Valvular & structural heart diseaseCohort study

3-Year Outcomes of Balloon-Expandable Valves

JACC Cardiovasc IntervPublished

  • Retrospective cohort study
  • propensity-score matched
  • registry-based (STS/ACC TVT Registry with CMS linkage)

Authors' conclusion

Patients with small-prosthesis BEVs (20 mm) had identical 3-year survival as those with larger (≥23-mm) BEV valves.

Study context

Population
Patients receiving balloon-expandable valves in the TVT Registry with Medicare linkage
Participants
316,091 patients · 8,100 matched pairs
Exposure
20-mm vs ≥23-mm balloon-expandable valves
  • 20-mm balloon-expandable valves (BEV)n = 8,100
  • ≥23-mm BEVn = 8,100reference
Outcome
Mortality
Follow-up
3 years

Main finding

As reported in the abstract

Hazard ratio

0.97

95% CI 0.90–1.05

By group

20-mm BEV vs ≥23-mm BEV
HR 0.97 (95% CI 0.90–1.05)

Observational data: associations, not effects.

Further findings

Discharge mean gradient

P < 0.0001

OutcomeHR (95% CI)P value
3-year mortality, MG <10 mm Hg vs MG 10 to 30 mm Hg1.25 (1.22–1.27)

3-year mortality by prothesis-patient mismatch (PPM) category

Measured severe PPM associated with increased mortality (33.5% vs 32.9% vs 32.1%)
P < 0.0001
Predicted no PPM associated with increased mortality (33.5% vs 31.1% vs 30%)
P < 0.0001

Left ventricular ejection fraction (LVEF)

Low mean gradient (MG) and severe measured PPM associated with lower LVEF

Original publication

3-Year Outcomes of Balloon-Expandable Valves. JACC Cardiovasc Interv. Published 21 August 2024. doi:10.1016/j.jcin.2024.06.001

Summarised from the published abstract; every number is checked against it