Outcomes After Transcatheter Aortic Valve Implantation in Patients Excluded From Clinical Trials.
JACC Adv
; 2(2): 100271, 2023 Mar.
Article
em En
| MEDLINE
| ID: mdl-38938299
ABSTRACT
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Idioma:
En
Revista:
JACC Adv
Ano de publicação:
2023
Tipo de documento:
Article
País de afiliação:
Estados Unidos