Melanie Cole (Host): Welcome to UAB Med Cast. I'm Melanie Cole. Joining me today, we have a panel, with Dr. Jesse Jones. He's an Assistant Professor and an Interventional Neuroradiologist, and Dr. Junjian Huang. He's an Interventional Radiologist and an Assistant Professor. They're both with UAB Medicine and they're here to tell us today about an exciting Basivertebral Nerve Ablation. Doctors, thank you so much for joining us today. Dr. Huang, I'd like to start with you. Can you please set the stage for us with the scope and the magnitude of people suffering with back pain that don't want to be on opioids or can't find relief in other ways?

Junjian Huang, MD (Guest 1): Well, thank you very much, Melanie, for having us on. So, to start with, low back pain is one of the most common musculoskeletal ailments and the leading cause of years lived with disability in the world. It's also one of the most expensive occupational disorders with around 30 million people currently suffering from low back pain in the US, resulting in nearly 50 million physician visits annually.

Now, the complex nature of low back pain results in many, many issues for these patients because there are things that can be done such as avoiding aggravating factors, going to the chiropractor, having some physical therapy, or eventually going to some sort of pharmacologic intervention or even procedures like injections.

The problem is that the results of these are very heterogeneous and transient. The FDA approved, Basivertebral Nerve Ablation in 2019, and what the Basivertebral Nerve is is a series of peripheral nerves existing within the vertebral body that innervate the vertebral body endplates. What they have found is that in patients with low back pain, a lot of them, around 36 to 50% have what they call axial back pain resulting from degenerative disc disease.

So when the disc has issues and becomes dried out, what winds up happening is it causes inflammation of the adjacent vertebral bodies. And this inflammation results in recruitment of nocisceptive fibers and these congregate near the BVN or the basi vertebral nerve before going to the spinal cord and telling your brain that your back hurts. What researchers have done and what, industry has done is they've helped create a new procedure where we can intercept the signal. And by ablating this nerve, cause reduction of pain signaling into the brain. And the results of two level one studies, one with five-year follow-up have shown 75% reduction in pain in 75% of patients who undergo this procedure. And that's something that Dr. Jones and I have started offering here at UAB and we really appreciate the opportunity to talk more about it.

Host: That is so exciting. This is real cutting edge technology. And Dr. Jones, I'd like you to tell us that UAB has become one of the premier centers in the world offering this procedure. Tell us about how you got involved in this offering, and how did this really come about? And then I'd like you to speak a little bit about the procedure itself, how it works.

Jesse Jones, MD (Guest 2): Well, it's funny you mentioned that, Melanie, when Dr. Huang first came to me and proposed building a practice here at UAB, I admit I was a little suspicious at first. Dr. Huang had learned this with another physician, Dr. Hirsch at Harvard before coming to UAB. And I really didn't think it was going to work, to be honest.

You know, we see a lot of people with back pain and like Dr. Huang says, they try a lot of things and mostly things just don't work for them or they're transient. But what we found as we've started doing these procedures is a surprisingly high level of positive outcomes in these patients, and it's been very rewarding to see these people to come back into clinic or when you call them to say, Hey, my back pain is so much better after this procedure.

And the procedure itself's quite simple. It's an outpatient procedure where a patient will come in, in the morning and then leave a few hours later after the procedure's over. In short, it involves accessing the BVN as, Dr. Huang mentioned, which is done percutaneously or through a needle puncture in the back using X-ray guidance.

And once we've reached the level of where the BVN is located within that vertebral body, we activate a device. At the tip, it heats up and burns that nerve and it ablates it. And once that process is done, all the hardware comes out and the hole is quite small and it's just sealed up with some bandaids.

Host: Wow, that's amazing. Dr. Huang, as far as the procedure itself, is there a difficult learning curve since you're the one who brought this to UAB and to Dr. Jones? Are there some technical considerations you'd like to share with other providers to help them achieve better outcomes? What were some of the barriers to beginning this procedure at UAB? How did you overcome them? And tell us a little bit about the learning curve for it.

Guest 1: Well, it depends on what kind of procedures you were trained to do. So, for interventional radiologists, our training is essentially rooted using fluoroscopy and CT. So when we started doing these here, we started off in CT to make sure that we had pinpoint precision with our ablation probes, because the BVN is located at the junction of the anterior portion of the posterior one third and the posterior portion of the middle one third of the vertebral body.

It's not located in the center. So you have to get more posterior than you usually would for something like a unipedicular kyphoplasty unipedicular vertebroplasty. So that was the first learning curve was, probe positioning and we achieved that using CT. Once we got the hang of getting our probe in the right place, we transitioned to fluoroscopy. And as of now, we've done so many. I think Dr. Jones and I have combined to do well over 60 of these. And our practice has, you know, gotten much more streamlined and now we're able to hit the target under biplane with the most complex level being S1. That level requires a little bit more lateral to medial navigation of the ablation probe and of the, of the trocar itself in order to get into the middle one third of the vertebral body.

So I think we're still getting better and better at it. The key thing is you just have to have a good sense of staying safe within the pedicle. And really understanding where you are in relation to imaging so that way you don't miss the BVN and you don't cause any sort of transagression of the sequel sac.

Host: Dr. Jones speak about patient selection. What are the indications for the procedure itself, and are there some contraindications for some people?

Guest 2: Yeah, patient selection is key to good outcomes. If you don't choose people who are, are right for the procedure, you end up with a lot of unhappy people. And the key to selection again is, is imaging and it's a very image intensive procedure in patient populations. So we typically start with either a nuclear medicine bone scan or an MRI.

And what we're looking for on those studies is some indication of inflammation in the structures subtended by the basi vertebral nerve. And that's gonna be the endplates of the vertebral bodies and the disc space itself. So when we find these characteristic findings, that really guides our patient selection.

And a typical patient is going to say, Hey, doc, I've got this pain. It's in my lower back. It doesn't so much, radiate down my legs. It may radiate towards my hip a bit, but no further than my knee. And it's worsened with activities and if I can just sit down or lay down, and get off my feet, it feels better. I've had some, some nerve blocks in the past. Some epidurals and I may have gotten some transient relief, with some of them and not others. But nothing really permanent. And that's a pretty typical story that we'll hear. But in terms of other selection features, one nice thing about the basi vertibral nerve ablation is that people can be advanced in age or have medical comorbidities, but that doesn't preclude them from getting the procedure.

It's a minimally invasive procedure. It does not involve general anesthesia, and it's an outpatient, procedure. And so we can bring people in, in their eighties or nineties, or with their medical conditions that they're struggling with, and that's not going to prevent them from getting a treatment.

Host: I think that's what makes it really amazing is that there is a larger patient population that can benefit from this kind of technology. Dr. Huang, is it safe? What do we know about safety and efficacy as of now? And tell us how your outcomes have been. What are your patients saying about it?

Guest 1: Well, first of all, I'd like to start off with very well said, Dr. Jones. I'd like to first start off with a review of the formal indications. The formal indications for this procedure is you have to have a patient with axial back pain, which is exactly as Dr. Jones described, non radiculopathy. That's the first part of the indication. They have to have axial back pain for greater than six months. The second component of the formal indication, is that they've had to have had some form of non-operative management, whether that be injections or PT or anything that's not surgical. And they had to have had that for six months.

And then finally, the last component of that, is an MRI demonstrating modic type one or type two changes at L3 through S1. The other thing I want to talk about is something that Dr. Jones mentioned about bone scan. If you look at the existing literature, the two level one studies were done by Fischgrund.

The Intercept trial and the SMART study. They showed 75% success in patients, and they used these three as the linchpin for their patient selection. If you look at European studies, namely the, the De Vivo study. They had 90 plus percent success and their imaging criteria utilized MDP Spect, which is bone scan.

So there's a little bit of controversy in terms of which imaging modality may be the best for patient selection, but that's the formal indication. But just know that, this is a new procedure and that there are continuing studies trying to optimize patient selection that I think we can be part of the conversation.

Now, in terms of safety profile, one of the primary worries of people who are in the space is that the BVN tracks along with the vascular pedicle of the vertebral body. So people are worried, are you going to cause osteonecrosis? With five year follow up in over 400 patients within two level one studies, the answer is you're not going to have that happen.

There is a 0.03% chance of fracture. In all of literature for BVNA, there was one fracture and that patient was undergoing hormonal therapy for gender transformation. So, you know, when that happens, whether or not the steroids impacted the integrity of the bone remains to be seen.

But those are the major worries. And I would say that the procedure is incredibly safe. Minor considerations with this procedure is transient worsening of radiculopathy because when you're intervening on the bone, you have to get into the bone, and a lot of times in patients who have degenerative disc disease, their neuroforamin are a little bit narrowed and the jostling and the manipulating of the vertibral body may cause a transient radiculopathy, which have all recovered within weeks.

In terms of our experience at UAB, we've done approximately 60 patients and we don't have 100% follow up on them. But for the 50 or so patients we have follow up on, we're in line with the data. About 77% of our patients endorse relief. The exact quantification of relief is difficult.

I will tell you that anecdotally, I have had patients tell me that they are 80 to 90% better, and one patient I did this procedure on, actually told me that he had an unable to bend for 10 years, and after my procedure, he was able to bend over for the first time in a decade without pain. I had another patient who had a L5-S1 fusion performed. And we did her L5-S1, because she had persistent pain and signal increase on bone scan, and she came back and said that her pain was 85% better. So this procedure carries a lot of promise for our patients.

Host: Dr. Jones, can you tell us how patients can gain access to having this procedure?

Guest 2: I think this is a procedure that be spread, you throughout the state and the region with the right training. Um, because it is new, it does take a certain skillset and a dedication to learn the nuances of the technique. I'm not currently aware of anyone else in Alabama doing the procedure.

Hopefully that changes in the next five years as it becomes more learned about through things like this podcast. At the current time, patients are free to reach out myself or Dr. Huang, on UABs website or a telephone number and get a consultation with us so we can understand what's going on with them and talk about potential treatment options.

Host: Dr. Huang, I'd like to give you the last word here. What do you see as the medical impact of this procedure for back issues today? You mentioned it a little bit at the beginning, and what are the conditions under which you believe patients would benefit most from your experience in this procedure?

Guest 1: So, I would say that this procedure has tremendous potential impact for patients with axial back pain and a stable spine. And the reason I say that is because if you look at the aggregate data, we're looking at BVNA offering 75% percent of patients with axial back pain and meeting the criteria for this procedure, 75% of these patients are going to get 75% relief that lasts for about five years or more. If you compare that to other interventions within this space, that is unparalleled. So I think that it will act as a fantastic bridge for patients where nonsurgical management is not giving them the relief they want, and they are either not candidates for or do not desire surgical fusion.

Host: Thank you both so much for joining us today and telling us about this exciting technology and procedure that you're doing at UAB Medicine. Thank you again. And for more information, you can visit our website at uabmedicine.org. That concludes this episode of UAB Med Cast. For updates on the latest medical advancements, breakthroughs, and research, please follow us on your social channels. I'm Melanie Cole.