Welcome to the STS ACC TVT Registries Educational Overview. The content in this presentation was developed and provided by Joan Michaels, Christina Cutros, and Liza St. Clair. I am Karen Colbert and I will be narrating this presentation. The objectives for this registry overview are for the learner to be able to define the purpose and background of the STS ACC TVT Registry, identify inclusion criteria for the STS ACC TVT Registry, and to outline the role of registry governance. The TVT Registry is designed to support a national surveillance system to assess the characteristics, treatments, and outcomes of patients receiving transcutaneous valve therapies. Patient-level data are submitted by participating hospitals to the Society of Thoracic Surgeons and the American College of Cardiology Foundation's Joint TVT Registry. The purpose of the TVT Registry includes, number one, collecting pertinent and standardized data elements from participating hospitals, healthcare providers, and others that measure and assess the quality of care for patients receiving TVT, number two, providing confidential periodic reports to participating hospitals, healthcare providers, and others to evaluate and improve the quality of care in these areas, and three, permitting and fostering appropriate research based upon the data collected by means of the TVT Registry. The secondary aim of the TVT Registry is to serve as a scalable data infrastructure for post-market studies. The importance of the STS ACC TVT Registry. Aortic stenosis is the most common valvular heart disease and traditionally treated with a surgical valve repair or replacement procedure. However, aortic stenosis affects about 2% of people who are over 65 years of age, therefore for this geriatric population whose risk factors and comorbidities are likely higher and may have prohibited the option of being treated with a surgical valve repair or replacement, they now have the option of a less invasive procedure. TVT procedures could be a viable and appropriate option in this population. Lastly, in those who have symptoms, without an intervention, the chance of death at five years is about 50% and at 10 years is about 90%. Therefore, it is worth identifying those that can benefit from these TVT therapies or surgical valve repair or replacement interventions at an early stage in their disease process. The STS ACC TVT Registry is a collaborative effort between STS and ACC. The registry launched immediately after the first FDA TVT approved valve was introduced to the United States market. In May 2012, CMS announced a National Coverage Decision or NCD for TAVR. The NCD for TAVR stipulates the requirements that must be met in order for hospitals to be eligible for reimbursement. This includes participating in a national audited registry and following the patient out to one year post-procedure. Two years after the TAVR device was approved by the FDA and CMS, the first approved TVT mitral procedure device soon followed. In July 2014, the FDA approved MitralClip for degenerative mitral regurgitation. A National Coverage Decision for transcatheter mitral valve repair was announced in August of 2014 with similar requirements for hospital participation and a national audited registry and following the patient out to one year post-procedure. In June of 2017, the FDA expanded the use of the TAVR-Edward-Sapien 3 valve for use in the mitral valve position, which has now allowed for TVT mitral replacement procedures. The science of TVT therapies is changing and the treatment options are expanding for this population. Registration Criteria All patients entered into the STS-ACC TVT registry should be 18 years and older. The three procedures currently collected by the registry are transcatheter aortic valve replacement, transcatheter mitral valve repair, which encompasses mitral leaflet clip procedures, and transcatheter mitral valve replacement. In the future, the registry will expand to capture and include tricuspid repair and replacement procedures. What Data Are Collected? The data collected in the registry includes demographic provider and facility characteristics, history risk factors, cardiac status and health status, indications for the procedure, pre-, intra-, and post-procedure data and adverse events, frailty scale and quality of life or KCCQ, and outcomes at discharge, 30 days and 1 year. There are two important data points that are collected by the TVT registry for TAVR procedures. The first is the 5-meter walk test and the second is the Kansas City Cardiomyopathy Questionnaire or KCCQ-12. The 5-meter walk test is used to measure frailty, especially in older adults. By utilizing a frailty measurement tool, it will measure the body's response to physiologic stressors. This will aid the heart team to determine if a surgical or a TVT procedure is more suitable for the patient. Due to the significance of this test and current supporting literature, it has become an important predictor on how well the patient will do after a TAVR procedure and has been adopted into the TVT registry risk-adjusted metric mortality algorithms. As noted earlier, the second important data point collected by the registry is the Kansas City Cardiomyopathy Questionnaire or KCCQ-12. The KCCQ-12 is a quality of life patient survey that is completed prior to the TVT procedure at 30 days and one year post-procedure. For the post-procedure KCCQ-12 surveys, it is the hope that the patient receives a higher score than their pre-procedure score to reflect the success of the TVT procedure and a better quality of life. Similar to the 5-meter walk test, the KCCQ-12 has also been strongly linked to the patient's success and outcomes of the TVT procedure and has been incorporated in the risk-adjusted mortality algorithms. Currently, one in three patients show a poor outcome one year after TAVR. Therefore, continued efforts are needed to improve patient selection and procedural post-procedural care in order to maximize health status outcomes of this evolving therapy. As a nationally recognized surveillance tool, the STS registry is well positioned within the healthcare industry and provides participants weekly access to their data and metric performance through an interactive dashboard and quarterly benchmarked feedback through the published outcomes report. These data support ongoing quality improvement efforts by hospitals performing this life-saving intervention. The TVT registry has also become a tool for outside stakeholders. Healthcare systems, states, and payers use it to assess the incidence and trends of procedures and the quality of care delivered by providers and the centers engaged in performing these procedures. It supports numerous research initiatives and informs clinical practice and guideline development. The TVT registry is governed by a 7-10 member steering committee with a chair and ex-officio members from the TVT registry research and publication subcommittee and NCDR management board. Committee members have expertise in clinical practice, financial management, quality measurement and improvement, and or health system strategy and innovation. The steering committee provides strategic oversight and direction of the registry, guidance for program activities, and helps identify and prioritize research initiatives. Committee recommendations are provided to the NCDR management board, thus helping to inform and influence the direction of the NCDR. This concludes the overview of the STS ACC TVT registry. Thank you for your participation.

STS ACC TVT Registry

transcutaneous valve therapies

patient-level data

collaborative effort

post-market studies