Game-changer: New Guidelines for Interosseous Ablation of Basivertebral Nerve

[drusso]

---

Members don't see this ad.

ISASS Guideline – Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain – ISASS – The International Society for the Advancement of Spine Surgery

ISASS - The International Society for the Advancement of Spine Surgery

www.isass.org

"Intraosseous ablation of the basivertebral nerve is a relatively new minimally invasive treatment for the relief of CLBP that is diagnosed using well-established clinical and MR imaging findings. The procedure is supported by Level I evidence including 2 RCTs demonstrating a statistically significant decrease in pain and an improvement in function with outcomes sustained to at least 24 months in a limited number of studies. These results were seen in a patient population that is one of the most expensive and difficult to provide care for and in this era of rising healthcare costs and increasing need for therapies to reduce the use of opioids, BVN ablation may provide a treatment option to fill the gap in the treatment paradigm for patients that fail non-surgical treatment."

 

[emd123]

Interesting and seems like it would be easy to do, especially if you're comfortable with vertebro/kypho. I've always wondered if this same mechanism is how kyphoplasties relieve pain so quick, i.e., the heat release from the exothermic reaction of the cement hardening resulting in effective ablation of the nerves inside the vertebral body. I hope this pans out and if so, we can start doing it in the not too distant future.

 

[DoYouEvenLiftBro]

At AAPMR comment from the crowd mentioned they were waiting on a CT report because believed one of their mid 40s pts autofused L3-L4 (I think they said 8 months out).. It’s a long ablation ~15 minutes. Curious what 5 year out scans would show.

 

[clubdeac]

This is what I just posted about on another thread ----> Intracept

 

[lobelsteve]

I think it was the Smart trial that showed the sham group had clinically meaningful improvement in ODI at 15pts. Where 10 points is the cutoff. Sign me up for Sham at a lower price.

 

[drusso]

I think it was the Smart trial that showed the sham group had clinically meaningful improvement in ODI at 15pts. Where 10 points is the cutoff. Sign me up for Sham at a lower price.

How many ODI points did the Poly-methyl methacrylate arm show?

 

[drusso]

I think it was the Smart trial that showed the sham group had clinically meaningful improvement in ODI at 15pts. Where 10 points is the cutoff. Sign me up for Sham at a lower price.

"Participants in this study were of working age (mean of 47 years), reported severe disability impact from their low back pain (mean ODI of 42), and more than 68% had been experiencing CLBP for greater than 5 years. At 3 months, the mean ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). The reduction in ODI experienced by the treatment arm was twice the minimally clinically important difference of ≥ 10 points and responder rates were 75.6% in the treatment arm compared to 55.3% in the sham control arm. There were no serious device or procedure-related adverse events reported in patients randomized to the RF ablation treatment arm through 12 months.

This level 1 trial demonstrated significant functional improvement in patients treated with RF ablation of the BVN for CLBP compared to patients treated with a sham procedure. Safety of the procedure was also demonstrated. The results supported BVN ablation as a minimally invasive treatment for the relief of chronic low back pain."

 

[lobelsteve]

With sham this good, who needs mu-shu?

 

[hyperalgesia]

Whenever I see "CLBP" in a research paper to justify an interventional tx, I assume it's another money grab. At least stick with the "vertebrogenic" moniker to allow chir- I mean doctors to keep some dignity.

 

[Wkrdoc]

How are you guys targeting these patients?

axial back pain with modic changes on MR +\- failed L-RFA?

 

[BobBarker]

Yes, I haven’t done one but I would say axial pain, failed RFA/failed LESI/back covered in heating pad burns with modic changes are the ones I have in mind.

 

[clubdeac]

They have fairly strict inclusion criteria from what I’ve read. Must have chronic axial lbp, no radicular symptoms, no stenosis or neurogenic claudication and modic changes on imaging

 

[SSdoc33]

They have fairly strict inclusion criteria from what I’ve read. Must have chronic axial lbp, no radicular symptoms, no stenosis or neurogenic claudication and modic changes on imaging

That's not very strict.

Also, the studies on this dont say anything about failing RF.

I think this could be useful, but its not clear how it would get paid, nor how much.

 

[pmrmd]

Also, the studies on this dont say anything about failing RF.

I think this could be useful, but its not clear how it would get paid, nor how much.

HOPD only. In the ASC it would have to be a $5-7.5k charge to patient. Office is a no-go. Would you honestly do this procedure prior to treating the facets for an axial back pain?

 

[SSdoc33]

HOPD only. In the ASC it would have to be a $5-7.5k charge to patient. Office is a no-go. Would you honestly do this procedure prior to treating the facets for an axial back pain?

no, id probably go after the facets first as well, but i dont think they did int he study. they just looked at Modic changes.

even trying to get this set up in a hospital setting right now would be very tedious. the reps say they have to figure out a payment structure with the hospital who may or may not cover the balance of the procedure. a lot of this may end up falling on the patient. thats why, as i said, it isnt all that clear. no local hospital models to emulate. no clear RVU/$ equivalent. i like the idea of the procedure, but it needs to be more mainstream, at least in my situation.

 

[pmrmd]

no, id probably go after the facets first as well, but i dont think they did int he study. they just looked at Modic changes.

even trying to get this set up in a hospital setting right now would be very tedious. the reps say they have to figure out a payment structure with the hospital who may or may not cover the balance of the procedure. a lot of this may end up falling on the patient. thats why, as i said, it isnt all that clear. no local hospital models to emulate. no clear RVU/$ equivalent. i like the idea of the procedure, but it needs to be more mainstream, at least in my situation.

Agree with you fully. I want to offer this but considerable expense to patient makes we wary. Who is going to pay that kind of money? I was told $10k for me to buy two of the kits to get trained too.

 

[Taus]

So it’s dead on arrival then.....

 

[NJPAIN]

Agree with you fully. I want to offer this but considerable expense to patient makes we wary. Who is going to pay that kind of money? I was told $10k for me to buy two of the kits to get trained too.

It's the same crap all of the companies are pulling. Show us the money and we will train you. In other words, have 5 patients ready to go or buy x number of kits and then we can talk.

 

[Ligament]

My local hospital did not approve the intracept to be performed. For those of you who did get the hospital credentialing committee to approve, how did you accomplish it?

Secondly, how is it being paid for?

 

[clubdeac]

just read there multi-center sham controlled study in more detail. The sham and active treatment group really do no separate all that much. The graphs looking at their change in ODI and VAS are nearly identical. I'm no longer impressed...

 

[deleted993114]

just read there multi-center sham controlled study in more detail. The sham and active treatment group really do no separate all that much. The graphs looking at their change in ODI and VAS are nearly identical. I'm no longer impressed...

Well.......................... similarity to sham treatment has never stopped anyone before from doing procedures before. Pain management has been plagued by this for decades.

 

[iwumd07]

Well.......................... similarity to sham treatment has never stopped anyone before from doing procedures before. Pain management has been plagued by this for decades.

That’s probably because “sham” procedures actually work pretty well. Placebos are great tools.

 

[olafa]

It seems its mainly being done at academic centers, (for those patients with chronic LBP, endplate changes )they are still working out details. It was presented at SIS meeting impression they did rule out facet first, end plate modic changes type 1 or 2 exclusions - radicular pathology, stenosis, prior surgery, osteoporosis, herniations >5mm, spodylolisthesis etc.
below are most recent publications, 5 yrs followup still in progress. It would be nice to see how this plays out