The treatment of spinal compression fractures has become big business. There are over 750,000 spinal compression fractures treated annually. 25% of adults will experience some sort of spinal compression fracture in their lifetime, and as of 2005 figures, $17 billion plus is spent treating these fractures on an annual basis.
So the question must be asked, why do we treat spinal compression fractures, and is there a cost benefit to this modality of treatment? Considering that baby boomers are not aging gracefully, it is estimated that within the next ten years 33% of the US population will be over 65 years of age. Osteoporosis is a disease of the aging. People with osteoporosis are quite susceptible to vertebral compression fractures. VCFx are very painful, and the possibility of long-term disability is a major concern. Over the years the treatment options have included, preventive medicine such as estrogen and calcium replacements, weight bearing exercises, analgesics, bracing, and surgical intervention.
Based on the AAOS guidelines and two Level II studies, quality of evidence was critical in supporting practice guidelines. It seems that they found that there was not enough of high quality evidence to support or oppose non-surgical and holistic treatments. Yet, they supported treating VCFx with signs and symptoms suggesting acute injury within 5 days of onset and the patient being neurologically intact with calcitonin. Calcitonin is indicated for elderly patients with low bone mass. The use of calcitonin may result in increased bone density particularly in the spine with a plateau effect in 18 months.
The AAOS made strong recommendations against the use of vertebroplasty in patients that are neurologically intact. The question must be asked, was there enough of data in these studies to substantiate their report? If these findings are inconsistent, why did they even bother to publish this information? It is difficult to comprehend the motivation of the AAOS. What we do know is that the ideal vertebral body for augmentation is one that has collapsed less than 50%. So the question must be asked was this a political ploy, or was this valid information?
If you experienced a VCFx wouldn't you want to Relieve the Pain, Restore Mobility and Resume Functioning? TSB wants to know what our readers think, and is there an underlying motivation behind the AAOS throwing this out into the public domain?
From comments to the weekend op-piece:
ReplyDelete1:12:
# 1: vertebroplasty works
# 2: payors will get rid of it, if given the chance
# 3: AAOS' positioning statement is a political move that will blow up in their face
# 4: NASS as usual is too busy with back room dealings, so no time to respond..... if they even knew how.
# 5: there's some good editorials in the non-NASS journal: Spine
Would you mind elaborating on #3? Thanks
6:37
They think they are showcasing themselves as responsible citizens by publicly declaring a procedure ineffective on incomplete evidence, and hope that no one notices that only a very small percentage of their membership performs these. They left kypho alive, because those few members that do treat fractures tend to work (closely) with Kyphon. If many people are sufficiently uninformed and follow their guidelines, the average cost per fracture treated will dramatically increase. Most significantly, they have opened the door for outsiders to ask them to scrutinize other procedures that they actually do tons of. Given the fact that AAOS apparently only looks at what at least on paper are prospective randomized controlled studies -they did stop short of double blind (sic!)- there will be many indications/procedures that would not pass muster. THA rings a bell?
kick em when theyre up...kick em when theyre down...kick em where they sit, kick em all around...
ReplyDeleteGiven that Interventional Radiologists do the vast majority of the vertebroplasties out there, this was a backhanded way for AAOS (and surgeons) to slap down the competitive specialty by recommending against this procedure. Makes no sense, really, since surgeons wouldn't do a VP anyways - it doesn't pay enough.
ReplyDeleteBut here's the real kicker - AAOS published their guidelines just as the VERTOS II paper was published, which showed in a Level I trial that VP superior to conservative therapy for VCFs. Coincidence these "guidelines" came out too late to incorporate it into their "analysis" - I think not. They would have had to support VP if they had honestly incorporated it. Now their guidance looks even more political in light of these results.
Finally, what will the committee chairs do when they (or their mothers) get their VCF? Bedrest and vitamin D for 2 months? Ha!
What is less expensive? A vertebroplasty/kyphoplasty, or 2-3 months of bed-rest and all the medical issues that arise from that?
ReplyDeleteThe studies AAOS used to compare kyphoplasty and vertebroplasty which were considered supportive of the FREE data were:
ReplyDeleteOne Austrian study (Grohs): 51 non-randomized pts, with no mention of how many actually were seen at follow-up, an apparent suboptimal vertebroplasty technique, possibility of conflict of interest open;
One Italian study (De Negri): 21 non randomized pts, VP 18 levels in 10 pts, KP 15 levels in 11 pts, 2 pts received VP instead of KP because collapse was too severe, 11 of 21 pts seen at last follow-up, possibiliy of conflict of interest open;
One Taiwanese study (Liu): 100 randomized patients; no difference between VP or KP except 2 new adjacent Fx in KP, no mention of follow-up rates, no conflict of interest, recommend VP over KP.
Given the quality of these papers, especially the first two, one would not expect them to hold much sway with any normal thinking clinician. Oh well....
My conclusion: my mother gets a VP.
To 12:58
ReplyDeleteThe Medtronic/Danek/Kyphon business models are the stuff of legends. The possibility of conflict of interest is WIDE open.
Anyone else find it interesting that most of the Vertebroplasty companies are copying balloons to be used in "Balloon Kyphoplasties" yet out of the other side of their mouthes saying VP is "better"... HUH?
ReplyDelete"oh and just use a uni-lateral approach" until we can legally say bi-lateral is superior... (wink wink)
Not interesting, sad, but also completely expected. As vertebroplasty pays less than 1/4 of what kyphoplasty pays, it is not surprising that everyone chases the big bucks. The really sad part is that the use of the balloon, which is nothing but a very expensive urinary catheter, does not convey any benefit over doing a vertebroplasty. And that assumes that both are done in a technical and clinical correct manner.
ReplyDeleteAssuming both procedures will accomplish some level of pain relief, i've certainly never seen a VP reduce a fracture, nor do i believe you can control the cement as well with a VP. My own mother has had a KP...
ReplyDeleteThe balloon in Kyphoplasty does nothing except:
ReplyDelete1) create a cavity for safe cement injection
2) move all of the poor bone in the vertebral body to the periphery, autografting the outer portion and sealing off exits for cement to leak.
3) Reduce kyphosis angles in fractures vertebral bodies over twice as much as cement injection alone.
No big deal. Who needs a balloon?!?!?
If you have ever seen the two procedures and the results on xray, you are well aware of the superiority of kyphoplasty. If my mom had a fracture, she would definitely get a kypho,
All the balloon Kypho does is prevent the PMMA from extravating. Kyphx is not viscous, and leakage is common (and under-reported). People really do not know how dangerous this procedure can be. There is absolutey zero data supporting a balloon kyphoplasty as restoring vertebral height vs Vertebroplasty...just great marketing.
ReplyDeleteAs for reimbursements, sure Kyphoplasty is reimbursed higher than vertebroplasty..just as TLIF is more than a PSF w/o interbody. The reimbursements also vary based on inpatient vs outpatient procedures.
if it were me, ill take a belt and suspenders pedicle screw construct above and below vs kypho/vertebro any day. It's over-marketed and under-reported
The new steerable needle looks pretty sweet! Depuy is going to be co-marketing with Osseon on their steerable needle to be used along with the Confidence PMMA high viscosity cement. Uni pedicilar and now it will be a Kyphoplasty because of the cavity creation. At least according to the folks at the NASS booth.
ReplyDelete6:08.... You'd rather have a 12cm incision and 4 to 8 screws rather than 2 three millimeter incisions???? You're so tough!!!!
ReplyDeleteFor all those who claim to have witnessed the 'superiority' of kyphoplasty in other areas than price:
ReplyDeleteKyphoplasty and Vertebroplasty Produce the Same Degree of Height Restoration, AJNR 2009
Vertebroplasty Versus Kyphoplasty: Biomechanical Behavior Under Repetitive Loading Conditions, Spine 2006
Kyphoplasty Reduction of Osteoporotic Vertebral Compression Fractures: Correction of Local Kyphosis Versus Overall Sagittal Alignment, Spine 2006
Kyphosis correction and height restoration effects of percutaneous vertebroplasty AJNR 2003
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM Search product codes 'HRX' and 'NDN'
....and codes 'OAR', 'JDZ', 'GDI', or just search 'kyphon'.
ReplyDelete@ 7:03 P.M. send TSB a check; payment for your Depuy advertisement on his blog
ReplyDeleteDePuy Confidence= No one cares.
ReplyDeleteObama care will fix everything. VCFx will get braces and sent home. Unless you have cash.
ReplyDeleteThe coding boundaries changed in order to bring competition to Kyphon. Ok, now what? Other companies (I'm with one of the "other" ones) are trying to get in on this with balloons, needles, curettes and whatever else. There is nothing really out there that changes the game. Kryptonite can't deliver their bone forming putty so thats dead, and the HA garbage from MSD will die out
quick if not already.
This market is open to Ortho, Nuero, and the IR/INR market. The statement from AAOS was to slam the IR market for sure. So what, it will go away and guys will continue to do this procedure untilnthe gov says no.
Grandma had multiple fractures, no brace for her, she had a VP.
Cautious review of research is essential for accurate treatment recommendations
ReplyDeleteBy David Veino
Rigorous clinical research is, undeniably, the foundation and lynchpin of our industry. Without it, we would not have new product innovation, clinical outcomes would not advance and, most importantly today, we would not be able to drive cost efficiency in the health care industry.
For this reason, the industry must be cautious which studies it promotes and ensure that research and its parameters are appropriate for the medical devices and treatments that it is looking to validate.
Similar to other practices within orthopedics, spine treatments and devices should be held under the microscope to ensure that all new products and services are supporting surgeons’ needs and improving patient outcomes.
Story continues below↓
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Study in the NEJM
As we come together for the 2010 Annual Meeting of the North American Spine Society, one great example of this necessity in the spine practice is “A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures” published in the August 2009 New England Journal of Medicine (NEJM). The study found no beneficial effect of vertebroplasty as compared to a sham procedure in patients with painful osteoporotic vertebral fractures. The findings of this study rippled across trade, national and even broadcast outlets, eventually culminating in a recent guidance against vertebroplasty issued by the American Academy of Orthopaedic Surgeons. But, was the study truly rigorous enough to warrant the condemnation of this treatment option?
The study in the NEJM assessed a patient population of 78 people with sub-acute vertebral fractures and did not use MRI scans to confirm the presence of those fractures. Not only is vertebroplasty a recommended treatment for patients with acute vertebral fractures, any study that is measuring the effectiveness of a specific procedure should confirm the existence of the condition that it is looking to correct.
Conflicting findings
Another study, “Vertebroplasty Versus Conservative Treatment in Acute Osteoporotic Vertebral Compression Fractures” or Vertos II, recently published in The Lancet arrived at conclusions contrary to the NEJM study — specifically that vertebroplasty is a safe and effective procedure.
This is a perfect example of why individual treatments should not be condemned until they are proven ineffective by rigorous research. The Vertos II study, for example, reviewed 208 patients and focused solely on patients with acute vertebral fractures that were confirmed by an MRI scan. The study also found that pain is relieved immediately following vertebroplasty; continued relief lasts for a minimum of a year and exceeds that resulting from bed rest, bracing and pain medication; and does so at an acceptable cost.
Surgeons will always have the final decision on which procedure they want to use and which they don’t. But before people rush to judgment or the condemnation of a specific procedure, they need to ensure that the research that surgeons use to inform treatment decisions is sound and provides patients with the maximum benefit.
David Veino is the national director of sales & marketing at Stryker Interventional Spine, a division of Stryker Corporation.
Cautious review of research is essential for accurate treatment recommendations
ReplyDeleteRigorous clinical research is, undeniably, the foundation and lynchpin of our industry. Without it, we would not have new product innovation, clinical outcomes would not advance and, most importantly today, we would not be able to drive cost efficiency in the health care industry.
For this reason, the industry must be cautious which studies it promotes and ensure that research and its parameters are appropriate for the medical devices and treatments that it is looking to validate.
Similar to other practices within orthopedics, spine treatments and devices should be held under the microscope to ensure that all new products and services are supporting surgeons’ needs and improving patient outcomes.
Study in the NEJM
As we come together for the 2010 Annual Meeting of the North American Spine Society, one great example of this necessity in the spine practice is “A Randomized Trial of Vertebroplasty for Painful Osteoporotic Vertebral Fractures” published in the August 2009 New England Journal of Medicine (NEJM). The study found no beneficial effect of vertebroplasty as compared to a sham procedure in patients with painful osteoporotic vertebral fractures. The findings of this study rippled across trade, national and even broadcast outlets, eventually culminating in a recent guidance against vertebroplasty issued by the American Academy of Orthopaedic Surgeons. But, was the study truly rigorous enough to warrant the condemnation of this treatment option?
The study in the NEJM assessed a patient population of 78 people with sub-acute vertebral fractures and did not use MRI scans to confirm the presence of those fractures. Not only is vertebroplasty a recommended treatment for patients with acute vertebral fractures, any study that is measuring the effectiveness of a specific procedure should confirm the existence of the condition that it is looking to correct.
Conflicting findings
Another study, “Vertebroplasty Versus Conservative Treatment in Acute Osteoporotic Vertebral Compression Fractures” or Vertos II, recently published in The Lancet arrived at conclusions contrary to the NEJM study — specifically that vertebroplasty is a safe and effective procedure.
This is a perfect example of why individual treatments should not be condemned until they are proven ineffective by rigorous research. The Vertos II study, for example, reviewed 208 patients and focused solely on patients with acute vertebral fractures that were confirmed by an MRI scan. The study also found that pain is relieved immediately following vertebroplasty; continued relief lasts for a minimum of a year and exceeds that resulting from bed rest, bracing and pain medication; and does so at an acceptable cost.
Surgeons will always have the final decision on which procedure they want to use and which they don’t. But before people rush to judgment or the condemnation of a specific procedure, they need to ensure that the research that surgeons use to inform treatment decisions is sound and provides patients with the maximum benefit.
MDs need to put a stop to 'void creation' equals kyphoplasty. Dfine, Osseon, Arthocare or anybody else simply touting void creation as billable as a kyphoplasty is asking you to commit Medicare fraud. You don't believe me take a close look at your LCD where most state that you need to use a balloon or implant to create the void (there is NO national policy for vertebroplasty or kyphoplasty…CPT codes are used to identify procedures in an attempt to simplify billing, they DO NOT grant permissions). We don't put a stop to this now we are sure to kill reimbursement for these wonderful procedures. KYPHOPLASTY EQUALS FRACTURE REDUCTION...at the end of the day if the only reason that you are creating a void is so you can bill at the more expensive kyphoplasty rate, take a look in mirror and ask yourself if you're really doing the right thing (for yourself, your patient, your staff and your hospital).
ReplyDeleteAlso, how about we develop a protocols for Vertebroplasty and Kyphoplasty?
My suggestion -
Kyphoplasty when: bio-concave or wedge fracture and you have an opportunity to restore body dimensions, fear of endplate cement leak, fear of epidural cement extravasation, patient can withstand longer procedure and has pedicles large enough to place trocar.
Vertebroplasty when: extremely sickly patient - why are we spending more money on end of life patients...if you simply treating the pain then vertebroplasty is your answer, acute fracture w/ no end plate changes, vertebra plana, fracture older than 6-8 weeks.
As physicians we need to do the right things by our patients. Find it very difficult for one to argue that one procedure is better than another...they BOTH have their place.
I'm new to industry (hardware rep) attended NASS, saw and increased my knowledge of these devices. From this "green horn" point of view can't say what's better or worse. However, did observe a surgeons presentation with an Osseofix device from Alphatec. Some cases he deployed the device and filled with PMMA and others like trauma he deployed device without using PMMA. As the NASS New Bee, this caught my attention a device for treating fracture, stabilizing, restoring height, cement or no cement.
ReplyDeleteOsseofix: DOA......
ReplyDeletewhat do you mean when you say Kryptonite can't deliver their bone forming putty? Do you mean they can't produce it or can't get into the void?
ReplyDelete