Transcatheter aortic valve replacement (TAVI) using the CoreValve System (Medtronic) was associated with reduced 1-year mortality compared with surgical aortic valve replacement (SAVR) in 750 patients at high surgical risk who underwent an attempted implantation procedure in the CoreValve U.S. Pivotal High Risk Trial. In a planned report of 5-year follow-up data, all-cause mortality was 55.3% with TAVI and 55.4% with SAVR, and the rates of major stroke were 12.3% with TAVI and 13.2% with SAVR. Freedom from severe structural valve deterioration was not significantly different between the two groups, and freedom from valve reintervention was 97.0% with TAVI and 98.9% with SAVR. Of note, 33.0% of the TAVI group received a permanent pacemaker, compared with 19.8% of the SAVR group. Overall, mid-term survival and rates of stroke in this population of high-risk patients were similar with TAVI and SAVR, with similar device safety, performance and durability.
Gleason, T. G. et al. 5-year outcomes of self-expanding transcatheter versus surgical aortic valve replacement in high-risk patients. J. Am. Coll. Cardiol. 72, 2687–2696 (2018)
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Lim, G.B. Mid-term outcomes with CoreValve versus surgery. Nat Rev Cardiol 16, 71 (2019). https://doi.org/10.1038/s41569-018-0140-7