Should TAVR Replace Surgery for Aortic Stenosis in Low- to Intermediate-Risk Patients?

Abstract

Transcatheter aortic valve replacement (TAVR) was initially envisioned as a less invasive option for patients with severe symptomatic aortic stenosis who either were not candidates or were very high-risk candidates for surgical aortic valve replacement (SAVR). Based on data from the original Placement of Aortic Transcatheter Valve (PARTNER) trials as well as the CoreValve Pivotal trials, TAVR is now approved and accepted in the treatment of severe symptomatic aortic stenosis in extreme-risk and high-risk patient populations. Thus far, the randomized controlled trial data for TAVR have been noninferior or even superior to both medical therapy and SAVR. Recently, the US Food and Drug Administration expanded the indications for 2 balloon-expandable devices, and CE Mark status was awarded to a self-expanding device for use in patients at intermediate risk. Given all the data, the logical next step is to study low-risk patient groups. Anecdotal and nonrandomized data have been conflicting when comparing TAVR to SAVR in low-risk patients. Two low-risk randomized trials have started in the United States, and ultimately these trials will determine the feasibility of TAVR as an acceptable alternative to SAVR in low-risk patients with severe aortic stenosis.