2019 aats/acc/ase/scai/sts expert consensus systems of … · 2019-05-14 · cardiology (),...

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T H E A M E R I C A N C O L L E G E O F C A R D I O L O G Y F O U N D A T I O N , T H E A M E R I C A N S O C I E T Y O F

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EXPERT CONSENSUS SYSTEMS OF CARE DOCUMENT

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2019 AATS/ACC/ASE/SCAI/STSExpert Consensus Systems ofCare Document: A Proposal toOptimize Care for Patients WithValvular Heart DiseaseA 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
Writing Rick A. Nishimura, MD, MACC, Co-Chair*
Committee Patrick T. O’Gara, MD, MACC, Co-Chair*
Joseph E. Bavaria, MD, FACCyRalph G. Brindis, MD, MPH, MACC, FSCAI*John D. Carroll, MD, FACC, MSCAI*Clifford J. Kavinsky, MD, PHD, FACC, MSCAIzBrian R. Lindman, MD, MSC, FACC*Jane A. Linderbaum, RN, MS, APRN, CNP, AACC*Stephen H. Little, MD, FACC, FASExMichael J. Mack, MD, FACC*

0

This document was approved by the American Association for Thoracic Su

Approval Committee, American Society for Echocardiography (ASE) Boa

Interventions (SCAI) Board of Directors in October 2018. The Society o

December 2018.

The American College of Cardiology requests that this document be cited

Kavinsky CJ, Lindman BR, Linderbaum JA, Little SH, Mack MJ, Mauri L, Mira

consensus systems of care document: a proposal to optimize care for patient

Thoracic Surgery, American College of Cardiology, American Society of Ech

and Society of Thoracic Surgeons. J Am Coll Cardiol 2019;73:2609–35.

This article has been copublished in Catheterization and Cardiovascular I

Journal of Thoracic and Cardiovascular Surgery, and the Annals of Thoracic

Copies: This document is available on theWorldWide Web sites of the Ame

Cardiology (www.acc.org), American Society of Echocardiography (www.ase.o

and Society of Thoracic Surgeons (www.sts.org). For copies of this document, p

([email protected]).

Permissions: Multiple copies, modification, alteration, enhancement, and

permission of the American College of Cardiology. Requests may be comple

copyright/permissions).

Laura Mauri, MD, MSC, FACC*William R. Miranda, MD*David M. Shahian, MD, FACC, FACSyThoralf M. Sundt III, MD, FACCk

*American College of Cardiology representative. ySociety of Thoracic

Surgeons representative. zSociety for Cardiovascular Angiography and

Interventions representative. xAmerican Society of Echocardiography

representative. kAmerican Association for Thoracic Surgery

representative.

https://doi.org/10.1016/j.jacc.2018.10.007

rgery (AATS) Council, American College of Cardiology (ACC) Clinical Policy

rd of Directors, and the Society for Cardiovascular Angiography and

f Thoracic Surgeons Executive Committee approved the document in

as follows: Nishimura RA, O’Gara PT, Bavaria JE, Brindis RG, Carroll JD,

nda WR, Shahian DM, Sundt TM 3rd. 2019 AATS/ACC/ASE/SCAI/STS expert

s with valvular heart disease: a joint report of the American Association for

ocardiography, Society for Cardiovascular Angiography and Interventions,

nterventions, the Journal of the American Society of Echocardiography, the

Surgery.

rican Association for Thoracic Surgery (www.aats.org), American College of

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Nishimura et al. J A C C V O L . 7 3 , N O . 2 0 , 2 0 1 9

VHD Systems of Care Document M A Y 2 8 , 2 0 1 9 : 2 6 0 9 – 3 5

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TABLE OF CONTENTS 6.2. Process Components for Advanced HeartValve Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2620

PREAMBLE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2610

1. INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2611

1.1. Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2611

1.2. Statement of the Problem . . . . . . . . . . . . . . . . . . 2611

1.3. Purpose of the Document . . . . . . . . . . . . . . . . . . . 2612

1.4. Elements of the Model . . . . . . . . . . . . . . . . . . . . . 2612

Figure 1. Relationships Among Primary CareClinicians, General Cardiologists, andValve Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2613

2. METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2614

3. HISTORICAL PERSPECTIVE FROM OTHER

PROGRAMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2614

Table 1. Comprehensive/Advanced Care Centersin Other Areas of Medicine . . . . . . . . . . . . . . . . . . . . . 2615

4. PROPOSED STRUCTURE FOR AN INTEGRATED

MODEL OF CARE FOR PATIENTS WITH VHD . . . . 2615

4.1. Underlying Principles . . . . . . . . . . . . . . . . . . . . . . 2615

4.2. Role of the Primary Care Clinician . . . . . . . . . . . 2616

4.3. Comprehensive (Level I) and Primary (Level II)Valve Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2616

5. STRUCTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2617

5.1. Structural Requirements of All AdvancedValve Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2617

Table 2. Structure of Valve Centers . . . . . . . . . . 2618

Table 3. Additional Possible Catheter-BasedTherapies at Level I Centers . . . . . . . . . . . . . . . . 2619

5.2. Structural Components of AdvancedValve Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2617

5.2.1. Transcatheter Treatments . . . . . . . . . . . . . 2617

5.2.2. Cardiac Surgical Procedures . . . . . . . . . . . 2617

5.2.3. Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2619

5.2.4. Personnel, Institutional Facilities, andInfrastructure . . . . . . . . . . . . . . . . . . . . . . . 2619

Table 4. The Multidisciplinary Team—

Minimum Requirements . . . . . . . . . . . . . . . . . . . 2620

6. PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2620

6.1. Process Requirements for Advanced HeartValve Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2620

Table 5. Processes for Valve Centers . . . . . . . . . 2621

6.2.1. Function of the MDT . . . . . . . . . . . . . . . . . 2620

6.2.2. Registry Participation . . . . . . . . . . . . . . . . 2622

6.2.3. Research . . . . . . . . . . . . . . . . . . . . . . . . . . . 2622

6.2.4. Education . . . . . . . . . . . . . . . . . . . . . . . . . . 2622

6.2.5. Training . . . . . . . . . . . . . . . . . . . . . . . . . . . 2623

7. PERFORMANCE METRICS . . . . . . . . . . . . . . . . . . . . . 2623

7.1. Assessment of Quality of Care and Developmentof Performance Metrics for VHD Centers . . . . . . 2623

Figure 2. Categorization of Sites Based onTAVR Volume and Risk-Adjusted Mortality . . . . 2624

7.1.1. TAVR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2625

Table 6. TAVR Program Performance MinimumQuality Benchmarks . . . . . . . . . . . . . . . . . . . . . . . 2626

Table 7. TAVR Program Performance Criteria . . 2626

7.1.2. Surgical Mitral Valve Repair . . . . . . . . . . . . 2626

Table 8. Mitral Valve Repair PerformanceCriteria—For Primary Degenerative MR . . . . . . . 2627

7.2. Public Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . 2627

8. OBSTACLES AND CHALLENGES TO A

VHD SYSTEM OF CARE . . . . . . . . . . . . . . . . . . . . . . . 2628

9. SUMMARY AND NEXT STEPS . . . . . . . . . . . . . . . . . . 2628

PRESIDENTS AND STAFF . . . . . . . . . . . . . . . . . . . . . . . 2629

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2629

APPENDIX 1

Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2631

APPENDIX 2

Author Relationships With Industry andOther Entities (Relevant) . . . . . . . . . . . . . . . . . . . . . . . 2632

APPENDIX 3

Peer Reviewer Relevant RWI . . . . . . . . . . . . . . . . . . . . 2634

PREAMBLE

This statement was commissioned as aMultisociety ExpertConsensus Systems of Care Document by the AmericanAssociation for Thoracic Surgery (AATS), American Collegeof Cardiology (ACC), American Society of Echocardiogra-phy (ASE), Society for Cardiovascular Angiography andInterventions (SCAI), and Society of Thoracic Surgeons

J A C C V O L . 7 3 , N O . 2 0 , 2 0 1 9 Nishimura et al.M A Y 2 8 , 2 0 1 9 : 2 6 0 9 – 3 5 VHD Systems of Care Document

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(STS). Expert Consensus Systems of Care Documents areintended to summarize the position of these partneringorganizations on the availability, delivery, organization,and quality of cardiovascular care, with the intention ofestablishing appropriate benchmarks. These Systems ofCare Documents are overseen by the ACC Task Force onHealth Policy Statements and Systems of Care.

With the rapid evolution and dissemination of trans-catheter technologies, as well as advances in surgicalrepair and valve replacement techniques, there is animperative for the cardiovascular community to establishthe provider, institutional, and systems-based standardsfor delivery of high-quality valvular heart disease(VHD) care. The AATS, ACC, ASE, SCAI, and STS have,therefore, joined together to provide expert consensusand, wherever feasible, evidence-based recommendationsfor systems of care related to VHD, in the spirit of ensuringaccess to quality outcomes. The writing group anticipatesthat future updates to this consensus statement will benecessary as newer imaging and treatment technologiesbecome available and more data are generated regardingpatient outcomes, cost, and cost-effectiveness.

Dharam J. Kumbhani, MD, SM, FACCChair, ACC Task Force on Health Policy Statements and

Systems of Care

1. INTRODUCTION

1.1. Background

In the past decade, the evaluation and management ofpatients with VHD has changed dramatically. Advances innoninvasive imaging have enabled reliable, reproducible,and objective measurements of valve disease severity,along with an appreciation of any associated hemody-namic and structural consequences. There is enhancedunderstanding of the natural history of VHD basedupon longitudinal studies of large numbers of patientsthat have correlated outcomes with noninvasive mea-surements as well as with data obtained during exercisetesting. Advances in surgical techniques, especiallythose associated with valve repair; improved operativeresults; and perioperative management strategies havecontributed substantially to better patient outcomes.Transcatheter aortic valve replacement (TAVR) has revo-lutionized 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 anedge-to-edge clip device occupies a specific treatmentniche currently, and more options for this valve lesionare anticipated in the near future. Transcatheter mitralvalve replacement (TMVR) is the subject of intenseinvestigation, and tricuspid valve interventions in

high-surgical-risk patients are being developed. Collec-tively, these advances have led to an increasing numberof treatment options, lower thresholds for and earliertiming of intervention, and the provision of less-invasivetherapies to an older, sicker, and more frail population(1,2). As the number and complexity of VHD treatmentoptions have expanded, expert clinical judgment from anexperienced multidisciplinary team (MDT) has assumedincreasing importance.

The number of patients with significant VHD whocould benefit from appropriate intervention increases asa function of age. The elderly are the fastest growingsegment of the United States population. Estimates of theprevalence of moderate or severe aortic or mitral diseasein United States patients over the age of 75 years approach4% and 10%, respectively (3). The prevalence of moderateor severe VHD in a large-scale community screeningprogram of patients over age 65 years in the UnitedKingdom exceeded 11%, with a projected doubling before2050 (4). The number of patients who will be eligible forTAVR is estimated to increase 4-fold over the next 5 years(5,6). Accordingly, implementation of optimal treatmentstrategies for patients with VHD will affect a sizableportion of the population (7). Access to appropriate care iscritical, but as the complexity and cost of diagnosis andtreatment continues to increase, it will not be feasible forall institutions to provide the full complement of re-sources and clinical experts necessary to care for the fullspectrum of patients with VHD, while also ensuring thehighest-quality outcomes.

1.2. Statement of the Problem

Providing optimal care to patients with VHD is anincreasingly complex process, starting with early recog-nition and diagnosis at the primary care/general cardiol-ogy level and including appropriate timing of referral forfurther evaluation and management, MDT assessment,shared decision-making, and long-term follow-up. In thepast, intervention for VHD was often delayed until theonset of severe symptoms. It is now recognized that thelongstanding effects of VHD can lead to irreversiblechanges in left ventricular (LV) function, repeated hos-pitalizations, patient morbidity (e.g., atrial fibrillation,heart failure, endocarditis), reduced quality of life (QOL),and premature mortality, which can often be preventedby earlier treatment. However, prior studies estimatedthat nearly 30% to 50% of patients with severe VHD whomet guideline criteria for intervention were not appro-priately recognized or referred (8–11), even in highlyresourced environments (7,12).

There are an increasing number of treatment optionsavailable to patients with VHD; yet, not all patients areaware of or have access to the full spectrum of in-terventions. For most patients with severe primary MR,



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for example, it is well-recognized that mitral valve repairis superior to mitral valve replacement (13–15). However,repair rates for primary MR vary significantly among in-dividual surgeons and across institutions (16–20).Although repair rates for primary MR have increased (21–24), there remains concern that many patients withanatomy amenable to repair instead undergo valvereplacement, with adverse downstream consequencesrelated to LV dysfunction and the presence of valveprostheses. Similarly, some patients with symptomaticsevere AS, as well as their providers, may not be awarethat they would be eligible for TAVR due to the lack of asystem of care that might enable them to accesscomprehensive MDT consultation with all treatmentoptions being considered. Alternatively, TAVR may beinappropriately recommended when surgical aortic valvereplacement (SAVR), sometimes in combination withaortic or coronary bypass surgery, would be a better op-tion. Patients and referring providers may be unaware ofspecific physician competencies or experience, centervolumes, structure, processes, or outcomes. Other less-invasive procedures for selected valve-related problemsmay be performed only at certain institutions, such aspercutaneous closure of paravalvular leaks, alternative-access TAVR, and valve-in-valve procedures for degen-erated surgical bioprostheses. Ideally, personnel andresource restrictions at one institution should not negatethe opportunity for referral to another with a wider arrayof services and a more established MDT.

1.3. Purpose of the Document

The intent of this document is to propose a system of carefor patients with VHD, the primary goal of which would beto optimize outcomes for all patients and ultimatelyimprove the care of VHD at all centers. This approach isintended to increase the identification of patients withVHD and emphasize best practices as captured in the 2014AHA/ACC Guideline for the Management of Patients withValvular Heart Disease (2) and the 2017 AHA/ACC FocusedUpdate of the 2014 AHA/ACC Guideline for the Manage-ment of Patients With Valvular Heart Disease (25). It isalso intended to promote the efficient utilization of re-sources, facilitate communication and continuity of care,and emphasize the need for transparency in reporting ofand accountability for outcomes relative to nationalbenchmarks. The standards proposed for the optimalstructure and function of valve centers, as well as keyprocesses of care, mirror those in a companion 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Docu-ment: Operator and Institutional Recommendations andRequirements for Transcatheter Aortic Valve Replace-ment document (26). An interconnected system of pro-viders and institutions may help strike the right balancebetween access and quality outcomes. The case for

centers with the ability to offer more comprehensive careis logical, but it is critically important that patients andreferring clinicians be made aware of the quality of caredelivered in all centers. A major priority in optimizingVHD patient care is to identify and support centers withexcellent outcomes and improve outcomes at centerswhere opportunities exist, not simply to promote thosecenters with good reputations or large proceduralvolumes.

A systems approach to the management of patientswith VHD could help promote care among centers in amanner analogous to those adopted for the managementof other medical and surgical disorders such as stroke andtrauma (27,28), thereby improving outcomes. On the basisof experience in other disciplines, this proposal includesthe adoption of 2 tiers of valve centers, namely compre-hensive (Level I) and primary (Level II) valve centers, theattributes of which should be defined by objective criteria(Figure 1). The intent is not to limit the number of centersper se but rather to set performance and quality goals for avalve center to meet benchmarks to be considered eithercomprehensive or primary in a manner that would bemore objective than simple self-designation. The guidingprinciple in such a model would be to optimize the care ofthe individual patient by ensuring access to the right carein the right place at the right time, while promotingshared decision making (SDM) and respecting individualvalues and preferences. This principle can be applied tothe clinician who must identify the presence of poten-tially important VHD, to the primary center providinglocal care for several conditions, and to the comprehen-sive center offering the full spectrum of services. Anysuch system of care should allow patients to be cared forat the appropriate level, promote seamless transitionsbetween different levels of care when necessary, andplace a premium on communication and shared learning.Patients with VHD should be informed of their treatmentoptions, including those not routinely offered locally orthrough their health plan, and be given the opportunity topursue alternatives according to their own expectationsand preferences. The geographical, cultural, and financialbarriers to establishing a system of care are recognized;yet the rational dissemination of complex care modelsfounded on the principle of highest-quality outcomes thatmatter to patients remains an important goal.

1.4. Elements of the Model

Knowledge of VHD pathophysiology and natural history,the essentials of patient assessment, and the range ofavailable treatment options is expected across all levels ofproviders. Current knowledge and performance gapsaround recognition and treatment relate to the decline inphysical examination skills and a lack of appreciation ofthe improvement in outcomes seen in patients previously

FIGURE 1 Relationships Among Primary Care Clinicians, General Cardiologists, and Valve Centers


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deemed too ill or frail for intervention. It is the re-sponsibility of professional societies and individual valvecenters to provide education, support, and guidance forthe appropriate management of VHD patients and tominimize any such gaps. Many sections of the 2014 AHA/ACC Guidelines for the Management of Patients withValvular Heart Disease and its 2017 AHA/ACC FocusedUpdate of the 2014 AHA/ACC Guideline for the Manage-ment of PatientsWith Valvular Heart Disease are a resourcefor the primary care physician/general cardiologist. Inaddition, there are several ongoing ACC efforts to provideconcise and relevant tools for VHD patient diagnosis andtreatment, including the Managing Aortic Stenosis andEmerging Mitral Regurgitation Clinical Care initiatives.

The proposed system of care would typically begin atthe local level, with community providers and primary(Level II) valve centers communicating openly andcollaborating with a comprehensive (Level I) center(Figure 1). Ideally, patient movement within such a sys-tem would be predicated on the desire to match thecomplexity of disease with the appropriate resourceswhile placing a premium on maintaining relationshipsbetween patients and their longstanding healthcareproviders.

For example, there are patients with primary MR whomight benefit from referral to the highest level of VHDcare. Patients with severe primary MR may have complexvalve pathology that makes durable surgical repair tech-nically challenging, such as anterior leaflet or bileafletdisease, Barlow’s disease, or extensive annular or sub-valvular calcification. The decision to operate on anasymptomatic patient with severe primary MR and pre-served LV and systolic function is complex and hingescritically on the likelihood of a successful, durable repair

in the hands of an experienced mitral surgeon workingin collaboration with intraoperative echocardiographicimaging experts (1,2,17). In addition, the successful man-agement of atrial fibrillation at the time of mitral valvesurgery may require comprehensive approaches to abla-tion that are not widely practiced.

The management of patients with AS should also beconsidered in the context of the appropriate level of carewithin an organized system. Transfemoral TAVR hasbecome available in over 580 sites in the United States,but there remain nearly as many centers that only offerSAVR. Hence, access to TAVR technology, when consid-ered preferable to operative intervention, may requiredirected referral to a partner institution or center. Pa-tients who are not candidates for transfemoral TAVR maybenefit from alternate access techniques, which might notbe available at all TAVR sites. It is well-documented thatthe results of SAVR vary across sites (29,30). The optimalperformance of aortic valve surgery in some patients mayrequire additional operative techniques. Patient-prosthetic mismatch is not uncommon in small patientswho may receive small valves, resulting in compromisedlong-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 subvalvularobstruction, is not widespread, underscoring the need fora system of care that facilitates triaging such patients tothe appropriate level.

It is important that centers designated as havingVHD expertise not only perform certain procedures, butalso have MDTs capable of assessing and managingpatients according to evidence-based guidelines while



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emphasizing SDM. The MDT and the valve center areresponsible for maintaining performance standards andimproving quality. Communication between centers andamong referring providers is essential for fulfilling theseresponsibilities. Public reporting is a critical part of thecontinuous quality improvement process, and risk-adjusted results should be made available to referringphysicians, patients, and families.

2. METHODS

The ACC convened the Evolving Valve ManagementStrategies Roundtable in December 2016. The Roundtablewas a multidisciplinary effort to facilitate the identifica-tion of gaps and challenges in the care of patients withVHD and a component of the ACC’s Succeed in ManagingHeart Disease Initiative. Multiple medical and surgicalsubspecialty stakeholders and advanced practice clini-cians participated in the Roundtable. Also participatingwere representatives of government (i.e., pre- and post-market divisions of the Food and Drug Administration,Centers for Medicare and Medicaid Services, and NationalInstitutes of Health), industry, integrated health systems,and patient groups, as well as systems of care expertsfrom other specialties (stroke). The discussions identifiedsupport for the goals of providing patients with VHD ac-cess to an integrated system of care delivery, ensuringrigorous quality assessment and improvement, andfocusing on patient-centered outcomes. As a result ofthese discussions, a writing committee was formed tocreate a proposal outlining the structure, processes, andessential components of an integrated system of care forVHD patients.

The writing committee was composed of representa-tives from the AATS, ACC, ASE, SCAI, and STS. Existingorganized and tiered systems of care for the treatment ofseveral other acute disorders (trauma, stroke, S-Tsegment elevation myocardial infarction [STEMI]) andnon-acute (bariatric surgery, cancer) were reviewed bythe committee. A leading member of the Brain AttackCoalition had previously presented the elements of thatsystem to the Roundtable. Where appropriate, the writingcommittee referred to multisocietal recommendations foroperator and institutional procedural volumes, infra-structure, personnel, and reporting requirements. Thisdocument was built upon the 2014 AHA/ACC Guidelinesfor the Management of Patients with Valvular HeartDisease and its 2017 Focused Update, as well as other ACCdocuments, including the 2017 ACC Expert ConsensusDecision Pathway for Transcatheter Aortic ValveReplacement, the 2017 ACC Expert Consensus DecisionPathway for Mitral Regurgitation, the ACC/AATS/AHA/ASE/EACTS/HVS/SCA/SCAI/SCCT/SCMR/STS 2017 Appro-priate Use Criteria for the Treatment of Patients With

Severe Aortic Stenosis, and the 2018 AATS/ACC/SCAI/STSExpert Consensus Systems of Care Document: Operatorand Institutional Recommendations and Requirementsfor Transcatheter Aortic Valve Replacement (26,31–34).

The format was based on the Donabedian model, whichincorporates: 1) structure; 2) process; and 3) outcomes.The financial and political implications of developing asystem of care for VHD patients were discussed, takinginto account the tension between: 1) patient access tohighly impactful yet expensive technology; and 2) theneed to ensure highest-quality outcomes while mini-mizing cost, risks, and any potential unintendedconsequences.

The work of the writing committee was supportedexclusively by the ACC without commercial support.Writing committee members volunteered their time tothis effort. Conference calls of the writing committeewere confidential and attended only by committeemembers and society staff. A formal peer review processwas completed consistent with ACC policy and includedexpert reviewers nominated by the ACC (see Appendix 3).A public comment period was also provided to obtainadditional perspective. Following reconciliation of allcomments, this document was approved for publicationby the ACC Clinical Policy Approval Committee, the AATSCouncil, the ASE Board of Directors, the SCAI Board ofDirectors, and the STS Executive Committee of the Boardof Directors.

3. HISTORICAL PERSPECTIVE FROM

OTHER PROGRAMS

Organized and tiered systems of care in other areas ofmedicine have been developed and embedded in thecomplex and large U.S. healthcare system. Often a keyquestion is: what should constitute the designation of acenter within a system as specialized and comprehensive?Examples of requirements for such a designation areavailable in multiple areas of medicine, both for acuteproblems (stroke, trauma, and myocardial infarction) andselected chronic disorders (bariatric surgery for obesity,adult congenital disease, pulmonary hypertension)(Table 1). Each system is different in terms of its intentand outcome; however, each is an organized and tieredsystem of care. These systems also differ with respect toaccreditation 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 byclinicians at the primary care level who are responsible forinitial recognition and triage of patients with VHD.

The first U.S. Cancer Centers were established in 1960by the National Institutes of Health, with the objective ofaddressing research and training (35). Currently, there are70 specialized cancer centers across 35 states. Motivated

TABLE 1 Comprehensive/Advanced Care Centers in Other Areas of Medicine

Cancer Trauma Stroke Bariatric Surgery STEMI

Year Initiated 1960 1976 2001 2005 2006/2007

SponsoringOrganization

National Institutes ofHealth

American College ofSurgeons

Brain Attack Coalition American Society ofBariatric Surgery

American College ofSurgeons

American College of Cardiology(D2B Alliance)

American Heart Association(Mission: Lifeline)

Levels of Care Basic Laboratory CancerCenter

Cancer CentersComprehensive Cancer

Center

Level ILevel IILevel IIILevel IV

Acute Stroke-Readyhospital

Primary Stroke CenterComprehensive Stroke

Center

Bariatric Surgery Center ofExcellence

STEMI-referral hospital(non-PCI capable)

STEMI-receiving hospital(PCI-capable)

D2B indicates Door to Balloon; PCI, percutaneous coronary intervention; and STEMI, ST-segment elevation myocardial infarction.


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by the wide variability in the quality of care and thedisparate outcomes of patients with traumatic injuries,the American College of Surgeons published a statementin 1976 (36) describing 3 tiers of trauma centers withgraded infrastructure, personnel requirements, and sitevisits by an accreditation body. They proposed a coordi-nated network of centers, in which seriously injured pa-tients could be transferred to a regional center with thehighest available density of expert trauma services. Thedevelopment of this network of specialized trauma cen-ters has been associated with improved patient outcomesin both urban and rural areas (37,38).

Inspired by the successful outcomes achieved by theimplementation of trauma centers, the Brain Attack Coa-lition proposed and implemented the establishment ofmultidisciplinary acute stroke centers. The Coalition hasdefined the components of Primary and ComprehensiveStroke Centers and of Acute Stroke-Ready Hospitals(27,39,40). This initiative established the foundation foraccreditation of stroke centers. Based on the Brain AttackCoalition recommendations, different organizations (theJoint Commission, Det Norske Veritas GermanischerLloyd, and Health Care Facilities Accreditation Program)have developed certification programs to recognize hos-pitals possessing the required infrastructure andpersonnel to best treat patients with stroke.

Variability in surgical outcomes prompted the Amer-ican Society of Bariatric Surgery and the American Collegeof Surgeons to designate centers of excellence to stan-dardize care and ensure high-quality management ofmorbidly obese patients undergoing weight reductionsurgery (41). Similar to stroke centers, bariatric surgerycenters participate in an accreditation process that wasintroduced to ensure that quality metrics are met.

For patients with cardiovascular disease, the develop-ment of local networks to streamline and improvethe treatment and outcomes of patients with acuteSTEMI spread widely in response to the recognitionthat reperfusion times were often inappropriatelyprolonged (42). To ensure the provision of optimal care,networks for patients with chronic cardiovascular diseases

have also been established. For example, in the UnitedKingdom’s National Health Service, congenital heartdisease care has been redirected; 3 tiers of care, rangingfrom local to specialist surgical centers, have beenorganized to provide different levels of care accordingto patient need (43). In the United States, adultcongenital heart disease centers (https://www.achaheart.org/provider-support/accreditation-program) as well aspulmonary hypertension centers (https://phassociation.org/phcarecenters/medical-professionals/center-criteria/)have been formally designated after meeting rigorousrequirements upon external review. The European Societyof Cardiology has issued a position paper on heart valvecenters that mandates evaluation and care for all patientswith VHD by dedicated physicians working in specializedenvironments (44).

The aforementioned initiatives have had severaleffects, including: 1) increased access to high-quality caredue to awareness of a system that designates centersas having met criteria (including quality metrics) foraccreditation; 2) reduced mortality for trauma patients(45); 3) decreased mortality and improved rates of timelytissue plasminogen activator (tPA) administration/mechanical reperfusion in appropriate patients withischemic stroke (26,46); 4) improved safety and reducedcosts for patients undergoing bariatric surgery (47,48);5) improved guideline-directed therapy and outcomesin patients with STEMI (49); and 6) recognition-basedexternal accreditation using objective criteria and peri-odic reviews.

4. PROPOSED STRUCTURE FOR AN INTEGRATED

MODEL OF CARE FOR PATIENTS WITH VHD

4.1. Underlying Principles

The development of an integrated model of care forpatients with VHD is based on the concept of a graduatedsystem in which the first tier has the critical function ofrecognition and consideration of referral. Subsequently,the patient is matched on the basis of disease complexitywith the required center expertise, experience, and

https://www.achaheart.org/provider-support/accreditation-program

https://www.achaheart.org/provider-support/accreditation-program

https://phassociation.org/phcarecenters/medical-professionals/center-criteria/

https://phassociation.org/phcarecenters/medical-professionals/center-criteria/



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availability of resources. The following principles areemphasized:

n The primary goal is to improve the care of all patientswith VHD.

n The first step is recognition and subsequent diagnosisof VHD, usually by a primary care physician, advancedpractice provider, or general cardiologist.

n The second step often involves referral to a local gen-eral cardiologist who can further refine the diagnosis,initiate medical therapy as indicated, and identifythose who can be managed for the time being withoutfurther intervention or who may need more specializedcare such as surgery or transcatheter valve repair orreplacement.

n Access to specialized care requires establishmentof well-defined referral lines to centers having gradu-ated levels of expertise and resources (Figure 1).Increasing disease complexity often requires higher-order, comprehensive care at a Level I center, whereasless complex disease can be managed at a Level IIcenter.

n A Multidisciplinary Team (MDT) and an emphasis onpatient shared decision-making are essential to theoperations of both Level I and II valve centers.

n Full institutional support is required for provision ofappropriate imaging and procedural resources, equityamong the individual stakeholders of the MDT, carepathways that span the continuum, registry participa-tion, and results reporting.

n Transparency, public reporting, mandatory participa-tion in national registries, ongoing analysis of processesand outcomes, and a commitment to research areessential.

n Bidirectional communication and ongoing education ofmembers of the MDT and the community of referringproviders/centers are required to improve the quality ofcare in all settings.

n Processes of care should emphasize informed consent(information provided in various formats and lan-guages), SDM, patient experiences, and individualchoices.

4.2. Role of the Primary Care Clinician

By combining patient evaluations (history, physicalexamination, electrocardiogram, laboratory studies) withappropriate utilization of echocardiography (50), primarycare and practice-level clinicians play a vital gatekeeperrole within a system of care for VHD. Approximately 70%of all echocardiograms performed in Medicare benefi-ciaries are ordered by a noncardiologist provider (51).When significant VHD is suspected or confirmed,most patients should be referred to a local or regionalcardiovascular specialist for further evaluation and

management. The role of the primary care provider inrecognizing VHD symptoms, initiating diagnostic testing,referring for specialized care, and establishing patientexpectations cannot be overemphasized. It is alsorecognized that referral for specialized care may notbe appropriate for certain patients. Therefore, definedpathways for patient referral that incorporate bidirec-tional communication between primary and subspecialtyproviders should be created. As the breadth of diagnosticapproaches to VHD continues to expand (e.g., cardiacmagnetic resonance, computed tomography [CT], 3-dimensional [3D] echocardiography, strain imaging), andas surgical and catheter-based treatment options continueto evolve, educational programs directed at the primarycare provider assume increasing importance (11).

Although electronic medical record systems haveimproved the communication of personal health infor-mation between primary and subspecialty care providers,the systematic integration of imaging data has generallynot kept pace. A principal component of a well-designedsystem of care for VHD would be secure access to digitaldata of any diagnostic imaging procedure performed. Thisaccess would accelerate appropriate patient referrals,limit the need for repeat diagnostic procedures, and pro-vide a platform to facilitate feedback on image quality.The roles of brief, simple, handheld echocardiographicscans during physical examinations (supported by ma-chine learning algorithms to identify the potential needfor a more detailed study) and alert notifications (e.g.,suggesting referral to a specialist) on noninvasive imagingreports should also be considered.

4.3. Comprehensive (Level I) and Primary (Level II)Valve Centers

The proposed integrated model for a VHD system of careis shown in Figure 1. A Comprehensive (Level I) ValveCenter should have the resources and capabilities toevaluate and perform all commercially approved inter-ventional and surgical procedures. A Level I center shouldalso have advanced imaging modalities (e.g., 3D echo-cardiography, cardiac magnetic resonance) that may notbe available at a Level II center. A Primary (Level II) ValveCenter should have, at a minimum, the expertise andresources to perform transfemoral TAVR and surgicalprocedures such as isolated SAVR. The ability to performa durable mitral valve repair in patients with primaryMR due to posterior leaflet pathology is desirable butnot mandatory for a center to be defined as a Primary(Level II) Valve Center. If complex valve proceduresare performed at the Primary (Level II) Valve Center, thesame performance standards and expected outcomes asat a Comprehensive (Level I) Valve Center should beachieved. Patients can enter the system from multiplepathways. Each system of care should develop its own


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criteria for communication, feedback, and transfer.Level I and II Valve Centers should utilize the results oftesting performed at referring practices and centers.Facilitation of long-term care of patients at the locallevel is of critical importance.

The following sections of the document providerecommendations for Level I and II Valve Centerdesignations in relation to: 1) structure; 2) process; and3) outcomes. “Structure” consists of institutional facilitiesand infrastructure, personnel, and types of procedures.“Process” comprises the requirements and function ofthe MDT, including its participation in registries,research, and education. Finally, “outcomes” consists ofa combination of the number of procedures performedand procedural success, morbidity, mortality, and QOLafter intervention.

5. STRUCTURE

5.1. Structural Requirements of All Advanced Valve Centers

Table 2 lists the recommended minimum procedural,institutional, and infrastructural requirements for the2 levels of valve centers. Additional procedures maybe performed at each center but are not required. Table 3lists additional procedures that are not included in Table 2but may be of benefit to selected subsets of patients withVHD. The major distinction between centers resideschiefly in the broader spectrum of services and higherdensity of expert personnel available at the Level I(Comprehensive) Center.

5.2. Structural Components of Advanced Valve Centers

5.2.1. Transcatheter Treatments

Interventional cardiologists and cardiac surgeons atComprehensive (Level I) and Primary (Level II) ValveCenters should have the expertise in catheter-basedtechniques necessary for evaluating and managing VHD.These include invasive hemodynamic assessment of VHD,coronary angiography and intervention, and peripheralvascular angiography and intervention. Additionalexpertise for the interventionalist at a Comprehensive(Level I) Valve Center includes atrial septal puncture andpercutaneous closure of atrial septal defects. Procedur-alists at all centers must be able to prevent, recognize,and treat complications and be skilled in coronaryand 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 endovascular stents. Collec-tively, these skills provide necessary support for catheter-based valve therapies. Beyond technical and proceduralskills, the valve interventionalist must also developexpertise related to patient selection, including knowl-edge of the natural history of VHD, optimal timing for

interventions, appropriate judgment about anticipatedrisks and benefits of an intervention, and the ability todetermine the appropriate therapy for a specific pathol-ogy. These physicians should have the knowledge andskills to participate in SDM with patients and families.

The interventional procedural requirements forComprehensive (Level I) and Primary (Level II) ValveCenters are outlined in Table 2. Proceduralists at bothComprehensive (Level I) and Primary (Level II) ValveCenters should be able to perform TAVR using a trans-femoral approach and percutaneous balloon aortic valvedilation.

Comprehensive (Level I) Valve Centers should alsohave the personnel and facilities to perform alternative-access (nontransfemoral) site TAVR, including trans-thoracic and extrathoracic approaches. The additionalexpertise and procedural volumes at a Comprehensive(Level I) Valve Center would be expected to reduce therisk of complications related to nonfemoral access. Valve-in-valve procedures for degenerated aortic and mitralbioprosthetic valves should be available at a Compre-hensive (Level I) Valve Center. Selected operators at aComprehensive (Level I) Valve Center should be profi-cient in performing transcatheter mitral valve repair usingthe edge-to-edge technique, as well as percutaneousmitral balloon commissurotomy. Percutaneous closure ofparavalvular leaks should be offered by the Comprehen-sive (Level I) Valve Center. Other procedures might beperformed by the Comprehensive (Level I) Valve Center,such as left atrial appendage occlusion, complex septaldefect closures, and alcohol septal ablation. Emergingtherapies, including transcatheter mitral valve replace-ment, next-generation transcatheter mitral valve repairs,and tricuspid valve procedures, are not required but willlikely be performed at a Comprehensive (Level I) ValveCenter participating in ongoing investigational devicestudies. If a Primary (Level II) Center offers additionalprocedures that might traditionally be provided at aComprehensive (Level I) Center, the same quality andoutcome reporting requirements should be maintained.

5.2.2. Cardiac Surgical Procedures

Both Comprehensive (Level I) and Primary (Level II) ValveCenters are expected to perform isolated SAVR with orwithout coronary artery bypass grafting. A Comprehen-sive (Level I) Valve Center should have the personnel andresources for performing more complex surgical proced-ures to treat other subsets of patients with VHD. Thebenefit of performing these procedures at Comprehensive(Level I) Centers extends beyond merely technicalexpertise and higher volumes. The composition of theMDT, as well as infrastructural and institutional re-sources, can be leveraged to optimize decision makingand clinical care and to strengthen clinical training

TABLE 2 Structure of Valve Centers

Comprehensive (Level I)Valve Center

Primary (Level II)Valve Center

Interventional Procedures*

TAVR–transfemoral TAVR–transfemoral

Percutaneous aortic valve balloondilation

Percutaneous aortic valve balloondilation

TAVR–alternative access, includingtransthoracic (transaortic,transapical) and extrathoracic(e.g., subclavian, carotid, caval)approaches

Valve-in-valve procedures

Transcatheter edge-to-edgemitral valve repair

Paravalvular leak closure

Percutaneous mitral ballooncommissurotomy

Surgical Procedures*

SAVR SAVR

Valve-sparing aortic root procedures

Aortic root procedures foraneurysmal disease

Concomitant septal myectomywith AVR

Root enlargement with AVR

Mitral repair for primary MR Mitral repair for posterior leafletprimary MR†

Mitral valve replacement‡ Mitral valve replacement‡

Multivalve operations

Reoperative valve surgery

Isolated or concomitant tricuspidvalve repair or replacement

Concomitant tricuspid valve repair orreplacement with mitral surgery

Imaging Personnel

Echocardiographer with expertise invalve disease and transcatheterand surgical interventions

Echocardiographer with expertise invalve disease and transcatheter andsurgical interventions

Expertise in CT with application tovalve assessment and proceduralplanning

Expertise in CT with application to valveassessment and procedural planning

Interventional echocardiographer toprovide imaging guidance fortranscatheter and intraoperativeprocedures (52)

Expertise in cardiac MRI withapplication to assessment of VHD

Criteria for Imaging Personnel

A formalized role/position for a “valveechocardiographer” who performsboth the pre- and postproceduralassessment of valve disease

A formalized role/position for a “valveechocardiographer” who performsboth the pre- and postproceduralassessment of valve disease

A formalized role/position for theexpert in CT who oversees thepreprocedural assessment ofpatients with valve disease

A formalized role/position for theexpert in CT who oversees thepreprocedural assessment ofpatients with valve disease

A formalized role/position for aninterventional echocardiographer

Continued in the next column

TABLE 2 Continued

Comprehensive (Level I)Valve Center

Primary (Level II)Valve Center

Institutional Facilities and Infrastructure

MDT (Table 3) MDT (Table 3)

A formalized role/position for adedicated valve coordinatorwho organizes care across thecontinuum and system of care

A formalized role/position for adedicated valve coordinator whoorganizes care across the continuumand system of care

Cardiac anesthesia support Cardiac anesthesia support

Palliative care team Palliative care team

Vascular surgery support Vascular surgery support

Neurology stroke team Neurology stroke team

Consultative services with othercardiovascular subspecialties(see Section 5.2.4 Personnel,Institutional Facilities, andInfrastructure)

Consultative services withother medical andsurgical subspecialties(see Section 5.2.4 Personnel,Institutional Facilities,and Infrastructure)

Echocardiography–3D TEE;comprehensive TTE forassessment of valve disease

Echocardiography–comprehensive TTEfor assessment of valve disease

Cardiac CT Cardiac CT

ICU ICU

Temporary mechanical support(including percutaneous supportdevices such as intra-aorticballoon counterpulsation,temporary percutaneousventricular assist deviceor ECMO)

Temporary mechanical support(including percutaneous supportdevices such as intra-aortic ballooncounterpulsation, temporarypercutaneous ventricular assistdevice or ECMO)

Left/right ventricular assist devicecapabilities (on-site or at anaffiliated institution)

Cardiac catheterization laboratory,hybrid catheterization laboratory,or hybrid OR laboratory§

Cardiac catheterization laboratory

PPM and ICD implantation PPM and ICD implantation

Criteria for Institutional Facilities and Infrastructure

IAC echocardiography laboratoryaccreditation

IAC echocardiography laboratoryaccreditation

24/7 intensivist coverage for ICU

*A Primary (Level II) Center may provide additional procedures traditionally offered at aComprehensive (Level I) Center as long as the criteria for competence and outcomes aremet.†If intraoperative imaging and surgical expertise exist.‡If mitral valve anatomy is not suitable for valve repair.§Equipped with a fixed radiographic imaging system and flat-panel fluoroscopy, of-fering catheterization laboratory-quality imaging and hemodynamic capability.

AVR indicates aortic valve replacement; CT, computed tomography; ECMO, extra-corporeal membrane oxygenation; ICD, implantable cardioverter defibrillator; IAC,Intersocietal Accreditation Commission; ICU, intensive care unit; MDT, multidisciplinaryteam; MR, mitral regurgitation; MRI, magnetic resonance imaging; OR operating room;PPM, permanent pacemaker; SAVR, surgical aortic valve replacement; TAVR, trans-catheter aortic valve replacement; TEE, transesophageal echocardiography; TTE,transthoracic echocardiography; and VHD, valvular heart disease.



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TABLE 3Additional Possible Catheter-Based Therapiesat Level I Centers

Left atrial appendage closure

ASD or VSD closure

Alcohol septal ablation

Mitral valve replacement, mitral valve repair with techniques other thanedge-to-edge clip system (currently investigational devices)

Tricuspid valve repair

Pulmonary balloon valvotomy or valve replacement

ASD indicates atrial septal defect; and VSD, ventricular septal defect.


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around complex VHD patients. Advanced surgical exper-tise is required to perform complex aortic root proced-ures, including composite valve root replacement andvalve-sparing root repair. A Comprehensive (Level I)Center should also house the surgical skill and resourcesto treat patients with complicated infective endocarditis.In patients with AS who have concomitant septal hyper-trophy, a myectomy at the time of SAVR is sometimesnecessary to prevent dynamic outflow tract obstruction.Root enlargement to allow for larger-sized prostheticvalves should be available for patients with small annulussizes. Successful repair of mitral valve disease, includingdurable repair not only for primary MR involving theposterior leaflet, but also for anterior leaflet prolapse,bileaflet prolapse, and Barlow’s disease, should be offeredat the Comprehensive (Level I) Valve Center. Repair ofposterior leaflet prolapse might also be offered at a Pri-mary (Level II) Valve Center depending on the level ofsurgical and imaging expertise and experience. Surgicalmitral valve replacement should be available at bothLevel I and II centers. Annuloplasty repair of tricuspidregurgitation is often a straightforward addition to mitralrepair in appropriate patients. The evaluation and surgi-cal management (repair or replacement) of severe, sec-ondary MR with regional or global LV systolicdysfunction, however, can be challenging and, for somepatients, may be more appropriate at a Level I Center.Multivalve operations (other than simple annuloplastytricuspid repair added to mitral valve surgery), reoper-ative valve surgery, operations for prosthetic valveendocarditis, and hybrid transcatheter/surgical proced-ures are likely better suited for a Comprehensive (Level I)Valve Center.

5.2.3. Imaging

Consistent, high-quality imaging and interpretation arecritical to evaluation, management, and proceduralguidance for patients with VHD. Accurate echocardio-graphic assessment of the etiology and severity of VHD isoften the pivotal first step in management. Valve centersrequire an echocardiographer with expertise in valvedisease, which includes an understanding of pitfalls in

assessing valve lesion severity; quantification of lesionseverity; evaluation of complex, multivalve disease;determination of anatomic suitability and proceduralsuccess for both catheter-based and surgical procedures;and identification of postprocedural complications.

Although echocardiography is the primary imagingmodality for assessing VHD, cardiac and vascular CT hasbecome an indispensable tool for appropriate planning oftranscatheter interventions. Cardiac magnetic resonanceimaging is increasingly used to assess regurgitant lesionseverity and ventricular function. High-quality CT imageacquisition, post-processing, and 3D reconstruction areminimum requirements. Accurate measurements ofintracardiac and vascular access route dimensions arecritical.

As treatment options rapidly expand for VHD, a newspecialty of interventional echocardiography is emerging(52). Interventional echocardiographers blend a sophisti-cated knowledge of echocardiography with clinicalexpertise and can help guide management decisions atthe point of intervention. They have become integral tothe high performance of any MDT, especially at Compre-hensive (Level I) Centers. The interventional echocardi-ographer is a critical participant in select valve cases (e.g.,transcatheter mitral valve repair and repair of para-valvular leaks). Effectiveness in this role requires an in-dividual who has regular involvement in these proceduresand thus is familiar with the devices and procedural steps,is competent to provide interventionalists with imagingguidance for transcatheter procedures, understands howechocardiography can help avoid or identify proceduralcomplications, recognizes the unique echocardiographiccharacteristics of transcatheter devices and delivery sys-tems, is proficient with 3D imaging, and understands thetreatment goals of transcatheter valve procedures.

Although it is important that advanced imagingexpertise be readily available at Comprehensive (Level I)and Primary (Level II) Valve Centers, personnel repre-senting these imaging areas may vary between centers.Both cardiologists and cardiac anesthesiologists shouldhave the knowledge and skills to perform and interpretprocedure-based transesophageal echocardiograms,particularly if they are board certified in echocardiogra-phy. Cardiovascular imaging specialists provide advancedCT services in most institutions.

5.2.4. Personnel, Institutional Facilities, and Infrastructure

Complications are best managed, and outcomes opti-mized, by the provision of appropriate facilities and thetimely availability of relevant support teams. Compliancewith this basic principle requires an institutionalcommitment similar in scope to other interdisciplinarycardiovascular service lines such as heart transplantationand mechanical circulatory support programs. All centers

TABLE 4The Multidisciplinary Team—MinimumRequirements

n Interventional cardiologistn Cardiac surgeonn Echocardiographic and radiographic image specialist*n Clinical cardiology valve expertise*n Heart failure specialist†n Cardiovascular anesthesiologistn Nurse practitioner/physician assistant for pre- and periprocedural care

and MDT consultsn Valve coordinator/program navigatorn Institutionally supported data manager for STS/ACC TVT Registryn Hospital administration representative as necessary

*A single individual may provide both clinical and imaging expertise.†For patients with heart failure due to LV systolic dysfunction and secondary MR.

ACC indicates American College of Cardiology; MDT, multidisciplinary team; STS,Society of Thoracic Surgeons; TAVR, transcatheter aortic valve repair; and TVT, trans-catheter valve therapy.



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should have a formal MDT composed of personnel withexpertise in managing patients with VHD, including adedicated valve program coordinator (Table 4). Thereshould be a dedicated educational and support systemthat can help patients navigate the SDM process witheducational aides to explain their options. Both Level Iand II Valve Centers should have medical/interventionaland surgical codirectors who are committed and trainedto provide care to patients with VHD, as well as adequatenumbers of cardiologists, interventionalists, surgeons,imagers, and anesthesiologists with expertise in cardiacvalve disease. For patients presenting with heart failuredue to LV systolic dysfunction and secondary MR, a heartfailure specialist should be part of the MDT. Depending onthe size of the program and its participation in research,advanced practice providers, nurses, and research co-ordinators may also play an important role in the MDTand care of patients. Other members of the care teamcould include geriatricians, physical therapists, palliativecare experts, and social workers. Additionally, Level I andII Valve Centers should have an intensive care unit (24/7intensivist coverage for a Level I Center), cardiac anes-thesia, vascular surgery, cardiac electrophysiology ser-vices for pacemaker implantation, and the ability toprovide temporary mechanical support. The Comprehen-sive (Level I) Center should have access to emergentneurology consultations (particularly stroke services),subspecialty cardiac services (expertise in areas such ascongenital heart disease, pulmonary hypertension, andadvanced heart failure), and consultative medical andsurgical services (e.g., renal, gastrointestinal, endocrine,pulmonary, infectious disease). To facilitate alternative-access (nontransfemoral) TAVR and emerging mitral andtricuspid transcatheter therapies, a Comprehensive (LevelI) Center should have a hybrid procedure room with high-quality fluoroscopic imaging, surgical-quality lighting,hemodynamic monitoring, an adequate number ofdisplay monitors, and adequate space and equipment for

numerous personnel, temporary mechanical support,cardiopulmonary bypass, and rescue procedures. Accessto a ventricular assist device program is required for aComprehensive (Level I) Center, as certain high-risk pro-cedures may result in significant ventricular dysfunctionand hemodynamic deterioration. Finally, a Comprehen-sive (Level I) Center is required to provide a definedmechanism for timely case discussion and image sharingwith Primary (Level II) Centers, general cardiologists andprimary care providers.

6. PROCESS

6.1. Process Requirements for Advanced Heart Valve Centers

The process and functional requirements for Compre-hensive (Level I) and Primary (Level II) Valve Centers areoutlined in Table 5.

6.2. Process Components for Advanced Heart Valve Centers

6.2.1. Function of the MDT

The MDT plays a critical role in the collaborative evalua-tion, management, and treatment of patients with VHD.Each member of the team brings a perspective andexpertise that is fundamental to optimizing patient out-comes. Although the size and specific make-up of MDTteams may differ between Comprehensive (Level I) andPrimary (Level II) Valve Centers, these teams are foun-dational to all activities undertaken in any center.

The composition of the MDT is addressed in Section5.2.4. and Table 4. The MDT should meet regularly (pref-erably each week) to review cases, verify the results ofimaging and other pertinent studies, reach consensus onpatient management decisions, review outcomes, andassess quality. The patient’s individual needs and pref-erences should be discussed. Ideally, this approach le-verages the combined experience and expertise of thegroup and leads to more standardized and evidence-based decision-making. For patients presenting withheart failure due to LV systolic dysfunction and secondaryMR, a heart failure specialist is needed to ensure thatoptimal medical therapy has been instituted prior toconsideration of interventional treatments. Other mem-bers of the MDT, such as collaborators from geriatricmedicine, nephrology, and neurology, should be involvedas needed. Beyond simply recommending, for example,that a patient would be best treated with SAVR or withTAVR, these MDT meetings should also provide a forumfor detailed procedural planning. Input from differentteam members provides the best opportunity to preventor reduce complications. The MDT is also charged withreviewing performance metrics, outcomes, quality, andexternal reporting. Attendance should be taken at theseregular meetings, and the discussion and managementdecisions for each patient should be documented. An

TABLE 5 Processes for Valve Centers

Comprehensive (Level I)Valve Centers

Primary (Level II)Valve Centers

Documentation of formal referral and clinical pathways across thecontinuum of care

Documentation of communication pathways among Level I, Level II,and practice-level providers

Multidisciplinary Team

All patients are evaluated by the MDT All patients are evaluated by the MDT

The MDT educates patients regardingtreatment recommendations,treatment options, and the use ofan SDM process that incorporatespatient preferences.

The MDT educates patients regardingtreatment recommendations,treatment options, and the use ofan SDM process that incorporatespatient preferences.

The MDT meets on a regular basis(preferably each week) to reviewcases, reach consensusmanagement decisions, reviewoutcomes, and assess quality.

The MDT meets on a regular basis(preferably each week) to reviewcases, reach consensusmanagement decisions, reviewoutcomes, and assess quality.

Criteria/Metrics

Documentation of attendance atMDT meetings and recording ofthe discussion and decision-making process for casespresented

Documentation of attendance at MDTmeetings and recording of thediscussion and decision-makingprocess for cases presented

Documentation of an action plan toaddress performance and qualityareas needing improvement

Documentation of an action plan toaddress performance and qualityareas needing improvement

Regular morbidity and mortalitymeetings

Regular morbidity and mortalitymeetings

Registry Participation

Participation in the STS/ACC TVTregistry or other accepted nationalregistries

Participation in the STS/ACC TVTregistry or other accepted nationalregistries

Participation in the STS ACSD or otherapproved surgical database

Participation in the STS ACSD or otherapproved surgical database

Criteria/Metrics

TVT registryn 95% completion of 30-day

vital statusn Of those alive, 85% completion

of KCCQ at 30 daysn 90% completion of 1-year


of KCCQ at 1 yearn Overall meets STS/ACC TVT

Registry performance metricsfor completeness and accuracywith $2 consecutive quartersof green rating/year

TVT registryn 95% completion of 30-day


of KCCQ at 30 daysn 90% completion of 1-year


of KCCQ at 1 yearn Overall meets STS/ACC TVT

Registry performance metricsfor completeness and accuracywith $2 consecutive quarters ofgreen rating/year

National surgical databaseparticipation that meets staterequirements

National surgical databaseparticipation that meets staterequirements

Surgical performance that meetsSTS 2- or 3-star rating criteria

Surgical performance that meetsSTS 2 or 3 star rating criteria

Research

Participation in pivotal RCTs comparingdevices or device with surgery(optional)

Publication of single-center ormulticenter patient outcomestudies (optional)

Continued in the next column

TABLE 5 Continued

Comprehensive (Level I)Valve Centers

Primary (Level II)Valve Centers

Education and Shared Decision Making

Continuing education ofMDT members

Continuing education ofMDT members

Education of patients andthe public

Education of patients andthe public

Documentation of participation withpatients in SDM using objectiveand validated resources anddecision aids

Documentation of participation withpatients in SDM using objectiveand validated resources anddecision aids

Training

Structural interventional fellowshipyear (optional)

Cardiac surgery training ininterventional structural heart skillsand procedures (optional)

Advanced training in echocardiographycardiac CT and CMR for theevaluation of VHD and guidance ofvalve procedures (optional)

ACC indicates American College of Cardiology; ACSD, Adult Cardiac Surgery Database;CMR, cardiac magnetic resonance; CT, computed tomography; KCCQ, Kansas CityCardiomyopathy Questionnaire; MDT, multidisciplinary team; RCT, randomizedcontrolled trial; STS, Society of Thoracic Surgeons; SDM, shared decision making; TVT,Transcatheter Valve Therapy; and VHD, valvular heart disease.


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important aspect of these meetings is to support theinteraction with patients in SDM using validated re-sources and decision aids to reach a final decisionregarding therapy (53).

Members of the MDT also function together duringthe performance of both surgical and interventionalprocedures. Many of the approved and emerging treat-ments for VHD require skillsets that extend beyondthe expertise of a single individual or type of training.The norm for these procedures should be the interactiveparticipation of multiple team members (surgeon, inter-ventionalist, echocardiographer, and cardiac anesthesiol-ogist, as appropriate) to reduce complications andoptimize outcomes.

The MDT also analyzes and compares institutionalSTS/ACC TVT Registry data against national benchmarksand develops an action plan to improve performanceand outcomes if necessary. In addition, a regular mortal-ity and morbidity conference should be held to reviewadverse outcomes, provide feedback in a safe environ-ment, educate all team members, and serve as a spring-board to quality improvement. Conference attendanceshould be documented. Continuing medical and nurseeducation credits should be provided, some of which canalso qualify for risk management to satisfy various statelicensing requirements. Data entrants are expected toparticipate in the ongoing activities of the STS/ACC TVTRegistry and STS ACSD, to enable accurate and timelyreporting. Extending MDT discussions beyond a single



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institution, while maintaining patient privacy andprovider security, may foster more rapid dissemination ofbest practices.

6.2.2. Registry Participation

Valve centers, MDTs, and professional societies need todevelop and implement a scientifically rigorous approachfor performance measurement and quality assessment.A commitment to programmatic quality improvementis essential. Valve centers performing TAVR mustdemonstrate active participation in the STS/ACC TVTRegistry, with submission to the registry of all casesthat use Food and Drug Administration–approved valvetechnology, including any off-label uses. Data reportedto the STS/ACC TVT Registry and compared againstnational benchmarks will facilitate maintenance of a safe,efficient, and effective valve program. This process willin turn help maintain uniformity, consistency, qualitycontrol, and a level playing field. All Comprehensive(Level I) and Primary (Level II) Valve Centers mustdemonstrate that data submissions meet STS/ACC TVTRegistry performance metrics for completeness andaccuracy, with at least 2 consecutive quarters of greenrating/year. Information on QOL and survival out to 1 yearwill be important.

For surgical procedures, participation in either the STSACSD or another approved national surgical registry thatproduces nationally benchmarked, risk-adjusted out-comes is essential. If there are requirements at the statelevel for participation in approved surgical registries,these should be met by all Comprehensive (Level I) andPrimary (Level II) Valve Centers.

Data completeness is important for accurate reportingof outcomes and establishing national benchmarks. Boththe STS Adult Cardiac Surgery Database and the STS/ACCTranscatheter Valve Therapy Registry hold participants torigorous standards. Participants in the STS ACSD who donot meet data completeness thresholds are not includedin the benchmark population for performance analysisand therefore will not be eligible to receive a compositescore or participate in public reporting. Participation in avalve registry was a condition of reimbursement ofthe National Coverage Determination by the Center forMedicare and Medicaid Services. Extensive efforts havebeen used to ensure data completeness and accuracy.Completeness of any follow-up in the STS/ACC TVTregistry is now 95%, with 89% of records having a 30-dayfollow-up completed and 68% having 1-year follow-upcompleted (54). A key outcome for the STS/ACC TVTregistry is patient-reported health status, which includesa QOL metric, the Kansas City Cardiomyopathy Ques-tionnaire (KCCQ). Currently, 90% of baseline KCCQ scoresare completed. The 30-day KCCQ score is 85% complete,with 1-year completeness being 73%. It will be important

that 1-year mortality metrics and KCCQ scores becompleted by all centers. It is expected that all heartvalve centers will meet these 2 national registry datacompleteness standards.

6.2.3. Research

Comprehensive (Level I) and Primary (Level II) ValveCenters should be leading investigative efforts to evaluatenew technologies and improve clinical management ofpatients with VHD. Early feasibility and first-in-manstudies will be appropriate for select Comprehensive(Level I) Valve Centers. Participation in pivotal devicetrials will be optional for both Comprehensive (Level I)and Primary (Level II) Valve Centers provided there is anadequate research infrastructure. There remain manyimportant clinical questions that will not be answered byindustry-sponsored trials but that may have a significantimpact on the treatment of patients with VHD, whichcan be addressed by single-center or multicenter trials.Comprehensive (Level I) Valve Centers should seekto address many other questions, either by review ofinstitutional data, analysis of existing literature, ornational registry data inquiries. The role of MDT dynamicsin outcomes and safety will need to be explored. Althoughefforts should be made to make the TVT and STS dataforms as brief as possible, additional data fields couldbe helpful to address important research questions. Addi-tionally, the TVT and STS registries should be leveraged toprovide a framework for executing pragmatic randomizedtrials that would answer clinically important questions withimproved efficiency, lower cost, and adequate power.

6.2.4. Education

Members of the Comprehensive (Level I) and Primary(Level II) Valve Centers should provide ongoing educationto clinicians at local, national, and international confer-ences. It is also important that the centers continue toeducate their own MDT members and other professionals.There should be particular emphasis on the continuededucation and support of the valve program coordinator,advanced practice providers, and nurses. Comprehensive(Level I) Valve Centers should interface with Primary(Level II) Valve Centers to discuss best practices, providefeedback on cases, and establish a shared understandingof when patients with VHD require referral for morecomplex care, as well as on-site coaching of the inter-ventional team for technical skills. It is also important toeducate patients and families to improve understanding,enable informed consent, and emphasize SDM. Furtherdevelopment and validation of SDM tools for patientswith VHD is needed. Finally, education of the publicabout VHD may help improve early detection and opti-mize the timing of referral. Educational strategies shouldbe tailored to local learners, with needs assessment-based


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curricula, repetition, and feedback. In addition to valvecenters, education regarding VHD is the responsibility ofall stake holders, including device companies, imagingcompanies, and professional societies.

6.2.5. Training

Although the field continues to evolve rapidly, certainaspects have matured to the point where it is now time toimplement more formalized training programs in VHD.Learning curves are to be anticipated, and procedure-based physicians who have been in practice since beforethe advent of transcatheter valve procedures will needto return to a structured training environment for proc-toring. Such programs should include instruction onthe technical and procedural aspects of intervention, aswell as cognitive aspects related to patient evaluationand the timing of intervention. The Comprehensive(Level I) Centers have the responsibility to provide on-sitesupport and education to the Primary (Level II) Centers.Expertise in VHD among cardiologists, surgeons, inter-ventionalists, and imagers can be thought of as asubspecialty. By analogy, although heart failure can becared for by internists and general cardiologists,advanced heart failure and transplant cardiologists areoften needed to manage more complex cases requiringtiered medical and device therapies, mechanical circula-tory support, or transplantation.

The rapidly changing nature of evaluation and treat-ment options for patients with VHD warrants specializedtraining and expertise. This reality has important impli-cations for the training of cardiac surgeons, interven-tional cardiologists, imagers, and general cardiologists.There needs to be a new breed of VHD specialists who notonly perform procedures, but also understand the un-derlying pathophysiology of VHD and are able to evaluatepatients and determine optimal therapy. It is beyond thescope of this document to describe formal training path-ways in VHD. Although not all Comprehensive (Level I)Valve Centers need to have formal fellowships in VHD, itis envisioned that most of these centers will provide suchtraining (55).

7. PERFORMANCE METRICS

The delivery of high-quality care requires the ability tocollect data regarding the number of all treated patientsand their outcomes. Collection of such data serves as thefoundation for assessment of practice and proceduralpatterns and promotion of improvements in processand outcomes. Comparison to external benchmarks hasthe additional merit of maintaining uniform standardsacross institutions.

The proposed metrics and reporting discussed hereinare relevant to both Comprehensive (Level I) and Primary

(Level II) Valve Centers. Such reporting will initially beperformed by the individual valve centers. Reportingfrom regionalized systems of VHD care (Figure 1),including metrics regarding communication and transi-tions of care, would be an aspirational goal.

7.1. Assessment of Quality of Care and Development ofPerformance Metrics for VHD Centers

The assessment of quality is fundamental to any systemof VHD care. The collection of key patient-level dataelements and the ability to adjust outcomes to account forthe diversity of patient characteristics enable the transi-tion from descriptive data to validated and objectiveperformance metrics based on national benchmarks.Successfully assessing quality of care and performance forVHD centers requires a long-term and comprehensiveapproach to gathering the appropriate data on eachpatient; sharing it with an analytic center; and receivingstandardized, objective, and actionable reports thatinclude validated performance metrics benchmarkedagainst the performance of other centers. The 2 estab-lished national registries collecting VHD-related data arefocused, respectively, on surgical and transcatheter valveinterventions; they represent important resources for theproposed system of VHD centers.

At the same time, there is a need to more broadlyassess the quality of care in VHD patients in a way that isdisease-based, comprehensive, and focused on morethan simply procedures and operations. Because VHD is achronic condition and the care of these patients extendsover years, quality may be outstanding or poor at multipletime points. Timely detection of significant VHD, accurateassessment of disease severity, optimal timing of a valveprocedure, and vigilant postprocedure surveillance andtreatment, can all affect QOL in important ways beyondsimply the technical success of the intervention. VHD hasa more complex pathophysiology than just the valve;the care of VHD patients is often directed at changesin chamber size and function, thromboembolic compli-cations, rhythm and conduction abnormalities, secondarymanifestations of hepatic and renal dysfunction, andcomplex pulmonary and system vascular changes. Theseissues in comprehensively assessing quality of care are, infact, daunting, but they need to be identified as importantelements in optimizing outcomes.

The overall goals of reporting performance metrics are:

1. To provide patients and referring physicians withexperience and results achieved at individual valvecenters;

2. To promote the highest-quality standards for the careof patients with VHD; and

3. To establish a mechanism for every center to havea process for self-examination, and to improve

FIGURE 2 Categorization of Sites Based on TAVR Volume and Risk-

Adjusted Mortality

This schematic categorizes TAVR programs by their case volumes and

risk-adjusted clinical outcomes. Most programs have sufficient case

volumes to achieve technical competence and acceptable results,

although these volumes may not be sufficient to allow statistically

valid quality assessments. A few programs may have adequate vol-

umes to meet TAVR requirements and ensure statistically valid quality

assessment but still appear to have suboptimal performance. These

programs need to take immediate actions to improve their outcomes

as it is likely they are underperforming. Some programs with lower

volumes appear to have acceptable outcomes, but because of their

small sample sizes, their outcome data are less statistically reliable.

These programs must continue to assess their quality vigilantly.

Finally, some programs have low volume and less than optimal

outcomes. Although these outcomes are statistically less certain,

action should be undertaken immediately to further assess and

improve quality (26). TAVR indicates transcatheter aortic valve

replacement.



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continuously by using objective data that are bench-marked against national standards reported throughprofessional society registries.

The committee recognizes that the ultimate metrics forquality standards are patient outcomes—both immediateand, ideally, long-term. However, it must be acknowl-edged that there are significant limitations to gatheringdata, performing analyses, and reporting results. Assess-ing in-hospital and short-term results of surgical opera-tions and transcatheter procedures provides a beginning,but long-term outcomes, including the patient’s func-tional status and QOL after such treatments, are key to alearning healthcare system.

There are learning curves associated with all cardiacprocedures, including TAVR (56–58). Analysis of earlySTS/ACC TVT Registry data shows the cumulativeTAVR volume-outcome relationship is strong during thelearning curve, which is expected given that this isa procedure with potentially high risk in an elderlypatient population (59). In their analysis, Carroll et al. (59)noted that there was a steep slope for improved majoroutcomes in the first 100 cases. Thus, minimum operatorrequirements are outlined in the 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Oper-ator and Institutional Requirements for TranscatheterAortic Valve Replacement (26).

The committee acknowledges that outcomes willimprove with experience. Volumes alone are not neces-sarily the best surrogate for quality, but a volume–outcomeassociation does exist for many cardiac procedures (60–66). Conversely, there are some procedures, such astransfemoral TAVR, that are becoming less complex andmore routine with time and for which there may not be asstrong a volume–outcome association. Therefore, volumerecommendations must be incorporated carefully andselectively into any determination of which hospitals aredesignated as VHD centers. Volume thresholds are partic-ularly challenging to determine with scientific rigor.Nevertheless, there is a need for standards because careefficiency and quality improve with the frequency of per-formance of major procedures and operations, just asexperience leads to better results with most human en-deavors. The primary motivation behind volume recom-mendations is not to exclude centers, but rather to serve as1 metric in the identification of centers that are mostcapable of providing certain services. Patient-centeredoutcomes constitute the ultimate quality of care metricsand are more accurately demonstrated when volumes aresufficiently large to permit reliable statistical analysis.

The committee thus proposes that the heart valvecenters be evaluated using both procedural volumes andavailable outcomes for each procedure. The thresholds forlow-, moderate-, and high-volume centers should be

based on the distribution of the number of proceduresperformed by valve centers throughout the country,combined with available data on the minimum number ofprocedures shown to be an inflection point for outcomes.

An example of the potential relationship between vol-ume- and risk-adjusted outcomes is shown in Figure 2. Anannual threshold volume might distinguish between low-,moderate-, and high-volume centers from an experiential(but not necessarily statistical) perspective and wouldnot exclude any center from performing the procedure.The combination of volume and risk-adjusted outcomecan help to define desirable levels of performance.In Figure 2, the upper-left quadrant represents higher-volume centers with optimal risk-adjusted outcomes,most likely demonstrating higher quality. The upper-rightquadrant represents high-volume centers with less thanoptimal risk-adjusted outcomes, for which immediateaction should be taken to identify and address


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problems leading to higher mortality. In both instances,our confidence in estimating acceptable or substandardrisk-adjusted outcomes is greater with higher-volumeprograms because these programs’ sample sizes arelarger. However, it should be emphasized that thenumber of cases that might qualify as moderate to highvolume on the basis of procedural experience is notnecessarily the same as the sample size necessary toproduce reliable estimates of quality, which may requireaccumulation of data over several years.

The lower left and right quadrant centers with lowervolumes pose 2 problems: potentially inadequate vol-umes to achieve or maintain competence, and samplesizes that are too small to reliably estimate outcomes, asdiscussed in the following text. The lower-left quadrantcenters should continue to assess their outcomes vigi-lantly, as their small sample sizes render their seeminglyacceptable risk-adjusted outcome estimates less statisti-cally reliable. The lower-right quadrant centers shouldundertake immediate corrective actions. Although thereis greater uncertainty regarding the statistical reliabilityof their results, their low volumes and suboptimal out-comes are worrisome.

For TAVR, serious adverse outcomes—including stroke,major bleeding, vascular complications, and mortality—were initially shown to decrease with increasing operatorexperience and volume (59). As new technologies areintroduced and less severely ill patients become eligiblefor the procedure, the threshold volumes suggested inthis document may be periodically updated in response toongoing analyses from national registries and center-specific experiences.

The writing committee acknowledges the difficultyin correctly assessing the performance of low-volumeprograms. The confidence intervals around a binaryevent such as death increase dramatically at lowervolumes, producing a graph with a “funnel on its side”appearance, with the wide end at low volumes. Becauseof these wide confidence intervals, the results from alow-volume program (small sample size) have substantialstatistical uncertainty. It is quite difficult to ascertainfrom this sample what the true underlying performance isof such a program. In contrast, the narrower confidencelimits inherent with moderate- and high-volume pro-grams (large sample size) mean that estimates of theirtrue underlying performance are more reliable, enablingtheir observed performance to be more confidentlycompared with expectations for their case mix.

To help mitigate the statistical challenges of evaluatinglow-volume programs, a 3-year rolling data time frame isrecommended to provide more observations and betterassess true differences in outcomes. Consistent withstandard profiling practice, the committee recommendsidentifying true quality outliers as having risk-adjusted

performance that is statistically significantly differentthan expected for their case mix on the basis of the overallperformance of the benchmark population of providersfor similar patients. Statistical significance is usuallydetermined by assessing whether the 95% confidenceintervals around the provider’s point estimate of risk-adjusted mortality include the overall average mortality,or whether the confidence intervals around their ratio ofobserved to expected mortality include unity (i.e., 1).Low-volume centers, particularly newer programs withless than 3 years of rolling data, need to be vigilant intheir own internal assessments if “signals” or “trends” forpoor quality are detected despite not reaching a 95%confidence level due to the challenge of accurate assess-ment of low-volume center quality. To provide largersample sizes and greater statistical power, there could bea 3-year grace period for new or smaller sites to accumu-late a sufficient number of cases before full accountabilityof outcomes is required. During the 3-year grace period,outcomes should be carefully monitored on a case-by-case basis, possibly including monitoring methodssuch as Cumulative Sum Control Charts and Variable LifeAdjusted Display analyses, and worrisome trends in sub-optimal outcomes should be addressed with action plansto enhance clinical performance. A minimum yearly vol-ume of cases will be required to ensure programmaticefficiency and statistical relevance of outcomes.

The following section addresses the outcomes thatshould be reported on the basis of currently availablemetrics for TAVR, SAVR, and mitral valve repair. Inthe future, composite, multidimensional performancemeasures will further increase the effective number ofendpoints for these procedures. This format will set thefoundation for future procedures as they are evaluatedand accepted into clinical practice.

7.1.1. TAVR

The recommended outcome measures for TAVR need toaddress goals of care that may differ depending on age,life expectancy, and comorbidities. These goals mayinclude improving QOL and functional status as well asreducing rates of rehospitalization and death over a 1- to5-year time period. TAVR is now available for intermedi-ate–surgical-risk patients and potentially soon for low–

surgical-risk patients. The goals of care for these patientsoverlap somewhat with those for higher–surgical-riskpatients, but would also need to account for longersurvival postprocedure. Clearly, there is a need to deter-mine whether TAVR succeeds in improving functionalstate and QOL after hospital discharge or a 30-day timewindow and out to at least 1 year for all patients. Thesedata can also be used to: 1) track the types of patientstreated by the valve center; and 2) stratify outcomesaccording to these types.

TABLE 6TAVR Program Performance Minimum QualityBenchmarks

2018 Criteria

Primary Outcome Metrics Performance Requirement

In-hospital risk-adjustedall-cause mortality

n Based on 95% confidence intervals andnational benchmark data, the program’sperformance is “as expected” or “betterthan expected.”

30-day risk-adjusted all-causemortality

n Based on 95% confidence intervals andnational benchmark data, the program’sperformance is “as expected” or “betterthan expected.”

30-day all-cause neurologicalevents, including TIAs†

n Funnel plots using 95% (outlier) and/or90% (warning) limits indicate that theprogram’s performance falls within theselected boundaries.*

30-day major vascularcomplications†

n Funnel plots using 95% (outlier) and/or90% (warning) limits indicate that theprogram’s performance falls within theselected boundaries.*

30-day major bleeding† n Funnel plots using 95% (outlier) and/or90% (warning) limits indicate that theprogram’s performance falls within theselected boundaries.*

30-day moderate orsevere AR†

n Funnel plots, using 95% (outlier) and/or90% (warning) limits, indicate that theprogram’s performance falls within theselected boundaries.*

Primary Outcome Metrics in Development

1-year risk adjusted all-cause mortality

Patient-reported health status (KCCQ) at 30 days and 1 year versus baseline

30-day and 1-year risk-adjusted mortality and morbidity (composite index)

Adapted from Bavaria et al. (26)*As available for reporting.†Presently only in-hospital and, shortly, 30-day mortality outcomes are risk adjusted.Therefore, other outcomes are not risk-adjusted and need to be interpreted in thecontext of a program’s constellation of patients with their spectrum of characteristicsthat impact outcomes.

AR indicates aortic regurgitation; KCCQ, Kansas City Cardiomyopathy Questionnaire;and TIA, transient ischemic attack.

TABLE 7 TAVR Program Performance Criteria

TAVR Quality RequirementsTo have optimal outcomes, a program will have:n Minimum quality requirement: STS/ACC TVT Registry–reported 30-day

risk-adjusted all-cause TAVR mortality above the bottom 10% for metricsoutlined in Table 6.

Threshold for low- versus moderate- to high-volume centersn $50 cases/year or 100 cases over 2 years

SAVR Quality RequirementsTo have optimal outcomes, a program will have:n $2 hospital-based cardiac surgeons who both spend $50% of their time

at the hospital with the proposed TAVR programn A quality assessment/quality improvement program:

n Active participation in the STS National Database to monitoroutcomes

n Quality metric: STS 2- or 3-star rating for isolated AVR and AVR þCABG in both reporting periods during the most recent reporting year

Threshold for low- versus moderate– to high-volume centersn $30 SAVRs/prior year or 60 SAVRs over 2 years*

Adapted from Bavaria et al. (26)*For the purposes of this hospital volume requirement, SAVR is defined to include allSAVR (mechanical, bioprosthesis, homograft, autograft [Ross], composite valve graft,or root replacement) or aortic valve repair procedures, including concomitant valveresuspension for acute aortic dissection and valve-sparing aortic root replacement.Simple adjuvant aortic valve procedures (e.g., suturing closed regurgitant aortic valvesin an LVAD patient, excising a papillary fibroelastoma or thrombus) are not included.

ACC indicates American College of Cardiology; AVR. aortic valve replacement; CABG,coronary artery bypass grafting; LVAD, left ventricular assist device; SAVR, surgicalaortic valve replacement; STS, Society of Thoracic Surgeons; and TAVR, transcatheteraortic valve replacement.



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Tables 6 and 7 include outcomes measures of quality fora TAVR program proposed in the 2018 AATS/ACC/SCAI/STS Expert Consensus Systems of Care Document: Oper-ator and Institutional Requirements for TranscatheterAortic Valve Replacement (26). These proposed metricsare the beginning of an evolution in outcome assessmentthat can eventually approach the level of maturity, vali-dation, and sophistication of SAVR. As outlined inTables 6 and 7, any valve program with an outcome metricthat falls into the bottom 10% for at least 2 consecutivequarters may have a quality issue that should prompt animmediate improvement effort. A primary goal is to pro-mote the ability of all centers to achieve both adequatevolumes and acceptable outcomes (i.e., the upper-leftquadrant in Figure 2). It is anticipated that most low-volume sites will steadily increase their number of pro-cedures due to the approval of moderate-risk patients forTAVR, Food and Drug Administration approval of addi-tional indications for TAVR usage, and ongoing aging ofthe U.S. population.

7.1.2. Surgical Mitral Valve Repair

Surgical mitral valve repair is a well-established proced-ure that mandates unique quality metric requirements. Ithas been shown that the short- and long-term results ofmitral valve repair are superior to replacement in patientswith severe primary MR. For patients with asymptomaticsevere primary MR, surgical repair is reasonable provideda successful and durable repair rate >95% with an oper-ative mortality <1% can be expected at a given center(1,2). The treatment options for asymptomatic, severeprimary MR should be considered by an MDT, with repairoffered only if these high standards can be met.

Data from New York State suggest that higher totalannual surgeon volume is associated with increasedrepair rates for primary MR, with an improved 1-yearsurvival and steady decrease in reoperation risk when>25 total mitral operations are performed annually. Inaddition, mitral valve repair rates among surgeons withvolumes of <25 mitral operations per year increasesignificantly if they operate at an institution in whichanother surgeon performs >50 mitral cases per year withmitral valve repair rates for primary MR >70% (17). Usingthis observational study as a single example, an appro-priate cut-off for low and high surgical volumes for mitralvalve operation might be >25 per year per operator or >50per year per institution.

Current data from the Society of Thoracic Surgeonsdatabase (67) indicate a repair rate well below 95% forprimary degenerative disease among 867 centers in NorthAmerica, reporting more than 10 such cases over a 3-year

TABLE 8Mitral Valve Repair Performance Criteria—For Primary Degenerative MR*

To optimize outcomes, a mitral program will have:n Repair rate >75%n 30-day operative mortality <1%

Threshold for moderate or high volume:n Annual case volume of 25 per surgeon or 50 per program

*In the absence of calcification of the annulus or leaflet.

MR indicates mitral regurgitation.


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period. Accordingly, on the basis of expert consensus andrelevant data, it is proposed that a designated valve centershould exceed that average and achieve a surgical mitralvalve repair rate of greater than 75% for patients with pri-mary degenerative MR in the absence of calcification of theleaflets or annulus (Table 8). In these patients, the 30-dayoperative mortality rate should be less than 1%. Thisquality metric applies to all valve centers that are per-forming mitral valve operations for primary MR. To ach-ieve this metric, it is anticipated that some centers maylimit surgical mitral valve repair to those pathologies thatare most easily approached (e.g., isolated posterior leafletprolapse or partial flail), whereas more experienced sur-geons at a Comprehensive (Level I) Valve Center would beexpected to undertake repair of more advanced pathol-ogies, as reviewed previously. In addition, each valvecenter may choose to limit the scope of surgical practice forindividual surgeons to ensure that repair rate thresholdsare met or exceeded. Many would consider mitral valverepair to constitute a surgical subspecialty (68); higherindividual surgeon volumes are associated with higherrepair rates, decreased reoperation risk and improvedsurvival (17). Such data support the concept of preferentialreferral to an expert surgeon, who would more likelyoperate in a Level I valve center.

7.2. Public Reporting

The public has a right to know the outcomes and qualityachieved at a valve center. The U.S. medical systemis competitive, and marketing by hospitals and healthcaresystems should not be confused with a rigorous approach tohigh-quality, objective, comprehensive, and valid measures ofperformance. Public distribution of data can be misleading inthe absence of data quality controls, adequate risk adjust-ment, and national benchmarking of each hospital’s results.Public reporting of risk-adjusted outcomes is an ethical re-sponsibility, and one that is supported by professional soci-eties. Public reporting of a performance measure relevant to aVHD center requires a major national effort that involvesmultiple years of work. In the cardiac surgical field, STS hasbeen a leader; reviewing its experience is key to consideringwhat a system of VHD centers will need to report in additionto SAVR outcomes.

Currently, approximately 65% of cardiac surgeryprograms in the United States report their outcomes

publicly. There is evidence that those programs that do sohave better outcomes than those that do not (69),although the evidence regarding this association is vari-able. In addition, experience has shown that the processmay have unintended consequences, such as risk aversion(70,71). The most commonly cited example of perfor-mance improvement is the New York State publicreporting of cardiac surgery outcomes (72–75). After theintroduction of CABG report cards in New York State, risk-adjusted mortality declined by 41% between 1989 (4.17%)and 1992 (2.45%), with a corresponding reduction in theprevalence of high- and low-outlier hospitals. Between1989 and 1992, New York Medicare patients experienced a22% decline in CABG mortality rates versus a 9% declinenationwide. In 1992, New York State had the lowestMedicare CABG mortality rate in the nation. Finally, it isimportant that outcomes be risk-adjusted to help preventrisk avoidance and inappropriately restrictive case selec-tion as causes of reduced mortality rates (72).

STS online public reporting enables participants tovoluntarily report and inform the public of their hospital’sor program’s heart surgery scores and star ratings.The STS began public reporting in 2010 and now publiclyreports outcomes for isolated CABG, isolated AVR,and AVR plus CABG. The Society has imminent plans toreport composite (risk-adjusted mortality, risk-adjustedmorbidity) outcomes for mitral valve replacement,mitral valve repair, and mitral valve replacement or repairplus CABG. The publicly reported data are readily acces-sible through the STS website and Consumer Reports.

To make this reporting easily understandable to thepublic and general consumer, a 3-star rating systemwas constructed. This system was based on a multi-procedural, multidimensional composite measure desig-ned to comprehensively evaluate the performance of aprogram or hospital on 1 of 5 common adult cardiac pro-cedures (isolated CABG, isolated AVR, isolated mitralprocedures, AVR þ CABG, and mitral procedures þ CABG)(30,67,76–78). A similar composite scoring for individualsurgeon performance, based on these 5 procedures, isbeing implemented in 2019 (79). A three-star rating in-dicates that the provider’s performance is statisticallysignificantly better than expected for their case mixwith reference to the benchmark performance of all STSprograms. A 1-star rating indicates performance worsethan expected for the provider’s case mix.

It is expected that both Comprehensive (Level I) andPrimary (Level II) Valve Centers will report outcomes ofboth surgery and transcatheter valve interventions (whenthe latter are available). In addition to risk-adjusted out-comes, transparency is needed for all stakeholders(including patients and referring physicians) regardingprocedural volumes, types of patients treated, and othermetrics described in this document.



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8. OBSTACLES AND CHALLENGES TO A

VHD SYSTEM OF CARE

The model proposed shares many features with otherwell-established systems, including integrated verticalhealthcare delivery systems in which primary care islinked to tertiary/quaternary care and regional, disease-based systems, such as those championed by theNational Brain Attack Coalition for acute stroke care. Bothtiered and disease-based models of VHD care should helppatients receive the level of care needed as a functionof disease complexity. Nevertheless, there are severallimitations to be recognized, including:

1. Access. The writing committee acknowledges thatmany patients may not be able or wish to travel to aremote center for VHD care for reasons related to age,frailty, geographic distance, separation from family,trust in their local caregivers, and the uncertaintycreated by placing their care in the hands of unfamiliarclinicians. There are additional barriers related tohealth plan coverage, restricted referral networks, lackof interoperability for both healthcare records andimaging, and perceptions of cultural bias. Many ofthese barriers have been addressed by large, verticallyaligned healthcare systems in which cardiovascularspecialists are employed and resources have alreadybeen consolidated to enhance efficiency. Referral outof network for other patients, however, may simply notbe possible in part because of the economic environ-ment that characterizes the current U.S. healthcareenvironment. In addition, some would argue thatseparation of patients from their local communitiesnegates the possibility of achieving SDM. Patientpreferences should always be respected, but aninformed discussion of all treatment options availableand the outcomes to be expected (as publicly re-ported), is an important prerequisite for successfulSDM. Education, communication, and transparencycan address some but not all of these issues. Culturalbarriers to access involve more than simple geographyand require interventions that are beyond the scope ofthis document. Whereas supporting a primary (Level II)valve center in a geographically remote/rural area isfeasible on a selective basis, expanding the number ofvalve centers in metropolitan areas already populatedby several programs is more difficult to rationalize.

2. Communication. The interoperability of electronichealth records and digital imaging data needed toenable seamless patient movement within a VHD sys-tem of care is not available even within some verticallyintegrated health systems.

3. Cost. Comprehensive (Level I) Valve Centers willexperience the higher costs associated with the

management of more complex and higher-risk patientsundergoingmore expensive carewith longer stays. Start-upand maintenance costs to establish and sustain the infra-structure required to provide comprehensive care for com-plex patients are substantial. Patients and families mayincur higher costs related to travel or out-of-network care.

4. Professional and institutional skepticism. The writingcommittee also acknowledges that the simple cons-truct of a tiered system of care may create theperception that this proposal would perpetuate thedominance of larger centers at the expense of smallercenters. The proposed concept of a system of care forVHD patients is not conceived to deny individuals andinstitutions the opportunity to provide services, norshould it be perceived to impede the ability of acommitted center to achieve its strategic goals. Rather,it is intended to focus more on outcomes and notsimply on procedural volumes, while providing aplatform to guide best practices and promote qualityimprovement across all centers interested in the careof patients with VHD. Additionally, the proposal is notTAVR-specific but rather is meant to highlight therange of services, expertise, and experience requiredto care for patients across the spectrum of VHD.Health services research to assess the impact of atiered system of care on patient outcomes, quality, andcost must be supported.

5. Knowledge and performance gaps. As discussedthroughout this document, these persist despitethe collective efforts of institutions, health systems,and professional societies. Enhanced collaborationand more targeted educational efforts are needed toreduce the observed variability in care and outcomes.

9. SUMMARY AND NEXT STEPS

The increasing burden of VHD, coupled with the emer-gence of improved imaging techniques, better surgicaloutcomes, and transcatheter therapies, has stimulateddiscussions regarding optimal strategies for care delivery.The focus of this document is not to ask whether thereare too many, too few, or just the right number ofself-designated advanced valve centers, but rather toinitiate a discussion regarding whether a regionalized,tiered system of care for patients with VHD that accountsfor the differences in valve center expertise, experience,and resources constitutes a more rational delivery modelthan one left to expand continuously without direction.Admittedly, access to appropriate, high-quality careremains a concern and one that is not fully addressed here,although the role of the practice-level clinician in recog-nition and diagnosis is acknowledged. This proposal


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emphasizes performance and outcome standards for allproviders and centers.

There are several next steps, beginning with broadeducational programming. Strategies to shorten thelearning curve associated with the performance of newinterventions and incorporation of iterative changes insurgical techniques deserve emphasis. Centers can sharebest practices for efficient MDT functioning and SDM.Communication standards, particularly at transitions ofcare, can be formalized. The emergence of clinical regis-tries has enhanced centers’ ability to assess and comparequality. Setting performance standards both within andacross centers is thus now feasible. The Joint Commissionhas instituted a Comprehensive Cardiac Advanced Certi-fication Program for individual hospitals that includesVHD care (80). External review, monitoring, and feedbackat a system level, however, will be key processes goingforward. These will require dedicated personnel andfinancing. There is a great deal of detailed work ahead torealize the goals of this proposal to the satisfaction ofpatients and the many other stakeholders involved.

PRESIDENTS AND STAFF

American Association for Thoracic Surgery:

David H. Adams, MD, PresidentCindy VerColen, Chief Executive Officer/Executive

DirectorAdam Silva, Associate Director of Administration

American College of Cardiology:

C. Michael Valentine, MD, FACC, PresidentTimothy W. Attebery, DSc, MBA, FACHE, Chief Executive

OfficerWilliam J. Oetgen, MD, MBA, FACC, Executive Vice

President, Science, Education, Quality, andPublications

Joseph M. Allen, MA, Team Leader, Clinical Policy andPathways

Sahisna Bhatia, MPH, Project Manager, Clinical Policy andPathways

Amelia Scholtz, PhD, Publications Manager, Science,Education, Quality, and Publications

American Society of Echocardiography:

Jonathan R. Lindner, MD, FASE, PresidentRobin Wiegerink, MNPL, Chief Executive Officer

Society for Cardiovascular Angiography and

Interventions:

David A. Cox, MD, MSCAI, PresidentRobert Bartel, MSc, FACEHP, Vice-President,

Education & QualityEmily Senerth, Senior Manager, Clinical Documents &

Quality

The Society of Thoracic Surgeons:

Keith S. Naunheim, MD, PresidentRobert A. Wynbrandt, JD, Executive Director and

General CounselWilliam F. Seward, Associate Executive Director

RE F E RENCE S

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38. Norwood S, Fernandez L, England J. The early ef-fects of implementing American College of Surgeonslevel II criteria on transfer and survival rates at a rurallybased community hospital. J Trauma. 1995;39:240–4;discussion 244–5.

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40. Alberts MJ, Wechsler LR, Jensen ME, et al. For-mation and function of acute stroke-ready hospitalswithin a stroke system of care recommendations fromthe brain attack coalition. Stroke. 2013;44:3382–93.

41. Champion JK, Pories WJ. Centers of excellence forbariatric surgery. Surg Obes Relat Dis. 2005;1:148–51.

42. O’Gara PT, Kushner FG, Ascheim DD, et al. 2013ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive sum-mary: a report of the American College of CardiologyFoundation/American Heart Association Task Forceon Practice Guidelines. J Am Coll Cardiol. 2013;1:485–510.

43. Edwards FH, Cohen DJ, O’Brien SM, et al. Devel-opment and validation of a risk prediction model for in-hospital mortality after transcatheter aortic valvereplacement. JAMA Cardiol. 2016;1:46–52.

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45. MacKenzie EJ, Rivara FP, Jurkovich GJ, et al.A national evaluation of the effect of trauma-centercare on mortality. N Engl J Med. 2006;354:366–78.

46. Xian Y, Holloway RG, Chan PS, et al. Associationbetween stroke center hospitalization for acuteischemic stroke and mortality. JAMA. 2011;305:373–80.

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50. Pearlman AS, Ryan T, Picard MH, Douglas PS.Evolving trends in the use of echocardiography: astudy of Medicare beneficiaries. J Am Coll Cardiol.2007;49:2283–91.

51. Douglas PS, Garcia MJ, Haines DE, et al. ACCF/ASE/AHA/ASNC/HFSA/HRS/SCAI/SCCM/SCCT/SCMR 2011Appropriate Use Criteria for Echocardiography. A Reportof the American College of Cardiology FoundationAppropriate Use Criteria Task Force, American Society ofEchocardiography, American Heart Association, Amer-ican Society of Nuclear Cardiology, Heart Failure Societyof America, Heart Rhythm Society, Society for Cardio-vascular Angiography and Interventions, Society of Crit-ical Care Medicine, Society of Cardiovascular ComputedTomography, and Society for Cardiovascular MagneticResonance. J Am Coll Cardiol. 2011;57:1126–66.

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55. Kavinsky CJ, Poulin MF, Mack MJ. Training instructural heart disease: call to action. Circulation.2018;138:225–8.

56. Alli O, Rihal CS, Suri RM, et al. Learning curves fortransfemoral transcatheter aortic valve replacement inthe PARTNER-I trial: technical performance. CatheterCardiovasc Interv. 2016;87:154–62.

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58. Minha S, Waksman R, Satler LP, et al. Learningcurves for transfemoral transcatheter aortic valvereplacement in the PARTNER-I trial: success andsafety. Catheter Cardiovasc Interv. 2016;87:165–75.









































































































































































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60. Birkmeyer JD, Stukel TA, Siewers AE, Goodney PP,Wennberg DE, Lucas FL. Surgeon volume and operativemortality in the United States. N Engl J Med. 2003;349:2117–27.

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62. Dewey TM, Herbert MA, Ryan WH, et al. Influence ofsurgeon volume on outcomes with aortic valve replace-ment.AnnThoracSurg. 2012;93:1107–12;discussion 1112–3.

63. McNeely C, Markwell S, Filson K, Hazelrigg S,Vassileva C. Effect of hospital volume on prosthesisuse and mortality in aortic valve operations in theelderly. Ann Thorac Surg. 2016;101:585–90.

64. Gonzalez AA, Dimick JB, Birkmeyer JD, Ghaferi AA.Understanding the volume–outcome effect in cardio-vascular surgery: the role of failure to rescue. JAMASurgery. 2014;149:119–23.

65. Khera R, Pandey A, Koshy T, et al. Role of HospitalVolumes in Identifying Low-Performing and High-Performing Aortic and Mitral Valve Surgical Centersin the United States. JAMA Cardiol. 2017;2:1322–31.

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ACC

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SAVR

SCAI

SDM

STEMI

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STS ACSD

TAVR

VHD

67. Badhwar V, Rankin JS, He X, et al. The Society ofThoracic Surgeons mitral repair/replacement compos-ite score: a report of the Society of Thoracic SurgeonsQuality Measurement Task Force. Ann Thorac Surg.2016;101:2265–71.

68. Gillinov M, Mick S, Suri RM. The specialty of mitralvalve repair. J Am Coll Cardiol. 2017;69:2407–9.

69. Shahian DM, Grover FL, Prager RL, et al. The So-ciety of Thoracic Surgeons voluntary public reportinginitiative: the first 4 years. Ann Surg. 2015;262:526–35;discussion 533–5.

70. Shahian DM, Jacobs JP, Badhwar V, D’Agostino RS,Bavaria JE, Prager RL. Risk aversion and publicreporting. Part 1: observations from cardiac surgeryand interventional cardiology. Ann Thorac Surg. 2017;104:2093–101.

71. Shahian DM, Jacobs JP, Badhwar V, D’Agostino RS,Bavaria JE, Prager RL. Risk aversion and publicreporting. Part 2: mitigation strategies. Ann ThoracSurg. 2017;104:2102–10.

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73. Hannan EL, Kumar D, Racz M, Siu AL, Chassin MR.New York State’s Cardiac Surgery Reporting System:four years later. Ann Thorac Surg. 1994;58:1852–7.

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American College of Cardiolog

American Association for Thor

aortic stenosis

American Society of Echocard

aortic valve replacement

computed tomography

Kansas City Cardiomyopathy Q

left ventricular

multidisciplinary team

mitral regurgitation

surgical aortic valve replacem

Society for Cardiovascular Ang

shared decision making

ST-segment elevation myocar

Society of Thoracic Surgeons

Society of Thoracic Surgeons

transcatheter aortic valve rep

valvular heart disease

75. Hannan EL, Siu AL, Kumar D, Kilburn H Jr.,Chassin MR. The decline in coronary arterybypass graft surgery mortality in New York State.The role of surgeon volume. JAMA. 1995;273:209–13.

76. Shahian DM, Edwards FH, Ferraris VA, et al. Qualitymeasurement in adult cardiac surgery: part 1––con-ceptual framework and measure selection. Ann ThoracSurg. 2007;83:S3–12.

77. O’Brien SM, Shahian DM, DeLong ER, et al.Quality measurement in adult cardiac surgery: part2––statistical considerations in composite measurescoring and provider rating. Ann Thorac Surg. 2007;83:S13–26.

78. Rankin JS, Badhwar V, He X, et al. The Society ofThoracic Surgeons mitral valve repair/replacement pluscoronary artery bypass grafting composite score: areport of The Society of Thoracic Surgeons QualityMeasurement Task Force. Ann Thorac Surg. 2017;103:1475–81.

79. Shahian DM, He X, Jacobs JP, et al. The Society ofThoracic Surgeons composite measure of individualsurgeon performance for adult cardiac surgery: areport of The Society of Thoracic Surgeons QualityMeasurement Task Force. Ann Thorac Surg. 2015;100:1315–24; discussion 1324–5.

80. The Joint Commission. ComprehensiveCardiac Center Advanced Certification Program. Avail-able at: https://www.jointcommission.org/approved_comprehensive_cardiac_center/. Accessed March 12,2017.

APPENDIX 1. ABBREVIATIONS

y

acic Surgery

iography

uestionnaire

ent

iography and Interventions

dial infarction

Adult Cardiac Surgery Database

lacement























































































https://www.jointcommission.org/approved_comprehensive_cardiac_center/

https://www.jointcommission.org/approved_comprehensive_cardiac_center/



2632

APPENDIX 2. AUTHOR RELATIONSHIPS WITH INDUSTRY AND OTHER ENTITIES (RELEVANT)—

2019 AATS/ACC/ASE/SCAI/STS EXPERT CONSENSUS SYSTEMS OF CARE DOCUMENT:

A PROPOSAL TO OPTIMIZE CARE FOR PATIENTS WITH VALVULAR HEART DISEASE

To avoid actual, potential, or perceived conflicts of interestthat may arise as a result of industry relationships or per-sonal interests among the writing committee, all membersof the writing committee, as well as peer reviewers of thedocument, are asked to disclose all current healthcare-related relationships, including those existing 12 monthsbefore initiation of the writing effort. The ACC Task Forceon Clinical Expert Consensus Documents reviews thesedisclosures to determine which companies make products(on market or in development) that pertain to the docu-ment under development. Based on this information, awriting committee is formed to include a majority of

CommitteeMember Employment Consultant

SpB

Rick A. Nishimura(Co-Chair)

Mayo Clinic, Division of CardiovascularDisease—Judd and Mary MorrisLeighton Professor of Medicine

None

Patrick T. O’Gara(Co-Chair)

Harvard Medical School—Professor ofMedicine; Brigham and Women’sHospital Cardiovascular Division—

Director, Clinical Cardiology

None

Joseph E. Bavaria Hospital of the University ofPennsylvania—Director, Thoracic Aortic

Surgery Program

None

Ralph G. Brindis ACC National Cardiovascular DataRegistry—Senior Medical Officer

Philip R. Lee Institute for Health PolicyStudies, UCSF—Clinical Professor

None

John D. Carroll University of Colorado Denver—Professor of Medicine; Director,

Interventional Cardiology

n St. Jude Medical†

Clifford J. Kavinsky Rush University Medical Center—Professor of Medicine

None

Brian R. Lindman Vanderbilt University Medical Center—Associate Professor of Medicine;

Medical Director, Structural Heart andValve Center

n Roche DiagnosticsMedtronic

Jane A.Linderbaum

Mayo Clinic—Assistant Professor ofMedicine; Associate Medical Editor for

AskMayoExpert

None

Stephen H. Little Houston Methodist Hospital—Associate Professor; John S. DunnChair in Clinical Cardiovascular

Research and Education

None

Michael J. Mack Baylor Scott & White Health—ChairCardiovascular Service Line

None

members with no relevant relationships with industry(RWI), led by a chair with no relevant RWI. RWI is reviewedon all conference calls and updated as changes occur.Author RWI pertinent to this document is disclosed in thetable below and peer reviewer RWI is disclosed inAppendix 3. Additionally, to ensure complete trans-parency, authors’ comprehensive disclosure information—including RWI not pertinent to this document—is availableonline. Disclosure information for the ACC Task Force onClinical Expert Consensus Documents is also availableonline, as is the ACC disclosure policy for documentdevelopment.

eakersureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational,

or OtherFinancialBenefit

ExpertWitness

None None None None None


None None n EdwardsLifesciences*

n Medtronic*n Medtronic Vascular*n St. Jude Medicaln Vascutek*n W.L. Gore*

n EdwardsLifesciences*

n Medtronic*

None


None None n Direct Flow*n Edwards

Lifesciences*n Evalve/Abbott

Structural Heart*n Medtronic*n St. Jude Medical†n Teledyne (DSMB)

n St. JudeMedical

None


None None n EdwardsLifesciences†

n Roche Diagnostics†

None None


None None n AbbottLaboratories*

n Medtronic*

None None

None None n Abbott Vascular*n Edwards

Lifesciences*n Medtronic*

None None

Continued on the next page

http://jaccjacc.acc.org/Clinical_Document/2018_Advanced_Valve_Centers_Author_Comprehensive_RWI_Table.pdf

http://www.acc.org/guidelines/about-guidelines-andclinical-documents/guidelines-and-documents-task-forces

https://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy

https://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy

CommitteeMember Employment Consultant

SpeakersBureau

Ownership/Partnership/Principal

PersonalResearch

Institutional,Organizational,

or OtherFinancialBenefit

ExpertWitness

Laura Mauri Harvard Medical School—Professor ofMedicine; Brigham and Women’sHospital Cardiovascular Division.Medtronic—Global VP of Clinical

Research and Analytics

n Biotronik†n Corvia†n St. Jude Medical†

None None n Abbott Vascular†n Biotronik†n Boston Scientific†n Corvia†

None None

William R. Miranda Mayo Clinic—Cardiology Fellow,Instructor in Medicine

None None None None None None

David M. Shahian Massachusetts General Hospital—VPQuality and Safety; Harvard MedicalSchool—Professor of Surgery; Chair,STS Council on Quality, Research, and

Patient Safety


Thoralf M.Sundt, III

Massachusetts General Hospital—Chief, Division of Cardiac Surgery;

Director, Corrigan MinehanHeart Center


This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships werereviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarilyreflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of $5% of the votingstock or share of the business entity, or ownership of $$5,000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% ofthe person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table aremodest unless otherwise noted.According to the ACC, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issueaddressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document or makes a competing drug ordevice addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional or other personal gain or loss as a resultof the issues/content addressed in the document.*No financial benefit†Significant relationship

DSMB ¼ Data Safety Monitoring Board.

APPENDIX 2. CONTINUED


2633



2634

APPENDIX 3. PEER REVIEWER INFORMATION—2019 AATS/ACC/ASE/SCAI/STS EXPERT CONSENSUS

SYSTEMS OF CARE DOCUMENT: A PROPOSAL TO OPTIMIZE CARE FOR PATIENTS WITH

VALVULAR HEART DISEASE

This table represents the individuals, organizations, andgroups that peer reviewed this document. A list of cor-

Reviewer Representation

Frank V. Aguirre Official Reviewer—BOG

Joanna Chikwe Official Reviewer—AATS TCar

Larry S. Dean Official Reviewer—SCAI Uni

Joseph A. Dearani Official Reviewer—STS

Daniel Engelman Official Reviewer—AATS He

Judy W. Hung Official Reviewer—ASE M

Chad Kliger Official Reviewer—SCAI LeHofst

Leonard Y. Lee Official Reviewer—AATS

Thomas E. MacGillivray Official Reviewer—STS De

Sunil V. Mankad Official Reviewer—ASE

James K. Min Official Reviewer—Task Force on ExpertConsensus Decision Pathways

Dalio

Sandra V. Abramson Organizational Reviewer—ACP

Oluseun O. Alli Organizational Reviewer—Novant Health

Mary Beth Brady Organizational Reviewer—SCAD

Samjot Brar Organizational Reviewer—Kaiser Permanente KaisI

Sameer A. Gafoor Organizational Reviewer—Swedish Medical

Brian B. Ghoshhajra Organizational Reviewer—SCCT

Rebecca T. Hahn Organizational Reviewer—Columbia UniversityCollege of Physicians and Surgeons

C

Uzoma N. Ibebuogu Organizational Reviewer—ABC UniD

Josh Rovin Organizational Reviewer—Baycare/Morton Plant

Scott R. Shipman Organizational Reviewer—AAMC

Amy E. Simone Organizational Reviewer—AAPA

Andrew Wang Organizational Reviewer—AHA

Puja Banka Content Reviewer—Imaging Council

Eric R. Bates Content Reviewer—Individual Expert

responding comprehensive healthcare-related disclosuresfor each reviewer is available online.

Employment

Prairie Cardiovascular Consultants—Interventional Cardiologist

he Icahn School of Medicine at Mount Sinai—Professor and Chief, Division ofdiothoracic; Professor of Cardiovascular Surgery; Heart Institute, Stony Brook

University Medical Center—Surgery Director

versity of Washington School of Medicine—Professor of Medicine and Surgery;UW Medicine Regional Heart Center—Director

Mayo Clinic—Chair, Cardiovascular Surgery

art, Vascular & Critical Care Services Baystate Medical Center—Interim Chief,Division of Cardiac Surgery; Medical Director; University of Massachusetts

Medical School-Baystate—Associate Professor of Surgery

assachusetts General Hospital Cardiac—Associate Director, Echocardiography,Division of Cardiology

nox Hill Hospital—Director, Structural Heart Disease, Cardiovascular Medicine;ra/Northwell—Assistant Professor, Donald and Barbara Zucker School of Medicine

Rutgers Robert Wood Johnson Medical School—Chairman

Bakey Heart & Vascular Center—Chief, Division of Cardiac Surgery & ThoracicTransplant Surgery

Mayo Clinic—Associate Professor of Medicine

Institute of Cardiovascular Imaging at New York Presbyterian Hospital—Professorof Radiology and Medicine; Director

Lankenau Heart Pavilion—Medical Director, Cardiovascular Imaging Center;Director, Interventional Echocardiography

NOVANT Heart and Vascular Institute—Assistant Professor

Johns Hopkins University School of Medicine—Vice Chair for Education,epartment of Anesthesiology and Critical Care Medicine; Associate Professor,

Anesthesiology and Critical Care Medicine

er Permanente Los Angeles Medical Center and Kaiser Permanente Research—nterventional Cardiologist and Vascular Specialist; Chair, Regional ResearchCommittee; The University of California, Los Angeles—Assistant Clinical

Professor of Medicine

University of Michigan Medical School—Associate Professor

Massachusetts General Hospital—Service Chief, Cardiovascular Imaging;Program Director, Cardiac Imaging Fellowship

olumbia University College of Physicians and Surgeons—Associate Professorof Clinical Medicine

versity of Tennessee Health Sciences Center—Associate Professor of Medicine,ivision of Cardiovascular Diseases; Methodist University Hospital—Director of

Structural Heart Disease Intervention

Morton Plant Hospital—Director, Center for Advanced Valve and StructuralHeart Care; Director of Transcatheter and Aortic Therapies

Association of American Medical Colleges—Director of Primary Care Affairsand Workforce Analysis

Emory University Hospital Midtown—Physician Assistant, Department ofCardiothoracic Surgery Structural Heart & Valve Program

Duke University Medical Center—Professor of Medicine;Director, Cardiovascular Disease Fellowship Program

Boston Children’s Hospital—Assistant Professor of Pediatrics

University of Michigan—Professor of Medicine

Continued on the next page

http://jaccjacc.acc.org/Clinical_Document/2018_Advanced_Valve_Centers_PR_RWI_Table_Comprehensive.pdf

Reviewer Representation Employment

Blasé A. Carabello Content Reviewer—Vascular Heart DiseaseGuideline Writing Committee

East Carolina Heart Institute at ECU—Professor and Chief, Division of Cardiology

Michael S. Firstenberg Content Reviewer—Surgeons’ Council Northeast Ohio Medical Universities—Director, Adult ECMO Program; Director,Surgical Research; Associate Professor of Surgery and Integrative Medicine;

Summa Akron City Hospital—Cardiothoracic Surgeon

Linda D. Gillam Content Reviewer—Health Affairs Committee Morristown Medical Center—Chair, Department of Cardiovascular Medicine

David R. Holmes, Jr. Content Reviewer—ACC Roundtable Participant Mayo Clinic—Professor of Medicine, Department of Cardiovascular Medicine

Alexander Iribarne Content Reviewer—Surgeons’ Council Dartmouth Hitchcock Medical Center—Assistant Professor of Surgery

Patricia Keegan Content Reviewer—ACC Roundtable Participant Emory Structural Heart and Valve Center—Structural Heart Coordinator

Thomas M. Maddox Content Reviewer—Task Force on Health PolicyStatements and Systems of Care

Washington University School of Medicine/BJC Healthcare—Director,Health Systems Innovation Lab (HSIL); Washington University School of

Medicine—Professor of Medicine (Cardiology)

Elizabeth N. Perpetua Content Reviewer—ACC Roundtable Participant University of Washington Medical Center—Director, Structural Heart Services;Associate Director, Center for Cardiovascular Emerging Therapies;

Teaching Associate, Cardiology and Cardiac Surgery

Donnette Smith Content Reviewer—ACC Roundtable Participant Mended Hearts—President

Carl L. Tommaso Content Reviewer—TAVR Requirements WritingCommittee Chair

NorthShore University Health System—Associate Director, CardiacCatheterization Labs; Rush Medical College—Associate Professor of Medicine

William A. Van Decker Content Reviewer—Health Affairs Committee Temple University Hospital—Assistant Professor of Medicine

Gaby Weissman Content Reviewer—Cardiovascular Training Council Medstar Washington Hospital Center—Director, Cardiovascular MagneticResonance Imaging (MRI) Core Laboratory

Frederick G. P. Welt Content Reviewer—Interventional Council University of Utah Health Sciences Center—Director, Interventional Cardiology

Michael J. Wolk Content Reviewer—Task Force on Health PolicyStatements and Systems of Care

Weill Medical College of Cornell University—Clinical Professor of Medicine

AAMC ¼ Association of American Medical Colleges; AATS ¼ American Association for Thoracic Surgery; ABC ¼ Association of Black Cardiologists; ACC ¼ American College ofCardiology; ACP ¼ American College of Physicians; AHA ¼ American Heart Association; ASE ¼ American Society of Echocardiography; ASNC ¼ American Society of Nuclear Cardiology;SCA ¼ Society of Cardiovascular Anesthesiologists; SCAI ¼ Society for Cardiac Angiography and Interventions; SCCT ¼ Society of Cardiovascular Computed Tomography; STS ¼ Societyof Thoracic Surgeons; TAVR ¼ transcatheter aortic valve replacement.

APPENDIX 3. CONTINUED


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