2019 AATS/ACC/ASE/SCAI/STS expert consensus systems of care document: A proposal to optimize care for patients with valvular heart disease: A joint report of the American Association for Thoracic Surgery, American College of Cardiology, American Society of Echocardiography, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons

Abstract

See Commentary page 2214. See Commentary page 2214. This statement was commissioned as a Multisociety Expert Consensus Systems of Care Document by the American Association for Thoracic Surgery (AATS), American College of Cardiology (ACC), American Society of Echocardiography (ASE), Society for Cardiovascular Angiography and Interventions (SCAI), and Society of Thoracic Surgeons (STS). Expert Consensus Systems of Care Documents are intended to summarize the position of these partnering organizations on the availability, delivery, organization, and quality of cardiovascular care, with the intention of establishing appropriate benchmarks. These Systems of Care Documents are overseen by the ACC Task Force on Health Policy Statements and Systems of Care. With the rapid evolution and dissemination of transcatheter technologies, as well as advances in surgical repair and valve replacement techniques, there is an imperative for the cardiovascular community to establish the provider, institutional, and systems-based standards for delivery of high-quality valvular heart disease (VHD) care. The AATS, ACC, ASE, SCAI, and STS have, therefore, joined together to provide expert consensus and, wherever feasible, evidence-based recommendations for systems of care related to VHD, in the spirit of ensuring access to quality outcomes. The writing group anticipates that future updates to this consensus statement will be necessary as newer imaging and treatment technologies become available and more data are generated regarding patient outcomes, cost, and cost-effectiveness. Dharam J. Kumbhani, MD, SM, FACC Chair, ACC Task Force on Health Policy Statements and Systems of Care In the past decade, the evaluation and management of patients with VHD has changed dramatically. Advances in noninvasive imaging have enabled reliable, reproducible, and objective measurements of valve disease severity, along with an appreciation of any associated hemodynamic and structural consequences. There is enhanced understanding of the natural history of VHD based upon longitudinal studies of large numbers of patients that have correlated outcomes with noninvasive measurements as well as with data obtained during exercise testing. Advances in surgical techniques, especially those associated with valve repair; improved operative results; and perioperative management strategies have contributed substantially to better patient outcomes. Transcatheter aortic valve replacement (TAVR) has revolutionized the treatment of patients with symptomatic, severe aortic stenosis (AS) and now provides a less-invasive treatment option for many eligible patients. Transcatheter repair of mitral regurgitation (MR) with an edge-to-edge clip device occupies a specific treatment niche currently, and more options for this valve lesion are anticipated in the near future. Transcatheter mitral valve replacement (TMVR) is the subject of intense investigation, and tricuspid valve interventions in high-surgical-risk patients are being developed. Collectively, these advances have led to an increasing number of treatment options, lower thresholds for and earlier timing of intervention, and the provision of less-invasive therapies to an older, sicker, and more frail population.1Vahanian A. Alfieri O. Andreotti F. et al.Guidelines on the management of valvular heart disease (version 2012): The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio–Thoracic Surgery (EACTS).Eur Heart J. 2012; 33: 2451-2496Crossref PubMed Scopus (3185) Google Scholar, 2Nishimura R.A. Otto C.M. Bonow R.O. et al.2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: e57-e185Crossref PubMed Scopus (2084) Google Scholar As the number and complexity of VHD treatment options have expanded, expert clinical judgment from an experienced multidisciplinary team (MDT) has assumed increasing importance. The number of patients with significant VHD who could benefit from appropriate intervention increases as a function of age. The elderly are the fastest growing segment of the United States population. Estimates of the prevalence of moderate or severe aortic or mitral disease in United States patients over the age of 75 years approach 4% and 10%, respectively.3Nkomo V.T. Gardin J.M. Skelton T.N. Gottdiener J.S. Scott C.G. Enriquez–Sarano M. Burden of valvular heart diseases: a population–based study.Lancet. 2006; 368: 1005-1011Abstract Full Text Full Text PDF PubMed Scopus (3134) Google Scholar The prevalence of moderate or severe VHD in a large-scale community screening program of patients over age 65 years in the United Kingdom exceeded 11%, with a projected doubling before 2050.4d'Arcy J.L. Coffey S. Loudon M.A. et al.Large–scale community echocardiographic screening reveals a major burden of undiagnosed valvular heart disease in older people: the OxVALVE Population Cohort Study.Eur Heart J. 2016; 37: 3515-3522Crossref PubMed Scopus (270) Google Scholar The number of patients who will be eligible for TAVR is estimated to increase 4-fold over the next 5 years.5Carroll J.D. TAVR prognosis, aging, and the second TAVR tsunami: insights from France.J Am Coll Cardiol. 2016; 68: 1648-1650Crossref PubMed Scopus (18) Google Scholar, 6Lindroos M. Kupari M. Heikkila J. Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample.J Am Coll Cardiol. 1993; 21: 1220-1225Crossref PubMed Scopus (939) Google Scholar Accordingly, implementation of optimal treatment strategies for patients with VHD will affect a sizable portion of the population.7Durko A.P. Osnabrugge R.L. Van Mieghem N.M. et al.Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections.Eur Heart J. 2018; 39: 2635-2642Crossref PubMed Scopus (154) Google Scholar Access to appropriate care is critical, but as the complexity and cost of diagnosis and treatment continues to increase, it will not be feasible for all institutions to provide the full complement of resources and clinical experts necessary to care for the full spectrum of patients with VHD, while also ensuring the highest-quality outcomes. Providing optimal care to patients with VHD is an increasingly complex process, starting with early recognition and diagnosis at the primary care/general cardiology level and including appropriate timing of referral for further evaluation and management, MDT assessment, shared decision-making, and long-term follow-up. In the past, intervention for VHD was often delayed until the onset of severe symptoms. It is now recognized that the longstanding effects of VHD can lead to irreversible changes in left ventricular (LV) function, repeated hospitalizations, patient morbidity (eg, atrial fibrillation, heart failure, endocarditis), reduced quality of life (QOL), and premature mortality, which can often be prevented by earlier treatment. However, prior studies estimated that nearly 30% to 50% of patients with severe VHD who met guideline criteria for intervention were not appropriately recognized or referred,8Bach D.S. Awais M. Gurm H.S. Kohnstamm S. Failure of guideline adherence for intervention in patients with severe mitral regurgitation.J Am Coll Cardiol. 2009; 54: 860-865Crossref PubMed Scopus (117) Google Scholar, 9Bach D.S. Siao D. Girard S.E. Duvernoy C. McCallister Jr., B.D. Gualano S.K. Evaluation of patients with severe symptomatic aortic stenosis who do not undergo aortic valve replacement: the potential role of subjectively overestimated operative risk.Circ Cardiovasc Qual Outcomes. 2009; 2: 533-539Crossref PubMed Scopus (281) Google Scholar, 10Wang A. Grayburn P. Foster J.A. et al.Practice gaps in the care of mitral valve regurgitation: Insights from the American College of Cardiology mitral regurgitation gap analysis and advisory panel.Am Heart J. 2016; 172: 70-79Crossref PubMed Scopus (34) Google Scholar, 11Iung B. Delgado V. Lazure P. et al.Educational needs and application of guidelines in the management of patients with mitral regurgitation. A European mixed–methods study.Eur Heart J. 2018; 39: 1295-1303Crossref PubMed Scopus (35) Google Scholar even in highly resourced environments.7Durko A.P. Osnabrugge R.L. Van Mieghem N.M. et al.Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections.Eur Heart J. 2018; 39: 2635-2642Crossref PubMed Scopus (154) Google Scholar, 12Dziadzko V. Clavel M.A. Dziadzko M. et al.Outcome and undertreatment of mitral regurgitation: a community cohort study.Lancet. 2018; 391: 960-969Abstract Full Text Full Text PDF PubMed Scopus (180) Google Scholar There are an increasing number of treatment options available to patients with VHD; yet, not all patients are aware of or have access to the full spectrum of interventions. For most patients with severe primary MR, for example, it is well-recognized that mitral valve repair is superior to mitral valve replacement.13Jokinen J.J. Hippelainen M.J. Pitkanen O.A. Hartikainen J.E. Mitral valve replacement versus repair: propensity–adjusted survival and quality-of-life analysis.Ann Thorac Surg. 2007; 84: 451-458Abstract Full Text Full Text PDF PubMed Scopus (103) Google Scholar, 14Chikwe J. Goldstone A.B. Passage J. et al.A propensity score–adjusted retrospective comparison of early and mid-term results of mitral valve repair versus replacement in octogenarians.Eur Heart J. 2011; 32: 618-626Crossref PubMed Scopus (110) Google Scholar, 15Shuhaiber J. Anderson R.J. Meta-analysis of clinical outcomes following surgical mitral valve repair or replacement.Eur J Cardiothorac Surg. 2007; 31: 267-275Crossref PubMed Scopus (156) Google Scholar However, repair rates for primary MR vary significantly among individual surgeons and across institutions.16Bolling S.F. Li S. O'Brien S.M. Brennan J.M. Prager R.L. Gammie J.S. Predictors of mitral valve repair: clinical and surgeon factors.Ann Thorac Surg. 2010; 90 (discussion 1912): 1904-1911Abstract Full Text Full Text PDF PubMed Scopus (245) Google Scholar, 17Chikwe J. Toyoda N. Anyanwu A.C. et al.Relation of mitral valve surgery volume to repair rate, durability, and survival.J Am Coll Cardiol. 2017 April 24; ([E-pub ahead of print])Crossref PubMed Scopus (158) Google Scholar, 18Gammie J.S. O'Brien S.M. Griffith B.P. Ferguson T.B. Peterson E.D. Influence of hospital procedural volume on care process and mortality for patients undergoing elective surgery for mitral regurgitation.Circulation. 2007; 115: 881-887Crossref PubMed Scopus (226) Google Scholar, 19Kilic A. Shah A.S. Conte J.V. Baumgartner W.A. Yuh D.D. Operative outcomes in mitral valve surgery: combined effect of surgeon and hospital volume in a population-based analysis.J Thorac Cardiovasc Surg. 2013; 146: 638-646Abstract Full Text Full Text PDF PubMed Scopus (73) Google Scholar, 20Vassileva C.M. Boley T. Markwell S. Hazelrigg S. Impact of hospital annual mitral procedural volume on mitral valve repair rates and mortality.J Heart Valve Dis. 2012; 21: 41-47PubMed Google Scholar Although repair rates for primary MR have increased,21Badhwar V. Thourani V.H. Ailawadi G. Mack M. Transcatheter mitral valve therapy: The event horizon.J Thorac Cardiovasc Surg. 2016; 152: 330-336Abstract Full Text Full Text PDF PubMed Scopus (22) Google Scholar, 22Chatterjee S. Rankin J.S. Gammie J.S. et al.Isolated mitral valve surgery risk in 77,836 patients from the Society of Thoracic Surgeons database.Ann Thorac Surg. 2013; 96 (discussion 1594–5): 1587-1594Abstract Full Text Full Text PDF PubMed Scopus (52) Google Scholar, 23Gammie J.S. Sheng S. Griffith B.P. et al.Trends in mitral valve surgery in the United States: results from the Society of Thoracic Surgeons Adult Cardiac Surgery Database.Ann Thorac Surg. 2009; 87 (discussion 1437–9): 1431-1437Abstract Full Text Full Text PDF PubMed Scopus (413) Google Scholar, 24Badhwar V. Rankin J.S. Thourani V.H. et al.The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2018 update on research: outcomes analysis, quality improvement, and patient safety.Ann Thorac Surg. 2018; 106: 8-13Abstract Full Text Full Text PDF PubMed Scopus (32) Google Scholar there remains concern that many patients with anatomy amenable to repair instead undergo valve replacement, with adverse downstream consequences related to LV dysfunction and the presence of valve prostheses. Similarly, some patients with symptomatic severe AS, as well as their providers, may not be aware that they would be eligible for TAVR due to the lack of a system of care that might enable them to access comprehensive MDT consultation with all treatment options being considered. Alternatively, TAVR may be inappropriately recommended when surgical aortic valve replacement (SAVR), sometimes in combination with aortic or coronary bypass surgery, would be a better option. Patients and referring providers may be unaware of specific physician competencies or experience, center volumes, structure, processes, or outcomes. Other less-invasive procedures for selected valve-related problems may be performed only at certain institutions, such as percutaneous closure of paravalvular leaks, alternative-access TAVR, and valve-in-valve procedures for degenerated surgical bioprostheses. Ideally, personnel and resource restrictions at one institution should not negate the opportunity for referral to another with a wider array of services and a more established MDT. The intent of this document is to propose a system of care for patients with VHD, the primary goal of which would be to optimize outcomes for all patients and ultimately improve the care of VHD at all centers. This approach is intended to increase the identification of patients with VHD and emphasize best practices as captured in the 2014 AHA/ACC Guideline for the Management of Patients with Valvular Heart Disease2Nishimura R.A. Otto C.M. Bonow R.O. et al.2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: e57-e185Crossref PubMed Scopus (2084) Google Scholar and the 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease.25Nishimura R.A. Otto C.M. Bonow R.O. et al.2017 AHA/ACC focused update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines.J Am Coll Cardiol. 2017; 70: 252-289Crossref PubMed Scopus (1812) Google Scholar It is also intended to promote the efficient utilization of resources, facilitate communication and continuity of care, and emphasize the need for transparency in reporting of and accountability for outcomes relative to national benchmarks. The standards proposed for the optimal structure and function of valve centers, as well as key processes of care, mirror those in a companion 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement document.26Bavaria J.E. Tommaso C.L. Carroll J. et al.ACC/AATS/SCAI/STS expert consensus systems of care document: operator and institutional requirements for transcatheter aortic valve replacement.J Am Coll Cardiol. 2018 Jul 18; ([E-pub ahead of print])PubMed Google Scholar An interconnected system of providers and institutions may help strike the right balance between access and quality outcomes. The case for centers with the ability to offer more comprehensive care is logical, but it is critically important that patients and referring clinicians be made aware of the quality of care delivered in all centers. A major priority in optimizing VHD patient care is to identify and support centers with excellent outcomes and improve outcomes at centers where opportunities exist, not simply to promote those centers with good reputations or large procedural volumes. A systems approach to the management of patients with VHD could help promote care among centers in a manner analogous to those adopted for the management of other medical and surgical disorders such as stroke and trauma,27Alberts M.J. Latchaw R.E. Selman W.R. et al.Recommendations for comprehensive stroke centers: a consensus statement from the Brain Attack Coalition.Stroke. 2005; 36: 1597-1616Crossref PubMed Scopus (475) Google Scholar, 28Sampalis J.S. Lavoie A. Boukas S. et al.Trauma center designation: initial impact on trauma–related mortality.J Trauma. 1995; 39 (discussion 237–9): 232-237Crossref PubMed Scopus (106) Google Scholar thereby improving outcomes. On the basis of experience in other disciplines, this proposal includes the adoption of 2 tiers of valve centers, namely comprehensive (Level I) and primary (Level II) valve centers, the attributes of which should be defined by objective criteria (Figure 1). The intent is not to limit the number of centers per se but rather to set performance and quality goals for a valve center to meet benchmarks to be considered either comprehensive or primary in a manner that would be more objective than simple self-designation. The guiding principle in such a model would be to optimize the care of the individual patient by ensuring access to the right care in the right place at the right time, while promoting shared decision making (SDM) and respecting individual values and preferences. This principle can be applied to the clinician who must identify the presence of potentially important VHD, to the primary center providing local care for several conditions, and to the comprehensive center offering the full spectrum of services. Any such system of care should allow patients to be cared for at the appropriate level, promote seamless transitions between different levels of care when necessary, and place a premium on communication and shared learning. Patients with VHD should be informed of their treatment options, including those not routinely offered locally or through their health plan, and be given the opportunity to pursue alternatives according to their own expectations and preferences. The geographical, cultural, and financial barriers to establishing a system of care are recognized; yet the rational dissemination of complex care models founded on the principle of highest-quality outcomes that matter to patients remains an important goal. Knowledge of VHD pathophysiology and natural history, the essentials of patient assessment, and the range of available treatment options is expected across all levels of providers. Current knowledge and performance gaps around recognition and treatment relate to the decline in physical examination skills and a lack of appreciation of the improvement in outcomes seen in patients previously deemed too ill or frail for intervention. It is the responsibility of professional societies and individual valve centers to provide education, support, and guidance for the appropriate management of VHD patients and to minimize any such gaps. Many sections of the 2014 AHA/ACC Guidelines for the Management of Patients with Valvular Heart Disease and its 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease are a resource for the primary care physician/general cardiologist. In addition, there are several ongoing ACC efforts to provide concise and relevant tools for VHD patient diagnosis and treatment, including the Managing Aortic Stenosis and Emerging Mitral Regurgitation Clinical Care initiatives. The proposed system of care would typically begin at the local level, with community providers and primary (Level II) valve centers communicating openly and collaborating with a comprehensive (Level I) center (Figure 1). Ideally, patient movement within such a system would be predicated on the desire to match the complexity of disease with the appropriate resources while placing a premium on maintaining relationships between patients and their longstanding healthcare providers. For example, there are patients with primary MR who might benefit from referral to the highest level of VHD care. Patients with severe primary MR may have complex valve pathology that makes durable surgical repair technically challenging, such as anterior leaflet or bileaflet disease, Barlow’s disease, or extensive annular or subvalvular calcification. The decision to operate on an asymptomatic patient with severe primary MR and preserved LV and systolic function is complex and hinges critically on the likelihood of a successful, durable repair in the hands of an experienced mitral surgeon working in collaboration with intraoperative echocardiographic imaging experts.1Vahanian A. Alfieri O. Andreotti F. et al.Guidelines on the management of valvular heart disease (version 2012): The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio–Thoracic Surgery (EACTS).Eur Heart J. 2012; 33: 2451-2496Crossref PubMed Scopus (3185) Google Scholar, 2Nishimura R.A. Otto C.M. Bonow R.O. et al.2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: e57-e185Crossref PubMed Scopus (2084) Google Scholar, 17Chikwe J. Toyoda N. Anyanwu A.C. et al.Relation of mitral valve surgery volume to repair rate, durability, and survival.J Am Coll Cardiol. 2017 April 24; ([E-pub ahead of print])Crossref PubMed Scopus (158) Google Scholar In addition, the successful management of atrial fibrillation at the time of mitral valve surgery may require comprehensive approaches to ablation that are not widely practiced. The management of patients with AS should also be considered in the context of the appropriate level of care within an organized system. Transfemoral TAVR has become available in over 580 sites in the United States, but there remain nearly as many centers that only offer SAVR. Hence, access to TAVR technology, when considered preferable to operative intervention, may require directed referral to a partner institution or center. Patients who are not candidates for transfemoral TAVR may benefit from alternate access techniques, which might not be available at all TAVR sites. It is well-documented that the results of SAVR vary across sites.29D'Agostino R.S. Jacobs J.P. Badhwar V. et al.The Society of Thoracic Surgeons Adult Cardiac Surgery Database: 2016 update on outcomes and quality.Ann Thorac Surg. 2016; 101: 24-32Abstract Full Text Full Text PDF PubMed Scopus (72) Google Scholar, 30Shahian D.M. He X. Jacobs J.P. et al.The Society of Thoracic Surgeons Isolated Aortic Valve Replacement (AVR) Composite Score: a report of the STS Quality Measurement Task Force.Ann Thorac Surg. 2012; 94: 2166-2171Abstract Full Text Full Text PDF PubMed Scopus (89) Google Scholar The optimal performance of aortic valve surgery in some patients may require additional operative techniques. Patient-prosthetic mismatch is not uncommon in small patients who may receive small valves, resulting in compromised long-term outcomes. The expertise to perform more-complicated operations, including aortic valve repair, valve-sparing root reconstruction, root enlargement, composite valve graft replacement, ascending aortic/hemi-arch replacement, and myectomy for subvalvular obstruction, is not widespread, underscoring the need for a system of care that facilitates triaging such patients to the appropriate level. It is important that centers designated as having VHD expertise not only perform certain procedures, but also have MDTs capable of assessing and managing patients according to evidence-based guidelines while emphasizing SDM. The MDT and the valve center are responsible for maintaining performance standards and improving quality. Communication between centers and among referring providers is essential for fulfilling these responsibilities. Public reporting is a critical part of the continuous quality improvement process, and risk-adjusted results should be made available to referring physicians, patients, and families. The ACC convened the Evolving Valve Management Strategies Roundtable in December 2016. The Roundtable was a multidisciplinary effort to facilitate the identification of gaps and challenges in the care of patients with VHD and a component of the ACC’s Succeed in Managing Heart Disease Initiative. Multiple medical and surgical subspecialty stakeholders and advanced practice clinicians participated in the Roundtable. Also participating were representatives of government (ie, pre- and postmarket divisions of the Food and Drug Administration, Centers for Medicare and Medicaid Services, and National Institutes of Health), industry, integrated health systems, and patient groups, as well as systems of care experts from other specialties (stroke). The discussions identified support for the goals of providing patients with VHD access to an integrated system of care delivery, ensuring rigorous quality assessment and improvement, and focusing on patient-centered outcomes. As a result of these discussions, a writing committee was formed to create a proposal outlining the structure, processes, and essential components of an integrated system of care for VHD patients. The writing committee was composed of representatives from the AATS, ACC, ASE, SCAI, and STS. Existing organized and tiered systems of care for the treatment of several other acute disorders (trauma, stroke, S-T segment elevation myocardial infarction [STEMI]) and non-acute (bariatric surgery, cancer) were reviewed by the committee. A leading member of the Brain Attack Coalition had previously presented the elements of that system to the Roundtable. Where appropriate, the writing committee referred to multisocietal recommendations for operator and institutional procedural volumes, infrastructure, personnel, and reporting requirements. This document was built upon the 2014 AHA/ACC Guidelines for the Management of Patients with Valvular Heart Disease and its 2017 Focused Update, as well as other ACC documents, including the 2017 ACC Expert Consensus Decision Pathway for Transcatheter Aortic Valve Replacement, the 2017 ACC Expert Consensus Decision Pathway for Mitral Regurgitation, the ACC/AATS/AHA/ASE/EACTS/HVS/SCA/SCAI/SCCT/SCMR/STS 2017 Appropriate Use Criteria for the Treatment of Patients With Severe Aortic Stenosis, and the 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Operator and Institutional Recommendations and Requirements for Transcatheter Aortic Valve Replacement.31Nishimura R.A. Otto C.M. 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Brindis R.G. et al.2018 AATS/ACC/SCAI/STS expert consensus systems of care document: operator and institutional recommendations and requirements for transcatheter aortic valve replacement: a joint report of the American Association for Thoracic Surgery, the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.J Am Coll Cardiol. 2018 July 18; ([E-pub ahead of print])PubMed Google Scholar The format was based on the Donabedian model, which incorporates: (1) structure; (2) process; and (3) outcomes. The financial and political implications of developing a system of care for VHD patients were discussed, taking into account the tension between: (1) patient access to highly impactful yet expensive technology; and (2) the need to ensure highest-quality outcomes while minimizing cost, risks, and any potential unintended consequences. The work of the writing committee was supported exclusively by the ACC without commercial support. Writing committee