Biacuplasty

[cdw]

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New member here, so pardon my ignorance. Is anyone doing biacuplasties yet and if so, how's it going? My Baliss rep is hounding me to start, but I just don't believe in devolumizing the disc. Any prelim info in this technique as compared to annuloplasty if chemical radic is the problem? How about if axial mechanical pain refractory to facet workup?

 

[ampaphb]

New member here, so pardon my ignorance. Is anyone doing biacuplasties yet and if so, how's it going? My Baliss rep is hounding me to start, but I just don't believe in devolumizing the disc. Any prelim info in this technique as compared to annuloplasty if chemical radic is the problem? How about if axial mechanical pain refractory to facet workup?

Had a discussion about the technique the other day - don't belive the problem is devolumizing, but I am not certain you will be able to address posterolateral anular tears adequately.

 

[cdw]

Thanks for your reply. Does anyone know if the patients' activity restriction is the same as for IDET? (like that would ever get reimbursed, so all this banter may be a moot point)

 

[ampaphb]

Thanks for your reply. Does anyone know if the patients' activity restriction is the same as for IDET? (like that would ever get reimbursed, so all this banter may be a moot point)

The Saals simply made up those restrictions - there is no science behind them, the same way there is not science behind the speed at which you ramp up the temperature.

 

[Mister Mxyzptlk]

Another cure in search of a disease.

 

[Aether2000]

I went to the Cleveland Clinic training on this technique recently and have the machine but have performed zero cases yet. Unlike IDET, the thermal energy is lower but not nearly as low as pulsed RF. The thermal excursion of IDET worked because the temperatures were turned up to the point local charring occurred. With BA technique, the heat is created in vivo in the tissues, and in a very large volumetric area. The RF energy is transferred 3.5 cm laterally, 1cm anteriorly, and 1cm cephalocaudad. The cooled RF probes, as has been used in other tissues such as liver, demonstrates little or no char.
The Cleveland protocol does use the same restrictions and hard shell bracing as IDET, at least at this early stage.
The technique's success depends on accurate discography and having ruled out significant z joint contributions, having more than 50-65% disc height remaining, and having motivated compliant patients. Obviously the interruption of neuronal signal transfer from the annulus and nucleus will not reconstitute the disc proper due to inhibition of nutrient availability due to calcium deposits over the trabecular subchondral cannaliculi vascular supply nor will it help the ligamentous hypertrophy of the ligamentum flavum nor the mechanical effect of annular bulging due to central nuclear desiccation. So I see the technique as one step in a multistep process for reconstitution of the disc. I did not think it possible to do so until I saw Hoogland's 2 year outcome data from his intradiscal endoscopic endplate fenestration technique that showed the black disc turning white and significant sustained pain reductions....

 

[ampaphb]

So do you believe you can address posterolateral anular tears with this device?

 

[Aether2000]

No. Posterior lateral annular tears are a mechanical rent in the multiple lamella of the annulus and as was demonstrated in bench studies on coblation, the tears become larger when exposed to RF energy. However, one may possibly be able to address some of the pain due to the neural ingrowth into the annulus and nucleus pulposis through biaculoplasty. We need some sort of collagen welding in order to address the tears themselves.

 

[ampaphb]

No. Posterior lateral annular tears are a mechanical rent in the multiple lamella of the annulus and as was demonstrated in bench studies on coblation, the tears become larger when exposed to RF energy. However, one may possibly be able to address some of the pain due to the neural ingrowth into the annulus and nucleus pulposis through biaculoplasty. We need some sort of collagen welding in order to address the tears themselves.

So the chemically mediated radicular pain from the release of neuclear cytokines, and painful micro-motion at the level of the rent persist. And in addition, neural ingrowth lateral to the insertion sites of the probes, does not appear to be adequately addressed, as the energy is predominatly directed along the posterior margin.

That being the case, an alternate deployment methodology seems required before this technology provides reasonable construct validity, IMHO.

 

[nvrsumr]

Any thoughts on the attached paper?

Abstract This article was a preliminary
report of prospective clinical
trial of a group of patients with
chronic discogenic low back pain
who met the criteria for lumbar
interbody fusion surgery but were
treated instead with an intradiscal
injection of methylene blue (MB) for
the pain relief. Twenty-four patients
with chronic discogenic low back
pain underwent diagnostic discography
with intradiscal injection of
MB. The principal criteria to judge
the effectiveness included alleviation
of pain, assessed by visual analog
scale (VAS), and improvement in
disability, as assessed with the
Oswestry Disability Index (ODI) for
functional recovery. The mean follow-
up period was 18.2 months
(range 12–23 months). Of the 24
patients, 21 (87%) reported a disappearance
or marked alleviation of
low back pain, and experienced a
definite improvement in physical
function. A statistically significant
and clinically meaningful improvement
in the changes in the ODI and
the VAS scores were obtained in the
patients with chronic discogenic low
back pain (P=0.0001) after the
treatment. The study suggests that
the injection of MB into the painful
disc may be a very effective alternative
for the surgical treatment of
chronic discogenic low back pain.

 

[Aether2000]

I repeated this study with 10 patients and found only 1/10 had any relief whatsoever. Perhaps the Chinese are extraordinarily sensitive to the color blue.

 

[drrinoo]

I repeated this study with 10 patients and found only 1/10 had any relief whatsoever. Perhaps the Chinese are extraordinarily sensitive to the color blue.

is the Hoogland technique analogous to the Steadman microfracture technique for chondral defects of the knee?

 

[Aether2000]

Yes it is. The initial description by Hoogland during conferences was "end plate abrasion" ostensibly with a currette like device, but the actual procedure is fenestration rather than abrasion.
Regarding lateral neural ingrowth, that is a valid point, but the annulus fibrosis demonstrates the majority of tears in the posterior 11 lamellar layers rather than in the much thicker anterior 20 lamellar layer system. Lateral thermal excursion is up to 1cm lateral to the probe in 3 diminisions, therefore the entire posterior annulus, posterior nucleus and part of the lateral annulus would be covered in an arc extending approximately 90 degrees

 

[Disciple]

That being the case, an alternate deployment methodology seems required before this technology provides reasonable construct validity, IMHO.

Paz?

 

[Aether2000]

Biaculoplasty may indeed be a cure in search of a disease. I will have a few patients enrolled in a protocol trial and will let you know the outcomes. With the machine were included Sinergy probes and cables for SI treatment, Acutherm adapter cable, and jumper cable adapters for my car on those cold Indiana winter nights.

 

[nvrsumr]

Thanks algos. Interesting someone has tried this intervention. Peng(the author) seems be a pretty good researcher whose published some other studies on pathologic innervation of discs; correlating HIZs to path and positive discos, etc..

I had thought about trying to replicate in the future but had some worries about possible complications ie. leak through an annulur tear into the epidural space. Any thoughts on possible complications or why this intervention didnt work in your trial? The idea seems to be valid- methylene blue is used for neurolysis in other areas (ie puritis ani) and the study design was adequate with failed conservative care, discography and VAS plus disability outcomes.

Frustrating that a simple, inexpensive idea with a study to back it up and great preliminary results doesnt seem to pan out.

 

[Aether2000]

Perhaps the chronicity of pain prior to intervention has something to do with the outcome. My patients all had IDD for years and many were on opiate therapy oral or transdermal. There was a recent report demonstrating the poor results of epidural steroids in those taking opiates vs those not taking opiates, but that may reflect severity of disease or secondary gain rather than overt technique failure. Nonetheless, my patients were receiving opiates, but met the criteria used by Peng for his study, so I really have no idea why MB had such dramatically different results than the Chinese study...
The concentrations of MB and the co-anesthetic were used in exactly the same amounts and concentrations as Peng...go figure...

 

[trauma_junky]

More efforts need to be focused at biochemically inhibiting the NGF-trkA response post injury. Then you will have completely blocked the development of increased perceived pain. The amplification of neurites into the annulus post injury is greatly increased and is part of what augments the transition from acute to chronic pain in this injury pattern. It is very similar to dental patterns of injury initially. Biacuplasty appears to be the best alternative to denervating the posterior sinuvertebral nerves, thus eliminating the pain that has be put into place by the activation of the NFG-trkA pathway. It at least provides the patient with the best outcome chances, intuitively. But who needs to make scientific decisions anymore, this is the age of evidence based medicine, lets just wait for someone to prove the obvious before anyone does anything.

 

[Tenesma]

posterior vertebralspinous nerves?

and you are going to denervate them how??

hmmmm... am not sure what you are talking about....

the innervation of the disc is a bit more complicated than that... what about the ascending branch of the sinuvertebral nerve? or the un-named branches off the dorsal root ganglion? or the descending sinuvertebral nerve? or the various branches that run through the gray rami communicantes from above and below?

Biacuplasty is a very interesting concept - but I think it will lead us down the IDET road in similarities. Baylis reps have been pushing this REALLY hard - and they are kind of becoming annoying - so maybe i am become biased against it just based on their marketing techniques

I like to quote Dreyfus and Bogduk - the best treatment for discogenic pain is no treatment at all - primarily because all of our treatments so far suck - and the best that surgeons can come up with are discectomies - and I saw too many complications for the current generation of disc replacements to foresee surgeons jumping on the bandwagon.

I also like Pauzas ideas of regenerative approaches - instead of cooking lets heal the disc...

Also the IDET brothers aren't performing IDETs anymore - I wonder if that is a myth but that is the word on the street - have they lost confidence in the technique that they sold to smith&nephew? or am i just spreading rumors?

 

[ampaphb]

posterior vertebralspinous nerves?

and you are going to denervate them how??

hmmmm... am not sure what you are talking about....

the innervation of the disc is a bit more complicated than that... what about the ascending branch of the sinuvertebral nerve? or the un-named branches off the dorsal root ganglion? or the descending sinuvertebral nerve? or the various branches that run through the gray rami communicantes from above and below?

He/she is a med student - stop picking on him - had you even heard of the sinuvertebral nerve in med school? (personally I just rolled my eyes when I read the clearly *****ic post, and moved on - responding just seemed like you were mentally attacking someone without the ability or the armamentarium to engage in a fair fight)

Biacuplasty is a very interesting concept - but I think it will lead us down the IDET road in similarities. Baylis reps have been pushing this REALLY hard - and they are kind of becoming annoying - so maybe i am become biased against it just based on their marketing techniques

I think it has a chance of being a better mousetrap - kind-of IDET version 2.0[/quote]

I also like Pauzas ideas of regenerative approaches - instead of cooking lets heal the disc...

Last time I spoke to Kevin, he was advocating the annular and nuclear repair or replacement technologies. It is the Germans who are pushing chondrocytes and stem cells, and the folks at Rush, Jefferson, and Pitt who are working on individual growth factors.

Also the IDET brothers aren't performing IDETs anymore - I wonder if that is a myth but that is the word on the street - have they lost confidence in the technique that they sold to smith&nephew? or am i just spreading rumors?

No one in California does many IDETs anymore - you can't get them paid for. Personally, I think THAT is why Bayliss is pushing us to use 06499, but I also heard the concept of billing it as RF of the SV nerves on either side - given that that would give you a total of 4 nerves, it makes it financially viable, although not exactly lucrative

 

[drusso]

No one in California does many IDETs anymore - you can't get them paid for. Personally, I think THAT is why Bayliss is pushing us to use 06499, but I also heard the concept of billing it as RF of the SV nerves on either side - given that that would give you a total of 4 nerves, it makes it financially viable, although not exactly lucrative

ampaphb,

A couple of thoughts:

1) A had the opportunity to do an IDET in fellowship after none had been performed for almost 3 years. It was an ideal patient for the indication (single level, posterior annular tear, concordant disco, no disability/compensation issues) and lo' and behold, the patient did well. What killed IDET was not that it was a bad technology, but "indication creep." People got carried away...that's my N=1 experience.

2) Are you talking about using 64622 Lumbar Z-Joint RF (1st nerve) and 64623(additional levels) for biaculoplasty? I thought that those specifically referred to dorsal rami. I was told that you could bill 6 levels for SIJ denervation using these codes, but not "disc denervation" per se.

 

[ampaphb]

ampaphb,

A couple of thoughts:

1) A had the opportunity to do an IDET in fellowship after none had been performed for almost 3 years. It was an ideal patient for the indication (single level, posterior annular tear, concordant disco, no disability/compensation issues) and lo' and behold, the patient did well. What killed IDET was not that it was a bad technology, but "indication creep." People got carried away...that's my N=1 experience.

2) Are you talking about using 64622 Lumbar Z-Joint RF (1st nerve) and 64623(additional levels) for biaculoplasty? I thought that those specifically referred to dorsal rami. I was told that you could bill 6 levels for SIJ denervation using these codes, but not "disc denervation" per se.

My N was 4 in fellowship, and 2 thus far in a year of private practice. I do think the target zone was off (nociceptors live in the periphery, not at the anular-nuclear junction), the device was virtually unsteerable once you entered the anulus, and the lesion was inadequate in size to address the pathology. It was a good beta, or at best version 1.0, but I have always been taught to wait for at least 1.1, or 2.0.

As for billing Biaculasty, I spoke to a colleague who practices outside of Richmond. When he went to a course sponsored by Bayliss, the instructor, speaking off-label, suggested billing 64640 x4

 

[Tenesma]

i would be careful with billing z-joint denervation for SIJ - i have tried it and actually got slammed by insurance company and had to recode to destruction of "other peripheral branch" and then they didn't even pay for it - ouch.

 

[Diamox]

Just wanted to get a sense of the progress of Biacuplasty, IDET, other RF for internal disc disruption (IDD) from the group. This thread was posted over a year ago and a few studies have come and gone since then. I'm working on the last few slides of a ppt on IDD for the junior residents and thought I should add a few "potentially up and coming" non-invasive treatment options. I understand that the evidence for Biacuplasty is still dim and people are split over the IDET issue. Recently, in another post, one of the attendings noted the concept of "indication creep" for IDET as one of it's down falls. Hopefully this will not be the case with Biacuplasty and we can see if it really works.

There are currently 2 Biacuplasty RCTs registered that are recruiting.

comments?

 

[lobelsteve]

Based on Medicare dropping the ability to get any reimbursement for thermal disc procedures, I think the time has come and gone for this modality.

 

[ampaphb]

Comp, PIP/No-fault, and self pay remain viable patient poulations

 

[PMR 4 MSK]

Comp, PIP/No-fault, and self pay remain viable patient poulations

Comp will sometimes approve but does anything really work on this population? Or PIP? Will self-pay pts actually pay for this?

 

[ampaphb]

... but does anything really work on this population? Or PIP?

This population deserves the same chance to get better that all my patients do. Sure I tend to approach them with a bit more skepticism, but I am often surprised with positive outcomes despite my bias going in, so I am simply not smart enough to predict who will respond and who will not.

I see no logic in denying Comp or No-Fault/PIP patients appropriate care merely because some in this population have secondary gain issues - to deny them access to the best treatment modalities available strikes me as unreasonable.

 

[brori]

This population deserves the same chance to get better that all my patients do. Sure I tend to approach them with a bit more skepticism, but I am often surprised with positive outcomes despite my bias going in, so I am simply not smart enough to predict who will respond and who will not.

I see no logic in denying Comp or No-Fault/PIP patients appropriate care merely because some in this population have secondary gain issues - to deny them access to the best treatment modalities available strikes me as unreasonable.

I second that.

 

[PMR 4 MSK]

I don't disagree, and I tend to use the same algorythms and heuristics on pts with other insurances as I do with these groups. I just think only being able to utilize certain modalities on the groups with the smaller chance of them working will bias their anecdotal success rate. It also shifts the risk-benefit ratio more against you in an already statistically more litiginous group. Proceed with caution.

 

[Diamox]

Going back to my OP, I was more concerned about the science and discussion of the disc procedures. Any comments in that regard?

thanks,

 

[clubdeac]

I wanted to resurrect this thread one last time. So I've now done about 10 biacuplasties and must say I have not been impressed (response rate less than placebo). All were on positive one level disks on disco. I know you guys out in pp are probably not doing this anyway due to reimbursement but I was curious if anyone out there was seeing better results. Any thoughts?

 

[Jcm800]

I wanted to resurrect this thread one last time. So I've now done about 10 biacuplasties and must say I have not been impressed (response rate less than placebo). All were on positive one level disks on disco. I know you guys out in pp are probably not doing this anyway due to reimbursement but I was curious if anyone out there was seeing better results. Any thoughts?

i think the results are bad because i think it is procedure in search of a diagnosis. I think that we grossly overestimate the clinical significance of anular tears and "discogenic pain" and i think that we probably are not as good at discograms as we think we are, or at least the data may be as accurate as we think.

I know i basically do a fraction of discos as i used to, anyone else? Unless requested, i really dont do them, and i dont get a lot of requests much anymore...

 

[Aether2000]

The pathology may be too complex for the biaculoplasty. The technique heats (barely) the mid annulus fibrosis with the potentlal to disrupt neural ingrowth. What it does not do is:
1. close the annular fissue
2. repair the inflammatory membrane on the outer annulus
3. repair the endoneural scar tissue that forms
4. interrupt the mid nucleus pulposis and probably outer nucleus pulposis neural ingrowth
5. restore the native chemical millieu
6. restore the biomechanical properties of the nucleus pulposis/annulus fibrosis complex
7. reduce strain on the posterior annulus
8. restore the endplate nutrient transfer
9. repair the apoptotic discocytes

We still have a ways to go to accomplish all these things...

 

[deleted185747]

So far in fellowship I have attempted 2 biaculoplasties and aborted both due to getting massive motor stim during testing. We were using a kimberly clark / bayalis machine and the cooled RF - disc probes. I am trying to figure out why we got motor stim (glut and hamstrings were contracting) when we were in L5/S1 disc at the junction of the posterior and middle third of the disc.

Any ideas? I'm wondering if the rep knows what she is doing because the needle was in the disc in the correct location on both cases.

 

[pmrmd]

The pathology may be too complex for the biaculoplasty. The technique heats (barely) the mid annulus fibrosis with the potentlal to disrupt neural ingrowth. What it does not do is:
1. close the annular fissue
2. repair the inflammatory membrane on the outer annulus
3. repair the endoneural scar tissue that forms
4. interrupt the mid nucleus pulposis and probably outer nucleus pulposis neural ingrowth
5. restore the native chemical millieu
6. restore the biomechanical properties of the nucleus pulposis/annulus fibrosis complex
7. reduce strain on the posterior annulus
8. restore the endplate nutrient transfer
9. repair the apoptotic discocytes

We still have a ways to go to accomplish all these things...

Where did you get this algos? From Yeung's 2006 article or do you know more. I have been concluding that pain is at the surface quite often.

 

[lobelsteve]

So far in fellowship I have attempted 2 biaculoplasties and aborted both due to getting massive motor stim during testing. We were using a kimberly clark / bayalis machine and the cooled RF - disc probes. I am trying to figure out why we got motor stim (glut and hamstrings were contracting) when we were in L5/S1 disc at the junction of the posterior and middle third of the disc.

Any ideas? I'm wondering if the rep knows what she is doing because the needle was in the disc in the correct location on both cases.

As a fellow doing an experimental procedure, you should be listening to the attending and not the rep.

 

[Ligament]

So far in fellowship I have attempted 2 biaculoplasties and aborted both due to getting massive motor stim during testing. We were using a kimberly clark / bayalis machine and the cooled RF - disc probes. I am trying to figure out why we got motor stim (glut and hamstrings were contracting) when we were in L5/S1 disc at the junction of the posterior and middle third of the disc.

Any ideas? I'm wondering if the rep knows what she is doing because the needle was in the disc in the correct location on both cases.

You were not in the disc sufficiently... Did you check a fergusons view if at l5s1? Easy way to determin this

 

[clubdeac]

I didn't realize you were supposed to check sensory and motor stim... I did about 15 of these when I first started and never checked stim. Hmmmm

 

[BobBarker]

Anybody doing biacculoplasty today?

 

[bedrock]

I don't think anyone pays for it.

 

[lobelsteve]

Only Leo....

 

[Aether2000]

No insurer pays..we are starting to offer it asa cash procedure

 

[NJPAIN]

No insurer pays..we are starting to offer it asa cash procedure

With all of the limitations that were indicated who are you offering to?