Transcatheter aortic valve replacement (TAVR) has transformed the treatment of symptomatic severe aortic stenosis. Randomized clinical trials have demonstrated the clinical effectiveness of TAVR for patients at extreme, high, and intermediate risk for undergoing a surgical valve replacement.1-4 These well-designed clinical trials necessarily involved trade-offs between a focused, carefully defined study population and subsequent generalizability. Current US Food and Drug Administration (FDA) labeling for TAVR reflects this balance, illustrating that the manufacturers have met the standard of demonstrating a reasonable assurance of its safety and effectiveness through rigorous clinical studies among selected patients with severe aortic stenosis.
Joynt KE, Kramer DB. Off-label Use of High-Risk Cardiovascular Devices: Widening the Lens. JAMA Cardiol. 2017;2(8):832–834. doi:https://doi.org/10.1001/jamacardio.2017.1732
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