Article Abstract

Message from “real-world” data of transcatheter versus surgical aortic valve replacement

Authors: Tomo Ando, Luis Afonso

Abstract

Comparative outcomes between transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR), which is one of the most important themes in structural heart disease intervention today, have largely been dependent on data from randomized controlled trials (1-4). However, randomized controlled studies do not actually reflect the outcomes of “real-world” TAVR versus SAVR because of relatively stringent inclusion and exclusion criteria. Furthermore, these trials and procedures are often performed in experienced, high-volume centers. In fact, we previously reported worse mortality in TAVR compared to SAVR when the meta-analysis was performed with propensity-matched studies from “real-world” data but similar mortality when only randomized controlled studies were pooled (5). This observation raised a concern that TAVR may not confer similar benefit compared to SAVR outside the randomized clinical trial setting. Accordingly, a large, non-randomized study to examine the real-world comparative outcomes between TAVR versus SAVR was clearly warranted.

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