Auto-regulated bioprosthetic total artificial heart as bridge to transplantation: the EFICAS study.

BACKGROUND AND AIMS: Refractory advanced biventricular heart failure (RAHF) has a poor prognosis, and many patients are ineligible for left ventricular assist device (LVAD) support. The "historical" total artificial heart (TAH) is associated with high rates of stroke, bleeding, and haemolysis. The bioprosthetic TAH (bio-TAH), a pulsatile, autoregulated, and haemocompatible device, was assessed here as a bridge to transplantation.

METHODS

EFICAS (NCT04475393) was a prospective, multicentre trial conducted at 10 French centres. Adults with RAHF who were ineligible for LVAD support and listed or eligible for heart transplantation were enrolled. The primary composite endpoint was survival at 180 days free from disabling stroke, device malfunction requiring reoperation or urgent transplantation, or elective heart transplantation. Secondary endpoints included serious adverse events, NYHA class, the 6-min walk test, and quality of life measured using the EQ-5D-5L.

RESULTS

Fifty-five patients underwent implantation (December 2022 and May 2025; median age, 56 years [IQR, 48-63]; 49% INTERMACS profiles 1-2; 36% on VA-ECMO). The primary endpoint was achieved in 40 patients (72.7%; 95% confidence interval, 57.1-85.1), exceeding the prespecified "historical TAH" threshold of 38% (p<0.0001). At 180 days, 96% were free of disabling stroke, 76% were discharged, and 92% were NYHA class I-II. Median 6-minute walk distance improved by 305 m (p=0.0002) and EQ-5D by 40 points (p<0.0001). No haemolysis occurred, and major bleeding was limited to the first 30 days.

CONCLUSIONS

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.