European Heart Journal (2014) 35, 1497–1503 doi:10.1093/eurheartj/ehu183
The Acute Cardiovascular Care Association Clinical Decision-Making Toolkit A new manual for immediate bedside decision-making to improve the management of patients with acute cardiovascular conditions The Toolkit is authored by key opinion leaders, experts in each specific disease. The content is based on ESC clinical practice guidelines and clinical experience and encompasses all acute cardiovascular care. It includes: † key symptoms (chest pain, dyspnoea, syncope), † acute coronary syndromes (general concepts, non-ST-segment elevation ACS, STEMI), † acute heart failure (heart failure and pulmonary oedema, cardiogenic shock), † cardiac arrest and CPR, † rhythm disturbances (supraventricular tachycardias and atrial fibrillation, ventricular tachycardias, bradyarrhythmias), † acute vascular syndromes (acute aortic syndromes, pulmonary embolism), † acute myocardial/pericardial syndromes (acute myocarditis, acute pericarditis and cardiac tamponade). The treatment protocols are visually presented in very clear tables and diagrams, so physicians can immediately see the path their patient needs to follow. Two examples of practical, guideline-based, diagnostic and therapeutic guidance at a glance (Figure 1). The entire toolkit can be viewed at: http://www.escardio.org/communities/ACCA/education-research/ awareness/Documents/ACCA-Toolkit-Abridged-version.pdf Its small pocket format enables doctors to carry it conveniently at hand for quick access to all the relevant ESC guidelines and illustrations to help them decide within seconds how to best treat emergency cardiac patients. The Toolkit can be used in every setting where acute cardiovascular care is provided: ambulances, emergency departments, CCUs, ICUs . . .. One Emergency System in Madrid (SAMUR) adopted it immediately and ordered one copy for each of its physicians who work in medical ambulances. We would like all professionals in these settings to have access to the Toolkit and the ACCA Toolkit App, which is currently under development. We also believe the toolkit can be extremely useful as a teaching resource for trainees and students. Dr Ervigio Corral Torres, Deputy Director-General of SAMUR— Proteccio´n Civil, the ambulance service in Madrid, Spain, said: ‘When patients have a heart attack they are initially seen by the first aid team, who have little time to decide how to diagnose and treat them. In these
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: [email protected].
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Managing patients with acute cardiovascular diseases has become increasingly complex over the years. Several of the syndromes, some life-threatening, require immediate diagnosis and treatment. The best acute care relies not only on specialists but also on systems that involve many non-cardiologists. Critical decisions must often be made quickly by professionals with different backgrounds and levels of expertise in environments with limited resources. Furthermore, important variations in the quality of care and management of high-risk patients persist among different centres, regions, and countries. This poses a significant clinical challenge. Based on gaps and challenges identified by 50 national representatives of acute cardiovascular care during several workshops conducted at the April 2013 summit, we realized that there was no uniform guide to help clinicians make correct decisions rapidly for patients with different cardiovascular problems. We made this issue a priority for the Acute Cardiovascular Care Association (ACCA) of the European Society of Cardiology (ESC) and designed a clinical decision-making toolkit to help non-experts and experts in-training who care for patients with acute cardiovascular conditions to make the best immediate bedside decisions. Our aim is to help improve the quality of acute cardiovascular care and we need tools and interventions to achieve this goal. The toolkit is just one of the instruments that ACCA has developed for quality improvement. The ACCA Clinical Decision-Making Toolkit is a simple instrument and comprehensive resource that is easy to use in environments where initial acute cardiovascular care is typically provided. It is available in PDF format on the ESC website and includes algorithms, tables, and other guidance that, according to the preface, ‘are based either on the latest clinical practice guidelines or the clinical experience of a number of European experts in each field when guidelines are not available’.
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Figure 1 (A) Diagnostic algorithm for acute coronary syndromes. hsTn, high-sensitive troponin; ULN, upper limit of normal. (B) Diagnostic criteria for tachyarrhythmias.
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The ACCA Clinical Decision-Making Toolkit is available through different platforms: † printed booklet—available at many Congresses where ESC is represented; † web-based file: already 11500 downloads and 22 000 page views; † mobile application for smartphones/tablets available at ESC Congress 2014. Discover the ACCA Toolkit now and get your free online copy:
The ACCA Clinical Decision-Making Toolkit is produced by ACCA and developed and distributed through an educational grant from AstraZeneca and Novartis Pharma AG. AstraZeneca and Novartis Pharma AG were not involved in the development of this publication and in no way influenced its contents. The Acute Cardiovascular Care Association (ACCA), www.escardio.org/ ACCA
Cardiology in Russia Dr Albert Galyavich briefly discusses the history of cardiology in Russia, with the important achievements made in this century The contribution of Russian cardiology to the world of cardiology is quite original. It includes the method of measuring blood pressure (Korotkov, 1905),1 lifetime diagnostics of myocardial infarction (Obrastzow and Straschesko, 1910),2 the theory of atherogenesis (Anischkov, 1913)3, and intracoronary thrombolysis (Chazov et al. 1976).4 Cardiology was established as a specialty in Russia in 1978 (at that time the USSR). Since then, cardiology care has been actively developing with the help of the Minister of Health, Evgeny Chazov. The network of cardiology clinics that were established in the country is making an essential contribution in the fight against cardiovascular diseases (CVDs). Cardiovascular diseases are the leading cause of mortality in Russia and constitute 56.7% of all deaths. Significant mortality from CVDs increased in the 1990s of the last century. During 1992–96, the country lost 3.5 million people. The analysis of mortality figures from CVD during 1993– 2012 showed that the number of deaths exceeded the number of saved lives by a magnitude of 3.6 during the decade. The dramatic situation was recognized as a national priority. A set of measures to manage the high CVD mortality was developed, which formed the basis of the
federal target programme ‘Prevention and treatment of hypertension in the Russian Federation’ and was approved by the Russian Federation Government for 2007–12. As a result, the vector line orientation for CVD mortality was changed in our country and the number of saved lives exceeded the number of deaths by a factor of 6.2. As part of the National Priority Health Project ‘Health’ from 2008, the system of care for patients with acute CVDs including acute coronary syndrome (ACS) was established in many Russian regions. The greatest success in the management of ACS has been in the regions of Krasnodar, Krasnoyarsk, Tatarstan, Yekaterinburg, Samara, and some others, where the ‘7 days per week/365 days per year’ ACS management approach was introduced. Modern antithrombotic drugs, hardware, and methods for treating critically ill patients (intra-aortic balloon pump counterpulsation, electromechanical and energy systems modelling and optimization methods (FSNP) have become more widely used. The number of Russian cities where heart transplantation has been performed increased (Moscow, St Petersburg, Krasnodar, Yekaterinburg, Kazan, and Kemerovo). There was a reduction in CVD mortality of 20.5%, from 927.5 to 737.1 per a population of 100 000 during the 10 years (2003– 13).
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critical moments our ambulance doctors will be able to quickly consult the ACCA toolkit, which helps them make the correct decisions in seconds for patients . . . Our ambulance doctors are now going to use the toolkit in their daily practice and I have no doubt that it will be another tool to improve the survival of patients with myocardial infarction and other acute cardiac problems’. The ACCA committee for the young added: ‘For young doctors, the decision-making in these situations is challenging. Theoretically prepared but with a lack of experience, it could be difficult for them to organise their thoughts and act rapidly at the same time. The ACCA Clinical Decision-Making Toolkit offers a perfect tool to guide young professionals through this process supporting their theoretical knowledge. The ACCA toolkit provides an up-to-date evidence-based support for residents during their training’. Prof. Steen D Kristensen, ESC Secretarytreasurer added ‘The ACCA Clinical DecisionMaking Toolkit is comprehensive yet easy to use. It is an excellent guide for young and older clinicians working in the field of Acute Cardiac Care. The app or the paper version will help us, and our patients will benefit’. The toolkit was launched at the last Acute Cardiac Care Congress 2013 in Madrid. Numerous printed copies were freely distributed and they are available at many national cardiac society meetings where the ESC is represented. Translated versions are in progress.
1500 The CVD mortality of the working-age population decreased by 28.4%, from 248.7 to 178 per a population of 100 000 over the same period.
(established in 2012), the National Scientific Society of Cardiovascular Prevention and Rehabilitation (created in 2007), and Russian Society of Cardiosomatic Rehabilitation and Secondary Prevention (created in 2009) and others. The number of Russian doctors’ interested in participating in cardiology congresses has increased. As a result, more than 5000 physicians took part in RSC Congress held in St Petersburg in 2013, where presentations from 36 Russian cities and 53 international reports from 34 countries were introduced. Today .10 cardiology journals are published. Links with International Societies of Cardiology—ESC, AHA, ACC, EAS, IAS, and others—are strengthened. Taking into account the positive demographic changes and the improvement of cardiac care, we have reason to hope for progress in the fight against CVD in Russia resulting in a further reduction in mortality. Russian cardiology is moving forward.
References 1. Lewis WH. Clinical sphygmomanometry. Bull NY Acad Med 1941;17:871. 2. Obrastzow WP, Straschesko ND. Zur Kenntniss der Thrombose der Koronarterien des Herzens. Zeitschrift fur Klinische Medizin 1910;71:116–132. 3. Anischkov N. Experimental atherosclerosis in animals. In Cowdry E, ed. Cowdry’s Arteriosclerosis. New York: Macmillan; 1933. p271 –322. 4. Yaipc FJ, Natcffca MS, Naiafc AC. j er. Coutrjlprpoaropf ccfefojf vjbrjopmjijoa qrj pstrpn jovarltf njplarea. Tfr. arwjc. 1976;4:s8–12.
Added sugars and cardiovascular diseases The consumption of added sugar increased consistently during the twentieth century but has been slowing down since 2000 Carbohydrates are the body’s primary source of energy and provide about four calories per gram. This nutrient category includes sugars, starches, and fibre. Carbohydrates are classified into two categories: simple carbohydrates and complex carbohydrates. Simple carbohydrates are primarily mono- and disaccharides, which are naturally occurring in fruits, vegetables, dairy products, and grains. Complex carbohydrates are polysaccharides, which are naturally occurring in starch. The Academy of Nutrition and Dietetics (formerly the American Dietetic Association) recommends that to ensure a balanced diet, 45 –55% of the total caloric intake be provided by complex carbohydrates such as starch and mono- and disaccharides such as fruits and dairy products. Throughout the world, sugars, derived from sugar cane, sugar beet, or starch, are the second largest contributor to carbohydrate in the diet.
Added sugars are disaccharides (composed of fructose or sucrose) which are added to foods and beverages during industrial processing and hence are referred to as sugars that are not naturally occurring. The main sources of added sugars in the diet are sugar-sweetened beverages, cakes, cookies, sweets, ready-to-eat cereals, and gum. The American Heart Association and the World Health Organization recommend that no .7–10% of the total caloric intake should come from added sugars, which is equivalent to 20–40 g/day depending on total energy intake. Worldwide trends show that the availability of added sugars (or caloric sweetener) for consumption has increased over the last decades. Between 1962 and 2000, per capita consumption of added sugars increased by 74 kcal, equivalent to 18.5 g. This increase in calories from added sugars occurred particularly in low- and middle-income countries. In the USA, the daily consumption of
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Russia CVD mortality 2003 –12 In our opinion, there are several reasons for the mortality reduction, lowering the level of social stress, the increase in the economy, improving the technical equipment of health facilities, increase in the number of cardiologists and improvement in their educational level. Today there are .10 000 cardiologists in Russia. Most of them are members of professional organizations. The largest is the Russian Society of Cardiology (RSC), which was created in 1963, today has 5000 members. Along with the RSC are a number of cardiology subspecialty societies: Heart Failure Society (founded in 1999), Antihypertensive League (founded in 1998), Russian National Society of Atherothrombosis (founded in 2004), Russian Medical Society of Hypertension (established in 2006), the National Society of Atherosclerosis (founded in 2009), the Society of Emergency Cardiology
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50 –55% of fructose and 45– 50% of glucose. The metabolic response to fructose differs from glucose. Unlike glucose, fructose does not need insulin to be metabolized and fructose bypasses a major rate-determining step in glycolysis and its metabolism occurs more rapidly and almost exclusively in the liver. The high inflow of fructose to the liver favours triacylglycerol synthesis and very low density lipoprotein production.3 Fructose has been shown to cause a variety of metabolic effects such as dyslipidaemia, hypertension, and increase visceral adiposity in randomized control trials. Given the evidence for an association between added sugar intake and obesity, diabetes, and CVD, strategies to implement the current recommendations to limit the intake of added sugars should be enforced.
References 1. Welsh JA, Sharma AJ, Grellinger L, Vos MB. Consumption of added sugars is decreasing in the United States. Am J Clin Nutr 2011;94:726 –734. 2. Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu F. Added sugar intake and cardiovascular diseases mortality among us adults. JAMA Intern Med 2014;174: 516– 524. 3. Fried SK, Rao SP. Sugars, hypertriglyceridemia, and cardiovascular disease. Am J Clin Nutr 2003;78:873S –880S.
Human metabolic disease: lessons from the extremes Rare conditions can shine light on normal physiology and identify drug targets for more common diseases Environmental factors have largely determined the growing prevalence of obesity and diabetes over the last 50 years. But individual susceptibilities are biologically based and that biology is strongly determined by genetic inheritance. Prof. Sir Stephen O′ Rahilly (Cambridge, UK) told the scientific symposium on the metabolic origins of disease held in March 2014. ‘People who are susceptible to the environment are genetically predisposed to being susceptible and those who are resistant are genetically predisposed to being resistant. That is true both of obesity and the consequences of obesity which are insulin resistance and diabetes’. The genes can be found by conducting genome-wide association studies. An alternative approach is to find people with extreme versions of these disorders, who are likely to have major genetic defects in pathways that control body weight, fat mass, or insulin action. These people provide short cuts to understanding key molecular
control points that could be drug targets for more common diseases. There is also the opportunity to develop specific therapies for them. O′ Rahilly’s lab has discovered multiple genetic defects that cause severe, early-onset obesity. The vast majority of the genes were acting in the brain. The dominant phenotype was an effect on food intake, with increased appetite and reduced satiety. O′ Rahilly says: ‘These genetic defects were essentially neurobehavioral in nature, they were not metabolic as such’. They were able to cure congenital leptin deficiency by giving back the gene product. Drug trials are underway in melanocortin-4 receptor deficiency. The lab continues to discover new genetic defects and has recently started, together with the Sanger Institute, sequencing all the exomes of 1000 severely obese young children. O′ Rahilly points out that healthy adipose tissue is an important part of normal health. The triglyceride droplet in the fat cell has been designed by evolution to store excess energy and release it when there is insufficient food. Patients with unhealthy adipose tissue have genetic defects in their ability to make the triglyceride
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added sugars increased by 35%, equivalent to 21 g, between 1977 and 1996. However, recent estimates show that the consumption of added sugars decreased significantly between 2000 and 2010. Despite this encouraging trend, added sugar intake is still exceeding the dietary recommendations and national consumption of added sugars is still higher than 30 years ago (76.7 vs. 59.0 g).1 High added sugar intake has been associated with overweight and obesity, diabetes, and the development of cardiovascular disease (CVD) and CVD risk factors. The association between added sugars and CVD has been mostly assessed through studies focusing on sugar-sweetened beverages. However, a recent longitudinal study based on the National Health and Nutrition Examination Survey (NHANES), investigating the association between added sugars and CVD mortality, found that people who consumed between 17 and 21%, compared with people who consumed 8%, of calories from added sugars had a 38% higher risk of CVD mortality and people whose added sugar consumption was .21% of calorie had a two-fold increased risk of CVD mortality.2 The principal mechanisms linking intake of added sugars to CVD suggested in the literature are an elevated hepatic de novo lipogenesis, which leads to hypertension and accumulation of visceral and ectopic fat, resulting in increased triglycerides and LDL-cholesterol and decreased HDL-cholesterol. Inflammation, b-cell dysfunction, and insulin resistance might also result from the increase glycaemic load cause by added sugar intake. The two main forms of added sugars in the diet are sucrose and, especially in the USA, high-fructose corn syrup, which both contain
1502 droplet or regulate it in the fat cell. These patients reproduce the characteristics of the metabolic syndrome. ‘Your brain determines how fat you want to be [and] your fat tissue determines how safely you can store fat in your body’, says O′ Rahilly. Tipping over into diabetes requires the development of insulin resistance in the skeletal muscle and the liver because they are the
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major tissues in which insulin acts for carbohydrate homeostasis. Studies of human genetic defects in insulin signalling have helped scientists learn more about signalling that is pathologically turned on or off. Jennifer Taylor MPhil [email protected]
The effects of obesity and ageing on the heart: are they so different? Genevie`ve Derumeaux discussed the latest evidence that obesity may contribute to premature ageing at EuroEcho-Imaging 2013 Mitochondrial function is disturbed by both obesity and ageing, and studies have shown that caloric restriction can limit the effects of mitochondrial ageing. Obesity leads to disturbances in cardiomyocyte survival and function and in mitochondrial respiratory dysfunction. In young people, obesity has been associated with a decrease in telomere length within the cardiomyocyte, indicating a more pronounced ageing process. Obesity had no additional effect over age on telomere length in older patients. ‘This is a strong argument supporting the concept that in the young, obesity plays a key role in inducing premature cardiac senescence’, says Derumeaux. In isolated cardiomyocytes from old (obese and normal weight) and young obese patients, there is disturbed mitochondrial biogenesis and signs of increased oxidative stress and proapoptotic activation. Caloric restriction improves longevity by altering cellular responses to stress. This includes a decrease in chronic inflammation, a reduction in various hormones and growth factors, increased resistance to oxidative stress, and the potentiation of antioxidant mechanisms. These actions decrease the severity of metabolic, cardiovascular, and neurological diseases. Derumeaux says: ‘In preclinical rodent models, decreasing body weight is associated with improved survival and the degree of improvement depends on the level of caloric restriction’. The mechanisms contributing to cardiac dysfunction in obesity and ageing are intrinsic and extrinsic. Depending on which mechanisms are at play, patients may display metabolically healthy obesity or metabolically unhealthy obesity and ageing. The former is resistant to comorbidities, while the latter is susceptible. Derumeaux concludes: ‘We know that obesity and aging do not always lead to cardiomyopathy so it’s important to identify which factors are responsible for myocardial dysfunction. This will enable us to target our cardioprotection efforts and reduce the impact of myocardial insults such as ischemic events’.
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The risk of heart failure increases with obesity and with age. It has also been shown that obesity- and ageing-related cardiomyopathies lead to arterial resistance and loading modifications. Myocardial remodelling affects the left ventricle (LV) and the left atrium (LA). In the LA, there is progressive enlargement, while in the LV, there is concentric left ventricular hypertrophy associated with diastolic dysfunction and, at the very late stage, with a decrease in systolic performance. ‘This phenotype pattern of obese cardiomyopathy and aging cardiomyopathy is quite similar’, says Derumeaux. ‘We cannot differentiate with echocardiography. The question is whether or not there is some potentiation when both aging and obesity are present’. While obesity and ageing ultimately have similar effects on cardiac remodelling, some pathways are shared and others are not. Obesity exerts effects on the heart through increased lipid storage, modification in insulin resistance, and inflammatory infiltrates. Obesity also has effects on the muscle, adipose tissue, and liver, which may lead to modifications in myocardial function. The ageing heart is associated with structural modifications including fibrosis and an increase in myocardial triglyceride content. The latter also occurs in obesity. When myocardial triglyceride content increases, there is a decrease in diastolic performance. It appears that ageing and obesity share this pathway and that there may be some potentiation. In contrast, diastolic performance and exercise capacity are preserved in older athletes but decline with age in sedentary patients as relaxation of the myocardium is impaired. Data from the MONICA/KORA cohort show that in the general population obesity appears to be the most important risk factor for left atrial enlargement. In this study, left atrial enlargement was perceived to be an index of premature cardiac ageing. But Derumeaux says: ‘It’s not a definite answer because we have no data showing that left atrial enlargement in young obese patients’ leads to a pure phenotype of the aging process within the heart’. Both ageing and obesity deregulate molecular longevity pathways which are also metabolic pathways. The four important pathways that regulate cell functions and longevity are the sirtuin, insulin/insulin growth factor, mTOR, and AMP-activated kinase pathways. All the pathways interact and each has a direct effect on metabolism. Impairment in any of the pathways may lead to compromised myocardial function. This can occur through DNA damage, an increase in p53 (a marker of cell senescence) and mitochondrial dysfunction.
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Medical research could soon be jeopardized by new European Union data protection regulations A case is made for less stringent regulations than those that are under consideration by the European Union ‘sealed and locked’ data may be used for research in a form that does not guarantee against re-identification.7 Physicians must acknowledge that patients are not adequately informed about possible secondary uses of their medical data for medical research, are not asked to give clear informed consent, and are misled about the level of anonymity of their data and the risk of re-identification.8 The time has come to think differently, to reach a balance between the fundamental right of data protection and the need for medical research. Rather than newer restrictive EU regulations, possible solutions might originate from a frank debate as to the role and importance of confidentiality and consent for medical research using patient records. This debate needs to include medical researchers, health professionals, and the general public. Citizens have the right to be aware of the potential use of their own medical records, but should eventually allow medical investigators the right to use their own data with the only purpose being to provide the citizens with the best possible research and care.
References 1. Berkman ND, Lohr KN, Ansari M, McDonagh M, Balk E, Whitlock E, Reston J, Bass E, Butler M, Gartlehner G, Hartling L, Kane R, McPheeters M, Morgan L, Morton SC, Viswanathan M, Sista P, Chang S. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update. Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US) 2008. 2. Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013;346:f3534. 3. European Commission. Proposal for a regulation of the European parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). COM(2012) 11 final. 2012. http://ec.europa.eu/justice/data-protection/ document/review2012/com2012_11_en.pdf. 4. European Parliament. Draft report on the proposal for a regulation of the European parliament and of the council on the protection of individual with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). COM(2012)0011-C7 –0025/2012 – 2012/0011(COD). www. europarl.europa.eu/meetdocs/2009_2014/documents/libe/pr/922/922387/ 922387en.pdf.
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Health research is essential for better public health and individual patient records provide a vital resource for medical research for the benefit of society. These records form the basis for clinical registries evaluating prevalence of diseases and allow observational studies that have led to breakthroughs such as, the definition of risk scores for patients with coronary heart disease (Framingham score, EUROScore) or atrial fibrillation (CHA2DS2-VASc, HAS-BLED). Registries have been the basis for the design of pivotal breakthrough pharmacological studies and the basis for the evidence of emerging serious adverse events of marketed drugs.1 However, new European Union (EU) legislation may, in the near future, hamper most epidemiological and medical investigations.2 In January 2012, the EU published its plans to reform European data protection laws. The European Commission proposed that the new General Data Protection Regulation replace the EU’s 1995 Data Protection Directive 95/46/EC.3 The original draft regulation recognized that access to patient data is valuable for medical research and stated that scientific research would be exempt from the strictest requirements in managing personal data. In January 2013, the Civil Liberties, Justice and Home Affairs (LIBE) Committee made amendments to Articles 81 and 83 of the proposed Regulation that would significantly reduce the scope of the exemption and could prevent use of personal data when specific consent is lacking. Amendments allow member states to have exceptions only in cases of investigations ‘of an exceptionally high public interest.4 The data protection rules being proposed for the EU, which are likely to go to the newly elected EU parliament in 2015, would make conducting research using data in the EU ‘impractical’.5 The proposed regulations would require researchers to request explicit and time-limited consent from citizens for using identifiable, pseudonym, or linked data. The use of personal health data in research without specific consent would be prohibited or become impossible in practice, even though medical research is subject to ethical approval and strict confidentiality safeguards and the identity of individuals is often masked. Without access to personal data, such as individual health records, medical progress would be seriously impeded.6 This also poses a significant risk to economic investments in scientific infrastructures, including registries, cohort studies, and biologic banks. These large studies involve millions of individuals across Europe who have given consent for their data to be used in health research. On the other hand, we must admit that privacy and consent are vital components of properly conducted medical research. Indeed, medical scientists should recognize that there is a serious lack of transparency regarding collection of health records. Patients are told that data used for research are under ‘pseudonyms’, but even
1504 5. Stenbeck M, Allebeck P. Do the planned changes to European data protection threaten or facilitate important health research? Eur J Public Health 2011;21: 682– 683. 6. Hakulinen T, Arbyn M, Brewster DH, Coebergh JW, Coleman MP, Crocetti E, Forman D, Gissler M, Katalinic A, Luostarinen T, Pukkala E, Rahu M, Storm H, Sund R, To¨rnberg S, Tryggvadottir L. Harmonization may be counterproductive – at
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least for parts of Europe where public health research operates effectively. Eur J Public Health 2011;21:686–687. 7. Brown I, Brown L, Korff D. Limits of anonymisation in NHS data systems. BMJ 2011; 342:d973. 8. Brown I, Brown L, Korff D. Using patient data for research without consent. Law, Innovat Technol 2010;2:219 –258.
CardioPulse contact: Andros Tofield, Managing Editor. Email: [email protected]
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The Acute Cardiovascular Care Association Clinical Decision-Making Toolkit A new manual for immediate bedside decision-making to improve the management of patients with acute cardiovascular conditions The Toolkit is authored by key opinion leaders, experts in each specific disease. The content is based on ESC clinical practice guidelines and clinical experience and encompasses all acute cardiovascular care. It includes: † key symptoms (chest pain, dyspnoea, syncope), † acute coronary syndromes (general concepts, non-ST-segment elevation ACS, STEMI), † acute heart failure (heart failure and pulmonary oedema, cardiogenic shock), † cardiac arrest and CPR, † rhythm disturbances (supraventricular tachycardias and atrial fibrillation, ventricular tachycardias, bradyarrhythmias), † acute vascular syndromes (acute aortic syndromes, pulmonary embolism), † acute myocardial/pericardial syndromes (acute myocarditis, acute pericarditis and cardiac tamponade). The treatment protocols are visually presented in very clear tables and diagrams, so physicians can immediately see the path their patient needs to follow. Two examples of practical, guideline-based, diagnostic and therapeutic guidance at a glance (Figure 1). The entire toolkit can be viewed at: http://www.escardio.org/communities/ACCA/education-research/ awareness/Documents/ACCA-Toolkit-Abridged-version.pdf Its small pocket format enables doctors to carry it conveniently at hand for quick access to all the relevant ESC guidelines and illustrations to help them decide within seconds how to best treat emergency cardiac patients. The Toolkit can be used in every setting where acute cardiovascular care is provided: ambulances, emergency departments, CCUs, ICUs . . .. One Emergency System in Madrid (SAMUR) adopted it immediately and ordered one copy for each of its physicians who work in medical ambulances. We would like all professionals in these settings to have access to the Toolkit and the ACCA Toolkit App, which is currently under development. We also believe the toolkit can be extremely useful as a teaching resource for trainees and students. Dr Ervigio Corral Torres, Deputy Director-General of SAMUR— Proteccio´n Civil, the ambulance service in Madrid, Spain, said: ‘When patients have a heart attack they are initially seen by the first aid team, who have little time to decide how to diagnose and treat them. In these
Published on behalf of the European Society of Cardiology. All rights reserved. & The Author 2014. For permissions please email: [email protected].
Downloaded from http://eurheartj.oxfordjournals.org/ by guest on November 19, 2015
Managing patients with acute cardiovascular diseases has become increasingly complex over the years. Several of the syndromes, some life-threatening, require immediate diagnosis and treatment. The best acute care relies not only on specialists but also on systems that involve many non-cardiologists. Critical decisions must often be made quickly by professionals with different backgrounds and levels of expertise in environments with limited resources. Furthermore, important variations in the quality of care and management of high-risk patients persist among different centres, regions, and countries. This poses a significant clinical challenge. Based on gaps and challenges identified by 50 national representatives of acute cardiovascular care during several workshops conducted at the April 2013 summit, we realized that there was no uniform guide to help clinicians make correct decisions rapidly for patients with different cardiovascular problems. We made this issue a priority for the Acute Cardiovascular Care Association (ACCA) of the European Society of Cardiology (ESC) and designed a clinical decision-making toolkit to help non-experts and experts in-training who care for patients with acute cardiovascular conditions to make the best immediate bedside decisions. Our aim is to help improve the quality of acute cardiovascular care and we need tools and interventions to achieve this goal. The toolkit is just one of the instruments that ACCA has developed for quality improvement. The ACCA Clinical Decision-Making Toolkit is a simple instrument and comprehensive resource that is easy to use in environments where initial acute cardiovascular care is typically provided. It is available in PDF format on the ESC website and includes algorithms, tables, and other guidance that, according to the preface, ‘are based either on the latest clinical practice guidelines or the clinical experience of a number of European experts in each field when guidelines are not available’.
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Figure 1 (A) Diagnostic algorithm for acute coronary syndromes. hsTn, high-sensitive troponin; ULN, upper limit of normal. (B) Diagnostic criteria for tachyarrhythmias.
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The ACCA Clinical Decision-Making Toolkit is available through different platforms: † printed booklet—available at many Congresses where ESC is represented; † web-based file: already 11500 downloads and 22 000 page views; † mobile application for smartphones/tablets available at ESC Congress 2014. Discover the ACCA Toolkit now and get your free online copy:
The ACCA Clinical Decision-Making Toolkit is produced by ACCA and developed and distributed through an educational grant from AstraZeneca and Novartis Pharma AG. AstraZeneca and Novartis Pharma AG were not involved in the development of this publication and in no way influenced its contents. The Acute Cardiovascular Care Association (ACCA), www.escardio.org/ ACCA
Cardiology in Russia Dr Albert Galyavich briefly discusses the history of cardiology in Russia, with the important achievements made in this century The contribution of Russian cardiology to the world of cardiology is quite original. It includes the method of measuring blood pressure (Korotkov, 1905),1 lifetime diagnostics of myocardial infarction (Obrastzow and Straschesko, 1910),2 the theory of atherogenesis (Anischkov, 1913)3, and intracoronary thrombolysis (Chazov et al. 1976).4 Cardiology was established as a specialty in Russia in 1978 (at that time the USSR). Since then, cardiology care has been actively developing with the help of the Minister of Health, Evgeny Chazov. The network of cardiology clinics that were established in the country is making an essential contribution in the fight against cardiovascular diseases (CVDs). Cardiovascular diseases are the leading cause of mortality in Russia and constitute 56.7% of all deaths. Significant mortality from CVDs increased in the 1990s of the last century. During 1992–96, the country lost 3.5 million people. The analysis of mortality figures from CVD during 1993– 2012 showed that the number of deaths exceeded the number of saved lives by a magnitude of 3.6 during the decade. The dramatic situation was recognized as a national priority. A set of measures to manage the high CVD mortality was developed, which formed the basis of the
federal target programme ‘Prevention and treatment of hypertension in the Russian Federation’ and was approved by the Russian Federation Government for 2007–12. As a result, the vector line orientation for CVD mortality was changed in our country and the number of saved lives exceeded the number of deaths by a factor of 6.2. As part of the National Priority Health Project ‘Health’ from 2008, the system of care for patients with acute CVDs including acute coronary syndrome (ACS) was established in many Russian regions. The greatest success in the management of ACS has been in the regions of Krasnodar, Krasnoyarsk, Tatarstan, Yekaterinburg, Samara, and some others, where the ‘7 days per week/365 days per year’ ACS management approach was introduced. Modern antithrombotic drugs, hardware, and methods for treating critically ill patients (intra-aortic balloon pump counterpulsation, electromechanical and energy systems modelling and optimization methods (FSNP) have become more widely used. The number of Russian cities where heart transplantation has been performed increased (Moscow, St Petersburg, Krasnodar, Yekaterinburg, Kazan, and Kemerovo). There was a reduction in CVD mortality of 20.5%, from 927.5 to 737.1 per a population of 100 000 during the 10 years (2003– 13).
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critical moments our ambulance doctors will be able to quickly consult the ACCA toolkit, which helps them make the correct decisions in seconds for patients . . . Our ambulance doctors are now going to use the toolkit in their daily practice and I have no doubt that it will be another tool to improve the survival of patients with myocardial infarction and other acute cardiac problems’. The ACCA committee for the young added: ‘For young doctors, the decision-making in these situations is challenging. Theoretically prepared but with a lack of experience, it could be difficult for them to organise their thoughts and act rapidly at the same time. The ACCA Clinical Decision-Making Toolkit offers a perfect tool to guide young professionals through this process supporting their theoretical knowledge. The ACCA toolkit provides an up-to-date evidence-based support for residents during their training’. Prof. Steen D Kristensen, ESC Secretarytreasurer added ‘The ACCA Clinical DecisionMaking Toolkit is comprehensive yet easy to use. It is an excellent guide for young and older clinicians working in the field of Acute Cardiac Care. The app or the paper version will help us, and our patients will benefit’. The toolkit was launched at the last Acute Cardiac Care Congress 2013 in Madrid. Numerous printed copies were freely distributed and they are available at many national cardiac society meetings where the ESC is represented. Translated versions are in progress.
1500 The CVD mortality of the working-age population decreased by 28.4%, from 248.7 to 178 per a population of 100 000 over the same period.
(established in 2012), the National Scientific Society of Cardiovascular Prevention and Rehabilitation (created in 2007), and Russian Society of Cardiosomatic Rehabilitation and Secondary Prevention (created in 2009) and others. The number of Russian doctors’ interested in participating in cardiology congresses has increased. As a result, more than 5000 physicians took part in RSC Congress held in St Petersburg in 2013, where presentations from 36 Russian cities and 53 international reports from 34 countries were introduced. Today .10 cardiology journals are published. Links with International Societies of Cardiology—ESC, AHA, ACC, EAS, IAS, and others—are strengthened. Taking into account the positive demographic changes and the improvement of cardiac care, we have reason to hope for progress in the fight against CVD in Russia resulting in a further reduction in mortality. Russian cardiology is moving forward.
References 1. Lewis WH. Clinical sphygmomanometry. Bull NY Acad Med 1941;17:871. 2. Obrastzow WP, Straschesko ND. Zur Kenntniss der Thrombose der Koronarterien des Herzens. Zeitschrift fur Klinische Medizin 1910;71:116–132. 3. Anischkov N. Experimental atherosclerosis in animals. In Cowdry E, ed. Cowdry’s Arteriosclerosis. New York: Macmillan; 1933. p271 –322. 4. Yaipc FJ, Natcffca MS, Naiafc AC. j er. Coutrjlprpoaropf ccfefojf vjbrjopmjijoa qrj pstrpn jovarltf njplarea. Tfr. arwjc. 1976;4:s8–12.
Added sugars and cardiovascular diseases The consumption of added sugar increased consistently during the twentieth century but has been slowing down since 2000 Carbohydrates are the body’s primary source of energy and provide about four calories per gram. This nutrient category includes sugars, starches, and fibre. Carbohydrates are classified into two categories: simple carbohydrates and complex carbohydrates. Simple carbohydrates are primarily mono- and disaccharides, which are naturally occurring in fruits, vegetables, dairy products, and grains. Complex carbohydrates are polysaccharides, which are naturally occurring in starch. The Academy of Nutrition and Dietetics (formerly the American Dietetic Association) recommends that to ensure a balanced diet, 45 –55% of the total caloric intake be provided by complex carbohydrates such as starch and mono- and disaccharides such as fruits and dairy products. Throughout the world, sugars, derived from sugar cane, sugar beet, or starch, are the second largest contributor to carbohydrate in the diet.
Added sugars are disaccharides (composed of fructose or sucrose) which are added to foods and beverages during industrial processing and hence are referred to as sugars that are not naturally occurring. The main sources of added sugars in the diet are sugar-sweetened beverages, cakes, cookies, sweets, ready-to-eat cereals, and gum. The American Heart Association and the World Health Organization recommend that no .7–10% of the total caloric intake should come from added sugars, which is equivalent to 20–40 g/day depending on total energy intake. Worldwide trends show that the availability of added sugars (or caloric sweetener) for consumption has increased over the last decades. Between 1962 and 2000, per capita consumption of added sugars increased by 74 kcal, equivalent to 18.5 g. This increase in calories from added sugars occurred particularly in low- and middle-income countries. In the USA, the daily consumption of
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Russia CVD mortality 2003 –12 In our opinion, there are several reasons for the mortality reduction, lowering the level of social stress, the increase in the economy, improving the technical equipment of health facilities, increase in the number of cardiologists and improvement in their educational level. Today there are .10 000 cardiologists in Russia. Most of them are members of professional organizations. The largest is the Russian Society of Cardiology (RSC), which was created in 1963, today has 5000 members. Along with the RSC are a number of cardiology subspecialty societies: Heart Failure Society (founded in 1999), Antihypertensive League (founded in 1998), Russian National Society of Atherothrombosis (founded in 2004), Russian Medical Society of Hypertension (established in 2006), the National Society of Atherosclerosis (founded in 2009), the Society of Emergency Cardiology
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50 –55% of fructose and 45– 50% of glucose. The metabolic response to fructose differs from glucose. Unlike glucose, fructose does not need insulin to be metabolized and fructose bypasses a major rate-determining step in glycolysis and its metabolism occurs more rapidly and almost exclusively in the liver. The high inflow of fructose to the liver favours triacylglycerol synthesis and very low density lipoprotein production.3 Fructose has been shown to cause a variety of metabolic effects such as dyslipidaemia, hypertension, and increase visceral adiposity in randomized control trials. Given the evidence for an association between added sugar intake and obesity, diabetes, and CVD, strategies to implement the current recommendations to limit the intake of added sugars should be enforced.
References 1. Welsh JA, Sharma AJ, Grellinger L, Vos MB. Consumption of added sugars is decreasing in the United States. Am J Clin Nutr 2011;94:726 –734. 2. Yang Q, Zhang Z, Gregg EW, Flanders WD, Merritt R, Hu F. Added sugar intake and cardiovascular diseases mortality among us adults. JAMA Intern Med 2014;174: 516– 524. 3. Fried SK, Rao SP. Sugars, hypertriglyceridemia, and cardiovascular disease. Am J Clin Nutr 2003;78:873S –880S.
Human metabolic disease: lessons from the extremes Rare conditions can shine light on normal physiology and identify drug targets for more common diseases Environmental factors have largely determined the growing prevalence of obesity and diabetes over the last 50 years. But individual susceptibilities are biologically based and that biology is strongly determined by genetic inheritance. Prof. Sir Stephen O′ Rahilly (Cambridge, UK) told the scientific symposium on the metabolic origins of disease held in March 2014. ‘People who are susceptible to the environment are genetically predisposed to being susceptible and those who are resistant are genetically predisposed to being resistant. That is true both of obesity and the consequences of obesity which are insulin resistance and diabetes’. The genes can be found by conducting genome-wide association studies. An alternative approach is to find people with extreme versions of these disorders, who are likely to have major genetic defects in pathways that control body weight, fat mass, or insulin action. These people provide short cuts to understanding key molecular
control points that could be drug targets for more common diseases. There is also the opportunity to develop specific therapies for them. O′ Rahilly’s lab has discovered multiple genetic defects that cause severe, early-onset obesity. The vast majority of the genes were acting in the brain. The dominant phenotype was an effect on food intake, with increased appetite and reduced satiety. O′ Rahilly says: ‘These genetic defects were essentially neurobehavioral in nature, they were not metabolic as such’. They were able to cure congenital leptin deficiency by giving back the gene product. Drug trials are underway in melanocortin-4 receptor deficiency. The lab continues to discover new genetic defects and has recently started, together with the Sanger Institute, sequencing all the exomes of 1000 severely obese young children. O′ Rahilly points out that healthy adipose tissue is an important part of normal health. The triglyceride droplet in the fat cell has been designed by evolution to store excess energy and release it when there is insufficient food. Patients with unhealthy adipose tissue have genetic defects in their ability to make the triglyceride
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added sugars increased by 35%, equivalent to 21 g, between 1977 and 1996. However, recent estimates show that the consumption of added sugars decreased significantly between 2000 and 2010. Despite this encouraging trend, added sugar intake is still exceeding the dietary recommendations and national consumption of added sugars is still higher than 30 years ago (76.7 vs. 59.0 g).1 High added sugar intake has been associated with overweight and obesity, diabetes, and the development of cardiovascular disease (CVD) and CVD risk factors. The association between added sugars and CVD has been mostly assessed through studies focusing on sugar-sweetened beverages. However, a recent longitudinal study based on the National Health and Nutrition Examination Survey (NHANES), investigating the association between added sugars and CVD mortality, found that people who consumed between 17 and 21%, compared with people who consumed 8%, of calories from added sugars had a 38% higher risk of CVD mortality and people whose added sugar consumption was .21% of calorie had a two-fold increased risk of CVD mortality.2 The principal mechanisms linking intake of added sugars to CVD suggested in the literature are an elevated hepatic de novo lipogenesis, which leads to hypertension and accumulation of visceral and ectopic fat, resulting in increased triglycerides and LDL-cholesterol and decreased HDL-cholesterol. Inflammation, b-cell dysfunction, and insulin resistance might also result from the increase glycaemic load cause by added sugar intake. The two main forms of added sugars in the diet are sucrose and, especially in the USA, high-fructose corn syrup, which both contain
1502 droplet or regulate it in the fat cell. These patients reproduce the characteristics of the metabolic syndrome. ‘Your brain determines how fat you want to be [and] your fat tissue determines how safely you can store fat in your body’, says O′ Rahilly. Tipping over into diabetes requires the development of insulin resistance in the skeletal muscle and the liver because they are the
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major tissues in which insulin acts for carbohydrate homeostasis. Studies of human genetic defects in insulin signalling have helped scientists learn more about signalling that is pathologically turned on or off. Jennifer Taylor MPhil [email protected]
The effects of obesity and ageing on the heart: are they so different? Genevie`ve Derumeaux discussed the latest evidence that obesity may contribute to premature ageing at EuroEcho-Imaging 2013 Mitochondrial function is disturbed by both obesity and ageing, and studies have shown that caloric restriction can limit the effects of mitochondrial ageing. Obesity leads to disturbances in cardiomyocyte survival and function and in mitochondrial respiratory dysfunction. In young people, obesity has been associated with a decrease in telomere length within the cardiomyocyte, indicating a more pronounced ageing process. Obesity had no additional effect over age on telomere length in older patients. ‘This is a strong argument supporting the concept that in the young, obesity plays a key role in inducing premature cardiac senescence’, says Derumeaux. In isolated cardiomyocytes from old (obese and normal weight) and young obese patients, there is disturbed mitochondrial biogenesis and signs of increased oxidative stress and proapoptotic activation. Caloric restriction improves longevity by altering cellular responses to stress. This includes a decrease in chronic inflammation, a reduction in various hormones and growth factors, increased resistance to oxidative stress, and the potentiation of antioxidant mechanisms. These actions decrease the severity of metabolic, cardiovascular, and neurological diseases. Derumeaux says: ‘In preclinical rodent models, decreasing body weight is associated with improved survival and the degree of improvement depends on the level of caloric restriction’. The mechanisms contributing to cardiac dysfunction in obesity and ageing are intrinsic and extrinsic. Depending on which mechanisms are at play, patients may display metabolically healthy obesity or metabolically unhealthy obesity and ageing. The former is resistant to comorbidities, while the latter is susceptible. Derumeaux concludes: ‘We know that obesity and aging do not always lead to cardiomyopathy so it’s important to identify which factors are responsible for myocardial dysfunction. This will enable us to target our cardioprotection efforts and reduce the impact of myocardial insults such as ischemic events’.
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The risk of heart failure increases with obesity and with age. It has also been shown that obesity- and ageing-related cardiomyopathies lead to arterial resistance and loading modifications. Myocardial remodelling affects the left ventricle (LV) and the left atrium (LA). In the LA, there is progressive enlargement, while in the LV, there is concentric left ventricular hypertrophy associated with diastolic dysfunction and, at the very late stage, with a decrease in systolic performance. ‘This phenotype pattern of obese cardiomyopathy and aging cardiomyopathy is quite similar’, says Derumeaux. ‘We cannot differentiate with echocardiography. The question is whether or not there is some potentiation when both aging and obesity are present’. While obesity and ageing ultimately have similar effects on cardiac remodelling, some pathways are shared and others are not. Obesity exerts effects on the heart through increased lipid storage, modification in insulin resistance, and inflammatory infiltrates. Obesity also has effects on the muscle, adipose tissue, and liver, which may lead to modifications in myocardial function. The ageing heart is associated with structural modifications including fibrosis and an increase in myocardial triglyceride content. The latter also occurs in obesity. When myocardial triglyceride content increases, there is a decrease in diastolic performance. It appears that ageing and obesity share this pathway and that there may be some potentiation. In contrast, diastolic performance and exercise capacity are preserved in older athletes but decline with age in sedentary patients as relaxation of the myocardium is impaired. Data from the MONICA/KORA cohort show that in the general population obesity appears to be the most important risk factor for left atrial enlargement. In this study, left atrial enlargement was perceived to be an index of premature cardiac ageing. But Derumeaux says: ‘It’s not a definite answer because we have no data showing that left atrial enlargement in young obese patients’ leads to a pure phenotype of the aging process within the heart’. Both ageing and obesity deregulate molecular longevity pathways which are also metabolic pathways. The four important pathways that regulate cell functions and longevity are the sirtuin, insulin/insulin growth factor, mTOR, and AMP-activated kinase pathways. All the pathways interact and each has a direct effect on metabolism. Impairment in any of the pathways may lead to compromised myocardial function. This can occur through DNA damage, an increase in p53 (a marker of cell senescence) and mitochondrial dysfunction.
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Medical research could soon be jeopardized by new European Union data protection regulations A case is made for less stringent regulations than those that are under consideration by the European Union ‘sealed and locked’ data may be used for research in a form that does not guarantee against re-identification.7 Physicians must acknowledge that patients are not adequately informed about possible secondary uses of their medical data for medical research, are not asked to give clear informed consent, and are misled about the level of anonymity of their data and the risk of re-identification.8 The time has come to think differently, to reach a balance between the fundamental right of data protection and the need for medical research. Rather than newer restrictive EU regulations, possible solutions might originate from a frank debate as to the role and importance of confidentiality and consent for medical research using patient records. This debate needs to include medical researchers, health professionals, and the general public. Citizens have the right to be aware of the potential use of their own medical records, but should eventually allow medical investigators the right to use their own data with the only purpose being to provide the citizens with the best possible research and care.
References 1. Berkman ND, Lohr KN, Ansari M, McDonagh M, Balk E, Whitlock E, Reston J, Bass E, Butler M, Gartlehner G, Hartling L, Kane R, McPheeters M, Morgan L, Morton SC, Viswanathan M, Sista P, Chang S. Grading the Strength of a Body of Evidence When Assessing Health Care Interventions for the Effective Health Care Program of the Agency for Healthcare Research and Quality: An Update. Methods Guide for Effectiveness and Comparative Effectiveness Reviews [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US) 2008. 2. Ploem MC, Essink-Bot ML, Stronks K. Proposed EU data protection regulation is a threat to medical research. BMJ 2013;346:f3534. 3. European Commission. Proposal for a regulation of the European parliament and of the council on the protection of individuals with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). COM(2012) 11 final. 2012. http://ec.europa.eu/justice/data-protection/ document/review2012/com2012_11_en.pdf. 4. European Parliament. Draft report on the proposal for a regulation of the European parliament and of the council on the protection of individual with regard to the processing of personal data and on the free movement of such data (General Data Protection Regulation). COM(2012)0011-C7 –0025/2012 – 2012/0011(COD). www. europarl.europa.eu/meetdocs/2009_2014/documents/libe/pr/922/922387/ 922387en.pdf.
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Health research is essential for better public health and individual patient records provide a vital resource for medical research for the benefit of society. These records form the basis for clinical registries evaluating prevalence of diseases and allow observational studies that have led to breakthroughs such as, the definition of risk scores for patients with coronary heart disease (Framingham score, EUROScore) or atrial fibrillation (CHA2DS2-VASc, HAS-BLED). Registries have been the basis for the design of pivotal breakthrough pharmacological studies and the basis for the evidence of emerging serious adverse events of marketed drugs.1 However, new European Union (EU) legislation may, in the near future, hamper most epidemiological and medical investigations.2 In January 2012, the EU published its plans to reform European data protection laws. The European Commission proposed that the new General Data Protection Regulation replace the EU’s 1995 Data Protection Directive 95/46/EC.3 The original draft regulation recognized that access to patient data is valuable for medical research and stated that scientific research would be exempt from the strictest requirements in managing personal data. In January 2013, the Civil Liberties, Justice and Home Affairs (LIBE) Committee made amendments to Articles 81 and 83 of the proposed Regulation that would significantly reduce the scope of the exemption and could prevent use of personal data when specific consent is lacking. Amendments allow member states to have exceptions only in cases of investigations ‘of an exceptionally high public interest.4 The data protection rules being proposed for the EU, which are likely to go to the newly elected EU parliament in 2015, would make conducting research using data in the EU ‘impractical’.5 The proposed regulations would require researchers to request explicit and time-limited consent from citizens for using identifiable, pseudonym, or linked data. The use of personal health data in research without specific consent would be prohibited or become impossible in practice, even though medical research is subject to ethical approval and strict confidentiality safeguards and the identity of individuals is often masked. Without access to personal data, such as individual health records, medical progress would be seriously impeded.6 This also poses a significant risk to economic investments in scientific infrastructures, including registries, cohort studies, and biologic banks. These large studies involve millions of individuals across Europe who have given consent for their data to be used in health research. On the other hand, we must admit that privacy and consent are vital components of properly conducted medical research. Indeed, medical scientists should recognize that there is a serious lack of transparency regarding collection of health records. Patients are told that data used for research are under ‘pseudonyms’, but even
1504 5. Stenbeck M, Allebeck P. Do the planned changes to European data protection threaten or facilitate important health research? Eur J Public Health 2011;21: 682– 683. 6. Hakulinen T, Arbyn M, Brewster DH, Coebergh JW, Coleman MP, Crocetti E, Forman D, Gissler M, Katalinic A, Luostarinen T, Pukkala E, Rahu M, Storm H, Sund R, To¨rnberg S, Tryggvadottir L. Harmonization may be counterproductive – at
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least for parts of Europe where public health research operates effectively. Eur J Public Health 2011;21:686–687. 7. Brown I, Brown L, Korff D. Limits of anonymisation in NHS data systems. BMJ 2011; 342:d973. 8. Brown I, Brown L, Korff D. Using patient data for research without consent. Law, Innovat Technol 2010;2:219 –258.
CardioPulse contact: Andros Tofield, Managing Editor. Email: [email protected]
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