Yesterday in our cath conference, we discussed the substudy from the prospective randomized trial called PREVENT-IV just published in the New England Journal of Medicine. That study evaluated the major adverse cardiac event rates of minimally invasive vein harvesting compared to open vein harvesting prior to coronary bypass surgery.
I was surprised to see that minimally-invasive vein harvesting had a higher combined complication rate of death, myocardial infarction (heart attack) and need for revascularization in the patients who received vein grafts harvested by the minimally-invasive technique. Following the presentation of the data, our surgeons were asked why this might be the case. While none knew for sure, they postulated that the art of harvesting vein-conduits using endovascular techniques might play a role (it's more difficult), or the effects of the thrombolytic state induced by on-pump bypass vs. off-pump bypass might create the discrepency in post-surgery vein survival, since patients are less likely to develop clinical thromboses in the post-open chest bypass population.
So this morning, I was surprised that President Obama toured Cleveland Clinic yesterday and had such an up-front experience with minimally-invasive robotic surgical techniques for mitral valve repair that hardly represents mainstream American health care. While the marvels of the technologyy cannot be disputed, like the endovascular vein harvesting study above, might we find that robotics could be as deliterious to patients compared to open chest techniques? After all, these techniques have yet to be compared in multicenter trials to more conventional open techniques for mitral valve repair. But more concerning as we move forward is this question: will academic centers be granted more funds to test comparative effectiveness research for robotics at the expense of front-line American health care? Surely, this won't be, will it?
Probably.
But when I see pieces like this I wonder why the article does not question the cost and risks of this technique compared to conventional open-chest procedures, especially in this era of touting the need for health care cost containment. How much is this piece about the marketing of this technique to the community (for financial gain) or to the President (for obtaining grants or political favors)?
Perhaps we should ask ourselves how many of the physicians and surgeons at Cleveland Clinic stand to earn a seat on the proposed MEDPAC board that will determine if Congress will approve payment for robotic techniques even when few data exist to show their superiority over conventional techniques.
Now that might make for some really interesting reading.
-Wes
6 comments:
Wes,
You have hit right on the isssue of why we need comparitive effctiveness research!
Like many new techniques, gizmos, and drugs, they are not compared to the current gold standard therapy, but instead to no therapy at all with some exceptions. You would not, for instance give one group of patients some new chemotherapy for their cancer while giving the other control group nothing. But in the instance of devices and such, it does not seem that these are often compared to the currently acceptable therapy iterms of both cost and efficacy. That is why we have Da Vinci robotic machines cropping up all over the place without alot of clear evidence that they provide clear benefit in outcome. the surgeons seem to love them, but I am not certain that this isn't because the ones who have them are seeing more patients attracted to their practice by virtue of patients seeking out the most current technology (I recall the similar phenomena years ago where patients would always ask if the surgeon did "lazar therapy", although it has never been clear whether this makes a difference clinically if the surgeon used a knife or a lazer for many procedures).
So the point is to have some independent researcher examine, in controlled studies, whether these new techniques make any differnece or not. Right now, the FDA does nothing but certify the efficacy of the device or procedure, but does not pay attention to the issues of whether it is better or even worse than the old way. If it is not more effective, it does not mean that the technique needs to be discarded, but it should not be reimbursed at a higher charge than the old technique if it offers no clear advantage. This pricing would make more sense in an market where the price to the patient is not constrained (since he/she has paid the insurance premium and wants "the best" with no concern to cost since this comes out of the insurers pocket.) After all, if you were buying a car and had two that were identical in quality, but one was more expensive than the other, which would you buy? The less expensive one, of course! This does not happen in health care where patients gravitate often to the most expensive places (in your part of the world, Northwestern, University of Chicago, Rush, which may not be the most cost effective places, but certainly have the nicest toys and the shiniest new buildings.
This is what would constrain some of the rise in costs if such information was availible and why comparative effectiveness research holds the most promise of constraining costs.
Keith,
Check your facts. The surgeons who do robotic valve repair/LIMA grafting are NOT reimbursed anymore than a standard CABG or valve surgery. The hospital actually loses money on the disposables used with the robot compared with standard valve repair. The robot doubles the OR time and there is a tremendous learning curve for the surgeon. The surgeon is actually losing money with the extra time for training and less procedures that can be completed. This is a complex issue.
We had CT surgery grand rounds on robotic surgery about a year ago. The CT surgeon said that there was a definite steep learning curve and that you still needed to have an experienced surgeon at the table in addition to the surgeon working w/ the robotic controls. He did emphasize that the robotics did allow smaller incisions especially if you were doing MVR or a single LIMA to LAD. He did not have data re: outcomes as they had only recently started using the robotics.
I can't see how the use of robotics in CTS would reduce costs. The equipment alone is very expensive.
CardioNP
so doctors won't be allowed to practice the way they believe to be best if cer shows 51% of one way is better than 49% of the other way preferred by their physician and they are on the wrong side of the coin flip? what if two years later another study shows oopsie we made a mistake, the other technique is better? that probably doesn't happen in medicine though.
all pacemakers have to be done with cephalic vein cutdowns because cer shows less ptx with this technique and someone decided reduced ptx is the desired outcome, even if the individual doctor believes other complications to be more likely (in their hands) using that technique? just because it doesn't make a differece nationally does not mean all docs are robots that can do things exactly the same way every time to every patient.
Dear Anonymous,
Nothing in comparitive effectiveness research would prevent you from deviating from the most cost effctive technique proven in a national study, but what it would do is make you or the patients pay the extra cost if you chose to do so. It would set the cost of the accepted technique, and any additional cost would be born b the patient. If you convince your patients that another method offers benefit that is not proven, you can eat the extra cost or have your patient pay the difference. This is how you constrain the creeping technology that is continuously giving us small, or possibly no, increase in patient outcomes at increasingly more expensive prices.
People seem to continuously attack the concept as goverment interference and beuracrats deciding what you can or can't have. Nothing constrains patients from having these other techniques or treatments; just don't expect the insurer, whether it is the goverment or private insurers to pick up the extra tab if it is not proven to improve quality or outcome for the patient.
who is going to set the cost of deviating from the standard? that even assumes some consensus can be achieved about what the standard is, let alone determine cost. we can't even determine cost right now to compare different facilities with.
the data on apples to apples health care comparisons is not at all extensive. are we really going to accept cass studies 30 years old when we compare bypass versus stents? patient weren't even taking aspirin back then. they didn't study anyone with heart failure. very few women. but those are the studies we cite when discussing what to do. to obtain the data and get widespread acceptance that the data is good will take enormous amounts of time, energy, money, if it is even possible. and that is with common medical conditions.
are we going to study whether tylenol helps a headache better than ibuprofen or placebo? if yes, no ibuprofen for you even if it works better for you?
i think your default is that one treatment option should be better to justify the cost. for me, i would say it has to be demonstrated convincingly to be worse to warrant reducing the payment. physicians still have to treat individual patients as you know, and i would err on the side of the physician in front of the patient.
obviously ymmv
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