Roundtable Discussion on ACC/AHA/SCAI Guidelines on Coronary Revascularization Discussion

Dr. Nahush A. Mokadam (Columbus, OH): Hello from AATS 2022! We're all delighted to be here and it's great to reconnect with colleagues and friends that we've not been able to see in some time. I'm Nahush Mokadam. I'm the Division Director of Cardiac Surgery at The Ohio State University and the Co-editor of cardiac surgery for the Seminars in Thoracic and Cardiovascular Surgery. Today, we're planning to discuss the recent American College of Cardiology (ACC)/American Heart Association (AHA)/Society for Cardiovascular Angiography and Interventions (SCAI) Guidelines for Coronary Revascularization.1Lawton J.S. Tamis-Holland J.E. Bangalore S. et al.2021 ACC/AHA/SCAI guideline for coronary artery revascularization.J Am Coll Cardiol. 2021; https://doi.org/10.1016/j.jacc.2021.09.006Crossref Scopus (312) Google Scholar As many of you know, this has generated a great deal of controversy in our specialty here in North America and abroad. We believe it's important for our members to understand the process behind how guidelines are written, how endorsements are made, and get some insights into the process and outcomes that we've seen as a result. In the description of this video, you'll see links to the guidelines, the executive summary, as well the editorial and the webinar that's been published.1Lawton J.S. Tamis-Holland J.E. Bangalore S. et al.2021 ACC/AHA/SCAI guideline for coronary artery revascularization.J Am Coll Cardiol. 2021; https://doi.org/10.1016/j.jacc.2021.09.006Crossref Scopus (312) Google Scholar, 2Lawton J.S Tamis-Holland J.E. Bangalore S. et al.2021 ACC/AHA/SCAI guideline for coronary artery revascularization: Executive summary: A report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.Circulation. 2022; 145https://doi.org/10.1161/cir.0000000000001039Crossref Google Scholar, 3Sabik J.F. Bakaeen F.G. Ruel M. et al.The American Association for thoracic surgery and society of thoracic surgeons reasoning for not endorsing the 2021 ACC/AHA/SCAI coronary revascularization guidelines.J Thorac Cardiovasc Surg. 2021; https://doi.org/10.1016/j.jtcvs.2021.12.025Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar, 4Coronary Revascularization Guideline: Why STS and AATS Did Not Endorse | STS. www.sts.org. Available at: https://www.sts.org/meetings/calendar-of-events/coronary-revascularization-guideline-why-sts-and-aats-did-not-endorse. Accessed July 20, 2022.Google Scholar We're lucky today to have with us 4 experts on coronary revascularization. Representing the group that crafted the guidelines, Dr. Lawton from Johns Hopkins University and Dr. Sellke from Brown University and representing the group that wrote the counterpoint are Dr. Sabik from University Hospitals in Cleveland, and Dr. Girardi from Weill Cornell Medicine. I'll have questions for all 4 of our panelists today, and I'm going to start with Dr. Lawton. Dr. Lawton, can you please educate us on how guidelines committees are formed, how members are selected, and go through the overall process on how guidelines are made? Dr Jennifer Lawton (Baltimore, MD): Thank you so much. I'd be happy to go over that process with you. It's a somewhat complicated process. The guideline is intended to improve the quality of care of patients with patients' interests in mind, and so it is written in a patient-centered approach. It's intended to define practices that meet the needs of our patients in most, but not all, circumstances and should not replace clinical judgment. It's meant to be a consolidation of previous guidelines, 2011 Coronary Artery Bypass Graft (CABG) guideline, 2011 Percutaneous Coronary Intervention (PCI) guideline, 2013 ST-elevation myocardial infarction (STEMI) guideline, the 2015 update on the STEMI guideline, the 2014 non-ST elevation acute coronary syndrome guideline, and the 2012 stable ischemic heart disease guideline.5Hillis L.D. Smith P.K. Anderson J.L. et al.2011 ACCF/AHA guideline for coronary artery bypass graft surgery: Executive Summary.Circulation. 2011; 124: 2610-2642https://doi.org/10.1161/cir.0b013e31823b5feeCrossref PubMed Scopus (0) Google Scholar, 6Levine G.N. Bates E.R. Blankenship J.C. et al.2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: A report of the American College of Cardiology Foundation/American Heart Association Task force on practice guidelines and the society for cardiovascular angiography and interventions.Circulation. 2011; 124: e574-e651https://doi.org/10.1161/CIR.0b013e31823ba622Crossref PubMed Scopus (1327) Google Scholar, 7O'Gara P.T. Kushner F.G. Ascheim D.D. et al.2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Circulation. 2013; 127: e362-e425https://doi.org/10.1161/CIR.0b013e3182742cf6Crossref PubMed Scopus (2165) Google Scholar, 8Levine G.N. Bates E.R. Blankenship J.C. et al.2015 ACC/AHA/SCAI focused update on primary percutaneous coronary intervention for patients with ST-elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention and the 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction.Circulation. 2016; 133: 1135-1147https://doi.org/10.1161/cir.0000000000000336Crossref PubMed Scopus (0) Google Scholar, 9Amsterdam E.A. Wenger N.K. Brindis R.G. et al.2014 AHA/ACC guideline for the management of patients with Non–ST-elevation acute coronary syndromes.J Am Coll Cardiol. 2014; 64: e139-e228https://doi.org/10.1016/j.jacc.2014.09.017Crossref PubMed Scopus (2198) Google Scholar, 10Fihn S.D. Gardin J.M. Abrams J. et al.2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: Executive summary.Circulation. 2012; 126: 3097-3137https://doi.org/10.1161/cir.0b013e3182776f83Crossref PubMed Scopus (0) Google Scholar So, the development of the guideline, how does this happen? Well, the American College of Cardiology and the American Heart Association have been working together since the early 1980s to develop guidelines. They use rigorous standards that meet external validity and collaboration. They ensure the development without bias or without improper influence. The guidelines are meant to provide a foundation for the delivery of quality cardiovascular care. There are systematic methods to evaluate and classify evidence. You're all familiar with the class of recommendation, which is based on the strength of the recommendation as well as the level of evidence, which is the quality of the data. The class of recommendation and the level of evidence are separate. The development of the guidelines takes a long process to classify the evidence available for each of the recommendations. The methodology is highly respected, and it's listed in the Institute of Medicine publication clinical practice guidelines that we can trust. So, what about the committee formation? So, forming a writing committee by the American Heart Association, American College of Cardiology Guidelines includes diversity including not only sex, race, ethnicity, intellectual perspectives, biases, and clinical settings. It is an explicit and transparent process and has equal representation of not only interventional cardiologists, but cardiac surgeons. There are also 2 non-interventional cardiologists on the committee, 1 anesthesiologist, 1 PhD nurse practitioner, and 2 lay representatives—which happen to be patients who have undergone cardiovascular procedures—who brought a unique perspective to the committee and kept us grounded at many times. It also has multiple stakeholder representatives, including SCAI, Society of Thoracic Surgeons (STS), and American Association for Thoracic Surgery (AATS). The ACC and the AHA also have strict guidelines regarding relationships with industry. The chair of the committee has to be completely without relationships with industry. And 51% of the committee has to be without relationships with industry. What about the timeline? I mentioned it's a very long process if you've ever been involved in 1 of these, and I can recommend the process and being part of a writing committee is a very rewarding thing to do and be part of the AHA and the ACC. I was asked to be the chair of the guideline in 2018. The committee met for the first time in March of 2019. After that, you can see that the manuscript was published in December of 2021, so it took a long time. There were weekly calls during those 2 years. Sometimes the calls would be an hour in length or longer, multiple hours in length. We also had another in-person meeting. There were multiple versions of writing, rewriting, revising, voting, revoting, after which time, when a draft document becomes available, it goes to both internal and external reviewers. All of the comments are then responded to by the committee. All of the members of the writing committee vote and approve of the document, and it goes on to publication. So those are some of the details of the writing committee. Dr. Mokadam: Well, thank you, Dr. Lawton. That's a great deal of work and thank you for signing up and doing that. Dr. Sabik, can you educate our audience on how the endorsement process goes and who is involved in the endorsement process? Dr. Joseph F. Sabik III (Cleveland, OH): Sure. I'd be happy to. I suppose it really starts with the review. As the document is being written, the ACC/AHA reach out to those societies and ask them to have a primary reviewer as well as an alternate. They then select a reviewer, who then reviews the document for the respective society or association. They write their comments and return it to the committee. As I understand it, and Jennifer can attest to this, there are probably hundreds of comments that they receive, and the chair and the co-chair go through many of these. And the important ones, or the ones they feel need discussion, are then brought to the writing committee for discussion. After the document is either changed or not changed, the reviewer gets responses back as well as the document to review. Once the document is ready, it's then sent to the leadership of the societies and associations, and the leadership reviews it. But they also strongly rely on the recommendations from the reviewer, as well as from their representative on the writing committee, as to whether or not they should endorse the document or not. In this particular case, I think since both the STS and AATS had concerns over the document, they decided to work together to see if they could further influence and modify the document so they could endorse it. But at the time, it was decided that there would be no longer any changes. And so that's why the societies decided not to, because it was pretty consistent from the AATS and STS reviewers and leadership that it was probably not in the best interest of patients. Dr. Mokadam: Thank you. Dr. Sellke, focusing on the positive, there were a number of items in these new guidelines that were really positive. And I'd like to get your perspective on what those really positive things are from the perspective of cardiac surgery. Dr. Frank W. Sellke (Providence, RI): Well, the committee did look at virtually all literature related to coronary revascularization, whether it's PCI or bypass surgery perioperative care. The guidelines are definitely up to date. There are some very capable people on the writing committee, and we had a tremendous amount of discussion on all these areas. There were some disagreements, and it didn't always involve disagreements between surgeons and cardiologists. There were disagreements among the surgeons, also among the cardiologists, but a tremendous amount of discussion. As Dr. Lawton mentioned, we met every week on the phone, generally for 2 hours. And it was a very time-consuming process. I think we covered pretty much every area very thoroughly. And I would say, over 95% of the topics covered, we reached a pretty clear consensus, so it wasn't that controversial. And I would think the STS and the AATS also signed off on these particular areas. And like I said, the information was very up-to-date. There was tremendous amount of discussion. I think we did reach consensus on the vast majority of the topics covered, but there were a couple that were in dispute. And personally, I think what's– somewhat unfortunate that we couldn't reach consensus with the STS and the AATS. But again, it wasn't necessarily the surgeons against the cardiologists. There were tremendous amount of discussion, support, multiple voting sessions to see if we can sway 1 group or the other. But again, just the thoroughness of the document and the amount of information covered, I think, is a very strong aspect to the ACC/AHA guidelines. Also tremendous review process. I also served on the guidelines task force for a couple years, a few years before being named to the writing committee. I had to review every guideline that came through, as did other members to the guidelines task force. So the amount of review is just incredible. I don't think it's superseded by any other guidelines, so just the thoroughness, the amount covered. And I think we did come to consensus on the vast majority of the topics. Unfortunately, there were a couple that we didn't reach consensus on. Dr. Mokadam: Thank you, Dr. Sellke. Dr. Girardi, 1 of the key features of controversy is the interpretation of data in studies. And not necessarily to go into details of those studies, but process. How can you advise our members on how they can interpret the studies for themselves and come to their own conclusions? Dr. Leonard N. Girardi (New York, NY): Certainly, the STS and the AATS very thoroughly vetted the supporting data that led to the recommendations from the writing group. And there's a lot of data to be reviewed. And so, in this particular case, I think it behooves each and every surgeon to go in there and read what they can to try to educate themselves on the perspective that the surgical societies took on this. There's a lot of hard statistics. It is certainly a process that 1 needs to educate oneself on. And then I think it really is a good idea to go in there and really try to put together the supporting documentation, the supporting statements, that back up the recommendations, and then go back and see how you can tie together the recommendations from the data with, subsequently, what was sent forward by the writing group. And I think that's where we really had the most difficulty, trying to contextualize what was said in the supporting documentation or the supporting text back with the recommendation, and clearly, we had a difference of opinion. And so, I think we welcome each and every surgeon that is affected by this and to go back and review and see what they think. It's certainly going to take a lot of time. There's a lot of documentation there to go through, but I think it's a worthwhile exercise. Dr. Mokadam: Thank you. Dr. Sabik, in the published editorial you mentioned a proposed change to the process of assigning surgeons to various guideline committees.3Sabik J.F. Bakaeen F.G. Ruel M. et al.The American Association for thoracic surgery and society of thoracic surgeons reasoning for not endorsing the 2021 ACC/AHA/SCAI coronary revascularization guidelines.J Thorac Cardiovasc Surg. 2021; https://doi.org/10.1016/j.jtcvs.2021.12.025Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar Can you go into more detail on what you had in mind and what you're proposing? Dr. Sabik: Sure. I'd be happy to. As Dr. Lawton has mentioned, there are representatives from the STS and AATS. But if you look at the composition of the committee, it's still a majority cardiologists and a minority of surgeons. And when you look at the surgeons, the AATS and STS each have the opportunity to nominate surgeons, and then one is selected from the STS and the AATS, so we have to be approved by the cardiology societies. I think the remainder of the surgeons are chosen by the cardiology societies, the AHA, ACC, and that's another 6 if I remember correctly. So there'd be 8 on the committee, and then again, a minority. We do not have the opportunity to approve the cardiologists or review them. We think it should be a fair and equal process. We think the surgical societies should have the opportunity to nominate the surgeons for the committee. And if the cardiology societies believe they would like to approve our nominees, we believe we should have the same opportunities to approve the nominees by the ACC and AHA. So, I think that we're just asking for more of what we believe to be a fairer process to make sure that the surgeons who are on the committee are aligned with the views of the surgical societies and that there's equal representation, and that if the surgeons are going to be approved by the cardiology societies, the surgical societies should have the opportunity to approve the cardiologists on the writing committee. Dr. Mokadam: That's very interesting. Thank you. So, Dr. Lawton, it took 11 years to revise the coronary guidelines. The last 1 was in 20115, and maybe it was 10 minus a month, so it was almost 11 years. In light of this controversy, has there been any discussion to accelerate the next revision? Dr. Lawton: Great question. There has been a change in the way that the American Heart Association and the American College of Cardiology do guidelines, and that has nothing to do with this discussion that we're having today and was already in effect. But if you look at the document itself, it begins with the top 10 which the 10 changes or the newest, hottest things, if you look at the end, you can see there's an area of questions that are unanswered. So the committee didn't feel that there was enough data to support a recommendation, and that's at the end. You'll also find at the end the relationships with industry, all the references, and also all the RWIs of all the authors. So each recommendation, if you look at the whole guideline itself, you can see the recommendation is listed, followed by a synopsis and then a recommended supportive text. That is felt to be a knowledge chunk if you will. So they came up with this so that in the future, they can easily remove the chunk and place a new chunk into the same guideline rather than having multiple updates, and that's a way to update this sort of living document. Dr. Mokadam: Great. Look forward to having a more than every-11-year update. Dr. Sellke, back to you. We're living in a world of social media that tends to amplify controversies in manners that exceed expectations. What role if any do you think social media played in the evolution of this sequence? Dr. Sellke: Well, social media is playing a greater role in putting out information whether it's political or scientific, and I think it's just a good medium for the exchange of information and debate on these things. And while some of the trials that were involved with coming up with the recent guidelines did make it into the social media and were subject to intensive discussion, I really don't think that by itself had that much of an impact. The members of the writing group were all very well-versed in the medical literature pertaining to the revascularization procedures and the guidelines. So while the exchange of information has gone from the printed page to the internet to now social media, Facebook and Twitter and LinkedIn, I really don't think it had a major impact on the construction of the new guidelines. Dr. Mokadam: That's reassuring. So, Dr. Girardi, can you give us some insight? What's the best path forward now? Are the surgical societies going to create their own guidelines? How do we come to terms with our cardiology colleagues and those who vehemently support the guidelines versus those who oppose them? Dr. Girardi: I think Dr. Sabik gave us a little bit of an idea of how we would like to move the path forward, but we just want to be clear that without question, we think what's best for the patients is unanimity, and that is with our cardiology colleagues, not going back and forth between the 2 groups and the 2 specialties trying to figure out who's got the upper hand. It's really all about trying to provide the best care for the patients not only in the short run, but in the long run, and I think the surgical societies have yet to really make any commitment to moving forward with their own guidelines. That's certainly not a goal. We would strive for equality and more equal representation, as Dr. Sabik outlined.3Sabik J.F. Bakaeen F.G. Ruel M. et al.The American Association for thoracic surgery and society of thoracic surgeons reasoning for not endorsing the 2021 ACC/AHA/SCAI coronary revascularization guidelines.J Thorac Cardiovasc Surg. 2021; https://doi.org/10.1016/j.jtcvs.2021.12.025Abstract Full Text Full Text PDF PubMed Scopus (10) Google Scholar I think that would put us on a path forward that I think we could work with the AHA and ACC in a way that we could come up with guidelines that represent all the specialties and we finally come up with guidelines that we think are best for the patients. That's really where we'd like to go. Dr. Mokadam: Well, thank you very much. I'd like to thank our panelists for spending time with us today. I learned a lot. I hope you in the audience learned a lot also. It's a controversial topic and that's okay. Controversy is part of medicine, and we're going to learn from this and move on and all do better for our patients. If you do post this webinar on social media, please be sure to tag AATS HQ, AATS Journals, STS_CTSurgery, TSSM, and AATS 2022. Thank you so much for your time and good luck. To view the Webcast of this AATS 102nd Annual Meeting Discussion, see the URL below: Webcast URL: https://www.aats.org/resources/roundtable-discussion-on-acc-aha-scai-guidelines-on-coronary-revascularization.