Heart failure & cardiomyopathies
Short-term safety, feasibility, and performance of a novel soft robotic biventricular mechanical circulatory support device avoiding blood contact – The MISSION reBEAT trial
Authors' 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.
Study context
- Population
- End-stage heart failure patients immediately before elective LVAD implantation
- Participants
- 10 end-stage heart failure patients
- Exposure
- Device support vs baseline haemodynamics
- Outcome
- Implantation time
Methodological detailsfirst
- First
Main finding
As reported in the abstract
Implantation was rapid
3±2 min
Observational data: associations, not effects.
Further findings
| Outcome | Estimate | P value |
|---|---|---|
| Haemodynamics (MAP, SW, CPO)Baseline vs support | MAP 67.5 ± 10.6 vs. 76.2 ± 11.7 mmHg | P < 0.01 |
| Haemodynamics (MAP, SW, CPO)Baseline vs support | SW 347.8 ± 118.2 vs. 434.1 ± 131.0 mJ | P < 0.01 |
| Haemodynamics (MAP, SW, CPO)Baseline vs support | CPO 407.9 ± 108.2 vs. 503.7 ± 116.2 mW | P < 0.01 |
- Haemodynamics (mean arterial pressure (MAP), stroke work (SW), cardiac power output (CPO)): support pressures of 65-66 mmHg; improvements towards baseline
- Haemodynamics (MAP, SW, CPO): device presence reduced preload dependent haemodynamics in some patients
Atrioventricular valve function and interventricular balance
- Effects were observed, which were not significant
Safety
- Procedure-related adverse events
- two
- No device- or procedure-related severe adverse events
- Absence of new ECG abnormalities, and no tissue injury
Original publication
Summarised from the published abstract; every number is checked against it