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.1, 2 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 U.S. population. Estimates of the prevalence of moderate or severe aortic or mitral disease in U.S. patients over the age of 75 years approach 4% and 10%, respectively.3 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 2050.4 The number of patients who will be eligible for TAVR is estimated to increase fourfold over the next 5 years.5, 6 Accordingly, implementation of optimal treatment strategies for patients with VHD will affect a sizable portion of the population.7 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 (e.g., 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 30–50% of patients with severe VHD who met guideline criteria for intervention were not appropriately recognized or referred,8-11 even in highly resourced environments.7, 12 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.13-15 However, repair rates for primary MR vary significantly among individual surgeons and across institutions.16-20 Although repair rates for primary MR have increased,21-24 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 Disease2 and the 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease.25 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. 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,26, 27 thereby improving outcomes. On the basis of experience in other disciplines, this proposal includes the adoption of two 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.1, 2, 17 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.28, 29 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 (i.e., premarket 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 nonacute (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.30-34 The format was based on the Donabedian model, which incorporates: (a) structure; (b) process; and (c) outcomes. The financial and political implications of developing a system of care for VHD patients were discussed, taking into account the tension between: (a) patient access to highly impactful yet expensive technology; and (b) 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 without commercial support. Writing committee members volunteered their time to this effort. Conference calls of the writing committee were confidential and attended only by committee members and society staff. A formal peer review process was completed consistent with ACC policy and included expert reviewers nominated by the ACC (see Appendix C). A public comment period was also provided to obtain additional perspective. Following reconciliation of all comments, this document was approved for publication by the ACC Clinical Policy Approval Committee, the AATS Council, the ASE Board of Directors, the SCAI Board of Directors, and the STS Executive Committee of the Board of Directors. Organized and tiered systems of care in other areas of medicine have been developed and embedded in the complex and large U.S. healthcare system. Often a key question is: what should constitute the designation of a center within a system as specialized and comprehensive? Examples of requirements for such a designation are available in multiple areas of medicine, both for acute problems (stroke, trauma, and myocardial infarction) and selected chronic disorders (bariatric surgery for obesity, adult congenital disease, pulmonary hypertension) (Table 1). Each system is different in terms of its intent and outcome; however, each is an organized and tiered system of care. These systems also differ with respect to accreditation and designation within a tiered structure. While this review focuses on specialized centers of care, there is no intent to diminish the important role played by clinicians at the primary care level who are responsible for initial recognition and triage of patients with VHD. American Society of Bariatric Surgery American College of Surgeons American College of Cardiology (D2B Alliance) American Heart Association (Mission: Lifeline) Basic Laboratory Cancer Center Cancer Centers Comprehensive Cancer Center Level I Level II Level III Level IV Acute Stroke-Ready hospital Primary Stroke Center Comprehensive Stroke Center STEMI-referral hospital (non-PCI capable) STEMI-receiving hospital (PCI-capable) The first U.S. Cancer Centers were established in 1960 by the National Institutes of Health, with the objective of addressing research and training.35 Currently, there are 70 specialized cancer centers across 35 states. Motivated by the wide variability in the quality of care and the disparate outcomes of patients with traumatic injuries, the American College of Surgeons published a statement in 197636 describing three tiers of trauma centers with graded infrastructure, personnel requirements, and site visits by an accreditation body. They proposed a coordinated network of centers, in which seriously injured patients could be transferred to a regional center with the highest available density of expert trauma services. The development of this network of specialized trauma centers has been associated with improved patient outcomes in both urban and rural areas.37, 38 Inspired by the successful outcomes achieved by the implementation of trauma centers, the Brain Attack Coalition proposed and implemented the establishment of multidisciplinary acute stroke centers. The Coalition has defined the components of Primary and Comprehensive Stroke Centers and of Acute Stroke-Ready Hospitals.26, 39, 40 This initiative established the foundation for accreditation of stroke centers. Based on the Brain Attack Coalition recommendations, different organizations (the Joint Commission, Det Norske Veritas Germanischer Lloyd, and Health Care Facilities Accreditation Program) have developed certification programs to recognize hospitals possessing the required infrastructure and personnel to best treat patients with stroke. Variability in surgical outcomes prompted the American Society of Bariatric Surgery and the American College of Surgeons to designate centers of excellence to standardize care and ensure high-quality management of morbidly obese patients undergoing weight reduction surgery.41 Similar to stroke centers, bariatric surgery centers participate in an accreditation process that was introduced to ensure that quality metrics are met. For patients with cardiovascular disease, the development of local networks to streamline and improve the treatment and outcomes of patients with acute STEMI spread widely in response to the recognition that reperfusion times were often inappropriately prolonged.42 To ensure the provision of optimal care, networks for patients with chronic cardiovascular diseases have also been established. For example, in the United Kingdom's National Health Service, congenital heart disease care has been redirected; three tiers of care, ranging from local to specialist surgical centers, have been organized to provide different levels of care according to patient need.43 In the United States, adult congenital heart disease centers (https://www.achaheart.org/provider-support/accreditation-program) as well as pulmonary hypertension centers (https://phassociation.org/phcarecenters/medical-professionals/center-criteria/) have been formally designated after meeting rigorous requirements upon external review. The European Society of Cardiology has issued a position paper on heart valve centers that mandates evaluation and care for all patients with VHD by dedicated physicians working in specialized environments.44 The aforementioned initiatives have had several effects, including: (a) increased access to high-quality care due to awareness of a system that designates centers as having met criteria (including quality metrics) for accreditation; (b) reduced mortality for trauma patients45; (c) decreased mortality and improved rates of timely tissue plasminogen activator (tPA) administration/mechanical reperfusion in appropriate patients with ischemic stroke34, 46; (d) improved safety and reduced costs for patients undergoing bariatric surgery47, 48; (e) improved guideline-directed therapy and outcomes in patients with STEMI49; and (f) recognition-based external accreditation using objective criteria and periodic reviews. By combining patient evaluations (history, physical examination, electrocardiogram, laboratory studies) with appropriate utilization of echocardiography,50 primary care and practice-level clinicians play a vital gatekeeper role within a system of care for VHD. Approximately 70% of all echocardiograms performed in Medicare beneficiaries are ordered by a noncardiologist provider.51 When significant VHD is suspected or confirmed, most patients should be referred to a local or regional cardiovascular specialist for further evaluation and management. The role of the primary care provider in recognizing VHD symptoms, initiating diagnostic testing, referring for specialized care, and establishing patient expectations cannot be overemphasized. It is also recognized that referral for specialized care may not be appropriate for certain patients. Therefore, defined pathways for patient referral that incorporate bidirectional communication between primary and subspecialty providers should be created. As the breadth of diagnostic approaches to VHD continues to expand (e.g., cardiac magnetic resonance, computed tomography [CT], 3-dimensional [3D] echocardiography, strain imaging), and as surgical and catheter-based treatment options continue to evolve, educational programs directed at the primary care provider assume increasing importance.11 Although electronic medical record systems have improved the communication of personal health information between primary and subspecialty care providers, the systematic integration of imaging data has generally not kept pace. A principal component of a well-designed system of care for VHD would be secure access to digital data of any diagnostic imaging procedure performed. This access would accelerate appropriate patient referrals, limit the need for repeat diagnostic procedures, and provide a platform to facilitate feedback on image quality. The roles of brief, simple, handheld echocardiographic scans during physical examinations (supported by machine learning algorithms to identify the potential need for a more detailed study) and alert notifications (e.g., suggesting referral to a specialist) on noninvasive imaging reports should also be considered. The proposed integrated model for a VHD system of care is shown in Figure 1. A Comprehensive (Level I) Valve Center should have the resources and capabilities to evaluate and perform all commercially approved interventional and surgical procedures. A Level I center should also have advanced imaging modalities (e.g., 3D echocardiography, cardiac magnetic resonance) that may not be available at a Level II center. A Primary (Level II) Valve Center should have, at a minimum, the expertise and resources to perform transfemoral TAVR and surgical procedures such as isolated SAVR. The ability to perform a durable mitral valve repair in patients with primary MR due to posterior leaflet pathology is desirable but not mandatory for a center to be defined as a Primary (Level II) Valve Center. If complex valve procedures are performed at the Primary (Level II) Valve Center, the same performance standards and expected outcomes as at a Comprehensive (Level I) Valve Center should be achieved. Patients can enter the system from multiple pathways. Each system of care should develop its own criteria for communication, feedback, and transfer. Level I and II Valve Centers should utilize the results of testing performed at referring practices and centers. Facilitation of long-term care of patients at the local level is of critical importance. The following sections of the document provide recommendations for Level I and II Valve Center designations in relation to: (a) structure; (b) process; and (c) outcomes. “Structure” consists of institutional facilities and infrastructure, personnel, and types of procedures. “Process” comprises the requirements and function of the MDT, including its participation in registries, research, and education. Finally, “outcomes” consists of a combination of the number of procedures performed and procedural success, morbidity, mortality, and QOL after intervention. Table 2 lists the recommended minimum procedural, institutional, and infrastructural requirements for the two levels of valve centers. Additional procedures may be performed at each center but are not required. Table 3 lists additional procedures that are not included in Table 2 but may be of benefit to selected subsets of patients with VHD. The major distinction between centers resides chiefly in the broader spectrum of services and higher density of expert personnel available at the Level I (Comprehensive) Center. Interventional cardiologists and cardiac surgeons at Comprehensive (Level I) and Primary (Level II) Valve Centers should have the expertise in catheter-based techniques necessary for evaluating and managing VHD. These include invasive hemodynamic assessment of VHD, coronary angiography and intervention, and peripheral vascular angiography and intervention. Additional expertise for the interventionalist at a Comprehensive (Level I) Valve Center includes atrial septal puncture and percutaneous closure of atrial septal defects. Proceduralists at all centers must be able to prevent, recognize, and treat complications and be skilled in coronary and peripheral vascular rescue and retrieval techniques (e.g., use of snares and forceps) for embolized devices; pericardiocentesis; and vascular access management, including use of covered end