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Heart patients set to receive treatment tailored to their genetic and health information
An innovative project using artificial intelligence (AI) to personalise therapies for patients with cardiovascular disease has kicked off at a meeting in Utrecht, the Netherlands.
The NextGen project has received ¤7.6 million from the EU’s Horizon Europe programme and will be delivered by a 21-member consortium, including the European Society of Cardiology (ESC).
Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for nearly 18 million fatalities every year.
In the EU, CVDs are responsible for approximately one in three deaths.3 CVD comes with a high price, and is estimated to cost the EU ¤282 billion annually, equivalent to 2% of Europe’s GDP.4 CVD also takes its toll on individuals, often leading to disability, absence from work, premature retirement, and absenteeism.
Personalised medicine, whereby prevention and treatment of disease is tailored to an individual’s unique genetic make-up and health information, holds promise for shifting the dial on the burden of CVD. Now is the time to harness the potential of individualised treatment. Genetic information is more readily available than ever before as the cost of laboratory analysis continues to fall, and cutting edge AI techniques make it possible to combine vast amounts of data in record time.
NextGen will capitalise on these trends by bringing together clinical research organisations, universities, small and mediumsized enterprises (SMEs), and professional associations to integrate multiple sources of data on individual people. This work is complex due to data privacy and governance requirements, the presence of multiple standards across Europe, varying formats of data, and the sheer volume of information.
The first step will be to map out the initiatives already underway to ensure that the project is truly ground-breaking and meets an unmet need. Consortium members will then develop novel tools to merge different types of data in a secure way that upholds individual privacy and allows the information to be used in research. The effectiveness of the methods for removing current barriers to data integration in CVD will be demonstrated in real-world pilot studies.
The work will complement the 1+ Million Genomes initiative, which aims to enable secure access to genomics and clinical data across Europe, and the European Health Data Space, a European Commission governance framework for the safe and secure exchange, use and reuse of health data.
Consortium member Professor Panos Deloukas of Queen Mary University of London, UK, said: “This is a tremendous opportunity and a challenge we have in building the right toolbox that will allow [us] to unite CVD patient data across Europe and implement precision medicine to improve cardiovascular healthcare.”
Project co-ordinator Professor Pim van der Harst of University Medical Center Utrecht, the Netherlands, said: “No two people are exactly the same, and so it makes sense that each person needs a slightly different strategy to optimise their health. Personalised medicine is therefore the way forward for preventing heart disease, speeding up diagnosis, and monitoring and treating people with CVD. To develop individualised therapies, we need to compile as much information as possible about individuals, and that’s where NextGen comes in. The unique picture we generate will then form the basis for improving cardiovascular health and wellbeing.”
Results of AFFECT-EU Project
People at risk should be tested for atrial fibrillation every time they attend a health appointment, according to results of the AFFECTEU project, which is holding its final event today in Brussels, Belgium. Patients at high risk of the disorder, such as those with heart failure or prior stroke, should be invited for a screening test.
Scientific coordinator Professor Renate Schnabel of the University Hospital Hamburg-Eppendorf, Germany said: “Screening for atrial fibrillation can identify undiagnosed atrial fibrillation so that the condition can be managed according to guidelines, including starting anticoagulation medication to prevent strokes. AFFECT-EU has concluded that opportunistic screening, where at-risk groups are screened when they contact the healthcare system, plus targeting patients at particular risk, may be a productive and cost-effective way to implement screening across Europe.”
Atrial fibrillation is the most common heart rhythm disorder globally.1 The number of adults aged 55 years and older living with the condition in the European Union is expected to more than double from 8.8 million in 2010 to 17.9 million by 2060.2 People with atrial fibrillation are up to five times more likely to have a stroke than their healthy peers.1 The disorder often has no symptoms and remains undiagnosed until a stroke occurs.3,4
The four-year, EU-funded AFFECT-EU project brought together healthcare professionals, patient representatives, payers, and industry in a consortium of 26 partners, including the European Society of Cardiology (ESC), to define a feasible atrial fibrillation screening strategy for healthcare systems across Europe, with the ultimate aim of preventing subsequent strokes and premature death.
The ability of atrial fibrillation screening to reduce strokes was identified by the consortium in a contemporary meta-analysis in 35,836 participants.5 A further study by the consortium in 11 European countries found that there were no national screening programmes, and most atrial fibrillation was detected in patients with symptoms.6 But in a survey conducted by the group in 18 European countries, GPs said screening for atrial fibrillation was nearly as important as screening for common cancers.7
A subsequent analysis by project members demonstrated that screening result in savings of stroke-related costs regardless of the method (e.g. opportunistic or targeted). Project members then developed a budget impact analysis calculator that can be used by health regulators and payers to estimate the financial impact of implementing a screening programme over a fiveyear period.
Regarding who is at elevated risk of atrial fibrillation or stroke and should therefore be screened, studies by consortium members identified that the following are risk factors: increasing age, obesity, high blood pressure, and high blood levels of N-terminal pro B-type natriuretic peptide (NT-proBNP), which is commonly tested to diagnose heart failure.8-13
Project manager Daniel Engler of the University Hospital HamburgEppendorf, Germany said: “People with atrial fibrillation are more likely to be severely disabled or die from a stroke or heart failure than those without atrial fibrillation,14 making prevention an imperative to reduce morbidity and maintain a high quality of life.
AFFECT-EU has paved the way for well-implemented atrial fibrillation screening programmes to increase the number of new diagnoses, leading to guideline-adherent care, thereby reducing stroke risk and atrial fibrillation disease burden.”
Trial to Prevent Sudden Death after a Heart Attack
The first clinical trial to challenge the routine implantation of a defibrillator in myocardial infarction survivors with heart failure has enrolled its first patient. The PROFID EHRA trial is part of the EU-funded PROFID project, which aims to personalise the prevention of sudden cardiac death after myocardial infarction and involves a consortium of 21 multidisciplinary partners including the European Society of Cardiology (ESC).
Sudden cardiac death is a major public health problem responsible for approximately one in five fatalities in Europe. Most sudden cardiac deaths occur in myocardial infarction survivors. To prevent these deaths, patients whose heart pumps less well than it should following a heart attack currently receive an implantable cardioverter defibrillator (ICD). However, modern drug treatments have been shown to lower the risk of sudden death in these patients, thereby reducing the need for lifesaving ICD shocks.1-5
Dr. Nikolaos Dagres, chief investigator of the trial, said: “The PROFID EHRA trial is set to influence clinical practice around the world by closing a huge evidence gap that has existed for the past 20 years. The trial is re-evaluating the role of ICD implantation in post-myocardial infarction patients in the context of contemporary medical treatment and will provide vital new information to optimally guide therapy and address this serious health issue.”
The study will test whether in post-myocardial infarction patients with symptomatic heart failure and reduced left ventricular ejection fraction (35% or less) drug treatment alone is not inferior to drug treatment plus an ICD for preventing sudden death in heart attack survivors with heart failure and a reduced pump function.
Professor Gerhard Hindricks, chief investigator of the trial, said: “PROFID EHRA is a groundbreaking study that could change the prevention of sudden cardiac death in clinical practice. Currently, many patients who receive an ICD never need one, while some who could benefit miss out. This trial will provide novel, randomised evidence on which patients should receive a defibrillator, and which patients can be spared an unnecessary procedure which typically requires an overnight stay in hospital and may lead to complications or unintended shocks from the device.”
The trial will recruit some 3,595 patients from 180 hospitals in 13 countries – namely Austria, Belgium, Czechia, Denmark, France, Germany, Hungary, Israel, Poland, Spain, Sweden, the Netherlands, and the UK. The first patient was enrolled from the Heart Centre Segeberger Kliniken in Germany.
Participants are being randomly allocated to 1) optimal medical therapy alone or 2) optimal medical therapy plus ICD implantation. Participants will be followed up for around 2.5 years for the primary outcome of all-cause death. The investigators will also examine the impact of the two treatment strategies on death from cardiovascular causes, sudden cardiac death, hospital readmissions for cardiovascular causes, length of stay in hospital, quality of life, and cost effectiveness. The study is due to last for approximately 49 months, with results expected in early 2027.
Professor Jose L. Merino, EHRA president and national coordinator of the PROFID EHRA trial in Spain, said: “The PROFID EHRA trial is set to redefine the use of ICDs in myocardial infarction survivors, and is therefore a very important scientific study for the European Heart Rhythm Association (EHRA) and for clinical practice globally.”
