Key result
The bioprosthetic total artificial heart achieved a 72.7% primary composite success rate at 180 days, significantly exceeding the prespecified 38% historical threshold (95% CI 57.1-85.1; P<0.0001).
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Randomized trial demonstrates high 180-day survival with a bioprosthetic artificial heart in severe biventricular failure, indicating an effective bridge to transplantation.
Absolute Event Rate: 72.7% vs 38%
p-value: p=<0.0001
Vincentelli et al. (2026) studied Refractory advanced biventricular heart failure (RAHF) (n=55). Bioprosthetic total artificial heart (bio-TAH) vs. Historical TAH threshold was evaluated on survival at 180 days free from disabling stroke, device malfunction requiring reoperation or urgent transplantation, or elective heart transplantation (95% CI 57.1-85.1, p=<0.0001). The bioprosthetic total artificial heart achieved a 72.7% primary composite success rate at 180 days, significantly exceeding the prespecified 38% historical threshold (95% CI 57.1-85.1; P<0.0001).
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