So I'm going to get started here. If you want to take a seat please. Good afternoon everybody. Thank you for joining us. I'm delighted to be here. I'm Ali Mustafi. I'm the session director. You cannot hear us? The mic is on. Good. I'm Ali Mustafi. I'm an interventional physiatrist. I come to you from Boston. I did most of my training between the medical schools in Boston and the fellowship and I have a practice there in Boston. This kind of stuff is what I do. I am joined today with two out of the three people on the agenda. Mike DePalma unfortunately couldn't attend so we're going to pick up the slack between the rest of the speakers. Dr. Zachary Isaac is the chief of spine and pain management at Spalding at Harvard Medical School. He's a good colleague of mine and he runs a show at Mass General in Bigham system for 20 years or so. So it's glad to have him here. Dr. Bhagrava who is coming up. He went to upload his talk. He's an interventional physiatrist and a pain doctor with long credentials. He did his residency at Temple and a UPenn graduate for his interventional physiatry. He actually happens to be an orthopedic surgeon with multiple fellowships on that background. So he's very well and if anybody feels stiff, he's a master in yoga as well. So we could do that for you this afternoon. Our talk is supposed to be about spinal stenosis, new advancements, some of the interventional stuff that some of you may know and some of you may already perform. It's supposed to be thought provoking on whether this is something that you want to incorporate in your practice or there's enough evidence that you feel comfortable to move forward with them. So the first half of the third of the talk is going to be about the spinal stenosis diagnosis and all that. We have different people here with different backgrounds. So we're going to make sure that residents and fellows are also listening to the talk and understand it. We will move into treatments that is done through pain fellowships and then advanced procedures and I will touch based on surgical stuff so we can compare talks. I hope it's scientific. I hope everybody learned something today and we are going to have a 15 minutes at the end to have a Q&A. Please turn your cell phones to silent. If you have a getting text, please go ahead and put it on vibrate as well so you can get those so it doesn't interfere with the speech. You're not supposed to tape or videotape the screen. And that's all I have for you. So I'll allow Dr. Zachary Isaac to come to the stage. All right. Thank you very much for the introduction. I have no relevant financial disclosures. So let's get right into it. Spinal stenosis, not an obscure topic. We all see it every day. We can diagnose it from just a few moments of conversation. And patients have a very stereotypical clinical presentation. But one thing I've really loved about my job is that you're a diagnostician every step of the way. Whether they're coming in with a back hip complex, all of you are trying to sort out how much is hip mechanic, how much is back mechanic. If it's a neck shoulder complex, you're trying to ascertain how much is neck versus shoulder or the relative interactions between the two. Patients are very, very focused on living their best life. They want to feel free in their body. They want to be able to be active, play with their kids, golf, and walk unencumbered. Spinal stenosis hits us in all of those areas and limits our ability to walk as much as we want. And we need to take frequent breaks. And this is very demoralizing to our patients because it's so unpredictable with good days and bad days. The spinal canal anatomy doesn't change, but yet there's such a fluctuating quality to how patients present with their neck and back symptoms. And the next thing that adds complexity is that when we're doing our diagnostic steps, we're ordering MRIs, right? That's our anatomic delineating defining study. But yet we see these kind of scenarios all the time where this guy is doing this with this back, you know? So he's happy with a round of PT, a two-level transforaminal, and he's back to doing Spartan races and carrying things everywhere. And you can see he has essentially critical stenosis and a grade one spondylolisthesis at L4-5 with degenerative motic changes. So anybody with that, if degenerative changes were proportionate, should not be doing these things. So our talk is going to progress from me talking about the physiology of spinal stenosis, but eventually progress to some of these more advanced procedures. And so just if I'd like to just survey the audience, if you can take out your phones and do a quick QR code snap and start to respond. Admittedly, this may be a big disappointment. I've been trying to get the interactive nature to work with the media environment here, but because of complexities around taping and not being able to log in with the right credentials on my own laptop, we may not get some data. But I'm going to see if it populates my desktop, my laptop here, which is logged in, and I might be able to at least present a little data so you get a cross-sectional analysis of what people are doing for their patients with stenosis presently. All right, we'll just do it the old-fashioned way. We'll do a raise of hands because we don't have the technology to make this work. So let's go through just a show of hands. If we're talking about some of the more bread-and-butter, translaminar, transforaminal-type epidural steroid injections for patients with stenosis, just by a show of hands, who's incorporating this either into their own practice or as a referral for patients with spinal stenosis? So I venture to say a good 85% of you are. Any of you incorporating MILD in your practice for that? Okay, great. And COFLEX? And VERTIFLEX? And MINUTEMAN? Great. So there's certainly some people here that are versed in these newer technologies. So just going back to the original we all learn in med school when we're learning lumbar stenosis, it comes from the ancient Greek word stenos, or narrow. And they have a variety of symptom complexes with this condition with low back pain, but not necessarily. It's amazing how many patients with stenosis don't have low back pain, and they have predominantly this neurogenic claudication, this heaviness in the legs when they walk. Subvariants of them seem to have ridiculous symptoms. I surmise that maybe there's some instability at that segment, it pinches off the nerve, and suddenly they're behaving like a herniated disc, or there's a small herniated disc and they get preferentially one-sided, ridiculous symptoms. They commonly have sensory disturbances, whether it's that nocturnal cramping in their calves or numbness, tingling, loss of vibratory sensation, can't feel their feet. And then motor disturbances, certainly some EHL weakness and other subtle deficits. So patients will come in and they'll make a diagnosis, and you've given them a degenerative diagnosis here, so they'll commonly ask you, what's the future hold for me? So we'll propose another question. 60-year-old with low back and leg pain with standing and walking. The MRI demonstrates lumbar stenosis. He asks what the future holds for the next three years. So three choices are, your symptoms are most likely going to progress with age. Second choice is, your symptoms are most likely going to improve. And third choice is, your symptoms are most likely going to stay the same. So let's do a quick audience show of hands. Your symptoms are most likely going to progress with age. What if I said three years is the horizon that this study is referencing, so you don't have to say forever. Obviously, everything's going to get a little worse with age. If we made it three years, because that's what this study is referring to, let's reframe it. Your symptoms are most likely going to progress over the next three years. Second is, your symptoms are most likely going to improve. And then the third one, your symptoms are most likely going to stay the same. Great. And I'll get to that study in just a little bit. So the diagnosis, obviously, it's made based on this clinical history of back and extremity pain provoked with lumbar extension, relieved with lumbar flexion, confirmed with cross-sectional imaging, such as CT or MRI. And in this study, where they tracked people for three years, about one-third of patients reported improvement. About 50% had no change in symptoms. And only 10%, 20% were really enduring a progressive decline of their back, leg, and walking tolerance. So it's not always so doom and gloom, but it is very distressing to our patients to receive a diagnosis that is degenerative. When this study by Tompkins Lane et al, it's a Delphi-type study where they survey a lot of clinicians all over the world. And they surveyed a panel of 279 clinicians from 29 countries. And the symptoms that were the top items in their survey that came across as being most inter-agreement of being compatible with the diagnosis of stenosis were leg or buttock pain while walking, flexing forward to relieve symptoms, feel relief when using a shopping cart or bicycle, motor or sensory disturbance while walking, normal symmetric foot pulses, lower extremity weakness, and low back pain. And then after about six items were positive, there was very, very strong agreement and additional questions really didn't aid in getting closer to agreement. The physical examination of patients with spinal stenosis, they commonly have a little bit of a wide-based gait. They can have an abnormal Romberg, lose balance more readily. They commonly have decreased vibratory sensation. Pinprick can be also diminished. They can have weakness in their EHL. Ankle reflexes are commonly gone. And this forward flexion alleviating the symptoms is very stereotypical of this. Now when we look at straight leg raise, it's important to contrast that with disc herniations which commonly have a positive straight leg raise. Spinal stenosis typically does not have a positive straight leg raise. Anecdotally, I do find that when patients have a synovial cyst causing radicular pain, they seem to have more inflammation and a more hot straight leg raise in my experience. So a lot of different imaging terms are thrown around as being diagnostic of spinal stenosis. We really get MRIs as our preferential first line one. And if we can't, a CT. We really look at the cross-sectional area of the dural sac. Other features that you want to look out for are this ligamentum flavum thickening, facet joint hypertrophic changes, bulging discs. They all contribute to that triple hit that creates that trefoiled, triangulated narrowing stenosis. The nerve root sedimentation sign, which I'll show you some imaging of different grades of stenosis and the way that the nerve roots no longer layer in that nice somatotopic with empty CSF, but rather clumped together. And this redundancy of the spinal nerve roots I'll also show you some MRIs of that where the cauda equina becomes very jumbled because of the tasseling effect. But what's really amazing to me is that there seems to be still, despite all of this, a very weak correlation with who becomes symptomatic. And I'll go over some of the other mechanisms that are in play here. We came up with a classification scheme for spinal stenosis at the Brigham that we showed 80% inter-specialist agreement and even non-radiologists. So we had spine surgeons, physiatrists, anesthesia pain docs, residents, all who learned a scaling system and then applied it. And there was a very good inter-rater reliability in terms of agreeing what's a normal stenosis, what's a mild stenosis, what's a moderate and a severe stenosis. You could see here that a nice normal one, you have free distribution of the nerve roots without crowding. And as you start getting to milder, you have slight clouding of the nerve roots and some increased trafoiling of the canal. In moderate, you start to really get that sedimentation appearance where the nerve roots are beginning to lose their nice organization and be clumped closer together. And in severe stenosis, your nerve rootlets of the cauda equina become quite indistinct. So here's a clinical case that came in last week or two. This is the pre-surgical MRI and this patient has multi-level degenerative disc disease. You can appreciate that there is scoliosis because it's not a good midline cut at all levels. You can see that there's degenerative end plate changes, there's hints of slips. And on the axial T2, you can see facet hypertrophic changes, right-sided preferential lateral recess narrowing. He was offered options of either a multi-level decompression fusion. He opted for a minimally invasive type procedure with the surgeon that did it combined interspinous spacer technology along with a partial decompressive laminectomy. You can see here that some degenerative changes there with some complex scoliosis and other curvature. So they didn't want to do a straight laminectomy and didn't want to go as invasive as a fusion. And this is the post-surgical MRI. And unfortunately, there wasn't an effective decompression of the central canal. And in fact, a little bit of an increased protrusion and foraminal quality started to arise post-surgically. And none of it really addressed this foraminal narrowing that's happening that could contribute to the patient's more clinically relevant symptoms of right anterior thigh pain and pretibial symptoms on the right. We can come up with a classification system for foraminal stenosis also, and also with decent iterator reliability. And we can look at the amount of fat effacement. If it's three sides or less, you still have fat showing, it falls into the mild. It's moderate when you start to have fat effaced all the way around. And we start to put it into the severe bucket when the shape of the nerve is distorted, and there's evidence of compression of the nerve root. This is a MRI of the lumbar spine where it demonstrates that cauda clannar nerve roots coming in and out of the plane. So it looks very clumped. And sometimes the radiologist may call it arachnoiditis, which isn't really what it is. It's more a tasseling or redundancy of the cauda clannar and the canal due to this very severe stenosis with an associated slip at that L4-5 level. You could see hypertrophic facet changes, ligamentum flavum enfolding, bulging disc, all creating a severe stenosis picture where the nerve rootlets descending are very indistinct. All right, so here's another question. Which of the following risk factors has the most influence on having symptoms of back and leg pain with lumbar stenosis? Peripheral arterial disease, severity of stenosis on MRI cross-section, clumping redundancy of spinal nerve roots, diabetes type 2, or erosive end plate changes. So show of hands, peripheral arterial disease, severity of stenosis on MRI cross-section, clumping redundancy of spinal nerve roots, diabetes mellitus type 2, and erosive end plate changes. Great. The correct answer is actually diabetes mellitus type 2. It increases by three to fourfold the odds ratio of having symptomatic stenosis when it's moderate. So some microvascular effect is happening at the level of the cauda clannar. So one of the oldest theories around lumbar stenosis is, is it vascular? So the plexus around the spinal stenosis is largely valveless. So that, when it were recumbent, it pools in that epidural plexus, and that might be part of the leg cramping phenomenon that we see in patients with lumbar stenosis. Some of the posterior vasculature has valves, but the majority of this epidural plexus is valveless. Lumbar stenosis, this is a venogram, which they used to do in the 70s. Less now, obviously. But we do see that patients with vascular congestion from heart failure or congenital spinal stenosis when pregnant, they develop more sciatica, neurogenic claudic symptoms. And in this study that I mentioned before, the odds ratio was three to four in patients with lumbar stenosis developing, if they have diabetes, to be more symptomatic. But in the severe subset, they had equivalent rates of diabetes and peripheral arterial disease, but there was a strong effect for that. A lot of complex factors with lumbar stenosis, though. If they have a leg length discrepancy in a scoliosis, the likelihood of success with surgery becomes less, like at least the patient satisfaction is less. This study in veterans, looking at a lot of the complex biosocial factors for decompressive laminectomy, they found that higher use of opiates was associated with less success, higher use of alcohol associated with more success. If they came in at a high level of baseline function, they actually did very well with surgery, like before they start to deteriorate. If they had high physical and emotional distress scores right before surgery, they actually did very well in this study of veterans. And if they had credibility, a greater credibility in the treatment and belief system in it, they were more likely to do well with surgery. This is one other concept that I came across when I was doing my literature review was this idea of CSF dynamics. The cerebrospinal fluid pulsation varies from each phase of our cardiac cycle, and it was an independent factor in who developed symptomatic stenosis. They can look at this with certain phases of MRI scanning, and more pulsatile CSF was associated with less symptomatic stenosis. But the CSF does become less pulsatile with age. And you can see this on the right side with the cardiac cycle with age, the degree of fluctuation declines. Another study looked at end plate defects and muscle mass. This was really interesting because trunk muscle mass, lumbopelvic alignment, and end plate defects, but not the severity of stenosis, were more associated with the severity of back pain when you have patients with spinal stenosis. And so some of these patients that have a mixed picture of axial as well as radicular pain with stenosis, the trunk muscle mass, end plate defects all play a role. So as I think about spinal stenosis, I really proposed, you know, do we want to think about lumbar stenosis as not just an entity defined by degenerative spinal anatomy, but a complex physiological and anatomic and biopsychosocial model that creates different phenotypes and emergent syndromes that we need to learn to understand better. And I'll end with my kids adventuring in Greece. Thank you, guys. APPLAUSE So Amit, you're up. Oh, boy, everybody's here, huh, for the conference. They said the maximum number of people. So, I'm going to cover on lumbar canal stenosis and what may I offer you. What are the choices and what options do we have? And Dr. Isaac covered a lot of it and he mentioned one thing in one of the multiple country studies was the last question was back pain. Then he again mentioned that there's a combination of things with the back pain and the leg pain. So, is it lumbar canal stenosis back pain or is it leg pain? I have no disclosures. So, according to ICD-10, there are two lumbar canal stenosis with neurogenic claudication and without neurogenic claudication. So, with the neurogenic claudication, obviously we have learned over the clinical diagnosis having pain while walking, but without neurogenic claudication, what is lumbar canal stenosis? Is it just looking at the MRI and deciding that this is lumbar canal stenosis? So, when you do a literature article, look at an article, what are they talking about when they say they treated lumbar canal stenosis with physical therapy or injection or nerve block? Are they talking about anatomical lumbar canal stenosis or neurogenic? So, let's go to that, the low back pain and radiculopathy. The medications which have been mentioned for this treatment, the various medications, the only thing they mention about is the oral NSAIDs. Lowest effective dose for the shortest time possible and benefits should be weighed against the risk of what is the oral steroids you're using because they are using multiple medications and they are elderly patients. You can also try out the SNRIs and TCAs and the other ones they say may be used, may not be used. You have paracetamol, which is acetaminophen, oral co-steroids, opioids, muscle relaxants, pregabalin and gabapentin. The literature says may be used, may not be, but mostly the top two ones can be used. The literature about physical therapy, that this is spinal stenosis with neurogenic claudication. So manual therapy, education and exercise with cognitive behavioral therapy will improve walking distance. Aqua therapy, it may help because of the warm temperature or the relaxing effect, but it does not have a long-term benefit. When you compare physical therapy with surgery, some of the studies literature says that after two years the results are kind of same and physical therapy may be equal. After surgery, obviously post-operative rehab and CBT is suggested. So what does North American Spine Society suggest about this? It's a very good slide if you're taking a board exam. It's insufficient evidence for pharmacological treatment, physical therapy or exercise for or against spinal manipulation. So all of them have insufficient evidence. It's not that they're good or bad, they don't have evidence to suggest either way. So exercises, lumbar flexion and aerobic fitness exercises like cycling exercises, they are beneficial, but the first word is supervision. They do much better when they're supervised. If you tell them to do a home exercise program, they're elderly patients, they do not follow the same exercise, they may not remember to do the exercise. So it's supervision was seen to be beneficial. Adding a psychological informed approach also might help and the balance exercises need to be evaluated. For brace, North American Against Spine Society suggests you can increase the walking distance with a brace, but it doesn't help when you take it off. So it can help while they're walking. The other ones, the traction, electrical stimulation or TENS unit, there's insufficient evidence. The acupuncture, again, insufficient evidence from North American Spine Society. Other literature, one study says it improves, the other one says no better than usual care. So the third one gives the option considered as a trial basis. Okay, so there's various, for acupuncture, there are different opinions. Now coming to the injections, which, I mean, how many people do injections? I was on the other side. So everybody does injections, okay? Most, or since then. So question becomes which route, what level, what is the volume, what medication, number of injections and grading, obviously, Dr. Isaac mentioned about that. What is the grading when you inject? What level do you think will benefit from that? And if it's a multilevel stenosis or a single level stenosis? Can I add one more? Yeah, there are plenty more. Insurance. That's always there, that's covering everything. So this was a study, this is also a multi-country study. This was done on spine surgeons and neurosurgeons in the Latin American countries. They looked at duration, they looked at all these spinal injections, if they would recommend and different questions. One of them was when would you start conservative treatment, duration of conservative treatment before the spine injections? So it's most of them say after, cover from two to three months, or two weeks to three months. So question is, which epidural injection, which kind? So this was a study on interlaminar versus bilateral transformer. This was a multilevel degenerative lumbar canal stenosis. For bilateral, they just divided the dose and in single level, in interlaminar, they injected all the medication together. The median age was about 63 and 62 years. The walking distance improved. So this is important, when you're looking at a follow-up, everybody looks at the pain score, but neurogenic clarification is walking. Has their walking distance improved? So it's very important to see in that study if the walking distance improved. So in this one, interlaminar epidural steroid injection, significantly higher, but both give a good result. And interlaminar is easier application in their study with more effectiveness and transformer was better if you had a prominent neuropathic pain. We'll come to the caudal separately, but now this was the other question about low back pain, whether you should do, if you had, because you find facet arthropathy and lumbar canal stenosis usually at the same time. So what kind of injection would you do now? Are you looking, now if you're looking at the anatomical MRI study, or you're looking at the neurogenic clarification. So if it was only back pain with the lumbar canal stenosis based on the diagnosis of MRI, this was the Latin American surgeons, spine surgeons, neurosurgeons. Most of them said facet joint, and some of them said we would also inject epidural injection. For the ultrasound guided and the fluoroscopy and caudal injection, so this compared by palpation, ultrasound, and fluoroscopy. They had injected the same amount of medicine, around 20 ml. So number of injections was two with a 30 day interval, and all three of them improved, whether you did it with fluoroscopy, palpation, or with ultrasound. The use of analgesics before or after was not documented, so it's difficult to make out if the study, if any of this helped or not. So level of injection, this study compared if you injected at the maximum level of stenosis, versus if you did it two levels cephalahead. Obvious, I mean you expected at the maximum stenosis to be better, and that's what the result in this, that at the maximum level it improved. So what does IPSIS, which is the International Pain and Spine Intervention Society, say about this, if you, where do you inject? So severe lumbar canal stenosis is not an absolute contraindication. And you need to see the cross-sectional imaging to ensure that there's adequate space, if you're going at the same space, that there's space for the needle to go in there. So safety is important. And you can do it target or at the adjacent level. The volume of injection, there's no published evidence, again this is the Interventional Pain Society, Pain and Spine Intervention Society, there's no published evidence that volume effects increase the risk of neurogenic injury. And eight mL of intralaminar and 20 mL of caudal has been documented without any significant complications. Having said that, so this was an adverse event with about almost 20 mL of caudal injection. Patient got caudaequina symptoms, which developed gradually over that whole day, but the patient completely improved in three months. Okay, so don't know what the reason was there. You can't say it's only all the 20 mL, but there's a possibility it can happen, and patient had severe canal stenosis. What kind of medication would you inject? So this study by Manchik at the group had two groups, one with local anesthetic, and the other one with steroids and local anesthetic. So both of them got significant pain relief and improvement. Both of them required about four procedures a year, and the improvement was around 40 weeks of the 52 weeks of the year. Now if somebody has spinal stenosis due to epidural lipomatosis, what would you inject in that? So this is, one is they said weight reduction, reduce the obesity, so that's a long term if you're looking at. The safe time between two epidural injections is unknown. So in their study, they said to inject, first injection to be a steroid, and the second to be a, if you had to do a second one, do a lidocaine. Now this is not research when I say I do it, okay? So based on the previous study, where lidocaine also benefits if you inject lidocaine only, okay, I prefer to inject lidocaine first injection in an epidural lipomatosis if it's really required. And no talk is complete if you don't have a regenerative medicine slide in it, right? So. Yeah. So this is a retrospective view of fluoroscopy, and they had 16 patients, seven of them are lumbar canal stenosis, and the average pain relief was 76%, so I mean this needs to be reviewed a little bit more before coming to a conclusion here. Number of injections, so one to four have been mentioned, and this was again the study from the Latin America, and they mentioned again the same numbers, one to four, with the four being very few percent, most of them are one to three injections. We talked about the number of injections earlier about this same study with four injections approximately for a year. Now MRI grading, so this study looked at, came to a conclusion that the grade of lumbar spinal stenosis appears to have no effect, but if you do look at the numbers on the left, which is 34 patients who are either grade one or two, and on the right, if you look under the results, there are two weeks and eight weeks, there are 37 patients, and so the number of patients is kind of same, 34 patients and 37 patients, are they the same patients, or the majority of them being the grade one or two, so this may need to be again looked at further. This study had moderate outcomes that were better than severe stenosis. But again, if you look at the baseline walking distance of both the groups, it's over 300 meters. I mean a person with 300 meters of walking with severe stenosis, I mean my patients would barely be able to get to that door there if they had severe stenosis, if you're considering. This is 328, and they increased to 400 meters, so that's quite a bit of a difference here in this study, and this was interlaminar. If there's a multiple levels of spinal stenosis, this study from Middle East looked at, results are disappointing in the multilevel. It did help in some of the other ones, but multilevel, it was disappointing. The follow-up duration expected of relief is, this was again the Latin American study, they expect less than six months in most of the patients. Study by Delport mentions more than two months would be about 1 3rd of the patients, and this was a transformer or caudal injection. And now if you look at the literature, what they mention if it's recommended or not based on the follow-up, the first study had like, it included radiculopathy, so if you see a study with radiculopathy included, it's not spinal stenosis. And they're including spinal stenosis and radiculopathy, and they said limited evidence and not effective. But they only included one in the study, and it's a meta-analysis. The second one is epidural injection, not suggested, again, if they're basing it on the previous guideline. And then we have the third study, which shows that either lidocaine or the steroids in the lidocaine are effective. So you have a conflict of evidence there. NAS also has included radiculopathy with neurogenic claudication in their studies, and so interlaminar and transformer and caudal help, but again, you have conflicted evidence, and they're including radiculopathy, so it's not a pure literature on lumbar canal stenosis. There are various smaller adverse effects. We already mentioned one over the caudal equina, but vasovagal reaction, and these are listed here. Patients who will require surgery. So Latin Americans, again, the surgeons and the neurosurgeons, they suggested almost 80% will require surgery in the future. And that could be a little biased, but. The Cochrane study, which surgical option is better? Decompression or fusion with decompression? If there's no instability, decompression and fusion have the same results, but there's much more blood loss during surgery with fusion. What is the predictor for better results for walking after surgery? So this would be good for even any injections or any treatment, younger age, lower body weight, one-level operative segment decompression surgery, and better preoperative scores for trunk extensive strength and six-minute walking distance. So all this will help anybody if you're a younger person with less weight and less problems, less lumbar canal stenosis. Another Cochrane study about surgical versus non-surgical treatment. The author's point of view was that there's very little confidence to conclude treatment or a conservative approach is better. Which one is better? The rate of side effects ranged from 10% to 24% in surgical cases, so you can see which one is which. There are different algorithms. This was one of them. It's a little bit in detail, so I put it, it's in the references. I wouldn't go away because this would take a little bit of time. Diagnosis, you make a diagnosis. Medical treatment, conservative treatment, and then you follow up gradually with medical, epidural steroid injections, and if surgery or what kind of surgery procedures. For conclusion, treatment is multidisciplinary, including cognitive behavioral therapy. There's no specific medication. You may want to combine it. Physical therapy, including aerobic exercises under supervision. Lumbar brace helps walking, but no benefit after taking off. Other modalities in treatment are not of much help. Injections may require further studies, including with reference to grading of spinal stenosis. And decompression surgery may be the choice of surgery, if no instability. I'll leave the surgery part and the other part to Dr. Ali to elaborate more. And if you're doing future studies on lumbar canal stenosis, it'll make it much easier if we mention what is the age group of person who's 32 years and a person who's 80 years. Their lumbar canal stenosis is different. Pain history, whether it's low back pain or leg pain, are you doing it based on the MRI? Walking distance, pre and post, because we are talking about neurogenic claudication. If you don't mention walking, how much they're walking after your treatment, we don't know whether it helped. MRI details of grading, level of stenosis, whether it's multilevel or one level. Injections performed, what level did they perform the injection? And the type of injection, medication, and dosage. These are my references. Thank you. 20 cc with caudal, ouch. That probably hurts. Thank you. So my task today is introduce to some and explain what the supporting evidence are on more advanced procedures that are done for spinal stenosis. I have lots of information to share with you, so I'll try to stay within time. So central canal stenosis, as we have described, is just narrowing the central canal, whether it's your facet joints have arthropathy, if it's your ligament of flavum is unfolding, and or the disc is protruding, all will result in spinal stenosis. So as a result, you're gonna have a shape of hourglass in the middle, and that's what the sonotic segment is. Most of your patients will tell you that if they're in an extension or an upright, they will have more neurogenic claudication and they sit or flex forward. And the reason that of the buckling of the ligament of flavum and the central canal is less so if they have a forward bending position. So in this particular area, there's a little bit just more space. So leaning over a shopping cart or leaning over the counter or taking breaks and sitting down is the reason that it's an internal space issue. So you go from, you would never go from a completely normal triangulation to that, but you just enough improve it. And if you believe in a vascular component, and that probably is the reason that these patients do actually better. So a clumping of the nerve root that Dr. Isaac said is the sign of a severe spinal stenosis. In this particular case, at the index level of L4, this is a severe spinal stenosis, corresponds to the L4-5. And if you don't do this often, if you want to get into doing procedures, you need to kind of do some measurements on this, your own measurements. So what's the diameter of the central canal? What's the thickness of the ligament of flavum on the right side? What's the thickness of ligament of flavum on the left side? And why is it in a triangular shape? Is this more of a disc issue? Is it ligament of flavum or facet or maybe both? Because you have some options for some of these tissues and you don't have options for the other ones. So, and compare that to your L4-5 segment, the ligament of flavum in this particular patient was about nine millimeter on the left side and 7.7 millimeter on the opposite side. Together, that's a 16 millimeter. Your diameter, average diameter of spinal canal is 1.8 centimeter, that's 18. So this is a five millimeter central canal. That is a severe spinal stenosis. So put it in the perspective of measurement, it makes sense. Whereas this one, ligament of flavum, believe it or not, is about three millimeter. That's still abnormal because you have, but you have such a large canal there that is not really causing a critical spinal stenosis at that index level. So I propose to you that we probably have a treatment gap between what we traditionally learn in pain management fellowships or interventional spine fellowships that goes from a conservative care, which Dr. Amit nicely summarized for us today. All the injections depends on what you are comfortable with or what you think works better for your patients. But that's kind of where our fellowships, at least when I did it 20 some odd years ago, that's where we stopped because after that, if there was no improvement in our symptoms, we either went to a pure pain management medication and all that, which was not quite desirable or at least successful, or we would say maybe you wanna take a look at surgical options and we would defer to our surgeons. So there is what I propose there is a treatment gap in middle that these interventions that we nowadays are dabbing into is gonna fill that gap. And the surgeons have been trying to fill that gap as well and I'll explain that how they have been doing that. So if you think about our surgical solution, believe it or not, the first laminectomy unsuccessful patient died in 1814. So we have been doing this for 200 and some odd years. The first fusion was done in 1911. So we have been doing fusion for 110 years. We have been doing plus 200 years of laminectomy. We know a lot about laminectomy, right? The very first successful one, the patient didn't die was 1829. So about 200 years or so. So this is a very well established, very well established and well studied, reasonably well studied. So if you're doing a direct laminectomy, direct laminectomy is an open laminectomy, incision is made and you can actually see what you're gonna remove. That's what you traditionally know as direct laminectomy versus a indirect decompression. Indirect decompression versus indirect, I'm sorry. The indirect decompression is if you put a spacer of some sort in between the spinous processes and you allow a flexion moment at the index of surgery and that would mean an indirect decompression. And that terminology we use and the surgeons use as well. So your traditional decompression or laminectomy is facet sparing. Maybe the surgeon tries not to touch the facet joint. If they start fiddling around the facet joint and around the parts, they get complications more and they may have to do interbody fusion with them. So it's an important thing to understand what is a laminectomy, what does a classic laminectomy look like. Now you could do a hemilaminectomy, bilateral, the two laminotomies. You could displace the lamina backwards, a laminoplasty, more commonly done in the neck. Or you could combine them with fusion, hopefully in the cases that they have instability, proven instability on the flexion extension films and now you decompress and fuse them. So that's really the tradition of how we wanna treat these. But if you are lucky enough to get a canal that is this large because part of the facet was removed, you generally don't see it this nicely decompressed but they're generally decompressed and you can see there is no more clumping of the nerve. This is actually the same patient. So it's an impressive amount of improvement at least in this particular patient. So what are the indications? Well spinal stenosis with neurogenic claudication which we have not been able to help has been traditionally the folks that they go for surgery. There are some that are of absolute indication like if you're getting cauda equina symptom or you're getting so much weak that there are falls that are happening, those generally they get bypassed pretty quickly to a surgical route. But they want us to, well surgeons also want us to fail in what we do before they consider taking the surgery because they're taking a bigger risk than potentially we are. But if you have a grade two sondolosis instability in that segment, if there's a lateral listhesis, so the vertebrae shift is to the side or you have a significant scoliosis, there's a good chance that in addition to just laminectomy you're gonna end up being instrumented. And generally the instrumentation is longer. So it could be complicated as you all know. You could have instability, especially if the parsis affected during their surgical treatment. It can become unstable and that's when you're gonna start seeing listhesis after they have done laminectomy three or four years ago. They have been very aggressive on it. They could get a kyphosis at the index level of surgery. So now you have a kyphosis and generally these folks come back with back pain. Obviously you guys know about infection and all that. Dural tear is about 13%. That's a high rate. When they're trying to get it done, they're really worried about the dural tear. They try to do the best they can, but sometimes with just very, very small canals it's hard to do so. So infection fail back syndrome or lack of success with surgery is a better name. I don't really necessarily like this, but this is what we call it today. It's one of the complications that we end up seeing in our clinics and often these folks, they get some sort of neuromodulation technology applied to them. That's up to about 15% of the cases. That's a pretty large number of patients we get this kind of complication. So what is the surgical outcome? If a laminectomy is considered, this is a 20-year-old study. Obviously we have been doing it much longer. In this particular case, over 400 patients were enrolled in it. They followed them for five years and they really only looked at the ODI. ODI, if you do that for your patients, you know 34 plus 18 is actually on the severe side. So you're gonna bump into 60s and 50s and 60s. That's a severe disability index. And in these patients, about 62% of them did very well with laminectomy and very well was kind of improvement of ODI more than 15 points is there, sort of these people are doing really well. So this is a study purely about laminectomy. What about fusion? So if I add instrumentation in a patient who is not stable, it is actually stable. This is not an instability issue. It's just spinal stenosis with neurogenic claudication without instability. What does addition of those bolts and screws do to you? They actually do nothing. So this study was there at 300 patients. They divided them with group that they just got decompressed and the second group got decompressed and fused. And they followed this patient with all the metrics that you see. This was actually fairly well done. They did the disability. They did the VAS scales for pain. They did the SF12 and they also did all the claudication thing. And they did something that in Europe they use it more often. It's called URQL and that's talking about how much mobility they have, normal mobility, self-care, usual activities, pain, and also some psychiatric aspects. So they followed all these metrics together and the addition of the fusion did not add any benefit for the patients. So if your surgeon is doing laminectomy fusion on a standard basis, it's a conversation to have because you're gonna end up with a lot of pale back syndrome that you need to work with and it's hard to treat them. So it's a good conversation. It's a healthy conversation. It's their own data. This is surgical data. We didn't do it. So another group compared every surgical possibility. So these are both direct and indirect decompression done by surgeons. So this is coflexes of the world, extops of the world, laminectomy, laminectomy and fusion and anything in between. All the surgical ones, they found 24 randomized studies that support of different types of surgical solution in there. Out of those there are 2,300 patients involved in those randomized studies. And again, laminectomy alone and laminectomy with fusion, the fusion did not add anything. So that came out of this sort of a Cochrane review type study. And what about the spacers that the surgeons insert? Not the ones we do, but the surgeons did. And that's generally between coflexes and extop. At that time extop was still available. And they realized the pain and the disability actually improved in both groups on an equal way. Whether you did a decompression or you put one of the spacers, they did relatively well. But the problem is that the surgical time for the surgeon to put a device was actually longer than it was for laminectomy. They are very quick in doing laminectomy. And then the chances of that your device will have a reoperation is higher than the decompression. So you're taking a smaller procedure, but there's a chance that they would have another operation at some point in the future. So, but a smaller procedure. So again, they've compared this to now surgery versus non-surgical. They found about 12,000, three or 13,000 citations about this, so they found a lot of stuff, but only about five RTCs in that, in the entire database that you can follow. And this was done back in 2016 or so. So one of them was surgery versus back brace and just exercise. There's no procedural thing, nothing there. That's one, and they found no difference. Randomized controlled study, just give him a back brace, have him exercise versus doing a laminectomy for spinal stenosis, interesting. The second one was surgery versus just spinal injections. So they didn't add anything else. So you're getting an epidural injection or a caudal or whatever at that time, they were studying it at that time. And they only followed them for six weeks. To me, it's just an insignificant amount of time for that study to kind of know really how it's gonna pan out. Most of the studies that are relevant is one year, two year, and five years. This was very short. There are three randomized studies that compares spine surgery. This is bundled spine surgery, all of them combined, versus patients that have a non-surgical and multimodal, meaning that's physical therapy, injection treatments, acupuncture, you name it, they combine them together. And out of those, for the first year or so, so the first 12 months, they were doing actually okay. But after the second month, and this is your conversion to actual surgery, after the second month, the people who did have laminectomy or decompression of some sort, they actually did better functionally. So a two year mark is different than the first year that you see them at. Sometimes we see this progress in our, but that 10 to 24% that Dr. Amit brought up, that is the number that you see, 10 to 24% is a complication. So these are the ones that they say, hey, we don't know if this helps or not. You guys just decide what it is. So there's no confidence in one over the other, so non-surgical versus surgical. So what did surgeons do to fill that gap? So the technologies, these are around 2010 to 2015, or 2008 to 2015 or so. One of them is off the market, the other one is still on the market, but I'll bring it up for you. So the one on the right side, it's called the X-stop. Those of you that have been in practice for 10 years, you have seen these. For the ones that you haven't been around for 20 years, this product went away and it's now, in Europe, I think, or somewhere in the world, they're still doing it, but not in the United States. And the one on the left side is a CoFlex that Dr. Zak actually had presented a picture on that, and we'll talk about it. So what about this device? So it's an inter-spinous device. It goes from lateral to medial. You need an incision. So this is an incision made. The surgeon will actually dissect down to the level of the spinous processes, identify all the structures. This comes in pieces. They put them together, lateral to medial. It goes together and clamps, again, your spinous processes. So it sits there, and that's supposed to create an indirect decompression internal canal. So this is an X-stop. Studied in 2009, early in the course of this particular medical device, 175% was enrolled. They followed them for four years, but this data is really the first two years' data that I'm presenting to you for that particular device. And eight of those patients end up having a laminectomy. So 160, some of them, they really did, and they kept this X-stop there. And you see the VAS scale dropped, so from a six out of 10 scale went down to about 3.9. So if you're going on a 100 scale, that's how they're looking at the improvement. But whoever improved, they maintained it for two years. So whether you're looking at disability index improvement or you're looking at pain index or pain scale, they actually did improve. Now this particular study was done in Germany, and they did something interesting. They say, well, we think that this device is better for the ones that we consider intermittent claudication, meaning I walk, I get it, I sit down, it goes away. But there are patients that they actually, on an ongoing basis, they will have neurogenic claudication. It's worse when they walk, but they still have leg pain when they sit. And these devices tend to not work as well for those patients. So this was the first observation on that. And the other thing that they did was cool. They said, if we get an upright MRI on these, we may be able to predict who actually would do better on these. Upright MRI back in 2009. So it was a pretty cool study from that perspective. So this is another study on Xtop. 100 people got Xtop. The other group did any other treatment, non-surgical. So they had non-surgical versus this particular device. The Xtop group did better in general than just medical management. Our controls are people who did physical therapy and injection treatment. So this is that kind of comparison between the two. But the satisfaction with the people who just did PT and injection wasn't too bad. 40% of them were actually happy versus the Xtop did better. So they did 71%. This is another two-year durability studies. Again, it was in favor of that. But this is comparing Xtop to a regular laminectomy. No fusion involved in this. They compared those two. Makes sense because this is one direct versus non-direct or indirect decompression. 100 people, 50 in this group, 50 in the other group. They followed them for two years. So people with laminectomy and all that. And they followed all the metrics on pain scale to SF36 to a Zurich crudication, which is a pretty good way of evaluating their leg pain. And at no point there was a difference between these two groups. So if they did an indirect decompression with this particular device at that time versus the laminectomy and followed them for two years, they did just about the same. The re-operation was higher for a device implanted, just like every other device that we talked about so far. And then the other one is that the one that failed your implant, if they did a regular laminectomy, they actually did okay. So you didn't burn any bridges by putting something smaller in them. So this is what they were trying to prove that this is a good device to do. Okay, and then also they looked at dynamics around the X-stop to see if we put this thing in there, what happens to the adjacent level. Nothing really happened at adjacent level. They actually moved very freely without this being interfering with it. But at the index level that they had inserted, flexion extension was limited. You expect it because it's clamping the backside of splashed processes. But the rotation was not infected and adjacent level changes. From a dynamic perspective, they were moving just about the same way that they would do in a normal person who didn't have one, which is actually interesting. So although this device was taken out of U.S. market back in I think 2015 or so, there's still studies being done. This one is more of a systematic review. It was just published this year, I believe. And they compared and they put multiple studies that they thought was relevant to them. And they basically found that the X-stop and laminectomy just about the same way. But interestingly, they lost the market not because it wasn't quite working. They lost it for political reason. That device is no longer in U.S. So the surgeons paid attention to a new one we called CoFlex. This is a device that looks like what you see there. And Zach had a nice X-ray of two level version of this. This device sits in the interspinous ligament. You have to sacrifice the ligaments in between because that has to get inserted in there. So you no longer have the supraspinous ligament in the X-stop, you kept it. And in this particular device, you have to actually resect all the ligaments in between. So you have to be able to implant this in between. So it's a surgically open surgical procedure but this device gets implanted in between the spinous processes. This particular one compared this particular device to a laminectomy and fusion. So this is a two year durability study for this particular. And they compared it to actually a decompression and fusion. This is supposed to be a motion preserving type device because it actually will move with you if you move, extend your spine, but it would resist you to do so. But it actually was considered a motion preserving device. So they wanted to make sure that it's not inferior to your combination of decompression and a pilaf. So that's what they were trying to prove. But they also wanted to see if there's 15 point reduction in your ODI, they're improving in pain by two at least. Minor amount, but two out of 10, two less degree of pain. And if the claudication improved. And you look at it as overall success between people who have decompression and fusion and this particular device was not statistically significant. So they both did okay. So the smaller procedure seemed to have hold compared to a very major decompression and pilaf. The vascular was better in both group. The SF12 was the same thing. The reoperation was higher for your implant just like we talked about the other one. So you have to accept that's the case. Interestingly, adjacent level disease, two years after the first surgical procedure they picked, the fusion surgical, people who went through fusion, they have additional surgeries. Not with a COVEX group. So you actually may have bought yourself an adjacent level surgery because the patient comes back, I'm not better. This is more relevant to the fusion. And we do see that in fusion right now. So if you were to, again, this was a bigger trial done. It was a five year durability. Does this medical device survive the market? And they looked at it at five year. And again, similar amount of improvement between people who had pilaf and decompression versus whoever had this particular implant implanted in them. In the group that they got implanted, only 20% of them required an injection at any level within the spine. Not just around, any level except. So you didn't really have to do injections on them again. Vascular was the same. ODI was actually both improved in the same way. Interesting with this particular device, and it's relevant to what we do in VertiFlex, there's actually a foraminal height restoration. So this can actually be applied to some of the foraminal impingement that patients will have alongside. So COVIS could be effective. It works for moderate spinal stenosis. It's still on the market, and it really doesn't burn bridges. So it doesn't mean that if you put this, you're gonna end up with a fusion. So that's what the conclusion of this particular study was. Another systematic review, sort of smaller procedure, shorter recovery, and so forth. So I'm gonna be respective to your time. Can we now fill that gap with what we do? And I think we could. We have three different type of things we do. We do a posterior decompression, removal of the ligamental flabum. So it's a minimally invasive lumbar decompression. Really what you're trying to do is removal of the ligamental flabum to just create some room inside the spinal canal. Okay, this is the smallest of the profiles of the procedure I'll present to you. Then you have a decompression, indirect decompression device which is the VertiFlex that we can talk about. And then there's three or four different things that we can do that actually does arthrodesis. Just like an X-stop would do, this would be an arthrodesis. So these are all designed for spinal stenosis. All of them are designed for moderate spinal stenosis. So if you're looking at removal of the ligamental flabum, you need to know what the thickness of the ligamental flabum is. More than two and a half millimeter is supposed to be it. I have never done one less than five millimeter. So the two and a half millimeters, you get an epidural, they're happy for eight months. You don't need to go put them through a risk of a procedure that's bigger. So understanding that who needs to have it is important. It is a surgical procedure. You will have it in the operating room. The patient is sedated for these procedures so they don't move. And then you would remove, actually, a substantial amount of ligaments. So what you see today is a Thursday. I did on Tuesday. So this patient is in the middle. We took a picture. That is about three and a half to three millimeter in diameter in the middle picture, about three or four millimeter long section. Usually, it doesn't come like that. It usually comes in those pieces that you see on the right side. Each of those small pieces is around two, two and a half millimeter in diameter. So you debulk enough there, you actually can remove a substantial amount. Now, interestingly, I don't think is the amount you take. It doesn't have to correlate with the more you take, the more the patient is going to do well. But as much as you can actually remove the ligament, the flavor of the patients will like you for it. So if you can remove that, you could also do this for adjacent level. Although, we currently think that if you have done about 100 of them, you want to tackle one of these. If you haven't done about 100 of these, I wouldn't suggest you to do so because the complication risk with these are higher. But you can actually do that. So moderate sinus stenosis, failed everything that we do, including all the injections. And I generally send them to the surgeon because I want him to say no to the actual regular surgery because the gold standard is still laminectomy. Unfortunately, that's what it is. But if the patient is not willing, they are medically complex. There are 85 and above. Try to get a surgeon to do operation on a nine-year-old. So these are folks that they really need your help. And spinal injections may actually be more complication prone. Severe spinal stenosis is not necessarily what is indicated for on paper. I will present to you our data on spinal stenosis for severe. So you may change your mind at some point. But if you have cauda quinae weakness and any of those red flags, you often want to bypass the surgical solution. Complication, device can fail. Hasn't done it. I have done probably 300 of them. But the idea is that this is not really, it's a very simple device. It's a very, very, very simple medical device. And it shouldn't fail, but it can. Dural tear is more, this is a blunt tool on the side of the dura. So even if you touch it, you're not going to cut it. But if you don't know what you're doing and flip it and you do funky stuff with it or they have had surgery before, your risk of dural tear can be higher in those cases. Again, it's extremely low. The company claims that it's a similar risk as an epidural injection. You take it for what it is, but I think it's a safe procedure. So what is the data behind it? This was done 12 years ago. So this is not a new procedure. Folks at the Cleveland Clinic, they started with this. Dr. McHale did that. And there were 40 patients there. They followed this patient nicely for how much walking they do, how much standing they do, what's the ODI, what's the vascule, and tried to follow this through. And they found that they walked from 250 feet to about 4,000 feet. So this is a significant amount of walking has been increasing these folks, patient, and the pain level in the vas had improved. Fast forward to another study. This was a one-year durability study done by Tim Deere. Same age, same time frame in 2012. Larger study, so N number was 112. They followed these patients for three, six, and one year. So it's a one-year durability study. And they found on the metrics that we are interested in, they actually did well. I'm running through it just for the sake of time because I have more stuff. The MIDAS study was the one that Medicare looked at for ability to approve this procedure a little bit more widespread. They compared it to epidural injection. These patients either had the mild procedure or they would have allowed four epidural injection in one year with 80 milligram or 40 milligram of triametamerone. That was the study at that point. Nothing else was done. At six months mark and one mark in the ODI pain scales, as well as satisfaction, mild was superior by almost double the digits. So if the 62% of folks with mild were happy with their ODI, only 35% were happy with the one that were getting four epidural injections. So it's from a functional perspective, these folks actually did much better. They completed the study in a two-year durability study. Same MIDAS study, same Dr. Statz group. They followed these patients forward. And they still had 22 points reduction in ODI two years out. So if they were successful in your hands today, or three months after the procedure, they tend to keep this success follow-up for about two years. And that's what we see. And in this study, they did better in pain reduction. So they had almost four digits drop in pain. The other one was in the twos or so. And then so the claudication improved. So the next slide, I think, is the re-operation rate for these folks is actually on the lower side. So the chances of they would get operation is similar to the spacers that is being placed. So this is, again, Tim Deere. 10 years later, he went back and did what's called the real-world study. That means that in a real world, we don't just do epidurals. We do physical therapy, we give them a back brace, we do medication, you add an epidural injection. So you're doing multiple things at the same time. So they did that. And then for a bunch of group of patients, they added the Mild to the mix. So Mild was an additional tool. And they followed this for one year, and they followed them for two years. So it's a longitudinal studies. And in these metrics, there were 155. About 60 or five of them were in each arm. And they followed these patients throughout. And they looked at the outcome of it. And basically, on ODI, the people who had the Mild procedure had about 14-point improvement on the ODI side. And the walking improved by almost 200%. So whatever their baseline was, they went up by 200%. And there was no complication. But I think what's important, and what you guys were talking about, this is really an important slide. Because what they observed, that the blue line is a group that they were adding the Mild procedure to. And the orange line are the people that they just continued doing the multiple procedures that we do, and the physical therapy, and so forth. If you followed them for one year, 5.8% of the people who had Mild procedure decided that they need a laminectomy, or they need a Veriflex, or some other procedure that is invasive, not your epidurals, more invasive procedures. 25% of your people who you were just injecting and physical therapy was done, they needed the surgery part. Fast forward that to two years, the difference is astounding. Because 10% of folks with Mild, so 10%, one out of 10, of that group, they decided that they need one more procedure. That could be an implant, it could be a decompression, some people do stimulator, and so forth. But out of the first group, epidurals and treatments of such, 77%, that's where your 80% number that you came up, 77% actually needed to go to an intervention that is much more than an epidural injection. So this is a good slide, because if you're thinking about introducing it, look at your patient at two years duration, don't just look at them in a few months that they come back for a new injection. So I'm going to skip this, but from a cost perspective, it's actually cheaper than conservative care for you. So this is data on severe spinal stenosis. It's a very preliminary data. We have done about 80 of these cases. The oldest is 96. The average age group was 82 in these people, average. The ODI average on this paper was in the 50s. So they're all severely disabled. And the surgeons would basically say no to these people. I picked a little older group of patients, because they're really more desperate. And out of 80 of them, and we have been following them through, there's about 20 point reduction in ODI. So they go from severe to moderate, or they will go from moderate to mild. And these are pinpoint severe spinal stenosis that you would like to send to surgeons. They actually do OK with this procedure. And five of them, out of 80, 81, five required laminectomy. It's a good data. So it's a good procedure, even for severe stenosis. And they walk about five times more than the baseline. So if they walk for five minutes, they would do 25 minutes. And that's for somebody at 90s, that's amazing. So they could get to the kitchen, get a glass of wine, go to dinner with the family. They could park a little closer, and they could walk it. So this data is to be done. I have summarized in your slides, all the studies about mild are here. So if you want to have more detailed information, I put them all there. What about indirect decompression? So we have a indirect decompression device that we could put in there. VertiFlex is the name of it. That's the one that most people do, because it has the most amount of studies on it. Again, this is not a fusion device. It's an extension limiting device, meaning that you want to try to keep them as straight as possible. And they can flex as much as they want into it, that they would limit them in an extension. And again, as we talked about, if you can keep them in a straight position, you have a better chance of reducing, or indirectly decompressing them. It's a device that looks like that spider that you look in. I'm gonna put a side-by-side picture. I did this patient's VertiFlex in 2020. The left side shows you the clumping of the nerve root at the index level L3-4. The right side MRI was done for a completely not related thing. And eventually, if you look at the central canal, it's about one centimeter. I measured it, I can see it, it's about one centimeter. And look at the nerve roots. They're no longer as clumped as you saw it on the left side. So it actually does a nice job. I just don't MRI them, because if he doesn't come back to me, I don't need to do anything. But this was done because they had done another thing, and I kind of piggybacked on it. So, moderate spinal stenosis, neurogenic claudication that improves with sitting. So you have to have that. Otherwise, I wouldn't consider this for your patients. And in this particular study, they did the decompression and they wanted to, I'll tell you how they kind of followed the patient. So 12 weeks of physical therapy, multiple injections, and you decide what the tool is in your pocket that you want to do, if this is the one you want to do. If they're allergic to titanium, they can't have it, because that's the titanium device, just like all the implants that are placed. It's not for cauda equina, it's not for your severe spinal stenosis. They may get a stress fracture of the adjacent level and it loses its efficacy. So it's not detrimental to their health, it just loses its function. So, it can migrate, is a device that you put in there. If you don't have a compliant patient and they're not going to listen to you, not to twist and turn and bend for the first six weeks, they may actually dislodge this, because it takes four to six weeks for this thing to settle in, okay? So, but if you have a compliant patient, it could be very good. If you have a kissing spine, you're going to have a very hard time putting this in. If you have a BMI of 40, I wouldn't suggest you to do this procedure for them. There is a two-year and a five-year durability study already on this, because this has been on the market for a while. And the data of the two-year, from a durability perspective, is that there was 70% reduction in your leg pain severity in these patients who have this implanted, which is pretty cool. This was done back in 2015, and what they had at that time is what the surgeon had at that time. They compared this device to an X-stop, because that's what the indirect decompression is. We have this, so let's kind of compare that two together, and they both grouped it really well in terms of pain relief. So it's not really inferior to what the X-stop was doing for their patient. I think this is a better slide. This is a five-year durability studies. The 66% is actually back pain relief. Now, I don't expect my patients with spinal stenosis that I do mild procedure, the back pain to go away. I actually tell them they're not going to. But whereas this particular study, five-year durability, the actual improvement of back pain was 66% of patients. I think that's remarkable. But 75%, so three out of four patients actually did very, very well with the neurogenic claudication. It could be opioid sparing for you. So about 85% or so, they got better, and when you ask the patient who wants to do it, it was a good idea, about 90% of them did. All those metrics you see in the bottom, at the end of 12 months, when they drop in the pain, improvement of ODI and improvement of claudication, if they got to that point, they maintained it for five years. So it could be a sustainable pain relief for these patients. Multiple studies here are lined up for you. So this is the Medicare claim data. I'm going to move on to the, because we are running on slide. What about the last one? So if they had this, mild was compared, by the way, to X-stop, because mild came out at the beginning, and the mild procedure is actually the, it was a safer procedure compared to X-stop. The reoperation for X-stop was higher than mild was, but the X-stop kind of went out of market, so they stopped looking at those two together. What about these devices that they fuse things? So if you have a big heart, and you are okay with doing these procedures, you can actually cause arthrodesis between the spinous processes. And it is a, there are multiple devices now out there. Some of them are only indicated between L1 and L4. There's one that also includes L5, because you don't really have a nice spinous process at L5, so the design has to be different. And I think a bunch of these are also coming out. But what do we think about it? So this is the one that I saw a couple of people put their hands on. It's called the Minuteman device. It's basically like a molly when you hang something on a sheetrock. It has this sort of flaps that comes out. And you actually have a two and a half centimeter on the lateral. You actually dilate the tissue. You don't cut things. And once you can get to the interspinous space, you can actually nicely insert this in the between. You will actually decorticate the bone. You want it to bleed a little bit. And then you will actually put bone grafts in there. So this is actually a fusion device. It's designed to be a fusion device. The designation of this is spinal stenosis with spondylolisthesis, just like any fusion would be. So this is not for people who just have spinal stenosis. It is designed for that. And your insurance will actually look for, if you put the fusion code, because it's a regular fusion code for this thing, they will look for instability. They want you to have an x-ray that radiology says there's instability. So this is for those group of patients. So against grade one spondylolisthesis is probably the best indication for it. The device will end up looking something like this. It will grab the spinous process. It's pretty tight in there. And then it would take about, just like any other bone infusion, if it does fuse, it's gonna be about four to six months out, just like any other one. You protect them a little bit. What about studies? This is a small study that produced a 24-month study. I don't like this study. And the reason is they're comparing this to just a decompression, not to a fusion. So this is not pound to pound sort of comparison. But in this group, they did well with the pain, at least 35 to 50% reduction in Minuteman, and they had 70% improvement. They claimed they had 89% fusion rate, which is actually incredible. I think regular fusion rates are about 80%, 85% or so. So what about that gap now? Okay, so this is what we think. There was a gap right here. We have some stuff in there. There is some data in there. If you belong to different societies, different society makes recommendation just like NASS. The Dr. Deer and Dr. Dawood's group, they really think that there is enough evidence to kind of put this in your algorithm, okay? And that's the whole idea, is it's time for you to think about these procedures somewhere in the algorithm of care, whether you do it or somebody of your colleagues doesn't. So in their category of, I think this is a busy slide. So these are the guys that they're gonna go to surgery or neuromodulation, meaning that they either had a previous surgery or they have red flag signs that you wanna kind of bypass them to the surgical group. But if there is no red flag sign, they have spinal stenosis, then they're kind of not having any much of a difference between whether you're doing mild or you're doing a VertiFlex, they're kind of in the same bucket for them versus if you have an instability or a grade one with a little bit of movement, they're recommending some sort of fusion device in there. So this is a common, there's only society that I know that is actually supporting this. Most of the folks in here are private practice. Most of these procedures are done in private practice. Understanding there are some limitations, your surgeons are not gonna like you as much if you start doing things, I've lost a lot of friends. So understanding that this, there is probably a gap here. And that's the idea. There are minimally invasive, there really are. All these patients go home. All of them go home three days of Percocet. So this is a small procedure. The fusion will hurt more, the rest of the procedure, next day, we call them every day and we see them two weeks and six weeks and 12 weeks. So they actually do okay postoperatively, easy to do. You have to understand that these are advanced procedures, the spaces are there, the mild procedures are there. If you're picking a smaller, if there is no difference, pick the smallest profile of the procedure. A six millimeter incision versus two centimeter incision, pick the sixth one if you think they're gonna be able to help them. But they have to have the criteria in which you help them, right? So they could be opioid sparing. This is not a bad thing. Incidence of back surgery in five year with some of these things is actually low. So you may buy them a few years, and if they're really old, they may actually die from other medical complications before they need another procedure to be done. So think about them, where they fit from the age perspective but also from a utility perspective. Patient, what else do I wanna say? There are really definitely need for randomized control study comparing some of these things together. But there is room for them. You have to have the right setting and you have to have the right skills to do these. If you don't have surgical skills, should not be done because these are some of the more open surgical procedures. I'm gonna ask our two esteemed colleagues to come up. We're open for questions. I see a microphone there. It probably helps if you talked into the microphone for your questions. Thank you. Question, I don't, with the, let me answer this question, with the some of the fusion devices for the spinous process region, does that prevent future other more advanced surgeries or create a difficult if a spine surgeon later does need to do a fusion or other procedure? So if you have a solid fusion the surgeon will have a hard time removing this. They have to do a wide laminectomy, they have to instrument them. You mentioned after a particular procedure you are more liable to have adjacent level surgery within the next two years, more likely level above or level below, any particular difference? I don't think that that particular, it was about fusion more than the instruments we do, but they didn't have any mention of just calling adjacent level. We end up seeing it more above. More above, thank you very much. Well, question, is that because the fusion is more likely at L5, S1 or L4, L5? Actually, the frequency of L4, L5 is higher than L5, L1. Okay, thank you. Do you see any evidence comparing mild and very flex to endoscopic decompression? Could you repeat the last part? Endoscopic, so one of the neurosurgeons in my institution does endoscopic lumbar decompression, so when I talk to him about mild, he says, well, I can visualize that endoscopically, so have you seen any evidence comparing those? So there is no studies that I know of. Excuse me guys, there's a question-answer session going on, please. So I have not run into a study that does tube-based surgery, that's your minimally invasive tube-based that the surgeons do versus these procedures. In general, if you ask the spine surgeons, they most often, because I send them to surgeon first, they really try to defer the question. Thank you guys. I'm gonna go in the front of the room, if you have more questions, I'm happy to help you, I just want to empty the room for the next talk. Sorry guys, whoever is talking, I'm sorry.

spinal stenosis

treatments

Dr. Ali Mustafi

neurogenic claudication

diagnosis

imaging

epidural steroid injections

minimally invasive techniques

fusion devices

personalized treatment

surgical outcomes

endoscopic decompression