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This article is the author's final published version in JACC: Advances, Volume 2, Issue 2, March 2023, Article number 100271.

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Background: The use of transcatheter aortic valve implantation (TAVI) in patients with aortic valve disease excluded from clinical trials has increased with no large-scale data on its safety. Objectives: The purpose of this study was to assess the trend of utilization and adjusted outcomes of TAVI in clinical trials excluded (CTE) vs clinical trials included TAVI (CTI-TAVI) patients. Methods: We used the National Readmission Database (2015-2019) to identify 15 CTE-TAVI conditions. A propensity score-matched analysis was used to calculate the adjusted odds ratio (aOR) of net adverse clinical events (composite of mortality, stroke, and major bleeding) in patients undergoing CTE-TAVI vs CTI-TAVI. Results: Among the 223,238 patients undergoing TAVI, CTE-TAVI was used in 41,408 patients (18.5%). The yearly trend showed a steep increase in CTE-TAVI utilization (P = 0.026). At index admission, the adjusted odds of net adverse clinical events (aOR: 1.83, 95% CI: 1.73-1.95) and its components, including mortality (aOR: 2.94, 95% CI: 2.66-3.24), stroke (aOR: 1.20, 95% CI: 1.07-1.34), and major bleeding (aOR: 1.49, 95% CI: 1.36-1.63) were significantly higher in CTE-TAVI compared with CTI-TAVI. Among the individual contraindications to clinical trial enrollment in the CTE-TAVI, patients with bicuspid aortic valve, leukopenia, and peptic ulcer disease appeared to have similar outcomes compared with CTI-TAVI, while patients with end-stage renal disease, bioprosthetic aortic valves, and coagulopathy had a higher readmission rate at 30 and 180 days. Conclusions: CTE-TAVI utilization has increased significantly over the 4-year study period. Patients undergoing CTE-TAVI have a higher likelihood of mortality, stroke, and bleeding than those undergoing CTI-TAVI.

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