TAVR Approval Shows Promise for Cardiac Cath Labs
The Food and Drug Administration (FDA) expanded the indication for transcatheter aortic valve replacement (TAVR) in 2016 when it approved two TAVR devices for intermediate-risk aortic-stenosis patients.
It specifically targets patients with at least a 3% STS-predicted risk of dying within 30 days of surgery. The action followed the release, four months earlier, of intermediate-risk trial results that showed that TAVR was equal or superior to surgical aortic valve replacement (SAVR).
This is, perhaps, the logical evolution of TAVR adoption. TAVR received the FDA’s approval for high-risk patients four years ago and the second-generation of TAVR valves has yielded encouraging results compared to surgery in high-risk patients. Those results include less risk of mortality and perivalvular leaks than first-generation products. Going further, the start of two low-risk trials for TAVR earlier this year suggests that the procedure could be recommended for lower-risk patients instead of surgery.
Implications for Cath Labs
This trend promises a larger role for cardiac catheterization labs. Cath Labs will be under more stress to manage more procedures and adapt to evolving nonsurgical intervention procedures. To maintain high levels of efficiency it will be crucial to have anytime/anywhere access to a patient’s complete cardiovascular medical record. Features such as customizable reporting tools will allow the cath lab to analyze and document care practices as these procedures evolve and their appropriate usage grows.
A single-database CVIS system can capture all the parallel workflow data generated by structural heart procedures such as cardiac catheterization. The integrated visibility that CVIS provides into all images, reports, waveforms and measurements can help establish credibility when procedures break new ground — as TAVR is doing with intermediate-risk patients.
An advanced CVIS should be robust enough to provide a single or tightly integrated system that can facilitate the visualization, interpretation and comparison of all imaging data for a cardiovascular service line in a single client environment. That’s a big advantage for clinicians who have had to cobble together and make sense of disparate data streams from independent standalone systems involving multiple workstations, graphical user interfaces and sign-on requirements.
Implications for TAVR
There are implications of TAVR related to measurements that make a strong case for a CVIS implementation.
TAVR growth is inevitable and now is the time to define how your organization will manage the data generated to support these procedures to show appropriate use and quality of care. Storing measurements, made to determine valve sizing, in a central repository such as a CVIS for subsequent analysis is crucial to prove quality and decrease the number of valves used per patient due to improper sizing.
It’s essential to choose a complete CVIS instead of a department-only system for two reasons. First, multiple modalities are frequently used to support TAVR cases, so storing the data in a CVIS ensures that everyone involved in the care process can access the results. Second, improving patient outcomes over time requires careful analysis of the initial measurement, the model and size of the valve placed and the patient’s condition at least six months later—analysis that a CVIS easily facilitates.
Since more than 150,000 TAVR devices have been implanted throughout the world, a considerable database about their durability is building up. By storing TAVR procedural data in a CVIS, hospitals can create a high-quality TAVR program and more readily share their data with pertinent organizations such as the American College of Cardiology.