Project description
New device prevents sudden cardiac death
Sudden cardiac death (SCD) represents a major public health concern since it is responsible for about 20 % of all deaths in Europe. It affects mostly patients with myocardial infarction (MI) precedents. SCD can be prevented with the implantable cardioverter-defibrillator (ICD) device. However, it is costly and associated with potentially serious complications. The ICD is recommended as a prophylactic solution for post-MI patients, but only a few of them receive the device, while the majority of implantations are directed to patients without a medical recommendation for it. The EU-funded PROFID project will use clinical datasets and advanced technology to develop a clinical decision support instrument that will predict the individual SCD risk and identify post-MI patients suitable for an ICD device.
Objective
Sudden cardiac death (SCD) is a major public health problem accounting for ~20% of all deaths in Europe with an estimated yearly incidence of ~350-700,000, often in patients with previous myocardial infarction (MI). In SCD, the heart suddenly and unexpectedly stops beating. If untreated, the patient dies within minutes, but SCD can be successfully prevented by an implantable cardioverter-defibrillator (ICD). The ICD is highly effective, but is associated with potentially severe complications and high healthcare costs. Based on historical evidence, guidelines recommend prophylactic ICD implantation in post-MI patients with left ventricular ejection fraction (LVEF)≤35% to prevent SCD. However, only a minority of these patients will ever need the device. In addition, in absolute numbers the majority of SCD cases occurs in patients with LVEF>35% who are currently not considered for prophylactic ICD. Due to the inherent risks and considerable health care expenditures, a personalised treatment approach for ICD implantation is urgently required. Using state-of-the-art methods and large clinical datasets from established international cohorts and registries across different European geographies, PROFID will develop a clinical decision support tool (risk score) to predict the individual SCD risk and identify those post-MI patients that will optimally benefit from an ICD. Two parallel randomised clinical trials will validate implementation of the risk score to determine ICD implantation, while health economic analyses will assess its economic impact on health care systems. A software tool for clinical use of the risk score will be implemented, and a pilot run in 3 European regions with participation of insurance companies and authorities. The unique composition of the consortium with key opinion leaders, patient organisations, large hospital chains, payers, policy makers and state authorities across Europe, will ensure implementation into routine clinical practice.
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IA - Innovation actionCoordinator
13125 Berlin
Germany
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
Participants (25)
Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
04289 Leipzig
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1081 HV Amsterdam
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
3511 EP UTRECHT
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M13 9PL Manchester
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80335 Munchen
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YO10 5DD York North Yorkshire
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42285 Wuppertal
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28010 Madrid
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
28010 Madrid
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06903 Biot Sophia Antipolis
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60323 FRANKFURT AM MAIN
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31076 Toulouse Cedex 3
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B4 7ET Birmingham
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40 055 Katowice
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8000 Aarhus C
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104 22 Stockholm
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31096 Haifa
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1085 Budapest
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779 00 Olomouc
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LS2 9JT Leeds
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20145 Milano
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95447 Bayreuth
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Participation ended
1114 AB Amsterdam-Duivendrecht
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
8200 Aarhus
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28040 Madrid
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