals for smoking cessation or pulmonary rehab if appropriate and they we have a transitions in care clinic where patients get seen within one to two weeks after discharge by the same nurse practitioners and then are also enrolled in our physician COPD clinic where they are so then then further cared for longitudinally and where we can sort of interface together with some of our colleagues from sleep medicine so we by design sort of have try to geographically bundle our expertise that we share in office space it's very easy for me to go over and ask you know the interventional pulmonary folks and say hey look this is their CT scan can you please take a look at it what do you think is this a candidate for bronchoscopic lung volume reduction surgery or is this a candidate for you know heated high flow at home so that those things i think are very helpful but it requires really a multidisciplinary approach we talked about that that you know COPD is a complex is part usually of complex comorbidity that these transitions are an opportunity that every institution i think that wants to implement sort of a structured transitions program it's helpful to identify what resources do you have available what are your strengths what can you build on what your patients look like what do they need and where are their hurdles i think focusing on what's known to work is helpful and really doing the basics well and then as you know institutions build on these programs i think it's very helpful especially in light of the sort of conflicting data that we really track what we're doing whether that is in the qi approach or sort of like in a prospective trials approach to really understand what parts of these bundles help or i'm sure these bundles help some people but they may lead to increased utilization others and to sort of help stratify the patients in the future i think we will get more data we will understand what what things are helpful and efficacious and what things are maybe less efficacious and more costly i think that increases in telemedicine that we've seen after COVID have been very helpful the hospital at home services are very attractive although we've been hearing a lot about them for like 20 years now and it really hasn't caught on as much for obvious reasons but i think that we certainly share one patient who we treat at home very frequently in a sort of hospital at home setting so i think that's a that's a promising avenue i think as as sort of the way that our hospitals work changes a little bit and then i think that we're going to be able to predict better not just who's going to have another exacerbation i think we have predictive models that are relatively good with that but maybe to say this type of patient might benefit from this intervention to sort of i think better match available interventions with the with the patients and that's it thanks to the wonderful COPD team at the University of Chicago thanks to my co-panelists thank you lucas we're gonna have questions at the end so write them down since we're doing on time and we're going to discuss now more advanced modalities like lung denervation i'm very thankful to have dr yunita here with us and I'll get you going. Well, thank you all for coming this afternoon. I want to thank Dr. Lostra for inviting me. So, the bad news is I'm not Jerry Kreiner. Good news is that he did loan me some of his slides and so you'll have some, I think, very interesting information. So, lung denervation and advanced COPD, I have to pull this over. We practiced before, but it's finished. So, my disclosures is that I'm part of the clinical trials for Nuvera on lung denervation and that I want to just make clear that lung denervation has not been FDA approved. These are my objectives. Oh, here, okay. This is, I guess, the next one. Okay. Before talking about lung denervation, I want to talk a little bit about exacerbations and why they're important. So, in the goal 2023 report, they list and they highlight in the management of stable COPD that, quote, the main treatment goals are reduction of symptoms and future risk of exacerbations. And why do they think this is so important? Well, exacerbations lead to increased risk of future hospital admissions. Excuse me. Everybody turn off your phones. Okay. Everybody put yours on mute. Emergency department visits and worsening healthcare status, they increase the risk of cardiovascular events. They lead to acceleration and pulmonary function decline. And they lead to an increased risk of mortality that peaks in the first week after an exacerbation. And then those who have frequent exacerbations, they have worse health outcomes. They, as measured by the SGRQ, they have a threefold increased risk of cardiac death. And they have an increased mortality that increases with the frequency of exacerbation. We didn't have audience questions, huh? I thought we were supposed to. So, I put some in. Okay. All right. So, exacerbations of COPD lead to which of the following? Increased risk of future hospitalization, accelerated decline in lung function, worsening health status, increased mortality, or all of the above. So, I think most of you are paying attention. If you think about it, you probably can get this. And even if you weren't here, if you're a good test taker, you could probably get this right, huh? Let's see. Nine, ten. Get there. You can do it on the app or you can scan the QR. We'll go ahead. All right. Wow. 100%. All right. Okay. You haven't fallen asleep yet. This is great. Okay. All of the above. Okay. Well, who are these patients with frequent COPD exacerbations? Well, almost half of the patients on triple therapy continue to experience exacerbations. These are our patients, right? By the time they hit our pulmonary clinic, they're on triple therapy or failed triple therapy. These are our people. The strongest predictor of future exacerbations is simply the patient's frequency of exacerbation the year prior. And we know that this is a stable phenotype. In other words, patients who get exacerbations get exacerbation. We see these patients every day in our clinic. We know who they are. We know what's going to happen to them over and over again. And unfortunately, there's not a lot we can do besides we kind of talked about and what most everybody is doing. So lung denervation. This is where it steps in, we hope. What is it? It is a one-time outpatient bronchoscopy procedure that aims to ablate the vagal nerve innervation of the airways and to reduce or eliminate inappropriate neuronal hyperactivity. The treatment goal is to reduce the frequency and severity of exacerbations in patients who have frequent exacerbations. And what's the rationale for this? This didn't just come out of thin air. We know historically in animal studies and in humans that vagotomy decreases airflow resistance, that it abolishes airway basal tone, that it abolishes reflux mucus hypersecretion, that it reduces airway inflammatory responses to particulate inhalation, and abolishes airway hyperreactivity. And then we know that the stimulation of the vagus nerves causes bronchoconstriction and that hypoxia-induced airway narrowing is absent in lung transplantation because they don't have the nervous innervation. Furthermore, when they, so to test this theory, they did animal studies of targeted lung denervation. And the first study they looked at reduction in airways resistance. So on the left-hand graphic, there's atropine, reduces airway resistance about 25, 30%. And that over time attenuates and goes back to baseline somewhere around 20 to 30 minutes. When they did a targeted lung denervation, the same sort of phenomenon was seen and it lasted out to at least 120 minutes. And that's, so that's the vagal efference. But as well, the vagal efference are affected. So this is something called Brewer, I can't pronounce it, Herring Brewer Reflex, something like that. It's when you have pressure in the airways, those pressure receptors, sensors, then feed back to the bright stem, to the respiratory center and stop inspiration. So on the left upper one, this is before TLD, you have a cessation of inspiration. Post TLD, you have, you no longer have that feedback. And so you continue to breathe. And this is in animals, I think it was a sheep mom, I can't remember. So on the bottom left was the treatment also, but this treatment, when they tested it proximal to that treatment, that reflux was still intact. So it's only distal are those receptors affected. In addition, they saw attenuation of the respiratory sinus, arrhythmias, and only saw some mild fibrosis in the airways, and that there was no significant effect upon the bronchial epithelium at 30 days. So this suggested that this sort of treatment might be effective and appear to be safe. In addition, out fairly far at 365 days and 640 days, there was a decrease in neuronal staining. So based on this work, they, largely by Marty Mays, but there were others, they developed this device called target lung denervation. Get this arrow to go over. There it is. That show? Oh, there it is, okay. So this is the generator of the radiofrequency ablation, that's the energy that's used. This is the catheter, and that goes through the scope. It has a balloon with cold chilled saline in it that cools the bronchial epithelium so it doesn't get damaged. And it's aimed at both the left main and the right main. In addition, there's an esophageal cooling balloon that protects the esophagus and the vagal innervation of the esophagus as well. These are the four clinical trials that have been performed or are ongoing. The first three have been completed. There's three-year data. Let me just touch on the third, the Airflow-2 trial. Go back here just a little bit. In this one, they had 82 patients, multi-centered European trial, one-to-one randomization with sham and treatment group. So the 41 patients who were in the sham group had 39%, 39% of them had respiratory SAEs, and only 15% in the treatment group had respiratory SAEs at one year. And this was durable out to two years as well. This is severe exacerbations of COPD out to two years. So again, it appears durable and effective. And this led to their pivotal trial, Airflow-3. And again, this is a double-blind sham control trial. Nobody inside of that room who does this leaks hopefully any information out. And to tell you the truth, when I'm following these patients, I don't get to see them. So I can't tell them. And even if I did, I usually don't remember which one they got anyway. They get to, once the sham control subjects have completed one-year follow-up, they can then get the procedure as an open label. One-to-one randomization, primary endpoint being reduction in moderate or severe exacerbation at one year, 375 subjects, 75 enrollments, 33 international sites. With inclusion criteria of two plus moderate or one plus severe exacerbations of COPD in the previous year, CAT score greater than or equal to 10. And they had to be on optimal therapy, medical therapy with two or three drugs. Okay, second question. Which bronchoscopic procedures are FDA approved to treat COPD? So TLD, targeted lung denervation, yes or no? Endobronchial valves, think about it. Your colleagues are out there, are they putting these valves in or you're calling your IP people to do this? Pulsed electricity or electroporation, coils, cryospray ablation, small airway stents. It's probably pretty straightforward. You've sent patients for certain things and the rest of them, hopefully, at some point you'll be doing it, but not yet. Unless it's for a trial. Okay, we'll go on. So yes, all right. So either we have a really smart group or we have a dumb question maker, I'm not sure. All right, so my last slide. And I have to say, I adapted this from Jerry Kreiner. I really like this slide. At the top here, advanced, so this is kind of applies to our talk, advanced COPD comprehensive care. We want to optimize all these things. We didn't talk about medical therapy. I mean, that's obviously something that has to be optimized. It's not part of our panel today. There's a lot of exciting stuff going on. You've probably heard about a lot of it. So I'll leave it at that. Inpatient, outpatient transition, something I didn't really pay attention before being asked to be on this panel. I thought, that's interesting. I think that's extremely important, so thank you. Pulmonary rehabilitation we'll hear about and of course, oxygen devices and ventilation devices. So beyond this, I keep people start thinking about these patients in two categories, emphysema with hyperinflation and chronic or airflow obstruction, which includes chronic bronchitis. What do we have available? So surgical options, that's great, but it only works for very small subset. Bronchoscopic lung volume reduction can be very, very good, but also very limited. And if those don't work, it's lung transplantation or nothing. These are things that can be done bronchoscopically. So with emphysema and hyperinflation, we have bronchoscopic lung volume reduction. The endobronchial valves, again, are the only ones that are FDA approved. The rest of these, coils, vapor ablation, sealants, small airway stents are being evaluated. On the airflow obstruction side, TOD is being evaluated for chronic bronchitis. It's cryospray, ablation, and pulse electricity or electroporation. And then these small airway stents that maybe take care of both of these. Again, most of these are not FDA approved. The ones in red though, I think are interesting. I think they may lead to something, one or more of these. And I hope that somebody in next year, in the next two years, will be up here talking to you. And I would love to be that person talking about one or more of these in the future. Thank you. We are gonna close and then open for questions. We're gonna discuss bone and rehabilitation in COPD. I'm really excited about this talk because we're talking about innovations in access. I tried to practice how to say Dr. Borbo, last name, got it right. Well, very good. Excellent. Thank you and thanks for inviting me. Sounds like we all have something in common. Jerry Kreiner is a good friend of mine. And I've been given that topic, certainly something that I've been doing now for almost 30 years. I'm gonna get to... Down here. It's there and now you can... Press and it's going up. Good, okay, thank you. And for this topic, I have no disclosure. Then everyone, just... Is that a little bit higher here that I can slide? Sorry. Okay, there, I don't have to. Then what I'd like to do in the next 10, 15 minutes at most, okay, is to review the effectiveness. I think I'm preaching to people who should know about this. It's gonna be very short. But then focus more on telepulmonary rehab. And hopefully being able to give you a take home message. This is what we know. This is the last Cochrane Review, 2015. And we've stopped to do Cochrane Review. In fact, it's rare that you close a Cochrane Review. That one was including over 60 RCT. And it became very clear, okay, from Yves Lacasse who was leading that Cochrane Review as a senior author on this, that when you look at the, you really look at the result, okay, on the, okay, the exercise capacity as measured here by the six meter walking test. And then after when you look at the quality of life and dyspnea, dyspnea measured by the CRQ on the dyspnea scale and the St. George respiratory questionnaire for quality of life, that all of these improvement that you see here as a mean effect, but also as a lower limited, the 95 confidence interval are all not only statistically significant, but above the NCID, minimal clinical importance difference. That I think, okay, from these meta-analysis, if we had a drug here, we would have quite a star in our drug panel that we should be using. And that's another story. And when you look at how does it work, okay, then there's tons of data now showing a primary rehab in COPD has clear proven benefit. And this is done largely through the lower extremity, the ambulation is obviously one of the most important function in terms of our ability or our disability. And it's done through an endurance training that is the component of the exercise training that is the most important. And then you have here, okay, what kind of regime do we need, okay, to bring these people, okay, to a certain level of intensity of training, that you can get the right adaptation because everything is about adaptation and physiology and the physiology of exercise. Then you get, okay, you get an adaptation of the peripheral muscle, okay, where there are major change in the typology of the, okay, of the cell, also, okay, down to the mitochondria and to the capillarity. And that obviously result into an increase in the patient capacity to exercise. And it's been tested, okay, in any kind of patient, okay, and that's why from different reference here, it's been shown to be effective in any disease, severity, sex, ethnicity, or even age. Then again, this is kind of the magical drug, okay, that we, when I'm listening to me, I still don't understand why it's been so difficult, okay, to implement and even in the state to be paid properly for this to be done in many country. And now let's move on into the pulmonary rehab alternative mode of delivery, because this is where we know from relatively traditional delivery in person, either as an outpatient or an inpatient center. And there's been alternative mode of delivery. We are referring here to tele-rehab. Research has started much before COVID, where it's interesting that we're talking about it because we've been through that epidemic, okay, that has been taking us, okay, and locked down our patient and ourself, okay, but what are the evidence of safety and benefit? And lucky we are, we had, okay, this Cochrane Review that came out, in fact, in 21, the lead author on that is Narelle Cox from Australia, and this is a whole study done before COVID. Okay, then it's, those were all RCT. They were included on the following criteria of needed to have an exercise training, at least 50% of the rehab had to be delivered by tele-rehabilitation, and delivered to any of the variety of location, that could be directly into the patient home or an healthcare center that was remote, some of these program could be kind of satellite, okay, to a major, okay, or a central site, could be performing group or individually, physically present or virtually, and could include visual interaction of all sort from video conferring or audible interaction or both between patient and the healthcare professional. This is the result and started from the end of the table, okay, to the right, and we're gonna move to the left of the table. You have the top study, and you have the bottom study. The top study are the study that use a little bit more technology, the bottom study are the study that use the more fundamental technology, which is called the telephone. I know we don't know what a telephone is anymore, only when I might take my cell phone, okay, I'm not too sure what is the main use, okay, it's certainly not being a telephone. But, and then to the right, you can see that they all had in common aerobic exercise, and that would be through different type of cycling or walking and so on. Then in the program, the tele-rehab program could, as you can see on the top one, there was a lot of different video conference, web-based, real-time, plus or minus telephone weekly, where the bottom one were mainly telephone weekly. Okay, when we did our study, like Malte and myself, okay, that's one of the first study that was done at home to publish in 2008. We had the telephone, okay, and we had the PolarWatch to assess for the heart rate. Some of you probably don't even know what the PolarWatch is, okay? And that's from my time, sorry. Then, okay, then you can see that the outcome here that were looked at and the comparison for some of these study were to a control and for other study that it was to the traditional rehab program that were non-inferiority randomized clinical trial. They all give the similar result. It's all, okay, improving, in fact, okay, on the six-minute walk test, that's probably the way that it was measured in terms of the exercise capacity. In most of the study, this now, else related quality of life, some in terms of hospitalization. But of importance here, it is that, okay, the comprehensive face-to-face, there was a comprehensive face-to-face assessment that we still don't have completely, even in the most highly technology, we still don't have a way to prescribe the exercise without having an in-person assessment. It might come, okay, but we still don't have a matrix that we can do from remote that would allow us to prescribe the exercise. And they all have. And that's one thing that we miss a lot in the COVID where in some of these program turn out not to be real rehab program. Although we were calling them rehab, a lot of these program were done at home with resistant training, but not really endurance training that part, which is the most important part from the exercise training. And rehab is also education and so on, but here we're focusing mainly, okay, on the evidence A, which is the exercise training program. And they all had aerobic resistant exercise training that was individually prescribed. Then what can we conclude? Across multiple trial performed in virtual group and individual at home with a large variety of Tilly Rehab delivery platform. And that's you, you have the list here of all these that can be from a different study. Resolve from this concurrent review and update RCT suggests that Tilly Rehab has similar benefit to those of center-based pulmonary rehab across a range of outcome. That's kind of interesting. It's kind of risky also, because at the same time that you, you calculate that from a concurrent review, that may be for us the way to interpret that and say, thanks God, now we have different way of delivering pulmonary rehab. And that is one of the way that could fit for certain patient, but not necessarily for all patient. Where there could be for depending who grabs on that, some insurance payer, name it the way you want to name it, we're going to say, we're okay now, we're going to do Tilly Rehab and everyone. Okay, and that's going to be, and it's coming. I know this is something that has been going and discussed in the state. It's something that has been discussed in some European country also. Okay, then there is a risk into that. And that's what I'm going to show you. What is the risk of all of that? There's been qualitative evidence, benefit value by patient with respect to Tilly Rehab. There's some that I'm mentioning here, with reference to backup, convenience and flexibility, feeling supported by staff and their peer. It is possible to do that remote. The satisfaction with the technology component. Again, that's sometimes it's, people feel that, because the technology is there and somewhere, someone is behind, even remote behind that technology, patient feel that there is always someone that check on them. And no direct report evidence of undesirable effect. What is the problem of all of that? The problem of all of that, when you get these results out, is that we probably have selected the right population. And then when we're coming after to say, I'm going to generalize that now to my entire population, then obviously, maybe we don't know. ETS came just recently and I'll invite everyone to read that guideline. To me, it's a very, very good guideline. It's not because my name is on it, you're going to say I'm not in the first order of the guideline, I've done very little in that guideline. The lead people in that guideline are, they've done a fantastic job, it's been done so well. Just reading that guideline, you're going to understand all the aspect. And obviously, there are a PICO question as we're getting familiar. And that, there is one PICO question on the tele-rehab, where it come with a strong recommendation, moderate quality evidence. The balance of desirable and undesirable effect does not favor one intervention, tele-rehab or center-based, over the other for specific patient population and outcome tested to date. Again, there is a risk about guideline. That I can see the risk here, depending who use these data, that people can decide that if there is no difference, therefore, we can use one or the other. And I'm going to vote for this one and I'm going to go for this one for any patient. We know when we practice tele-rehab, that it's not so simple. There is moderately quality evidence supporting similar improvement exercise capacity as measured by the six-minute walking test and low quality evidence supporting similar improvement in quality of life in this case. Then the recommendation by others. Other guideline, because tele-rehab has only recently emerged as a treatment intervention, no recommendation regarding its use for patient with chronic transplantary disease are usually available in the other guideline. Goal has, in 23, make the recommendation that tele-rehab in the COPD deliver via different model, likely beneficial, safe in patient with stable condition, potential for increased access in low or medium income country. This is certainly not evidence-based because this has not necessarily been done. Okay, and evidence-based still evolving at best practice are not yet established. And when we look at the implementation now, there's some consideration of implementing tele-rehab. There are some feasibility of implementation that we have to consider. One is not known for resource-intensive program. It's not being widely described, such as those requiring specialist equipment, infrastructure, web support, smartphone, that we don't spend a lot of time describing these and the cost of that, what it takes, okay? Might not be suitable for some people. We've already, I've already mentioned that, especially those people who are, maybe it's less common now. Everyone has a tablet, everyone has a phone, everyone has a computer, but we've been through that in COVID and we know that it's been a little bit more complicated than we thought it would be. It need a lot of support in terms of resources that we don't necessarily have. Okay, at least that was our experience in Canada. Some model of remotely supported tele-rehab program may result in lower intensity supervision and exercise training. A robust service of audit. How are we gonna, we know when we take a drug, we have no control, there is a quality control, there is a body called the FDA in the state and so on, that that drug is gonna be what you take. When we do this program and if we change the rule and we get away from what has been evidence-based and show to be really effective, then we may just be sliding slowly, getting away from what is the right treatment and not even realizing it. When do we do audit? When do we evaluate what we're doing? Rarely, we don't have time. Very often, this is not even part of, okay, quality improvement that we call. Then, I'm going backward here, what is it? It's like I'm touching a computer for the first time. Trust me. Okay, just before. No, it's, okay, here. Okay, research needed. This is something that Goal has mentioned in his last report and ATS as well. There's still many questions that remain unanswered. Lack of standardization of delivery platform, no one single best mode. Variation in the test suitable to prescription of exercise and outcome assessment. Variation in timing of intervention. Duration of benefit. Timing mean after exacerbation that has not been assessed. Duration of benefit, unclear what type of patient. The optimal candidate to participate in antiliria. And unknown cost effectiveness. Finally, the take-home message here, and that's coming from ETS and I certainly approve this, is that, importantly, the current body of published evidence support the use of center-based for people with stable COPD is much larger than that for tiliria. And I think that's remain important. Our experience now is much, much more with traditional pulmonary rehab than it is in tiliria. And I think it would be safe to say that we're still learning. Not that we cannot do it, like I have in my institution. I could share my experience with you. Roberto Benzo is here. They're implementing one right now, and I'm sure in this room there are other people. But I think it's safe to say that we are still learning. Suggestion are made that tiliria because there has an alternative pulmonary rehab option. And not as a replacement for center-based pulmonary rehab. Because of the heterogeneity of remote rehabilitation intervention study, there is currently insufficient evidence to determine if one model of tiliria is better than another one. Thank you.

pulmonary rehabilitation

chronic obstructive pulmonary disease

COPD

tele-rehabilitation

exercise capacity

quality of life

dyspnea

endurance training

peripheral muscle function

home-based rehabilitation

COPD

Chronic Obstructive Pulmonary Disease