EuroShock

Heart attacks are common and can leave survivors suffering cardiogenic shock (CGS), with its extremely high risk of early death (42% versus 4% for non-CGS) and high incidence of chronic heart failure, with its associated socio-economic disease burden (ill-health, recurrent heart failure admissions, no return to full-time activities, need for expensive therapeutic devices and life-long drugs). Outcomes from CGS are even worse in, females, the elderly (mortality>70%) and high-risk sub-groups. The incidence of CGS in Europe alone is >50 000 patients pa. This unacceptably high mortality/morbidity rate represents a true unmet clinical need. No clear strategy exists to improve outcomes, with ad hoc therapies given too late in a spiraling, irrecoverable process.

EURO SHOCK aims to improve outcomes for CGS patients. At its core is a robust phase3 randomised trial comparing a novel strategy of very early use of ECMO (Extracorporeal Membrane Oxygenation) to the current standard of care. Evidence suggests very early ECMO will halt the spiral of decline and so significantly reduce 12-month death rate and need for heart failure re-admissions. Since both costs of CGS, and ECMO are high a health-economic cost-efficacy analysis will be core. A cardiac magnetic resonance imaging sub-study will test novel protocols in sick patients and provide mechanistic data. We will test transfer networks for CGS patients and analyse ECG data to determine which patients benefit most from the early transfer.

Our multidisciplinary consortium comprises renowned physician-scientists, statisticians, health economists and technology providers, including specialised ECMO SME. EURO SHOCK will impact on heart attack survivors, healthcare providers and Europe`s medical technology sector by 1) reducing healthcare costs associated with CGS 2) provide novel cost-effective framework for cardiac interventions 3) delivering innovative healthcare technologies and 4) informing guidelines for effective CGS intervention.

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In the EURO SHOCK trial we are developing a novel Telecardiology Monitor (TCM) able to acquire 6/12 ECG leads, arterial pulse wave, pulse oximetry and temperature, and to directly communicate the enrolled patient, caregiver and the physician. In addition to ECG, oxygen saturation and temperature, this TCM estimates pre-ejection period (PEP), pulse arrival time (PAT), pulse travel time (PTT), respiratory rate and waveform, hence providing a wealth of cardiorespiratory information using only sensors placed on distal points of the arms. These signals and parameters will be communicated to a remote control centre by Wi-Fi or 3G/4G technology. It is expected that this telehealth technology will improve patient adherence to follow-up programs and contribute to home-based medical trials wherein the contractility of the heart and arterial stiffness must be assessed at relatively short time intervals. This technology is compact enough to be incorporated in existing hand-held medical devices such as ECG recorders or Body Composition Analysers. It can also be built into devices such as smart watches, watch straps, wristbands, weighing scales, steering wheels and any other items easy to contact with the hands or feet.