A set of minimum core data elements for TAVR evaluation that are necessary to clinical, regulatory and hospital quality assessment and also fulfill reporting requirements for the U.S. Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) can help reduce data burden while still maintaining the need for evidence generation, according to a task force statement published March 30 in JACC: Cardiovascular Interventions.

Matheus Simonato, MD, et al., reviewed TAVR research published in the New England Journal of Medicine, The Lancet or JAMA between 2009 and 2020 to identify data elements used in high-impact trials and multicenter, multidevice registries and reconcile a set of minimum core TAVR data elements. After identifying data elements from published research, two task forces – one from the STS/ACC TVT Registry and another from the Predictable and Sustainable Implementation of National Cardiovascular Registries (PASSION CV) and Heart Valve Collaboratory – met separately to review the data elements. Both task forces then reconvened to create the final list of minimum core data elements. 

The researchers identified 326 studies. Of these, 176 were excluded for irrelevance to the topic, and 109 were excluded because they lacked original research. In the remaining 41 papers, 17 met inclusion criteria for the final analysis. For inclusion, studies had to include patients with aortic stenosis, with TAVR in native valves as the intervention of interest. Control groups had to consist of patients receiving SAVR, TAVR with a different device or medical management. In addition, no specific outcomes could be selected, and included research had to be randomized or prospective observation studies evaluating FDA-approved devices with a minimum follow up of one year. 

In total, 276 data elements were identified, 216 of which are listed in the STS/ACC TVT Registry Version 3.0 data collection form (57 baseline demographics and comorbidities, 35 baseline laboratory tests and imaging, 25 procedural, 79 follow-up outcomes, and 20 follow-up laboratory tests and imaging). After separate discussion in each task force, followed by combined discussion of both task forces, there was unanimous agreement on 132 elements as minimum core data elements (45 baseline demographics and comorbidities, 16 baseline laboratory tests and imaging, 11 procedural, 48 follow-up outcomes, and 12 follow-up laboratory tests and imaging).

The remaining 84 data elements were included in a list of comprehensive TAVR data elements. Common reasons for exclusion from the minimum core dataset included a belief that the element was challenging to accurately assess (36.9%) or was captured in duplicate (33.3%) or unlikely to affect clinical outcomes (10.7%). The minimum core data elements were implemented and designated as the required dataset in the STS/ACC TVT Registry as of January 2021.

According to the researchers, the minimum core data elements are “essential to clinical, regulatory, and hospital quality assessment” and “represent the minimum dataset targeted to fulfill FDA and CMS reporting requirements for TAVR.” They note that the basic dataset supports “efficiency, speed, and predictability of future TAVR device evidence collections and concomitantly reduce[s] the burden on hospitals.” They conclude that “processes and principles of core data element’s structure can facilitate similar approaches for other structural heart devices, cardiovascular devices and medical devices in general.”

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and VHD, Interventions and Structural Heart Disease

Keywords: Aortic Valve, Data Collection, Registries, Aortic Valve Stenosis, Medicare, United States Food and Drug Administration, Prospective Studies, Laboratories, Transcatheter Aortic Valve Replacement, Centers for Medicare and Medicaid Services, U.S., Follow-Up Studies, STS/ACC TVT Registry, National Cardiovascular Data Registries

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