Great. Thank you, Dawn. Take it off. Okay. Thank you, Cindy and Arnold. My task is to go over the data, and this data is going to span from right before the previous document to 2022. Arnold already underwent some of the key takeaways, and so did Cindy in terms of the rates of emergency surgery. But I want to highlight that there have been several new studies both in the US and abroad that have demonstrated excellent outcomes and low complication rates in more complex lesion subsets. I think most of you are aware of the landmark Seaport elective trial, which took place about a decade ago. It was 18,000 patients randomized to have PCI at hospital with surgery on-site versus one without. There were actually very few exclusion criteria at the time. Unprotected left main, severely low ejection fraction, or planned atherectomy for a de novo lesion. Those were really the only exclusion. There were 60 centers, so it was quite generalizable. The average PCI volume was only 150 PCIs a year at these centers. The randomization was three-to-one surgery, no surgery on-site to surgery on-site. It was quite a large trial. Unequivocally, the outcomes were similar in terms of death, were about one percent at both types of centers and emergency cabbage, as mentioned before, extremely low, and lowest in hospitals without surgery on-site at 0.1 percent versus 0.2 percent in those with surgery. After that, there were a series of randomized trials and several registries. In 2015, this meta-analysis was performed of 23 studies. Four of these were randomized, 19 were registry studies. You can see this is over 133,000 patients. I think we'd be able to see a signal if anything was going on. All-cause mortality and emergency bypass were similar in the sites, and the trends, as always, showed actually lower or trends towards lower emergency bypass when you are operating at a surgery without site center without an increase in mortality, which is extremely reassuring. This was seen both in PCI for acute MI and also non-primary PCI, which was the bulk of the patients done at this time. The pooled effect was, again, no different. There are more contemporary studies that have been taking place between 2015 and 2021 from countries all around the world. There was an ACS registry in Japan. There was the national inpatient sample from the United States, which is an administrative dataset. There's very comprehensive data from Michigan in both the primary PCI and non-primary PCI population, and also in New York. There are several states we know that have very extensive PCI registries, as well as these administrative databases, and none of these were able to document any difference in the outcomes. It didn't matter which population we were looking at, whether this is STEMI, NSTEMI, or elective patients. Interesting trends did emerge in terms of the likelihood of undergoing PCI at a center without surgery on-site. Over the time period of these studies, which often ranged from about 6-10 years, there was three to sevenfold increase in the number of cases done in these centers. I think that's, again, a trend we did see based on the great outcomes that we were observing in PCI. What about outside the United States? The United Kingdom in particular, we have MAMAS on our writing group, and we had an inside look at what's going on at the UK, as well as they have a very good registry, BCIS. They actually have no formal criteria to exclude PCI at sites without surgery. The majority of PCI in the country is actually done at sites without surgery. Sixty-three percent of all PCIs in the UK are done without surgery, and up to 40 percent of left-main cases, and those using some form of circulatory support are undertaken at these centers. When adjustments were made for baseline variables, no differences could be discerned in performing these at different centers. That's extremely reassuring. More recently, in 2020, there were two publications focusing specifically on the subset of left-main, one of them from Australia and one from the UK, both detailed, well-validated registries. In Australia, about 19 percent of unprotected left-mains were undertaken at sites without surgery, and there was no relationship with mortality, both in hospital and 30-day. In the UK, as we spoke, again, pretty contemporary here up to 2020, almost 40 percent of left-main PCIs are done with surgery off-site. These are very reassuring. What about other complex lesion subsets that we've been concerned about over the years, having higher complication rates in general? Here's two publications from the last year. One is with atherectomy. Basically, it's a small series, but reporting very, very good outcomes with very low in-hospital MACE and low coronary perforation and no reflow rates, as well as another very small series of CTOs that just shows that, independent of the technique with very skilled operators and the right resources on hand, that mortality rate can be kept at a very low level. Although we're not necessarily advocating to perform the most complex lesions at sites without surgery, in certain of the centers that have facilities to rescue patients undergoing these types of complex procedures, it may certainly be reasonable. Just to summarize, over the past decade, there have been over hundreds of thousands of patients in these trials, both observational and randomized, emerging data on what we traditionally considered more high-risk lesion subsets, showing that we can perform PCI safely without surgery on-site. I cannot underestimate the importance of PCI volume, operator experience, and lab experience, and the ability to get these types of outcomes and to rescue patients that have complications. But these are all data the committee used to make the current recommendations. Thank you. Thank you, Dawn, for that review. It's reassuring that we haven't seen any data that shows there's harm, and it's always been the fear of something that sometimes holds us back, and it's often our leading centers who push the envelope. I make the note that sometimes the guidelines have to catch up with what is already happening. We see that with same-day surgery guidelines as well, that we've really just adjusted to what people are already doing.

percutaneous coronary intervention

on-site surgery

Seaport elective trial

outcomes

complications