CHAPTER 2. Heart Team: Concept and Utility MAIN BENEFITS BARRIERS. Praveen Chandra, Rashmi Xavier, Manoj Dhanger, Rohit Goel, Naresh Trehan

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1 CHAPTER 2 Praveen Chandra, Rashmi Xavier, Manoj Dhanger, Rohit Goel, Naresh Trehan Heart Team: Concept and Utility The concept of The Heart Team approach is gaining popularity in present-day cardiology to provide holistic evidence-based and ethically correct treatment to the patients with various cardiovascular diseases. At present, it has gained popularity in coronary artery disease while planning revascularization strategies in complex coronary artery diseases with multiple comorbidities to ensure a rational approach with evidence-based medicine for better outcomes. The other situation where this team work has played an important role in the management of severe symptomatic aortic stenosis with comorbidities in the form of a poor frailty index, older age groups, severe LV dysfunction, etc. This concept came into existence after the SYNTAX trial (SYNergy between PCI [Percutaneous coronary intervention] with TAXUS and Cardiac Surgery) 1-5 and now with the introduction of transcatheter aortic valve replacement (TVAR) This requires a joint consensus between the treating cardiologist, cardiothoracic surgeon, anesthetist, radiologist where relevant to come to a conclusion in high-risk candidates, to provide the safest modality of treatment for better outcomes. The main goal of this treatment is to provide a patient centric care where the family and patient participate in the decisions that are being informed and taken by the team. The various alternatives to the treatment of a disease are discussed in the presence of the patient and family and the outcomes of each approach is also discussed in order to understand and meet their expectations. 13,14 The final treatment that is offered to the patient is only provided once the family and the team gives their final decision. MAIN BENEFITS Broader input by different physicians into a complex decision-making process. Minimize fragmented decision making and improve coordination of care. Facilitate shared decision making with patients and families. Improve timeliness and consistency of decisions when multiple providers are likely to be involved, increasing satisfaction for both patients and physicians. Minimizing concerns related to physician s self-referral. Allow more intricate and patient-centered treatment plans to be developed (e.g, hybrid revascularization). Enhance patient enrollment in research protocols. Increase educational opportunities by incorporating continuing medical and trainee programs. BARRIERS Engaging different physicians from a broad range of specialties into a complex decision-making process. Ensuring a streamlined process for integrating and summarizing input from multiple viewpoints in a Heart team in a systematic manner. Including active participation by the patients and families into the decision-making process by the heart teams while maintaining efficiencies. Ensuring accurate communication of discussions held by Heart Teams to patients and their families.

2 6 Improving mechanisms for fair and equitable remuneration of services provided by physicians and health systems, particularly across specialists and between cognitive and procedural services This has now been imbibed into the guideline documents, and the heart team has emerged as a class 1 indication in both the 2010 European Society of Cardiology and the European Association for Cardio-Thoracic Surgery Guidelines for coronary revascularization 15 and the 2012 ACC/AHA Guidelines for Coronary Artery Bypass Grafting surgery. 16 The goal of the multidisciplinary Heart Team is to offer a balanced and complementary approach to patient care by joint and shared decision making among different medical care stakeholders such as cardiac surgery and interventional cardiology. By exploring the multiple options available and sharing them with the patients and their families where applicable, more optimal shared decision making is achieved, along with a tailored recommendation for therapy for a more informed and engaged patient. From the professional point of view, this concept improves the interdepartment interaction and improves their cognitive skills, and generates a healthy platform for discussion and debate to practice medicine in complex case scenarios. APPLICATIONS IN CORONARY ARTERY DISEASE A lot of data exists on the role and classes of indications for the best modality of treatment in various severities of coronary artery disease. 1,16-25 However, the fundamental question is what is the ideal therapy in the given situation keeping in mind not only the lesion but also the comorbidities, age, family needs and expectations. Hence, this multidisciplinary team work is required to come to a safe decision in complex cases. 1, Many patients, however, fit between these two ends of the spectrum of cases, because of which multiple treatment considerations exist. There is a burgeoning amount of information from RCTs (e.g., the SYNTAX 1 and FREEDOM [Future Revascularization Evaluation in Patients With Diabetes Mellitus: Optimal Management of Multivessel Disease] 26 and EXCEL [Evaluation of XIENCE PRIME Everolimus Eluting Stent System {EECSS} or XIENCE V EECSS Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization] 27 trials), large-scale observational registry data (e.g. the New York State Trial 28 ), and, most recently, the largest and most robust data set from the National Heart, Lung, and Blood Institute ASCERT [ACCF-STS Database Collaboration on the Comparative Effectiveness of Revascularization Strategies] trials, 23,24,29 performed jointly by investigators from the Society of Thoracic Surgeons and the American Section 1: Introduction College of Cardiology. Outcome data from both RCTs and registries are invaluable in constructing as complete a picture as possible, although each has advantages and disadvantages (Table 1). This is complicated by the fact that there is often some degree of discordance between the very carefully controlled RCTs and the larger, more real-world registries. Moreover both the revascularization strategies are very different with their own pros and cons of each. This approach which comprises of a cardiologist, cardiothoracic surgeon, interventional cardiologist can work together and focus on specific patient issues, considerations and expectations along with the family and patient in context with the evolving data from RCTs and registries and with the full information of the benefits and risks of each procedure before reaching to a conclusion as to which approach to adopt. Combining first-hand patient expectations, their consideration of hierarchical endpoints such as death, myocardial infarction, stroke, and need for subsequent procedures with available scientific data forms the basis for personalized treatment recommendations. APPLICATION IN TRANSCUTANEOUS AORTIC VALVE IMPLANTATION The second major role of the heart team concept is in the management of patients with severe symptomatic aortic stenosis with the advent of a percutaneous approach by interventional cardiologists as compared to the standard approach of surgical aortic valve implantation especially in high risk candidates with multiple comorbidities. This new approach has been found noninferior to the available surgical approach in high-risk candidates in the PARTNER Trial. A total of over 1 lakh procedures have been performed worldwide. The reason that this new approach was adopted was mainly because Many patients with severe aortic stenosis are not offered traditional surgical aortic valve replacement, either because of high or even prohibitive surgical risk or patient preference. In patients at prohibitive surgical risk, compared with standard medical therapy, TAVR results in improved survival. In patients at high risk for surgical treatment but who are operable, TAVR results in similar survival rates at 2 years of follow-up. There are differences in risk profiles between surgical aortic valve replacement and TAVR. In the randomized PARTNER A (Placement of AoRTic transcatheter Valve) trial, although there was no significant difference in mortality between the two groups, patients undergoing TAVR had an increase in periprocedural strokes, both major and minor, at 30 days and at 1 year and increased major vascular complications. 30

3 Chapter 2: Heart Team: Concept and Utility 7 Table 1 Advantages and disadvantages of different modalities of treatment of CAD Revascularization Strategies: CABG Advantages compared with PCI Survival benefit in more complex disease particularly with left internal Mammary artery left internal mammary artery (LIMA) use More complete revascularization Reduction in subsequent myocardial infarction Reduction in need for subsequent revascularization procedures More invasive Longer recovery Increased periprocedural stroke Low use of multiple arterial grafts resulting in placement of venous conduits With potential development of subsequent vein graft disease Subsequent surgical procedures, if needed, are more difficult PCI: Advantages Compared with CABG Less invasive Treatment of focal ischemic producing lesions leaving other lesions for later (targeted revascularization) Shorter recovery Can be repeated if needed Patient preference Not shown to have a survival advantage or to decrease subsequent MI Outside of primary PCI Less complete revascularization Vascular access bleeding Potential for stent thrombosis and need for dual antiplatelet therapy May need to be repeated Placement of very distal stents may preclude subsequent ability to place Surgical grafts Hybrid Coronary Revascularization Advantages Minimally invasive LIMA to LAD with long-term survival benefit Placement of DES rather than vein grafts to circumflex and right coronary artery (Heart Team) approach Completion of angiography after surgery Excellent choice in patients with limited conduit availability Excellent choice in patients who difficult-to-approach lesions with traditional grafting (e.g., AV groove lesions with multiple branching small epicardial coronary arteries subtending significant myocardial territories) Need for hybrid operation room/catheter laboratory or two procedures Reimbursement issues Still requires a surgical procedure Not shown to have a survival advantage or to decrease subsequent MI versus standard of care CABG when possible No long-term randomized clinical trial data on relative safety/ efficacy versus conventional CABG Source: Holmes Jr, et al. JACC Vol. 61, No. 9, The Heart Team of Cardiovascular Care. 2013: On the other hand, surgical AVR was associated with more major bleeding and more atrial fibrillation. The conclusions were that both approaches were acceptable in high-risk patients but the difference existed in the periprocedural complications. These essential but complex pieces of information must be communicated to referring physicians and to patients and their families in terms of patient selection and risk/benefit ratio as well as procedural performance. This process has been the focus of multiple expert consensus documents in this field. These documents deal not only with patient selection and procedural performance but also center and operator credentialing and experience. A central component of each of these documents has been the Heart Team. In patients undergoing TAVR the Heart Team consists of the cardiovascular surgeon, the interventional cardiologist, a structural heart disease expert, and imaging specialists. This Heart Team approach has been recommended by multiple specialty societies and has been made mandatory by regulatory and reimbursement agencies including the US Food and Drug Administration and Centers for Medicare and Medicaid Services based upon several issues. 6-8,31 These issues include the facts that there is already an established surgical option, which has been tested over the past 25 years however, in situations where patients are elderly with multiple comorbidities and a high frailty index, makes this approach more complicated with additional risks. The consideration of TAVR includes evaluation of peripheral arterial access and underlying coronary artery disease, as well as the severity of the aortic stenosis and the presence or absence of LV dysfunction. Most importantly, the procedural performance improves when both cardiac surgeons and interventional cardiologists perform the procedure together hence outcomes are better. This combination of facts including the risk/benefit ratio of either surgical AVR, TAVR, or medical therapy requires assessment by a multidisciplinary team to be comfortable with the recommendation to optimize patient care and to educate the patient and the family. As can be seen from the aforementioned examples, the Heart Team has become an integral part of the practice of modern cardiovascular care to optimize patient selection through identification of the risk/benefit ratio of different strategies, evaluation of the increasingly large and robust data sets of both RCTs and observational registries, patient and family education, and procedural performance and follow-up. COMPOSITION The composition of the Heart Team will vary depending on the specific patient issue and will also vary from institution to institution.

4 8 In the case of coronary revascularization, it should consist of: Cardiovascular surgeon The interventional cardiologist The primary cardiologist, who is most familiar with the specific patient and family considerations. In the case of TAVR, the team will also include consideration of involvement of Expert imaging specialists Neurologists Vascular medicine physicians Cardiac anesthesiologists All of whom are important in patient selection and procedural performance. CONCLUSION Heart team concept is becoming an important concept in present-day cardiological practice and requires to become a routine practice to ensure better outcomes in the best interest of the patient. This has become a class I recommendation in the ACC/AHA guidelines in the management of complexities dealing with the heart. As mentioned earlier, this is the way to provide holistic care to our cardiology practice. REFERENCES 1. Serruys PW, Morice MC, Kappetein AP, et al. Percutaneous coronary intervention versus coronary artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009;360: Genereux P, Palmerini T, Caixeta A, et al. SYNTAX score reproducibility and variability between interventional cardiologists, core laboratory technicians and quantitative coronary measurements. Circ Cardiovasc Interv. 2011;4: Girasis C, Garg S, Raber L, et al. SYNTAX score and clinical SYNTAX score as predictors of very long-term clinical outcomes in patients undergoing percutaneous coronary interventions: a substudy of SIRolimus-eluting stent compared with paclitaxel-eluting stent for coronary revascularization (SIRTAX) trial. Eur Heart J. 2011;32: Palmerini T, Alessi L, Dangas G. Revascularization of unprotected left main coronary artery disease: strategy selection and systematic risk assessment. Catheter Cardiovasc Interv. 2012;80: Head SJ, Mack MJ, Holmes DR, et al. Incidence, predictors and outcomes of incomplete revascularization after percutaneous coronary intervention and coronary artery bypass grafting: a subgroup analysis of 3-year SYNTAX data. Eur J Cardiothorac Surg. 2012;42: Holmes DR Jr, Mack MJ. Transcatheter valve therapy: a professional society overview from the American College Section 1: Introduction of Cardiology Foundation and the Society of Thoracic Surgeons. J Am Coll Cardiol. 2011;58: Holmes DR Jr, Mack MJ, Kaul S ACCF/AATS/SCAI/ STS expert consensus document on transcatheter aortic valve replacement. J Am Coll Cardiol. 2012;59: Tommaso CL, Bolman RM, Feldman T, et al. Multi-society (AATS, ACCF, SCAI and STS) guidelines: operator and institutional requirements for transcatheter valve repair and replacement. J Am Coll Cardiol. 2012;59: Kodali SK, Williams MR, Smith CR, et al. Two-year outcomes after transcatheter or surgical aortic-valve replacement. N Engl J Med. 2012;366: Makkar RR, Fontana GP, Jilaihawi H, et al. Transcatheter aortic valve replacement for inoperable severe aortic stenosis. N Engl J Med. 2012;366: Leon MB, Smith CR, Mack MJ, et al. Transcatheter aorticvalve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363: Smith CR, Leon MB, Mack MJ, et al. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Eng J Med. 2011;364: Selby JV, Beal AC, Frank L. The patient-centered outcomes research institute (PCORI) National priorities for research and initial research agenda. JAMA. 2012;307: Patient Protection and Affordable Care Act, Pub L No , 124 Stat 727, g Kolh P, Wijns W, Danchin N. The Task Force on Myocardial Revascularization of European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). 16. Patel MR, Dehmer GJ, Hirshfeld, et al. ACCF/SCAI/STS/ AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update: a report of the American College of Cardiology Foundation Appropriate Use Criteria Task Force, Society for Cardiovascular Angiography and Interventions, Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, American Society of Nuclear Cardiology and the Society of Cardiovascular Computed Tomography. J Thorac Cardiovasc Surg. 2012;143: O Connor GT, Olmstead EM, Nugent WC, et al. Appropriateness of coronary artery bypass graft surgery performed in northern New England. J Am Coll Cardiol. 2008;51: Patel MR, Dehmer GJ, Hirshfeld JW, et al. ACCF/SCAI/ STS/ AATS/AHA/ASNC/HFSA/SCCT 2012 appropriate use criteria for coronary revascularization focused update. J Am Coll Cardiol. 2012;59: MacKenzie TA, Malenka DJ, Olmstead EM, et al. Prediction of survival after coronary revascularization: modeling short-term, midterm and long-term survival. Ann Thorac Surg. 2009;87: Weintraub WAS, Grau-Sepulveda MV, Weiss JM, et al. Prediction of long-term mortality after percutaneous coronary intervention in older adults: results from the National Cardiovascular Data Registry. Circulation. 2012;125:

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