Transcatheter Aortic Valve Replacement Outcomes During the Public Health Emergency Flexibility Period

Objective: To compare transcatheter aortic valve replacement (TAVR) outcomes during the period when public health emergency (PHE) flexibilities were in place with outcomes during a period before they were introduced. Methods: Patients who received a native TAVR with either a SAPIEN 3 or SAPIEN 3 Ultra valve from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry between June 22, 2019, and August 30, 2022, were placed into one of two cohorts: (1) pre-PHE cohort, and (2) peri-PHE cohort. Outcomes included in-hospital events and events occurring 30 days post-TAVR. Patients were matched 1:1 on their propensity of receiving a TAVR during the pre- or peri-PHE periods. After matching, relative risk was calculated for each in-hospital outcome and HRs for outcomes 30 days post-TAVR. Results: In this study, 173,434 patients met inclusion criteria; after 1:1 matching, there were 37,063 patients in each cohort. There was no difference between cohorts in in-hospital outcomes, including all-cause mortality, stroke, composite of mortality and stroke, pacemaker, or major vascular complications. Similarly, there was no statistically significant difference in 30-day outcomes between the cohorts. Conclusion: In this large-scale retrospective study of 74,126 patients undergoing TAVR procedures from 2019 to 2022, no significant differences existed in TAVR outcomes during the PHE period.