Welcome to this learning activity titled an STS-ACC TVT registry overview. After participating in this learning activity, the learner will be able to define the purpose and background of the TVT registry, identify inclusion criteria for the STS-ACC TVT registry, and describe data which are collected for the TVT registry. All patients 18 years and older are entered into the STS-ACC TVT registry when they have a qualifying procedure. The four procedure pathways include transcatheter aortic valve replacement, TAVR, transcatheter mitral valve repair, transcatheter mitral valve replacement, and transcatheter tricuspid procedures both replacement and repair. 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 collecting pertinent and standardized data elements from participating hospitals, health care providers, and others that measure and assess the quality of care for patients receiving TVT, providing confidential periodic reports to participating hospitals, health care providers, and others to evaluate and improve the quality of care in these areas, and 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. Aortic stenosis is the most common valvular heart disease and traditionally treated with surgical valve repair or replacement procedure. However, it 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, it may prohibit the option of being treated with a surgical valve repair or replacement. Now, with the option of a less invasive procedure, a TVT procedure 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's worth identifying those that can benefit from these TVT therapies or surgical valve repair or replacement interventions at an early stage of their disease process. The STS-ACC TVT registry is a collaborative effort between the Society of Thoracic Surgeons and the American College of Cardiology. The registry launched immediately after the first FDA TVT-approved valve was introduced to the U.S. market. In May 2012, CMS announced a national coverage decision for TAVR. 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 one year post-procedure. Two years after the TAVR device approved by the FDA and CMS, the first approved TVT mitral procedure device soon followed. In July 2014, the FDA approved MitraClip 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 in 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-Sabian 3 valve for use as a mitral valve which is now allowed for TVT mitral replacement procedures. The science of TVT therapies is changing and the treatment options are expanding for this population. The data collected in the registry includes demographics, provider and facility characteristics, history, risk factors, cardiac status and health status, indications for the procedure, pre, intra and post-procedure data and events, frailty scale and quality of life or KCCQ, outcomes at discharge, 30 days and one 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 of how well the patients will do after a TAVR procedure and has been adopted into the TVT registry risk model algorithms. As noted earlier, the second important data point collected by the registry is the Kansas City cardiomyopathy questionnaire or the 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. Like 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 model algorithms. Currently, 1 in 3 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 TVT 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 benchmark feedback through the published outcomes reports. 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 who use it to assess the incidents and trends of procedures and the quality of care provided by providers and the centers engaged in performing these procedures. It supports numerous research initiatives, 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 the NCDR oversight committee. Many members have expertise in clinical practice, financial management, quality measurement, quality 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. Many recommendations are provided to the NCDR oversight committee, thus helping to inform and influence the direction of the NCDR. Thank you for participating in this learning activity titled STS-ACC TVT Registry Overview. After completing this learning activity, the learner will now be able to define the purpose and background of the STS-ACC TVT registry, identify inclusion criteria for the TVT registry, and describe the data which are collected for the TVT registry.

STS-ACC TVT registry

transcatheter valve therapies

transcatheter aortic valve replacement

mitral valve repair

tricuspid procedures