Jim Morrison once sang;
Medicare patients undergoing spine surgery fell during the period from 2002-2007. This was driven by a decrease in the rates of pure decompression surgeries. However, during this period there was an increase in complex fusions utilizing pedicle screws, rods, cages and biologics. The highest risk for major complications was observed in complex fusions, in addition, higher hospital costs were associated with these procedures.
What has surfaced is that there is a need for more evidence regarding the efficacy of these surgeries, especially, lumbar stenosis. One author stated, "it seems implausible that the number of patients with the most complex spinal pathology increased 15 fold in just six years. The root cause of this problem is diagnosed by Dr. Eurgene Carragee of the Standford University School of Medicine who states, "...devices are aggressively marketed, so much so that there promotion may sometimes cross the line of professional conflict of interest among profession leaders and institutions." Complex fusions are more profitable for surgeons because reimbursement is significantly higher.
So in closing, TSB must ask our readers, "Are surgeons performing more complex spinal fusions?" And, "are we seeing procedures that compromise an ethical obligation to patients in lieu of monetary rewards?" TSB wants to know what our readers think?
I'm not a surgeon, but you need to look past complications to outcomes. I would bet long term outcomes are better with fusion utilizing hardware than disctomy alone. Of course, complications were higher with fusion because it is simply a larger surgery.
ReplyDeleteSurgeons?
MM: Why the disdain for this industry that you cover? I don't get it...You a generally insightful blog. I think it does benefit the industry (surgeons, reps, everyone). But, I sense fatigue and disdain in your opinions.
This isn't my opinion. I am reporting on what was written in a AMA Journal.
ReplyDeleteI have heard that there was a potential change during the study time as it relates to what qualified as a complex procedure. This is a retrospective study with a poor study design similar to the SHAM vertebroplasty study. This is not to say there are not more complex procedures being done, just that this study may not be the most accurate assessment.
ReplyDeleteAs usual, half truths lead to wholehearted misinformation...show me one surgeon who likes to stand there for 3-4 hours and incur risks without benefit to his patient. The issue with respect to spinal stenosis is simply this; laminectomy alone doesn't hold up over the long term, second and sometimes third surgeries are performed to stabilize what had been rendered unstable. Hmmmmmmmmmm. Stupid me, why not stabilize the spine with any number of dorsal process fusion devices that allow simultaneous decompression along with stability. Now here's the rub. These devices shouldn't cost 4000 to 9000 dollars each. They are simple to insert, are not difficult to troubleshoot, go in quickly, with minimal blood loss, and in the right patient I'm seeing better than 70% good results. By the way, instead of performing instrumented (pedicle) fixation, with huge incisions and blood loss, I can offer this procedure to my overweight diabetics and they get better. I'm not a fan of Carragee after he tried to discredit discography. I consider him our resident progressive who has an axe to grind. If the implant companies have any brains they would lower the prices on these implants and push for their proper use
ReplyDeleteRobin Young weighs in;
ReplyDeleteI suppose, if one wanted to characterize spine surgeons in a simplistic way, one could say there are two kinds of spine surgeons -- implant surgeons and procedure surgeons.
The implant surgeon makes a very good living with internal fixation and has probably been part of a clinical study for motion preservation.
The procedure surgeon emphasizes MIS, lasers and other technique driven technologies. Implants are also part of their practice, but not the focus.
In the "bread and butter" spine patient (45-65 year old) with healthy bone stock and a long active life ahead, implant surgery has been reasonably successful and is, I think, getting better as both patient selection techniques and implants and instruments improve.
But the fastest growing patient population, the Medicare and elderly, has been largely ignored (except from KYPHON). Now the industry is playing catch up. The old saying that when your only tool is a hammer, every problem looks like a nail, is appropriate, I think, here. The elderly population has 1.8x the complications (and serious ones, like heart disease, diabetes, osteoporosis) of the spine industry's traditional patient population. So the general approach to the elderly spine patient has been largely the same approach as for the younger patient. That will have to change.
This means that surgeons and industry will likely have to shift from the traditional implant focus to more procedural techniques and technologies. So, if the traditional mix is 80/20 in favor of implants over procedure, the elderly market may have to move to a more 50/50 or 40/60 approach.
Finally, the Study TSB references was designed and performed by long time critics -- Deyo and Carregee. Their conclusions, frankly, did not match their data. But they did match their pre-conceived notions and biases.
Decidedly not anonymous,
Robin Young
The study defined a "simple fusion" as one "involving a single surgical approach...[which] involved only 1 or 2 disk levels...". Thus, instrumentation, BMP's etc. could still be used in "simple" fusions. There is no discussion of how illiac crest grafts affect this, or how the use of BMP's to avoid such grafts would change the conclusions. Carragee's editorial uses a different definition of "complex fusions" which includes "instumentation". There are many more examples such as this which leads one to conclude that, as is usual these days, JAMA is more political than scientific.
ReplyDeleteDoes anyone know how many lumbar fusions are performed in the U.S. each year? I've heard both 200,000 and 400,000.
ReplyDeleteyup i know.
ReplyDeleteOkay, let's clarify some facts in case there are misunderstandings. First, it's only Medicare patients with spinal stenosis in the study, not spine surgery as a whole. Second, simply adding a PLIF, TLIF or any other anterior component to the posterior surgery converts it from "simple" to "complex" in this study.
ReplyDeleteYes, a decade or two ago, performing only posterior instrumentation and posterior fusions with decompressions was standard of care in these patients. Quite frankly many received only laminectomies in that time, and interbody techniques were considered by many to be too aggressive for the vast majority of older patients. Now, older patients are more active, youthful in their activities and expectations, have better bone quality, and the approaches and interbody techniques have evolved to make them more acceptable in the older populations. Surgeons have migrated toward interbody techniques in these patients because they believe the outcomes are better. And that's the equation that's missing from the article. They are only stating the increase in cost, but nothing about potential increases in benefit. Yet that's precisely the motivation for most surgeons, and that's far from an "implausable" rationale. In fact, that's the most likely one.
So it would be nice if Deyo and Company would pursue intelligent discussion of whether TLIF/PLIF, PLF, or lami alone in stenotic 80-year olds is clinically and economically worthwhile, instead of overgeneralizing, and hoisting inflammatory and misrepresenting conclusions on the masses.
Very nice post 11:04am
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