Valvular & structural heart disease

Late Clinical Outcomes of Balloon-Expandable Valves in Small Annuli: Results From the PARTNER Trials

JACC Cardiovasc IntervPublished Pooled analysis of the PARTNER 2 SAPIEN 3 intermediate-risk registry and the PARTNER 3 low-risk randomised trial

Authors' conclusion

Five-year clinical outcomes were excellent and comparable between patients with small vs large aortic annuli. Outcomes in patients with small annuli were not affected by 30-day MG or PPM.

Study context

Population
Intermediate- and low-risk patients undergoing transcatheter aortic valve replacement (TAVR) with a balloon-expandable valve (PARTNER 2 S3 registry, PARTNER 3 RCT)
Participants
1,355 participants
Comparison
Small vs large aortic annuli after TAVR
  • Small annulin = 476
  • Large annulin = 879reference
Outcome
Composite of:
  • All-cause death
  • Disabling stroke
  • HF hospitalization
Follow-up
5 years

Pooled result

As reported in the abstract

Death, disabling stroke or HF hospitalization
Primary endpoint rates similar, small vs large annuli: 36.3% vs 35.8%
P = 0.83

Further pooled results

Primary endpoint at 1 year

P = 0.94

Bioprosthetic valve failure · 5 years

P = 0.46

Primary endpoint, female patients (subgroup)

P = 0.90

Primary endpoint at 1 year — Primary endpoint rates similar, small vs large annuli: 7.8% vs 8.0%
P = 0.94
Bioprosthetic valve failure — Infrequent in both groups: 2.9% vs 2.1%
P = 0.46

5-year outcomes vs prosthesis-patient mismatch (PPM) and 30-day mean gradient (MG) (small annuli)

No association with any severity of PPM
P = 0.22
No association with 30-day MG
P for nonlinearity = 0.96

Safety

Bioprosthetic valve failure · 5 years

P = 0.46

Original publication

Late Clinical Outcomes of Balloon-Expandable Valves in Small Annuli: Results From the PARTNER Trials. JACC Cardiovasc Interv. Published 24 February 2025. doi:10.1016/j.jcin.2024.11.006

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