2018 AATS/ACC/SCAI/STS expert consensus systems of care document: Operator and institutional recommendations and requirements for transcatheter aortic valve replacement

This multisocietal expert consensus systems of care document was commissioned by the American Association for Thoracic Surgery (AATS), the American College of Cardiology (ACC), the Society for Cardiovascular Angiography and Interventions (SCAI), and the Society of Thoracic Surgeons (STS). Expert consensus systems of care documents are intended to summarize the position of these partnering organizations on the availability, delivery, organization, and quality of cardiovascular care. With the rapid evolution and dissemination of transcatheter aortic valve replacement (TAVR) technology, it is imperative that the cardiovascular community work together to identify the criteria for performing these procedures safely and successfully. Such criteria serve to guide both practitioners and institutions in the development and maintenance of TAVR programs in the spirit of optimizing quality outcomes. The unique qualifications to participate in this field comprise specific interventional skills, high-tech equipment, collaborative clinical management, evolving approaches for alternative access, and multidisciplinary decision-making. The AATS, ACC, SCAI, and STS have joined together to provide recommendations for institutions and individuals to assess their potential for instituting and/or maintaining a high-quality TAVR program. The first multisocietal document on institutional and operator requirements for performing TAVR was published in 20121 and is now updated to reflect the current evolution in practice and quality benchmarks. A strong emphasis on a team-based approach for patient management remains unchanged. Where possible, the writing committee's recommendations are rooted in the robust data accrued from the STS/ACC Transcatheter valve therapies (TVT) registry. The writing group has included a multimodal approach to quality measurement that allows the requirements to evolve in anticipation of newer treatment modalities; expansion to younger and lower-risk populations; and emerging evidence regarding patient outcomes, cost, cost-effectiveness, and durability. This document presents the types and details of currently available outcome metrics that enable an objective assessment of site performance. Importantly, additional metrics are under development to make this a more comprehensive assessment, including alive and well at 1 year. The incorporation of these additional metrics will diminish the need to rely on raw volume numbers. Quarterly reports sent to sites by the STS/ACC TVT Registry include site data and national benchmarks that are updated regularly for TAVR. Similar quality assessment/quality improvement processes are well-established in the STS adult cardiac surgery database for SAVR programs. The Duke Clinical Research Institute has performed a preliminary analysis of the most recent STS/ACC TVT Registry data that show a clinically meaningful association of higher mortality and other major complications with site annual volume below the recommended threshold of 50 procedures/year. Further analysis of these data is needed to confirm these preliminary findings and to more fully understand the factors associated with these worse outcomes. This further analysis is also needed to assess why some low-volume sites have acceptable outcomes and others do not, and to understand if these sites improve over time. The committee feels that elimination of annual procedure volume requirements would result in a possibility of increased TAVR risk-adjusted mortality and major complications in the US despite five consecutive years of improving outcomes. The goal of the writing committee was to provide a quality framework for any center providing TAVR as a treatment option for aortic valve disease in the US. While this document specifically addresses TAVR requirements, it should be placed in a larger context and specifically address the broader goal of optimizing the care of all patients with severe aortic valve disease. Since publication of the original document in 2012, TAVR indications have been extended into groups of patients who are eligible for SAVR at intermediate to high risk; TAVR has also become an alternative to reoperation for those with severe bioprosthetic aortic valve degeneration.2-4 Programs are now evaluating a broad spectrum of patients who may be appropriate for either form of valve replacement (i.e., TAVR and SAVR). The approval of a TAVR valve for a specific STS SAVR risk population does not necessarily mean that TAVR should be the chosen procedure for any particular patient in that population. The writing committee recognizes that adequate TAVR outcomes data are now available, permitting an evolution from an exclusively prerequisite skills-based set of recommendations to an integration of actual TAVR quality and experience as the basis of qualifications for the performance of TAVR. The primary objective of this updated document is to promote standards that will help centers achieve high-quality outcomes for patients who have clinically significant aortic valve disease. TAVR continues to be a dynamic, evolving therapy. The phases of TAVR development and distribution in the U.S. healthcare system as well as the transitions in operator and institutional requirements are presented in Figure 1. The TVT Registry has gathered data from over 100,000 patients who have received TAVR. These data are now focused in three new directions within the 2018 document: Emphasis on Direct Measures of Quality Care: This 2018 document provides additional quality metrics that complement requirements presented in the 2012 document.1 TAVR case-volume requirements ensure foundational data minimum needed for measurement of quality outcomes. Beginning in 2018, direct measures of quality of care for both TAVR and SAVR programs will be emphasized. Two types of quality measures are already available for TAVR program evaluation: Figure 2 shows the categorization of sites based on their TAVR volume and risk-adjusted outcome measures, such as the observed-to-expected ratio of an outcome measure (e.g., risk-adjusted in-hospital, 30-day, and ultimately, 1-year mortality). One goal of this 2018 document is to promote the ability of all centers to achieve both adequate volumes and acceptable outcomes (i.e., the upper left quadrant in this schematic). The characterization of quality using the Donabedian triad of structure, process, and outcomes measures is a reasonable framework for establishing TAVR quality.5 The 2006 Institute of Medicine report, "Performance Measurement: Accelerating Improvement," provides a framework for translating the need for assessment of performance in health care into measures of quality.6 The measures are related to the key periods of patient evaluation, procedure performance, postprocedure care, and assessment of medium-term outcomes. This document incorporates several measures into the proposed site requirements. This document is an update to the 2012 Multisociety (AATS, ACCF, SCAI, and STS) Expert Consensus Statement: Operator and institutional requirements for transcatheter valve repair and replacement, Part 1: TAVR.1 The writing committee was composed of representatives from the AATS, ACC, SCAI, and STS. Partnering societies used the ACC's policy on relationships with industry and other entities (RWI) to author this document. To avoid actual, potential, or perceived conflict of interest that may arise as a result of industry relationships or personal interests among the writing committee, all members of the writing committee, as well as peer reviewers of the document, were asked to disclose all current healthcare-related relationships, including those existing up to 12 months before initiation of the writing effort. Because this document needed the input of clinical experts, leadership from the four partnering societies decided to allow an exception to the usual prohibition on clinical trial participation in industry-sponsored trials provided there was no compensation involved. Activities involving a clinical trial as a steering committee member or principal investigator were not considered relevant relationships. Author and peer reviewer RWI pertinent to this document are disclosed in Appendices B and C. In addition, to ensure complete transparency, authors' comprehensive disclosure information (including RWI not pertinent to this document) is available online. The work of the writing committee was supported exclusively by the partnering societies without commercial support. The Chairs have no RWI and are responsible for the content of this document. The ACC disclosure policy for document development is available online. Writing committee members volunteered their time to this effort. Conference calls of the writing committee were confidential and attended only by writing committee members and relevant AATS/ACC/SCAI/STS staff. A public comment period was held to obtain further feedback. Following reconciliation of all comments and sign-off by the writing committee and oversight task force, this document was approved for publication by the approval bodies of the partnering societies. The structural measures of quality include the requirement that operators and institutions have the skills, experience, foundational TAVR and SAVR volume, and facilities that are fundamental to delivering TAVR and SAVR. These quality measures of program structure are outlined in Tables 1 and 2. There are learning curves associated with TAVR.7-9 For instance, nonfemoral TAVR involves an important learning process, with 30–45 cases needed to reach a plateau for procedure time and device success.10, 11 Analysis of early STS/ACC TVT Registry data shows that the cumulative TAVR volume-outcome relationship is strong during the learning curve, which is expected given that this is a novel procedure with high risk in an elderly patient population.12 In their analysis, Carroll et al.12 noted that there was a steep slope for improved major outcomes in the first 100 cases. TAVR case-volume requirements listed in this document ensure foundational data minimum needed to maintain program and operator effectiveness and efficiency as well as sufficient sample size for measurement of quality outcomes. Sites that are not in the higher-volume/experienced tier programs may provide high-quality TAVR care, typically via the well-established transfemoral approach. This is especially relevant to the more geographically isolated locations and to underserved patient populations in the US. The 2018 operator and institutional requirements support the ongoing activities of such sites. These programs should have an active quality assessment and improvement process. Higher-risk cases and those requiring more complex access at these low-volume sites should be referred to higher-volume centers with sufficient experience and expertise in complex or alternative-access cases. The defining principle of the MDT is an institutionally based joint cardiology and cardiac surgery effort.13, 14 TAVR programs should only be established if this multidisciplinary partnership is present. Additional providers, including imaging physicians, anesthesiologists, nurses, social services, and administrative support personnel, are also necessary. A comprehensive MDT is mandatory for a TAVR program.15 With increasing use of conscious sedation, the perfusion, and operating room (OR) teams will not be necessary in many transfemoral procedures.16 Additionally, an anesthesiologist may not be present in some instances, depending on patient severity and the training and skillsets of other staff; however, anesthesia and hemodynamic support must nonetheless be readily available. One of the cornerstones of the success of transcatheter valve programs is the partnership between cardiologists and cardiac surgeons, the underlying principle being that no one individual, group, or specialty possesses all of the necessary skills for optimal patient outcomes.13, 17 The success of these programs depends on a group of professionals, each with his or her own skillset, working together to provide the best possible patient-centered care.13, 18 There are specific and unique cognitive and technical skills that are essential for all physicians for optimal performance of TAVR irrespective of specialty background.19, 20 For the purpose of this document, the term "TAVR proceduralist" refers to either interventional cardiologists or cardiac surgeons. These clinicians should possess extensive knowledge of valvular heart disease (VHD), including the natural history of the disease, hemodynamics, appropriate diagnostics, and imaging, optimal medical therapy (particularly of comorbidities), application and outcome for both TAVR and SAVR, procedural and perioperative care, and long-term follow-up.21 There should also be mastery of post-acquisition CT software for detailed analysis of the heart, aorta, and peripheral vessels. Surgeons should have experience with surgical vascular access and postprocedural repair techniques, particularly pertaining to the axillary, subclavian, and carotid arteries as well as transapical, transaortic, and other alternative access approaches when the transfemoral arterial approach is not possible. It is understood that the entire spectrum of cognitive and technical skillsets required may not be possessed by a single individual TAVR proceduralist but that the combined skills of the procedural team will be complementary and synergistic. The field of percutaneous repair of cardiac structural abnormalities has advanced rapidly in the last decade. Training for TAVR should occur by one of two pathways: (1) a formal training program incorporated into cardiology fellowship or cardiovascular surgical residency; or (2) formal proctorship wherein an established interventional cardiologist or cardiac surgeon participates in an established TAVR program under the tutelage of an experienced team. Ongoing education courses with didactics focused on new concepts of TAVR, hands-on experience with device-specific equipment, simulation, viewing live cases performed by experienced operators in an interactive format, experienced device-specific proctors, and formalized fellowship training should be available as new innovations and products are introduced. Noninvasive imaging Physical space—the implantation suite should have a sterile environment that meets OR standards. Furthermore, it should have sufficient space to accommodate the necessary equipment for uncomplicated implantations as well as any additional equipment that may be necessary in the event of complications. This includes space for anesthesiology, echocardiography, hemodynamic support, and cardiopulmonary bypass equipment and a surgical team. A specifically designed hybrid OR interventional suite is ideal; however, in the absence of such a facility, the interventional cardiac suite should have: Most importantly, the hospital should be dedicated to providing these services and support financially and without time constraints on the personnel involved. A special consideration is radiation safety training for all of the personnel involved in delivering TAVR. A dedicated administrator as a member of the team is necessary. The complexity of TAVR and the magnitude of institutional resources required are similar to established heart transplant and cardiac assist device programs. An MDT is required, similar to the transplant and assist device programs. The concept of an MDT was endorsed by the CMS through the establishment of certification criteria for the use of heart transplantation and cardiac assist devices in centers and, moreover, for eligibility for reimbursement of services provided. The same regulatory system was applied to professionals providing these services. TAVR programs should undergo a similar regulatory process with CMS endorsement. Centers should be approved for TAVR programs if they have addressed the quality benchmarks in this document (see Section 7: Criteria for Establishing a TAVR Program and Maintenance of Competence) and the appropriate infrastructure and committed hospital support. The institutional commitment required for a successful program goes beyond the space, personnel, and specialized facilities set forth in the previous text. The complex and time-consuming preprocedure patient triage process and the amount and intensity of postprocedure patient care after discharge are labor-intensive for physician and nursing staff, as are the informed consents and communications with patients, families, and referring providers. Additionally, technological and administrative support for the medical, nursing, and technical personnel involved is required, preferably in a central setting. Ancillary testing facilities (e.g., pulmonary function testing, echocardiography, vascular duplex scanning, clinical laboratory, and multidetector CT) should be of high quality and able to accommodate the patient volume in a timely fashion. By their nature, these procedures should only be performed in institutions that routinely perform surgical aortic valve operations and participate in the STS National Database with outcomes that equal or exceed those expected for their case mix on the basis of national benchmarks. Similarly, only institutions with interventional cardiology programs that have established and successful programs endorsed by the National Quality Forum with percutaneous coronary intervention (PCI), BAV, catheter closure of periprosthetic valvular leaks, and insertion of septal closure devices with outcomes that equal or exceed those established nationally for similar procedures, should offer TAVR. Long-term outcome reporting is obligatory, to track not only survival, but also other parameters, including periprocedural complications (e.g., cerebrovascular accident, vascular, renal, infectious), aortic regurgitation, pacemaker needs, TAVR reintervention, TAVR structural valve failure, subsequent SAVR, and QoL. This reporting is essential because long-term outcome goals for these new procedures have not been established at this early stage. Participation in a national data registry or registries (e.g., the STS/ACC TVT Registry, STS National Database, ACC National Cardiovascular Data Registry [NCDR]) is mandatory.13 The measures of process quality in TAVR, defined as best practices and standardized processes that are accepted and incorporated into programs, are outlined in the 2017 ACC Expert Consensus Decision Pathway for TAVR in the Management of Adults with Aortic Stenosis.15 Current process measures include the incorporation of the ACC/AATS/AHA/ASE/EACTS/HVS/SCA/SCAI/SCCT/SCMR/STS 2017 Appropriate Use Criteria for the Treatment of Patients with Severe Aortic Stenosis,23 documentation of MDT-based decision making during patient selection, and procedure performance by a cardiologist and surgeon. Patients and families need to be involved in the process of SDM in relation to VHD.24 Best practices may include: (1) directing patients and families to an objective, noncommercial SDM tool designed by patients and clinicians, to provide knowledge regarding aortic valve disease and its treatment; and (2) access to decision aids that allow for assessment of patient-specific risk and benefit for both TAVR and SAVR.25 Other best practices7 include offering patients access to their medical records and training clinicians to help patients define their goals and treatment preferences. SDM has been actively promoted by CMS to enhance beneficiary engagement and incentives.26 TAVR is currently approved in the US for patients with severe native aortic stenosis (AS) and an intermediate or higher predicted operative 30-day mortality risk for SAVR, as well as valve-in-valve (ViV) indication for degenerated aortic bioprosthetic valves in patients who are at high risk for reoperation. Patients with these categories of valve disease need a multidisciplinary approach for their evaluation. There should be documentation that each patient has been made aware of the of implantation as well as the and for both of they are a for treatment with TAVR, SAVR, or either form of therapy. The patient should be informed both which therapies are available at their hospital and the recommendations to the best outcomes given their specific and goals of care. The volume and outcomes of both TAVR and SAVR for the site should be with the This the for SDM with the key of patient preferences. Patients to institutions should also be by an Establishing and maintaining a TAVR program several key and For all patients with aortic stenosis criteria for valve replacement, there should be documentation of the For patients TAVR, there should be documentation of an by one surgeon involved in the TAVR program. TAVR volume and quality requirements To have optimal outcomes, a program will have: SAVR volume and quality requirements To have optimal outcomes a program will have: Quality assessment/quality improvement institutional participation in the STS/ACC TVT Registry and STS National Database or a registry MDT with documentation of the In the National for TAVR in one of the major requirements for programs were that cardiac have the patient and the for aortic valve replacement and both have the for their clinical and the is available to the heart There should also be documentation of an additional physician who has the patient the for all of valve and the for their clinical must be available to the For all patients with aortic stenosis criteria for valve replacement, there should be documentation of the For patients TAVR, there should be documentation of by one surgeon involved in the TAVR program. The proposed TAVR proceduralist for a new TAVR program should document the Quality assessment/quality improvement participation of in STS/ACC TVT Registry and STS National Database or a team with documentation of the There are that many patients with severe the indications for TAVR are not currently being provided information regarding their treatment There are two potential associated with of TAVR. patients with severe especially those at risk for SAVR, may not of the TAVR some patients SAVR, especially those being at only offering SAVR, may not be informed when TAVR is an appropriate The MDT approach provides patients and families with a comprehensive and as to TAVR, SAVR, or both are appropriate for It is to patients who are by physicians and without TAVR programs are being informed of their potential eligibility for TAVR. It is important to understand that there are over programs in the US that only offer SAVR. The requirements for patient education and SDM outlined in this document are programs that offer TAVR and/or SAVR. et using of Aortic Transcatheter TAVR patients, were the first to an risk based on the outcome was defined as or in of patients a outcome at months alive without at 1-year outcomes after TAVR in three sites at which was this group used a threshold of to The patients a mortality with for those who were not outcome in of the of the the STS/ACC TVT Registry was using and 1 those who health a 1 mortality after as high as those who they health at et that as by the of a major on TAVR outcome in a for all other patients with a a mortality at 2 with for those with a of with an intermediate outcome for those with a of three to of patients with a were by 2 years from patient that high mortality over the first years after TAVR, an important consideration is TAVR in patients who will not any benefit or have after TAVR, or may experience to and/or a of a risk that such individuals is and the task of patients for procedural is appropriate will be et that of TAVR patients experienced at that a multidisciplinary activities of predicted when for STS and Such measures should be incorporated into the TAVR triage process, with active and care on the to avoid performing TAVR in patients who are not to benefit from the In current is used to assess the clinical to of Patients with no clinical improvement after successful should not be considered for TAVR. The evolution of TAVR in the with patients before and two trials are patients to SAVR or TAVR. indications for TAVR into lower-risk the long-term outcomes of TAVR have become a major because in to that of the of bioprosthetic TAVR valves is are available for patients considered to be at high or risk for the procedure to an valve for the patient An ongoing is the of patients most to benefit from TAVR who are either or at risk for such as disease, recent coronary disease, severe pulmonary disease, severe pulmonary severe regurgitation, active and were criteria in the a of patients were not Other such as and disease, were not incorporated into the risk assessment process in the early these patients were the mortality of patients who received TAVR in the and trials were and has been focused on the use of metrics that identify patient and procedure that are of or outcomes, both early and at 1 or mortality are by Other outcomes that have been include health and objective measures of These outcomes are best understood when they are before and after TAVR. reports in are for defining the of