Short-term safety, feasibility, and performance of a novel soft robotic biventricular mechanical circulatory support device avoiding blood contact – The MISSION reBEAT trial
Arjang Ruhparwar, Stephan Schueler, Ulrich Stock, Jasmin Hanke, Jan Schmitto, Henning Pauli, Jan Karsten, Christian H Møller, P H Møller-Sørensen, Michael R Schmid, Adam K McDiarmid, Johann Bauersachs, Stephen Wildhirt, Bastian SchmackAbstract
Aims
Mechanical Circulatory Support (MCS) remains limited in advanced heart failure due to blood-contact complications and the absence of biventricular support. We report the first prospective clinical trial of a novel soft-robotic, biventricular, pulsatile technology placed externally around the heart without blood contact, designed to deliver individualized cardiac assistance (reBEAT®, AdjuCor GmbH, Munich, Germany).
Methods and Results
The system was temporarily applied in 10 end-stage heart failure patients immediately before elective LVAD implantation. Devices were custom-manufactured using preoperative CT scans to match individual cardiac anatomy. Safety, feasibility, and effects on haemodynamics were evaluated. Implantation was rapid (3±2 min), demonstrating procedural feasibility. We observed two procedure-related adverse events while no device- or procedure-related severe adverse events occurred. Absence of new ECG abnormalities, and no tissue injury confirmed safety. An iterative assessment on haemodynamics provided key insights into individualized cardio-circulatory support. While device presence reduced preload dependent haemodynamics in some patients, low average support pressures of 65–66 mmHg produced variable improvements towards baseline, predominantly on the pressure signal: mean arterial pressure (MAP; 67.5 ± 10.6 vs. 76.2 ± 11.7 mmHg, p<0.01), stroke work (SW; 347.8 ± 118.2 vs. 434.1 ± 131.0 mJ, p<0.01), and cardiac power output (CPO; 407.9 ± 108.2 vs. 503.7 ± 116.2 mW, p<0.01). Additionally, effects were observed on atrioventricular valve function and interventricular balance, which were not significant.
Conclusion
This soft-robotic biventricular MCS platform provides short term evidence of a safe and feasible approach to pulsatile biventricular support without blood contact. Significant increases in MAP, CPO, and SW towards baseline indicate functional effects. Continuous device-driven workflow improvement is mandatory and further data are required to refine individualized optimization strategies. This technology may offer a novel biventricular assist modality. Its reduced complexity may enable broader adaption for both temporary and durable support. Avoiding blood contact and enabling balanced biventricular assistance will be central drivers of its continued clinical development.