Collaborative valve registry shines as example of cooperation, data excellence

Good data are key to understanding new processes and improving care. This was underscored by a paper published in the February issue of Health Affairs, which promoted the Transcatheter Valve Therapy Registry as a model for collaboration and harmonized patient data collection.

According to authors John D. Carroll, MD, from the University of Colorado School of Medicine in Aurora, and colleagues, the registry encompassed more than 27,000 patients treated with transcatheter valve devices. These patients, enrolled through 2014, represent nearly all U.S. transcatheter valve patients. The collaboration between the Society of Thoracic Surgeons, the American College of Cardiology, the Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) synchronized more than 300 data elements to provide standard definitions for cardiologists.

In 2012, CMS made participation in the registry mandatory for reimbursement of related procedures. The registry currently encompasses data on transcatheter aortic valve replacement and mitral valve repair devices approved by the FDA. The authors noted that the only device in the registry not FDA-approved, as yet, was the Sapien 3 valve (Edwards Lifesciences).

Carroll et al wrote that the registry allows devices to be monitored for safety and to efficiently effect recalls, if necessary. Owing to the nature of the data, near real-time analysis could provide assessments of risks and benefits, identify potential safety signals and facilitate surveillance, clearance and approval of future device updates, they posited.

However, more than 300 data elements make the system cumbersome. EMRs are not currently designed to mesh with this or other registries; Carroll et al suggested addressing this as a means for system improvement, and further refinement of data elements may assist in this effort.