Transcatheter Aortic Valve Replacement in Low-Risk Patients Within the Observational Study of Effectiveness of SAVR–TAVI Procedures for Severe Aortic Stenosis Treatment Study

Abstract

Transcatheter aortic valve replacement (TAVR) is a novel, disruptive technology that is revolutionizing the management of patients with aortic stenosis (AS). The landmark Placement of Aortic Transcatheter Valves (PARTNER) trial demonstrated that in patients with symptomatic severe AS who are not suitable for surgical aortic valve replacement (SAVR), TAVR significantly reduced the rates of death, with a number needed to treat only 5 patients to save 1 life at 5 years. In high-risk patients, the PARTNER trial demonstrated equivalent survival after TAVR using the Edwards Sapien balloon–expandable valve (Edwards Lifesciences, Corp, Irvine, CA) and SAVR although periprocedural risks differed with each procedure.1,2 Using the Medtronic self-expanding transcatheter heart valve (Medtronic, Inc, Minneapolis, MN), the CoreValve US Pivotal trial demonstrated the safety and efficacy of TAVR in extreme risk AS patients and superior survival with TAVR compared to SAVR in high-risk patients.3,4 These historic trials have generated unprecedented excitement and attention within the cardiology community. Cardiologists have eagerly pursued expanding indications, including, in large part, the expansion of this technology to healthier populations. Industry has also invested tremendously to rapidly address device pitfalls with novel transcatheter heart valve design iterations. Several valves are currently in development, and within a decade of the PARTNER trial, we are already commercially implanting third-generation devices. See Article by Rosato et al Soon after the completion of the aforementioned landmark trials, attention shifted to the use of TAVR in intermediate-risk patients. Multiple observational studies—primarily based on European centers—have attempted to elucidate comparative outcomes for TAVR and SAVR in intermediate-risk patients and have shown comparable short and midterm mortality between groups using propensity-score methodology.5–7 Piazza et al7 conducted an observational study derived from a large database (n=3666) of patients undergoing percutaneous and surgical AVR at 3 European …