10101664Comprehensive remote monitoring system for Congestive Heart FailureClosedCollaborative R&DInnovate UKCongestive heart-failure (CHF) is a progressive condition suffered by 60 million patients worldwide in which heart muscle weakness restricts patient activity and reduces life expectancy. Treatment involves high health service costs. CHF patients suffer a series of acute destabilisation episodes, progressively damaging the heart and causing distress and hospitalisation. Patients receive a cocktail of drug therapy, which does improve survival and reduce the frequency of hospitalisation, but monitoring is necessary as every individual responds differently. Standard care, which involves infrequent clinic visits for assessment, results in sub-optimal therapy and seldom prevents acute episodes. Additional non-invasive remote monitoring has been ineffective. Once-daily Pulmonary Artery Pressure (PAP) monitoring from a resting CHF patient with an implanted sensor, recently approved for home use, has reduced hospitalisation and become the gold-standard method. However, roughly half of CHF patients are asymptomatic at rest and are poorly served by this method. An NHS initiative, Heart Failure @Home, promotes clinically safe, remote interaction between specialist teams and patients, ensuring timely care tailored to individual needs. We have developed a low-power implantable PAP sensor and wearable reader to enable the combination of these features, supplemented by more comprehensive monitoring. Continuous monitoring will capture transient cardiovascular events and, when combined with activity monitoring, will provide better information for all CHF patients. We can derive heart rate and respiratory rate from the PAP signal, then further derive measures of the variability of each. We will be developing AI algorithms to analyse the full measurement set to determine patients’ cardiac responses to everyday activity. This will enable automated triage of a CHF patient population and the earliest warning of impending episodes. This ability will disrupt the inefficient calendar-driven appointment regime, replacing it with a needs-driven regime. Rapid detection of an impending destabilisation will automatically provoke clinical intervention and therapy adjustment to restabilise the patient, avoiding the costs to the patient and health service. Our proposed system will have a retail price of ~£7,900, about half the approved system cost, and will be recovered by preventing just one hospitalisation. In this phase of work we will refine the design with patients and clinicians and complete the groundwork for formal safety testing and early clinical studies after the grant. This includes planning verification and validation (V&V), drafting pre-GLP and GLP study protocols, and preparing quality documentation in collaboration with a specialist contract design and manufacturing partner (CDMO).