Hello and welcome to the ACC Quality Summit. Today our team from the Ohio State Wexner Medical Center will be discussing how we reduce the risk of bleeding in PCI patients. Ohio State is recognized as one of the top 25 hospitals in the U.S. in cardiovascular quality. We are consistently recognized as one of America's best hospitals by the U.S. News and World Report. Now let me tell you a little bit about Ohio State. We are a world-class public research university with 59,000 undergraduate, graduate, and professional students, 34,000 full-time employees, one of the largest and most diverse academic medical centers in the country, and the only academic medical center in Central Ohio, with the Midwest highest-ranked hospital for safety and patient care. Our seven hospitals and our network of community-based offices and caregivers manage more than 1.7 million patient visits every year. The University Hospital has about 900 beds and the Ross Hart Hospital has 150 beds, as well as Ohio State East with 190 beds. We have eight cath labs. We are a high-volume center with nine interventional cardiologists and a very active fellowship program. Let me introduce our team here today of interventional cardiology operations and quality. We have Dr. Dean Bedolos, who is the medical director for the Maine Heart Hospital. We have Dr. Attar, who is the medical director for the East Hospital, Eric Ballinger, director of the cath lab, Daniel Blaze, who is a PharmD with a specialty in cardiology. We have both managers for each of the cath labs, and from quality and patient safety, we have three project or program managers. My name is Dean Bedolos. I'm an interventional cardiologist and a cath lab director at the Ohio State University. Well, several years back, we noticed that we had an increase in bleeding complications when we were doing our NCR bleeding metrics, so we knew we needed to do something. Well, we developed several strategies, and the first thing we did was we tried to convince our physicians to change from a femoral to a radial-first lab. So, how did we do that? Well, first is we showed the data. We showed objective data that showed that radial approach decreased the risk of bleeding, which may result in better outcomes. In addition, we had to get a commitment from the group that we were going to work together. We knew there was going to be a learning curve, but we were going to work together to make the radial-first approach a standard in our laboratories. One thing that we did that helped was every month, we would show the physicians and the percentage of radial access and result in a little bit of competition to help push us along. In addition, we shared patient satisfaction scores that really showed that they preferred the radial approach. Another strategy is we started utilizing the SDR bleeding risk calculator, and in addition, we developed several protocols to help reduce bleeding. One was we standardized our heparin dosing for PCI. We developed algorithms for when to transfuse appropriately, and we developed sheath pooling algorithms for not only our order sets, but developed a dedicated sheath pooling team. This is an example that I was talking about regarding physician reporting with radial access by operator. You can see the target goal was 70%. You can see all the various operators, A through K, and it shows you where you stood among your peers and really was a motivator to try to get to that target. Several of the strategies that I mentioned in the last previous slides came from a bleeding and vascular complication reduction task force that was developed in 2013. You can see several of the missions of the task force listed on this slide. The task force was well-rounded. It had physicians, it had nursing, it had pharmacists, it had quality members, and it is important to get the perspective and the input from all team members to analyze the complication and to come up with action plans how to reduce the reoccurrence. Another strategy that I did not mention is the immediate review of a complication the day of and providing feedback to the proceduralist who performed the procedure that results in a complication. So immediate feedback and hopefully this led to the understanding of why the complication occurred and perhaps how to avoid it in the future. Thank you, Dr. Medoulis. My name is Danielle Blake. I'm the pharmacist who works at the CADLEB Equality Team on the Bleeding Reduction Initiatives. The initiative dates back to 2011 when our CADLEB started to build our radial program. In 2013, there were a couple of important points we realized as we started to focus on our patients who had a bleeding event. First, as the number of radial cases increased, the number of femoral cases would go down. This means the nursing staff that was pulling the sheaths would take care of less patients with femoral sheaths as time progressed. So we needed to have a standardized process for pulling sheaths including an order set and process for training the nurses who would be pulling these sheaths. We also noticed there were patients who were being transfused but did not have any documented site of bleeding. This led us to standardize our thresholds for bleeding as well as making sure the interns and residents contacted the attending physician if a patient was hemodynamically stable before transfusing the patient. In 2014, we realized the physician's perceptions of who was at low, moderate, or high risk for bleeding varied. So we started to use the bleeding risk calculator for each case. This calculator gave us an objective way to identify who may be at high risk for bleeding. This also helped us to enforce using the radial first approach in those patients who are at high risk for bleeding. When we implemented the bleeding risk calculator and the radial first approach, we recognized an opportunity to standardize the use of bivalorudin. At the time, we were using bivalorudin in 80 to 90% of our patients and it was much more costly than it is now. But by knowing the bleeding risk of our patients and that we could use radial access, the physicians felt more comfortable with not using bivalorudin in all patients and in only in those who would benefit most. In 2016, we started using ticagrelor as our preferred P2Y12 inhibitor. One of the advantages to using ticagrelor is that it has a quick onset of platelet inhibition and a higher degree of platelet inhibition than clopidogrel, which was our workforce up to this point. Once we started using more ticagrelor, the physicians felt comfortable cutting back on the use of glycoprotein 2B3 inhibitors, especially in those patients that were at high bleeding risk unless they were inadequately loaded with a P2Y12 inhibitor or they had a lot of clopidogrel. As we used less bivalorudin and more heparin, we recognized there was a lot of variability in the initial heparin dosing, when and how often ACTs were checked, and the repeat heparin dosing. So we developed a heparin dosing protocol. In 2017, our ACPR program also started, which did have an impact in our bleeding rates, and Patty will discuss that further later on in the presentation. In 2018, we further revised our heparin protocol to include checking an ACT at baseline for those patients who arrived to a lab and have already received an anticoagulant, especially heparin. This allowed for us to adjust our initial dose, decreasing the chance of having a high ACT. The ACC definition of bleeding changed, which did have an impact on the number of patients who had a bleeding event. Our quality team identified we could do a better job at documenting comorbid conditions for our patients to further address our observed to expected numbers, not only for bleeding, but for mortality also. Last, we joined the ACC bleeding campaign to not only learn from others, but share what we have learned throughout the past nine, almost ten years. This is our heparin dosing protocol. It is put on a laminated poster in all the cath labs, so as the physicians, nurses, and cath lab staff who are performing their cases, they can quickly review and refer to it to see how much heparin to get. As previously noted, we revised our initial protocol to encourage checking a baseline ACT in patients who are anticoagulated. We have dosing for patients who are on a glycoprotein 2B3 inhibitor or who have received a thrombolytic to include a lower dose of heparin as the ACT goal is lower for these patients to minimize their bleeding risk. We also have a dosing strategy for those patients who have not received those agents. The bottom of the chart also tells the staff how frequently to check ACTs. The pre-cath nurses have a pre-procedure process they work through prior to the patient arriving to the cath lab. This includes looking at what antiplatelet and anticoagulants they have already received. They also calculate the bleeding risk of the patient and whether they are at low, moderate, or high risk for bleeding. They calculate the patient's creatinine clearance, contrast risk, contrast threshold, and contrast timeout. The creatinine clearance is important for the staff to have to make adjustments for medications like bivalorudin. If the dose is not adjusted for a reduced creatinine clearance, this can put the patient at increased risk for bleeding. At the start of the case, the pre-cath nurses, cath lab staff, and physicians pause and review the safety checklist. This includes what antiplatelets, including aspirin and P2Y12 inhibitor, and anticoagulants the patient received prior to arriving to the cath lab. They will also discuss the bleeding risk of the patient. Once all of this information is reviewed, the physician will discuss whether they will use radial first approach or whether they have to use femoral approach. At the end of the case, a debrief is performed. This reviews the access site that was used, was it a high stick if it was femoral, and ensures the correct orders are placed using the order set so the nursing staff accepting the patient know if the patient had a femoral, cath, if a closure device was used, or if they need to pull the sheath, how often the vascular site needs to be checked, and how long the patient is on bed rest. The debrief also includes a reminder to discuss post-procedure anticoagulation and when to restart it. The development of all these tools, including the pre-cath assessment using the bleeding risk calculator, heparin dosing protocol, safety checklist at the beginning and the end of the case, has evolved over the years as we review our bleeding event rates as a group and try to get them as low as possible. I'd like to take a few minutes to talk to you about one of our innovative programs we started a couple years ago. This is the Extracorporeal Cardiopulmonary Resuscitation, or ECPR, program. So, what is it? This program targets out-of-the-hospital cardiac arrest patients due to pulseless ventricular tachycardia and fibrillation, and or fibrillation. It's in collaboration with the Columbus Fire Department, where they bring all eligible refractory VT-VFib patients to the Ohio State Medical Center, bypassing any other local hospital. The patients are taken by EMS directly to the cath lab and placed on Extracorporeal Membrane Oxygenation, or ECMO, with a potential for PCI. We started this program back in 2017, and we've been monitoring this data for quite some time. So, how does it impact our ACC and CDR risk-adjusted or standardized risk metrics? The patients actually risk-adjust very well for mortality, but the acute kidney injury and the standardized risk bleeding metric are impacted somewhat in this population, primarily because they are a very shocky patient, and secondly because ECPR in and of itself is required to have packed red blood cells. So, it doesn't always mean the patient is bleeding, but of course if you get blood after the procedure in a certain time frame, of course that's counted in the data registry. This is an example of our check-off list that we use when the patient comes directly to the cath lab. So, there's several things that the cardiologist or cardiothoracic surgeon are required to check to make sure we've done prior to the procedure, and then there's things that I actually put out of here to highlight that the perfusionist is responsible for, and one of those things, as you can see, is the transfusion of blood products. So, as I said earlier, we've been monitoring this for a little bit of time, and when we look at the risk standardized bleeding, if we just simply look at an observed and a predicted ratio for bleeding for those patients in the registry, we can see that there was 43 patients with an O to E ratio of 1.18, but if we remove three of those during that time frame, three of them that had ECPR, the O to E ratio falls to 1.11. So, it's not perfect yet, but it definitely does impact that metric. If you would like to find out more about our program, it's been published. The ECPR outcomes was published in the Journal of Interventional Cardiology, and you can see that Dr. Dean Bedoulis was lead author. So, let's take some time to look at the data and talk about our actual outcomes. As Dr. Bedoulis discussed earlier, we started a strategy where we were changing from radial to femorals, and so this slide actually shows you a period of time from 2011 all the way to 2019. Our goal, if you remember, was to try to do radials about 70% of the time, and so the red bars would be femoral, the blue are the radial approach. So, you can see a nice upward trend with the radial approach. When we look at this slide, where we're looking at whether or not the patient's got red blood cells or transfusions, excluding any patient who might have had a cabbage, what the bars show is the increased use of radial approach, and of course, the trend line shows you the reduction in red blood cell transfusions for two reasons. One, we did put a protocol into place where we were pretty stringent on when a patient can actually get a transfusion, and of course, secondly, we were using the radial approach. So, we think both of those things actually had a nice impact. What this slide shows is whether or not we're moving in the right direction. So, this is a slide over time, and you can see that we had some issues in bleeding back in 2013, 14, 15, but once we started to put some of our strategies into place, it dropped considerably. And then in 17, as you remember, about halfway through, we started our eCPR program. So, in 2018 and 19, we bumped up just a little bit in that, which we think might have been contributed to that program, but we obviously are moving in the right direction. If we had a trend line there, the trend line would be going down. So, in conclusion, you really do need a multidisciplinary team that's required for your initiatives. We incorporated several strategies so that we could reduce the incidence of bleeding. We've been actively involved with the ACC NCDR initiative to reduce bleeding in PCI patients, which we believe contributed to our overall processes of care. This also allowed us to share best practices and to learn from others as well. We used the data and set goals from the registry. These goals are discussed at our mortality and morbidity conferences, as well as our leadership quality conferences. However, as you know, just like with the eCPR program, we are going to utilize any strategy necessary to save a life. We just need to understand the data so that when our leadership asks us about this metric, we can speak to it. We can speak to why. It is one of the anthem metrics, and so you gain points or lose points depending on your bleeding, and so we just need to make sure that everybody's on the same page and they understand what the data is actually saying. So we really hope you enjoyed this presentation today, and hopefully the information that we shared is valuable to you. And if we were in a live conference, this would be the part of the conference where we would take questions and answers. So we hope that you have a great day. Thank you.

ACC Quality Summit

risk of bleeding

PCI patients

radial-first approach

multidisciplinary team