future of interventional spine

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analgesic

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Hi everyone,

I believe that minimally invasive endoscopic procedures will be the future of spine surgery. Currently there is no board accreditation for these types of procedures. This being the case, I am hoping that pain interventionalists and interventional spine specialists will have the priveledge/opportunity to learn these types of procedures. I highly encourage anyone interested in advancing the practice of interventional spine to check out this website www.microspine.com . I believe this could begin the paradigm shift toward more minimally invasive procedures. However, it would be very unfortunate if neurosurgeons and orthopaedists were the only physicians allowed to perform these procedures. There is the consideration that it is still surgery regardless if it is less invasive. That being said surgeons may be the only practitioners allowed to get in on this. Hopefully, physicians like algos and other members of the ASIS will strive to develop avenues and relationships for this new evolution in minimally invasive spine care. If interventional cardiologist can stick stents into coronary arteries then interventional spine specialists should be allowed the opportunity to do this sort of minimally invasive spine surgery
👍 😎
 
If i was going to have anyone poking around my spine, it would be a neurosurgeon or an ortho spine surgeon.....definitely not a physiatrist.

I think that these interventional procedures will be incredibly lucrative for physiatrists, (bare in mind i am interested in physiatry)...but i do not believe we should be allowed to do anything more than pain med (with injections) because we are not trained in surgery and this could potentially be a HUGE risk for our patients.

we do not need to do these things when there are better qualified docs out there who can perform these procedures much more safely.

If you want to go into spine surgery, then you should go into ortho or neurosurgery.......do not go into PM&R.

if we practice medicine unsafely, lawyers will actually have a valid argument to sue us and protect the public (but for now, i think they're still scum)
 
marcus_aurelius said:
If i was going to have anyone poking around my spine, it would be a neurosurgeon or an ortho spine surgeon.....definitely not a physiatrist.

I think that these interventional procedures will be incredibly lucrative for physiatrists, (bare in mind i am interested in physiatry)...but i do not believe we should be allowed to do anything more than pain med (with injections) because we are not trained in surgery and this could potentially be a HUGE risk for our patients.

we do not need to do these things when there are better qualified docs out there who can perform these procedures much more safely.

If you want to go into spine surgery, then you should go into ortho or neurosurgery.......do not go into PM&R.

if we practice medicine unsafely, lawyers will actually have a valid argument to sue us and protect the public (but for now, i think they're still scum)

There are 3 group of spine surgeons (or any surgeon) in the market.

Group 1: These surgeons are born surgeons. They were created to become surgeons to help the mankind. They possess innate surgical skills and very obsessive in performance. They do everything perfect right from the skin incision. They are just like lexus commercials....aiming for relentless pursuit of perfection.

Group 2: These group of people accidently become surgeons and cultivate their skills by years and years of practice. They reach the pinnacle of performance very close to their retirement.

Group 3: These group become surgeons by mistake. Even their skin incisions will speak for their surgical skills. They will never turn into better surgeons in their life time.

You can also categorize physiatrist depending on their skills. There are some physiatrists who were born to become spine surgeons unfortunately have turned direction and have become physiatrists. They possess great skills for minimally invasive procedures. If you end up with group 3 spine surgeon, he could ruin your back with a bad surgery. If you are fortunate to see a finest physiatrist, he could fix your back to perfect shape. It all depends. Do not generalize.
Welcome to the greatest field of physiatry.! 🙂
 
Spine Specialist said:
There are 3 group of spine surgeons (or any surgeon) in the market.

Group 1: These surgeons are born surgeons. They were created to become surgeons to help the mankind. They possess innate surgical skills and very obsessive in performance. They do everything perfect right from the skin incision. They are just like lexus commercials....aiming for relentless pursuit of perfection.

Group 2: These group of people accidently become surgeons and cultivate their skills by years and years of practice. They reach the pinnacle of performance very close to their retirement.

Group 3: These group become surgeons by mistake. Even their skin incisions will speak for their surgical skills. They will never turn into better surgeons in their life time.

You can also categorize physiatrist depending on their skills. There are some physiatrists who were born to become spine surgeons unfortunately have turned direction and have become physiatrists. They possess great skills for minimally invasive procedures. If you end up with group 3 spine surgeon, he could ruin your back with a bad surgery. If you are fortunate to see a finest physiatrist, he could fix your back to perfect shape. It all depends. Do not generalize.
Welcome to the greatest field of physiatry.! 🙂

do interventional fellowships train fellows adequately in minimally invasive surgery? an ortho spine fellowship is 3 yrs...i'd think they would have had soooooo much more practice in surgery and spine surgery in particular to kick a physiatrists butt procedurally in quality of care...even if they were not a born surgeon. Practice makes perfect....if interv. spine is only ONE YEAR....i dont see where you would get the practice to become REALLY GOOD. i'm not against physiatrists performing these procedures, but i'd like to see the number of years of training increase. til that happens, i'd rather have a spine surgeon cut open my spine than a pmr.
 
marcus_aurelius said:
do interventional fellowships train fellows adequately in minimally invasive surgery? an ortho spine fellowship is 3 yrs...i'd think they would have had soooooo much more practice in surgery and spine surgery in particular to kick a physiatrists butt procedurally in quality of care...even if they were not a born surgeon. Practice makes perfect....if interv. spine is only ONE YEAR....i dont see where you would get the practice to become REALLY GOOD. i'm not against physiatrists performing these procedures, but i'd like to see the number of years of training increase. til that happens, i'd rather have a spine surgeon cut open my spine than a pmr.

Every ortho spine fellowship I've heard of is 1 year. There are so many different minimally invasive procedures out there and none has really come out as much better than the others, to my knowledge. I would be very surprised if a surgical spine fellow does more than a couple different types of of these procedures.
 
I think internists should be allowed to do laparoscopic surgery. It doesn't really look like real surgery anyway, I think you should be able to learn this in a 1 year fellowship or so 😉
 
DistantMets said:
Every ortho spine fellowship I've heard of is 1 year. There are so many different minimally invasive procedures out there and none has really come out as much better than the others, to my knowledge. I would be very surprised if a surgical spine fellow does more than a couple different types of of these procedures.


yeah, but they still have 5 addtl yrs of ortho surgery behind them, and neurosurgeons have 6 or 7 yrs....so why would i want a pmr w/ the bare minimum surgical experience operating on my back again?....

...i think its a great get rich quick scheme, but a bad idea....pain treatment is fine, injecting is fine, minimally invasive spine SURGERY...NOT FINE.....malpractice rates would be sky high.
 
I suppose it depends on the carrier and the location. In my area, the malpractice carrier has 4 sublevels of pain medicine coverage with minimally invasive spine being a level 3. Our rates are indeed higher....about $2000-3000 more than anesthesiologists practicing full time anesthesia.
 
Anyone doing vertebroplasty? I have heard of that procedure branching out to the interventional pain management field.
 
I have performed vertebroplasty since 2000. Currently the companies sponsoring the cements and injection products (eg. Stryker, Cardinal, etc) are very actively pursuing pain physicians to perform these procedures as is Kyphon. The profit potential for vertebroplasty is now 4 times that of kyphoplasty after the new reimbursement codes. Kyphoplasty costs patients $14,000 while vertebroplasty costs $2,500.
 
Algos,

Could you clarify? With the costs you've mentioned, do you mean that the profit potential for Kyphoplasty is four times that of vertebroplasty ?
 
That is exactly what I mean. The reimbursement for physicians performing kyphoplasty (can only be performed in a hospital due to the $5,000 disposable equipment costs) is $600 under Medicare as of Jan 2006. Vertebroplasty reimburses $2500 for one level by Medicare. If an ASC is "rented" for $500 and the disposables are $500 (eg Cardinal Health Kit complete), then the profit is $1500. If the same procedure is performed in an office as many now are, the profit is $2000. If a non-kit is used (individual elements put together), the cost is $300 and the profit is $2200.
Remember, patients pay a significant deductable and copay in this day and age. A 20% copay on the entire cost of kyphoplasty that is about $14,000 (kyphoplasty cost) can wipe out an elderly persons entire savings.
 
analgesic said:
Hi everyone,

I believe that minimally invasive endoscopic procedures will be the future of spine surgery. Currently there is no board accreditation for these types of procedures. This being the case, I am hoping that pain interventionalists and interventional spine specialists will have the priveledge/opportunity to learn these types of procedures. I highly encourage anyone interested in advancing the practice of interventional spine to check out this website www.microspine.com . I believe this could begin the paradigm shift toward more minimally invasive procedures. However, it would be very unfortunate if neurosurgeons and orthopaedists were the only physicians allowed to perform these procedures. There is the consideration that it is still surgery regardless if it is less invasive. That being said surgeons may be the only practitioners allowed to get in on this. Hopefully, physicians like algos and other members of the ASIS will strive to develop avenues and relationships for this new evolution in minimally invasive spine care. If interventional cardiologist can stick stents into coronary arteries then interventional spine specialists should be allowed the opportunity to do this sort of minimally invasive spine surgery
👍 😎

i think i might have to humble myself by shoving my foot in my mouth....


....i've been reading up on some of the minimally invasive spine procedures and they seem very doable. I would still like the fellowship of interventional spine to possibly be an extra year long.

sorry for giving you a hard time analgesic.

is there a difference between interventional spine and spinal cord injury fellowships?

these procedures sound really cool....using CT scans to visualize the spine and making a puncture like incision to perform minimally invasive surgery.....i wonder if PMR's will get to perform these procedures in the future.

i myself have been debating betw pmr spine and ortho spine but pmr seems to be a better lifestyle while i can still explore my interests in spine. just curious but is there a lot of biomechanics work in pmr as well?....do any pmr's work in research related to outcomes in patients of inserting those spinal disc transplants...do pmr's in iv spine get to insert those discs at all?...or is it mainly vertebroplasty......i would be curious to see what procedures would be reserved for interventional spine pmr's in the future that would not be available to pain docs.

the things technology is coming up with...wow..cool stuff.
 
algosdoc said:
That is exactly what I mean. The reimbursement for physicians performing kyphoplasty (can only be performed in a hospital due to the $5,000 disposable equipment costs) is $600 under Medicare as of Jan 2006. Vertebroplasty reimburses $2500 for one level by Medicare. If an ASC is "rented" for $500 and the disposables are $500 (eg Cardinal Health Kit complete), then the profit is $1500. If the same procedure is performed in an office as many now are, the profit is $2000. If a non-kit is used (individual elements put together), the cost is $300 and the profit is $2200.
Remember, patients pay a significant deductable and copay in this day and age. A 20% copay on the entire cost of kyphoplasty that is about $14,000 (kyphoplasty cost) can wipe out an elderly persons entire savings.

I just got back from the APS meeting in San Antonio where I spoke with a rep at the Stryker booth. I was told that their Vertebroplasty system can be used interchangebly for Kyphoplasty while buying the balloon separately, thereby decreasing the equipment costs. So, can Kyphoplasty be performed in an ASC? Is general anesthesia required?
 
It is my understanding the kyphoplasty code is not covered in ASC. It is also my understanding kyphon sells the balloons in a kit and not separately...
Unless the Stryker rep has specific connections, he is mistaken. If not, please post contacts here for accessing these balloons...
Thanks!
 
disciple...

your question scares me, because it implies that you are considering doing kypho or vertebtroplasty without appropriate training...

no, you don't need general anesthesia - most of these are done around the country w/ procedural sedation or w/ MAC.

My personal preference is MAC, because a lot of the vertebral compression fracture population has significant co-morbidities (old, severe COPD, etc) and I don't want to be involved w/ their sedation...

The problem w/ kypho or vertebro is that while it is gratifying, it has a higher inherent risk due to higher procedure related morbidities, and is primarily a medicare population.
 
Tenesma said:
disciple...

your question scares me, because it implies that you are considering doing kypho or vertebtroplasty without appropriate training...

I plan on doing them after fellowship.

But, I would like to start my own practice without taking a whole year off to set it up. So, I'm gathering information.

I'm almost certain that the rep did tell me that the balloon could be purchased separately. But, I'll contact Stryker and verify/clarify this.
 
marcus_aurelius said:
i think i might have to humble myself by shoving my foot in my mouth....


....i've been reading up on some of the minimally invasive spine procedures and they seem very doable. I would still like the fellowship of interventional spine to possibly be an extra year long.

sorry for giving you a hard time analgesic.

is there a difference between interventional spine and spinal cord injury fellowships?

these procedures sound really cool....using CT scans to visualize the spine and making a puncture like incision to perform minimally invasive surgery.....i wonder if PMR's will get to perform these procedures in the future.

i myself have been debating betw pmr spine and ortho spine but pmr seems to be a better lifestyle while i can still explore my interests in spine. just curious but is there a lot of biomechanics work in pmr as well?....do any pmr's work in research related to outcomes in patients of inserting those spinal disc transplants...do pmr's in iv spine get to insert those discs at all?...or is it mainly vertebroplasty......i would be curious to see what procedures would be reserved for interventional spine pmr's in the future that would not be available to pain docs.

the things technology is coming up with...wow..cool stuff.

Marcus,

No offense taken. I always welcome a difference in opinion for that allows me to contemplate things I have not considered. I am only interested in promoting and developing this relatively new area in spine care. I decided on physiatry because I was sick of seeing and hearing about so many cases of failed back surgery. To answer your question there is a huge difference in a spinal cord injury fellowship(more inpatient) and an interventional spine fellowship(more outpatient). Spinal cord injury fellows do not do any interventional spine procedures with the exception of intrathecal baclofen pumps. However, they are now doing studies at our hospital to implant spinal cord stimulators in individuals w/ SCI to maintain the cough reflex. Interventional spine fellows are more geared toward interventional procedures to treat spinal pain and restore biomechanical integrity. I seriously doubt there are any PMR docs doing disc implants but there have been no long term studies to prove there efficacy anyway. If I was on the table I would rather try a trial of intradiscal ozone and PT or a percutaneous endoscopic discectomy. Having a disc implanted is still a very invasive procedure that requires alot of cutting. With leaders like Algos and others the future of interventional spine looks bright. Hang in there Marcus, I for one am optimistic/enthusiastic. 👍
 
algosdoc said:
I have performed vertebroplasty since 2000. Currently the companies sponsoring the cements and injection products (eg. Stryker, Cardinal, etc) are very actively pursuing pain physicians to perform these procedures as is Kyphon. The profit potential for vertebroplasty is now 4 times that of kyphoplasty after the new reimbursement codes. Kyphoplasty costs patients $14,000 while vertebroplasty costs $2,500.
😀 Could you please review for us the financial rewards for implanting, refilling, managing and maintaining Intrathecal pain pumps and their catheter systems? I have heard something about the "annual annuity" that a provider can expect from this line of work while treating non-malignant pain. Thanks
 
There is a huge variation in income derived depending on the insurance carrier, the obligatory write-offs of medications, the particular medication chosen, etc. The pump and catheter plus trial income is about $1000-2000 and each refill brings in profit $90-500 depending on whether the physician or a nurse fills the pump. We schedule refills generally about every 4-6 months. We use inexpensive meds (hydromorphone) to keep the patient cost reasonable.... Clonidine is expensive. Morphine has a higher degree of inflammation and presumably granuloma formation than does hydromorphone.
Prialt will never be used in our practice until the cost comes down out of the stratosphere.
 
analgesic,

where are they placing the leads in the ventral epidural space spanning the mid to upper thoracic segment (intercostal mm contractions) or upper cervical to facilitate periodic diaphragmatic contraction on a demand basis?

also are the frequency parameters typically in the 2-4 Hz and is the PW around 100 msec to correlate with the chronaxis of the A-alpha fibers?

what about the cycling....

Much of the functional e-stim literature has focused on peripheral surgical implants...but it would be interesting to see if perc. leads could manage some of these problems....

finally, are any of your colleagues placing stims at T2-3 to mitigate autonomic dysreflexia?
 
algosdoc said:
It is my understanding the kyphoplasty code is not covered in ASC. It is also my understanding kyphon sells the balloons in a kit and not separately...
Unless the Stryker rep has specific connections, he is mistaken. If not, please post contacts here for accessing these balloons...
Thanks!

Got back from ISIS yesterday where I spoke with a second Stryker rep (at their booth) who stated that their system could be used interchangebly for kyphoplasty and that the balloon could be purchased separately.

Maybe I'll check this out directly with Kyphon.

If such is true, is the Kyphoplasty code covered if the procedure is performed in office?
 
If such is true, is the Kyphoplasty code covered if the procedure is performed in office?

I'm sure some may disagree, but I would NEVER consider doing vertebro/kypho in the office! Scarey stuff. Once you've actually seen/done these procedures, hopefully you'll appreciate the sphincter factor associated with them. Anesthesia is a primary consideration, I also prefer MAC, but you must consider your facilities. Unless you can ensure a sterile inoffice OR, you shouldn't even consider it. However, that's just how I was trained. I'd appreciate hearing from others.

Another issue is this. Based on the current research, or lack thereof, there isn't any substantial evidence supporting the use of kyphoplasty. I don't even plan on doing them. In addition to the lack of evidence, I've always been nervous about the ballons. It has always seemed illogical to me that inducing mechanical expansion of an already unstable vertebral body could actually be free of additional risk. Anyone else had this concern?
 
An interesting anesthetic that is useful for more extensive procedures is a fentanyl spinal of 25-75 mcg. The analgesia is intense without dampening motor function or sharp sensation. I have used this anesthetic for many years through a 25ga Quincke or a small Whitacre needle. I have used this for vertebroplasty or endospine procedures for years.
 
An interesting anesthetic that is useful for more extensive procedures is a fentanyl spinal of 25-75 mcg. The analgesia is intense without dampening motor function or sharp sensation. I have used this anesthetic for many years through a 25ga Quincke or a small Whitacre needle. I have used this for vertebroplasty or endospine procedures for years.
 
An interesting anesthetic that is useful for more extensive procedures is a fentanyl spinal of 25-75 mcg. The analgesia is intense without dampening motor function or sharp sensation. I have used this anesthetic for many years through a 25ga Quincke or a small Whitacre needle. I have used this for vertebroplasty or endospine procedures for years.
 
An interesting anesthetic that is useful for more extensive procedures is a fentanyl spinal of 25-75 mcg. The analgesia is intense without dampening motor function or sharp sensation. I have used this anesthetic for many years through a 25ga Quincke or a small Whitacre needle. I have used this for vertebroplasty or endospine procedures for years.
 
Disciple said:
Got back from ISIS yesterday where I spoke with a second Stryker rep (at their booth) who stated that their system could be used interchangebly for kyphoplasty and that the balloon could be purchased separately.

Maybe I'll check this out directly with Kyphon.

If such is true, is the Kyphoplasty code covered if the procedure is performed in office?

It appears that on the Kyphon website, all the components can be ordered separately by catalog number.
 
Unless the kyphon balloon is affordable, it would not be financially plausible to perform this procedure in an office or an ASC...
 
Am I alone regarding my concern about kyphoplasty ballons and performing kypho/vertebro in an office?
 
algosdoc said:
An interesting anesthetic that is useful for more extensive procedures is a fentanyl spinal of 25-75 mcg. The analgesia is intense without dampening motor function or sharp sensation. I have used this anesthetic for many years through a 25ga Quincke or a small Whitacre needle. I have used this for vertebroplasty or endospine procedures for years.

Hi Algos,

This generated a good educational discussion at our fellowship.

Ordinarily, the potency of fentanyl (IV) is considered to be 100 fold greater than MSO4...but in the intrathecal space, all bets are off. Since the lipophillicity of fentanyl effectively 'dampens' the risk of side effects, while preserving potency.

If you used MSO4 equivalents in lieu of fentanyl, you would've used 2.5 mg above...this of course, would be fatal because of the CSF migration with the hydrophillic MSO4; even for TKRs, 0.1 mg- 0.2 mg MSO4 is sufficient and warrants an overnight ICU or PACU admission...but fentanyl's spread would be limited and it would preferentially bind to the spinal cord...

Is this your understanding, as well?

Secondly, I am assuming that you are administering the intrathecal fentanyl in the hospital setting or ASC....is this correct? I was confused, since you mentioned doing vertebroplasties in the office...and iF done in the ASC/HOPD setting, have you encountered any post-discharge problems with IT fentanyl or do you just get a hug from your patients for excellent post-op analgesia?

Thirdly, does the administration of intrathecal drugs (from a licensing/legal standpoint) require IV sedation certification or do you just need a license to store opioids in your facility
 
We do not have a special licensure for any type of office anesthetic administration required in our state, but even if we did, it would be interesting to try to classify intrathecal fentanyl. It is not a traditional regional anesthetic, it certainly is not a general nor is sedation....hmmmmm....

Our patients remain in the clinic for a period of time after fentanyl, and we have had no difficulties with urinary retention outside of 6 hours. Early pruritis that resolves and occasional nausea were the only side effects noted.

It is my understanding: that lipophilic drugs remain closer to the point of entry rather than migrate. I have seen this with patients for pump trials: given intrathecal lumbar catheter continuous morphine gives excellent pain relief and also prevents withdrawal syndrome from sudden cessation of high dose oral opiates. The same is not true for infusions of intrathecal sufenta, that give great pain relief under the same circumstances but do not prevent the overt withdrawal syndrome. Ostensibly, this must be due to sufenta not reaching the higher spinal and intracerebral opiate receptors due to lipophilicity, whereas morphine does have a gradient that reaches above the foramen magnum. But contrast my experience with the following abstract:
Anesthesiology. 2000 Mar;92(3):739-53.
Comparative spinal distribution and clearance kinetics of intrathecally
administered morphine, fentanyl, alfentanil, and sufentanil.
Ummenhofer WC, Arends RH, Shen DD, Bernards CM.
Department of Anaesthesia, University of Basel, Kantonsspital, Switzerland.

BACKGROUND: Despite widespread use, little is known about the comparative
pharmacokinetics of intrathecally administered opioids. The present study was
designed to characterize the rate and extent of opioid distribution within
cerebrospinal fluid, spinal cord, epidural space, and systemic circulation after
intrathecal injection. METHODS: Equal doses of morphine and alfentanil,
fentanyl, or sufentanil were administered intrathecally (L3) to anesthetized
pigs. Microdialysis probes were used to sample cerebrospinal fluid at L2, T11,
T7, T3, and the epidural space at L2 every 5-10 min for 4 h. At the end of the
experiment, spinal cord and epidural fat tissue were sampled, and each probe's
recovery was determined in vitro. Using SAAM II pharmacokinetic modeling
software (SAAM Institute, University of Washington, Seattle, WA), the data were
fit to a 16-compartment model that was divided into four spinal levels, each of
which consisted of a caternary arrangement of four compartments representing the
spinal cord, cerebrospinal fluid, epidural space, and epidural fat. RESULTS:
Model simulations revealed that the integral exposure (area under the curve
divided by dose) of the spinal cord (i.e., effect compartment) to the opioids
was highest for morphine because of its low spinal cord distribution volume and
slow clearance into plasma The integral exposure of the spinal cord to the other
opioids was relatively low, but for different reasons: alfentanil has a high
clearance from spinal cord into plasma, fentanyl distributes rapidly into the
epidural space and fat, and sufentanil has a high spinal cord volume of
distribution. CONCLUSIONS: The four opioids studied demonstrate markedly
different pharmacokinetic behavior, which correlates well with their
pharmacodynamic behavior.
 
25 to 75mcg of fentanyl intrathecal is fine...and can't be compared to morphine -

the prob w/ anything over 30mcg (in my opinion) is the high rate of intense pruritus...
 
algosdoc said:
Unless the kyphon balloon is affordable, it would not be financially plausible to perform this procedure in an office or an ASC...

Forgive my ignorance, I am not in practice yet.

The Stryker rep quoted me a savings of $800 using Stryker Vertebroplasy components + Kyphon balloon, vs using all Kyphon components. If performed in an office or ASC, wouldn't much of the hospital cost that elevates the cost to 14K be eliminated?
 
The concerns about kyphoplasty that should give one pause:
1. Are the balloons affordable and will kyphon actually sell the balloon to you? BTW you need two balloons for each level.
2. There is an incidence of ballon rupture up to 25% in some studies, therefore one should have extra expensive balloons waiting.
3. If the cavity created at the end of the needle is too small to advance the uninflated balloon, kyphon provides a manual drill. Does stryker do the same?
And if not, what are you going to do when you run into that situation?
4. Is there an inherently greater legal liability risk if one runs into complications by trying to piece together parts of different kits when a single complete kit is already available?
5. Posterior wall retropulsion of fragments is a very real issue albeit rare. The balloon hyperpressurization may make such a dicey proposition in an office setting.
6. Do you have sufficient visualization on your office fluoroscopy for kyphoplasty? The needles are somewhat larger than vertebroplasty requires and therefore the image sharpness and medial pedicle visualization is critical.
7. Is the CPT code covered in an office setting for kyphoplasty? It is a different code than vertebroplasty.
 
i think the real question should be: is there any literature evidence that kyphoplasty has any benefits over straight vertebroplasty (other than what kyphon reps tell you?)

talk to john mathis who w/ herve deramond developed the field...
talk to josh hirsh who has done over 3,000 vertebroplasties and a ton of kypho...

it is all a lot of marketing hype... now if you advertise yourself as some who can do both then you can catch a few more referrals, but you have to ask yourself what is the best thing for my patient?
 
Tenesma said:
i think the real question should be: is there any literature evidence that kyphoplasty has any benefits over straight vertebroplasty (other than what kyphon reps tell you?)

talk to john mathis who w/ herve deramond developed the field...
talk to josh hirsh who has done over 3,000 vertebroplasties and a ton of kypho...

it is all a lot of marketing hype... now if you advertise yourself as some who can do both then you can catch a few more referrals, but you have to ask yourself what is the best thing for my patient?

J Spinal Disord Tech. 2005 Jun;18(3):238-42.
Minimal invasive stabilization of osteoporotic vertebral fractures: a prospective nonrandomized comparison of vertebroplasty and balloon kyphoplasty.

* Grohs JG,
* Matzner M,
* Trieb K,
* Krepler P.

Department of Orthopaedic Surgery, Medical University Vienna, Wien, Austria. [email protected]

OBJECTIVE: During recent years, the benefits of balloon kyphoplasty and vertebroplasty have been frequently discussed for the treatment of osteoporotic vertebral compression fractures. Because of the lack of comparative studies, we performed an investigation to describe the mechanical effects and the impact on life quality during a follow-up period of 2 years. METHODS: Patients with nonrecent fractures of vertebral bodies, ongoing bone remodeling, and major kyphotic deformity were treated with minimal invasive stabilization. The median duration of pain was 8 weeks before surgery. Because of the availability of the equipment, 28 patients were nonrandomly assigned to balloon kyphoplasty and 23 patients to vertebroplasty. The follow-up was performed 2 years after surgery. RESULTS: The kyphotic wedge of the vertebral bodies was decreased 6 degrees by balloon kyphoplasty but not by vertebroplasty. With both methods, we found a rapid decrease of pain down to one-half of the preoperative value. A long-lasting effect on pain was found only after balloon kyphoplasty. In the kyphoplasty group, a decrease of the Oswestry Disability Index (ODI) score was found during the first postoperative year. After 2 years, the ODI was not different from preoperative values in both groups. CONCLUSIONS: In nonrecent fractures, the reduction of the kyphotic wedge by balloon kyphoplasty was superior in decreasing pain persisting over a period of 2 years. The ability to improve disability after kyphoplasty was limited to 1 year. In nonrecent fractures, the consequences of age and osteoporosis seem to equalize the effects of the restored sagittal profile on disability but not on pain.
 
Wow, a study of convenience with a changeover from one method to the other after the equipment became available.

I am really blown away and agree that we should all switch to kypho.
 
f_w said:
Wow, a study of convenience with a changeover from one method to the other after the equipment became available.

I am really blown away and agree that we should all switch to kypho.

Easy to be critical - why dont you do an RCT, and then we can all take pot shots on YOUR methodology
 
why dont you do an RCT

I'll be glad to do that. The design shouldn't be too difficult and yes, this can be done in a statistically sound manner.

Why don't we have kyphon finance it. So far, they are just telling us that they have the better mousetrap and expect us to take their word for it. If they wanted to market a new drug, they would have to provide a trial demonstrating 'non-inferiority' to the alternatives. Why not with medical devices/methods ?

I like to burn money like the next guy. Except that it is not my money but the patients.
 
I think the best part of the article was the title. As far as EBM goes- well it falls short. Review the broader base of literature on the subject and you do not get the double blind multi center RCT not funded by an interest holding party.

I have no problem taking things with a grain of salt, it's just how big a grain do we allow before falling from science to science fiction.

PAZ- Don't make me lecture on EBM- I went to the PD's course at EVMS because my PD was too lazy when I was the Chief.
 
f_w said:
I'll be glad to do that. The design shouldn't be too difficult and yes, this can be done in a statistically sound manner.

Why don't we have kyphon finance it. So far, they are just telling us that they have the better mousetrap and expect us to take their word for it. If they wanted to market a new drug, they would have to provide a trial demonstrating 'non-inferiority' to the alternatives. Why not with medical devices/methods ?

I like to burn money like the next guy. Except that it is not my money but the patients.

And when Kyphon tells you they wont, as one assumes has been the case for other investigators, how do you next propose we should proceed?
 
lobelsteve said:
I think the best part of the article was the title. As far as EBM goes- well it falls short. Review the broader base of literature on the subject and you do not get the double blind multi center RCT not funded by an interest holding party.

I have no problem taking things with a grain of salt, it's just how big a grain do we allow before falling from science to science fiction.

PAZ- Don't make me lecture on EBM- I went to the PD's course at EVMS because my PD was too lazy when I was the Chief.

Gee, is that anything like being too lazy to look up articles yourself, and instead leaving that task to your senior fellow? :laugh:
 
And when Kyphon tells you they wont, as one assumes has been the case for other investigators, how do you next propose we should proceed?

Have the reimbursement for kypho and vertebroplasty rolled into one (technical, equipment and professional). Once kyphon can demonstrate the superiority of their approach, we can go back to the two-tiered payment.

I realize that there won't be a big RCT financed by the NIH for this. While I am aware of the problems with company funded research, (especially in this type of 'open label' situation), we are willing to accept this bias for everything else why not for devices ?
 
paz5559 said:
Gee, is that anything like being too lazy to look up articles yourself, and instead leaving that task to your senior fellow? :laugh:

You mean Sr citizen fellow? :scared:
Don't make me take a 3 week old fellow and let him at your perm this week.

Steering back on track.

Does anybody have an answer as to whther kypho can be performed in an office setting, ASC setting, or reserved to hospital setting. State laws will vary on this.

The difficulty in setting this up is the relationship the Pain doc has with the spine surgeon- Ortho or NS. I could not perform a kypho knowing my backup plan is to call 911 ansd then ask a local spine guy to help me out of some retropulsed cement amd fragments. That would be bad medicine. I would need as established protocol should the situation ever arise, notwithstanding the likelihood of the situation arising. I'm not willing to take that risk when the same procedure can be done by the spine doc in the hosptial.
 
lobelsteve said:
You mean Sr citizen fellow? :scared:
Don't make me take a 3 week old fellow and let him at your perm this week.

Steering back on track.

Does anybody have an answer as to whther kypho can be performed in an office setting, ASC setting, or reserved to hospital setting. State laws will vary on this.

The difficulty in setting this up is the relationship the Pain doc has with the spine surgeon- Ortho or NS. I could not perform a kypho knowing my backup plan is to call 911 ansd then ask a local spine guy to help me out of some retropulsed cement amd fragments. That would be bad medicine. I would need as established protocol should the situation ever arise, notwithstanding the likelihood of the situation arising. I'm not willing to take that risk when the same procedure can be done by the spine doc in the hosptial.

Steve you ignorant slut - the problem lies in the reimbursement - you cant do kypho in an outpatient setting because you lose money. Kyphon is desperately trying to get ASC-based coding, but at present, the euqiptment costs more than the payment, and as such, it is financially not viable.
 
crap study in crap journal....

there is NO evidence that kypho actually statistically makes a big difference as far as vertebral height goes... and there is NO evidence that increasing vertebral height is actually a source of pain relief...

plus please convince me of how doing vetebroplasty is a moneymaker - if i can do 5 procedures/hour in my fluoro suite in my office - why would i want to go to the hospital (definitely ain't doing them in my office - morbidity too high) where i might be forced to sit around while an emergent case gets done, or the pt is arguing w/ anesthesia, or the pt codes intra-op and i then have to spend time in the ICU writing notes.... ???
 
crap study in crap journal....

Oh, such harsh words.
there is NO evidence that kypho actually statistically makes a big difference as far as vertebral height goes...

I reviewed the literature 2 years ago, I believe that there was one halfway decent study that showed a 3mm difference (which worked out to be about $1000/mm).

and there is NO evidence that increasing vertebral height is actually a source of pain relief...

It is one of these things that seems to make sense on a biomechanical basis but lacks support in the outcome data.
Sure, would be nice to keep the little old ladies from getting more and more hunched over (reducing vital capacity) and exerting more and more force on the anterior edge of the vertebral body. I am just not sure that there is support in the outcome data for these lofty ideals.
 
f_w said:
Oh, such harsh words.


I reviewed the literature 2 years ago, I believe that there was one halfway decent study that showed a 3mm difference (which worked out to be about $1000/mm).
.

hey dude;
got the reference? i have a memory of the same study..
 
There is a huge variation in income derived depending on the insurance carrier, the obligatory write-offs of medications, the particular medication chosen, etc. The pump and catheter plus trial income is about $1000-2000 and each refill brings in profit $90-500 depending on whether the physician or a nurse fills the pump. We schedule refills generally about every 4-6 months. We use inexpensive meds (hydromorphone) to keep the patient cost reasonable.... Clonidine is expensive. Morphine has a higher degree of inflammation and presumably granuloma formation than does hydromorphone.
Prialt will never be used in our practice until the cost comes down out of the stratosphere.

We've had 4 patients develop granulomas from high concentrations of morphine (40 to 60 mg/ml). We switched all those patients to Prialt and now the granulomas are nonexistent. At $400 a pop, it's expensive and only stable for 45 days.
 
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