The Heart Team for Mitral and Aortic Technologies in 2015: Is It Viable?
"Viable" or "viability" has been defined, respectively, as: 1. Capable of existence and development as an independent unit, and 2. Having a reasonable chance of succeeding or financially sustainable.1 Both definitions are germane as they relate to the concept of the heart team in 2015 and beyond. The mantra of team-based care has been the basis for many medical disciplines and now for the whole changing field of medicine. This concept is the core of the integrated practice unit (IPU), which is the proposed optimal method of delivering care. This rests on the concept that bringing diverse professional experiences and knowledge bases to bear on the specific patient at hand will lead to improved selection of therapeutic options and will facilitate more optimal, patient-centered care. Such teams have been the standard in the transplant arena, nursing care, rehabilitation units, intensive care facilities and in dialysis centers. More recently, the concept has become ensconced in the professional societal guidelines in the field of coronary revascularization as Class 1 indications in patients with multivessel or complex coronary artery disease (CAD) in the setting of stable, non-urgent symptom presentation.2,3 In the latter setting, heart teams have been promulgated because there have been two competing strategies for revascularization: percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG), both of which have advantages and disadvantages, and both of which have advocates and even zealots. As part of the drive to practice evidence-based medicine, in this setting, both a surgeon and an interventional cardiologist are called to render opinions to the patient on the relative merits of each strategy so that the patients and his or her family have a base of understandable knowledge to make the best decisions for themselves. The combination of a minimally invasive surgical left internal mammary placed to the left anterior descending coronary artery with the treatment of the remaining disease with PCI as an alternative to CABG for patients with multivessel disease as a hybrid approach has recently gained renewed interest. It is the subject of a National Institutes of Health (NIH) grant proposal and truly mandates a heart team approach.
This heart team approach, which was featured in the pivotal Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial, has been migrated to the field of structural heart disease.4 With structural heart disease, there are different issues to be considered in the application of a heart team. For aortic stenosis, there was a gold standard of care, surgical aortic valve replacement (AVR). Transcatheter aortic valve replacement (TAVR) was initially used in a patient who was truly inoperable. As experience has developed, it has become apparent that the definition of "inoperable" is like that of the "p" word of avant garde "art or literature," namely in the eyes of the beholder. It then became apparent that as the technique of TAVR developed that it would be employed in higher risk patients, some of whom could have been or might have been treated surgically with the gold standard.
The heart team evolved in this setting to include a structural heart disease specialist (often with imaging expertise), a cardiac surgeon, and an interventional cardiologist to participate in patient evaluation, determination of risk/benefit ratios and then recommendation of care. Other drivers for this evolution included the different skills and experiences of the cardiac surgeon and cardiologist in peripheral percutaneous versus surgical access, treatment of vascular complications requiring vascular interventional skills as well as cardiac complications such as acute aortic regurgitation, or annular rupture. Working together, both groups could cross train and the patient could benefit. That was the carrot for the heart team approach – to enhance learning opportunities for both specialities. The stick was the National Coverage Determination (NCD) by the Centers for Medicare and Medicaid Services (CMS), which mandated that care be given by a heart team approach as a condition of reimbursement.5
The heart team has been invaluable in this now 12-year journey since the first case in 2002.6 The authors of this article believe that everyone has benefited, most of all the patient. However, it may become more difficult in the future as smaller delivery systems are developed with local anesthesia and with continued evidence development in lower risk surgical patients. As these developments occur and as vascular access becomes more straightforward, both cardiac surgeons and interventional cardiologists will be able to perform the procedures as a single operator. As lower risk patients are treated, patients will, of course, desire to be treated less invasively. The idea that this could be done without "cracking your chest" remains seductive to patients. However, the discussion should become more robust as the options increase; accordingly, the need for a heart team approach to optimize decision making and enhancing patient-centered care will be central to quality initiatives in medicine. The field will continue to evolve: which patient, which device, which approach. There will indeed be multiple options and considerations; these can be best focused by the multiple stakeholders involved working together. There will be challenges (scheduling, reimbursement, and convenience, among others), but in the end we should be driven by quality of care and outcomes.
There are some differences in the field of mitral valve disease. Wherein the field of mitral valve balloon valvuloplasty for mitral stenosis developed solely within the domain of interventional cardiology, the space of mitral valve regurgitation (MR) is less advanced. There are some similarities for MR and TAVR in that there is a gold standard procedure, namely mitral valve repair in high volume centers, by selected high-quality surgeons. In this space in the U.S., there is only a single device approved (MitraClip, Abbott Vascular, Santa Clara, CA), although several others are in development and in human early feasibility trials around the world. The field, as was true with aortic stenosis, needs cross fertilization of the disciplines. Cardiac surgeons have had a unique understanding of the three-dimensional structure and function of the mitral valve by virtue of the real-time experience of direct visualization. Interventional cardiologists, on the other hand, have the experience of working on a beating heart with catheter-based techniques through transseptal access to the left atrium and mitral valve. Working together with echocardiographers to provide navigation and integrate the heart team will enhance not only knowledge of the pathophysiology and anatomy, but also bring the development of new approaches aimed at the treatment of the complex structure of the mitral apparatus with its several components. There will be patients, mostly with primary (degenerative) mitral regurgitation, in whom a surgical repair remains the best option with low risk and excellent long-term results. There were will be other patients in whom a surgical approach is either not feasible or associated with very high predicted risk. Working together, the heart team of a cardiac surgeon, interventional cardiologist and echocardiographer, the team will be able to identify optimal candidates for a variety of procedures, either surgical or catheter-based mitral repair or now transcatheter mitral valve replacement (TMVR) which will be performed by a transapical access surgical approach for the foreseeable future. A National Coverage Determination (NCD) was also issued for transcatheter mitral valve repair, mandating that patient evaluation by a heart team composed of both a cardiac surgeon and an interventional cardiologist is required for reimbursement of the procedure, but that a single person "skilled in the art and practice" of the procedure, either a cardiologist or surgeon, can be the sole operator.7
Optimally, everyone on the heart team should be involved in procedural planning, procedural performance, and post-procedural care. Since transcatheter mitral valve replacement (TMVR) will be performed by a transapical approach, the heart team will remain united during performance of the procedure. Systems of care should have the following as their goal: treatment using optimal patient selection criteria, with the right device and the right approach delivered at the right time, and, in doing so, optimize quality of care.The heart team concept has evolved in multiple other areas of cardiovascular care beyond heart failure/cardiac transplantation, coronary artery disease, aortic and mitral valve disease. The treatment of thoracic aortic disease, including the aortic arch and ascending aorta, is now commonly treated by a team of cardiac surgeons, vascular surgeons, and imaging specialists using hybrid procedures that combine endovascular and surgical approaches. Adult congenital heart disease with all the intricacies of the complex disease in patients who have survived multiple procedures over many decades is best managed by a multidisciplinary team approach. The management of persistent and long-standing persistent atrial fibrillation has defied effective treatment with catheter-based techniques and an effective "maximally invasive" surgical option, the Cox Maze procedure has not been widely adopted. However, electrophysiologists and cardiac surgeons are working together on "hybrid" approaches employing a combination of minimally invasive surgical approaches and endocardial ablation techniques that show promise. Another disease that is increasingly being effectively treated by a collaborative approach is hypertrophic obstructive cardiomyopathy (HOCM). With some patients with suitable anatomy being able to be treated with septal ablation, others are best treated by a minimally invasive surgical approach. Multidisciplinary clinics for HOCM are becoming increasingly common.
The heart team approach is not a panacea for all things. There are practical details in implementation and practice. Quality of care needs to remain the mantra of professional societies, physicians, surgeons, medical institutions, patients, and payers. As the Mayo Brothers espoused, "the needs of the patient come first." After all, why does it make sense for a patient's treatment to be determined by which door of the hospital or which specialist's office they happen to walk into? We can do better than that. By a heart team approach that includes shared patient decision making, the patient is better served. Together, we can develop innovative new approaches such as TMVR and hybrid approaches for CAD, atrial fibrillation, and aortic aneurysmal disease. We are better together than apart. The heart team approach should not only remain at the heart of aortic and mitral valve disease care, but also be adopted in many other areas of cardiovascular disease management.
- Merriam-Webster's Collegiate Dictionary. 10th ed. Springfield, Massachusetts: Merriam-Webster; 1998.
- Kolh P, Windecker S, Alfonso F, et al. 2014 ESC/EACTS Guidelines on myocardial revascularization: the Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur J Cardiothorac Surg 2014;46:517-92.
- Hillis LD, Smith PK, Anderson JL, et al. 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Developed in collaboration with the American Association for Thoracic Surgery, Society of Cardiovascular Anesthesiologists, and Society of Thoracic Surgeons. J Am Coll Cardiol 2011;58:e123-210.
- 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;360:961-72.
- Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Transcatheter Aortic Valve Replacement (TAVR) (20.32) (CMS website). 2012. Available at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=355. Accessed 12/16/2014.
- Cribier A, Eltchaninoff H, Bash A, et al. Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description. Circulation 2002;106:3006-8.
- Centers for Medicare & Medicaid Services. National Coverage Analysis (NCA) for Transcatheter Mitral Valve Repair (TMVR) (CAG-00438N) (CMS website). 2014. Available at: http://www.cms.gov/medicare-coverage-database/details/nca-details.aspx?NCAId=273. Accessed 12/16/2014.
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