From the ACC | Truly a transformative technology, transcatheter valve therapies (TVT) have provided unprecedented benefit to a host of patients with valvular heart disease (VHD) not amenable to or at high risk for surgical treatment, extending and improving their daily lives. Another transformation is now underway: a reinvigorated view of the management of VHD spurred by the potential capacity of TVT to treat a broader range of patients.

Yet, challenges identifying and managing patients with VHD could limit these emerging technologies from reaching all who may potentially benefit. In the United States, some 1.5 million people have moderate or severe aortic stenosis (AS) and approximately 4 million people have significant mitral regurgitation (MR).

Against this background, the American College of Cardiology (ACC) convened a two-day Evolving Heart Valve Management Strategies Roundtable that brought together experts from 28 organizations representing a wide variety of medical specialties, industry, patients, integrated health systems, and other stakeholder groups, along with representatives from the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services.

The ACC is leading this effort to improve patient care and outcomes by identifying gaps in knowledge and care in evaluating and managing VHD, developing tools and resources, particularly at the point of care, to address identified shortcomings and determine priorities for future initiatives. Partnerships with key societies and stakeholders will be created to address these objectives.

Comprehensive discussions were held on the current issues and challenges in assessing and managing AS and MR, transcatheter aortic valve replacement (TAVR) for AS and its expansion to lower risk patients, and the emergence of transcatheter mitral valve interventions.

Identification of Patients With Valvular Heart Disease

The primary care physician (PCP), as the first point of contact for most patients, plays a critical role in identifying patients who potentially have VHD and would benefit from additional assessment and possible treatment. Recognizing this gatekeeping role, it is essential for the ACC to determine the education and support needed by PCPs and how this should be delivered to enhance the recognition of VHD and appropriate referral.

The Championing Care of Aortic Stenosis pathway may serve as a model for this PCP outreach. Tools could include a screening algorithm for identifying patients and a clinical decision pathway that contains criteria to guide patient referral to a cardiologist for more detailed assessment. Such tools could include, for example, prompts to order an echocardiogram (echo) if the PCP hears a heart murmur and stratification of comorbidities.

Among the recommendations from the roundtable participants was the incorporation of support tools within the process of care, embedded within the electronic health record (EHR). Such tools could then serve as a trigger for screening and documentation, and would allow for alerts to the PCP based on results of an echo or other assessments. Pushing results and echocardiographic interpretation to the caregiver at the point of care would contribute to timely review and appropriate referral and management.

A comprehensive assessment of a patient requires integrating clinical information with data from the echo and other imaging studies, and methods to integrate such a quantitative assessment into care should be created to improve patient referral by the PCP to the cardiologist, and by the cardiologist to the multidisciplinary heart valve team.

The cost-effectiveness of screening patients for VHD was raised, a consideration made possible by the declining cost of bedside echos, which would allow simple, inexpensive screening for stenotic aortic valves. Parameters for screening, such as age and interval, require determination.

Assessment of Patients With Valvular Heart Disease

Imaging is the cornerstone of assessing patients with VHD, and reliable data are required for a correct diagnosis and understanding the severity of disease. As such, the issues and challenges related to obtaining this reliable data that were raised by the roundtable represent a barrier to care, and training and other initiatives to address these were raised by the participants.

Standards must be defined for high-quality echo images to ensure accurate evaluation of patients and to ensure reproducibility and reduce variability between institutions. Setting these standards include defining the correct technical performance and data acquisition, and standardized evaluation and reporting with structured data elements and discrete data points to facilitate interpretation by PCPs and cardiologists. Further, at least Level 3 expertise for reading the preprocedure echos for valvular interventions by the echocardiographer should be required.

The standardized evaluation, structured data elements, and discrete data points also facilitate reporting in the EHR, deriving clinical decision support tools, and auditing.

Guidance from the ACC on imaging requirements and acquisition before, during, and after a transcatheter procedure for AS and MR was recommended. Performance measures, such as <5% missing data, and checklists for complete acquisition and reporting would be useful tools.

Training requirements for cardiologists and imagers should be determined, including COCATS, and whether imagers should be certified in valvular imaging. Is there a need for a valve echocardiographer who is a specialist in valve assessment? Recently, there is certification for advanced sonographers, and board certification is available through the National Board of Echocardiography. Partnering with the American Society of Echocardiography in regard to training and certification was advised.

Advanced imaging is playing a greater role in evaluating patients with VHD. Computed tomography (CT) and magnetic resonance imaging (MRI) will likely be used more in evaluating and quantifying MR, and augments the information from the primary modality of transthoracic echo (TTE) along with exercise testing. These modalities are also useful to evaluate the bicuspid valve, aorta, and left ventricular fibrosis. CT is integral to the evaluation for TAVR, including sizing the aortic annulus, and evaluating aortic valve calcification (although it is not reimbursed for asymptomatic patients). Procedure planning and guidance benefits from 3D transesophageal echo (TEE).

There is a role for ACC to advocate to payers for reimbursement of CT for the evaluation of VHD, through education of its importance for a thorough assessment. And to advocate to industry for technology improvements in echocardiography to improve acquisition and reduce error, e.g., for better standardization of 3D echo.

Aortic Stenosis Assessment

A knowledge gap hampers the capacity to correctly classify mild, moderate, and severe AS. Education is required of the referring community about the influence of age, comorbidities, and evaluation of left ventricular ejection fraction (LVEF) and flow. This understanding is needed to distinguish patients with low gradients but who have severe AS, and also to determine the optimal timing for AVR in the setting of severe AS when the patient claims to be asymptomatic and their symptoms can be attributed to aging and other causes.

In patients with a normal LVEF, the diagnosis of AS can be complicated by the presence of hypertension, which can lower atrioventricular gradients. This impact of hypertension is under-recognized, and education is needed about blood pressure management in these patients. A role for dedicated protocols for patients with hypertension and diastolic dysfunction was highlighted. Criteria are needed to determine the surgical risk of patients, which should incorporate predictors of quality of life after valve replacement.

Mitral Regurgitation Assessment

MR is a more complex disease than AS, complicating assessment and management. Knowledge gaps in understanding primary and secondary MR must be addressed with education regarding assessment and management to improve diagnostic accuracy and referral. This complexity extends to patient selection for emerging approaches, such as transcatheter mitral valve replacement (TMVR) versus repair.

Primary (degenerative) MR is primarily a disease of the mitral valve, whereas secondary (functional) MR is a disease of the heart (left ventricle) that in turn negatively impacts mitral valve function. Secondary MR is associated with advanced heart failure, and about 10% of patients with heart failure have some degree of MR. Atrial fibrillation, coronary artery disease, heart failure, and dilated cardiomyopathy contribute to secondary MR, and treatment of these underlying causes is a first step in its management.

The best methodology to document and quantify the impact of MR on quality of life is unclear, and limits the assessment of quality of life to determine the best timing for treatment. Functional testing is underused. Subjective measures include validated heart failure and quality of life surveys.

Management of Valvular Heart Disease

Optimizing care and outcomes in VHD requires management by an expert multidisciplinary heart valve team. The fast-paced evolution of TVT technologies and the anticipated treatment of a broader range of patients, including those with lower levels of risk and perhaps those who are not yet symptomatic, underscore the need for experienced centers to enhance procedural and long-term outcomes and ensure safety and appropriate patient care. Therefore, the ACC was called on to define the “center of excellence” and the heart valve team.

Further, to guide patient referral by the cardiologist to the heart valve team, the ACC was tasked with creating management algorithms and referral tools that fit within the process of care and trigger referral.

Defining the Center of Excellence

Robust discussions raised a range of considerations regarding a center of excellence. First among these was the appropriate naming of such a center, with proposals of valve center, reference center, and valvular heart disease center, to more aptly denote its role and to offset the notion that a center without this designation lacks quality care.

Other considerations were:

• What is the role of the center?
• Should the center be full-service, capable of all interventions and surgery for VHD? Allowed to specialize in a specific intervention?
• What are the data to rate quality?
  • Recognition that volume does not equal quality.
  • Incorporate the complexity of treatment provided and level of risk.
• What is the role of volume, when considering it drives the availability of resources?
•  Is certification by the ACC needed? Collaboration with the Society of Thoracic Surgeons (STS) for certification?
• What are the referral issues?
• Will insurance cover service at an out-of-network center?
• Will patients pay the high deductible for this expensive technology?
• Will ACC certification elicit out-of-network reimbursement?
• Should a center have its own network of referring institutions?
  • Does such a network facilitate more convenient patient follow-up?
• What are the requirements for imaging technology and expertise?
• What are the data points required for public reporting?

The breadth of services and expertise required of a center of excellence has the potential to impact the recommended treatment for a patient, and a full-service center allows for selecting the most appropriate procedure for the patient, rather than the specialty of a more narrowly focused center. The bottom line is ensuring full disclosure to the patient of the full range of the treatment options, from type of intervention, type of valve, medical therapy, not pursuing treatment, and palliative care.

Some potential barriers in relation to establishing a center of excellence are geographic access to care, hospital system considerations, finance and payer reimbursement, and restriction of trade. Identifying these and other barriers establishes the specific stakeholders, including payers and the Centers for Medicare and Medicaid Services, with whom the ACC must collaborate to establish these centers.

Barriers to care at a center of excellence include the lack of referral by cardiologists, in part due to lack of knowledge, including when to refer (and referring early). For example, the substantial decline in the risk of aortic valve replacement (AVR), even in older patients, is not well recognized. Echo is a gatekeeper, and better quality evaluation and reporting is needed. Lack of outcomes data from hospitals and operators also is a factor.

The Multidisciplinary Heart Valve Team

The multidisciplinary heart valve team is pivotal in the assessment and management of patients with VHD, and the role has evolved because of patient/disease complexity from determining surgical risk and candidates to determining who will benefit from TVT and defining the therapeutic approach (e.g., addressing combined valve lesions, using a staged approach such as TAVR followed by a MitraClip). Maintaining the heart valve team is critical, despite the eventual transition of TAVR to a cath lab-based procedure.

Issues raised related to the heart valve team were the lack of reimbursement for all team members, including the weekly comprehensive meeting, and for a second operator for TAVR.

In terms of composition of the heart valve team, a key consideration raised was ensuring competencies within the team, for example, a heart failure specialist or someone competent in treating heart failure should be a team member. Imaging expertise is required to determine candidates, plan the procedure, and evaluate postprocedural outcomes—and some suggest including the echocardiographer in the procedure for periprocedural evaluation to allow for real-time adjustments.

The members of the heart valve team should ideally include: cardiothoracic surgeon, interventionist, echocardiographer, geriatrician, heart failure specialist, electrophysiologist, anesthesiologist, geriatrician/palliative care expert, and nursing. Notably, whether the team should be organized by disease, i.e., an aortic valve or mitral valve team, which better matches the patient-centered treatment approach, rather than by interventional approach, i.e., a TAVR or SAVR team, was raised.

The potential transition of TAVR to a routine cath lab procedure raises the need for the ACC to define safety standards, such as the number of operators and an appropriate catheterization laboratory. Many call for the surgeon to remain in the room, and reinforce the need for close collaboration between the surgeon and interventionist, particularly for higher risk, complex cases. Guidance for patient selection and general anesthesia versus conscious sedation is needed too.

Data collection and outcomes reporting are essential for transparency and quality, and the ACC should lead the effort to define the parameters, including outcomes for patients who do not have an intervention, and establish a centralized registry. Such a registry also allows for auditing, and importantly can elucidate the relation between outcomes and operator experience and institutional volume, and the likelihood of satisfactory clinical outcomes. Further, such registries, along with clinical trial data, are needed to obtain the data needed for evidence-based clinical guidelines.

For MR, the National Cardiovascular Data Registry (NCDR) for transcatheter mitral valve repair should be expanded to capture data for all MR procedures, and data collection should include the acquisition of a postprodedure echo to define a successful mitral valve repair.

Shared Decision Making: Putting the Patient at the Center of Care

Shared decision making (SDM) between the patient and the physician is a class I recommendation of the ACC/American Heart Association VHD treatment guidelines. SDM is poised to become a measure of patient-centered and quality care, assessing the match between the patient’s desires and the treatment selected. Indeed, the CMS now requires documentation of SDM for reimbursement of left atrial appendage closure for patients with atrial fibrillation.

Patient engagement is central to SDM, and must elicit the patient’s preferences, values, and goals to inform the choice of treatment. Notably, physicians must recognize the difference between education about the risk and benefits for the purposes of obtaining informed consent and SDM. SDM is intended to be a deliberation between the patient and the physician, weighing the choices, not a determination of the treatment solely by the physician.

Decisions appropriate for SDM are in the setting of valid alternative treatment options, such a bioprosthetic or mechanical valve, that balance the benefit, risk, and goals for the specific patient. Patients at an intermediate level of risk represent a potential group of patients for SDM, as well as patients at high risk for whom there is clinical equipoise.

The five components of SDM are: 1) name all the treatment choices, 2) explain SDM, e.g., “I am the expert on the choices and you are the expert on how you weigh those choices, and we have a decision to make today,” 3) describe the choices using a decision aid, and ask the patient what she/he understands, 4) listen to what matters most to the patient, ask what is their specific goal of treatment, 5) make the decision, incorporating the patient preference and stating how it matches the treatment selected.

Recommendations for ACC initiatives are patient education about VHD and treatment choices, especially the creation of a website to provide a credible resource for physicians to recommend to patients, working with patient advocacy groups to address barriers in getting patients to cardiologists, and the creation of patient-centered, evidence-based decision aids or Apps to guide the physician and patient through the decisions about transcatheter or surgical treatment, type of valve and impact on subsequent care, and palliative care. For physicians, skills training in SDM (now in medical school), guidelines, and pay for performance are required.

Palliative care is among the choices for some patients. Yet, this remains a difficult topic for physicians, with little understanding of the best timing to involve the palliative care expert. Integrating this role within the heart valve team can assist this process, similar to the cross-disciplinary approach to end-of-life care and palliative care for patients with heart failure considering a left ventricular assist device as destination therapy.

However, limiting factors for making palliative care decisions include the lack of a consensus on when a procedure is not appropriate and the lack of data for decision making. Risk assessment tools are needed, ideally ones that also measure quality and integrate assessment of comorbidities, cognitive impairment, and family support, along with the expected gain in life expectancy.

Recommendations from the roundtable participants include mining the TVT registry and working with the geriatric community to create disease-specific decision aids and frailty assessments, as well as identify gaps in evidence, including predictors of quality, to determine data points for collection.

Management of Aortic Stenosis

The right treatment for the right patient at the right time to achieve the best possible outcomes is the goal of any treatment. However, the knowledge gaps that contribute to delayed referral and assessment extend to management of AS and MR.

The fairly rapid expansion of TAVR from inoperable or higher risk patients to the inevitable expansion to those with lower levels of risk, along with expansion of access routes and devices, has added complexity to management decisions. Clear criteria are needed for defining the patients most appropriate for TAVR or SAVR, including defining a threshold for excessive risk for TAVR, based on outcomes data, including from the TVT registry. An outcomes-based frailty assessment tool is also needed.

Multispecialty evaluation of each patient by the heart valve team is critical for treatment selection, and determining procedural factors, such as the valve selection and conscious sedation versus general anesthesia. TVT registry data are needed to refine valve selection, and prospective data are needed to determine optimal antithrombotic therapy, especially after valve-in-valve procedures.

Of note, the roundtable participants highlighted the need to address the current racial and geographic disparity to ensure the standard of care, i.e., TAVR for patients who are inoperable or at high risk, reaches all such patients, before it is extended to patients with lower levels of risk. Benchmarking against the TVT registry was recommended as a strategy to reduce this disparity.

The TVT registry must play a central role in the appropriate use of TAVR. Data collection is needed for robust auditing for quality control, benchmarking best practices (similar to the ACTION and CRUSADE registries for acute myocardial infarction), and evaluating outcomes, including in patients who do not undergo an intervention. These data will also provide the required information for education for appropriate referral.

Management of Mitral Regurgitation

Clinical decision making in MR is driven by the type, primary or secondary, and whether the patient is symptomatic or asymptomatic. In large part, the pathoanatomy drives treatment selection. Yet, as noted in regard to the assessment of MR, knowledge gaps and lack of outcomes data limit guidance for selecting mitral repair or replacement and evidence-based guidelines.

Although excellent outcomes are obtained with mitral valve repair in primary MR, a class I recommendation, patient selection and outcomes in secondary MR are not well understood. Secondary MR is more complex, requiring first the treatment of the primary disease, and patients are at a higher risk for adverse outcomes. There is less evidence of benefit in secondary MR, and the indications for surgery or transcatheter intervention are less clear than in primary MR.  The durability of repair also is not clear.

With the emergence of TMVR, there is a need for the ACC to define the prospective data required for clinical decision making to assist industry with protocol development for prospective, randomized, clinical trials.

Training for Interventions in VHD

The absence of standardized methods for training interventionists and cardiac surgeons to perform transcatheter valve procedures must be addressed. Considering the diversity of the field and the anticipated expansion of TVT to other areas within structural heart disease defining who should perform the procedures is of particular importance. The immediate evolution is from TAVR to interventions with more complex anatomy, such as the mitral and tricuspid valves, and the expanding number of devices and techniques.

The CMS National Coverage Determination has set the minimal volume levels for physicians and hospitals for performing transcatheter atrial and mitral procedures. However, technical expertise as measured by case volume may not reflect technical proficiency or the ability to transfer that skill to other types of procedures in VHD. Skills learned from prior procedures and surgeries may not necessarily translate into a readiness for transcatheter valve interventions, and the skillset for TAVR may not be applicable to performing transcatheter mitral valve replacement or repair.  Case volume also is limited as a metric because of the requirement of multiple operators for procedures.

A broader definition of proficiency is required, that better captures the technical expertise and cognitive knowledge required for patient assessment, selection, and management. The scope of cognitive knowledge reinforces the requirement for a multidisciplinary heart valve team.

Currently, none of the advanced interventional cardiology training programs are accredited by the Accreditation Council for Graduate Medical Education (ACGME). Of these programs, only 29% offer any training lasting a year or longer in VHD. COCATS 4 level 3 training in interventional cardiology is limited to just some exposure to structural heart disease.

Among the recommendations from the roundtable participants were: 1) develop standardized and accredited training programs in VHD with clear objectives, 2) design training programs to provide a foundation for lifelong learning, 3) increase the availability of and dependence on simulators within training programs, and 4) foster greater cross-pollination between interventionists and cardiac surgeons, to learn basic skills in each field.

The concept of a structural proceduralist, either an interventionist or cardiac surgeon, with devoted, intensive training in all currently available TVT technologies was raised. Different levels of training and proficiency were also proposed, such as a basic structural interventionist limited to common routine procedures and advanced structural interventionist trained for more advanced procedures.

The Next Steps

The cardiology community is encouraged to collaborate with the ACC as it builds relationships with relevant stakeholders to address issues and challenges raised by the experts participating in the roundtable and creates the resources and tools needed for patients, PCPs, and cardiologists. The work to establish high-quality, patient-centered, cost-efficient care for VHD requires many hands and many voices.

Keywords: Disease Management, Heart Valve Diseases, CardioSource WorldNews Interventions

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