New ESC registries launched on cardiac oncology and ACS

August 29, 2014

Barcelona, Spain - Saturday 30 August 2014: New ESC registries are being launched on cardiac oncology and acute coronary syndromes (ACS). The announcement comes as the long-term phase of the cardiomyopathy registry is started and the study on heart failure patients conducted in collaboration with the Organisation for Economic Co-operation and Development (OECD) begins an outcomes evaluation.

The registries are all part of the ESC's EURObservational Research Programme (EORP).

Professor Roberto Ferrari, Chairperson of EORP, said: "The programme is aimed at finding out whether ESC guidelines are being followed in our member countries. In countries where they are not implemented we can begin educational activities."

He added: "The registries provide robust data for governments and health authorities in Europe which is used to understand differences in cardiovascular disease burden and treatment and for health economic analysis. This year we are launching two new registries, one on the growing field of cardiac oncology and another on ACS. We begin registries with a one-year pilot in 9 to 12 countries and then expand it to all ESC countries."

The Cardiac Oncology Toxicity Registry is about anti-breast-cancer drug-related cardiotoxicity (ADRC). Chairperson Professor Patrizio Lancellotti said: "We are focusing on breast cancer because it is the most common cancer and there are many survivors due to a new treatment regimen. The longer survival time means that they have a high risk of developing cardiotoxicity from their cancer treatment which could lead to death."

The 12-month pilot is set to begin in September and will recruit 700 patients from cardiac imaging labs where assessment for cardiotoxicity is conducted. Participants will include breast cancer patients who will undergo or are undergoing chemotherapy and are under surveillance for left ventricular (LV) function and developing ADRC; breast cancer patients undergoing chemotherapy who have suspected asymptomatic ADRC and confirmed LV dysfunction; and breast cancer patients undergoing chemotherapy with confirmed ADRC who are developing heart failure symptoms.

Professor Lancellotti said: "Our goal is to collect information on current practices for identifying and treating ADRC. We will find out which patients are most at risk and how best to identify and manage this growing problem. Ultimately the data will help us to improve outcomes for this group of patients."

The new ACS Registry starts in September with a 6 month pilot in 10-12 countries. The focus is ST-elevation myocardial infarction (STEMI). Co-Chairperson Professor Uwe Zeymer said: "The diagnosis of STEMI is straightforward and there are good recommendations for reperfusion therapy, with primary percutaneous coronary intervention (pPCI) as the preferred strategy. This is promoted in the ESC's Stent for Life initiative."

He added: "We will document adherence to ESC guidelines regarding interventions and drug treatments and also record outcomes. Countries will then have evidence of the improvements needed in the acute care of STEMI patients which they can show to politicians and healthcare providers."

The long-term phase of the Cardiomyopathies and Myocarditis Registry has been launched and is open to adult and paediatric cardiology units. Data will be collected on hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy and clinically suspected myocarditis.

Chairperson Professor Perry Elliott said: "This is the first European registry on cardiomyopathies and myocarditis. Participating centres need to have a reasonable case load and appropriate facilities for the investigation and treatment of patients with heart muscle diseases. The aims are to compare practice across Europe and determine if patients are being investigated and managed in accordance with current ESC and other guidelines. We hope to recruit 1 000 patients each year."

He added: "Many cardiomyopathies are genetic diseases and a unique element of this registry will be an evaluation of whether patients receive appropriate genetic tests and genetic counselling."

Professor Elliott continued: "We want to know how patients are diagnosed, what their symptoms and outcomes are and how clinical practice varies between countries and centres. This registry will help raise the profile of a group of relatively uncommon or rare diseases so that we can develop new disease specific therapies and ensure that all patients in Europe receive the same standard of care."

The ESC/OECD project is beginning the evaluation of outcomes. The study is a collaboration between the ESC and OECD and uses three data sets: the ESC EORP Heart Failure Long-Term Registry, the OECD Health System Characteristics Survey (2012) and the OECD Health Statistics 2013 database.

The first phase of the study analysed the impact of clinical factors and health system characteristics on adherence to ESC heart failure guidelines in OECD countries. These results are presented at ESC Congress.

Study Chairperson Professor Aldo Maggioni said: "In the next phase of the study we will evaluate whether any of these clinical variables and health system characteristics predict outcomes of heart failure patients in OECD countries."

Professor Ferrari said: "Our success in increasing the lifespan of patients with cardiovascular disease means that clinical trials now need to be long and include many patients, making them very expensive. In the future I believe we will make more use of registry data. The EORP programme will cooperate with the European Medicines Agency (EMA) and local agencies so that our registry data can be used for drug approval. In future drugs may be registered under the condition that patients take part in the registry."

He added: "We will continue to work with the EMA on using our registries to provide safety and efficacy data on treatments which have been used for a number of years and need to be re-evaluated."

Professor Ferrari concluded: "EORP registries continue to provide real world information on clinical practice across Europe and are set to become even more important for raising standards and improving outcomes of patients with cardiovascular disease."

European Society of Cardiology

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