Good afternoon, warriors. Thank you for staying. So I'm going to present the side of this debate, outpatient surgery for cervical disc arthroplasty, and my only disclosure is that I've been a site PI for a number of devices. So when I looked at this, I said, well, let's look at four areas. What are the indications? Are these procedures safe in the outpatient setting? What are the outcomes? And finally, what are the economics? So, you know, the premise of this debate would have us believe that there's a huge amount of overlap between a cervical disc arthroplasty and posterior cervical foraminotomy. Obviously, it's much more limited than that in reality. Why is that? Well, the indications are different, and Tim's talked about that. You know, we're talking about unilateral radiculopathy, but how many times do you see a pure lateral foraminal disc protrusion? You do see them, but a lot of times they're central pathology. But even more important, if you look at the data for cervical disc arthroplasty, there's exclusions and contraindications, and those include facet arthropathy, significant disc-based collapse, however you define that, kyphosis, osteoporosis, and you start to limit the number of patients that are appropriate for cervical disc arthroplasty, let alone those patients that you have that either have central and or bilateral pathology. For posterior cervical foraminotomy, well, you know, certainly there's radiculopathy. We know it's probably a good operation for that, but if there's any central component, if there's kyphosis, who knows? We really don't know. How about axial neck pain from facet pathology? What's the outcome when you drill away a facet that's already arthropathic? We really don't know other than those indications that patients seem to do well in case series. For me personally, you know, I don't like posterior cervical foraminotomies and discectomies at the C4-5 level. I don't like manipulating the C5 nerve root, and it makes me uncomfortable, and I think patients tend not to do well with a posterior approach at that level. So in reality, what are we talking about? We're talking about comparable treatments for unilateral cervical radiculopathy for those patients who are younger with posterior lateral soft discs or proximal foraminal stenosis, because I think posterior cervical foraminotomy is much better for far lateral spondylotic disease. In truth, we know there are three operations, and there's some overlap with each, but for the purpose of this operation, we have to include, for this debate, we have to include ACDF, obviously, especially when you're talking about cervical disc arthroplasty. Well, how about safety? Well, I thank Dr. Adamson for this paper that he published a couple years ago. They've done 1,000, reported on 1,000 consecutive ACDFs in the outpatient setting, and they've had excellent results, about two-thirds one level and about one-third two levels, and, you know, only eight patients required hospital transfer, only 2% readmission rate, no perioperative deaths, and there were no significant differences between inpatient and outpatient cohorts. Well, is there actual data about arthroplasty? If you don't believe in ACDF and arthroplasty are virtually the equivalent procedure, and there are. There are certainly now case series coming forth, class three, class four evidence, which is pretty much what we have for foraminotomy, and they seem to be done safely, as you might imagine. Well, here's where we go into the difference between arthroplasty and posterior cervical foraminotomy, and that's evidence. You know, I'm sorry for the three font on this, but these are a list of class 1B level of evidence on efficacy of cervical disc arthroplasty. What's 1B? That's individual randomized controlled studies with narrow confidence intervals. We have this information. Why did they randomize arthroplasty against ACDF? Well, you know, they're both anterior approaches, but why not against foraminotomy? And why aren't there randomized prospective studies for foraminotomy? Well, food for thought, right? So, you know, people will criticize much of the literature on cervical disc arthroplasty, but if you actually look at the criticisms for these studies that the surgeon is not blinded to the procedure that he's doing, impossible, and that if you criticize many of the reports for these important IDE trials, that you'll see that some did not have an intent to treat analysis. Otherwise, you look at the literature on cervical disc arthroplasty, and it is the most robust literature for virtually any procedure that we would do in spine. So, what if we do look at the literature on prospective studies for ACDF versus foraminotomy, at least an anterior and a posterior approach? You know, two probably pretty classic studies, the Herkowitz study and the Corinth study, both of which randomized patients between these two treatments, and both of which ultimately showed superiority for the anterior approach. The other thing we know about studies, especially IDE studies, when you're following these patients for 10 years, is that you do know what the complication rates are, and you're sure of them. You know, in virtually all these studies, they had nearly 80 percent follow-up rates in the control and the treatment arms, which were the cervical disc arthroplasties. So, we know what the reoperation rate, all of the reoperations, are at the index level, and they're substantially fewer than the fusion, when we look at the cervical disc arthroplasties. And we also know what the adjacent level rates are, and we don't have to guess. We know, and we know if we follow these patients at least seven years, that there's a substantial difference. So, five percent, less than five percent reoperation for cervical disc arthroplasty, compared to almost 12 percent for ACDF. So, statistically significant. And if you look at two-level data that's maturing now, you can look at seven-year follow-up, and again, posterior probability of superiority is almost 95 percent, with reduction in reoperation rates at adjacent levels. You know, if you look at, you know, I think Dr. Adamson's data is fantastic. You look at the literature, you see fairly similar things. You know, for patients followed for at least two years in this series, over an 18 percent reoperation rate. I think that's, you know, substantially more than what's being reported in these studies. Well, just like Dr. Adamson's practice has done a lot of arthroplasty and ACDF, you know, we do a lot of foraminotomies at UVA. It's a good operation. And, you know, we reported on patients, over 160 patients, and they did very well initially over short interval periods of time. But one of the things you have to say, even in our limited retrospective case series, that there was a five percent instability rate from drilling away facet joints, and what was more concerning is at least 20 percent postoperative loss of lordosis. And by this, you know, we were talking about people tilting into substantial kyphosis. You know, you know, and foraminotomy must be a great operation because, you know, there's literature that says you don't even have to do the whole operation. You can go in, you can kind of drill some bone away, take a little bit of ligament. You don't even have to take the disc out, and it works just great. You know, for me, that says that's fodder for a prospective randomized study because, obviously, you have to consider some degree of placebo effect as well. So, posterior cervical foraminotomy has basically achieved parachute status. We don't need a randomized controlled study to know that a parachute's safer when you jump out of a plane, and we don't need randomized evidence that foraminotomies are good operations. So what about economics? I certainly give that to the posterior cervical foraminotomy probably about when you talk about direct costs. I think, you know, Tim was presenting data, you know, from their surgery center. You know, you're probably talking in surgeon's fees alone, and in instrumentation, you're looking at a reduction of about 50 percent versus ACDF. But, you know, if you look at arthroplasty, this is an interesting paper. This was, they did some Markov modeling for economic and decision analysis, and what it showed for patients from 45 to 65 years of age, arthroplasty is actually significantly more cost effective than ACDF as well. Why is that? Well, with arthroplasty, you also have a reduction in the number of codes. Bundling may eliminate some of that in the future, but again, you had earlier return to work, you had lower re-operation rates, and even if you said, okay, well, re-operation is going to be, you know, somewhat biased if these were IDE trials, even if you eliminate re-operations, cervical disc arthroplasty would be significantly less expensive than ACDF. So, when I look at this, you know, cervical disc arthroplasty, what are the clear indications for the procedure? I have to give double check marks and a victory for cervical disc arthroplasty over posterior cervical foraminotomy. Safety, I think, as Tim said, I think both are safe. Efficacy and outcomes, it's clear that there's more evidence to support cervical disc arthroplasty and we know more about it, the re-operation rates and the efficacy than we do about posterior cervical foraminotomy. Cost effectiveness, give a small nod, certainly, to the posterior cervical foraminotomy, but in my mind, cervical disc arthroplasty is the winner. Boom. Thank you very much. Appreciate your time. Thank you.

outpatient surgery

cervical disc arthroplasty

indications

safety

economics