Outcomes After Transcatheter Aortic Valve Implantation in Patients Excluded From Clinical Trials

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. 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. 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. 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. 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. [Display omitted]