Valvular & structural heart diseaseRandomised controlled trial
Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses
- Randomised controlled trial
Authors' conclusion
In patients who underwent ViV-TAVR for failed small aortic bioprostheses, those receiving a SEV exhibited a better valve hemodynamic profile at 1-year follow-up. There were no differences between SEV and BEV regarding functional status, quality of life, or clinical outcomes.
Study context
- Population
- Patients with a failed small (≤23 mm) surgical aortic valve undergoing valve-in-valve transcatheter aortic valve replacement (ViV-TAVR)
- Participants
- 98 patients
- Comparison
- Self-expanding vs balloon-expandable valves in valve-in-valve TAVR
- Balloon-expandable valves (BEV)n = 46reference
- Self-expanding valves (SEV)n = 52
- Primary endpoint
- Hemodynamic performance and clinical outcomes
- Follow-up
- 1 year
Primary result
As reported in the abstract
Hemodynamic performance · 1-year follow-up
Hemodynamic performance · 1-year follow-up
Intended valve performance BEV 30% · SEV 76% · P < 0.001
- SEV vs BEV: P < 0.001 — mean transaortic gradient
Further findings
NYHA class >II · 1 year
P = 0.505
HF hospitalization · 1 year
P = 0.214
| Outcome | BEV | SEV | P value |
|---|---|---|---|
| Quality of life (KCCQ) · 1 year | 77.9 ± 21.2 | 81.8 ± 14.8 | P = 0.334 |
| All-cause mortality · 1 year | 6.5% | 3.8 | P = 0.495 |
Safety
Stroke · 1 year
P = 0.369
MI · 1 year
P = 0.347
Pacemaker implantation · 1 year
P = 0.898
Original publication
Balloon- vs Self-Expanding Transcatheter Valves for Failed Small Surgical Aortic Bioprostheses. JACC Cardiovasc Interv. Published 23 October 2023. doi:10.1016/j.jcin.2023.10.028
Summarised from the published abstract; every number is checked against it