The Centers for Medicare and Medicaid services proposed a new set of policies that appear to expand the use of a procedure that allows doctors to replace the aortic heart valve without performing open-heart surgery.
The procedure, called transcatheter aortic valve replacement (TAVR), was first introduced as an alternative to surgical aortic valve replacement (SAVR) for the sickest patients, but its use has gradually expanded to more and more patients as clinical trials showed that the catheter-based approach was as good or, in some ways, better. The two leading makers of TAVR are Edwards Lifesciences, the market leader, and Medtronic.
In the March 19, 2019 JAMA, Holmes & Mack discuss the saga of the “rational introduction” of TAVR, and compare it favorably to the often uncontrolled introduction of new technology. https://jamanetwork.com/journals/jama/fullarticle/2728496?resultClick=1
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