reBEAT: mechanical heart support of the future

With "reBEAT", the Munich-based start-up AdjuCor has developed a novel system for cardiac support and successfully implemented it together with the Cardiac Surgery Clinic at Hannover Medical School (MHH). It works by providing direct mechanical support without direct blood contact. This makes implantation easier and the system safer.

In an interview with MEDICA-tradefair.com, Prof. Arjang Ruhparwar and Prof. Stephen Wildhirt explain the current state of development and what is planned for the future of reBEAT.

Prof. Ruhparwar, how did the collaboration between the MHH and AdjuCor come about?

Prof. Arjang Ruhparwar: I have done a lot of research on external cardiac support in the past. In the 80s and 90s, there were already approaches using skeletal muscles, known as dynamic cardiomyoplasty. Our research has focused on an electrically contractile muscle made of polymers that contracts under electrical stimulation.

This work was noticed by AdjuCor, who have also been working on external support of the heart muscle for years. AdjuCor contacted us to work on innovative cardiac support systems.

Can you explain the difference between traditional ventricular assist devices and your new approach?

Ruhparwar: Traditional systems are pumps that draw blood from the left ventricle and pump it into the aorta, which requires a lot of blood thinning to prevent clot formation. Our system, on the other hand, uses a customized, soft "shell" with cushions that provide direct mechanical support to the heart in synchrony with the heartbeat, without direct blood contact. The synchrony is created by the ECG recorded in real time.

With reBEAT, the risk of clots and bleeding can be reduced, and a more physiological blood flow can be established.

Prof. Stephen Wildhirt: In addition, reBEAT is able to support both the left and right ventricle, which is not the case with conventional systems. This approach opens up new possibilities for people with biventricular dysfunction and significantly increases the flexibility of treatment options.

Ruhparwar: The system is particularly suitable for patients with chronic heart failure and dysfunction of one or both ventricles. The low implantation complexity enables a faster procedure, which is particularly advantageous for seriously ill patients.

Wildhirt: But patients with bleeding risks also benefit from our system because, as already mentioned, no strong blood thinning is necessary.

What challenges did you face when developing reBEAT?

Wildhirt: The technological development of the system focused on the precise detection of ECG signals and the synchronization of electromechanical processes. This is crucial, especially for people with heart disease where electrical conductivity is impaired.

Another focus was on imaging to place appropriate implants around the heart to provide optimal support without being restrictive.

Wildhirt: We are currently in the middle of an acute human study in which seven patients have already been implanted in Hanover and Newcastle upon Tyne, UK, with Prof. Stephan Schüler. Over the course of this year, we plan to enroll a further five to seven patients to investigate optimization of system performance.

In addition, we are planning a further study for CE marking of the reBEAT product at the end of 2025 or beginning of 2026. Around ten patients will be followed up for six months in this chronic study.

What are the next steps for you and the development team?

Ruhparwar: We plan to conduct further clinical studies to test the long-term efficacy and safety of the system. We also want to further adapt the device to make it usable for a wide range of people.

Wildhirt: It is important to emphasize that our system represents a paradigm shift in cardiac support. It offers a less invasive, safer alternative to traditional systems and has the potential to significantly improve the lives of cardiac patients. We are optimistic and are working hard to achieve this goal.