By John D. Carroll, MD, FACC, vice chair of the STS/ACC TVT Registry Steering Committee

The STS/ACC TVT Registry was formed in 2011 with the impending approval of the first TAVR valve in the U.S. The first publication describing the registry noted its intent was to "provide a data repository and reporting infrastructure to monitor the safety and effectiveness of TVT devices." The article went on to clarify that the STS/ACC TVT Registry "represents a new model combining the needs of the medical device industry, regulatory and reimbursement agencies, clinicians, hospitals, patients, researchers, and professional societies." It was clear that the STS/ACC TVT Registry would lead to "multiple innovations."ⁱ

The STS/ACC TVT Registry serves as an essential component of the rational dispersion of TAVR, mitral valve repair and mitral valve replacement in the U.S., bringing transcatheter valve therapies into clinical practice as quickly as possible after the U.S. Food and Drug Administration (FDA) approval and collecting pre-procedure, procedure, and 30-day and one-year post-procedure data. This strategy of rational dispersion of these new technologies was articulated by David R. Holmes Jr., MD, MACC, then ACC president, and Michael J. Mack, MD, FACC, then Society of Thoracic Surgeons (STS) president, in their seminal paper.ⁱⁱ The goal of rational dispersion is to introduce these novel device therapies into clinical situations that mimic as closely as possible those in the randomized clinical trials.

The Centers for Medicare and Medicaid Services (CMS), in its initial national coverage determination (NCD) governing transcatheter valve replacement, mandated that hospitals performing TAVR participate in an approved national registry, like the STS/ACC TVT Registry. The mandate's primary goal was to verify that the results of TAVR in routine clinical use were similar to the results in randomized clinical trials. That goal has been met, but there are critical long-term issues to address as TAVR indications expand and new devices appear.

The STS/ACC TVT Registry is a national learning machine that provides all stakeholders with new insights into these therapies via multiple publications and presentations. Patients and clinicians have decision tools and predictive risk models based on voluminous patient-level data. TAVR teams receive quarterly feedback on their results with national benchmarks that enable them to improve care. The FDA receives robust and comprehensive data to monitor device safety. Industry has a less expensive means to satisfy post-approval FDA requirements, and data from the STS/ACC TVT Registry has allowed expansion of indications. CMS now has data on site performance for policy decisions on requirements for TAVR centers.

There are specific multiple uses of the STS/ACC TVT Registry that go beyond the general concept of rational dispersion. This registry has been unique in facilitating many stakeholders to use the data for a myriad of purposes – incorporating unique patient-centric metrics and by looking at long-term outcomes, for example. New uses for registry data continue to expand.

First, registry data enables quality assessment of transcatheter therapies for individual hospital programs and for the entire U.S., enabling programs to improve quality and assess their performance with national benchmarks and quarterly reports. This will further develop with ACC's new Transcatheter Valve Certification. As appropriate use criteria (AUC) are developed for each procedure, the STS/ACC TVT Registry will show sites how their program aligns with AUC metrics. Furthermore, outcomes are risk-adjusted with sophisticated algorithms developed by a Risk Model Committee in order to give a fair and balanced view of a program's performance.

Second, the STS/ACC TVT Registry is clinical knowledge machine and a prime example of a U.S. learning health care system that uses a clinical registry as its backbone. The list of research published using data from the STS/ACC TVT Registry continues to grow and has scientific oversight by a research and publication committee. The research has provided timely information on these new therapies, identified outcomes in groups of patients not treated in the pivotal clinical trials, and addressed all clinical questions outlined in the CMS NCD.

Third, the registry serves government agencies. For example, the FDA uses the registry to monitor the safety and effectiveness of approved devices and has embedded pre-approval continued access studies, as well as post-approval studies in the registry with the medical device industry to meet their regulator responsibilities.ⁱⁱⁱ This has led to expansion of approved indications for several of the devices, bringing new therapies to patients faster. For CMS, the registry provides the agency with data on patient access to these technologies, the quality of the outcomes and functional status with quality of life measures extending out to one year post-procedure. Further, linking patient records from the registry with CMS claims data allows additional assessments, such as the rate of rehospitalization, mortality and downstream complications like stroke. This linkage can extend the TVT outcomes assessment well beyond one year, increasing our understanding of the safety and effectiveness of these therapies in a diverse group of U.S. patients.

Fourth, the registry provides the medical device industry with regular reports regarding their devices used in real-world practice, offers an efficient and cost-effective infrastructure for pre- and post-approval studies, identifies data that can lead to improvement in delivery systems and devices, and allows an assessment of off-label use of devices that are not typically captured in post-approval studies.

Fifth, patients, families, the general public and clinicians can use the STS/ACC TVT Registry to help make health care decisions. Risk models have been developed for TAVR that provide a patient-specific assessment of their risk and potential benefit from the procedure. Furthermore, the metrics of hospital performance that are being developed and refined will soon lead to the ability to publicly report and help patients make decisions about where they might prefer to have their valve condition treated.

What started as a means of tracking important information about a new and evolving technology, the STS/ACC TVT Registry continues to be a valuable source of information, not only for showcasing how far we've come, but also for helping to determine where we are going in the future. Its well-established benefits provide value for the multiple stakeholders involved in the evolution of this practice-changing treatment.

The STS/ACC TVT Registry Steering Committee consists of members from the STS and ACC, as well as ex officio members from the FDA and CMS. Joseph E. Bavaria, MD, FACC, is the current Steering Committee chair. Bavaria is a past-president of STS and a professor of surgery at the University of Pennsylvania Perelman School of Medicine.

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1. Carroll JD, Edwards FH, Marinac-Dabic D, Brindis RG, Grover FL, et al. J Am Coll Cardiol 2013;62:78-86.
2. Mack MJ, Holmes DR. Journal of the American Medical Association 2011;306:2149-50.
3. Carroll JD, Shuren J, Syrek-Jensen T, Hernandez J, Holmes DR, et al. Health Affairs 2015;34:328-334.

Keywords: Quality Summit, Centers for Medicare and Medicaid Services, U.S., Benchmarking, Transcatheter Aortic Valve Replacement, Equipment Safety, United States Food and Drug Administration, Mitral Valve, Off-Label Use, Device Approval, Medicare, Medicaid, Registries, Outcome and Process Assessment, Health Care, National Cardiovascular Data Registries, STS/ACC TVT Registry, Cardiology Magazine, ACC Publications

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