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Transcatheter aortic valve replacement (TAVR) was approved in 2019 by the Food and Drug Administration (FDA) for the treatment of aortic stenosis in patients at low surgical risk. We sought to determine the impact of this approval on procedure volume and outcomes for all patients treated by TAVR or surgical aortic valve replacement (SAVR). All patients undergoing TAVR and SAVR in a single healthcare system were analyzed. We evaluated the shift in procedure volume, 2-year all-cause mortality, and 30-day complications in the 2 years before (August 16, 2017 – August 15, 2019) and the 2 years after (August 16, 2019 – August 15, 2021) the approval of TAVR for low-risk patients. Of 3,803 all-risk patients, 1,356 (35.7%) were treated by SAVR and 2,447 (64.3%) by TAVR. Two years after the approval, the volume of all AVR procedures decreased from 2,091 (55%) to 1,712 (45%) cases (SAVR: 810 (59.7%) to 546 (40.2%) and TAVR: 1,281 (52.3%) to 1,166 (47.7%)). There was a significant increase in low-risk TAVR (20.3% vs. 32.2%; p < 0.001) and no change in STS PROM score for SAVR (2.23 ±3.1 vs. 2.37 ±2.84; p= 0.63). After the approval, 30-day and 2-year mortality were significantly decreased in TAVR (4.84% vs. 1.97%; p <0.001; 12.4% vs. 9.52%; p= 0.027, respectively) but unchanged in SAVR (1.48% vs. 1.65%; p= 0.984; 4.44% vs. 4.95%; p= 0.77). Complications at 30-day were comparable for TAVR and SAVR in both periods. Two years after the approval of TAVR for low-risk patients, SAVR and TAVR demonstrated a shift in procedure volume with mortality benefit for TAVR and unchanged outcomes for SAVR.
Moubarak et al. (Wed,) studied this question.