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Finally mobile: How the MACH project gives children with heart failure more mobile autonomy

After CE certification of the mobile heart support system EXCOR® Active, a report from the Fraunhofer Institute analyses the potential impact on patients and families. The cooperation between RWTH Aachen University, Newcastle University, and the company Berlin Heart GmbH was conducted with the support of the University Hospital RWTH Aachen and the Newcastle Upon Tyne Hospital.

Those whose heart can no longer supply their body in the late stages of heart failure are dependent on a Ventricular Assist Device (VAD) to bridge the gap until a donor heart can be transplanted. For many patients, these VADs are implantable devices whose control unit and power supply batteries can be carried in small pockets, offering a comparatively high quality of life. This isn’t the case for the little ones. Because implantable VADs are too large for their small bodies, children with heart failure are supported by external blood pumps connected to the heart through cannulas until their transplantation. The compressed air for operating the blood pumps is provided by a drive unit. Until now, patients were confined to their hospital rooms by these units, often for months, sometimes even years. During this time, there are many restrictions – both for the patients and their families.

 

More mobile autonomy with EXCOR® Active

The innovation project “Mobile Autonomy for Children in end-stage Heart failure” (MACH), whose development was funded by the innovation pillar at EIT Health Germany’s, aims to ease the waiting time for these patients. Therefore, a mobile drive unit was developed for the EXCOR® cardiac support system by Berlin Heart, which gives those affected more freedom and improves their quality of life. The new mobile drive unit EXCOR® Active won the Horizon Impact Award 2020 for projects with significant social impact. CE certification in Europe was already achieved in 2019. A study by the Fraunhofer Institute has now examined the positive effects of the project for the first time. Among other things, it evaluated interviews from the Freeman Hospital in Newcastle Upon Tyne on to what extent affected families see the product as a potential relief for their lives and what concerns they have.

EXCOR® Active increases the childrens’ range of motion through a series of technical improvements. The previous model weighed about 90 kg, was significantly larger and louder, and – with a battery life of under 30 minutes – barely gave patients the possibility to move outside of the hospital ward. EXCOR® Active expands their movement space to the entire facility for the first time. The device is much more mobile, with a smaller 15 kg unit that takes up only a tenth of the volume and has a battery life of at least 5 hours. The facilitated operation also allows parents to operate the device themselves during outings on the clinic grounds.

 

More independence and quality time together for affected families

According to the Fraunhofer Institute’s report, the families perceived the prospect of the new technology as very positive, as it gives patients more mobility, privacy and independence. For instance, playing with one another or eating together at the table is made easier. Even walks are now possible with it, although only on the hospital grounds. Such opportunities finally allow children to interact with their own siblings again, from whom they were sometimes separated for a long time, in particular during the COVID-19 pandemic due to the strict visitation regulations. These social interactions are important for early development, for example in terms of language, social behaviour, and independence during everyday activities. Moreover, activities like these have a positive effect on the child’s mental health and psychosocial development. The greater freedom of movement also promotes the children’s physical development and can, for example, make it easier for stable patients to participate in school activities within the hospital.

The Berlin Heart EXCOR® Active aimed to enable discharge from the Pediatric Intensive Care Unit (PICU) to the general ward or a residential unit on hospital premises possible. In perspective, even care in the patient’s own home should be permitted. This would not only mean a revolutionary change in the situation for affected families but would also save approximately €10,000 per month, as hospital costs including accommodation for the family far exceed the cost of a full-time home care worker.

 

Future and limitations of the project

Despite these prospects, many of the parents from the survey have so far rejected the option of transferring their children’s care to the home. An important reason given was that parents often do not feel they can handle the amount of care required, and the assumption that care in a PICU is necessary for the child’s well-being. In addition, there is the concern of not being able to get help quickly enough in an emergency if the hospital is far away. In fact, it is acknowledged by experts that complications can occur with VADs, such as deposits in the blood pumps, which can lead to a replacement of the pumps. This makes close monitoring and immediate availability of treatment options necessary, which is why the possibility of home care would have to be assessed on a case-by-case basis.

However, the main reason given by parents in the survey is different: Within Eurotransplant countries, discharge from inpatient care can mean a downgrading of the child’s priority on the transplant waiting list. When a suitable donor is available, hospitalised children may be prioritised over children in in-home care. Although numerous other factors play into the decision that takes into account the condition of the children. This regulation was unproblematic before the introduction of the Berlin Heart EXCOR® Active as care was only possible within the hospital. Now, technological developments designed to make patients more mobile require a reassessment of these regulations.

 

Despite the reluctance towards the possibility of home care, the Fraunhofer Institute judges the product to be a great success as the quality of life of children before transplantation is significantly improved. It is assumed that with the help of the new technology, the waiting time for a donor’s heart can be eased for about 50 children per year in Germany alone.  With a change in the waiting list regulation, the EXCOR® Active reviewed here would facilitate a real revolution in the daily lives of children with heart failure and their families, the report concludes.

 

What the new drive unit means for the patients’ and their families’ lives is shown here:

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