Cardiogenic shock is still a major clinical challenge, despite the available devices. We developed a minimally invasive, transapical dual-lumened cannula, which can provide antegrade circulatory support and unloading for the left ventricle (LV). After using 3D printing technology, we wanted to test whether our prototypes are haemodynamically competent and implantable in an experimental large porcine model as a proof of concept study.

We implanted our cannula prototypes to 7 healthy porcines via median sternotomy (n = 6) and via minimally invasive access (n = 1), transapically, under fluoroscopic control, off-pump. The cannulas were connected to a heart-lung machine, and we went from 2.5, to 3.5, 4, 4.5, 5 and 5.5 l/min flow with 15–15 min intervals on each flow to ensure LV support. Different metabolic and haemodynamic parameters were continuously monitored.

Implantation time was 14 ± 5 min. The cardiac output of the right ventricle elevated with the LV and roller pump performance from baseline of 4.81 ± 2.09 to 6.17 ± 1.02 l/min at 5.5 l/min pump flow. Mean arterial pressure and central venous pressure changed from 68.9 ± 9.4 and 9.2 ± 2.4 mmHg, to 72.8 ± 11.3 and 9.8 ± 3 mmHg, respectively. Serum lactic acid and other metabolic parameters were not changed significantly.

We have successfully proved in a large animal study that our prototypes are implantable and can provide up to 5.5 l/min cardiac output. They could assist, then fully replace the function of the LV using a roller pump during our study. Further investigations are planned in the future using centrifugal pumps for longer-term support.