Valvular & structural heart disease
Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial
Authors' conclusion
Direct implantation of the balloon-expandable device in TAVR was not associated with an increased risk of moderate/severe HVD or major outcomes up to 6-year follow-up.
Study context
- Population
- Patients included in the DIRECTAVI trial since 2016 undergoing transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 balloon-expandable device
- Participants
- 228 patients
- Comparison
- Direct TAVR vs balloon aortic valvuloplasty (BAV) pre-TAVR
- Primary endpoint
- Moderate/severe hemodynamic valve deterioration (HVD), VARC-3 criteria (increase in mean gradient ≥10 mmHg to final mean gradient ≥20 mmHg, or new/worsening aortic regurgitation of 1 grade to ≥ moderate)
- Follow-up
- Median 3.8 (2.2-4.7) years
Methodological detailsMean age at follow-up 87 ± 6.7 years
- Mean age at follow-up 87 ± 6.7 years
Primary result
As reported in the abstract
Moderate/severe HVD
Direct TAVR
1.97 per 100 person-years
BAV
1.45 per 100 person-years
P = 0.6
Further findings
Predicted prosthesis-patient mismatch · similar
P = 0.7
Death, stroke, HF hospitalisation, pacemaker implantation
- Similar between groups: death
- P = 0.4
- Similar between groups: stroke
- P = 0.7
- Similar between groups: HF hospitalisation
- P = 0.3
- Similar between groups: pacemaker implantation
- P = 0.3
Original publication
Long-term follow-up of balloon-expandable valves according to the implantation strategy: insight from the DIRECTAVI trial. Am Heart J. Published 20 January 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →