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August 2017

Off-label Use of High-Risk Cardiovascular Devices: Widening the Lens

Author Affiliations
  • 1Brigham and Women’s Hospital and the Harvard T.H. Chan School of Public Health, Boston, Massachusetts
  • 2Harvard Medical School, Boston, Massachusetts
  • 3The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts
JAMA Cardiol. 2017;2(8):832-834. doi:10.1001/jamacardio.2017.1732

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.

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