Heart failure & cardiomyopathiesCohort study
Auto-regulated bioprosthetic total artificial heart as bridge to transplantation: the EFICAS study
- Prospective single-arm multicentre trial
- 10 French centres
Authors' conclusion
The bio-TAH achieved its primary endpoint with a favourable safety profile, supporting its use as an effective bridge-to-transplant strategy in patients with RAHF ineligible for LVAD support.
Study context
- Population
- Adults with refractory advanced biventricular HF ineligible for left ventricular assist device (LVAD) support, listed or eligible for heart transplantationimplanted Dec 2022–May 2025
- Participants
- 55 adults
- Exposure
- Bio-TAH vs prespecified historical total artificial heart (TAH) threshold
- Bio-TAHn = 55
- Outcome
- Survival free from disabling stroke, device malfunction requiring reoperation or urgent transplantation, or elective heart transplantation
- Follow-up
- 180 days
Main finding
As reported in the abstract
Primary endpoint achieved, n
40 (72.7%; 57.1-85.1) (%; 95% CI)
Exceeded prespecified "historical TAH" threshold of 38%
p<0.0001
Observational data: associations, not effects.
Secondary outcomes
Freedom from disabling stroke, discharge, NYHA class I-II · 180 days
- Free of disabling stroke
- 96%
- Discharged
- 76%
- NYHA class I-II
- 92%
6-min walk distance and EQ-5D
- Median 6-min walk distance improvement
- 305 m (p=0.0002)
- EQ-5D improvement
- 40 points (p<0.0001)
Safety
Haemolysis and major bleeding
- No haemolysis occurred
- Major bleeding limited to the first 30 days
Original publication
Auto-regulated bioprosthetic total artificial heart as bridge to transplantation: the EFICAS study. Eur Heart J. Published 31 August 2026. doi:10.1093/eurheartj/ehag704
Summarised from the published abstract; every number is checked against it