Lyndon, I might go back to you. I'm sorry to have taken it away for a second. You know, many questions have come up about local state regulatory issues. I know in California they, you know, they're not allowing PCI and ASCs at all. As a chair of government relations, you know, what is your picture of the country and how do we make change within our local institutions and our states? Will this document help? Definitely. So, the state, I was going to dive in and just repeat what Jeff said, which is, yes, the state actually decides whether or not you have to have any extra certification, if you are allowed to do cases or not, for that matter. I mean, it's still not allowed in every state in the union by any stretch. So, what we've done in SC&I government relations, we have actually gotten involved at the state level and have had some success actually within Pennsylvania. We've been involved in legal fights in Alabama. We've been involved in discussions in Mississippi. So, we have been very engaged in this whole process around whether or not it's possible to do PCI and ASC and then also what restrictions are involved. One of the actual questions in the chat that I'm going to add to the government relations agenda was the issue of not being able to do atherectomy in Florida. For instance, without having surgery on site. We had a lot of discussion about that as we were preparing that section of the paper. I think the consensus opinion was that you probably were increasing risk by not allowing atherectomy more than you were decreasing risk. So, again, that's something that I think is government relations in SC&I that we can try to get engaged at the state level. So, increasingly, yes, we are getting engaged at that level. But importantly, I'm assuming there's a lot of people that are watching this that are either already doing PCI without surgical backup or, as I mentioned, are thinking about the ASC space. I cannot emphasize enough that it's important you have to look at your state legislation, I mean your state regulations, because it varies broadly. Great. In the last few minutes, I'd like to go backward a second and see how did we get here? To what extent has new technologies enabled us to do PCI safer, along with transradial access? What about the MPELA PVAD? What about Shockwave? We just saw an email blast from Shockwave saying that IVL has been approved by SC&I, this document, to say that it's approved in all centers, including OVLs. So, I'd like to go down with each of you and say, you know, this is obviously practice of PCI has changed. And so, starting with Cindy, perhaps we can talk about, you know, what do you think is the biggest change that's happened, technology or technique? Oh gosh, you know, I'm going to date myself by saying that actually stenting is a big deal. When we were doing balloon angioplasty, I can't tell you how bad it was. We'd stand in the cath lab with a dissection for 30-45 minutes trying to tack up that dissection. You'd go home at 11 o'clock at night knowing you're going to get called back in with abrupt closure. So, in my lifetime, I think development of stents have made a huge difference. Great. Dawn, you're chair of NCBI right now. Am I the next oldest? Well, no, I think it's been iterative. Certainly, the radial wave really helped. And then, same-day discharge at centers with surgery on site was a tremendous breakthrough because we recognized if we're not even keeping them overnight at surgery sites, that's applicable to anywhere you're going to practice. So, I do see that, you know, a lot has evolved in the 20 years I've been here. And some of it is technology and lower complications and lower profile devices. And some of it is just that we are confident. We're confident of our results and we can show the data. And we've been collecting it as a field from the beginning. And I think that's unlike other fields. And we can really back up what we're saying with data, which helps us move forward. I just compliment what Dawn said, Arnold. I really like what you said, Dawn, about doing it in the hospital. And I've been doing this for 14-15 years now in the OBL and same-day setting. But for those that are new, younger operators, or even in the hospital where you have the comfort of the hospital and you're thinking or moving out to do this, get your experience in the hospital. It's a great venue. Discharge your patients if you're not already doing it. I know most operators already are, but start shifting that. But I will also say I'm sometimes afraid my own hospital because they don't have the follow-ups that I have in my OBL ASC. You know, we don't have staff to call the patient, you know, automatically and all that. So, make sure all those safety mechanisms are in play. Adir, final comments? We've been doing this for, you know, I've been doing it for 18 years now at the VA. And I think case selection is really helpful. You can sort of figure out who's going to be a problem and then try to not do those cases if you anticipate the risk of, you know, needing surgical backup is high. I think just having that experience, having great partners that you can, you know, talk about cases with, I think that has been probably the most important thing, is we were doing this before we had radial. We were doing it back in the femoral days in 2005 and 6 and 7, and we still were able to do it. I think the anticoagulation got better. You know, we got away from 2B3A, so the bleeding was a little bit less. Smaller sheets, better stents, imaging, I would say all the same things that have led to same-day discharges really made the same kind of movement for this no surgery on site. Yeah, and I'd like to agree with what Adir said about bouncing ideas off your colleagues. I think being in a larger setting, that's the most important thing in my opinion. I mean, you can stack any cath lab with stents and balloon pumps and impellas, right? But what you're missing is the person working in the lab right next door to you. If you have a complication, they can come in and help you. If you have a question, you can show them the films and get their opinion. And that's one thing that might be missing in some of these smaller hospitals or the ASCs. Yeah, but we have no penalty to transfer. We just transfer to ourselves at the university side. So I could see if you were having to transfer to another group and give that intervention away, how there might be some conflict for you. But it's nice that our group will just text each other and say, what do you think about this? And then Mladen's usually the one that says, nope, we should probably do that with surgery and backup. And then we'll send them over to the other site to do. Right. So just FaceTime with a video monitor. Yeah. We're going to Mladen next, but definitely highlighting what we need from an ASC environment when you're alone. You don't want to go into these environments alone. You need at least three years experience. We want someone there who has already gone through the hospital environment and has gone through these discussions with his colleagues before they embark on such an endeavor. Mladen, final comments or observations? My final comment is what I tell the fellows that good technique will not save you from a bad judgment and good judgment will save you from a bad technique. So I think that's what Dawn showed in her slides. We've learned a lot. I think the assessment has gotten better. But the other thing is I would also say those bad outcomes that Cindy showed, that was with actually simpler lesions. So think about these are actually type A lesions that did that poorly. And we do so well with way worse lesions. So again, it's been remarkable. I have to say that. Lyndon, and then Ted, and then so on. So one of the things I just want to say about the document, because this is actually a response to some of the questions here, Twitter things that I got. So this document in a number of areas, such as the lesion selection, patient selection, operator requirements, was less concrete in its recommendations. And that was done because of, I think, in the past, unintended consequences of documents that we've issued where we came out and said, you know, thou shalt do A, B, C, D. So I think there's a lot more flexibility in this document, but there was a huge emphasis on, you know, realizing your responsibility as the interventionalist and realizing the setting that you're in, you know, to Aladdin's comments about the judgment. You know, there's not going to be something that is not cookie cutter, and it's not going to be the same set of rules, depending on the operator, the years of experience, the location. So really just emphasizing the importance of the judgment and the physician's role in this. Number, and I don't want to bring up new topics necessarily, but we talked about informed consent briefly. I think that's an important thing to be thinking about as you're taking care of these patients. I came from a CV backup lab to a non-CV backup lab. I mentioned it to every patient that we don't have it on site, but we have a partnership and a transfer. And I've never had one patient say otherwise that they have any concerns there. So it's, I think it's becoming more mainstream, but I think it's still important to tell patients. And the other thing is just because we have PCI and a non-surgical backup lab, doesn't mean that we shouldn't be thinking about a heart team approach on the appropriate patient. So having that collaboration, if you can get that, it would be very important as well. Great point. Thank you. It's in all of our guidelines, the heart team. Ted, final word. I think in looking at the last three or four decades, the way in and the way out are key issues to guarantee patient safety. And I have no doubt looking at my experience, the ability to bail ourselves out with circulatory support equipment that's now available by multiple routes really gives us an enhanced safety in approaching the various cases that can now be done at institutions without surgery on site. When we all started, the bailout was bailout cardiac surgery. The bailout now is a combination of your experience, your equipment, circulatory support, and cardiac surgery. Thank you. Yeah, exactly. I think the concept really is that the bailout really is us. The first line, even if you have a surgery on site, is you need to be able to rescue that patient first. Because even in a surgery center, you're not going to get to surgery for two hours. So thank you again for all of your attention and all of your leadership. We're going to hand it off to Cindy for final words, because she started this document. And thank you for bringing us all together. Thank you so much for chairing this, Arnold. You did an amazing job. And I can tell you there's been incredible interest. There are huge numbers of attendees on this. And there's lots of requests for our slides. So I think we're going to try to compile our slides and make them available to all the attendees. And we obviously didn't get around to answering all the numerous questions that have been asked. But I'm sure there'll be subsequent conferences. And hopefully, we can keep in touch with people on this very, very important topic.

PCI

ASCs

state legislation

stenting

interventional cardiology