Valvular & structural heart disease

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

JACC AdvPublished Retrospective cohort study

Main finding · Net adverse clinical eventsResult — go to the resultAdjusted odds ratio 1.83 95% CI 1.73–1.95

Authors' conclusion

Patients undergoing CTE-TAVI have a higher likelihood of mortality, stroke, and bleeding than those undergoing CTI-TAVI.

Study context

Population
Patients undergoing Transcatheter Aortic Valve Implantation (TAVI), US National Readmission Database, 2015–2019
Participants
223,238 patients
Exposure
TAVI in clinical-trial-excluded vs clinical-trial-included patients
  • CTE-TAVIn = 41,408
Outcome
Net adverse clinical events:
  • Mortality
  • Stroke
  • Major bleeding
Follow-up
Index admission
Methodological detailspropensity-score matched
  • Propensity-score matched

Main finding

Net adverse clinical events

Adjusted odds ratio

1.83

95% CI 1.73–1.95

CTE-TAVIvs CTI-TAVI
aOR 1.83 (95% CI 1.73–1.95)

As reported in the abstract

Observational data: associations, not effects.

Further findings

OutcomeaOR (95% CI)
Components: mortality, stroke, major bleeding · index admissionMortality2.94 (2.66–3.24)
Components: mortality, stroke, major bleeding · index admissionStroke1.20 (1.07–1.34)
Components: mortality, stroke, major bleeding · index admissionMajor bleeding1.49 (1.36–1.63)
CTE-TAVI utilization trend · 2015-2019
18.5% · 41,408
CTE-TAVI utilization trend — Steep yearly increase in CTE-TAVI utilization
P = 0.026

Outcomes by individual contraindication (subgroups) · 30 and 180 days

Bicuspid aortic valve, leukopenia, peptic ulcer disease: similar outcomes vs clinical trials included TAVI (CTI-TAVI)
End-stage renal disease, bioprosthetic aortic valves, coagulopathy: higher readmission rate at 30 and 180 days

Original publication

Outcomes After Transcatheter Aortic Valve Implantation in Patients Excluded From Clinical Trials. JACC Adv. Published 31 March 2023. doi:10.1016/j.jacadv.2023.100271

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