Heart failure is a major health concern that affects about 2 % of the population and is especially prevalent among the elderly. Impaired cardiac performance can lead to reduced renal function, and the retention of fluids. “About 30 % of patients do not respond to diuretic medication, and nine out of ten heart failure admissions to hospital are due to fluid overload,” says IPUD project coordinator Nitai Hanani from Paragate Medical in Israel. “About a quarter of these admissions occur within less than a month of the previous hospitalisation event.” Current standards of care are therefore not particularly efficient or cost-effective. Indeed, the burden on healthcare systems of hospitalising and treating patients again and again is huge. A key challenge therefore is finding more efficient ways of improving care, which at the same time can boost the quality of life of patients.
Home-based implantable device
This was the objective of IPUD. This EU-funded project looked to validate a prototype implantable device that continuously removes excess fluid while patients are at home, and scale this up to make it commercially viable. “We also wanted to conduct the first human clinical trials,” adds Hanani. The device consists of an absorption chamber that resides in the abdominal cavity. By induction of a pump-driven vacuum, fluids are then withdrawn from the neighbouring tissues into the chamber, and from there cleared via a catheter. Hanani and his team believe that the system can provide a home-based treatment that goes beyond monitoring and is more cost-effective and less stressful than repeated hospitalisation. “The aim is to treat these patients at home, and keep them at home,” remarks Hanani.
Validation and further clinical development
The project enabled Hanani and his team to integrate the engineering and manufacturing capabilities they needed. “A lot of funding was also focused on validation, starting from preclinical safety studies,” he notes. A key step forward was establishing the infrastructure needed to conduct clinical trials. Medical staff were trained on how to work with the new device, and the first patient studies were carried out. This generated substantial data on the feasibility and efficacy of the device and helped the project team to identify the best way forward in terms of further clinical development.
Improved patient quality of life
Although it is still relatively early in the development process, Hanani was delighted to see how the device could improve the quality of life of patients. They were able to remove their oxygen masks and be treated in their own homes. Not having to repeatedly go to hospital would significantly cut healthcare costs and help to reduce the level of patient distress. “Through this project, we were able to properly assess for the first time this completely new treatment concept,” says Hanani. “Our main achievement was bringing this treatment into clinical settings.” Hanani notes that a great deal more work is required. Nonetheless, the results have been very encouraging. “We will continue to work on the next generation of this device, and bring this to commercialisation,” he adds.
IPUD, heart, renal, hospitalisation, cardiac, healthcare, diuretic, health