MyoCaid: A ventricular assist device for myocardial recovery

Research question: Can we develop a left ventricular assist device which can address the unmet clinical need of end-stage heart failure? Background: Heart failure is the biggest cause of death in the world, and is commonly caused by left ventricular systolic impairment. Efforts to support the left ventricle using mechanical devices, termed left ventricular assist devices (LVADs), have been successful in improving the prognosis of end-stage heart failure, but has a high perioperative and complication rate, making them an unsuitable substitute for heart transplantation. Heart transplantation relies upon an inherently scarce resource, and it is estimated that between 250,000 and 500,000 patients would benefit from heart transplantation if it were available. MyoCaid’s design is expected to reduce or eliminate many of the complications associated with conventional LVADs, and support left ventricular recovery. This work progresses MyoCaid from proof-of-concept, and progresses it to a first cadaveric implantation. Aims and Objectives: To have completed all aspects of MyoCaid’s development and manufacture in an appropriate manufacturing setting for a first-in-human study, and ready for cadaveric implantation. Methods: The research plan is split into optimisation, manufacturing and surgical implantation. Optimisation of the motor will be by the Linz Centre of Mechanotronics. Optimisation of the impeller by the University of Bath and Cardiology Devices. Manufacture and quality management will be performed by Manufacture of Active Implants and Surgical Instruments ( MAISI: for the impeller and power electronics) and Maxon UK (for the motor). BioHarv will work alongside these teams to tailor their pressure sensor to the MyoCaid device, and design and implement a closed loop feedback system for a physiological response. The project will be managed by CDL, who will co-ordinate PPI activities and communicate with stakeholders to contribute to the design process. 4 monthly reviews will be performed, with Go/No-Go decisions attached to each workpackage, and at an annual overview. Timelines for delivery: This is 3 year project withn clear deliverables attached to each work package. By the end of the first year, we will perform a 360 assessment, involving patients, stakeholders, the advisory team and the project steering committee, with an update of the ISO 14971 risk register and evaluation of progress to date. We expect that by 12 months into the project we have eliminated or mitigated the major technical risks. By the end of the second year, we expect to have reached a design freeze of all the components of the project, and by the end of the third year, we will measure success by the suitability of the device to safely pump human blood in the haemolysis rig, achieve human blood pressures in the mock circulatory loop, and be easily implantable in the cadaveric trial.. Anticipated Impact and Dissemination: This project will progress MyoCaid to the point where it is manufactured to a standard suitable for a first-in-human study. Ultimately, MyoCaid aims to be a destination therapy to treat end-stage heart failure, and is implantable in an older, frailer population using well established surgical techniques, with fewer complications than best-on-market devices. 60,000 people per year in the UK die due to heart failure, and we would expect MyoCaid to be an effective treatment for a significant proportion of these patients.