Julio Davalos: Thank you for the invitation to speak. I'm going to share with you our experience with percutaneous nephrolithotomy, PCNL, and the surgery center. Those are my disclosures. It's a lot to cover in eight, nine minutes, but I'll try to give you an overview and try to at least whet your appetite a little bit for this idea of transitioning from a hospital to a surgery center. Something that probably most of you feel is maybe best done in a hospital or something that you wouldn't necessarily consider taking on in the surgery center. Although following the robotics talk, I think we're certainly seeing that we can do quite a bit in the surgery center.

So just like what Ronney said, you don't want to start your first same day discharges. Our surgery center initially did not have overnight capabilities, so we had to do same day discharge. Maryland law has since allowed us to keep patients overnight, but we have such a great track record with sending them home the same day that we've never implemented an overnight stay within our surgery center. So interestingly, the very first same day discharge PCNL was first described back in 1986. So very few things are really new. If you kind of dig through the literature and talk to enough people, you'll see that things have been done in the past. Now of course that was from a hospital setting. Really the first series was described in 2010. So again, that's 12 years ago now. Then we started doing our surgery center cases in April of 2015. So we have about seven years of experience and we're around 1600 cases in now.

So I think there's also some terminology which gets in the way. Outpatient PCNL can include an overnight stay and that's more of an insurance issue or an insurance term. Really outpatient same day discharge is what we're talking about, either from a hospital setting or more importantly in a surgery center. And again, our surgery center is a free-standing center. It is not within a hospital. That's a question we also get asked often, is this some sort of trickery where you're doing it in a surgery center but it's really just designated a surgery center, but you're actually attached to an ICU, which we are not. I think we're about six or seven miles from the nearest hospital.

So what are my recommendations? It's pretty straightforward. You want to have a high volume of cases under your belt before you undertake this. You want to have an experienced team. I can't stress that enough. Having an experienced team is absolutely paramount. I was able to bring some of the hospital staff over to our surgery center, so it wasn't starting from scratch, but there were several new players. But you really want to try to have as many people that are familiar with the case. As we all know, as surgeons, you can't do it by yourself and you're only as good as your weakest link. So if you've got a good team around you, you're going to be more successful. I also think it's good to limit providers.

I think when you're trying to build high volume, you don't want to have 10 or 20 people trying to do this. I think if you can hone in on a few in your practice, depending on your practice size, your geography, that's probably a better way to tackle this. And again, start in a hospital setting, same day discharge from the hospital. I did about 50 cases in the hospital on the same day discharge and I tracked them to see if I had done these in ASC, how would these have fared? So I think anytime you look at any program, you're always looking at these three pillars; clinical, operational, and financial. We can talk about the clinical part, but if you can't operationalize something, if it doesn't make financial sense, then it doesn't really matter. Our surgery centers are something where you've got to make the bottom line work.

Clinically, it's interesting. In the beginning these were cherry picked cases. I'll fully admit that, the first 25 PCNLs we did in the surgery center, which again was back in 2015, 2016, these were healthy, young, relatively small stone burden, maybe a 20 millimeter stone. But since our experience has grown, really it's very few things that from at least patient selection in terms of stone burden, staghorns, complex kidney anatomy, those things don't really stop us from doing the case. It's more the things that stop anesthesia, anesthesia concerns. So cardiopulmonary issues, high BMIs and that's kind of where we are today. But again, when you start you want to start with those healthier, younger, more straightforward cases, of course.

I'm a strong believer that you need to obtain your own access. I think for patients, and again, this is a limited amount of time, but one of the things about doing this in an ambulatory setting is you need to make it mimic a ureteroscopy as much as possible. In my opinion, and I think all of you would probably agree, you can do a ureteroscopy as an outpatient with a same day discharge. So if you can make the PCNL as close to that as possible, meaning patients come in without pre-access, they don't have a tube and they don't have any site of pain other than maybe their stone and then you treat the stone, and I always say we're trying to get in and out without really even knowing that we were there. So I think getting your own access, if you can do that, I think that allows a patient to come in without having to have a tube already in place.

So there's several factors you can look at in a post-procedure. And again, this is a brief talk so we won't delve too much into it, but just educating your patients, having a good plan of care, setting expectations. I talk to patients and let them know, similar to the first presentation, "We are not going to keep you for eight hours, we're going to keep you for about an hour or two post-op." I try to really flesh out if there's a patient who's got pain control issues or anxiety, and those aren't things that are easy to put on the list necessarily, but you just make sure that you feel good about taking them to a place where they're going to come in and out and they understand that that's really the expectation, that this is not a hospital we're going to be able to keep you for hours and hours.

So operationally, again, I think similar to the first talk, you've got to have the right infrastructure, equipment, OR set up, et cetera. These are just some slides I'm going to kind of try to get through. But I think we all know what it takes to do a PCNL. It's not a simple procedure with just a few instruments. So there's sort of a lot of equipment in the room. You do need a good size footprint for your OR, so there's quite a bit of stuff. But you can get it in smaller rooms. I'm spoiled, I have a pretty large room with a lot of nice technology in it. But it's something that I think you need to think about that physical plan.

I think workflow is actually one of the biggest things you need to look at because just making sure that there's a good check-in process that, again, we all have run surgery centers and so you want to mimic what you've done with your other programs and make sure that you've got backup equipment, that you've got good clearance of the patients. Those are the things that really slow our day down is when you only have one scope, that's a really bad idea, or they didn't go see their cardiologist, now you're canceling the case. So those are the things we try to really work through so that we do have a very efficient system. And again, if you can get a third or fourth case on PCNL in one day, again, you're really getting into that spot where you're really optimizing the utilization of the surgery center and all the benefits that that brings.

So financial, again, I won't spend a lot of time on this, there's fixed costs. For us, thankfully our share of Medicare patients tends to be smaller. Medicare I think in general reimburses on the lower end. But stone patients are not Medicare age exclusively, so I think for stones we have around maybe 20, 25% of our patients are Medicare and the rest are commercial. So that's beneficial. And again, just like any business model, you're looking at fixed costs, variable costs can determine profitability. But these have been very profitable cases for us and it has managed for us to not only sustain but grow our program to other centers and other sites outside of Maryland.

So just a few quick clinical scenarios before I wrap things up. I do use a technique called ECIRS. I don't know how common that term is. Endoscopic Combined Intrarenal Surgery. I don't love the term. It's basically a ureteroscopy and a piece now at the same time. So not in every case can you do this, but in many cases if you can navigate around the stone with the ureter scope, you can actually visualize your access coming in. The nice thing is you can actually bill for the ureteroscopy, and there was a little bit of controversy with that. I think for next year they're going to really clean up the CPT language and terminology. So you do get reimbursed for the cost and the wear and tear the ureteroscopy adds to the case, but you do get reimbursement for that.

Here's just a couple videos. You can see how nicely, when you see the needle coming in, you can really guide each step. It really, I think, adds a layer of safety and really a lot of control to the procedure. I did thousands of cases without endoscopic guidance previously, but I think when shown in this video, you can see each of the dilation steps, the wires coming in, the balloon, so all that I think is really a nice thing that is a benefit of the ECIRS approach.

So our experience, like I said, we did our first cases in 2015. We're up to about 1660 cases over the last seven years. We're under a 2% transfer rate. Less than 10% of our patients have had even low grade Calvien 1 complications. We have now expanded to three sites with three higher volume surgeons, two within Maryland, one in our Colorado office. And we're expecting our annual cases across those centers to be over 500 a year. Thank you very much.