Additional Info
- Audio Fileuab/ua102.mp3
- DoctorsSolomon, George
- Featured SpeakerGeorge Solomon, MD
- CME SeriesClinical Skill
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=3031
- Guest BioGeorge Martin Solomon, MD specializes in Pulmonary, Allergy & Critical Care Medicine at UAB Medicine.
Learn more about George Martin Solomon, MD
Release Date: April 12, 2019
Expiration Date: April 12, 2022
Disclosure Information:
Dr. Solomon has the following financial relationships with commercial interests:
• Grants/Research Support/Grants Pending - Vertex, Translate Bio, Bayer, Insmed, CFF, NIH, Electromed
• Consulting Fee - Electromed
• Board Membership - Gilead, Vertex
• Payment for Lectures, Including Service on Speakers Bureaus - Insmed
Dr. Solomon does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers have any relevant financial relationships to disclose.
There is no commercial support for this activity. - TranscriptionMelanie Cole, MS (Host): UAB Medcast is an ongoing medical education podcast. The UAB Division on continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA Category 1 credit. To collect credit, please visit uabmedicine.org/medcast and complete the episode’s post-test.
Nontuberculous mycobacterium lung disease is particularly vexing for clinicians to diagnose and treat. My guest today is Dr. George Solomon. He’s an assistant professor in the division of pulmonary allergy and critical care medicine at UAB Medicine. Dr. Solomon, what is the prevalence of nontuberculous mycobacterium lung disease, and what do we know about this disease?
George Solomon, MD (Guest): Yeah, that’s a great question. We don’t know exactly what the prevalence of that illness is. I can tell you that the prevalence and incidence of new cases is certainly on the rise. A lot of that has to do with detection of the illness, awareness of the illness, an increasing aging of our population, but we don’t have a good estimate of prevalence and incidence. It’s not a common disease so it’s not a one in a thousand of the population have this illness, but it’s certainly not so uncommon that it’s considered a significantly rare illness anymore either. I believe that’s because of the shifting demographics of our population. We’re seeing more patients exposed and becoming symptomatic with the illness. So therefore, those numbers are influxed.
Host: One thing I found interesting, Dr. Solomon, is that NTM infection, unlike tuberculosis, don’t require public health reporting. Do you feel this hinders an accurate understanding of the epidemiology or may not be reflective of changes in prevalence?
Dr. Solomon: It’s a great question. The real reason why the infections are not reported as a public health concern the same as other communicable infections, like tuberculous, is really the communicability of the infection. In other words, the rate at which it’s passed from patient to patient. The understanding of the biology of the illness is such that most of the acquisition of the infection is from susceptible people getting it from the environment. Therefore, for it to be a public health reported illness doesn’t make as much sense.
That said, because we don’t catch the data in a standardized fashion, the estimates of incidence prevalence are going to be highly varied as we just discussed. So, part of me says that it’s the right thing to do because there are definitions of what has to be a reportable illness ‘cause of communicability. The other side to me says that if we were to make it a public health reported illness, we may have a better estimate of incidence and prevalence to understand how common it is.
Now soil samples are gathered for the amount of the organism being captured in the soil throughout the state. So, we have an idea of states that high levels of this being in the water supply and in the soil, which is the two common reservoirs for the infection for patients to inquire them. So, we have an idea about that, but as far as the number of new cases, we are going to be limited unless we make it a reportable illness.
Host: Dr. Solomon, you just mentioned soil and water. Where else might the bacteria be found and what are the mechanism of infection? How does NTM infection the body and what are some commonly encountered of NTM pulmonary infections?
Dr. Solomon: Great question. So, let me take the first part of your question first. So, the natural reservoirs that I stated for this infection are basically the environment. Our soil and water and especially the deep south. And, believe it or not, areas like archipelago islands, like Hawaii, have high amounts of these organisms in the soil and water samples. The bugs are a little bit smart in that they can lie in a dormant state, much like fungus can. So, they can live in a dormant state in these environments for a long time, requiring very little nutrients and only become sort of active and replicating when they hit their host, which is in this case humans.
The most common infection that we encounter, most common nontuberculous mycobacterium infection we encounter is called mycobacterium avium. It exists in a complex of several species, which are highly interrelated. Those organisms tend to present with an infection that tends to be an indolent infection. That tends to cause cough, malaise, and low-level fevers or night sweats in the host, the human host. So, the most common presentation of this illness tends to be an indolent illness with some fevers, cough, and the onset, eventually, of increasing pulmonary symptoms like cough and breathlessness as the most common presenting symptoms of this condition. But, because of the slow nature of these infections and their infectivity, we oftentimes see that patients have had symptoms that are suggestive of this for quite some time before they either present for diagnosis or are effectively diagnosed with a condition.
Host: Well then, Dr. Solomon, what are the diagnostic criteria because there are some related disorders were comparisons may be useful for a differential diagnosis, but what would even have a provider think along these lines?
Dr. Solomon: Yep. So, the common circumstances in which this condition is considered tends to be the right demographics or the right host susceptibility. So, let me try to explain what I mean by those two things. These infections tend to present most commonly in elderly patients. So that means patients that are in their sixth or later decades of life. Most commonly, patients infected are in the age range of 65 plus. So, these are patients that are, at present, considered in the senior citizen age bracket. So that age bracket with the symptoms I've outlined is the circumstance in which you should most effectively think this patient may have an NTM type infection.
Now there are other circumstances in which we encounter this very frequently too. Patients that have known structural lung disease. Those include chronic obstructive pulmonary disease, or COPD; known or established bronchiectasis due to any of a number of conditions, cystic fibrosis, primary ciliary dyskinesia. Any of a number of those including immunodeficiency disorders. Those patients are also exquisitely susceptible to picking this up earlier in life. So, if the condition is encountered, if those types of symptoms are encountered in a patient with a known bronchiectasis lung type disease or structural lung disease, it should be considered anywhere early anywhere in their presentation of illness.
If the de novo case, in other words the patient is having these types of symptoms, it’s more common to encounter and more likely to be diagnosed in patients who are older, in their sixth or later decades of life. So those are the two patient populations to which you should think about this condition. Not to say it can't happen sporadically in other age brackets in which there aren’t preexisting conditions that make the patient susceptible, but it’s most commonly encountered in those two patient buckets of groupings of patients.
Host: Then let’s talk about the standard therapies. Since it’s aerosolized and aerobic, what are the standard therapies you would use and what are some of the challenges when deciding on these therapies? Doctor since it can be in water heater or a shower or a spray bottle or even a hot tub, there’s all kinds of places. Is there then a process for checking the area where you suspect it might be present?
Dr. Solomon: That’s a great question. So, let me take the question of standard therapy first, and then I’ll answer your question about how to deal with preventative measures for the condition. So standard therapy for this condition depends upon the particular organism in this bucket of infections we call nontuberculous mycobacterium, or NTM infections, we encounter. We typically encounter most commonly—this would account for the overwhelming majority of cases. Probably 80 to 90% of cases, we encounter two different species.
One is the MAC complex, the mycobacterium avium complex we call MAI infection, most commonly. That accounts in the U.S for about two-thirds or greater or the cases that we encounter. That infection, assuming there aren’t complications arising from the infection like cavitary lung disease or extra pulmonary lung disease-- which we don’t have time to get to in the interview disease-- assuming it’s mild lung disease can be relatively well treated with a prolonged course of three oral antibiotics. Those usually involve, as a standard this is set by the American Thoracic Society in correlation with the IDSA, the Infectious Disease Society of America. Usually those two governing bodies recommend three oral antibiotics, which include a macrolide antibiotic, either clarithromycin or azithromycin, as well as the addition of two other antibiotics which were developed for treating tuberculosis including ethambutol and rifampin or one of its derivatives. Those antibiotics, in general, are effective at treating patients if taken effectively until you reach microbiologic cure, which means successive clear cultures of the organism and improvement of symptoms and radiology. Then the patient continues those on for 12 plus months after clearance. So, if that’s the case, that’s fairly easily treated infection.
Now there are other organisms, the second most commonly encountered organism is one called mycobacterium obsessive complex. It also has several interrelated species which are treated. These require a bit more aggressive therapy. They tend to be more invasive organisms. So, they require an initial period of oral plus intravenous antibiotics followed by a prolong period of oral plus inhalation antibiotics. So just to clarify, intravenous plus oral antibiotics for an initial period followed by inhalational plus oral antibiotics for a prolonged period. Depending on the type of organisms that’s encountered in that complex is exactly which of those are encountered are used and for how long. So that’s a good bit more complicated infection treatment regimen, but it also can be effective, and it’s been shown to be relatively effective and some longitudinal studies which have been conducted. So that sort of answers the outlay of how we treat it. It’s dependent upon what organism and then prolonged treatment to ensure sustained clearance of cultures and symptoms and radiographic appearance.
Now your other question related to is there a way to prevent this infection from either incurring to start with or from recurring once you’ve inquired it. There has been some literature looking at whether or not you should not use hot showers, for instance, because showers are known to aerosolize these infections to people with susceptible lungs. Studies have shown that in fact not using the shower does not prevent the patient from having encounters with this.
There are a couple things that I recommend to patients which are based loosely on the literature which I think are good ideas for patients. This first thing is, if possible, minimize significant soil exposure like significant farming, digging, gardening if it can be removed from the patient’s life without effecting their quality of life. The second is the circumstances in which we encounter a lot of these organisms being encountered in a more epidemic type of level is in patients that visit steam showers or saunas or enclosed hot tubs. So those are the circumstances in which you have a reservoir of water, which is not always changed out and cleaned effectively, and it’s very hot and it’s being aerosolized in a very aggressive fashion to create the circumstance that’s pleasing for people at a spa or resort or whatnot. So, I do tell patients that are susceptible of this or have had this infection before if at all possible, to avoid that circumstance in addition to the gardening or farming soil exposures. Those are not rooted in strong evidence for effectiveness of minimizing recurrence of infection. Really the key to recurrence of infection is to have effective microbiologic cure as outlined earlier and sustaining that with clearance.
The other thing that can help with patients, this has been shown in some studies, is clearing the airways of effected material. So, in addition to treating the infection with antibiotics, mechanical and medical therapies which clear infected mucous throughout the course of treatment and then beyond the course of treatment afterwards so that if infection were to try to reestablish itself, it’s removed quickly by enhanced mucous clearance therapies. Those have been shown to help reduce the re-infectivity rate. So that’s recommended by most practitioners that treat patients with this illness.
Host: What an interesting topic we’re discussing here today. Dr. Solomon, in summary, tell other physicians what’d like them to know about recognizing NTM lung disease and when you feel it’s very important to refer.
Dr. Solomon: Yeah. So, these are my kind of hallmarks for this. If you have a patient in which you expect mycobacterial disease, nontuberculous mycobacterial disease, it’s not one of those things that you're going to just stumble upon the answer that they have it or not. You're going to have to go searching. So, if they have susceptibilities we've outlined earlier or they're having a constellation of symptoms in a patient that you wouldn’t otherwise think is susceptible, you're going to have to get imaging and you're going to have to try to get sputum samples to try to look for this organism.
Now in certain circumstances throughout our state and throughout our country, all of that diagnostic evaluation is challenging to be able to be done in a local office. So, if it can't be done, make the referral even if you don’t know the patient has the illness. Even if you're just suspecting it based on a chest x-ray or a constellation of symptoms and we can assist with the diagnosis and then immediately moving a patient into treatment as we go along. So, I recommend early and often thinking about referral because this can be a very challenging illness to make the diagnosis for. Then the management of treatment for this is not trivial. It requires prolonged antibiotics which have a lot of side effects and require a lot of patient coaching and some knowledge about how to do that. So, I recommend early referral if you're considering this and don’t have a significant amount of experience dealing with the antibiotics or advanced diagnostics.
Host: Thank you so much, Dr. Solomon, for coming on with us today and discussing this really interesting topic that not everybody knows about and where it’s acquired and when it’s important to refer. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You're listening to UAB Medcast. For more information on resources available at UAB Medicine, you can go to uabmedicine.org/physician. That’s uabmedicine.org/physician. This is Melanie Cole. Thanks for tuning in. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua096.mp3
- DoctorsStandaert, David
- Featured SpeakerDavid Standaert, MD, PhD
- CME SeriesMedical Innovations
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5488
- Guest BioDavid Standaert, MD, PhD joined the University of Alabama at Birmingham faculty in July 2006. He serves as Director of the Division of Movement Disorders, Director of the APDA Advanced Center for Parkinson Research at UAB, and Director of the Center for Neurodegeneration and Experimental Therapeutics. He sees patients in a weekly clinic and oversees many clinical trials for new treatments of Parkinson's disease.
Learn more about David Standaert, MD, PhD
Release Date: January 24, 2019
Reissue Date: January 12, 2022
Expiration Date: January 11, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose.
Faculty:
David G. Standaert, MD, PhD
John N. Whitaker Professor and Chair of Neurology
Dr. Standaert has the following financial relationships with ineligible companies:
Grants/Research Support/Grants Pending - NIH, American Parkinson Disease Association, Department of Defense
Consulting Fee - Curium Pharma, Sanofi-Aventis
Royalties - McGraw-Hill (Book royalties)
All relevant financial relationships have been mitigated. Dr. Standaert does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers (Ronan O'Beirne, EdD and Katelyn Hiden), have any relevant financial relationships with ineligible companies to disclose.
There is no commercial support for this activity. - TranscriptionUAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Host): Recent work in Parkinson’s Disease has uncovered important links between activation of the immune system and the progression of Parkinson’s Disease. My guest to tell us about this today, is Dr. David Standaert. He’s the John N. Whitaker Professor and Chair of Neurology at UAB Medicine. Dr. Standaert, let’s start with a little bit of an explanation about why it’s important to understand inflammation and the immune system as it relates to Parkinson’s Disease.
David Standaert, MD, PhD (Guest): Well the role of the immune system in Parkinson’s Disease is really a hot new topic in research. Parkinson’s is a very common disorder. There are over a million people in the United States who are affected by Parkinson’s Disease and although we have treatments that can address the symptoms; there really is no treatment that can slow or alter the course of the disease. And the discovery of the role of the immune system is really opening new doors to thinking about ways of treating or perhaps even preventing Parkinson’s Disease.
Host: Then tell us about some of the latest research on this relationship and how it relates to the start or the progression of Parkinson’s.
Dr. Standaert: It’s actually been known for a long time that the brain shows inflammation in Parkinson’s Disease. This was discovered more than 20 years ago. But it was always assumed that this was a reaction to the disease process. In Parkinson’s there are neurons dying off in the brain, particularly neurons that make a dopamine. And the thinking was that the reason there was inflammation is there were dead cells and the immune system was sort of coming in to clean up the debris. What’s really changed in the last five or seven years is we’ve turned this on its head and started to ask maybe the immune system is actually causing damage. Maybe the immune system is part of the driver that makes Parkinson’s Disease get worse from year to year.
Host: Is it now considered an autoimmune disorder?
Dr. Standaert: I wouldn’t go so far as to say it’s an autoimmune disorder. There are upstream triggers for Parkinson’s Disease. We know some things about the cause of Parkinson’s. There is a genetic element to the disease, in fact, more than 50 different genes have been discovered, each of which contribute a small degree of risk. And there are certain proteins that are known to be involved such as the protein alpha-synuclein. Build up of this protein alpha-synuclein seems to be a core feature of Parkinson’s. It’s found in the Lewy body which is the feature that pathologists look for in the brain to diagnose Parkinson’s. So, there are some upstream drivers. But what we think is going on and I think many in the field have come to recognize is that these upstream causes eventually lead the immune system to engage. Build up of synuclein leads to abnormal forms of synuclein, then that gets recognized by the immune system which starts its attack and really drives the progression of the disease.
Host: So, then let’s talk about your research and the focus on neuroinflammatory mechanisms and the gap that you’ve seen in the research portfolio in centers across the country.
Dr. Standaert: Right, so, this work has really evolved in our laboratory and other laboratories around the world in the last five to seven years. A lot of the early work was done in animal model systems. So, in mouse models you can replicate many of these features. You can produce a mouse model of Parkinson’s Disease by overexpressing alpha-synuclein. This can be done through a variety of genetic techniques or you can actually just directly inject abnormal forms of synuclein into the brain and they seem to trigger off this process of aggregation and propagation. So, these kinds of models have been used to study the role of the immune system.
When you do this in an animal model, you do get a very vigorous immune response and we and others have shown that you can knock out very specific pieces of this, shut down the immune response and prevent the damage to the dopaminergic system in animal models. I think just in the last couple of years; this has started to move into human phase research. So, there has been some very important work done. Some of it out of New York and other places looking at the state of the immune system in patients with Parkinson’s Disease, showing that there’s specific abnormalities of T-cells and monocytes in the blood early in Parkinson’s Disease. And we’ve recently launched a large-scale project with the support of the NIH, funded through what’s called a Udall Center. These are large federal research centers around Parkinson’s Disease and ours is dedicated to really exploring the role of the immune system in patients with Parkinson’s at the earliest stags of the disease.
Host: Dr. Standaert, what type of providers would be needed to collaborate on this type of extensive research?
Dr. Standaert: Well, one of the things about studying Parkinson’s is we see a lot of patients with Parkinson’s here at UAB. We see over 7000 patient visits in the Parkinson’s clinic every year. But one of the things about studying this disease is we are really interested in the very early phases of this condition. We are really interested in reaching and being able to study patients who are at the very earliest stages and those are often ones who are not seen necessarily in our clinic. Many patients with Parkinson’s first present to their primary care provider, maybe a community neurologist and it’s sometimes difficult to get those patients referred in quickly enough that we can actually engage them in research. They tend to be referred much later in the course of the disease, where it’s harder to ask questions about the cause of the disease later in the game.
Host: Doctor, one of the things I found interesting during my research for this segment was the role of inflammation in Parkinson’s Disease as its pretty wide reaching, has led to another very hot topic in the field of this type of research which is specifically the gut of patients with Parkinson’s Disease. Speak about that a little bit.
Dr. Standaert: Right. So, the question becomes what are the drivers? If there is an immune response here in Parkinson’s; where does it begin and what really drives it? And as you mentioned, the gut – the mind-gut connection is now becoming a very important area of research and one of the causes of this may be the fact that some of these antigens, things like alpha-synuclein are found not just in the brain; they are actually found in the nervous system, in the neurons that are in the wall of the gut and in neurons in the peripheral part of the body as well.
And so, the question is whether there could be a bacterial component here. Could there be abnormal bacteria flora that trigger abnormal synuclein and thereby sort of ignite the immune process? What’s the evidence for this? Well, one of the pieces of evidence for this is that constipation is very common in Parkinson’s Disease and in fact, if you ask what is the best predictor that somebody in their 20s and 30s will later develop Parkinson’s; it’s actually constipation. There’s a large study done in Hawaii, the Honolulu Heart Study which looked at this and in men who had constipation, meaning less than one bowel movement a day, 30 years later they have a 12-fold increase risk of Parkinson’s Disease. This is really remarkable but shows that some of the Parkinson’s pathology probably begins outside of the brain. It begins in the bowel, it begins in the gut and it may in fact, be driven by some of the microflora that are present in our GI tract.
Host: Wow. That’s absolutely fascinating. And so, where do you see some of this research going? What do you see are some other uses for all of this information that you are getting, Dr. Standaert, that might be applied to other disease courses or additional work for Parkinson’s?
Dr. Standaert: Well, one of the things we are doing is we are trying to tackle directly this question of what is the state of inflammation in early Parkinson’s Disease. So, our Udall Center here is enrolling patients. We are using advanced imaging techniques like positron emission tomography to look directly at brain inflammation and studying more peripheral markers of inflammation. The idea to understand the state of immune activation early in the disease and could that serve as a target? Could that serve as a readout for an effective therapy of the disorder? If we can shut down the brain inflammation would that provide us a clue in terms of how to move forward with therapy of Parkinson’s. This idea probably can be extended to other degenerative diseases. There’s good evidence for inflammation in Alzheimer’s Disease. There’s a strong component of inflammation in diseases like Lou Gehrig’s Disease or ALS. So, many of these other neurodegenerative diseases may in fact, have an immune component and understanding the immune activation in Parkinson’s may allow us to bring these kinds of therapies forward to other chronic degenerative diseases of the brain as well.
Host: And as you wrap up to give other providers pretty much your best information on the research going on between the role of the immune system and Parkinson’s Disease; tell us a little bit about the NIH funded center and how this could possibly help to slow or stop the advance of Parkinson’s Disease.
Dr. Standaert: Yeah, our new NIH funded center which is called the Alabama Udall Center is really dedicated to this question. As I mentioned, it is going to be enrolling a cohort of patients with Parkinson’s and really studying them very carefully at the early stage of the disease. We also have projects in animal models that are looking at potential therapies. One of them is interfering with the action of a gene called LRRK2 or LRRK2 that’s linked to Parkinson’s. Another is a signaling pathway that’s known to be inflammation for which actually there are drugs already in development for other diseases that we might be able to repurpose for Parkinson’s Disease if we understood more about the signaling pathways. So, the NIH funded center is to really bring these ideas together and to bring the translational investigators and the clinicians together around this question of what are the targets? What are the opportunities for changing the function of the immune system in a way that might slow Parkinson’s Disease?
Host: What an interesting topic. Dr. Standaert, thank you so much for coming on explaining your research and the Udall Center to us and sharing your expertise for other providers. Thank you again. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You’re listening to UAB Med Cast. For more information on resources available at UAB Medicine you can go to www.uabmedicine.org/physician, that’s www.uabmedicine.org/physician. This is Melanie Cole. Thanks so much for listening. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua103.mp3
- DoctorsSolomon, George
- Featured SpeakerGeorge Solomon, MD
- CME SeriesMedical Innovations
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=3025
- Guest BioGeorge Martin Solomon, MD specializes in Pulmonary, Allergy & Critical Care Medicine at UAB Medicine.
Learn more about George Martin Solomon, MD
Release Date: April 12, 2019
Expiration Date: April 12, 2022
Disclosure Information:
Dr. Solomon has the following financial relationships with commercial interests:
• Grants/Research Support/Grants Pending - Vertex, Translate Bio, Bayer, Insmed, CFF, NIH, Electromed
• Consulting Fee - Electromed
• Board Membership - Gilead, Vertex
• Payment for Lectures, Including Service on Speakers Bureaus - Insmed
Dr. Solomon does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers have any relevant financial relationships to disclose.
There is no commercial support for this activity. - TranscriptionUAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Host): Cystic fibrosis therapies have entered a new era of protein based treatments that show promise for significant improvements in health. Here to tell us about that is Dr. George Solomon. He’s an Assistant Professor in the Division of Pulmonary, Allergy and Critical Care Medicine at UAB Medicine. Dr. Solomon, explain a little bit about cystic fibrosis today. Tell us what you know about the disease that you didn’t know say 20 years ago.
George Solomon, MD (Guest): That’s a great question. So, Melanie I will tell you first of all, cystic fibrosis is the reason I got into science and into pulmonary medicine. CF is a condition that results from genetic defects in a gene called the cystic fibrosis transmembrane regulator. And what that gene does is it encodes a protein which makes a channel that inserts itself into the cell surfaces throughout the body and helps to regulate the hydration status of the lungs, sinuses, kidneys, pancreas, GI tract, the entire body basically has this protein being expressed. Defects in this channel due to the gene problem result in a very severe illness that people die from prematurely. Years ago, they died in infancy or in early childhood. Now people tend to die more frequently in the third and fourth decades of life with this illness and it is really due to severe progressive pulmonary disease. Because that’s the organ that tends to be the most affected later in life with this condition.
This condition 20 years ago was in it’s infancy of therapies. The first therapies were developed in the 1990s and they were aimed at treating the mucus problem. The mucus in these patients gets extremely thick in the lungs and sinuses because it has the wrong hydration status and that sets off a cascade of problems including recurrent infections and recurrent mucus obstruction. So, most of the initial therapies were aimed at treating these types of chronic and acute infections and dealing with the consequence of the illness like the fact that they don’t make enough pancreatic enzymes to digest food and dealing with acute and chronic infections and the mucus obstruction.
So, that was the impetus for treatment until really ten years ago. Ten years ago, a landmark happened in treating this condition and a company developed and had approval in 2012 was the initial approval of a drug called ivacaftor and what ivacaftor does is it actually turns on the defective protein caused by certain of the gene mutations which cause cystic fibrosis. The patients that had access to ivacaftor initially were a very small group of patients, only about five percent of the patients afflicted with the illness. But it told us there was a way to treat the illness beyond just treating the downstream consequences. There was – we could take an illness caused by a known defect and treat the direct defect head on with a small molecule that can be taken by mouth. So, a pill that takes about five minutes to take once or twice a day could effectively treat this illness and drastically change the outlook for these patients in terms of their lung capacity and in terms of getting sick as frequently.
So, that’s a huge game changer and it set off a huge cascade that I hope we can talk about today in terms of new therapies for the illness.
Host: Then let’s do that. Let’s talk about that. Tell us more about a triple combination drug that is shown to be effective in improving lung function for patients with cystic fibrosis.
Dr. Solomon: Yeah, so, you’ve picked up on the newest and greatest. Let me give you just a little bit more history lesson so we can get to where we are today. So, after the approval of ivacaftor, initially that was for adult patients with a mutation called G551D. G551D is the mutation – is a notation, a particular type of notation for a genetic mutation that causes the protein the CFTR or that I spoke about protein earlier, causes it not to open and close properly. Now, unfortunately, that’s a very minor amount of the patients. A very minor number of patients have that particular type of mutation.
More of them have a mutation called F508del, in fact, in the north American CF population, there’s about 30 or 40,000 people with CF in the US. Those patients more often have this F508del mutation and it’s a much more severe mutation. It causes the protein not only to not open and close properly, but also to misfold. When proteins misfold, they get told in the cell don’t go to where you are supposed to do. Because it’s a recycling process, right, if you have a protein that’s not working, don’t send it to the right place, most of it gets degraded and recycled to save energy in the cell and to turn over the building blocks of the proteins that can be used for other more effective processes the cell needs.
Well, that leaves the patient with a very severe illness because they’ve got less functioning protein than they need to have. So, after the approval of ivacaftor the same pharmaceutical company that had developed ivacaftor began to screen in a very effective fashion thousands of compounds that might be effective at helping to ameliorate the problem of the protein not folding properly in other words, stabilizing that protein to fold a little bit better, escape the cell’s check point and put it where it needs to and maybe that would be enough to make the protein work. And so that was tested.
In 2014, the first of those drugs called lumacaftor was tested in that process and unfortunately it failed. But someone realized at that time wait a minute, maybe the protein needs to be turned on and maybe ivacaftor could turn the properly folded protein on a little bit better and make it work. And in fact, it did. So, thereafter, in 2015, approval for a combination of therapies called Orkambi is the trade name but it is lumacaftor plus the ivacaftor drug. Those were marketed to treat patients with two copies of the F508del mutation. In other words, both the mother and father had given the patient that mutation. And the patients had similar improvements in lung function as to what was observed with ivacaftor.
So, this told us gosh, we can make a stride in a much bigger patient population with cystic fibrosis, but the problem was that the patients didn’t get quite the same level or degree of benefit that had this mutation as did the patients that got the original ivacaftor drug with those original mutations. So, that set across a pathway to discover new drugs that might better fold the protein and help to stabilize it and allow it to work much better where it’s supposed to in the lungs and sinuses etc.
And so that has led us to our current strategy of addition of a new drug two of which are under investigation right now in phase 3 trials. The addition of those two drugs own to a sister drug called Symdecko which is very similar to Orkambi, but a little bit safer, it has a little bit better side effects and tolerability profile. So, that drug was developed a little bit after Orkambi. The Symdecko drug was and now we’re testing the addition of a third drug onto the combination Symdecko which is a drug called tezacaftor plus ivacaftor. So, a two drug combination is now going to become a third drug combination and we hope will go and seek and have successful FDA approval by the end of this year. And those patients, this has been released in press releases so I can discuss it with you. Those patients have dramatic greater than 10% improvement in the lung function and greater than 40 or 50% reduction in their number of flares and exacerbations of their illness. Not to mention, exceedingly good improvements in quality of life with on this drug. So, this is another game changer type condition.
And with the addition of these drugs, we think that 90% of patients who have cystic fibrosis worldwide, will benefit from this therapy. So, that tell us – if it get FDA approval and subsequent approval throughout the other regulatory bodies in Europe, Australia and New Zealand and other countries; we will have a therapy that’s highly effective for almost all of patients with cystic fibrosis. And the estimates are that these kinds of drugs will extend the life expectancy to the 50s maybe even 60s for most of these patients who 20 or 30 years ago would have been expected to live and die in their teenaged years. So, a significant move forward with these types of treatments.
This type of treatment in general, has been called CFTR modulators. CFTR is the abbreviation for that protein name I discussed earlier. And we have to give a basket of terms called modulators which means they modulate dysfunctional protein. That’s what that means. that’s why they are called CFTR modulators.
Just to outline, the ones that we have been discussing are ivacaftor; it’s called a potentiator because it opens the channel’s potential to be open more frequently. It makes the protein open or exist in an open state more than 50% of the time. The other drugs are called correctors because they correct misfolding of the protein and those are the several that I have outlined for you earlier which have been tested wither in isolation or in an approval state for combination with ivacaftor. So, we now have those two classes of drugs that have been added really not even in the last ten years, the last eight or nine years. Those have come to the forefront and have dramatically changed the outlook for patients with cystic fibrosis.
Host: Just incredible. Such a great description and I know there’s a lot of information we could discuss, but before we wrap up Dr. Solomon, please speak about the challenges present as far as being scrutinized for the costs, affordability and any other factors you’d like to discuss in CF patients such as CF related diabetes and where comorbidities might present a challenge.
Dr. Solomon: Yeah, that is - I believe those types of questions are what’s going to consume the next ten years of research in cystic fibrosis. Besides finding better or more effective therapies than these and what not; dealing with the modulators is challenging. One is they are extremely expensive. To be able to get a drug approved for a rare disease population, this drug is not cheap. It took a lot to develop it and therefore, the costs are being pushed onto patients and drug companies to foot that bill of all that cost to have be recounted and brought back from the development of very expensive drugs. That’s one challenge and as a result, the FDA has been early adopters of these medications.
But the regulatory agencies in Oceania in like Australia and New Zealand they have not approved all these drugs yet. And only more recently did the EMA which is the FDA equivalent for the European Union, did they approve many of these drugs for therapy in patients. So, in other words, regulatory agencies are struggling with the cost benefit analysis of these drugs. We know there’s a long-term benefit, but the costs are exceedingly high. The drugs cost upwards of a few hundred thousand dollars a year. So, that’s going to be an ongoing problem for these drugs moving forward but thankfully, they happen to be highly effective. So, we think that will help to ease the cost benefit analysis and the burden of that.
Now, you brought up other questions about comorbidities of the illness. Conditions like pancreatic endocrine and exocrine insufficiency which are very common presentations in people as they get older with cystic fibrosis especially CF related diabetes which is a condition – we don’t know if it will reverse or not. There are case reports and there are reports by physicians of improvement of control of diabetes when patients are on highly effective modulator therapy. But there’s not yet been a study suggesting that in fact, you can reverse the diabetic consequences these patients have by giving them a modulator because the pancreas is not as reversable in it’s illness. In other words, the destruction to it is more permanent and so whether or not the modulator can help to improve that function or not is an unknown question at this point. We think there is some evidence that it may. But we just don’t know yet at this point.
Now the other circumstance is pancreatic exocrine insufficiency or exocrine function and that’s really the release of digestive enzymes. And I will tell you that some of the trials of more recent modulators including the Symdecko there were studies done embedded into those pivotal trials that suggested that some patients have improvements of some laboratory values that suggest return of some pancreas function. So, we’re very hopeful that if we tune the right modulators to the right patients we may recover and improve some of these comorbidities of the illness. But we don’t know yet.
The final unanswered question is what’s going to happen to people that have chronic infections. We’ve encountered in patients that take ivacaftor that show them clear of very common and chronic infection called pseudomonas aeruginosa, but we don’t yet know if those patients are going to sustain that and if they clear it, if their lung in the new state in which it’s under being treated with the modulator; is it going to cause it to acquire new infections, to have lower or increased susceptibility to acquiring new infections? We just don’t know these answers to those yet and so those are – we are conducting a large number of observational studies of patients on these modulators where they are taking them for prolonged periods of time, three, four, five, six years and longer so we can really get an idea of what the natural history of the illness is going to be in light of taking these drugs long term.
Because long term therapy is not studied in the pivotal trials. Usually they are six months to one year studies. So, we don’t have a long term efficacy and natural history by studying them for FDA approval. But we do have these long term studies which under way or being planned for subsequent drugs we hope will reach approval. So, the answer to your – the long answer to your question is that we are trying to look at all these aspects and we are hopeful, but more studies are going to be necessary to answer those questions.
Host: Then wrap it up for us. What would you like other providers to take away from these incredible studies on cystic fibrosis therapies and when you want them to refer to one of your trials or even for a second opinion?
Dr. Solomon: Sure. So, cystic fibrosis is commonly treated by CF specific providers and we have a large center here at UAB and many other states have one or more centers for cystic fibrosis. There are a couple of reasons why we would love to have referrals to our center from people that may be practicing in the region. One is if you have a difficult diagnosis, okay so if you suspect cystic fibrosis but you don’t know, we have advanced diagnostic techniques here that can be employed that are not available at other centers in the region. It can help us to decide if the patient has the condition and then is there a trial, we can work them into to get them early access to therapy.
So, I think that second of all, I would say that we are a heavy enroller in clinical studies and also are initiating some studies of early access to modulator therapies for that kind of untreated group I discussed, that 10% that are not available at other centers in this region. So, if you have a patient that you think may have cystic fibrosis, you are having trouble making a diagnosis, having trouble treating their known cystic fibrosis or they want access to research for these types of therapies, we need referrals for those patients, and we would open and welcome those and they can be done also at the MIST line as you talked about earlier.
Host: Thank you so much Dr. Solomon for coming on with us today. It’s a very exciting time in this type of research. Thank you for sharing it with us today. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. This is UAB Med Cast. For more information on resources available at UAB Medicine you can go to www.uabmedicine.org/physician, that’s www.uabmedicine.org/physician. I’m Melanie Cole. Thanks so much for tuning in today. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua090.mp3
- DoctorsGunn, Andrew;Ahmed, Ali;Reddy, Sushanth
- Featured SpeakerAndrew Gunn, MD | Sushanth Reddy, MD | Ali Ahmed, MD
- CME SeriesClinical Skill
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5634
- Guest BioAndrew Gunn, MD is a board certified radiologist in Birmingham, Alabama. He is affiliated with University of Alabama Hospital.
Learn more about Andrew Gunn, MD
Sushanth Reddy, MD joined the faculty of the UAB Department of Surgery Division of Surgical Oncology in 2012 as an Assistant Professor. He also serves in the role of Associate Scientist in the Experimental Therapeutics Program at the UAB Comprehensive Cancer Center.
Learn more about Sushanth Reddy, MD
Ali Ahmed, MD is a Gastroenterology Specialist in Birmingham, Alabama. He graduated with honors from State University Of New York At Buffalo School Of Medicine in 2008. Dr. Ali Ahmed affiliates with many hospitals including University Of Alabama Hospital.
Learn more about Ali Ahmed, MD
Release Date: March 13, 2019
Reissue Date: March 31, 2022
Expiration Date: March 30, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose.
Faculty:
Dr. Gunn has the following financial relationships with ineligible companies:
Grants/Research Support/Grants Pending - Penumbra
Consulting Fee/Payment for Development of Educational Presentations/Payment for Lectures, Including Service on Speakers Bureaus - Boston Scientific, Varian Medical Systems
Dr. Ahmed has the following financial relationships with ineligible companies:
Grants/Research Support/Grants Pending - Novo Nordisk Pharmaceuticals, Conmed Corp, Janssen Biotech Inc., Alexion Pharmaceuticals, Pentax Medical, Salix Pharmaceuticals, Gilead Sciences, Bristol Myers Squibb, UCB Inc., Takeda Pharmaceuticals, Olympus America, Novartis Pharmaceuticals, Dova Pharmaceuticals, Covidien, Boston Scientific Corp, Amgen Inc., Abbvie Inc., Cook Medical
Consulting Fee/Payment for Development of Educational Presentations - Cook Medical, Interscope Inc.
Payment for Lectures, Including Service on Speakers Bureaus - Cook Medical
All relevant financial relationships have been mitigated. Drs. Gunn and Ahmed does not intend to discuss the off-label use of a product. Dr. Reddy, nor any other speakers, planners or content reviewers have any relevant financial relationships to disclose.
There is no commercial support for this activity. - TranscriptionUAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Host): Welcome. Our topic today in this panel style discussion is the management of complex pancreatitis. Here to tell us about that are my guests Dr. Andrew Gunn, he’s an interventional radiologist, Dr. Ali Ahmed, he’s an interventional gastroenterologist and Dr. Sushanth Reddy, he’s a hepatobiliary and pancreatic surgeon in surgical oncology and they are all at UAB Medicine. Gentlemen, welcome to the show. Dr. Reddy, I would like to start with you. Explain a little bit about pancreatitis. What is acute pancreatitis and can it become chronic?
Sushanth Reddy, MD (Guest): Thank you Melanie. Acute pancreatitis like all the itis’s is inflammation of the pancreas. The pancreas is a large organ located in the back of the upper portion of the abdomen. Unlike the other itis’s like tonsillitis or appendicitis, pancreatitis doesn’t always involve infection and that can be quite confusing to both doctors and patients alike. Acute pancreatitis is when the organ has been damaged by inflammation, but this is reversable. Several episodes of acute pancreatitis can lead to irreversible damage to the pancreas and this is called chronic pancreatitis.
Melanie: That’s an excellent explanation Dr. Reddy, thank you. And Dr. Ahmed speak a little bit about the etiology of acute pancreatitis and is there a hereditary link?
Ali Ahmed, MD (Guest): There are, well thank you for the question. There are many causes of acute pancreatitis. The main risks in the United States are gallstones and alcohol dependence. But genetic factors can also play a role and we will talk a little bit more about the hereditary pancreatitis a little bit later. Drugs, many medications, a common side effect will include pancreatitis and then sometimes it could be a bite of a scorpion, although rare, that can also cause pancreatitis. Most often that is found on textbooks and test questions.
And then iatrogenic which is when a physician does a procedure such as an ERCP or an endoscopic retrograde cholangiopancreatography which can unfortunately have side effect of causing pancreatitis. Now, regardless of the cause of the injury to the pancreas; the mechanism of injury is the same for all cases. There is a disruption of pancreatic enzyme secretion and that’s going to impede the exocytosis of the zymogen granules. These are the parts of the pancreas in the acinar cells that contain the digestive enzymes and if they get activated; this results in autodigestion and it sounds just as horrible as it is. You start digesting yourself. An acinar injury from autodigestion stimulates an inflammatory response and in some cases; this response can be very severe and result in multiorgan failure, sepsis, severe infection and in rare cases death.
To answer your second question about the hereditary link; there are several genes that have been associated with hereditary pancreatitis and some of the common ones are mutations in the serine protease 1 gene known as PRESS1 and that includes for a cationic trypsinogen and this is probably the most common cause of hereditary pancreatitis. Almost up to 80% of cases. Another gene that is associated is known as the serine protease inhibitor Kazal type 1 or SPINK1 and then cystic fibrosis associated with pancreatitis. Cystic fibrosis has many effects on many areas of the body and it can also cause thickening of the secretions from the pancreas and is associated with hereditary pancreatitis. And just to give you an idea, patients that have hereditary pancreatitis often have chronic pancreatitis in the first or second decade of life while those with the more common alcoholic pancreatitis will be diagnosed in their forties and fifties.
Melanie: Dr. Reddy what are some of the symptoms of acute pancreatitis? What’s the clinical presentation?
Dr. Reddy: I always ask my patients if they have had an episode of acute pancreatitis and many of them look at me and they say I don’t know what that is. If I hear that, I usually tell them, you haven’t had acute pancreatitis. Acute pancreatitis is a very memorable event in most people’s lives. People generally tell me that they have abdominal pain. The pain they can have, it can be quite severe. Traditionally, we talk about that pain being either in the epigastrium or the center of the upper portion of the abdomen or in the right side of the abdomen and some cases it can radiate to the back. A lot of folks also get nausea and vomiting. The onset of acute pancreatitis is typically anywhere from hours to at most about a day or so. Most patients will tell you that they were unable to control the pain at home. They had to come into the emergency department and receive pain medication in order to be able to control the pain. As Dr. Ahmed pointed out, people who have acute pancreatitis can actually go into multisystem organ failure and unfortunately that can happen relatively quickly. IV fluid resuscitation is an absolute necessity in the early management of people with pancreatitis.
Melanie: Dr. Reddy, sticking with you for a minute. How important is the early diagnosis as being crucial to improve the outcome prediction? How is it diagnosed?
Dr. Reddy: I will start Melanie with your second question which is how it is diagnosed. To have a clinical suspicion of pancreatitis is really, really important. Patients are diagnosed with acute pancreatitis if they carry either a classic symptom such as abdominal pain, nausea or vomiting combined with an elevation in biochemical markers specifically serum amylase or lipase and or a radiographic finding. In other words, a CT scan or MRI that shows evidence of pancreatic inflammation.
Early diagnosis is critical in the management of pancreatitis. I tell our students and residents to think of the pancreas as a gigantic sponge in the back of the abdomen. And just like the sponge in your kitchen, the pancreas can soak up so much liquid. The result of that is that patients can become acutely dehydrated very, very quickly. The first step in managing somebody with acute pancreatitis is to resuscitate them with IV fluids as quickly as possible. It’s not unusual to have to give anywhere from five to ten pounds worth of IV fluid within the first twelve hours after someone comes to the emergency room with acute pancreatitis, just to try to keep them hydrated enough to avoid multisystem organ failure. The most important factor when it comes to treating patients with pancreatitis is diagnosis and early fluid resuscitation.
Melanie: Wow, that’s great information Dr. Reddy. So, Dr. Ahmed, what are some of the possible complications from acute pancreatitis? As Dr. Reddy has pointed out, and you mentioned earlier about multisystem organ failure and the need to really hydrate heavily. Speak about some of the other complications that might arise if this is not treated quickly.
Dr. Ahmed: Yes, so the acute pancreatitis can have many complications and they include infection of the pancreas, pancreatic necrosis, and that can lead to the infection and sepsis that we have talked about, that Dr. Reddy mentioned. People can get recurrent attacks of acute pancreatitis so if you think one attack is bad, they can have more attacks, more frequently. They can have chronic pancreatitis where there is actually damage to the pancreas and is not able to perform its function in assisting in management of protein digestion, carbohydrate metabolism and in management and resulting in a lot of complications from that. Patients can get pseudocyst formation where fluid develops outside of the pancreas and that can result in blockage of the digestive tract with resulting nausea, vomiting and inability to eat. They may get bleeding and complications from bleeding and life-threatening bleeding. And the complication is also death. And I would say the other thing is in this new era with concern about pain medications; people may develop chronic pain and then dependence on pain medications.
Melanie: And Dr. Gunn to you now, what are some of the current issues in medical or surgical management? Speak about nutritional or pain meds, antibiotics, surgery. How is the management of complex pancreatitis treated?
Andrew Gunn, MD (Guest): Well I think what we have heard so far is the biggest problem with pancreatitis is the fact that there could be such a diversity of clinical presentations. Patients can present with abdominal pain, in the acute phase, they can present much later in the chronic phase. Patients can present without symptoms of infection. They can present with symptoms of infection. They can present without vascular complications, with vascular complications, without pseudocysts, with pseudocysts and so as far as medical and surgical management; the diversity of options depending on how that patient presents; can pose a problem for a physician who is trying to manage a patient with pancreatitis on their own. And that’s really the important part of having a multidisciplinary approach to pancreatitis because you can really bring in the expertise of a variety of physicians especially the surgical oncologist, or surgeons who could potentially remove part of an infected pancreas or part of a dead pancreas, but especially the combination of having an endoscopist like Dr. Ahmed or a skilled interventional radiologist because when there become infected collections in there, they need to be drained out and whether that’s drained endoscopically where the fluid goes back into the gastrointestinal tract or whether that’s a percutaneous image-guided drain placed by interventional radiology where we drain that fluid outside; those discussions are really best had in a multidisciplinary approach. And so, some of the current research in this area is really looking at what are the best ways to manage this drainage. Is it dual drainage, both endoscopic and interventional radiology, the size of the drains we put in, the size of the stents that we put in, what’s the appropriate timing of that and all of those things are active areas of research which is really exciting time for us at UAB with our pancreatobiliary disease institute.
Dr. Reddy: I would like to add for years surgery was thought to be the primary mainstay for treatment of pancreatitis and what we have learned the last fifteen to twenty years is that surgery probably should be reserved for those patients whom the other interventions that Dr. Gunn mentioned were not effective. And we have moved more toward a minimally invasive approach to treating patients with pancreatitis. The situation where we have to actually remove large portions of dead pancreas is a very rare event nowadays. And that’s a good thing for most of these patients.
Melanie: Dr. Ahmed let’s talk about diet now because I think that this is a big issue with someone who may have recurring flare ups of pancreatitis. What kind of diet is recommended to avoid these flare ups and why are some foods triggers at some point and sometimes they are not.
Dr. Ahmed: Well I think this is an excellent question and it brings straight from my patients to your question. A patient will tell me heh, I ate this last week and I was fine, and I ate it three months ago and I was sick or vice versa and it has almost no rhyme or reason and this speaks to Dr. Gunn’s point we don’t fully understand all the intricacies in the cause of pancreatitis. And that’s why there are a lot of variables that are unanswered. So, we have to sort of look at it in a focused approach and use some of the evidence that’s in the medical literature. So, a couple of things looking at acute pancreatitis and nutrition, we do know that early feeding is better than late feeding especially with the risk of infection that Dr. Reddy talked about. And we have also found that early feeding through the digestive tract is probably better than feeding through the vein or TPN or trans-parenteral nutrition. So, any time we can give enteral or feeding through either a tube going through the mouth, gastro-oral feeding or through the nose a nasogastric feeding, that’s going to be preferred. And studies have also shown that whether that tube gets past the pancreas for jejunal feeding versus in the stomach, it’s probably okay and in some cases if there is a blockage you obviously want to get beyond the blockage. But that addresses sort of nutrition in the early stage.
In terms of a diet for patients, people have studied low fat diet, high fat diet, controlling carbohydrates, protein rich diets and unfortunately, there is no real recommendation. For along time, we thought a low-fat diet would be appropriate for our patients, but recent data seems to show no evidence and the gastroenterologic pancreas work study group has actually recommended a healthy diet. So, we will follow a balanced diet and hope that that will help. And then I think outside of food, we also want to modify reversible risk factors. Tobacco, smoking use as we know increases complications, risk and susceptibility for pancreatitis through mechanisms that aren’t fully understood and then stopping alcohol. So, if those things we can control and have people on a healthy diet, that should help them long-term without giving them specific food recommendations.
Melanie: Dr. Ahmed, I’m sticking with you for a minute because I would like to ask you about vitamins or supplements and the risk for chronic malabsorption as you were mentioning about various tube feeding, what is the issue as far as absorbing the nutrients that they are going to need and what do you recommend as far as vitamins and supplements and even enzymes?
Dr. Ahmed: Yeah, that’s a very good point and I think as people progress to chronic pancreatitis; enzyme supplementation plays an important role and that becomes part of their regimen. And often helps with pain management and symptom control. Patients that have problems with absorption are going to have problems with absorbing vitamins and they are going to have vitamin deficiencies and it will be important for the physician to be looking out for that and sometimes they will have to check for vitamin deficiencies and do supplementation. People have looked at probiotics which is a hot topic but studies have not shown a benefit of probiotics in patients who have either acute or chronic pancreatitis. So, I think we come back to looking at managing pain, giving them enzyme supplementation when they have to, especially those patients that have enzyme insufficiency and then work on giving patients vitamin supplementation when they need it.
Melanie: Dr. Gunn what types of care are involved? Does this require the management of several aspects of care? You mentioned a little bit before the multidisciplinary approach. Speak about that a little bit in more detail.
Dr. Gunn: Yeah, I really do think it requires a multidisciplinary approach because as you can see, there is medical management for pancreatitis, there’s minimally invasive endoscopic management for pancreatitis, there’s minimally invasive percutaneous management for pancreatitis and then at the far end of the spectrum, there’s surgical management for pancreatitis. And so, all of these different specialties have a role to play and just kind of depending on where the patient presents in that spectrum and what their symptoms are; it’s worth a healthy discussion from a group of specialists to be able to decide what’s best for the patient. Here at UAB, we have recently started a pancreatobiliary disease center which involves surgeons, radiation oncologists, medical oncologists, gastroenterologists, interventional radiologists and radiologists and we have actually really seen even in the first few months that we have been doing this, great success in treating patients with very difficult pancreatic necrosis and chronic pancreatitis, being able to transition them away from drains and kind of back into normal lifestyles. So, I would say that a multidisciplinary approach is crucial.
Melanie: Gentlemen, I’m going to give you all each a last word. So, Dr. Reddy I’d like to start with you. Can acute pancreatitis be prevented and where do you see this whole multidisciplinary approach and treatment modalities and where do you see this going in the next five years?
Dr. Reddy: That’s a good question. Can acute pancreatitis be truly prevented? And as Dr. Ahmed pointed out, there are several modifiable things that we can do to try to minimize the risk of acute pancreatitis. The first and most important thing is stopping risks such as smoking or even alcohol abuse. I tell my patients that those that quit drinking will likely decrease their risk of pancreatitis, but it won’t turn to zero. The second most common cause of acute pancreatitis in the United States is gallstone related disease. And for patients who have gallstones; their gallbladder should be removed when it is safe after the acute pancreatitis flare has ceased. That could probably give you your best chance of avoiding another flare of pancreatitis for gallstone related disease.
In terms of things that I’m looking forward to in the next ten years or five years; it really comes down to things that Dr. Gunn has been pointing out this entire conversation. The idea that we can have multiple people working together to each bring their own expertise into a complex disease allows us to stop working in boxes and treat the patient from a true multidisciplinary approach. If I were a patient with a complex disease, I would love to know that I have got four or five doctors working together to try to treat me than having each person come in and give their single opinion and try to do things in a sequential manner instead of in a much more coordinated manner. That’s the thing that I’m looking forward to most is seeing the things that people are going to come up with from interventional radiology, from advanced endoscopy, showing me the different ways we can treat things without having to resort to much more invasive approaches that we have been doing in the last five, ten or fifteen years.
Melanie: Dr. Gunn your take on all of this, because it really is a fascinating interview when I have all three of you that work on different aspects of pancreatitis. So, from your vantage point, what would you like to see happen in the next five years and what would you like other providers to take away from this segment?
Dr. Gunn: Well first, I think what I’d like other providers to take away from this segment is that if you have a patient with pancreatitis and you feel like the support system around you isn’t sufficient to have a true multidisciplinary approach to that pancreatitis patient to feel free to send them over to us and so at least we can evaluate it in our multidisciplinary conference and we can – the patient isn’t necessarily going to stay at UAB; but that patient is going to be evaluated and we can send recommendations back to help physicians that are out in the community along and so that’s always our goal is to help all the patients in this region with this disease process to a more normal and healthy lifestyle.
As far as things that I see happening in the next five or ten years; I really think looking at some of the things that Dr. Ahmed was talking about as far as molecular markers, or genetic markers or some of these modifiable risk factors. If we can improve on some of those things to prevent pancreatitis from happening, I think would be some of the things that would be most advantageous looking forward into the next five years or so.
Melanie: And Dr. Ahmed, to you now. Promising new therapies and as you are an interventional gastroenterologist, where nutrition and all of these therapies are involved; what do you see happening in the next five to ten years and as a summary and a wrap up, tell other physicians what you would like them to know about pancreatitis and when it’s important that they refer.
Dr. Ahmed: Well I think pancreatitis has been around for centuries and in the last 100 years, I think we have had trouble advancing our knowledge of the disease process, partly because what happens in the animal model cannot be replicated in the human model. And part of it is just learning more about it. and like Dr. Gunn and Dr. Reddy have mentioned, I’m very excited about this interdisciplinary approach where we have different guys or different disciplines that work normally separately are now working together to solve complex patient care. Pancreatitis often involves lengthy hospital stay, huge cost to the health system, and a lot of time and by working together; we may become more efficient on how we approach these patients and hopefully result in better outcomes.
Looking forward, I think there are going to be advances in how we look at the pancreas. I mean I think from both the percutaneous approach and the endoscopic approach, there are new devices and tools that will look – will be a camera known as pancreatoscopy where we will be inside of the pancreas duct and have better tools to manage complex lesions within the pancreas that may down the road lead to chronic pancreatitis. So, perhaps we will be able to better identify which patients will develop chronic pancreatitis and maybe we will be able to have molecular or genetic therapies for people with genetic deficiencies to prevent them from progressing from acute to chronic pancreatitis and maybe even reverse their disease process.
For physicians out there, I think it’s very important to understand that these patients may get sick very quickly and as Dr. Reddy pointed out earlier in this talk; he had mentioned how early fluid and volume resuscitation is going to be very important to get patients better and if they are not getting better in a day or two; I think it’s very important to call quickly and get help from an institution that may have more resources because even though surgery is not often used and going forward, people may not be as equipped to handle the surgical procedures; knowing who can will be important and at the end of the road, surgery still remains an option for a small segment of patients.
Melanie: Thank you so much gentlemen for coming on with us today in this panel discussion and sharing your expertise on pancreatitis and letting other providers know the important red flags and the treatment options available and even the important information on prevention and promising new therapies. Thank you again for joining us. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You’re listening to UAB Med Cast. For more information on resources available at UAB Medicine you can go to www.uabmedicine.org/physician, that’s www.uabmedicine.org/physician. This is Melanie Cole. Thanks so much for listening. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua101.mp3
- DoctorsKazamel, Mohamed
- Featured SpeakerMohammed Kazamel, MD
- CME SeriesMedical Innovations
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5584
- Guest BioDr. Mohamed Kazamel is a neurologist in Birmingham, Alabama and is affiliated with University of Alabama at Birmingham Hospital. He received his medical degree from Mansoura University Faculty of Medicine.
Learn more about Mohammed Kazamel, MD
Release Date: March 11, 2019
Reissue Date: February 28, 2022
Expiration Date: February 27, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose
Faculty:
Mohamed Kazamel, MD
Associate Professor in Neurology, Neuromuscular Medicine & Neuropathology
Dr. Kazamel has the following financial relationships with ineligible companies:
Grants/Research Support/Grants Pending - NIH Porphyrias and Rare Disease Consortium
Consulting Fee/Honorarium - Alnylam Pharmaceuticals
All relevant financial relationships have been mitigated. Dr. Kazamel does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers (Ronan O'Beirne, EdD and Katelyn Hiden) have any relevant financial relationships to disclose.
There is no commercial support for this activity. - TranscriptionUAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Host): Today, we are examining the thermoregulatory sweat test and my guest is Dr. Mohammed Kazamel. He’s an Assistant Professor in the Department of Neurology at UAB Medicine. Dr. Kazamel, how might our sweat be one of the earliest manifestations of nervous system disorders?
Mohammed Kazamel, MD (Guest): First of all, thank you Melanie for having me again. So, the sweat function represents an integrated function of the whole nervous system from the central nervous system and specifically the area of the hypothalamus down to the brainstem and then the spinal cord and then the peripheral nerves and then the fine small nerve fibers which are very important in regulating the sweat function of our body. Lack of sweat gives us like an idea about the localization of any problem that happens in the central nervous system including the brain and the spinal cord or the peripheral nervous system including the small and the large nerve fibers.
Host: Then tell us about the thermoregulatory sweat test and how is it an important tool in assessing the entire pathway that controls sweat functions that can help to delineate the diagnosis in a variety of central and peripheral nervous system disorders?
Dr. Kazamel: So, the thermoregulatory sweat test tests the pattern of lack of sweat so what we do in our lab is that we ask patients to come on the morning of the test and they take off most of their clothes and then we dust the whole body with a certain kind of powder called alizarin powder and this powder has a specific quality of changing its color from sandy yellow to deep purple when it gets exposed to water or sweat. What we do after that is that we insert the patient into a closed booth and the temperature and the humidity inside the booth continues to raise slowly to make the patient sweat in a very controlled manner.
Then depending on which areas sweat and which areas do not sweat; we are able to localize where the lesion exactly. For an instance, people who have central neurodegenerative disorders like multiple system atrophy do not sweat at all. While people who have spinal cord lesions, specifically the high spinal cord lesions in the cervical or the upper thoracic spine do not sweat below that level. While people who have peripheral neuropathy, specifically the small fiber neuropathy type, they do not sweat on the most distal parts of their limbs namely the toes. So, this is how our sweat test helps us to localize where the lesion including central and peripheral nervous system disorders.
Host: When would the test be used Dr. Kazamel? What are the diagnostic criteria for administering this test?
Dr. Kazamel: So, we receive referrals for again, central and peripheral autonomic disorders and we receive referrals for people who have problems with number one, lack of sweat plus problems with their cardiac autonomic functions including orthostasis and difficulty of standing upright due to feeling of cerebral hypoperfusion symptoms including dizziness, lightheadedness, headache, tunnel vision, all of that. So, we receive those referrals for those patients having these symptoms, combined symptoms of cardiac autonomic failure and inability to maintain the blood pressure in upright position and also lack of sweat. And we try to evaluate those patients whether they are having a central problem like multiple system atrophy or advanced Parkinson’s disease or a peripheral problem like small fiber neuropathy, specifically diabetic small fiber neuropathy.
Host: What are some of the limitations of this test doctor? Is this a widely adopted protocol?
Dr. Kazamel: It’s not a widely adopted protocol at all. Some of the limitations of this test is it is really not available in every autonomic center in the country. In fact, six or seven autonomic centers in the country currently have this test. Although the test has been known for a long time. The test has historically – has been available in England since the 60s and Mayo Clinic in the 80s brought it into the US. Despite the fact that the test has been known since 80s, or the late 80s to more specific; only seven centers have adopted the test realizing its integrative importance in diagnosing people with – patients with autonomic dysfunction.
Host: Is that because it’s time consuming or requires very specialized equipment, a large clinical space and also speak about limitations in terms of how it can localize specific areas of your sudomotor dysfunction or where it cannot do just that.
Dr. Kazamel: So, first of all, the test is very – it is kind of laborious and it requires like an hour and a half to be conducted. It require preparation from the standpoint of the patient. We ask patients not to take any medications that interfere with their ability to sweat including very common antihistamine over-the-counter medications or allergy medications for an instance. Those have anticholinergic properties and they actually prevent patients from sweating. Also, we require the patient to come to the test in the morning very well hydrated, so they have the ability to sweat profusely if their sweat function is normal. It also, it takes some time to operate the test because some people do not sweat easily so we require them to stay inside the booth for like 50 or sometimes 60 minutes and some patients cannot tolerate that. So, these are the limitations when it comes to the technical aspects of the test.
Having said that, the appropriate preparation of the patient via detailed instructions has helped us here at UAB to avoid multiple of these limitations specifically the medication interference with the results of the test.
Host: Tell us how the results of the test are interpreted and the diagnosis. How is it made and what do those different patterns of sweat or lack of sweat help you to determine? Give us examples of what you might notice.
Dr. Kazamel: So, again, the lack of sweat pattern depends really on where is the lesion in the central or the peripheral nervous system. A patient who has late Parkinson’s disease dementia with Lewy Body or multiple system atrophy will not sweat at all despite appropriate heating and exposure to humidity, even if an hour passes. While patients who have spinal cord problems will not or lesions will not sweat below that level of the spinal cord. We see those cases in patients who have high spinal cord injuries at T6 or mid thoracic level or higher. Also, it happens on ipsilateral contribution, so it tell us also what side of the spinal cord is not functioning. Cases of small - peripheral neuropathy of the small fiber type, these do not sweat on their toes. So, pretty much these are the three localizing categories of – the three common localizing categories of central and peripheral nervous system disorders that we see. Sometimes people have problems with dermatomal lack of sweat distribution due to an active herpes zoster infection. We see those a lot. Some types of diabetic root problems we call them diabetic radiculopathies happen in the abdomen and these are quite painful and gets diagnosed with this test too if the patient is not able to sweat over that particular dermatome distribution on the trunk.
Host: Doctor, before we wrap up, how can this test help to manage and not just diagnose nervous system disorders?
Dr. Kazamel: That’s a very important question. So, we see cases of inflammation and degeneration of the autonomic ganglia called the autoimmune autonomic ganglionopathy. And these cases are very important number one to diagnose and because this is a – in the majority of cases are treatable cases and whenever we treat them with immunomodulatory treatment like IVIG or immunosuppressive treatment like large dose of steroids; this test is helpful in seeing people restoring their autonomic function specifically the sweat functions over time. Over time, what happens in these cases is that the powder starts to change its color over the areas that remained dry before treatment. So, the test is also an important in following up those cases.
Host: Then wrap it up for us, what you would like other providers to know about this test and the fact that it is being done at UAB Medicine and when you think referral if very important.
Dr. Kazamel: So, the thermoregulatory sweat test or the autonomic chamber remains an integrative test that helps us with other autonomic function testing that we have here in the lab to comprehensively evaluate patients with dysautonomia’s. Two categories of referral could benefit from this test. First the central autonomic dysfunction cases including late Parkinson’s disease patients who have typically hypotension and lack of sweat. Also, cases with dementia of Lewy Body and multiple system atrophy. The other category is the peripheral category of cases of small fiber neuropathy. This test and specific is the most sensitive test available with a sensitivity of 92% even more than the skin punch biopsy. So, cases of diabetic small fiber neuropathy or idiopathic small fiber neuropathy will benefit also from this test. So, these are the two categories of referral that I think we are able to help here using that test in our comprehensive UAB autonomic function testing laboratory.
Host: Thank you so much Dr. Kazamel for joining us today and telling us about this highly specialized test for nervous system disorders. Thank you again. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You’re listening to UAB Med Cast. For more information on resources available at UAB Medicine you can go to www.uabmedicine.org/physician, that’s www.uabmedicine.org/physician. This is Melanie Cole. Thanks so much for tuning in. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua099.mp3
- DoctorsLin, Chen
- Featured SpeakerChen Lin, MD
- CME SeriesClinical Skill
- Post Test URLhttp://cmecourses.som.uab.edu/mod/quiz/view.php?id=5553
- Guest BioChen Lin, MD is a neurologist in Birmingham, Alabama. He is currently licensed to practice medicine in Alabama, Illinois, and North Carolina. He is affiliated with UAB Hospital.
Learn more about Chen Lin, MD
Release Date: March 4, 2019
Reissue Date: February 14, 2022
Expiration Date: February 13, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose
Faculty:
Chen Lin, MD
Assistant Professor, Brain Injury and Stroke Rehabilitation
Dr. Lin has no relevant financial relationships with ineligible companies to disclose. There is no commercial support for this activity. - TranscriptionMelanie Cole (Host): UAB Medcast is an ongoing medical education podcast. The UAB Division of Continuing education designates that each episode of this enduring material is worth a maximum of 0.25 AMA PRA Category 1 credit. To collect credit, please visit uabmedicine.org/medcast and complete the episode’s posttest.
Approximately 800,000 patients experience a stroke in the US with Alabama having one of the highest rates in the country. Here to tell us about that is Dr. Chen Lin. He’s an Assistant Professor in the Department of Neurology and the Director of the Stroke Recovery Clinic at UAB Medicine. Dr. Lin, tell us about the current state of stroke care today. What’s the prevalence, the societal and global impact of stroke and what is different now about what we know about this disease?
Dr. Chen Lin (Guest): Hi Melanie, thank you for inviting me to talk with you about this very important topic. Stroke is the leading cause of disability in the world. As you mentioned, approximately 800,000 patients a year experience a stroke in the US and there’s 7,000,000 people in the US that live with stroke on a daily basis. Now here in Alabama we have one of the highest rates of stroke and we have the worst stroke mortality rate in the country. Despite all of that, only 30% of stroke survivors receive any outpatient stroke rehabilitation which results in less than optimal recovery. A lot of focus in current stroke treatment is on acute therapy, so getting the patient to the hospital as quick as possible to receive medication or surgical procedures but more and more focus is now on the outpatient side as well and transitions of care.
Host: Dr. Lin, as we’re going to talk about rehabilitation, which can result in this suboptimal recovery and the fact that they’re not getting it – I want to go back to something you said, why do you think that Alabama has such a high mortality, is it because of the rural areas or because awareness of the symptoms, and the acronym FAST and just not getting to the emergency room in time? What do you think are some of those reasons?
Dr. Lin: I think you’ve mentioned two very important factors. There’s a lot of territory in Alabama and it’s something that we face in the entire country really where there’s a shortage of neurologists and a shortage of comprehensive stroke centers and so Alabama has the University of Alabama Birmingham, which is the only comprehensive stroke center in the state, but also one of the reasons for the high mortality rate is genetics as well. So we often think of stroke as both an environmental factor and a genetic factor. So there’s things that we do that we can control and there’s things that we do that we can’t control. So unfortunately, some people do have bad genetics and there is a whole segment of the research world in stroke that is focusing on the genetics of stroke as well.
Host: Tell us about some of the latest advances going on in the treatment of stroke, including anything new that you can discuss with TPA or mechanical thrombectomy with tPA, what do you want to tell us?
Dr. Lin: So there’s a lot of great research going on and really the advent of tPA or IV alteplase in the last two decades has really transformed acute stroke care and so we’re able to – before whereas we were just watching people come in with stroke and weren’t able to do anything about it, well now with both tPA, alteplase, and mechanical thrombectomy, we have a high chance of making these people better. We’re able to change the way that people recovery from stroke just based on their acute intervention, but not just that, the fact that we have to educate patients, educate our own healthcare system, has been transforming how we get people from the community into our hospitals to deliver this care and beyond that care, in the hospital setting itself, we know that people in hospitals that have dedicated stroke units with dedicated nursing care, dedicated therapists, dedicated neurologists who all work together to provide stroke patients with the optimal evidence based research and care, we’re able to improve their outcomes and decrease mortality rates and in the long term we have to think about how we can stop people from having recurrent strokes, so more and more data is also coming out on the correct medications and the correct tests to do to find out why people are having strokes and what we could do to prevent recurrent strokes and what I’m interested in the most is in stroke recovery and rehabilitation. So prior to a lot of the acute care, that was where a lot of the focus and recovery research was focusing on therapy and how much therapy and the intensity of therapy. Unfortunately, we don’t have the correct dose, we don’t know the right dose to give in therapy, but we do know that early therapy can be beneficial in select populations. So we’re starting to see studies and trials that are focusing on patients not after years of stroke but soon after the stroke, several weeks, several months and so I think that is where one major factor will come into play in the next few years where we’ll learn about what we can do besides this therapy and develop new pharmaceuticals and new device interventions that we can implement in the subacute setting, or as I define that, after a few weeks of their stroke.
Host: Tell us a little bit about the Stroke Recovery Clinic at UAB and it’s one of only a handful of similar clinics across the whole country. Tell us a little bit about it.
Dr. Lin: Thank you for asking about the Stroke Recovery Clinic. We hope to improve some of the serious concerns regarding stroke and it’s high incidence and prevalence of disability across the southeast and particularly in Alabama. So the Stroke Recovery Clinic is a multidisciplinary clinic with the mission of improving the continuum of care for patients with stroke. We’ll be able to evaluate the stroke cause, evaluate how to best prevent future stroke, and determine patient rehabilitation needs all in one multidisciplinary clinic. Patients will have the opportunity to see multiple different providers including a neurologist, physiatrist, and therapist, all of whom are experienced providers in stroke care. During the clinic visit, we can tailor the services needed depending on the individual’s needs. This allows patients one convenient opportunity to be evaluated by multiple important services all in one appointment. You had mentioned the Stroke Recovery Clinic is one of only a handful of clinics across the country that are able to offer multidisciplinary care in the outpatient setting for stroke patients and it’s one of its only types like this in the southeast and in Alabama. In addition, our clinics will be focused on improving quality of care and outcomes after stroke. We’ll have unique opportunities for patients to participate in new research studies exclusive to UAB for stroke rehabilitation recovery in addition to some national clinical trials coming down the pipeline. The clinic will be hosted at the Outpatient Clinic at Spain Rehabilitation Center at UAB and it’ll occur every 4th Thursday of the month.
Host: Can you share with us how the timing and intensity of rehab affects recovery? Do you have some predictors of treatment response and some insights into why recovery plateaus after several months? What might be done to prevent this from occurring?
Dr. Lin: That’s a great question. So every study has proven that rehabilitation is beneficial for stroke patients. Now what we don’t know is the correct timing and the dose of rehabilitation that would benefit each patient from stroke early on in their course and so while there is early therapy after stroke during hospitalization, early and intensive therapy has not been shown to be beneficial. In fact, it could potentially cause more harm in patients. But that being said, early therapy is still something we still try to strive for in at least the acute hospital setting. Now that shouldn’t stop in the acute hospital setting. That’s something that we want to encourage in the Stroke Recovery Clinic because we see patients in clinic that are recently hospitalized. So within a week, a few weeks after their hospital stay and I think that is where we should continue to encourage and motivate patients to participate in therapy, get therapy, exercise, especially since you’re an exercise physiologist, you should – you know the importance of exercise here. So this is a continual lifelong process and that is the same considered for stroke recovery and wide plateaus. So natural recovery does slow down roughly between 6 months to a year after stroke, but we believe that stroke rehabilitation and recovery is a lifelong process. So even though the improvements after this one year are not known to be as large, people do get better. In fact, most stroke rehab and recovery trials in the past have focused on after a year, but that being said, more trials are looking at within a few weeks to several months, particularly in this outpatient period of time, and so I think the community has started to focus on the fact that we can intervene and change this plateau, and so often times it does take the effort of the patient, the family, and friends to help at this point to remain motivated. Sometimes there needs to be extra motivation, which is where our clinic can help and I think that’s why research opportunities in stroke recovery and rehab are so helpful because they provide additional resources and opportunities to improve. In fact, we have a study here with students here at UAB looking at how to improve motivation in stroke rehab and recovery. Again, while we do know of this traditional plateau, we do believe now that this is modifiable.
Host: Dr. Lin, one thing I found interesting in my research, was that with this recognition, that stroke units, thrombolytic therapy, enhanced rehab can improve patient care and outcomes as you said and hopefully reduce that plateau that might happen after 6 months, does this afford you the opportunity to focus on aspects of stroke care with stroke survivors and their families, their caregivers, to help with those transition across care environments whether its in the rehab setting, in the hospital, at home, tell us a little bit about that?
Dr. Lin: I think you’re absolutely correct in that the transitions of care has been becoming more and more important and a major aspect of the transitions are caregivers and so right now with the Stroke Recovery Clinic, we’re going to be working with the caregivers in determining their needs as well as the patients because we know that with the longitudinal care patients, the primary caregiver, their family or friend, are going to be very important in participation of the primary patient’s care because they often have disabilities that wouldn’t allow them to do certain activities and those are the people that are going to be able to help them and so when therapists work with patients, they’re also working with families and so when we’re in this clinic, we’re going to be able to work with the families, talk with the families, and get a sense of what their needs are, and as you had mentioned with the stroke unit in the hospital, well there’s not a model that is consistent across outpatient care, and so that’s something that we’re trying to develop in this recovery clinic, which is develop this unit of care, and so your family is as important as our therapist, our providers are as important as people you see in the community, and so we’re going to be there to help motivate the patient into participating in their recovery as much as they can. Most of our patients are very motivated, that’s why they’re in the clinic in the first place. So talking with you, getting the word out into the community, that this is a resource available I think is also a part of the educational component to allow more people and understanding that there are things we can do after stroke and even before stroke, so there’s lots of things that are done in the stroke world that people need to know about.
Host: Couldn’t agree with you more. So wrap it up for us Dr. Lin, what would you like other providers to know about the stroke recovery model that you’re using there at the stroke recovery clinic at UAB Medicine and when you feel it’s important that they refer?
Dr. Lin: So this Stroke Recovery Clinic is a new endeavor for our UAB community and there aren’t many models in strokes like this. So that leaves us a great opportunity that we get to create our own. All clinic patients will have an opportunity to participate in a dedicated recovery registry where we get to look at several stroke specific outcomes including quality of life and the caregiver concerns. We’ll also be able to identify new studies when they’re available and which patients to participate in the new stroke rehab and recovery studies. Now these are just some of the ways that will be different from a routine clinic and I think for referrals and other providers, understanding that stroke is a transition of care, longitudinal care, it’s not just about what we do in the hospital; it’s about what happens in the clinic setting and there’s lots of other things that we can be looking at including ways to prevent future strokes, what tests we’re doing to look at those stroke etiologies and then all the therapy components, all the research components added on, so at any point after a patient is discharged from the acute hospital, or their inpatient rehab, there’s an opportunity that they would benefit from the stroke recovery clinic. The fact that we have stroke neurologists, we have physiatrists, we have multiple therapists, we have neuropsychologists, social works, all in our clinic means that there’s going to be a chance that the stroke patient would benefit from at least two of our services.
Host: It is such a comprehensive program and Dr. Lin, thank you so much for coming on and for explaining the stroke recovery model and what other providers can take away from that and use and why they should be looking to UAB for that model. Thank you again for joining us. A community physician can refer a patient o UAB Medicine by calling the MIST line at 1-800-UAB-MIST, that’s 1-800-822-6478. You’re listening to UAB Medcast. For more information on resources available at UAB Medicine, you can go to uabmedicine.org/physician, that’s uabmedicine.org/physician. This is Melanie Cole, thanks so much for tuning in. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua098.mp3
- DoctorsBatra, Hitesh
- Featured SpeakerHitesh Batra, MD
- CME SeriesClinical Skill
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5494
- Guest BioHitesh Batra, MD currently serves as the director of the Interventional Pulmonology and Pleural Disease Program at UAB. He has completed an advanced fellowship in Interventional Pulmonology at Johns Hopkins University School of Medicine. Dr. Batra also holds a degree of Master of Business administration from the Collat School of Business of the University of Alabama at Birmingham.
Learn more about Hitesh Batra, MD
Release Date: February 11, 2019
Reissue Date: January 13, 2022
Expiration Date: January 12, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose
Faculty:
Hitesh Batra, MD, MBA
Director, Interventional Pulmonology and Pleural Disease Program
Dr. Batra has no relevant financial relationships with ineligible companies to disclose.
There is no commercial support for this activity. - TranscriptionMelanie Cole (Host): Today we're talking about the diagnosis and management of patients with central airway obstruction. Here to tell us about that is Dr. Hitesh Batra. He's an Assistant Professor of Medicine and the Director of Interventional Pulmonology and Pleural Disease Program in the Division of Pulmonary Allergy and Critical Care Medicine at UAB Medicine. Dr. Batra, explain a little bit about central airway obstruction, and who develops obstruction of the central airway. What is the prevalence of this?
Dr. Hitesh Batra, MD (Guest): Central airway obstruction has a wide range of causes, but the most common is lung cancer. Up to 30% of patients with lung cancer will develop some degree of central airway obstruction.
Host: What causes should be considered other than that when acute upper airway obstruction is suspected?
Dr. Batra: Right, so a lot of other conditions that are not related to cancer can also lead to central airway obstruction. Foreign body aspiration can lead to that, conditions that are benign, and I would say 'benign' with quotes because we actually prefer the word 'non-malignant' because these conditions are rarely benign because they could have serious effects on the patient and can sometimes be life-threatening. So those conditions would be- patients with lung transplant will have sometimes have airway complications. Tracheal stenosis because of trauma to the trachea, not uncommonly because of intubation. Idiopathic tracheal stenosis is another cause. A condition such as Wegener’s granulomatosis or what's called granulomatosis with polyangiitis can lead to tracheal stenosis. Those are some of the common non-malignant causes of central airway obstruction.
Host: Then speak about the imaging studies that would be helpful in making or excluding the diagnosis of acute airway obstruction, and are there other disease, Dr. Batra, that can mimic this same condition?
Dr. Batra: So when a patient presents with shortness of breath and airway obstruction is suspected, often the first test that is done is a chest x-ray, but chest x-ray can often be normal or can underestimate the degree of obstruction. So often when malignant or non-malignant airway obstruction is suspected, a CT scan of the chest is the best way test to evaluate the degree of obstruction and to really see what's going on the in airways. Your other question was can something mimic this? Yes, some pathologies of the airway such as severe asthma can sometimes behave like that, and there are some other conditions that are not necessarily mechanical obstruction, such as tracheobronchomalacia, which is collapse of the airway, particularly during expiration, which can look like mechanical central airway obstruction.
Host: So with the growth of sub-specialties, such as interventional pulmonology, have you seen more attention and research directed towards treating patients with complex airway pathology that could result in, as you said, from malignant or benign disease?
Dr. Batra: One thing we have seen, there definitely has been a rise in the prevalence of central airway obstruction and incidents of central airway obstruction over the past few decades, particularly because of the increase in the incidents of lung cancer. Now as that has been growing, there has been more attention to that, and there has been a rise of interventional nausea is a field over the past two or three decades and having more interventional pulmonology fellowships and laryngology fellowships, which is a sub-specialty of ENT. I do think that more and more centers are coming up with complex airway programs, where there's a collaborative and integrated approach to central airway obstruction where physicians from interventional pulmonology, ENT, and thoracic surgery get together to manage these patients, which can often be challenging. The number of complex airway programs in the country are very few though still, so definitely that is increasing and that recognition is increasing. At UAB, we do have a complex airway conference that we do every week or so to discuss these cases and come up with the best collaborative approach to manage these conditions. As for research, we do not see yet a significant increase in research that is going on towards these conditions. And part of that is I think the first step would be to make robust complex airway programs that deal with the condition using the existing knowledge that we have, and having that recognition that if you are at a center and you deal with a patient who has central airway obstruction, the best management for that patient might be referral to a center that has the expertise to deal with that.
Host: How do you determine the type of therapeutic modality to select? Speak about some of the parameters for your decision, and tell us about some of the latest therapeutic and diagnostic tools that are now available and that you're using there at UAB Medicine.
Dr. Batra: Right. So speaking of how do we decide first, the biggest thing that helps with the decision making is what are the symptoms that the patients are having? Now we should recognize the symptoms, because central airway obstruction happen very late in disease. A normal trachea, for example, is anywhere from sixteen to twenty millimeters in diameter. Patients do not develop dyspnea exertion until the trachea is about less than eight millimeters or so, and dyspnea at rest occurs at less than five millimeters. So by the time patients develop symptoms, often the disease is already severe. As far as deciding whether to intervene or not, one thing we need to have is the patient should have symptoms because of the problem. But two, it also depends on the location. Now with the available modalities that we have to handle airway obstruction, we can do very well with obstruction of the trachea, [Inaudible 00:07:08] bronchi, and then bronchus intermedius. But obstruction in distal bronchi is very challenging to deal with or treat.
As far as modalities that we use, there are a lot of ways we can deal with central airway obstruction, and that just comes down to what the etiology of the obstruction is. Often we do mechanical debulking of the tumor or whatever is causing the obstruction by either using a rigid bronchoscope or rigid forceps or microdebrider. While I'm speaking of that, I do think that most central airway obstruction should be managed with rigid bronchoscopy. There are some things, certain foreign bodies and certain obstructions that could be effectively managed with flexible bronchoscopy, but you have a secure airway, and to keep the procedure safe it is best to have rigid bronchoscopy either as the primary modality or have it available as a backup if needed. So these things should be treated at a center with the expertise in doing so.
In terms of the site mechanical methods of tumor debulking, there are several other modalities that we have to treat the obstruction or tumor that might be obstructing the airway such as laser or [Inaudible 00:08:28], and what to use when really depends upon what's the obstruction, where it is, and what all it is involving. We do have all of those modalities available at UAB.
Host: And as we wrap up, Dr. Batra, you mentioned your collaboration with other providers in this department. Please give us your summary of what you would like other providers to take away from this segment on central airway obstruction, your cross-collaboration with other providers, and when to refer to the specialists at UAB Medicine.
Dr. Batra: First and foremost, I would say is that it's really important to recognize that central airway obstruction can be treated, and to recognize that it should be treated urgently. Because it could be, for example, if a patient has lobar collapse or a whole lung collapse because of central airway obstruction, if we do not treat it beyond four to six weeks- treating it beyond that time can have minimum benefit or no benefit at all. So that's first and foremost. Second thing I would say is the treatment of most of the central airway obstructions should happen at a center that has expertise in treating this and has the ability to do rigid bronchoscopy and to use all those modalities that I just mentioned. And finally, like we've discussed, the collaborative approach is really essentially, particularly for the obstruction of the trachea where collaboration with laryngologists and thoracic surgeons is essential to have the best outcomes and best approach to these diseases. So for any physician out in the community, if you are practicing at a center that does not have the resources available that we just discussed or the expertise in treating central airway obstruction frequently, then I would suggest referring those physicians to a center that does, and UAB is one of them.
Host: Thank you so much, Dr. Batra, for joining us today, and sharing your expertise in this very interesting topic. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1(800) UAB-MIST. That's 1(800) 822-6478. You're listening to UAB MedCast. For more information on resources available at UAB Medicine, you can go to www.UABMedicine.org/physician. That's www.UABMedicine.org/physician. This is Melanie Cole, thanks so much for tuning in today. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua094.mp3
- DoctorsDavies, James Jr
- Featured SpeakerJames Davies, Jr., MD
- CME SeriesClinical Skill
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5509
- Guest BioJames Davies, Jr., MD has an active clinical practice with a specific interest in cardiac valvular disease. He serves as director of the Division of Cardiothoracic Surgery and holds the John W. Kirklin Endowed Chair of Cardiothoracic Surgery.
Learn more about James Davies, Jr., MD
Release Date: January 8, 2019
Reissue Date: January 24, 2022
Expiration Date: January 23, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose.
Faculty:
James E. Davies, Jr., MD
Division Director, Cardiothoracic Surgery; John W. Kirklin Chair of Cardiovascular Surgery
Dr. Davies has the following financial relationships with ineligible companies:
Consultant – Edwards Lifesciences
All relevant financial relationships have been mitigated. Dr. Davies does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers (Ronan O'Beirne, EdD and Katelyn Hiden), have any relevant financial relationships with ineligible companies to disclose.
There is no commercial support for this activity. - TranscriptionUAB Med Cast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA category 1 credit. To collect credit please visit www.uabmedicine.org/medcast and complete the episode’s posttest.
Melanie Cole (Melanie): Welcome. Our topic today is the INSPIRIS Valve and my guest to tell us about this is Dr. James Davies. He’s a Professor and the Director in the Division of Cardiothoracic Surgery at UAB Medicine. Dr. Davies explain a little bit about aortic valve disease and what are the hallmarks of it? Tell us a little bit also about the evolution of valve replacement and what’s different now.
James Davies, Jr., MD (Guest): So, the aortic valve is the last valve in the heart. There are four overall valves in the heart and the aortic valve is the last one before the blood ejects into the body. From aortic valve disease you can have either aortic valve stenosis or aortic valve insufficiency. Aortic valve stenosis is where the valve becomes either calcified or hardened and it doesn’t open properly. Aortic valve insufficiency is where the valve leaks. It can be either floppy and it leaks back or blood leaks back into the heart; so, either way, the valve is not functioning appropriately and they both put stress on the heart.
When you look at the hallmarks of the disease, especially aortic stenosis; without some type of surgical repair; uniformly this can be fatal. Even the data going back all the way into the 1960s, it still seems to be true today, is that without repair of severe aortic stenosis, the life expectancy can be as low as 50% at two years. Therefore, the hallmark has been aortic valve replacement.
Traditionally it is open surgical replacement done on cardiopulmonary bypass where we stop the heart and then replace the valve. More recently, we have also been doing some replacements where we do it through the groin where we actually do a transcatheter technique without stopping the heart, without opening the chest and we can replace the valve this way without ever completely stopping the heart and we are actually doing some of these procedures with patients where we can do them awake and they are not even fully put to sleep with anesthesia.
Melanie: Doctor what have been the typical valve choices when you are looking at surgical aortic valve options and you are discussing these with the patient, whether it is tissue valves or mechanical valves? What is it you have been telling them and then we are going to talk about the INSPIRUS.
Dr. Davies: So, the traditional valve choices are dividing into two main categories. One is a mechanical valve that’s made up of pyrolytic carbon material that functions as a mechanical type leaflet and one is a tissue-type valve. The mechanical leaflets can last usually almost indefinitely, but a blood thinner Coumadin has to be used for these patients. But those valves from a durability standpoint, will last indefinitely. The tissue type valves can be one of several different. They can either be porcine or pig, bovine or cow type valves. There are actually equine, or horse valves and human valves have been used. These valves have the benefit of normally not needing Coumadin or blood thinner and can be used with a less potent aspirin or aspirin and Plavix for these patients. But, depending on the age of the patients, these valves will wear out over time, just due to long-term wear and tear.
Melanie: So, then tell us about the INSPIRUS valve and how it’s a game changer for future transcatheter valve replacement and why do they call it resilient heart valves?
Dr. Davies: So, the INSPIRUS valve is a new valve that has been on the market now and has been FDA approved for about a year from the Edwards Lifesciences Corporation. Edwards is probably the main valve company for tissue valves in the setting of cardiac surgery. It’s a new valve that still uses an old platform that we have with a PERIMOUNT or the Magna Ease platform that they have that is a bovine pericardial valve but the new INSPIRUS valve has a couple of different techniques that really make it a – what we feel is a changer for long-term durability and for redo therapies in the future.
One is the Resilia treatment technique that the company has. It appears that hopefully it will make the valves last longer and less prone to deterioration. They are stating that some of these valves will last in the 15-18-year range. The data is not 100% for that because we don’t have patients out that long-term, but it appears very, very good in the early stages. We think these valves will last longer.
And the second is that the technique in the way they designed it and especially the sewing ring and the structure in the base of the valve is designed specifically to allow transcatheter aortic valve re-replacement in the future in a way that will be suitable to maximize the largest valve that can be put in at the next phase.
Melanie: That’s fascinating, and we are going to get into the valve in valve, the future prospects, but who would be the best candidates since this – since you discussed the lifetime of this particular valve. Who is the best candidate and why?
Dr. Davies: So, I think any patient in general, that has aortic stenosis or aortic insufficiency is a good candidate for the tissue-type valve. I always tell my patients that it’s a personal choice between a tissue and a mechanical valve with a lifestyle of using Coumadin versus not using Coumadin. Approximately 80-90% of all aortic valves in the country are currently tissue-type valves and so therefore, finding a tissue valve that will one, last longer and be a better option for transcatheter valve-in-valve technique in the future is the best thing we can find. So, specifically, probably optimal candidates are the younger patients, the patients that we know that are most likely going to need more than one procedure. We are trying to get them the longest time we can for the initial valve and then we are trying to make the option for the second valve be the easiest that we can to optimize the best valve we can put in the second time. So, any younger patient and by the definition of younger, I guess I would mean anywhere below 50, possibly at least below 60 years of age, but definitely patients below 50 years of age would be ideal for this type of procedure.
Melanie: So, then tell us why and how it makes it easier down the line for future percutaneous valve replacements. So, what does that mean for the patient if they are going to have to have a valve replaced in the future, that doesn’t require any open surgery, it now makes it easier, yes? Explain that a little bit for us.
Dr. Davies: So, the valves themselves like I said, will deteriorate. They become calcified and the end up having wear and tear and they will develop either recurrent aortic insufficiency or recurrent stenosis, so we have to be prepared to either one traditionally, do a redo surgery to re-replace the valve again. This puts the patient through a recurrent sternotomy or an open procedure on cardiopulmonary bypass. So, more recently in the last few years, with the advent of the transcatheter techniques; we are doing more of these by replacing these valves through the groin or to have them so that they don’t have to have recurrent open surgery on cardiopulmonary bypass. So, this allows them to have a much more minimally invasive or a less invasive technique that they can recover from quickly to have their second surgery. The Resilia valve makes this even better because the sewing ring is designed in a way that is not a complete ring initially. It’s somewhat of a partial ring that has overlap. So, when you go to replace a transcatheter valve inside this, you can actually expand the valve to expand this ring, this sewing type ring to maximize the largest sized valve that you can put in at the next stage. It’s very important because the larger the valve, the better the overall flow mechanics and the better the pressure change is for the patient so the less problems they will have with this valve long-term.
Melanie: What happens to the Resilia valve if you have to put a new valve in?
Dr. Davies: Basically, it is somewhat pushed to the side and the new transcatheter valve is set on a cobalt chromium steel cage, almost a stent-like structure that pushes the Resilia valve or the previous tissue valve to the side and then mounted and sewn on the valve itself is another bovine pericardial valve that is mounted on that cobalt chromium structure.
Melanie: That’s so cool Dr. Davies. Is there a standout case that you have been involved in? Can you tell us something interesting about doing this now and since it’s only been really FDA approved for about a year? Is there something really exciting you want to tell us?
Dr. Davies: So, there are some patients that have specifically come to us looking for this valve. Patients are more educated now with the internet and they are doing more research on their own and patients specifically. One quickly I can tell you about is a younger patient that I happen to know personally that his family are emailing and texting me recently about this type of valve. But there are other patients that I had. I had a roughly 24-25-year-old patient from one to two states over that specifically came here because they saw that we were one of first locations specifically I think the first in the south that put one of these valves in once it was FDA approved and they came here for this because he did not want to take Coumadin. He wanted to have a tissue valve. He wanted to maximize the length of the possibility of this valve and he wanted to make the best option for the second valve for his future therapies to be done. And so, he specifically sought us out for that type of valve. He did very, very well from the surgery. No issues at all and at his follow-up has been doing great. And hopefully it’s many years before we have to redo his valve, but we will be ready when he comes back.
Melanie: Then give us some predictors of treatment response. Tell us about some what you see going on in the future in this. I mean this is pretty advanced and a really exciting form of therapy. So, looking forward to the next ten years and since the studies haven’t been done for that long; what do you see is going to happen doctor?
Dr. Davies: So, the ideal therapy of what we are looking for a valve is a valve that can be placed that will last forever without having to use any anticoagulation. We are not quite there yet. We are still getting closer and closer. So, the ideal therapy is a tissue type valve that will last or some type of synthetic valve that will last the lifetime of the patient. But in the meantime, the technology between the tissue valve and the transcatheter techniques are evolving so much that the ideal situation in the next 10-15 years in my opinion, will be a tissue valve that will last 15-20 years and then another transcatheter valve that may last 15-20 more years. Now you are getting 30-40 years out of two procedures for these patients and hopefully that will extend almost all patients the life of their valve and they won’t have to have any other procedures done. So, then we can minimize the number of overall total procedures for these patients over their lifetime.
Melanie: Wrap it up for us what you would like the listeners, other providers, specifically, to take away from the fact that this is such a new technology and it’s really exciting and it’s really advancing the field of aortic valve replacement surgery so, by incorporating that expansion technology you described for us. So, wrap it up what you want them to take away from this message about the INSPIRUS valve.
Dr. Davies: So, first I’d like to make sure that everyone knows that aortic valve replacement is something we have done for quite a while. It’s very safe. The chance of having any significant complications are very low. Patients recover and do exceedingly well and feel so much better once the valve is replaced. But I’d like for them to know that the tissue-type valve that we are using expand our overall options to where patients of all ages are now candidates for these tissue-type valves. They don’t have to worry about if they have a tissue-type valve when they are in their twenties, they are going to have to have three, four or five procedures over their lifetime. I think we are rapidly approaching to where they can have one procedure in an open setting, have then one or two transcatheter techniques and hopefully may not need anything else done in the future to where the tissue-type valves will become even more and more the mainstay to where we can minimize the use of the blood thinner in these types of patients so they can be more active.
Melanie: It’s great information and thank you. What a fascinating interview this was Dr. Davies. Thank you for sharing your expertise and explaining this new exciting technology to us. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You’re listening to UAB Med Cast. For more information on resources available at UAB Medicine you can go to www.uabmedicine.org/physician, that’s www.uabmedicine.org/physician. This is Melanie Cole. Thanks so much for joining us today. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua095.mp3
- DoctorsChu, Daniel
- Featured SpeakerDaniel Chu, MD
- CME SeriesMedical Innovations
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5517
- Guest BioDr. Daniel I. Chu MD is an Assistant Professor in the Division of Gastrointestinal Surgery at the University of Alabama at Birmingham. He completed his undergraduate at Yale and medical school at The Johns Hopkins School of Medicine.
Learn more about Daniel Chu, MD
Release Date: January 8, 2019
Reissue Date: January 31, 2022
Expiration Date: January 30, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose.
Faculty:
Daniel Chu, MD
Associate Professor, Colon and Rectal Surgery
Dr. Chu has the following financial relationships with ineligible companies:
Support for Travel for Meetings or Other Purposes – ACS Japan
All relevant financial relationships have been mitigated. Dr. Chu does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers (Ronan O'Beirne, EdD and Katelyn Hiden), have any relevant financial relationships with ineligible companies to disclose.
There is no commercial support for this activity. - TranscriptionMelanie Cole, MS (Host): UAB Medcast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA Category 1 credit. To collect credit, please visit uabmedicine.org/medcast and complete the episode’s post-test.
UAB Medicine has partnered with Seamless MD, a patient engagement and care management platform in an effort to boost telemedicine capabilities. Here to tell us about that is Dr. Daniel Chu. He’s an assistant professor in the division of gastrointestinal surgery at UAB Medicine. Dr. Chu, welcome to the show. Tell us a little bit about the rationale, about the ERAS programs. And specifically, at UAB, how they got started and what did the health systems see as far as improvements in things like length of stay and pain scores for colorectal surgery patients.
Daniel Chu, MD (Guest): Well thank you very much for having me on the show. Enhance recovery programs is a multi-mobile pathway that was designed to recover patients better and faster after major surgery. And you're right, it really started in colorectal surgery because these patients had the longest length of stays, had the most complications. Just because you're dealing with the colon and small bowel and with lots of stool.
What was seen with enhanced recovery programs is major reductions in length of stay, as you have described, and also some other improvements such as the use of non-opioid medications. Enhanced recovery programs across the world, not just at our institutions, has really been shown to consistently improve this recovery and improve all of these metrics that patients love, and hospital systems love.
Where we’re at now at UAB is that we have had enhanced recovery for about four years now, in colorectal and multiple other surgical specialties. We’ve really looked at this at version 1.0. This is really our first go at this. We’ve had great results. Major reductions in length of stay, reductions in cost. All things that we love to see, but we actually think that we can do better than this. That we can even improve upon this version one to version 2.0. So that’s where patient centered technology, like Seamless, comes into play.
One of the things that we’ve known with enhanced recovery is that there’s about 15 to 20 different individual processes that happen within this recovery. If you are adherent or you follow each of these, the more that you follow the better the recovery. Out of 20, if you follow 20 of those instructions and procedures, you do really well. We’ve found that these technologies, like patient centered technology like Seamless, helps patients better understand the process and what it means to recover. It can therefore help improve the adherent to each of these kinds of processes. So that’s where we’re really hoping that this patient centered technology can go.
Essentially it further improves the patient’s experience after major surgery. Then, because of that, it will improve compliant with enhanced recovery processes. Then overall even further improvements in experiences and satisfaction for patients.
Host: So interesting. When you're speaking about adherence and compliance and how that really does work if they adhere to those things that ERAS dictates after surgery. Tell us a little bit, Dr. Chu. What is Seamless MD and how are you partnered with them?
Dr. Chu: Yeah. So, the way I describe Seamless is it falls under the umbrella of patient centered technology. So, this is the mobile technology that goes on your phone, it goes on the internet. You have your own login. It’s almost like a Map My Run, those exercise programs that are out there that you can follow. It does the same thing for your recovery after surgery. So, to be specific, patients once they're enrolled with Seamless—and we approach all of our patients for this possibility—they would install it, have their log in name from the day that we meet them in the clinic. Essentially it follows the patients all the way through the entire journey of surgery until the very end, and even until 30 days after they're discharged from the hospital. It basically helps educate patients, even before the operation day.
It educates them, teaches them about what to expect. I think instructions on what to do, such as taking your bowel prep and how to do it. It gets them to the operation. Even on the night of the operation, the program will help ask patients how they're doing. It can help remind patients on whether they’ve walked, what their pain control is like, how much opioids that they might be taking. It provides this real time feedback. Patients really feel like they're engaged with the whole recovery process and with all the providers that are involved.
We partnered with them about a year ago, with Seamless, in colorectal surgery in particular. Partly because thought we could take this to the next level. This platform is incredibly sophisticated. It’s very beautifully designed for patients. It’s a Toronto based program, invented in Toronto by an MD, Dr. Joshua Liu. They’ve had great results in Canada and some of the other institutions. We’re literally the first in the deep south here to have this program. We’ve expanded this now with a grant that was funded through the UAB Health Systems to help expand Seamless, not only in colorectal but also to other specialties including cardiac surgeries, thoracic surgery, and gynecology and oncology. These are all major service lines that I think could benefit from having this technology to help empower patients and get them more engaged in surgery, which is honestly very confusing to many people.
Host: Well it certainly is. So, is Seamless user friendly, Dr. Chu? Also, what about staff time? Does this help to save some of the staff time? Can you see what they’ve recording when they’re recording it in real time? Tell us a little bit about how that works with patient interface.
Dr. Chu: Absolutely. So, it’s extremely user friendly. That’s part of the reason why we partnered with them is that we really liked how it looked just from the very get-go. A lot of our work and health literacy really plays a role here too because we know the patients have the whole spectrum of literacy in their ability and capacity to understand information. Surgery is very, very confusing. The way we've presented the information to patients before hasn’t been very well. Seamless helps us do it better. It’s constantly engaged with patients. There’s an incredible education library that is there that’s very much picture based. Very visual instead of being text heavy. That patients can help understand how to take the bowel prep, how to change an ostomy. So that’s there, and that takes some of the load off of the nurses that we have in terms of education.
One of the things that seamless does too is it’s built real time. So literally we can log in and see all of our patients, almost like on a radar screen, who have Seamless installed. We can see what patients are saying in terms of how they feel, what their pain responses are like, if there’re any issues. It can literally be a red alert that’s set for patient’s that are having issues who are responding to questions saying I have an issue. That for now prompts basically a note to one of our nurses who can actually then get that red alert and then call the patient and follow up and help take care of the issue.
This actually happened last week where we had a patient respond to a Seamless question not doing well and my nurse was able to almost immediately respond within 10 minutes. The patient was so surprised, but it really got that patient out of trouble. That’s really where we see Seamless as playing a role here.
Host: So as far as what you’ve seen already, Dr. Chu. Obviously, this is, as you say, very user-friendly, but have you seen things like preventing readmissions or ER visits after surgery? Or even about preventing surgery cancellations. What are some of the patient reported outcomes?
Dr. Chu: Yeah, so that’s a great question. That’s an active part of the current project that we’re doing with this expansion and continued partnership with Seamless. We’ve seen it from a patient satisfaction standpoint with the use of the program and the use of the surgical services here at UAB over a 90%+ satisfaction. When patients get this program on their phone or have their login on the computer, they're incredibly engaged. Everyone uses it. Not just the patients, but their family members too in cases where patients themselves might have some difficulty using this technology. So, some of those patients reported outcomes of satisfaction is very good.
From a cancellation standpoint, I haven’t actually looked at that data quite yet. But that’s a great area to look at. I will say that all of our Seamless patients have had surgery. So, anyone who has Seamless has had an operation. So, I guess you could say it has a 100% there.
But some of the other technologies and outcomes that we’re looking at are things such as opioid use. Opioid crisis is huge in the United States. Surgeons are responsible for a lot of this. With Seamless, we’re actually able to chart the number of opioids that patients are using. The patients can even tell us through this application how many pills they're using. So, we actually have a map now that we can see across. We’ve had over 200 patients right now through colorectal in Seamless. We can kind of track globally what the common opioid utilization behaviors are. That can help us tailor our own opioid prescriptions that we give patients after colorectal. So, this app is really powerful, and it gives us this link to patients that patients really feel empowered to use. They can actually tell us things directly that we get immediately.
Host: That’s really cool. Technology is amazing. Dr. Chu as you wrap it up for us, tell us where you see telemedicine? And across all service lines and not just in colorectal surgery, where you see telemedicine and companies like Seamless MD and how they all fit together to make this cohesive multidisciplinary comprehensive care for patients so that it does reduce some of the complications we were discussing?
Dr. Chu: Yeah, absolutely. So, I think the future in medicine is going to hinge on technology. Telemedicine is, as you described, really nicely the umbrella term that will be used. Seamless is a part of that. How we envision this in the future here at UAB, Seamless takes care of the whole [inaudible] journey. It sort of is a foundation. It starts with the patient is in a clinic and it follows them to the operating day and then post-op. So, it’s a nice net and it engages patients throughout their whole journey.
What we can do with the other technology that’s out here, and UAB is really at the forefront with Dr. Eric Wallace and a lot of this technology. There are other technologies, applications that can build upon this. For example, besides Seamless UAB also has other programs that actually are more video based. So, if a red alert goes off on Seamless, for example, that can prompt the nurse’s attention. The nurses can then use some of these other technologies that’s almost like a virtual room. It can basically send a link through text messaging to the patient that they can click on that opens up within a program a HIPPA compliant and secure video communication channel where you can actually video with the providers or with a nurse and show each other hey my wound looks like this or my ostomy looks like this. What can we do? So many of our patients at UAB live far away, five hours/six hours away, and this is way more convenient.
What you're talking about right now, telemedicine, is something I think that we’re really just trialing right now. In fact, some of us had just gotten privileges within this world and we’re going to be test trialing it in the next couple of months. They're having remote visits where patients don’t physically come here, but I can see them in their home or at a facility that’s closer to them. I think telemedicine, such as a very accomplished technology like Seamless as kind of a platform and then building upon it with these other add-on pieces is where it’s gonna be going because of a coordinated care program for our surgical patients, especially taking account for all the distances that people have to travel.
Host: Well it certainly does. Fascinating Dr. Chu. An absolutely fascinating topic. Thank you so much for joining us today and explaining where you see the future of telemedicine going and how UAB medicine is using Seamless MD to really connect with their patients and increase compliance and help with ERAS. So, thank you again so much. A community physician can refer a patient to UAB by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You're listening to UAB Medcast. For more information on resources available at UAB Medicine, you can go to uabmedicine.org/physician. That’s uabmedicine.org/physician. This is Melanie Cole. Thanks so much for tuning in today. - HostsMelanie Cole, MS
Additional Info
- Audio Fileuab/ua091.mp3
- DoctorsKolettis, Peter
- Featured SpeakerPeter Kolettis, MD
- CME SeriesClinical Skill
- Post Test URLhttps://cmecourses.som.uab.edu/mod/quiz/view.php?id=5525
- Guest BioPeter Kolettis, MD is Professor of Urology at the University of Alabama at Birmingham. He joined the faculty in July of 1998 and has served as the Urology Residency Program Director since July 2003.
Learn more about Peter Kolettis, MD
Release Date: January 8, 2019
Reissue Date: February 7, 2022
Expiration Date: February 6, 2025
Disclosure Information:
Planners:
Ronan O’Beirne, EdD, MBA
Director, UAB Continuing Medical Education
Katelyn Hiden
Physician Marketing Manager, UAB Health System
The planners have no commercial affiliations to disclose.
Faculty:
Peter N. Kolettis, MD
Director, Urology Residency Program
Dr. Kolettis has the following financial relationships with ineligible companies:
Stock/Shareholder – GlaxoSmithKline
All relevant financial relationships have been mitigated. Dr. Kolettis does not intend to discuss the off-label use of a product. No other speakers, planners or content reviewers (Ronan O'Beirne, EdD and Katelyn Hiden), have any relevant financial relationships with ineligible companies to disclose.
There is no commercial support for this activity. - TranscriptionMelanie Cole, MS (Host): UAB Medcast is an ongoing medical education podcast. The UAB division of continuing education designates that each episode of this enduring material is worth a maximum of .25 AMA PRA Category 1 credit. To collect credit, please visit uabmedicine.org/medcast and complete the episodes posttest.
Welcome. Our topic today is vasectomy reversal. My guest is Dr. Peter Kolettis. He is a professor in the department of urology at UAB Medicine. Dr. Kolettis, what is the prevalence of vasectomies in this country? What’s the prevalence of men that are seeking reversal?
Peter Kolettis, MD (Guest): Well, vasectomy is one of the most common surgical procedures performed in the United States. It’s estimated that 500,000 men have the procedure done each year. It is estimated that between 4% and 10% of men that have a vasectomy seek to have it reversed in the future.
Melanie: Why would a man seek a reversal?
Dr. Kolettis: Most of the time it’s because the man is now in a new relationship. Most of the time it’s second marriage. Although, about 20% of the time, in my experience, it has been because the couple has for whatever reason changed their mind and desire to have more children.
Melanie: Doctor, what are some of the variables that may influence reversal success rates; and how important is the experience of the clinician in this decision?
Dr. Kolettis: The factors that determine success on the male side would be the time since the vasectomy, the way that the surgery is performed, and then what the fluid looks like during surgery. So, we examine the fluid under a microscope to look for sperm or parts of sperm, and also look at the gross appearance of the fluid. Then as far as technique, it’s important to use microsurgery because the results of microsurgery are better. Most people that do these surgeries use microsurgery.
On the female side, any female factors could obviously effect chance for pregnancy. So, it’s a combination of the male factors, which would determine the success of having sperm return into the semen. Then on the female side, any female factors. Those would be the factors that contribute to success.
Melanie: Speak about patient selection criteria and patient evaluation and what role that plays in order for reversal to be an option.
Dr. Kolettis: If a man is able to have surgery safely and have
anesthesia safely, then just about anyone would be a candidate for a vasectomy reversal if he chose to have it done. So, it’s very rare that someone would not be a candidate for it. The main thing is that the patient desires to have his own biological children. If he does, the choices between doing a reversal or doing what’s called sperm retrieval to obtain sperm to use for IVF—invitro fertilization or we refer to that as test tube baby. So those would be the factors to consider for men. Again, as long as he’s a suitable surgical candidate—meaning he doesn’t have so many significant medical problems that it’s not safe for him to have surgery—then he would be a candidate.
It’s important to consider any female factors that may be present. His partner could have fertility problems that would affect the chance for getting pregnant and also effect the chance for natural conception. This, then, could lead the couple to have the procedure to retrieve sperm and do IVF rather than have a vasectomy reversal done. The female partner’s age is very important because that’s related directly to fertility. We can't change that, but it’s important to counsel couples on chance for success and how it could be impacted by female factors and female partner age. So that’s an overview of how we would select couples for that. Mostly it’s couple’s choice.
Melanie: What about the usefulness of vasectomy reversal to alleviate post-vasectomy pain syndrome. Is that sometimes the reason a man would come to you?
Dr. Kolettis: It can be, but in my experience that’s very rare that reversal ends up being the treatment for post-vasectomy pain because there are many other non-surgical options that can be done first. So that’s very rare in my practice. I would presume that it’s also rare in other specialist’s practice because there are other ways to try to alleviate pain.
Melanie: Doctor, you mentioned microsurgery and the experience of the clinician. What are some of the factors that you would consider when choosing the type of vasectomy reversal to use on a particular patient?
Dr. Kolettis: Well, the factors to consider would be the time since the vasectomy and then the appearance of the fluid. If the appearance of the fluid from the end vas deferens is not favorable—meaning it’s sick fluid and we don’t see sperm or sperm parts—then one has to consider doing connection from the vas deferens to the epididymis rather than simply reconnecting the two ends of the vas deferens. So that’s the main decision that’s made during surgery.
Melanie: Is one preferable over the other?
Dr. Kolettis: Well, the connection of the epididymis is more complicated. What’s preferred is what is the indicated procedure, which is determined by what the fluid looks like. So that’s how we would decide which procedure to do. You can't predict ahead of time if someone will need the surgery to the epididymis. The risk of needing the surgery to the epididymis goes up as the time since the vasectomy increases.
Melanie: Is there a debate about the facts of antibodies on pregnancy rates after vasectomy reversal?
Dr. Kolettis: There is some debate about that. We know that vasectomy can cause anti-sperm antibodies. How that effects pregnancy rates after a vasectomy reversal is controversial because there are other explanations for someone not being able to establish a pregnancy. There are couples where anti-sperm antibodies are present and they’re still able to get pregnant. Then finally, it’s not possible to test for those ahead of time. In other words, prior to the surgery. The only type of testing that’s useful is to actually test the sperm themselves. So, in a man that’s had a vasectomy, there aren’t any sperm to test. So, I would say that most people don’t consider anti-sperm antibodies in the decision making. We know that the chance for success depends on the time since the vasectomy. The chance of having anti-sperm antibodies, one can’t really predict. So, it’s not really incorporated in the decision making, although it’s possible that could be reason for someone not being able to have a pregnancy.
Melanie: In summary doctor, tell other physicians what you would like them to know about vasectomy reversal and when to refer to UAB Medicine. And any techniques or interoperative considerations that you think it’s important that they understand.
Dr. Kolettis: First of all, I think that someone should be experienced in microsurgery to do the procedure. One should understand the decision making that is required during the procedure about whether to do the surgery to connect the vas deferens to the epididymis or not. One can have some idea of the probability of that based on the time since the vasectomy, but it is not possible to predict that with certainty ahead of time.
Also, when a couple is better served by sperm retrieval and IVF rather than a vasectomy reversal. You can do a vasectomy reversal for any time since the vasectomy. The longer the time interval since the vasectomy, the lower chance for success. I tend to advise where the vasectomy’s been 15 years or longer that their chance for getting pregnant is better doing IVF. That being said, a couple can choose to do whichever they are most comfortable with. Ultimately, it is their decision.
I think having someone comfortable with a microscope and all of the special instruments that are required to do a vasectomy reversal is important. Most people that do vasectomy reversals, I would expect, would be comfortable with that. Doing any procedure to retrieve sperm requires a specialized team that would be a urologist that does fertility surgery and then also the reproductive endocrinologist or the gynecology fertility specialist. So that’s how I would approach the couple that desires treatment in this situation.
Melanie: Thank you so much Dr. Kolettis for being with us today. A community physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST. That’s 1-800-822-6478. You're listening to UAB Medcast. For more information on resources available at UAB Medicine, you can go to uabmedicine.org/physician. That’s uabmedicine.org/physician. This is Melanie Cole. Thanks so much for listening.
- HostsMelanie Cole, MS
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