Additional Info
- Audio Fileuf_health_shands/ufhs079.mp3
- DoctorsChen, Si
- Featured SpeakerSi Chen, M.D.
- Guest BioSi Chen, M.D., graduated from New York University, School of Medicine, and then went on to complete her residency in Otolaryngology – Head and Neck Surgery at the University of Miami, Miller School of Medicine, Jackson Memorial Hospital. Dr. Chen completed fellowship training in Neurotology and Skull Base Surgery at House Ear Clinic/University of California Los Angeles.
As an academic physician, Dr. Chen provides training to resident physicians, fellow physicians, medical students, and staff. She also actively participates in research, teaching-conferences and grand-rounds. - TranscriptionThe University of Florida, college of medicine is accredited by the accreditation council for continuing medical education. ACCME to provide continuing medical education for physicians, the university of Florida, college of medicine designates this enduring material for a maximum of 0.25 AMA PRA category one credit physician should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole (Host): Welcome to UF Health Med EdCast with UF Health Shans Hospital. I'm Melanie Cole. Joining me today is Dr. Si Chen. She's an assistant professor in the department of otolaryngology, head and neck surgery at the University of Florida College of Medicine. And she's here to highlight cochlear implants, expanding access to hearing rehabilitation. Dr. Chen, it's a pleasure to have you with us today. As we get into this topic, can you tell us a little bit about hearing disorders that require interventions or that are amenable to interventions? What conditions are we talking about here today?
Dr Si Chen: Good morning, Melanie. Thank you so much for having me on the podcast. I'm happy to talk about hearing loss and in most of the adults that we're focusing on the adults today, we're talking about sensory neural hearing loss as a disease that may have multiple etilogies, including aging, noise, exposure, genetics, and other diseases. We're specifically focusing on the severe to profound level of sensory neural hearing loss when they've had, hearing aid rehabilitations, but have limited benefits from the hearing aids.
Melanie Cole (Host): Well, then let's get into that. Tell us about the limitations of hearing aids and when cochlear implants might be considered?
Dr Si Chen: Human loss, sensory neural human loss, essentially is a dysfunction at the level of the cochlea and the cochlear nerve. When the cochlea and cochlear nerves are not functioning due to either aging, noise, exposure or other etiologies, hearing aids are no longer helpful. So I'm sure you've probably met people who are frustrated with hearing aids or they just found knowhow from hearing aids. The reason of that is that hearing aids, essentially, no matter how advanced the technology is, is still simply an amplification of sounds, they make sounds louder, but cannot make you understand it better.
For example, you may hear, either on the hearing aids or an example of the telephone, you hear wobble, wobble, wobble, at very low tones. It's not clear. So you think if you just increase the volume, it would be much more clear speech, but that's not the case. So instead of hearing wobble, wobble, with the limits of hearing aids, you may still hear wobble, wobble, wobble very loud, but unfortunately not very clear. That's when you really start to think about what is the next step, what are the available hearing rehabilitation options for those patients. And cochlea implants are currently very good option for those patients.
Melanie Cole (Host): So then speak about cochlear implant evaluation, and what's involved and patient selection. Are there some people for whom this is contraindicated?
Dr Si Chen: Absolutely. So, cochlea implants are generally reserved for severe to profound sensory neural hearing loss. So for the cochlea implant evaluation, we take a multidisciplinary team approach. We want to first make sure that you have a older NG physician evaluation, where there are reasons for the hearing loss to be limited to the middle ear, like an infusion infection or tumor obstructing the sound from going through, then those are maybe surgically corrected and patients may improve with good benefits with the hearing aids alone.
So we do wanna make sure there are correctable etiologies identified on physical exam. Other things that may limit access to cochlea implant would be, either a tumor on the hearing, a balanced nerve or central processing disorders, such as neurodegenerative diseases. Although we do, offer cochlea implants, even when patients have Alzheimer's or Parkinson's, those are still good options for them, but we do counsel them carefully in terms of what cochlea implants can do for them.
Melanie Cole (Host): Such a fascinating and exciting time to be in your field. Dr. Chen. So tell us a little bit about the surgery itself and postoperative care. Follow up. Tell us a little bit about what's involved?
Dr Si Chen: So cochlea implant actually is one of the very fascinating innovations in our field. The FDA approval for cochlea implant only came about in 1985 for adults and for kids it's been approved since 1990s, but we've seen this huge expansion in terms what the technology can do thus to follow would be FDA expanded criteria for people to meet candidates for cochlea implant. The surgery is quite sure. I generally tell my patients that surgery only takes about one to two hours. Surgical intervention with the cochlea implant is actually the shortest part of their hearing rehabilitation journey.
They undergo an outpatient surgery, one to two hours. But they have a very long relationship with the cochlea implant program, including the surgeon and the audiologist in order to map the cochlea implant, to have the most comfortable level for them to optimize for their daily activity and improve their hearing and speech outcome. So the performance can be seen to improve dramatically even between six months to a year. So they continue to have significant improvement over time with the device, like that.
Melanie Cole (Host): Now I'd love for you to tell us about your hearing outcomes. And while you're doing that speak about, since we're talking about the adult population, speak about life effects as reflected in measures of quality of life, educational attainment, economic impact. Speak about your outcomes and how quality of life is really such an important factor.
Dr Si Chen: With the cochlea implant, when we test the cochlea implant candidates put before surgery, for example, if you ask them to listen to a test will be sentences. Most of the patients in order to qualify for Coch implant, they understand less than 40% of the sentences by Medicaid and Medicare criteria. That would be equivalent of having our conversation with somebody on the phone and not understanding more than half of the conversation on the phone.
So most of the cochlea implant patients can achieve anywhere between, 75, 85% of the conversation after cochlea implant. That is significant improvement. And some people even are superstar and they understand a hundred percent of the sentences. Obviously we do have, patients who don't perform nearly as well, but on average, you do see any significant improvement in conversation, even without lip reading, visual cues or other cue.
And the one simple, very good example of, the quality of life improvement is really a lot of patients would come and say, I haven't heard the bird chirping outside my window for so many years. It's so nice to hear that. And another example would be that, I went to a game with my grandchildren and I finally understood what they were talking. In a very noisy background before that, I couldn't understand that. So the quality of life impact is significant and people really start to engage socially with other people.
They become happier with their own sort of social interaction, and they're less likely to be anxious or depressed or participating in their own medical care.
Melanie Cole (Host): So what's exciting. What do you see happening in the next. 10 years or so if you were to give us a blueprint for further research, recent advances or ongoing research that are improving cochlear implant, performance, speak about anything you'd like other providers to know about?
Dr Si Chen: Absolutely. So with the Cochlear implant, we traditionally think of a big surgery. It's this external device that's implanted nowadays. it's much slimmer, think of the cell phones we had five to 10 years ago was much bigger and it's definitely slimmer and slimmer. We are looking at devices that are much better battery life. And we're looking at electro devices that are much better at replicating the frequency stimulation of a human hearing and sound. So I think with the programming of the cochlear implant has gotten so much better that we do have better algorithms to replicate natural sound.
In addition, I think a huge improvement is that, prior to 2019, we spent a lot of time counseling patients and say, you're sort of really in the gray area. Really don't like your hearing aids, but you're not quite bad enough for cochlear implants. So we used to have a huge group of patients who are very frustrated with hearing aids, but don't quite meet criteria for cochlea hints. And I really used to dread those appointments and say, we don't have anything for you to do unless your hearing gets worse. That's a terrible thing to sort of offer the patient.
Now with the FDA expansion of the Cochlear implant candidacy, we're really seeing. More and more patients being able to meet criteria to get Cochlear implants when they no longer benefit from hearing aids. So we see more and more people becoming eligible, with more residual hearing and at a younger age. And of course we're focusing on adults today, but the FDA approval really has been approved for patients as young as nine months of age.
Melanie Cole (Host): Do you have any final thoughts? What you'd like to leave other providers with regarding cochlear implants, quality of life and what you're doing there at UF Health Shans Hospital?
Dr Si Chen: Absolutely. So one of the major things, I think if you look at all of the cochlear implant providers, either physicians or audiologists, it's alarming and amazing to see that according to the American and Cochlear Implant Alliance that less than 10% of people who need a meat criteria for Cochlear implant, less than 10% of the people actually go on to receive Cochlear implants. So we do want to increase the awareness of this amazing technology and how far we've come from 1985 from having a honky device to a very slick and modern device.
And the capability of the Cochlear implant is to restore a relatively normal hearing and to improve their lives. And we really want to sort of work on that less than 10% access to the hearing rehabilitation option. We want to bring this option to more people and make it, a life changing experience for them.
Melanie Cole (Host): Thank you so much, Dr. Chen for joining us today, what an exciting time to be in your field and to refer your patient or to listen to more podcasts from our experts, please visit UFhealth.org/medmatters. That concludes today's episode of UF Health Med EdCast with UF Health Shans Hospital, for updates on the latest medical advancements, breakthroughs and research. Follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs077.mp3
- DoctorsJohnson, Jeffrey
- Featured SpeakerJeffrey Johnson, M.D.
- Guest BioJeffrey Johnson II, M.D., is an assistant professor and chief of the Division of Facial Plastic and Reconstructive Surgery in the University of Florida Department of Otolaryngology. Dr. Johnson received his medical degree from Indiana University School of Medicine in Indianapolis, Indiana. He then went on to complete his residency in Otorhinolaryngology- Head & Neck Surgery at the University of Texas Health Science Center in Houston, Texas. Dr. Johnson went back to Indiana University School of Medicine to complete his fellowship training in Facial Plastic and Reconstructive Surgery.
Learn more about Jeffrey Johnson, MD - TranscriptionIntro: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME, to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity. Welcome to UF Health Med EdCast with UF Health Shans Hospital. I'm Melanie Cole. Joining me today is Dr. Jeffrey Johnson. He's the division chief in facial plastic and reconstructive surgery and an assistant professor in the department of otolaryngology at the University of Florida College of Medicine.
Melanie Cole: And he practices at UF Health Shans Hospital. He's here to highlight nasal obstruction for us. Dr. Johnson, it's a pleasure to have you join us. As we get into this topic, tell us a little bit about the prevalence of nasal obstruction and what you see every day.
Dr. Jeffrey Johnson: So, this is a very common issue. There's multiple reasons to have nasal obstruction, but many people, you know, probably more than 50% of people suffer from some sort of nasal obstruction. That's difficulty getting airflow through the nose. And so people are getting chronic mouth breathers or at least intermittent mouth breathers. A lot of times it's more noticeable at night when people are lying down to sleep, but it could happen anytime throughout the day.
Melanie Cole: So, what are some of the most common causes that you see and deal with on a daily basis?
Dr. Jeffrey Johnson: The main issues we see are either more environmental related or structural. The environmental causes. These will vary throughout regions of the country, but usually have to do with pollen or pet dander, dust mites, other tree and wheat allergens. These particles are in the air. You're breathing through the nose. These are causing congestion. They cause increase in the size of the inferior turbinate, which are structures inside the nose that are designed to help warm and humidify the air as we breathe in, before it enters our lungs.
And when they become enlarged over time from chronic allergen exposure. That's what we call allergic rhinitis. So that's one of the most common diseases affecting adults. It's the most common chronic disease in children in the United States today, and a fifth, most common chronic disease in the US like overall population. Other symptoms would be clear red and watery eyes, itchy throat.
Melanie Cole: So Dr. Johnson as primary care providers are typically the first line of defense for patients as they present with some of these symptoms, tell us a little bit about what they would notice and what would send them for referral to ENT? Because sometimes these can be cared for in the primary provider or the medical home, but then there are times when the patient is presenting with other symptoms that would need referral.
Dr. Jeffrey Johnson: Definitely. And even if the cause is structural, not just the kind of allergens, like we talked about it, it is a deviated septum or they've had trauma in the past and there's some kind of structural abnormality. The first line of treatment is the same. And before we would pursue any kind of surgical intervention and as an ENT doctor, as a facial plastic surgeon, the first steps are a couple things. One is usually saline rinses. So one the major brain you'll see is Neo Meds sinus rinse. People might have heard of Netty parts.
You'll see ads on TV for Novage or other expensive ones. Not usually necessary, but some sort of nasal irrigation. It. Usually you're mixing distilled water with little premade saline packets, and that's getting rinse in one side of the nose and out the other side. So what this does, is it rinses out any of that mucus and clear drainage they're having it rinses out all the little allergen particles that are breathing into the nose, and it kind of moisturizes the nasal mucosa so that the Celia on the mucosa are moving well, gets your nose overall, cleaned and ready to receive the medication.
So the first line for allergic rhinitis or nasal obstruction is usually nasal steroid. The three most commonly used nasal steroids are fluticasone our trade name, Flonase, mometazone or trade name, Nasonex, and then triamcinolone, which goes by the trade name Nasal Court. These sprays are administered, at least once a day, usually twice a day, once in the morning, once at night.
It's important that the patient breathes through the mouth or holds their breath when they use the spray, rather than trying to inhale it strongly like a, like an asthma inhaler, the medicine's already aerosolized. So it will squirt into the nose where it needs to go. And the bottle needs to be aimed away from the septum, which is the layer of cartilage and mucosa that separates the two sides of the nose. So you want to end the tip of the bottle towards the outside corner of the eye on each side.
And that'll help prevent irritation of the nasal septum and for help prevent it from drying out too much. And so that's usually the first line treatment, the irrigations followed by the nasal steroids. It's also important to counsel the patients that these medications take about three to four weeks of daily use. To really get the full effect. It's not the sort of thing that will work immediately. Like other decongestants or over the counter decongestants. And many of these medications are over the counter now. Fluticasone can be bought over the counter or it can be got with a prescription.
If they have other allergy symptoms like itchy, watery eyes, scratchy throat, those sort of things. You could add an oral antihistamine second generation as well, which would be Allegra, Zytech or Claratin.
Melanie Cole: So then discuss when surgical intervention may be helpful. And what does that discussion look like with patients?
Dr. Jeffrey Johnson: So when patients have tried the irrigations and the nasal steroids for at least four to six weeks, and they haven't had any significant improvement, that's when it's a good time to refer to an ENT doctor to kind of see if there's other structural abnormalities going on. Ideally at that point in time, all the inflammation in the nose should be minimized. There are still cases where the medications just don't work that well. and you need to add on another medication or you may allergy testing, but either way, that's a good time to refer from primary care when they've failed the first line treatment, which is the nasal steroids.
And generally it depends what the actual issue. Usually there may be some bit of inferior turbinate hypertrophy. 70% of the population has a deviated septum. That doesn't mean 70% of the people in the population need a septoplasty, but is very common to have a nasal septal deviation. And that can either be from trauma. That could be minor, early on in life or major trauma with nasal fractures at the same time, or sometimes they just kind of grow crook ed as we develop. And so surgery, usually involves shrinking the sides of the inferior turbinates, straighten the septum.
And then a lot of people also have what we call nasal valve collapse. This is where the side walls of the nose and the cartilages that form the tip of the side walls of the nose are weak and they collapse against the septum obstructing the nasal airway as well. So it's usually important to figure out which of those three things are causing the issue. Generally surgery is done through just cuts on the inside of the nose without any external changes to the nose in most cases.
If people have had trauma previously, or there's other issues with the nose, either congenital or cosmetic deformities that they see as well, that can all be taken care of at the same time as the surgery for the inside of the nose.
Melanie Cole: Before we get into, when you feel that it's important for primary care providers to refer to ENT at UF health Shans Hospital. When you're speaking to patients about home care and things that they can do while they're doing lavage, steroids, possibly surgical intervention, what would you like them to know about triggers and things that happen at home? So that primary care providers may counsel their patients on these home care solutions.
Dr. Jeffrey Johnson: Very important. So, if they haven't had allergy testing or they have if they've had allergy testing, we may know what the triggers are, or even without that, the patient may notice that they're around the dog more, they get more symptoms, right? So pet dander may be an issue or there's a bunch of yellow pollen on all the cars outside. So maybe that's a trigger certain times of the year or worse. Other things like dust mites, you may not notice. So good things to do at home are get a HEPA filter for the room, make sure that you're laundering the sheets regularly.
Making sure that the house is clean overall, those things can all help. You can see there's certain times where you're outside versus inside that's worse, but main thing is just keeping the air quality as, as good as you can inside the house as well. And if you do have exposure to animals, then that seems to make it worse. Then maybe trying to limit that.
Melanie Cole: And when do you feel it's important to refer to ENT because that certainly is the question for the medical home and primary care is when can they deal with these in office and when should they refer?
Dr. Jeffrey Johnson: Definitely. I think once they have tried a patient on the nasal irrigations and the steroids and patients are actually been compliant with that, used for at least four or six weeks. And they've gotten no improvement or only minimal improvement. I think that's a reasonable time to refer refer. Or if on physical exam they see an obvious deviation of the septum or anything that looks like it might be a growth inside the nose or increased size of the inferior turbinate. Either way, we need to make sure that they've tried the nasal steroids for at least four or six weeks first.
That's really the major turning point in when we want to refer to ENT and then from there, we know you can we get allergy testing if necessary, we can try other nasal sprays to add on top of that. One of them is as elastin or Astilin, that's a nasal antihistamine. So you could add that in addition to the Flonase, at the time of referral, that's another option, but any obvious deformity of the nose would be a good 10 fur. And then once they've failed the irrigation nasal steroid routine for about a month or six weeks, that's a good time to refer.
One other thing to rule out during the initial period is something we call rhinitis Medica mentosa. So this is from overuse of oxymetazoline, trade name Afrin, but the more I've seen patients, the more I've noticed that VIX simply sailing all the, a few other brands have their own kind of nasal sinus spray that they've rebranded and it's just oxymetazoline under a new name. So patients don't know that it's Arine and if this is used more than three days in a row, you can get a rebound swelling of the nasal tissue. And that only thing that will make it feel better is more of the Aron or more of the oxymetazoline. That's really important that we get patients weaned off of this medication, if they are using it.
Melanie Cole: What a great point that you made Dr. Johnson so important and what an educational podcast this was, thank you so much for joining us today. And to refer your patient or to listen to more podcasts from our experts. Please visit UFhealth.org/medmatters. That concludes today's episode of UF Health Med EdCast with UF Health Shans Hospital. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs082.mp3
- DoctorsChoi, Calvin;Al-Ani, Mohammad
- Featured SpeakerCalvin Choi, M.D., MS, FACC, FSCAI | Mohammad Al-Ani, M.D.
- Guest BioCalvin Choi, M.D., MS, FACC, FSCAI is an associate professor of medicine in the UF division of cardiovascular medicine and specializes in interventional cardiology. His clinical interests include percutaneous management of complex coronary artery, structural and valvular heart disease. In particular, Dr. Choi has expertise in percutaneous management of coronary artery chronic total occlusion, Alcohol Septal Ablation for hypertrophic obstructive cardiomyopathy, Transcatheter Aortic Valve Replacement, or TAVR, Transcatheter Mitral Valve Replacement, Percutaneous Transvenous Mitral Commissurotomy, MitraClip, para valvular leak closure, Caval valve implantation and intra-cardiac defect closure for patent foramen ovale, atrial septal defect and ventricular septal defect. Dr. Choi earned a bachelor’s in electrical engineering and biology from University of Maryland, a master’s in physiology from Georgetown University and his medical degree from University of Maryland School of Medicine. Dr. Choi completed internal medicine residency, cardiovascular medicine fellowship and interventional cardiology fellowship at the University of Florida. Dr. Choi also completed a research fellowship at the National Institutes of Health and is a fellow of the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions. As the director of Cardiac Catheterization Laboratory at the Malcom Randall VAMC, Dr. Choi leads interventional cardiology at the Malcom Randall VAMC. As the physician director of quality for the UF division of cardiovascular medicine, Dr. Choi leads quality improvement initiatives for the division. Dr. Choi is fluent in Korean.
Mohammad Al-Ani, M.D., is an assistant professor in the division of cardiovascular medicine at the University of Florida College of Medicine. Dr. Al-Ani earned his medical degree from Jordan University School of Medicine in Amman, Jordan. After moving to the United States, he completed his residency in internal medicine, as well as a fellowship in cardiovascular diseases at the University of Florida School of Medicine. He went on to complete an additional fellowship in advanced heart failure. At UF Health, Dr. Al-Ani specializes in advanced heart failure and serves on the cardiac imaging team, with a special interest in multimodality imaging application in advanced heart failure population. In 2019, he received the Carl J. Pepine Award in cardiovascular research and, in 2017, the Most Outstanding Research Award from the University of Florida Department of Medicine. He belongs to several professional societies, including the Society for Cardiovascular Magnetic Resonance, the Heart Failure Society of America, and the International Society of Heart and Lung Transplantation. - TranscriptionThe university of Florida College of Medicine is accredited by the accreditation council for continuing medical education. ACCME to provide continuing medical education for physicians, the university of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA category one credit physician should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole (Host): Welcome to UF Health Med EdCast with UF Health Shands hospital. I'm Melanie Cole and joining me today is Dr. Calvin Choi. He's an associate professor of medicine in the UF division of cardiovascular medicine at the University of Florida College of Medicine. He specializes in interventional cardiology and he practices at UF Health Shands Hospital. And Dr. Mohammad Al-Ani,, he's an assistant professor in the division of cardiovascular medicine at the University of Florida College of Medicine. He specializes in heart failure, transplant and cardiac imaging, and he practices at UF Health Shands Hospital.
They're here to offer an update in hypertrophic cardiomyopathy. Doctors, thank you so much for joining us, Dr. Al-Ani, I'd like to start with you as we speak about the heritable heart diseases that involve structural changes in heart muscle. Can you tell us a little bit about hypertrophic cardiomyopathy, the prevalence, the scope of the issue we're discussing today and what you see in the trends?
Dr Mohammad Al-Ani: Yeah, sure. Hi, and, thank you so much for having us. So hypertrophy cardiomyopathy, involves really abnormal hypertrophy and, this array of MyCardial fibers, that gives rise to abnormal heart function. So, hallmarks are mycardial stiffness and hyperdynamic function. And there are also, associated structural change represented by hypertrophy of the muscle, in different patterns, so there are different phenotypes, the most common, phenotype recognizes, thickening of the septum, in particular. But, all other areas of the ventrical can become thickened and even the right ventricle can become thickened as well.
The chamber size, the ventricle chamber size may get small, and many patients have obstruction to blood flow. in ventricle, and there are also, some features of abnormal perfusion to the heart, abnormal micro circulation and abnormal function of the ventricle valve. So, each individual, with hypertrophic cardiomyopathy, they have their own combination of these, features, but the hallmark of the disease, all of these patients they have in common, abnormal hypertrophy and disarray of the, myocardial fibers. Most cases. occurred due to a gene mutation that we know of.
So about 60 to 70%, of patients, if they get tested, we're able to identify the mutation that's causing the hypertrophy, but, in the remaining cases we don't, detect a mutation. However, we think that there is probably a mutation under there that, is yet to be discovered. it runs in families for sure. And that's why genetic testing and counseling is important. From a diagnostic standpoint, we start thinking about hypertrophic cardiomyopathy when the left ventricular wall thickness is more than 15 millimeters.
And most individuals with modern therapies, they carry normal life expectancy and a common question that comes up is actually a confusion with athletes, heart. So athletes, can train their heart to become very efficient. And, with that sometimes comes thickening of the heart. So that can sometimes be confused with hypertrophic cardiomyopathy and we have ways to, tell apart if the person has, an athlete's heart that's healthy or is it an abnormal hypertrophy heart muscle.
Melanie Cole (Host): I'm glad you made that point, because that is an important distinction. And as we're talking about distinctions, Dr. Al-Ani. I'd like you to kind of tell us how these other things fit under the umbrella of hypertrophic cardiomyopathy, and speak about hypertrophic, obstructive cardiomyopathy, and left ventricular outflow tracted obstruction, and kind of how these all go together?
Dr Mohammad Al-Ani: So obstruction to blood flow occurs in about 75% of hypertrophic cardiomyopathy cases. It occurs in one or two places, it can occur either at the outlet of the left ventrical, where the mitral valve anatomy and motion, are abnormal. Leading to, abnormal movement or pulling of that anterior leaflet of the mitral valve into the left ventricular outflow. And that can cause various degrees of, obstruction to blood flow out of the left ventricle and various degrees of associated, mitral regurgitation.
And another common type that can also happen is obstruction of blood flow in the middle of the ventricle. So the chamber is a small, the chamber is hyperdynamic and so it can sort of close in the middle, of the ventricle when it's contracting, at maximum degree, you know, in mid and late [inaudible] and. that can cause, obstruction as well. Now obstruction can be provoked, so some patients have obstruction at rest, but others have, no obstruction of flow at rest, but they do obstruct. under certain circumstances. So if the left ventricle is underfilled, for example, the patient is performing valsalva bearing down.
The patient is dehydrated, or standing quickly, If the heart is stimulated to be, hyperdynamic such as with exercise, with fast heart rates, or when the patient has, low blood pressure, for example. and these are conditions that we try to bring when we test these patients in the echo lab, or in clinic, to identify that obstruction.
Melanie Cole (Host): Dr. Al-Ani sticking with you for just a minute here. I'd like you to speak about evaluation and how you diagnose these. When is genetic testing indicated? When do these show themselves and how have advances in some of the imaging enabled you in your diagnostic and therapeutic capabilities for these? Please speak about all of these things and evaluation symptom, risk stratification, tie that all together for us?
Dr Mohammad Al-Ani: Most individuals are really asymptomatic. So, some of them, they come to us because there is a family member who's affected and they like to be screened. And that's how we find out that they have hypertrophic cardiomyopathy. And some patients they do have, an array of symptoms, heart murmur is a common one. shortness of breath, dizziness, Passing out, syncope, somebody who has had an ECG that is very abnormal. So those are the common ways that, patients get diagnosed or, suspected to have hypertrophic cardiomyopathy and get referred to our clinic.
Now, in terms of diagnosis, the first thing we'll have to do is we'll have to establish that the heart structure. And so you would wanna do your normal cardiology evaluation with history and normal cardiac exam and an ECG. And usually with an ECG, you would often see, signs of hypertrophy left ventricle with very high voltage, QRS, and bizarre polarization pattern. And then, with cardiac imaging, starting with an echo, you would see a thickness of the left ventricle, as we mentioned, more than 15 millimeters, hyperdynamic function.
And, you would see, in most patients, obstruction to the LV, blood flow. And if we don't see that obstruction addressed, as we mentioned, we would do provocations, starting with Volvalvum. And if there is no obstruction with Volvalvum, then we may even exercise them with an echo, to bring out that obstruction. And if the above is concerning at least, of hypertrophic cardiomyopathy, then we will have to confirm the diagnosis by, obtaining either an MRI or a CT of the heart, to basically accurately and precisely measure that wall thickness.
Define where is this thickening happening and MRI also helps us detect fibrosis, that is very commonly associated with hypertrophic cardiomyopathy. And that ties into, risk stratification for arrhythmia that Dr. Choi, will tell us about later. and it also helps us, detect, the mechanism of any obstruction. Where is it happening and what's causing it because that can help us, relieve that obstruction later. And genetic testing, comes into, the picture in two ways.
In cases of borderline, testing where some signs indicate maybe hypertrophic cardiomyopathy, but others don't quite fit. Then genetic testing can help, break the tie. But more importantly, perhaps, and more commonly, if we diagnose a patient with hypertrophic cardiomyopathy, then first degree relatives of that person need to be screened and genetic testing help us because if we identify the gene in that person, you would test the first degree relative.
Then if they do have the gene, they need lifelong periodic screening and engagement with a cardiologist. If they don't have the gene, then they are screened out and they can pursue normal medical care without worrying about it.
Melanie Cole (Host): Wow. That was so comprehensive. So Dr. Choi, we did not forget about you. And so I would like you to speak a little bit more, expand on risk stratification, and what's also involved. I'd like you to start into medical management. When you're talking about starting with nonsurgical, some of the new medications available, please tell us what's going on as far as management?
Dr Calvin Choi: So in terms of risk stratification, we start with a thorough history and physical examination. As Dr. Alani mentioned with that information, we are able to streamline what is, effective and, most, efficient way to identify patients at risk. So some of the tests we've mentioned, echo cardiac CT, MRI, stress tests, ambulatory monitor are main stage of risk stratification. So in terms of risk stratification, we are interested in preventing sudden cardiac death in patients with hypertrophic cardiomyopathy.
Again, this is not something that affects vast majority of patients with hypertrophic cardiomyopathy, but very small subset of the patients are at risk for sudden cardiac death. The way to prevent that is, the placement of defibrillator. Class one indication includes sudden cardiac death, ventricular arrhythmia. Class two, many indications include family history of sudden cardiac death, lifted ventricular hypertrophy with septal thickness greater than 30 millimeters, unexplained syncope, APIC aneurysm. The ventricular,ejection fraction, less than 50% abnormal exercise, blood pressure response.
Either less than 20 millimeters of mercury increase or greater than 20 millimeters of mercury decrease in blood pressure during exercise. Class 2B indications include, non-sustained VT. And extensive late gadolinium enhancement and cardiac MRI where the scar or rather late gadolinium enhancement, exceeds 15% of the total myocardium. Moving on to the medical management. There are several options. Now, typically, first. strategy is to avoid vasodilators, which can precipitate hypertension and hence worsen outflow obstruction.
Now the dehydration and use of diuretics, are common, issues that we, advise patients to keep an eye out for. We advise patients to remain hydrated and avoid diuretics if possible. Some of the medications like digoxin can potentially worsen an outflow tract obstruction, due to positive inotropic effect. So digoxin is certainly a medication that we encourage patients to avoid. Other inotropic agents ca, precipitate outflow stroke obstructions as well. So these are the things that, first line recommendations to avoid precipitation of LV outflow obstruction.
In terms of treatment, we recommend controlling heart rate, hence improving the left ventricular filling and reduced LVOT obstruction. Typically beta blocker is used Veropamil, which is a non bioperine calcium channel blocker can be used. Dysoperamide, which is an anti arythmic agent with negative anti Tropic properties can be used as well. However, this is a second line agent. As mentioned before defibrillator is used to prevent sudden cardiac death in patients, who are at increased risk for certain cardiac death.
The novel agent, mavacanton is a new kid on the block. This is a recently approved by FDA for patients with hypertrophic obstructive cardiomyopathy. This is a first in class elective, cardiac myocin ATPA inhibitor. It reduces actin myocin crossbridge formation reduces contractility, improved cardiac efficiency, and studies have, supported its use in patients with hypertrophic cardiomyopathy with obstruction. Moving on to the invasive treatment. We have, septal reduction therapy.
There are two, options for sepal reduction therapy. One is myectomy and the other one is alcohol septal ablation. Myectomy is a surgical procedure where surgeons, under direct vision removed part of the, basal septal wall. Alcohol septal ablation is a chemical means of reducing the basal septal, with infusion of alcohol into a specific, septal perforator. So with respect to sepal reduction therapy, we are talking about myectomy and alcohol septal ablation. Now who, benefits from myectomy or alcohol septal ablation, is the question we often get asked.
So this is treatment options offered to patients with refractory symptoms, despite medical therapy. It does not correlate with, mortality benefit. However, it does improve patient's quality of life. Myectomy is a surgical procedure. It requires sternotomy and cardiopulmonary bypass, and resection of myocardium from the left ventricular basal septum. Alcohol septal ablation is a catheter based procedure and it requires suitable, coronary anatomy, where we inject alcohol into parts of the thick and hard muscle, to scar the tissue and hence, reduce the thickness of mycardium.
There's several differences between myectomy and alcohol septal ablation. As mentioned, myectomy is an open heart surgery that requires cardiopulmonary bypass and sternotomy. This alcohol septal ablation is a catheter based procedure does not require bypass does not require sternotomy. Myectomy is often considered a definitive therapy. Whereas alcohol septal ablation is often considered as a secondary therapy for patients who are at high risk or perhaps even an inoperable candidate due to other comorbidities.
The main, discussion I have with patients when we're talking about myectomy versus alcohol septal ablation is need for permanent pacemaker. With myectomy need for permanent pacemaker is approximately 5%. Whereas alcohol septal ablation, the risk is higher. We generally say it's in the ranges of 10 to 15%. So that is an important factor to consider because once you require permanent pacemaker, Either from myectomy or alcohol septal ablation, this is a permanent commitment. You cannot remove the pacemaker because you are dependent on pacemaker.
So it's not a temporary treatment, but a permanent treatment. Another difference between myectomy and alcohol septal ablation is the recovery period. Myectomy typically takes six to eight weeks of recovery. Whereas alcohol septal ablation typically patients are able to return to their normal activities within a week.
Melanie Cole (Host): This is such an interesting topic doctors, and as an exercise physiologist, I have seen this and it's just so important. What you're really imparting your expertise for other providers. And I'd like to give you each a chance for a final thought and Dr. Al-Ani, to start with you, please tell us about the UF HCM program. Tell us a little bit about the importance of the multidisciplinary approach and why that's so important for these patients and the unique areas that set you apart and why it's important to refer to the specialists at UF Health Shands Hospital?
Dr Mohammad Al-Ani: So, the program that we have, we're really proud of, at UF. We approach this, as a team. So we have a team from interventional cardiology, Dr. Choi, myself from heart failure and imaging. We also have, other, cardiologists, who specialize in electrophysiology, and imagin, interventional cardiology. We have a geneticist and we have cardiac surgery with us. And we try to, give attention to each patient to define their, particular phenotype and risk stratify, them for complications such as arrhythmias. Identify how much, quality of life, impairment they have due to hypertrophic cardiomyopathy and accordingly, would they need a defibrillator or not for protection? And what is the best way to improve cardiac function and blood flow so they can have a, good quality of life?
And so you cannot really refer a patient to us too early. If, hypertrophic cardiomyopathy is suspected in a patient, we are always happy, to see those patients, and arrange an evaluation for them as soon as possible. And we meet monthly in a multidisciplinary way, to review cases who are suspected to have, hypertrophic cardiomyopathy after we complete the initial workup, If you notice that I have, for providers who don't commonly see hypertrophic cardiomyopathy, that comes up a lot.
The first thing that comes up a lot is that, Dr. Choi Mentioned that, vasodilators, need to be avoided. Dehydration definitely can cause those symptoms to bring up. Now this is a hundred percent true. and we all are cautious about these medicines. However, that does not mean that we treat their blood pressure. If the patient is hypertensive, you would still treat the blood pressure. You have just to be cognizant that this is a hypertrophic cardiomyopathy patient, especially if they're obstructive hypertrophic cardiomyopathy and be very cautious about getting that blood pressure on the lower range.
But at the same time, if they need a blood pressure medicine that we can still use blood pressure medicines. And as Dr. Choi mentioned, we would normally start with a beta blocker or calcium channel blocker as our first choice. So that's one point. The other point is that young patients, we are always happy to see them sooner than later, because we all, know, as we have more, data come, on hypertrophy cardiomyopathy that if it starts early in life, then it progresses faster. And so, we're always happy to see those patients sooner than later.
The last thing I would say is a comment on Mavacampton. So we have in our program, started several patients on Mavacampton, and we have had great success with it. We have a streamlined way of, signing up patients to therapy and there is a very structured and FDA mandated follow up, to make sure that, we are dosing the medication, safely and make sure that, we monitor patients for side effects. And the main side effect that we all watch for is causing Ejection fraction or cardiac systolic function to drop too low.
So we want to relieve that hyperdynamic function to a normal function, but we don't want to reduce it below normal. And this is something we have a, streamlined way to systematically monitor and adjusted dose, to make sure that, we achieved that sweet spot.
Melanie Cole (Host): Thank you so much for that. Dr. Al-Ani and Dr. Choi last word to you. I'd like you to speak to other providers about anything exciting or the most exciting advances in inherited cardiac disease. Follow up what you really want. The key takeaways from this podcast today to be about.
Dr Calvin Choi: Dr. Alania has mentioned at US Health, hypertrophic cardiomyopathy. We provide a comprehensive evaluation. And complete treatment options for the patients. These include leading edge imaging studies, as well as, the latest pharmacotherapy, including Mapacampton. Each patient is evaluated and discussed amongst our interdisciplinary team, which consists of interventional cardiology, electrophysiology, heart failure, imaging, cardiac surgeons, as well as genetic counseling.
Now because hypertrophic Cardiomyopathy tends to be associated with a autosomal dominant genetic defect. Genetic counseling is a critical component of the evaluation and treatment, for hypertrophic cardiomyopathy and the patients who are, related to, hypertrophic cardiomyopathy patients.
Melanie Cole (Host): Thank you both so much for joining us today and sharing your incredible expertise to refer your patient or for more information, please visit UFhealth.org/hcm or to listen to more podcasts from our experts, you can visit UFhealth.org/medmatters. That concludes today's episode of UF Health Med EdCast with UF Health Shands Hospital, for updates on the latest medical advancements, breakthroughs and research, follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs078.mp3
- DoctorsFranke, Aaron
- Featured SpeakerAaron Franke, M.D., M.S.
- Guest BioAaron Franke, M.D., MS is an assistant professor of medicine in the Division of Hematology and Oncology at the University of Florida College of Medicine.
Dr. Franke received his undergraduate degree in psychology from Florida State University and his medical degree from Saba University School of Medicine in the Dutch Caribbean where he graduated summa cum laude.
He completed his internship and residency in Internal Medicine at University of Florida where he was recognized as the exemplary mentor of the year.
He most recently completed his fellowship in Hematology & Medical Oncology at H. Lee Moffitt Cancer Center & Research Institute in Tampa. During fellowship, Dr. Franke grew his passion for learning, teaching and the importance of adapting a multidisciplinary approach to patient care and medical education. He served as one of the inaugural founding members and co-directors of Moffitt’s Multidisciplinary Leadership Journal Club.
Here at UF Health, Dr. Franke will focus on thoracic oncology, seeing patients with lung cancer. He serves as the Associate Research Lead for the Thoracic Cancers Disease Site Group at UF Health Cancer Center.
His clinical and research interests focus on Thoracic and Head & Neck malignancies. He aims to conduct industry-sponsored, and investigator initiated clinical trials, as well as participate in large oncology clinical trial cooperative group efforts to expand patient access to promising novel targeted and immunotherapeutic agents for patients with advanced lung cancer.
Dr. Franke is board certified in Internal Medicine and Medical Oncology and Hematology. He is a member of the International Association for the Study of Lung Cancer (IASLC), American Association for Cancer Research (AACR), American Society of Hematology (ASH), American Society of Clinical Oncology (ASCO), and Florida Society of Clinical Oncology (FLASCO).
He also earned the rank of Eagle Scout with Scouts BSA - TranscriptionThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME, to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole, MS (Host): Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole. And joining me today is Dr. Aaron Franke. He's an Assistant Professor of Medicine in the Division of Hematology/Oncology at the University of Florida College of Medicine. And he's a research co-director of Thoracic Disease Site Group, and he practices at UF Health Shands Hospital. He's here to highlight neoadjuvant immunotherapy for resectable non-small cell lung cancer and the current challenges facing the shifting paradigm of early stage management.
Dr. Franke, it's a pleasure to have you join us today. Can you start with a little background on the evolution of treatment for non-small cell lung cancer in the case of mortality? What has been the standard of care?
Aaron Franke, MD: Sure. And thanks for having me here to talk about this very timely topic. So just to give a little background, you know, lung cancer, again, remains the leading cause of global cancer mortality. And non-metastatic, so early stage non-small cell lung cancer, is going to account for about 12% of all newly diagnosed cancers and about 20% of that mortality annually in the US.
So when about a third of patients present with early-stage tumors that are amenable to surgical resection, you know, despite this curative intent, surgery and systemic therapy that has been the standard of care that we'll talk about, the five-year overall survival, so the long-term survival, still remains poor. With about 65% if you have stage IB or II, that drops to about 41% in stage III. So the majority of these patients, as you go up in stage, still end up having recurrence, usually with distant metastatic disease.
I should say, based on a lays meta-analysis of all the randomized trials that showed, I guess, a minor benefit to the addition of platinum-based adjuvant chemotherapy for stage II to III non-small cell lung cancer, you know, based on a 4%, 5% benefit at five years, this has been our standard for, well, longer than I've been a doctor, Melanie.
And you know, the problem is that following curative intent treatment with surgery and chemotherapy are surveillance imaging, you know, what we use to detect recurrence, CTs, MRIs, they remain limited as they can really only identify macroscopic recurrent disease. And when this happens, it's most often advanced, incurable and usually metastatic. And historically, this has been associated with pretty poor outcomes.
Now, I said the standard of care had not changed for decades. Now, this shifted last year, when we saw the recently published IMpower010 results. So this was the first reported phase III study of adjuvant. Now, again, we're talking about neoadjuvant or preoperative therapy today. But to get there, we just need to highlight that adjuvant immunotherapy was kind of the first to change this paradigm last year in resectable non-small cell lung cancer. So the addition of atezolizumab, a PD-L1 immune checkpoint inhibitor gave us an improved disease-free survival for patients with stage II to IIIA resected non-small cell lung cancer whose tumors expressed PD-L1 at least 1%.
Now, we can dive into the subsets another time. But you know, looking at this, it seems the PD-L1 expression, the higher it went, as we see in most of the metastatic trials, really seem to be the driver of this benefit. And a similar trial with pembrolizumab, the KEYNOTE/PEARLS trial, we saw that they also had an improved DFS benefit or disease-free survival improvement regardless of PD-L1 for the stage IB to III resected non-small cell lung cancer.
So now, we dive into the story of today, right? There has been no direct trial level assessment of whether perioperative systemic therapy, chemotherapy or chemoimmune therapy is more beneficial either before or after surgical resection. Now, theoretically, the reason a lot of people live in the neoadjuvant camp, I'll say, is that there are several theoretical advantages, including leveraging systemic therapy in the preoperative neoadjuvant setting. And this helps us prioritize early sterilization of micrometastatic disease, tumor downstaging, increased rates of complete or R0 surgical resections, reduced surgical time and complications and decreased need for more invasive resection procedures like pneumonectomies.
In addition, giving the immunotherapy or chemoimmune therapy with the primary tumor still in place really maximizes your immune system exposure to the neoantigen burden of the tumor. So this ostensibly is what is leading to these deeper pathological responses. So there have been several neoadjuvant immunotherapy trials, most of them non-randomized, early phase or single arm to date, and they were designed using treatment response assessments. And we'll keep going over this as we go through the data and these include major pathologic response, so less than 10% viable tumor cells or a complete pathologic response or a path CR as we'll say today. And these were the primary study endpoints and the proposed surrogates for relevant oncologic outcomes. So having said that, that is where the standard has been. And we'll kind of talk about where it has shifted to just in the last six months or so.
Melanie Cole, MS (Host): So why don't you do that for us? Discuss the current challenges facing that shifting paradigm for us.
Aaron Franke, MD: Yeah. So, again, we had lots of early phase single arm trials. I was a part of a few of them. I think we had one here at UF Health Shands as well as that Moffitt Cancer Center where I was before. And these were just looking at a few doses of preoperative immune checkpoint inhibitor. And what they saw was a very high rate of pathologic downstaging and path CRs. You know, with chemotherapy, historically, you see about a 1% to maybe 4% rate of pathologic complete response giving neoadjuvant chemotherapy alone. So when these immunotherapy trials were showing 10%, 20% and above and later the chemoimmune therapy trials showing 30%, 40% rates of path CR, you know, we really started to scratch our head and wonder, "Okay, is this a good surrogate for long term survival? And is this a more meaningful approach than trying to give it in the postoperative or adjuvant setting?"
So, the first kind of study to tease this out for us, although non-randomized, was the phase II NADIM study, and this was looking at chemotherapy versus chemoimmunotherapy for three cycles for resectable stage III non-small cell lung cancer. Now, where this becomes a little tricky is, I should say, since 2018, when Dr. Scott Antonia announced the initial results of the PACIFIC, and this was the most practice-changing study in stage III non-small cell lung cancer in decades, our new standard of care for unresectable stage III really became chemoradiation followed by a year of consolidation immunotherapy with durvalumab.
Now, when you look at the NADIM study, this was stage III a and B tumors with 72% of these patients having what we call N2 nodes or pathologic clinical lymph node involvement at the N2 stations. To begin with, most surgeons are not comfortable outside of an academic center routinely operating on N2 nodes without preoperative therapy. You know, high rates of recurrence, high rates of R1 resections and high rates of pathologic upstaging of other lymph node groups once they get in there. And in addition, since PACIFIC has come out, I will tell you that even at our own center and in my own practice, really any patients with contraindication to surgery who don't want to undergo surgery or who have an N2 node or higher, they've really been going straight to the PACIFIC regimen. It has an overall survival benefit that has maintained itself five plus years now. So I think surgery was starting to get taken off the table without even much of a discretion for at least the IIIB tumors and most IIIA's.
So now, we're shifting this paradigm back and saying, "Okay, wait. We're actually having rates between 30%, 40% in the randomized study," maybe 25% of patients having a complete pathologic response, meaning when they go in there to cut the tumor out, there's actually no viable cancer cells left. So, this is a potentially curative population with otherwise thought to be high risk disease. So now, I think we're shaking up a little bit, who really is operative and who is not. And this is where the multidisciplinary team becomes even more crucial than it has always been in lung cancer, where the surgeons, the radiation oncologists, the pathologists, the medical oncologists, and the radiologists really need to be around the same table for, I would say, anybody with stage IIB to IIIB in a discussion of, "Okay, is this patient operable? And do they have clinical and tumoral features that suggest a pre-operative approach may be more beneficial or at least as beneficial? And why or why not should we pursue that as opposed to the standard cut it out and then give chemotherapy and immunotherapy on the back end?"
And these results were confirmed with the CheckMate 816 earlier this year at a AACR. And again, we saw 25% versus I think 3% pathologic complete response rate. This was associated with a prolonged event-free survival. Again, we still await overall survival data. There were less pneumonectomies. The operative time was less. And again, this was associated with higher PD-L1s had better tumor downstaging. There was CT DNA or circulating tumor DNA correlative data that showed higher rates of clearance with the chemoimmune therapy versus chemotherapy alone. And this is what led to the FDA approval of this regimen.
So cut two, okay? Now, we are three-quarters of the way through 2022, right? We now have a preoperative chemoimmune therapy for three cycles that is FDA approved for resectable non-small cell lung cancer, regardless of PD-L1. And now, we have adjuvant atezolizumab approved for stage II and III resectable PD-L1 positive group. And we have pembrolizumab that is probably very soon to get its approval for the same indication in the adjuvant setting.
So we now have two different treatment paradigms for essentially the same patient population. And the problem is that CheckMate 816 was the first phase III study in this realm to publish its results. It was in tremendous effort and a great trial. The problem with this trial is it is the only standalone neoadjuvant trial that was both performed and that will be reported. All of the other neoadjuvant studies that are highly anticipated are periadjuvant, meaning they give pre and postoperative immunotherapy with or without the chemotherapy. So it's really going to muddy the waters and kind of obfuscate who needs more treatment after surgery. And this has been, I'd say, the biggest point of debate, scratching our heads, lack of data, and really probably what I've gotten the most calls about from the community for physicians who are able to actually implement this neoadjuvant strategy and have this multidisciplinary surgical and radiation conversation, yet afterwards, they're wondering, "Do I give chemotherapy on the back end? Do I give immunotherapy on the back end? Is PORT or postoperative radiotherapy still of any benefit in this population?" You know, "Do we gauge it on the pathologic complete response, the circulating tumor DNA?"
So, while it is amazing that we now have a great treatment for our well-selected high-risk population that will hopefully continue to increase our rates of cure and maybe decrease some of the burden of 16 months of adjuvant therapy that we're used to slating patients too. It's definitely left us with so many questions, intriguing, but still very confusing, I would say, even for us that just specialize in one or two cancers, you know, think about the community oncologist that's treating 15, 20 tumor types in a day, this is a lot to take in and try to sit there and parse through what is the best clinical scenario for each patient and how do we really extrapolate from data that has no historical comparison for us to extrapolate from.
Melanie Cole, MS (Host): Wow, this is absolutely fascinating. And what an exciting time to be in your field, Dr. Franke, and thank you for pointing out the importance of that multidisciplinary tumor board and evaluating treatment approach and the utility of these several parameters as predictive biomarkers for therapy personalization. As we get ready to wrap up, please let other providers know what you'd like them to know about when they're planning therapy for patients with resectable non-small cell lung cancer, based on those individual patient considerations, the expert recommendations and the available clinical data that you've spoken, when you feel it's important they refer to the specialists at UF Health Shands Hospital.
Aaron Franke, MD: Yeah. I would say, for one, clinical trials are always a great option. So, even in the AE trial that I will hopefully be opening here in the coming months. You know, we're looking at circulating tumor DNA to help guide our periadjuvant therapy both in the pre and postoperative setting immunotherapy escalation. So clinical trials are always great. But let's say for the patient that doesn't wanna travel that lives far away and is just trying to get a second opinion, I think all patients in this stage II and III, if preoperative or postoperative therapy is going to be considered upfront, multidisciplinary discussion is I would say paramount and required. The only person who should be able to say operable, non-operable is that oncologic surgeon.
Now, having said that, and these will be the pearls I leave you with, there needs to be some very rational and pragmatic discussions between the surgeon, the med-onc and so forth that need to have realistic expectations. So if the surgeon comes to you and say, "This isn't really resectable, maybe we can give upfront neoadjuvant therapy and make him or her resectable," that is not the strategy that was used in any of these studies. And I will also say that, if you are expecting the tumor in the lymph nodes to kind of melt away from the mediastinum to help clear a plane of dissection, it actually usually involutes towards the mediastinum. So again, these are important anatomical considerations when you're trying to use this therapy to "downstage" a patient to make them resectable.
So these patients should be surgically operable, even if they have N2 disease. So I would say the patient I consider this most for, if you say, "Dr. Franke, who is that patient that you are thinking about this, you know, for the last few months?" And that would be a stage III single station N2 PD-L1 positive. And remember the importance of biomarker testing, EGFR and ALK, and I'll say even ROS1-negative patients, I would say these are not patients who should be implemented in this, regardless of their inclusion or exclusion from the studies. And I will tell you that EGFR and ALK were excluded from almost all of these studies. And remember, we have an adjuvant EGFR targeted therapy that is approved for resectable stage IB to III. So, I'd say the pearls to take away is multidisciplinary discussions are the underlying kind of mantra you want to revisit because it really has become very complicated. And if you don't have that access to that round table, you know, it is nice and easy to have a place like UF Health Shands and the UF Health Cancer Center to send your patient, even if it's for us to tee them up, to send them back to you and your surgeons, you know, to have that access to the multi-D discussion, I think really, one, obviously benefits the patients. It also benefits the physicians out in the community who again are trying to parse through very convoluted data at the current time. Exciting, but convoluted nonetheless.
Melanie Cole, MS (Host): Certainly a time of personalized medicine and therapy personalization. And thank you so much, Dr. Franke, for joining us today and sharing your incredible expertise. To refer your patient or to listen to more podcasts from our experts, you can visit ufhealth.org/medmatters.
That concludes today's episode of UF Health MedEd Cast with UF Health Shands Hospital. For updates on the latest medical advancements, breakthroughs in research, follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs076.mp3
- DoctorsCampbell, Kevin
- Featured SpeakerKevin Campbell, M.D.
- Guest BioKevin Campbell, MD is an assistant professor of medicine in the Department of Urology at the University of Florida College of Medicine.
Dr. Campbell received his undergraduate degree in biology with honors from Louisiana State University and his Master of Science degree in cell and molecular biology from Tulane University. He earned his medical degree with research distinction honors at LSU shortly thereafter.
He completed his internship in General Surgery and his residency in Urology at the University of Florida where he served as a UF Administrative Chief Resident. Dr. Campbell most recently completed his fellowship in Reproductive Medicine Surgery at Baylor College of Medicine.
Dr. Campbell specializes in Men’s Health including fertility management, hypogonadism and testosterone therapy, and the treatment of Peyronie’s disease. His clinical interests also include erectile dysfunction, male prosthetic urology, sexual disorders, as well as medical and surgical management of benign prostatic hyperplasia.
His research interests focus on male reproductive solutions involving restoration of sperm production after hormonal or medical suppression. - TranscriptionThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME, to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.
Melanie: Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole. And joining me today is Dr. Kevin Campbell. He's an Assistant Professor in the Department of Urology at the University of Florida College of Medicine, and he practices at UF Health Shands Hospital. Dr. Campbell, it's a pleasure to have you with us today to talk about vasectomy reversal provider and patient considerations. Can you first start by explaining a little bit about the prevalence of vasectomy and the prevalence of this procedure?
Dr. Kevin Campbell: Certainly. And thanks for having me back, Melanie. It's always good to talk with you guys. And this is something that I'm passionate about being in the field of men's health and fertility and infertility. And so vasectomy reversals are something that is very central to fertility in men who have undergone vasectomies, because vasectomies are pretty common. Five hundred thousand men each year undergo a vasectomy. And of those 500,000 men, about 20% of those have some desire for future fertility and 6% of those 500,000 men will undergo a vasectomy reversal.
So this is certainly something that's on the minds of some of these guys who undergo a vasectomy, though not everybody will undergo a reversal and some people will use other forms of of assisted reproductive therapies for a pregnancy. However, when we're looking at the aspects of contraception and sterilization, vasectomy is a safe and proven form of male contraception. So I tell guys the best way to do a vasectomy reversal is to not have a vasectomy. Although, certainly the vasectomy is something that many men will go through. And so having a vasectomy reversal as an option I think is fantastic for guys.
Melanie: Well then, for other providers counseling their patients, Dr. Campbell, please describe the workup for patients interested in vasectomy reversal. What are the certain criteria in order for this to even be an option?
Dr. Kevin Campbell: Certainly. So for a vasectomy reversal, a lot of the workup involves a basic encounter, including a history, a physical exam and often a laboratory evaluation of men who are considering a vasectomy reversal. And we're taking a special care to look at the reproductive history, the prior history of paternity, partner characteristics, what they're willing to go through from a financial standpoint or a surgical standpoint, if they've had histories of potential insults to the testicles and fertility such as chemotherapy, radiation, febrile illnesses and also their surgical history. Did they have complications with their vasectomy, other scrotal surgeries? And even other considerations too, such as use of testosterone, because we do know that testosterone therapy can decrease a patient's fertility.
And so once we do that with the history, we'll also do a physical exam. And so we're looking for different scars in the inguinal region or the groin indicating possible previous procedures. A scrotal examination is going to give us a lot of information because, when we do have vasectomy, we essentially interrupt the highway of sperm leaving the testicles. So we block, we cut and we cauterize or clip the vas deferens and sometimes remove a segment so that sperm aren't able to traverse that segment anymore. And so when we're looking to reverse that, we are noting if there's a big gap, if there's a lot of induration or inflammation behind the blockage on the testicle side, where sometimes there's additional inflammation, which can be a prognostic indicator of how well the vasectomy reversal is going to take. Now, we also note the testicular size and consistency. And if the testicles are very soft, that might indicate a decreased sperm production, or if they're nice and taut, then you might think that there's going to be a lot of sperm production and we just have more of an obstructive picture from the prior vasectomy.
So these are some things we consider on a history and physical, and we'll often get a laboratory evaluation as well, looking at the patient's testosterone and some of their sex hormones, including a FSH or follicle-stimulating hormone and LH or luteinizing hormone, because that's going to tell us if the patient is having a lot of their own sperm and testosterone production. So that's going to be the initial evaluation in men undergoing an evaluation for a vasectomy reversal.
Melanie: Well, thank you for that. And before we get into an outline of some of the surgical techniques and procedures, speak about provider and patient considerations. What are some of the factors you consider when choosing to perform this? Is there counseling involved? Why is that important?
Dr. Kevin Campbell: Yeah. So this hits on a very important part for fertility care, and that's a lot of the counseling. Because oftentimes with healthcare and medical care, there's a set right answer and a set pathway. And when we're talking fertility, there's usually a couple of options or discussion points that we should hit.
So vasectomy reversals are good for men who are averse to multiple interventions. Potentially, they may not have a provider who can perform in vitro fertilization or other assisted reproductive techniques or there may be other considerations such as post-vasectomy pain syndrome or the desire to have a natural pregnancy without assisted therapies that go into the counseling. And certainly, when we talk about partners, that becomes a big part of the workup as well. After a certain part or after a certain age, a patient and their partner may be recommended to undergo assisted reproductive therapy or, after a certain point, they may not be a very good candidate for something like IVF and so a vasectomy reversal again becomes a better option for these couple. So a lot of counseling goes into the decision making process of whether to proceed for a vasectomy reversal.
Vasectomy reversal is a very safe procedure and it's often done in the operating room with some general anesthesia so that the patient is asleep during the procedure. And the procedure is done as an outpatient procedure. And oftentimes we get return of sperm to the ejaculate within six to eight weeks, although we're following up the patients at every three-month intervals to make sure they're having sperm return to the ejaculate.
Melanie: Can you outline any surgical techniques and procedures that you would like other providers to know about and how important is the experience of the clinician in this decision and in these procedures for better outcomes?
Dr. Kevin Campbell: That's a great question and a great point to hit on. A lot of the success for a vasectomy reversal depends on the provider experience and the intraoperative decision-making. Vasectomy reversal can be considered a very straightforward or a very difficult surgery. About 50 to 60% of the surgery is all microsurgical suturing and tying of knots with sutures that's finer than a human hair. And so whenever the procedure is done, the prior vasectomy site is excised or cut out to unblock the testicle side or the sperm-producing side of the the prior vasectomy. At that point, we'll look at the sperm under the microscope. And this is very important because this is where much of the decision-making process occurs. If there is sperm in that fluid that's coming out of the testicle, then we know that the testicle side is unblocked and we can proceed by hooking the two ends up together for a regular end-to-end vas-to-vas or vasovasostomy. And that has about a 90% to 95% success rate in having sperm return to the ejaculate
If we make that incision and unblock the vasectomy and we don't see any fluid coming from the testicular side of our vas, then there's very high potential that there's additional blockages closer to the testicle, either from inflammation scarring or just time from the vasectomy to the vasectomy reversal. And so in that case, we have to start evaluating the vas deferens and the epididymis next to the testicle as the epididymis is the portion of the sperm tube or vas that exits the testicle. And so in that case, we might be taking the end of the vas and hooking it up to the epididymis to bypass any of these secondary obstructive points for what's called epididymovasostomy. And that has about a 60% to 65% chance of returning sperm to the ejaculate.
Now, oftentimes we don't know which one of these we're going to be doing until we're in the operating room. And so it's very important to have a skilled microsurgeon who is able to evaluate the sperm under the microscope and perform either one of these procedures. Oftentimes, we will be able to make an educated decision or guess if a patient will be undergoing a vasovasostomy or the more complex epididymovasostomy based on their time from their vasectomy. If it's been within 10 years, often we'll be able to do a vasovasostomy. However, if the procedure has been 10 years out or more, it's a high likelihood that we may be prepared to do an epididymovasostomy because of secondary obstruction for prolonged blockages. So again, a lot of this is intraoperative decision-making, so it's very important that the skilled microsurgeon performing the procedure has the ability to do both of these.
Melanie: Thank you for that. Now, can you discuss the postoperative considerations following vasectomy reversal, some of the variables that may influence reversal success rates?
Dr. Kevin Campbell: Yes. So you hit on a very important topic and that's postoperative care. So after a vasectomy reversal, in theory, there is sperm returning to the ejaculate right afterwards. Now, this sperm is often not the healthiest sperm because it's been blocked in the vas for some time, so it'll have short tails, lower motility, and potentially additional changes in morphology and changes to the DNA integrity of the sperm. So we anticipate the first sperm that's making its way back to the ejaculate to be rather unhealthy. And so, we check sperm counts and motility and other sperm parameters every three months following the procedure. And we anticipate to see a low motility right after the procedure. But the farther out we get and the more unblocked sperm and healthy sperm making its way into the ejaculate, we anticipate a higher rate of pregnancy the farther out we get up until six months or even a year following surgery. So oftentimes, we'll be checking the semen analyses multiple times after surgery. We also do this because, even in the best hands, the connection between the vas deferens during the vasectomy reversal can scar down. And so if we do see that scarring occurring, we know that sperm are going to start to bottleneck and back up behind that scar tissue. And so we want to try and save as much sperm as possible and either freeze that sperm or use assisted reproductive therapies to try and assist in a pregnancy to try and give the patient and their partner the best chance of a healthy and positive outcome.
Melanie: As we wrap up, this is so interesting and you're such a great guest, Dr. Campbell, let other physicians know what you would like them to know about vasectomy reversal at UF Health Shands Hospital and when you feel it's important they refer their patients.
Dr. Kevin Campbell: So at University of Florida at the Men's Health Clinic and the Fertility Clinic, we're happy to see all patients who are interested in a vasectomy reversal. A lot of what goes on, as we talked about, is a lot of patient counseling. So sometimes we talk to the patients and they are very excited about proceeding with a vasectomy reversal. And other times, they might find that there's another outcome or another course of action that would be better for that individual couple. So we really try and tailor the care towards the couples and not put them in any sort of non-Ideal category for them. So we really like to make a patient-centric decision here. So I would say if you're considering referring a patient to the men's health or infertility clinic, we would be happy to see them and discuss this further.
Melanie: Thank you so much, Dr. Campbell. What an informative podcast. And to refer your patient or to listen to more podcasts from our experts, please visit ufhealth.org/medmatters. That concludes today's episode of UF Health MedEd Cast with UF Health Shands Hospital. For updates on the latest medical advancements, breakthroughs and research, follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs075.mp3
- DoctorsZlotecki, Robert
- Featured SpeakerRobert Zlotecki, M.D., PhD
- Guest BioDuring my 15 years at the University of Florida, one of my areas if focus has been the multidisciplinary management of patients with pediatric sarcomas of soft tissue and bone. Currently, I serve as the Medical Director for the UF Department of Radiation Oncology and participate in several national professional societies and committees, including the American Board of Radiology and the Radiologic Society of North America. Clinical research productivity includes 55 peer-reviewed publications and several supporting grants. My clinical practice integrates translational research collaborations with our UF Prostate Disease Center, and also with our medical physics and informatics programs. Direct collaboration with colleagues in the UF Cancer and Genetics Institute connects my Ph.D. training in Pharmacology with the applied radiation biology, to facilitate the translation of laboratory research to clinical application in the delivery of multi-modality integrated cancer therapies. My specific technical interests include the management of metastatic cancers utilizing the technologies of Stereotactic Body Radiotherapy (SBRT) with Image Guidance (IGRT), which employ accelerated hypo-fractionation dose delivery protocols; and the development of emerging mobile and interactive technologies to enable an eMedical infrastructure to facilitate the collection of physician and patient reported quality and satisfaction data related to cancer diagnosis, treatment, and Quality of Life (QoL) outcomes.
- TranscriptionThe University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME, to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole (Host): Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole. And joining me is Dr. Robert Zlotecki. He's the medical director and a professor in the Department of Radiation Oncology at the University of Florida College of Medicine. And he practices at UF Health Shands Hospital. He's here to highlight Pluvicto for PSMA, positive metastatic castrate-resistant prostate cancer.
Dr. Zlotecki, welcome back. And thank you so much for being with us today. As we get into this absolutely fascinating topic, can you tell us a little bit first about metastatic castrate-resistant prostate cancer? Define it for us. Describe what you've been seeing in the trends, and you can even give us a little bit of diagnostic criteria to be labeled as hormone-refractory.
Dr Robert Zlotecki: So as everybody understands that prostate cancer is now one of the biggest killers of older men; lung cancer, no longer and heart disease, not so much even there. But prostate cancer, one of the biggest cancer risks and, although prostate cancer in many respects is now very well early diagnosed and managed and can be cured. There's unfortunately a segment of men who do have very high risk aggressive prostate cancer that does not respond to therapies well at all, becomes let's say rogue in some respects and becomes independent of the classic method of control, which is applicable to also to women with breast cancer, through the pathways of hormone manipulation.
These patients unfortunately develop metastatic disease early. It becomes aggressive and the use of hormone therapies only will work for so long in controlling or containing this disease. When the prostate cancer becomes independent of the hormone pathways, regulatory pathways, the metastatic spread can become aggressive and we need other pathways of treatment, the classic path, and then becomes the use of systemic chemotherapy agents in the Taxol or taxane family. But now, we're looking at a different method by targeting the prostate-specific membrane antigen, a marker on the cell system of cancer cells that would be amenable to directly bound or avid targeting and delivery with a radioactive element.
Melanie Cole (Host): Well, thank you for that, Dr. Zlotecki. And for other providers that are relatively new to these exciting advances, can you outline the current shift in thinking regarding systemic radiopharmaceutical therapies for prostate cancer as the treatment options in the past you've described for us? What's changed now? You can speak about Pluvicto, because the FDA has approved this now. So speak a little bit about this current shift in thinking.
Dr Robert Zlotecki: So Pluvicto has been FDA approved based on very recent clinical trials that have looked at the population of gentlemen with some of the most aggressive prostate cancer and who have progressed after the taxane chemotherapies have failed them. These gentlemen were demonstrated to have a significant advantage in their survival, their well-being and quality of lives with the use of Pluvicto or lutetium 177 PSMA radiotherapy treatment, systemically delivered. And this agent is now also in clinical trials for patients with earlier presentations of the prostate cancer. For example, patients who have not seen any taxane-based chemotherapy, because many gentlemen just do not want to accept taking a standard systemic chemotherapy drug, regardless of the tolerance of it, which taxane have variable effects in some folks, particularly neuropathy issues. There's also a clinical trial in gentlemen who are still hormone-sensitive and have not become castrate-resistant. So there's a steady shift of this type of therapy, what's called radioligand, very specific target therapy forward in the disease of prostate cancer.
Melanie Cole (Host): So what are some of the factors? You mentioned a few. I'd like you to expand a little that make a patient a candidate for this type of treatment. Now, is it used standalone at the point when a hormone no longer works? If they're on XTANDI or one of those? Is it used adjuvant? Tell us a little bit about patient selection?
Dr Robert Zlotecki: Right now, the FDA indications criteria for the prescription and delivery of Pluvicto include gentlemen who are with metastatic castrate-resistant prostate cancer who have progressed, whether they've received XTANDI or abiraterone, or other agents in addition to standard conventional androgen deprivation therapy. But the key issue is these gentlemen must also have had a trial of a taxane-based chemotherapy regimen and progressed on that drug therapy.
The other thing that must be demonstrated and confirmed is that the patient has a positive PSMA PET scan, which demonstrates uptake or avidity of the PSMA ligand and basically binding effectively to the prostate cancer cells. Once those criteria are met and the patient does have an acceptable performance status as well as acceptable laboratory parameters of both bone marrow and kidney function and also liver function, then the patient would be a very good candidate for systemic therapy with the drug Pluvicto, which has a huge advantage over previous systemic radiotherapy treatments and that it not only effectively targets and treats metastatic disease in the bone, but it will target cancer cells that are in lymph nodes and other soft tissues or organs, which previous agents could not reach.
Melanie Cole (Host): Wow. That is so exciting. What an exciting time to be in your field, doctor. So what have the clinical trials shown as far as its effectiveness and where do you see this headed in the future?
Dr Robert Zlotecki: The very good thing is that it has shown an absolute survival advantage in the patients who have been treated with this agent and who have unfortunately become resistant to practically all other therapeutic lines. That is a huge absolute there. Where do we see this type of therapy going? Just as the currently active clinical trials in progress are directing us, we are expecting this to come forward in the regimen of cancer therapeutics in prostate cancer, such that it'll be applied more effectively in the cure of, well, prostate cancer maybe, but in the control of metastatic prostate cancer or aggressive and resistant cancers, and may be replacing some therapies that only have minimal efficacy or limited time of efficacy, such as the taxane-based chemotherapy or some pathways of advanced or unique hormonal suppression. So, again, it won't be used in combination, but it will be coming forward in the overall regimen of systemic treatment for high risk and metastatic prostate cancers.
This is something we would also expect to see in other lines of cancer treatment development. Similar pathways of treatment have been evoked in metastatic neuroendocrine pancreatic cancer. And we should see it come along in other highly aggressive and metastatic cancers.
Melanie Cole (Host): As we wrap up, doctor, what a great guest you are. Can you please tell other providers when you feel it's important to refer and if there's any clinical trials or studies that you would like them to know about or to get their patients involved in? Please tell us about those now.
Dr Robert Zlotecki: Right now, there are several clinical trials. Most notably sponsored both by the Novartis, Corporation, which is PSMA4 for patients who have not been treated with taxane-based chemotherapy yet. The radiation therapy oncology group in cooperation with other clinical trial organizations has advanced patients with hormone-sensitive prostate cancer into treatment with the PSMA lutetium agents, Pluvicto. The biggest effect that we're hoping for to see in these trials, again, as an endpoint is an absolute improvement in overall survival for these patients. But we're also expecting, significant delays in any progression of the disease and, again, an overall improvement in the patient's quality of life by not only effectively managing their disease, but also by not subjecting them to side effects, greater effects from drugs and other therapies that may not have the efficacy and the viability that this agent hopefully should demonstrate.
Melanie Cole (Host): Thank you so much, Dr. Zlotecki, for joining us today. To refer your patient or to listen to more podcasts from our experts, please visit ufhealth.org/medmatters. That concludes today's episode of UF Health MedEd Cast with UF Health Shands Hospital. For more updates on the latest medical advancements, breakthroughs and research, you can always follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs074.mp3
- DoctorsMohamed, Basma
- Featured SpeakerBasma Mohamed, MBChB
- Guest BioDr. Mohamed is an Assistant Professor in the divisions of Perioperative Medicine and Neuroanesthesia. She came to us from our very own Anesthesiology residency program. Dr. Mohamed is originally from Alexandria, Egypt, where she received her MBChB degree. She received training in managing clinical anesthesia for surgical patients in several departments including Orthopedic Anesthesia, General Surgery, and the Post Anesthesia Care Unit.
Learn more about Basma Mohamed, MBChB - TranscriptionThe University of Florida College of Medicine is accredited by the Accreditation Council for continuing medical education, ACCME to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA category one credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity. Welcome to UF health med EdCast with UF health Chan's hospital. I'm Melanie Cole. Joining me today is Dr. Basma Mohamed. She's an assistant professor in the department of anesthesia and the divisions of perioperative medicine and neuro anesthesia. At the University of Florida college of medicine, Dr. Mohamed practices at UF Health Shands Hospital.
Melanie Cole: Dr. Mohamed, I'm so glad you could join us today to highlight Perioperative optimization of the elderly spine surgery patient. So can you start by discussing unique aspects of orthopedic care in elderly patients? What makes this group of patients unique for this type of practice? Some of the issues that surround them when they are experiencing spinal issues?
Basma Mohamed: Hello. Yeah. Thank you so much for inviting me to this podcast. So we have noticed over the last years that the population's aging and more and more patients are presenting to the spine surgeons with more symptomatic spine disease. What's really interesting is that the spine surgeon is always coming to the anesthesiologist and asking, well, this patient's elderly and high risk will be able to offer surgery without having a lot of complications. Afterwards, what we noticed that is very unique about this population is the fact that not just the list of comorbidities that they're experiencing, many of them have a list.
Medical problems that they need care for, but also what was not noticed from the anesthesia and also preoperative care standpoint, how functional they are, how much nutrition they take, how much social support they have. And from a psychological standpoint, many of them experiencing anxiety and depression. And on top of all of that, the cognitive status that they have, this might go unnoticed as well. And from the spine pathology itself, you have experienced a lot of pain issues. Over the years. And by the time you are surgical candidates, you're really suffering so much from pain.
So as a result of this, I think a preoperative evaluation that focuses only on medical optimization is not enough for that population. And that's why we decided to group together and just look at literature and look at this patient population, how unique they are and offer them different options for different aspects that I've talked about.
Melanie Cole: That's so interesting, and it really is. An exciting time to be in this field because of this aging population. Now, Dr. Mohamed, it's interesting for perioperative in that it involves that entire timeframe from pre two post surgery. And you just mentioned how pre is just really not enough, but before we get into the elements that define these periods, can you discuss what ties them all together? The unifying goal of the perioperative optimization of the elderly patients.
Basma Mohamed: So the goal is first to make sure that we optimize every aspect that I've talked about. In addition to the medical comorbid optimization. At the same time, we need to provide the adequate evidence based clinical care during the surgery, and also after the surgery to expedite the recovery and hopefully discharge them home and not really needing any skilled nursing facility or anything like that.
Melanie Cole: So tell us about a comprehensive preoperative evaluation what's involved in that. And what are some of those quality of life considerations you mentioned before when you're considering the treatments for these patients?
Basma Mohamed: Great. So currently at UF Health Shands Hospital, when the spine surgeons decided the patient is high risk, and also they will benefit from having spine surgery. They refer them specifically to the anesthesia preoperative clinic in a form of anesthesia consult. During that consult, we pay so much attention to their medical comorbidities, but we also assess the functional status using a six minute walk test and afer assessment test. We also like to evaluate their nutritional status using preen as a lab test. We do preoperative cognitive screening.
And we have a wonderful group of neuropsychologists who dig deep in that population and evaluate them through extensive neuropsychology testing to predict their risk of delirium. Afterwards, in addition, they also offer psychological evaluation and in some situations they were able to tell us if this patient has an undiagnosed anxiety or undiagnosed depression that will need further optimization before we proceed with surgery. We also evaluate the level of social support and we provide them with a patient education material that can help them through the entire preoperative continuum.
Melanie Cole: Can you expand just a little bit? And you mentioned the frailty assessment and the importance, the methods that we're seeing in the literature today, what do they say about that?
Basma Mohamed: Surprisingly frailty assessment has been extensively studied in the general surgery population, but if you look at the PubMed recently in the last couple years, there's a huge number of studies and thematic reviews that have focused so much on feral in that population, fine surgery population. Every study category, they will focus on patients that are really either high risk from a medical standpoint or from a surgical standpoint. The focus really on fertility is it's mainly, it's an age related kind of decline in the patient physiological function to the point that they really become vulnerable to stressors.
So at this time there are so many, I mean, there are between 11 to 28 different frailty assessment tools that have been tested, validated, and modified based on the clinical feasibility and applicability in a clinical setting. However, the main focus on frailty is the combin. Impact of multiple comorbidities and the function status of the patient. I can explain a little bit more by explaining that, for example, at our institution, what we do with through assessments that we assess their ability to being physically active, their walking speed, the self-re exhaustion whether they lost weight over the last six months or not.
And then we finally, we test their weakness or the strength of their hand grip. These are five different elements that focus so much on one domain, which is the functional status. And it gives you an idea about overall how functional they're gonna be now and how functional they're gonna be afterwards. And for frail patients, we offer some opportunities for optimization, which I can talk about a little bit later.
Melanie Cole: Well, that's what I would like to talk about is those opportunities for optimization. And one of the words we hear now much more often is pre rehabilitation. So for frail elder patients in preperation of spine surgery. How is this improving clinical outcomes? How does it benefit the patients speak if IRO is involved and how this type of program really assesses and prepares older adults prior to surgery?
Basma Mohamed: Yes. So, we have a unique collaboration with the physical therapy group at our institution. So back in 2017, we decided to gather and look at the literature of the general surgery population and see what really was done so far in the frail elderly population. They help us design a prehab rehabilitation program where it's focusing on the core strengths in addition to some ideas for aerobic exercise. But the whole idea is core strength for that population. So they can prevent any kind of postoperative complications, which I'm gonna elaborate a little bit more.
So those patients are really are frail, so they fail the frailty test and we get them up and get them walking for six minutes. And if they read below 50% predicted of their six minute walk test. Then we send it to prehab. They get evaluated one time by our physical therapist and they design a program that is really progressive over a period of eight to 12 weeks. I have to tell you, we have some success stories where patients, when they came back, their frailty score was really lower and the six minute walk test could go from like single digit to like 90 plus percent predicted, which is very, very helpful to understand that prehab could be really a potential benefit for those patients.
At this time during once they get optimized through prehab and through all the other elements that I mentioned earlier when they get scheduled for surgery, we follow an enhanced recovery after surgery protocol for the entire surgical encounter. So intraop, we focus on optimizing fluid intake, optimizing P manage. If the patient needs blood transfusion, we focus on patient blood management protocols if needed. And then afterwards, which is a key element postoperative phase. We focus so much on early ambulation participation, physical therapy, early nutrition. And then we found out that at least there was a decrease of one or one and a half day in the hospital length of stay. And the increased instance of ICU stay in those patient.
Melanie Cole: While we're thinking about prehabilitation. What do you feel? Dr. Mohamed is important to note about discharge planning for patients undergoing orthopedic and spine procedures. What's important to note as far as geriatricians and other providers, where they fit into this continuum. What's involved in this geriatric co-management? Rehab social support, you've mentioned a couple of times, as well as ongoing adjuvant therapy. How do you weave all of these elements together? Because that's really what gives us the best outcomes.
Basma Mohamed: Absolutely. I think coordination of care with different champions in different cases of care is very essential. Many times, especially for patients that don't live or don't pro get their care within the UF Health Shands Hospital. We try to communicate with their primary care physician to give them a heads up. Hey, by the way I'm referring this patient for prehab, it goes for prehab is this is, and that this patient's undergoing such and such surgery expect post care to be such and such. We predict that this patient will require rehab facility afterwards or being discharged home or any of these things that we try to predict for them.
But at the same time we are trying to improve our own hands on care for postoperative care for those patients. But as you can imagine for anesthesiologist, I have such a good grip on the preoperative and intraoperative phase. And then for postoperative concerns, I communicate all the time with the spine surgeons without any.
Melanie Cole: Well, I think that communication is really so important. As you said, give us your final thoughts for other providers on the perioperative optimization of the elderly spine surgery patient, and what. You would really want them to know when they're trying to build these types of programs.
Basma Mohamed: Great. Yeah, there are tons of resources currently online. There was a very nice recent article that I can eventually maybe send you a link to that. But what I would highly recommend is that the fact that caring for the elderly population in the form of only optimizing their medical comorbidities is not enough. We need to have a way of standardizing. Regular primary care in a way that identifying fairly early identifying cognitive impairment really early and trying to optimize them from a primary care standpoint. So by the time they come to us, you don't have to wait for surgery for like three months or so, because. By the time the patient gets referred to surgery, they took a lot of time from primary care to pain interventions.
And then finally coming to us for the surgeon to tell them, no, you cannot have surgery until you get prehab. That's really difficult. I really wanna emphasize the fact that up until now, prehab is not really considered as a standard of care to pre-op optimized patients, but that's what we're aiming for. We're trying to track and do research on those patients where in a way that we need to prove that prehab can improve them or can help optimize their post-operative outcomes. And hopefully we can change the guidelines and the recommendations to include it as part of the recommendations.
Melanie Cole: Well, thank you so much. And I hope you'll come on and join us again and update us as things work around and improve. And thank you so much for joining us again, to refer your patient or to listen to more podcasts from our experts. Please visit UFhealth.org/medmatters. That concludes this episode of UF Health Med EdCast with UF Health Shands Hospital. I'm Melanie Cole. Thanks so much for joining us today. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs073.mp3
- DoctorsDuff, Patrick
- Featured SpeakerPatrick Duff, M.D.
- Guest BioDr. Duff attended college at Harvard University and then pursued a Master’s Degree in Public Administration at the University of Virginia. He then changed career plans and entered medical school at Georgetown University, where he graduated from and then began a long service obligation with the U.S. Army. While in military service, he completed residency training in Obstetrics and Gynecology at Walter Reed Army Medical Center and fellowship training in Maternal Fetal Medicine at the University of Texas in San Antonio. He has served as a faculty member at three of the Army’s major teaching centers: Walter Reed, Letterman, and Madigan. He completed his military service as Director of Obstetrics at Madigan Army Medical Center in Tacoma, Washington and retired from active duty, accepting a faculty position in the Division of Maternal Fetal Medicine at the University of Florida.
He has worked at the University of Florida for 24 years and has formerly served as the Residency Program Director and Director of Fellowship Research until stepping down in July 2013. He continues to serve as Associate Dean for Student Affairs. - Transcriptionpreroll: The University of Florida College of Medicine is accredited by the Accreditation Council for continuing medical education, ACCME to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA category one credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole (Host): Welcome to UF Health Med Ed Cast with UF Health Shands Hospital. I'm Melanie Cole joining me is Dr. Patrick Duff. He's a Professor of Maternal Fetal Medicine at the University of Florida College of Medicine, and he practices at UF Health Shands Hospital.
He's here to highlight Group B Strep infection in pregnancy. Dr. Duff, it's a pleasure to have you join us today. Can you start by distinguishing between early and late onset Group B Strep infection?
Patrick Duff, M.D. (Guest): Yes. Thank you for having me. Early onset neonatal Group B Streptococcal infection typically occurs within the first seven days following delivery. It's usually manifested as either pneumonia, septicemia or meningitis and early onset neonatal Group B Streptococcal infection, almost always results from direct transfer of the organism from the colonized mother to the baby.
In contrast, late onset neonatal Group B Streptococcal infection typically occurs beyond the seventh day of life. And it tends to be manifested more as meningitis and septicemia. The prognosis for early onset neonatal Group B Streptococcal infection is usually a little worse than for late onset infection because more preterm babies tend to have the early onset version of the infection.
Host: Do we have some risk factors Doctor, do we know for early onset Group B Streptococcal infection? Do we have some group or risk that is higher than another?
Dr. Duff: Absolutely. There's been a tremendous amount of research in this field in the past 30 years. And there are several very well-defined risk factors for early onset neonatal Group B Streptococcal infection. One is prematurity. Second is prolonged labor, particularly in the presence of ruptured membranes. Indigent patients and women of color are probably at greater risk for having early onset neonatal Group B Streptococcal infection. Maternal fever during labor is also an important risk factor.
Host: So what are some of the most useful methods for identifying maternal Group B Strep colonization in the mother?
Dr. Duff: So that's very pertinent and wonderful question. I think today, the gold standard for identifying mothers who are colonized with Group B Streptococcal infection is a culture. The sample for the culture is typically taken from the lower portion of the vagina, the perenium and the area right around and just inside the anus and with optimal culture technique about 20 to 25% of all pregnant women will in fact be positive for Group B Streptococcal infection. The culture is typically done in a selective broth. When laboratories try to save money by not using selective culture media, they may miss up to 50% of colonized women.
Host: So then let's talk about strategies for reducing the frequency of early onset neonatal Group B Strep infection. And as we're talking about mitigation strategies and prevention, Dr. Duff, can you tell us a little bit about the ACOG policy statement that's been endorsed by the American Academy of Pediatrics, the American College of Nurse Midwives, the Association of Women's Health, Obstetric, and Neonatal Nurses, the Society for Maternal Fetal Medicine? It seems like all the big ones are endorsing these policy statements. So speak about those mitigation strategies and those policies initiatives?
Dr. Duff: Well, you're absolutely right. Through the years, there have been various organizations that have weighed in and suggested different methods preventing or reducing the frequency of neonatal Group B Streptococcal infection. And finally, in the last few years, we've had very good consensus among all the organizations that you cited, plus the Centers for Disease Control.
And I think the very best mitigation strategy that we have today is to do the following: in patient who presents to the labor and delivery suite in preterm labor with or without ruptured membranes, those individuals should be cultured for Group B Streptococcal infection and treated if colonized.
For all other patients, which of course is the majority of patients, the strategy today, and the standard of care is to perform atgenital track culture at 36 to 37 weeks gestation. If the patient tests negative, then she does not need prophylactic antibiotics during labor. If she tests positive, however, she should be targeted for antibiotic prophylaxis during labor. The two drugs of choice today for prophylaxis are penicillin or ampicillin. In patients that are allergic to penicillin, there are three alternate drugs that can be used depending on the type of allergy that the patient has. For patients with mild allergy to penicillin, the drug of choice is typically cefazolin, a first-generation cephalosporin. For patients who have more severe allergies to penicillin, the drugs of choice are either clindamycin, if you can document that the organism is sensitive to that antibiotic or vancomycin. These antibiotics should be started right at the time the patient is admitted to the labor and delivery suite and continued through the point in time that the patient is delivered. And with implementation of this particular strategy, the medical community has been able to decrease the rate of early onset neonatal Group B Streptococcal infection dramatically.
Host: Such an interesting topic. And thank you for speaking to those points and getting to my question about the special considerations for antibiotic prophylaxis in patients that have allergies to penicillin. I'd like you to speak to other providers now, Dr. Duff, what are some of the key takeaways and components for primary care physicians, obstetrician gynecologists, obstetric nurses, advanced care nurse practitioners, all of those healthcare providers that are involved. Can you speak to prevention, screening, reducing the incidence, kind of wrap it all up for us on Group B Strep infection and early onset neonatal disease.
Dr. Duff: Absolutely. So again, we need to screen all patients who unexpectedly are admitted to the hospital with preterm labor, with or without ruptured membranes. Everyone else, which is the vast majority of patients, should be cultured at 36 to 37 weeks of gestation for Group B Streptococcal infection. And I should point out that there are some rapid tests that are based on polymerase chain reaction methodology for Group B Streptococcal infection, but they are probably not as sensitive as the culture methodology. So perform cultures routinely at 36 to 37 weeks. Women that test positive, their charts should be flagged so that they can be treated intrapartum with prophylactic antibiotics.
These drugs are given intravenously. Therapy is begun right at the start of labor and continued until the patient has delivered. And I think a very subtle, but very important point here is that if the patient has a severe allergy to penicillin, the choice of alternate agents is either clindamycin or vancomycin.
But about 10 to 15% of strains of Group B Streptococcal infection, are in fact resistant to clindamycin. So if the laboratory has not done sensitivity testing to demonstrate that the organism is sensitive, the patient should be treated with vancomycin. If the organism is sensitive to clindamycin, then clindamycin can be used.
But vancomycin is essentially 100% effective against all strains of Group B Streptococcal infection. And recently the CDC revised some of its recommendations for dosing of both penicillin, ampicillin, cefazolin and clindamycin and vancomycin, and those dosing regimens are referenced in the article that you cited originally.
Host: What an excellent informative podcast this was. You're a great educator, Dr. Duff. And if people have questions, if other providers have questions related to this podcast, can you please give your email for them to contact you?
Dr. Duff: Absolutely. I would be delighted to answer any question that may have been generated by this discussion. And my email is Duff, all lower case, DUFF, P for Patrick@ufl.edu.duffp@ufl.edu.
Host: That's duffp@ufl.edu and Dr. Duff, I thank you so much for joining us and sharing your expertise with other providers today. To refer your patient, or to listen to more podcasts from our experts, please visit UFhealth.org/medmatters. That concludes today's episode of UF Health Med Ed Cast with UF Health Shands Hospital.
For updates on the latest medical advancements, breakthroughs and research, don't forget to follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs072.mp3
- DoctorsShahid, Zain
- Featured SpeakerZain Shahid, MD
- Guest BioZain Shahid, M.D., is an assistant professor in the division of vascular surgery and endovascular therapy at the University of Florida College of Medicine.
He received his Bachelor of Medicine and Bachelor of Surgery at the Aga Khan University in Karachi, Pakistan. He graduated with honors and was awarded a merit scholarship for being among the top 15% in his class.
He started his general surgery residency at Johns Hopkins Hospital in Baltimore. He then moved to University of Texas, Southwestern Medical Center where he completed his residency and also served as the chief resident. Subsequently, he completed a vascular surgery fellowship at the University of Florida College of Medicine.
Dr. Shahid’s clinical interests include treatment of complex aortic aneurysms and dissections using fenestrated endografts. In addition, he treats patients with renal and mesenteric occlusive disease, cerebrovascular occlusive disease, peripheral vascular disease and hemodialysis access.
Dr. Shahid is board certified in general surgery through the American Board of Surgery. His peer-reviewed articles and oral presentations have specific interests in aortic dissection, appendicitis and surgical residency programs. - TranscriptionScott Preroll: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME, to provide continuing medical education for physicians. The University of Florida College of medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole, MS (Host): Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole. And today, we're discussing physician-modified endovascular grafts for treatment of aortic aneurysm. Joining me is Dr. Zain Shahid. He's an Assistant Professor in the Division of Vascular Surgery and Endovascular Therapy at the University of Florida College of Medicine, and he practices at UF Health Shands Hospital. Dr. Shahid, I'm so glad to have you with us today. I found this fascinating research. I'm really glad we're doing this topic and I've been looking forward to this podcast. Can you start with a little bit of the evolution of endovascular repair of aortic pathology in patients with aortic aneurysm? Why has this shown to be a bit prohibitive? Why the need for improved device design?
Dr. Zain Shahid: Yeah. Thank you, Melanie, for having me. So, overall, generally open repair has been the gold standard for a pair of abdominal and thoracoabdominal aortic aneurysms. Over the past three decades or so, however, there has been refinement of EVAR technology. And now that's available and there've been various commercial endograft systems that are now available. Many of those are now in their third or fourth generation. That has led to a transition of clinical practice from open surgical repair to EVAR in the elective management of abdominal aortic aneurysms and in some cases, thoracoabdominal aortic aneurysms. Currently, in the US actually, EVAR far exceeds open repair, especially out in the community.
Over time as this transition has happened, we have seen patients who've had endovascular repair done 10 to 15 years ago now starting having problems. That can mean they've had migration of their endografts, they've developed endoleaks, they're developed infections or other issues, that have required secondary interventions, either more complex endovascular repairs or open repairs.
Melanie Cole, MS (Host): Well, thank you for that explanation. So as more and more patients who would be deemed unsuitable candidates may be based on anatomic criteria, I'd like you to tell us now about physician-modified endovascular grafts. What are they and what does that mean when you say physician-modified? Does it mean custom design has been promoted with each device? Custom made for a specific patient? Please explain that to other providers.
Dr. Zain Shahid: Yeah. So physician-modified endovascular grafts is a term that's used to describe physician modifications or modifications that I make to commercially available abdominal and thoracic endograft. So that means creation of fenestrations or holes, direction branches. or scallops. It sort of depends on the patient's anatomy and what we are treating. So these devices are specifically made for each patient or modified for each specific patient. No two devices are the same and there are certain sort of ways how you modify those. And there are certain indications for this, which we'll discuss in a bit.
Melanie Cole, MS (Host): So I'd like to get right into that. And then tell us about the role of PMEG in the treatment of complex aortic aneurysms. Tell us about those clinical indications and patients selection.
Dr. Zain Shahid: Right. It is indicated for patients with complex abdominal aortic aneurysms, which includes juxtarenal aneurysms, pararenal and suprarenal aneurysms. It's also indicated for patients with a thoracoabdominal aortic aneurysms types 1 to 5, depending on what the patient has. They're also indicated in patients who have had chronic dissections with now aneurysmal dilatation and something that we see more and more commonly, it's also indicated in patients who have had failed prior endovascular aortic repairs, or EVARs or open repairs. These patients are generally not candidates for open repair. They're not candidates for commercially available fenestrated endografts, and they cannot be enrolled in industry-sponsored clinical trials for the new and upcoming endografts.
We do have a pretty strict inclusion and exclusion criteria. So I told you a little bit about what the indications are as far as, and obviously those patients are included in the study. But in addition to that, patients need to be 18 years of age or older and be able to sign consent for the procedure. There are very specific anatomical criteria that are also important. There needs to be a good proximal landing zone in the aorta of appropriate size. We also need an appropriate distal landing zone, either in the aorta or the iliac vessels of appropriate size. And then we need to have our target vessels, which are generally the visceral vessels in which include the superior mesenteric artery, celiac artery and the renal arteries to be of certain size to be able to put stents in.
In addition, the overall health of the patients is important. We do these procedures in hopes that we prolong their life and their aortic-related morbidity and mortality is decreased. So we do want to see that the predicted one-year rupture risk of the aneurysm is higher than the one-year mortality after repair, so in case we're doing a complicated operation, which will eventually prolong their life.
Melanie Cole, MS (Host): As far as challenges, Dr. Shahid, one might imagine that any device customization involves a time delay between patient sizing, manufacturer of the device, the implantation event itself. Tell us a little bit about how long currently the process takes in the best of circumstances and how you have found to be the case. How have you addressed this challenge?
Dr. Zain Shahid: Yeah. So that's a good question. So these modifications are made onsite at UF Health Shands Hospital, that is we make those modifications ourselves. So the grafts that are provided by the company are commercially available. We have them on stock. So there's no as such delay for a new graft to be made for the patient. We make the modifications the day of the operation.. So, for example, if a person comes in to clinic today and wants this operation, and he has a very large aneurysm and we think it needs to happen within a week or so, we can fit them in the schedule as soon as tomorrow. Generally, no one needs that kind of thing, but maybe even next week. And then what we do is every patient gets a CT. So we upload the CT scan in our special central line software. And then we take precise measurements to the nearest millimeter as to where the important branches, which I mentioned, which are generally the celiac, the SMA and the renals come off. And then you modify the graft the day of the operation based on those measurements. It takes me approximately one to two hours to make the modifications to the graft. And i usually start making the modifications before the patient is brought back into the operating room. And by the time the patient comes in, is intubated and has the appropriate lines placed by the anesthesia team, the graft is ready and we're ready to start the case.
Melanie Cole, MS (Host): Wow. That's absolutely fascinating. Now, I'd like to address the elephant in the room, Dr. Shahid, for other providers, does there exist a legal risk to modifying an existing FDA-approved medical device? Does this involve product liability? Can you speak to other providers about this portion of this?
Dr. Zain Shahid: Yeah. That's a good question. So this is considered an off-label repair, no doubt about that. And I am very clear to my patients and our consents are very clear about that. Again, we are only offering this to patients who are not candidates for an open operation, not candidates for sort of commercially available endovascular grafts, fenestrated endovascular grafts, and can not be enrolled in clinical trials. And these patients understand that. And we get special refferals with the understanding that that's what they will be getting.
Now, we have sort of collected some data over the last couple of years, which we are planning to submit to the FDA to try to obtain an investigational device exemption. So we can do these procedures under the umbrella of a clinical trial. I think that will expand our indications and allow us to treat more patients as well.
Melanie Cole, MS (Host): Is there a difficult learning curve to what you're doing? You said it takes you a couple of hours to modify the device. Are there technical considerations you'd like to share with other providers to help them achieve better outcomes should they head into this?
Dr. Zain Shahid: So, yes, I think there is a steep learning curve for this. These procedures are generally done at sort of large academic centers, because it's not just me, it's a whole team to be honest. So you need to have good anesthesia staff. You need to have good nurses. You need to have good. Surgical techs, good IR techs and A good ICU team to sort of understand what we're doing. The modification, like you said, takes one to two hours. And I think over time I've sort of become faster in doing these. I think initially, when I was in training, when I was doing these, it took me three hours or longer to modify a graft.
Really the most important thing about modification is your planning. So when you do your measurements on your CT scan, they need to be really accurate. And generally, what we do here at UF Health Shands Hospital is I make my own measurements, and there's a second person and sometimes a third person who does their own measurements. And then we compare. And this is to the nearest millimeter to make sure that our measurements are accurate. And then we make those modifications and there are multiple ways to make modifications. I mean, people do it a little differently, but what we've seen and we've had good results with is just reinforcing our fenestrations with the PTFE or Teflon and we put special coils around them that allows us to see them really well on the fluoroscopy. So I think I think it's not easy for people everywhere in the community to do these cases because of the support needed and the complexity of imaging required. So for those reasons, most of these patients are referred to pick a tertiary or quaternary care centers, and there very few of those that are actually doing these operations.
Melanie Cole, MS (Host): That's a great point that you made. And I'd like you to reiterate that as we wrap up. I'd like you to first tell us how your outcomes have been and where do you see this going in the future? Do you have final thoughts for physciains as far as immediate device modification and how it really, as you just said, should be performed at centers completely familiar with all advanced endovascular, aortic and visceral artery techniques and a high volume of these fenestrated procedures.
Dr. Zain Shahid: Right. Yep. So the outcomes, so our outcomes over the last two years have been excellent. We've had no deaths in the first 30 days, which is amazing. Our target vessel cannulation, which are our SMEs, celiac and the renals has been close to a hundred percent. Spinal cord ischemia, which is a major risk with complex aneurysms, specifically large thoracoabdominal aortic aneurysms has been less than 3% to 5% in our series. Secondary reintervention rate for endoleaks or aneurysms proximally or distally has been less than 5% to 7%. In addition, the incidents of major cardiac events, renal dysfunction, stroke, et cetera, and other in-hospital complications have been low. But of course, I think this all seems very rosy, but I think as we continue to do more cases and gather more long-term data, I think these numbers are bound to change.
And then as far as sort of closing statements, I think this is a really complex operation. I think straightforward endovascular repairs, infrarenal repairs, absolutely can be done anywhere in the community, people who have basic understanding of aortic pathology. This requires team effort. This requires a lot of complex sort of planning, equipment and it requires a lot of knowledge in how to, A, do the operation and what to do if the operation doesn't go well, I mean, it's bound to happen at some point where you're in a spot where you're not sure what to do next. You need sort of your partners that have an understanding of how to deal with those issues. And you need to have experienced with those issues. And that can only be done in places who do a high volume of these cases. I think if you're doing one or two of these a year, I think the outcomes are bound to be not that good, like with any other sort of complex operation. We've now been doing one or two a week. So as you can imagine, we've had those complex issues, we've dealt with those and we thankfully have really good outcomes.
Melanie Cole, MS (Host): What an interesting interview this was. Thank you so much, Dr. Shahid for joining us today and sharing this incredible information and this incredible technique that you're using at UF Health Shands Hospital. To refer your patient for physician-modified endovascular graft for treatment of aortic aneurysms or to listen to more podcasts from our experts, you can visit ufhealth.org/medmatters.
That concludes today's episode of UF Health MedEd Cast with UF Health Shands Hospital. For updates on the latest medical advancements, breakthroughs and research, follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
Additional Info
- Audio Fileuf_health_shands/ufhs071.mp3
- DoctorsFabregas, Jesus
- Featured SpeakerJesus Fabregas, MD, MPH, FACO
- Guest BioJesus C. Fabregas, MD, MPH, FACP is an Assistant Professor of Medicine in the Division of Hematology & Oncology at the University of Florida College of Medicine.
Learn more about Jesus Fabregas, MD, MPH, FACO - TranscriptionScott Preroll: The University of Florida College of Medicine is accredited by the Accreditation Council for Continuing Medical Education, ACCME, to provide continuing medical education for physicians. The University of Florida College of Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 credit. Physicians should claim only the credit commensurate with the extent of their participation in this activity.
Melanie Cole (Host): Welcome to UF Health MedEd Cast with UF Health Shands Hospital. I'm Melanie Cole, and I invite you to join us as we discuss colorectal cancer awareness. Joining me is Dr. Jesus Fabregas. He's an Assistant Professor of Medicine in the Division of Hematology and Oncology at the University of Florida College of Medicine, and he practices at UF Health Shands Hospital.
Dr. Fabregas, thank you so much for being with us today. Can you just help us as we get into this topic to recognize colorectal cancer as a major cause of morbidity and mortality? Tell us the prevalence and what you've been seeing in the trends.
Dr Jesus Fabregas: Well, hello, Melanie. Thank you very much for having me As you said, I am a practicing oncologist here at UF Health Shands Hospital. And the problem is big. We know that colorectal cancer is the third leading cause of cancer death in both women and men with an estimated of 52,000 or more persons in the US predicted to die of colorectal cancer in 2022. We know that it's most frequently diagnosed among persons age 65 to 74. And there is a disturbing trend. We are seeing more and more cases of colon cancer being diagnosed in people younger than 50 years of age.
So two to three decades ago, 5% of the new colorectal cancer occurred in this population less than 50 years of age. But currently, we are seeing up to 11% of the new colon cancer cases affecting young people. We know that the incidence is increasing. For example, in adults ages 40 to 49 years old, the incidence has increased 15% from 2000 up to 2015 and only approximately 70 to 75% of people are compliant with the screening. So it's important to screen and to diagnose early the problem.
Melanie Cole (Host): So we're going to get into the screening, but Dr. Fabregas, do you have any thoughts about why you think it is starting -- I read that in the literature as well -- that it's starting to affect the younger population. Do you have any theories about that? And do you envision possible screening at younger and younger ages?
Dr Jesus Fabregas: Yes, Melanie. Excellent question. There are many possible culprits for this disturbing trend. For one, we have the diet, more specifically the Western diet, diets that are high in red meat, diets that are high in sugars, in processed foods. Also, obesity, excessive alcohol consumption, inactivity, sedentarism, all of those have been shown in observational studies to be linked with early incidence of colon cancer. However, we do not have a definitive answer yet, so to speak. So the researchers continue to try and answer this question.
As far as the second part of the problem, if we should be screening patients younger, the answer is yes. Just last year, the United States Preventive Task Force changed its guidelines to start screening or at least to consider start screening patients at the age of 45, just because of these disturbing trends. Previously, it was 50 and above up to 74 and, in special cases, 84 years of age. But now, the guidelines say that starting at the age of 45 is very important for the average risk population.
Melanie Cole (Host): Well, then let's talk about the screening methods out there. As we know, the gold standard, the colonoscopy, one of the very few, not only screening, but preventive measures that we have for colon cancer, the guidelines that are set out by the US Preventive Services Task Force, as you said, have been changing. Is there any controversy on age? Tell us a little bit, whether it's 45 or 50, what are we looking at for colonoscopy now? What are the protocols?
Dr Jesus Fabregas: Adults aged 45 to 49 years of age, the USPSTF recommends screening for colorectal cancer. That is the new kid on the block, so to speak. Adults aged 50 to 75 years of age, there is a continuous recommendation to keep screening these patients with, like you said, colonoscopy. That's just one of the many options every ten years. And perhaps, there is a slight controversy in adults ages 76 to 85 years of age. And the answer is to personalize this screening, meaning that if it is a patient whose life expectancy might be limited due to severe or moderate comorbidities, then perhaps it doesn't make sense to do screening in this population. However, if it is a very healthy 76 to 85 years old person who has many years to live, then definitely those patients will require screening. At the end of the day, in these population subset, it's a decision made after a discussion between the provider and the patient.
Melanie Cole (Host): Well, it certainly is. So now, let's talk about colon cancer itself. Colonoscopy, not withstanding, if somebody is diagnosed, tell us a little bit about how it's staged and some of the symptoms at presentation.
Dr Jesus Fabregas: Thanks, Melanie, for the question. There are four stages, I, II, and III and IV. This is what I tell my patients, stage I is when the cancer is very small and it is limited exclusively to the colon. Stage IV on the other end of the spectrum is when the cancer has been widespread. It's when it's in the bones, liver, or when it's outside of the surgical field, when it is not curable for the most part, so to speak. Stage II is when the cancer is a little bit on the big side and it is starting to spread through the muscular layer of the colon. And a stage III is when the disease is local regional, when it is big and when there is heavy involvement of lymph nodes.
As far as the symptoms go, you have the typical symptoms of fatigue, weakness. These are nonspecific. However, some other symptoms such as blood in the stool, abdominal pain, weight loss, changes in bowel habits, rectal pain, or changes in the caliber of the tool are very important. I want to tell all the patients that it is important to seek medical attention with their primary care provider in case of any or a combination of these very telling symptoms. So awareness, early diagnosis are key.
Melanie Cole (Host): Certainly is. And now let's speak about some of the exciting advances in treatments for colon cancer in your field. For other providers, Dr. Fabregas, tell us a little bit about what's going on that's exciting, whether it's radiation, targeted therapies, immunotherapies, surgical intervention. Tell us what's going on in the field.
Dr Jesus Fabregas: All of that, Melanie. There are many exciting changes. For example, pembrolizumab is a checkpoint inhibitor, a type of immunotherapy that trains the immune system to attack colon cancer cells. This is a very effective treatment option for patients with advanced colon cancer. It primarily works in patients who have microsatellite instability-high disease. This is a marker that we check in the colon cancer tumoral sample once it is diagnosed, once it is resected or biopsied. On the side of the targeted therapies, we have anti-BRAF medicines. BRAF 3600E is a common mutation in patients with colon cancer. We have now approvals for targeted therapy with encorafenib, binimetinib and cetuximab to treat these patients once they have progressed on standard chemotherapy. Between targeted therapy, immunotherapy and newer chemotherapy combinations, there is hope for patients with colon cancer.
Melanie Cole (Host): Doctor, for these patients, engaging multidisciplinary teams for better outcomes is such an important part of the approach. Tell us a little bit about your team and how you utilize that multidisciplinary approach.
Dr Jesus Fabregas: Melanie, anybody who has a diagnosis of colon cancer wants to have a world-class team of experts on their corner. Thankfully at UF Health Shands Hospital, we have a strong multidisciplinary team comprised of interventional radiologists, radiation oncologists, medical oncologists, surgeons, specializing in colorectal malignancies that treat these types of disease every single day. We, for example, meet every Thursday from 6:30 AM to 8:00 AM, and we go through every single case of rectal cancer or colon cancer that is diagnosed IN our institution. And we go through the different therapeutic options for the patients. The surgeons say something, the medical oncologists give their opinion. And then the radiation oncologists, pathologists, the rest of the team weigh in. At the end, we come up with the best treatment plan for the patient.
Melanie Cole (Host): Is there anything you'd like to share with other providers as far as research studies or things on the horizon? What do you see happening? What would you like to see happening?
Dr Jesus Fabregas: Melanie, the field is changing rapidly. I am very passionate about circulating tumor DNA. Previously in the old ages, after a patient had surgery for colon cancer, we used only clinical factors to determine whether a patient needed chemotherapy or not. We looked at the size of the tumor, the evidence of lymph node involvement or not, the evidence of lymphovascular invasion, perineural invasion, CEA levels. However, now there is a game changer on the field and that is circulating tumor DNA, CT DNA. This is a personalized test that we collect from each patient based on the DNA of the patient's specific tumor. And it is a way to detect minimal residual disease after surgery. We at the University of Florida Health Shands hospitals, we have clinical trials using CT DNA to determine whether a patient will need or will benefit from chemotherapy or not after having surgery. So we are not blindly giving chemotherapy anymore. We are making decisions based on the latest cutting-edge personalized biomarker technology. And this is going to be probably approved in the near term. And this is going to be a game changer. This is just going to expand through all of the guidelines nationwide.
Melanie Cole (Host): Well, it certainly will. What an exciting time to be in your field, Dr. Fabregas. Thank you so much for joining us today. To refer your patient or to listen to more podcasts from our experts, please visit ufhealth.org/medmatters. That concludes today's episode of UF Health MedEd Cast with UF Health Shands Hospital. For the latest on medical advancements, breakthroughs and research, please follow us on your social channels. I'm Melanie Cole. - HostsMelanie Cole, MS
- Post Test URLhttps://cme.ufl.edu/mededcast/
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