Welcome, everyone. I'm Dr. Cindy Grimes. I'm the Chief Scientific Officer at Northside Hospital Cardiovascular Institute in Atlanta, and I'm very pleased to present this J-Sky Conversations regarding our new SKY Expert Consensus Statement on PCI without Surgical Backup, published January 30th of 2023. This, of course, was a SKY document, but it was done in conjunction with members from the ACC, the British Cardiovascular Interventional Society, the Canadian Interventional Society, as well as the Outpatient Endovascular and Interventional Society. And we're going to be giving an overview. Jeff Carr, who is actually the founding president of this Outpatient Endovascular and Interventional Society, will be presenting this, and he's also the Medical Director of the Cardiac and Endovascular Center in Tyler, Texas. Along with Jeff, we have Greg Demler, who was instrumental in doing the two previous versions of this, dating back to, when was the first one, Jeff? Do you remember, 2007? About 2006. 2006, yeah. So this is, at least the aspect of without surgical backup has been a hot topic for SKY for a number of years. Dr. Ted Schreiber, who joins us from Ascension, he's the Director of Cardiovascular Services at Ascension in Macomb, Michigan, and Ted will give us the perspective as a high-volume operator in a hospital without surgical backup. And also with us is Mamas, he's the Professor of Medicine at Keele University in the United Kingdom, and he's going to give us the international perspective. And basically, he has done numerous studies looking at this from the British and international perspective. Welcome, everyone. So Jeff, why don't you do the overview? Okay. Well, thank you, Cindy, and it's really my pleasure to introduce this consensus statement that was just updated recently in the Journal of SKY on percutaneous coronary intervention without on-site surgical backup. Well, as Cindy mentioned, and Greg was a part of, the first document, we believe, was in 2006 and an update in 2014. So our most recent document is nearly 10 years old, and it was based on the evidence base at the time, and two randomized trials, the MASCOM and the CPORT-E trial, in terms of performing the safety of performing elective PCI in settings that did not have surgery on-site. We say no SOS or without surgery on-site. And yet, since that time, we have seen a significant increase in volume and complexity of doing elective PCI in these settings. Supporting that is in 2017. As of 2017, nearly 29% of all elective PCIs and nearly 40% of radial PCIs were performed as a same-day discharge. Coincident with that, and also because of the advances that we have in procedural technology, equipment, and pharmacology, we see a migration away from the hospital setting to freestanding facilities, such as OBLs or office-based labs and ambulatory surgery centers. And we'll discuss this a little bit further along in the presentation and perhaps in the discussion section. But what this document set out to do and the authors wanted to do was to update the body of evidence. And we now have several new studies that are shown here in Table 1 to the right, both in the U.S. and abroad. We have six of these 12 studies were published outside of the U.S. And there are studies such as a meta-analysis looking at 23 different studies in over a million patients, as well as registries and national databases and VA databases and other sources with claims data, looking at different observational studies and international experiences, putting together, and this is all since 2014 through the near end of 2022. And the summary of these data that is outlined in this paper is that we see that PCIs performed at no surgery on-site centers still have very low rates of complications and the outcomes are similar as well as those PCIs that are performed with surgical backup. Coincident with this, and we see this borne out with these studies, that there's an advancing age, comorbidities, and lesion complexities of the procedures, the PCIs that are being treated. And with that, we still have very low periprocedural complication rates. They've either declined or remain constant. And also the rates of emergency surgery with these studies and this experience stays as low as 0.1% in most of the series. Well, not only that, but complex PCI is being performed in some of these centers, including unprotected left main. And we have seen with that, at least the published series, there's no increase in MACE or emergency bypass surgery compared to the PCIs performed at the surgical centers. And although we don't have any comparative studies in other complex PCI subgroups, such as CTOs and atherectomy, we do have some observational studies also published showing reasonable outcomes. And this suggests that there's feasibility of performing selected cases of CTO and coronary atherectomy with experienced operators and facilities. I think one of the sentinel features of this paper is the authors wanted to develop a new treatment algorithm on several different fronts that would help practitioners and facilities. And so what we set out to do is create this table and organize the table based on site of service and assessing both the patient's clinical and lesional risk characteristics, as well as reviewing what the operator experienced, both recent and accumulated, the experience and rescue capabilities of each of the sites and compare those and provide some guidance as to what facilities should be considering and what they should be thinking about as they set up services and experience and facilities and operate on certain types of lesions and patients. And so I just want to walk you through briefly on this. I think it helps to kind of frame our discussion. If you look at the four columns to the right on this table, it's divided first the freestanding facilities, the ASC and OBL on the left. And of course, there's no ICU or co-team or blood transfusion capabilities in these centers. All centers that we'll discuss here should have balloon pump capability for bailout situations and to support transport if needed. But you see to the right here, the hospitals are broken up into level one and level two that do not have surgery on site or cardiothoracic surgery and specifically on site. And so on a level one, we would have an experience that the guidelines suggesting less than 200 PCI, so a lower volume type of cath lab in this hospital setting. This hospital setting as a level one is not as well staffed. They don't have 24-hour service for anesthesia, radiology, vascular surgery and thoracic surgery support. Whereas the level two does have more equipment, staff, staffing resources that would support that, including, as you can see, rescue capabilities with PVAD or ECMO, as well as vascular and thoracic surgery capability. So dividing these two different hospital systems in this regard, whereas the far right, of course, we have cardiac surgery facilities with full capabilities on the experience side, the teams and the equipment support. As we jump down to the lower half of this table, we can see the suggestions for the lesional characteristics and also the equipment that might be used. And so with plaque modification devices in a freestanding facility at this time, a cutting balloon or IVL lithotripsy might be the safest way to go with this rather than coronary atherectomy at this time until more experience and data might be available to us in the future to certain subgroups like that. So there's a suggestion that in the freestanding facilities with OBLs and ASCs to avoid patients that might be at need for, of course, a high transfusion need or risk, calcified lesions, low AF, CTOs, unprotected left maze and degenerative vein grafts. Whereas these similar characteristics might be the same for a hospital that doesn't have surgery on site, the level one type of hospital, but of course they have transfusion capabilities. So that's kind of the differentiator there in terms of cases that might be included. The cases that could be considered for plaque modification in the level two no SOS hospitals might be rotational and orbital atherectomy along with IVL. However, he might want to consider avoiding the epicardial retrograde CTOs and high risk cases that such as a last remaining vessel or conduit. Those would be better served in the full cardiac surgery facilities. I want to finish up with this slide discussing the reimbursement differences. As we know there are differences in the payment for PCI based on the place of service and the type of insurance. And you see the table to the right here, we broken out the hospital outpatient department on the top two lines, both commercial and Medicare. We have the ASC, both Medicare and commercial, and then the OBL on the bottom two. And if you draw your attention to the payment differences, the Medicare allowable for an outpatient PCI in the hospital outpatient department is just over $10,000. Whereas the exact same procedure, the PCI in the ASC for a Medicare allowable is 40% less at just over $6,000. And of note is the copays to the patients are coincident with this as a percentage of that allowable. So the patients require responsibility for those payments less as well in ASC setting. So because of this, and this was actually a policy that occurred in 2020 when Medicare allowed coverage for PCI excluding high-risk subsets. Again, in 2020, they allowed for that payment that you see there. And we have seen because of that, there's a quite a bit of interest in the U.S. in migrating patients to this lower cost side of service. This was not an accident by Medicare. It was quite intentional. They stated this in their final rule. And the intent is to have quality for patients, but also at a much lower cost. And you can see there is a substantial difference. And due to this, we think there will be a significant continuation of migration away from the hospital toward ASCs around the country based on state requirements at this time. The Bain Group has done some analytics and from an ASC side, they have estimated that within a few years, they believe that nearly a third of the procedures done in the ASCs in the U.S. would be cardiovascular or in nature. So there's quite an interest in this on many levels. But of course, this paper really understands that and sets out to establish a framework and guidelines with some evidence base to date that will help us make really good and safe decisions for our patients. So with that, I'll turn it back over to Cindy to continue on with our discussion. Thank you for that outstanding overview. I want to open this up to the panel, but maybe start with Greg. Greg, you're a statesman. You've been working in this area for at least 18 years. Do you have any concerns about how this has been liberalized to allow lots of new procedures to be done in different settings? Well, Cindy, it's been a very interesting evolution. I mean, this started back in the year before actually I became SC&I president when actually a very credible guy came to the meeting and was starting a program in a rural area in Arizona, but felt a lot of headwinds because at the time doing PCI without on-site surgery was a class three, you know, you will do great harm from the guidelines, from the ACC, AHA guidelines. But, you know, we kind of decided, well, we'll take a fresh look at it. And in fact, when we did, we saw a lot of support for doing this mainly coming from overseas where individuals have been doing it for a long time with excellent safety records. So we went ahead and put this document together and published it just sky and sky alone. But, you know, that's how it got started. And then, you know, the next thing was really the wave that hit was the fact that PCI did seem to be the better therapy for patients with acute myocardial infarction. And one of the pivotal points was a paper by somebody named Grimes and Keeley that was published on looking at 23 studies that really kind of tipped the balance. And that led to a lot of the smaller hospitals saying, well, we want to provide the best possible care for our patients who are undergoing or are suffering a myocardial infarction. So that started. It was very difficult for hospitals to maintain good finances with just one, you know, just doing PCIs for acute MI. So that gradually started shifting into doing low-risk elective cases. And that led us up to about 2014 when the second sky document, this time in collaboration with the other societies, was published. And as Jeff has outlined, we've now continued to move this forward. You know, it's a completely logical and understandable extension to move into this area. I guess I do have a few concerns about it. I'm sure the individuals that have started doing this use nothing but the highest level of standards and quality in doing this. And that's what's been outlined in this document. But as things are released, as we all have learned along the way that when you have these large multi-center trials of a new drug, well, when the drug gets out there and everybody starts using it, the results seem to lose some of their luster. And so I think this, as this is outlined in the document, and again, I think it's a fantastic idea. There's very little literature to support this now, but we need to be collecting that information even though it seems like it's a very logical extension. Well, I think we all agree. I mean, Jeff is spearheading his registry, the cardiac registry for outpatient procedures. And Mamas, you are instrumental in many of these huge international registries. Why don't you tell us what you found in some of your studies? So, I mean, obviously the UK has a very different healthcare system from the US. And so PCI and non-surgical centers is the majority of PCI taken. So in the UK, in a population of 167 million patients, 74 out of the 118 centers that do PCI are non-surgical centers. We've really been doing this since around the year 2000, where we saw a big expansion in PCI services. Significant proportion or the majority of PCI undertaken in the UK is undertaken in non-surgical centers. We've looked at complex subgroups. So for example, the paper that you co-authored with us in around left main. So around 35% or one in three of all left main PCIs undertaken in the United Kingdom are undertaken in non-surgical centers. We show that paradoxically in non-surgical centers, people are more likely to use intravascular imaging, more likely to do complex cases and have very similar outcomes to the surgical centers. So there's no detriment in quality. Similar findings in arthrectomy, similar findings in primary PCI. I think the key though, as one of the other speakers mentioned, is data collection. So in the UK, it's mandatory. We have to collect data from every PCI that we do. It's transparent, it's reported nationally, both at the operator and the center level. I think that's very much what I would encourage US to do as we push the boundaries in the sorts of cases that we do in non-surgical centers. Yeah, I think Sky and ACC American Heart absolutely agree with the necessity to participate in a registry to capture some of this data. Now, Ted Schreiber, you are ultimate high volume operator, chip operator. You do a lot of high-risk complex and Pella-assisted angioplasties. And then your hospital all of a sudden consolidated and that's happening all across the US. There's consolidation of services. And then all of a sudden they're moving the surgeons into one center. Well, what does that leave with the rest of the hospitals that were doing high volume? Maybe you could tell us about your experience with that, Ted. Sure. So Cindy, I came to Michigan in 1988 to learn coronary angioplasty and have stayed in the state performing relatively high volumes of angioplasty for the last 32, 34 years. In the last three years, with particularly of the advent of COVID, the cardiac surgery volume, which was already decreasing by half from the turn of the century, went down even further. And several hospitals, including the one that I practice at, asked the question, does it make clinical and economic sense to maintain an open heart surgery program just so that we can have full angioplasty service to our patients? And the administration and I as a medical administrator made a decision that didn't make sense. The state of Michigan, however, is highly regulated, as you know, and what sort of procedures you can do at which hospital are very dependent on the 2014 consensus statement that Greg coauthored with you and others. So initially with COVID, the state didn't ask us too many questions and we didn't really restrict the nature of cases that we are doing. But about a year and a half ago with COVID on the way, the state got tougher and asked hospitals, what are you doing? And we decided we better not to do anything that's not in the 2014 consensus statement. So the types of cases overall without accounting for growth went down by about 15%. And the patients either were transferred or were readmitted to St. John's Detroit Hospital, which is the parent tertiary care hospital, or didn't have the cases done or went elsewhere. So this made a real impact. And this is a real question that the hospitals are asking the state of Michigan, over a third of the hospitals are not performing 150 bypasses a year, and more than half are not performing 300 bypasses on open hearts, which is the actual statutory requirement. My hospital was the first one to decide that doesn't make sense. But the bigger question then is, how is it for our population, which tends to be elderly, poor and underserved? Do we just tell them go somewhere else or what? And we're very welcoming of the new consensus statement that we're publishing. Thank you. Yeah, and I think that some of this data that Mamas and others have put out just shows that high volume operators such as yourself should be able to do excellent work without the surgeons being there. In fact, working at a tertiary care center, we never check to see if the surgeon's in the hospital. We just go about our business, and it's extremely rare to need open heart surgery. In fact, Jeff, I don't know whether you mentioned, did you mention the rate in many of these trials is like 0.1%, so very, very low rates of surgery. I remember back in the day when we started my career doing interventional procedures, the rate was like four to 6%, right? And they had an operating room available at all times. Right. Yeah. You bring up a good point, Cindy, because even in some of the larger institutions, and I came from one, it could be a significant delay to get somebody directly from the cath lab to the operating room in the hospital. So in this paper, we discussed having about a 30-minute transport time capability to get to definitive care, but a lot of times the OR is taken up anyway in a facility. So the time distance factor is always an issue for a remote site. Yeah, I think that we decided in our document not to have absolute time restrictions, because you're right. I mean, many of these studies showed that in-hospital referral to the OR took almost two hours, the median time. And so I think what we decided is that these hospitals that are gonna be doing more complex procedures, they really need the state-of-the-art, you need to have covered stents that can track easily, not the old versions that require you to change out the guide and things. So not to mention any brand names, but it needs to have, we really need to have all the balloons and stents and bailout procedures readily available. Well, we found in our experience of over 15 years of doing PCI in an OBL setting, and it's not in all states, it's really state-specific whether or not you can perform PCI. A lot of it's based on CON, but we found that sometimes it goes so routine and so well so often that our very experienced staff, we choose those staff members to be part of our OBL-AC, they can even become complacent. So we have mock drills mandated all the time, quarterly or biannually, and we go through step-by-step to make sure all the emergency, from the phone calls to the products on the shelf, to the ambulance, all that communication. And we go through from start to finish for a mock emergency, should it ever be needed. Right. I guess the other issue is that with introduction or more widespread use of vascular imaging, I think we're doing procedures much more safely. I mean, for calcific lesions, we have different options now. We're seeing a lot less perforations because we're managing the calcium much more appropriately. And certainly in the UK, I would say it's very few centers, if at all, that don't have access to such technologies these days. Well, and I think that one of the criticisms of the 2014 document was if you were doing a PCI at a hospital without surgical backup, you really were told not to use atherectomy. And so they felt like if they would have the failed angioplasty, and they would try to balloon more and more and more, and they thought that it was more risky to the patient compared to if they could have just pulled an atherectomy device off the shelves. And so that was another reason we wanted to expand this a little bit. Cindy, the reality of the situation, for example, at my hospital, the last time someone went to open-heart surgery was 2015, with probably about 9,000 to 10,000 intercurrent coronary interventions since then until now. And if you think about who in the old days when we all started, if there was acute closure in the cath lab, there was a balloon pump, and we went to the OR doing CPR. If that happens now, we can, A, bail out, B, put the patient on circulatory support. And in any event, the ORs are either closed because they were being used or the surgeons not on site. So the reality of the situation is thanks to technology and experience, we've become by necessity very experienced at bailing ourselves. And it's a very rare case that has to go to the OR these days. Right. Well, that brings up another point that when we're talking about expanding the complexity of cases in many of these centers, we're talking about very experienced operators doing it. So if you're just finishing your fellowship, that absolutely should not be what you're going to, the type of cases you're going to do. And then the less backup, you should actually be even more experienced. And Jeff, I mean, you can speak to this. I mean, you have multiple decades behind you and Ted, you as well. And so, you know, I don't want the viewers to think that we're saying that any interventional cardiologists can do these type of procedures because that is not the case at all. These are high volume, very experienced operators with good support teams in their cath labs. Yeah, that's an excellent point, Cindy. I have, there are 10 operators in my single specialty practice, and we brought in two younger physicians during the course of our 15 years. And we mentored them. We wouldn't allow them to do PCI very early on till we knew their experience in the hospital. We have two major hospitals, you know, that we operate out of or work out of. And so we needed to see their experience. They needed to have some track record, not just what their fellowship director signed off on. And we also assigned mentorship and then had case reviews very early on. And certainly any, we really created an environment of open communication so that they didn't feel alone. And, you know, we're here, I say we're all kind of senior on this panel here. So we may not be as close to that as when you come out and you look around the table and you don't see the experience at least nearby that can be concerning or disconcerting, depending on, you know, the experience and level of the fellow. But regardless of how good you are as a fellow, there's nothing to substitute for going through emergencies and bailing yourself out. As we all know, you gain so much experience for that and confidence, and that just needs time. And you need to have those experiences. This paper was not trying to be proscriptive in preventing that to happen, but really highlighting the importance of that, of that mentorship and of proven track record to your point, Cindy. You know, do straightforward cases early on, get experience and have mentorship. One thing that perhaps hasn't been touched on yet is any unintended consequences. And I couldn't help but think of that looking at one of Jeff's slides about the different classifications, because we've heard our cardiac surgeons complain about this from the first angioplasty that was done, that we're kind of siphoning off all the ideal cases and doing PCI on that and leaving the, you know, kind of the terrible cases for surgery. And now what we've seen is we're going to siphon off a lot of these very low risk cases for OPLs and ASCs, and that's going to put higher risk cases on the remaining laboratories, which, you know, competent and very skilled operators should be able to handle, but there will be a shift, just like there will be, I mean, this is a disruptive technology in terms of what the hospitals are going to see in terms of their finances. So these are all, that is not being in any way, shape or form that we shouldn't move forward to do this. We should, but all those things need to be watched as this whole area evolves a little bit farther. Well, that's a really interesting point, Greg. I really appreciate that. I hadn't really thought of it in that way until now until you said it. I do echo what Cindy has said earlier too about, and Ted, you did, about measuring outcomes in MAMAs, measuring outcomes in transparency. And I think Cindy alluded to one of the efforts that we have underway now is the OEIS, the Outpatient Endovascular and Interventional Society National Registry. And we have a panel of experts guiding the formation of this cardiac registry. And it's in development now. We expect it to be launched in 2023. And we hope that everyone performing in all sites of service is at same day discharge. That's really the focus of the cardiac module, the PCI portion of the cardiac module is to really identify and assess what's happening in a same day discharge setting, whether it be the hospital outpatient department, ASCOBL, all that can be put into this registry. So we'll have data and be able to track hopefully on a broader national scale as they're a movement and as there's opportunities even to advance further the complexities of these cases in a safe manner. Excellent. Well, I thank all of you for joining tonight and helping in the publishing of this amazing paper. And Greg, thank you so much for your outstanding editorial. Well, you're quite welcome.

SKY Expert Consensus Statement

PCI without Surgical Backup

January 2023

panel of experts

evolution of PCI without surgical backup

data collection and registries

patient safety