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Who should receive a device to prevent sudden cardiac death?

Cardiac Arrest
Acute Cardiac Care

Copenhagen, Denmark – 3 April 2022:  Heart images may help to predict the risk of sudden cardiac death in heart attack survivors, according to the largest analysis of cardiac magnetic resonance (CMR) data to date. The late breaking research from the PROFID project is presented at EHRA 2022, a scientific congress of the European Society of Cardiology (ESC).1

“Heart attack survivors are selected for an implantable cardioverter defibrillator (ICD) based on their heart’s pump function, known as left ventricular ejection fraction,” said principal investigator Dr. Nikolaos Dagres. “Many patients who could benefit from a defibrillator do not qualify. On top of that, medical and interventional treatment of myocardial infarction has improved to the extent that very few patients who do qualify for an ICD will ever need it. PROFID aims to develop a risk prediction model and introduce – for the first time – a personalised approach to allocating ICDs.”

Sudden cardiac death accounts for approximately one in five fatalities and is usually a result of myocardial infarction. A prophylactic ICD is recommended for patients with an ejection fraction of 35% or lower,2 but most sudden cardiac deaths occur in those with an ejection fraction above 35%.

The investigators previously reported that prediction of sudden cardiac death was poor using ejection fraction alone and remained inadequate after also considering demographics, medical history, medication, clinical characteristics, biomarkers, and electrocardiographic and echocardiographic parameters. Today the researchers report the predictive performance of the model with the addition of CMR imaging measurements.

Two CMR measures potentially relevant to heart attack patients were added to the model. The first was the size of infarct scar, which refers to the area of dead heart muscle after a heart attack. The second was the size of the grey zone, which is the border between infarcted scar area and healthy myocardium containing healthy and dead tissue. Deadly arrhythmias originate from this zone.

The researchers analysed seven datasets from Europe and the US with a total of 2,104 patients. Participants had 1) previous myocardial infarction regardless of ejection fraction and/or 2) ischaemic cardiomyopathy with ejection fraction below 50%. The average age of participants was 64 years and 1,539 (73%) were men. A total of 421 (20%) patients had an ICD at baseline and 1,683 (80%) did not. The primary outcome, analysed at 12 months, was appropriate ICD therapy in those with a device and sudden cardiac death or a potentially deadly arrhythmia in those without an ICD.

Preliminary results presented today indicate a potentially relevant role of CMR in risk stratification for sudden cardiac death after myocardial infarction.

Dr. Dagres said: “We will continue to update the model with different combinations of CMR measurements. It will then be used to inform patient selection for ICD treatment in the PROFID-Reduced and PROFID-Preserved trials. Our ultimate goal is to avoid ICD implantation in truly low risk patients and protect those at high risk with an ICD.”

PROFID-Reduced will enrol patients with an ejection fraction of 35% or less but with a low predicted individual risk according to the model; they will be randomised to receive an ICD or not. PROFID-Preserved will include patients with an ejection fraction above 35% and a high predicted individual risk according to the model; they will be randomised to ICD versus no ICD.

 

ENDS

Notes to editor

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Funding: PROFID has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 847999.

 

Disclosures: Nikolaos Dagres, Niels Peek, Rob Van Der Geest, Christine Albert, Francisco Leyva, Le Mai Parkes, Jan Tijssen, Katherine Wu, Glen Martin, Gerhard Hindricks - nothing to disclose. Lluis Mont: has received honoraria for lecturing, consulting from Abbott, Biosense, Boston Scientific, Medtronic and Biotronik; has received funding for research and fellowship programme from: Biosense, Boston Scientific, Medtronic and Biotronik; is a stockholder for Galgo Medical. Ivo Roca is a lecturer for Biosense and Abbott. Gianluca Pontone has received honorarium as speaker and/or research grant from GE Healthcare, Bracco, Boehringer, Heartflow. Dan Lee reports grants from St. Jude Medical Inc, grants from National Institutes of Health during the conduct of the study; grants from Abbott Laboratories outside the submitted work. Christian De Chillou: Biosense Webster honoraria <€10k/year; Abbott honoraria <€10kyear.

 

About PROFID: PROFID is an EU-funded project conducted by European cardiology leaders, including the ESC, and coordinated by the Leipzig Heart Institute, Germany. The modelling was performed at the University of Manchester, UK.

 

References and notes

1The abstract “Cardiac magnetic resonance imaging for prediction of risk for sudden cardiac death after myocardial infarction, the updated PROFID clinical prediction model” will be presented during the session “Late Breaking Clinical Trials I - devices and prevention sudden cardiac death” which takes place on 3 April at 13:55 CEST in Room 1.

2Priori SG, Blomström-Lundqvist C, Mazzanti A, et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Europace. 2015;36:2793–2867.

 

About the European Heart Rhythm Association

The European Heart Rhythm Association (EHRA) is a branch of the European Society of Cardiology (ESC). Its aim is to improve patients’ quality of life and reduce sudden cardiac death by limiting the impact of heart rhythm disturbances. 

About the EHRA Congress  #EHRA2022

EHRA 2022 is the annual congress of the European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC).

About the European Society of Cardiology

The ESC brings together health care professionals from more than 150 countries, working to advance cardiovascular medicine and help people to live longer, healthier lives.

 

Information for journalists about registration for EHRA 2022

EHRA 2022 takes 3 to 5 April at the Bella Center in Copenhagen, Denmark and online. Explore the scientific programme.

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