European Heart Rhythm Association launches a practical guide on new oral anticoagulants in atrial fibrillation

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1 European Heart Journal (2013) 34, doi: /eurheartj/eht051 European Heart Rhythm Association launches a practical guide on new oral anticoagulants in atrial fibrillation The European Heart Rhythm Association of the European Society of Cardiology has developed a practical guide on how to use the new oral anticoagulants for stroke prevention in atrial fibrillation Three to four new drugs are set to appear on the market and each will come with educational materials including the summary of product characteristics (SmPCs). But Prof. Hein Heidbuchel of the University of Leuven and Chair of the European Heart Rhythm Association s (EHRA) Education Committee, says: The problem is the overload of information, which is very similar for the four drugs but with some important nuances might confuse physicians more than help them. In addition, SmPCs often do not have the advice clinicians need in their clinical practice because they are bound by legal restraints. As a scientific organization, EHRA decided to summarize the information on the four drugs, highlighting the similarities and differences. Heidbuchel adds: We can stick our neck out and go further than the SmPCs by suggesting, admittedly often based on limited data, what to do in specific clinical scenarios. The guide has 15 chapters on clinical situations, including start up and follow-up for patients on these new drugs. A template is provided for a follow-up card to be used by all healthcare workers, which, e.g. also indicates the next appointment and what should be checked. The chapter on drug interactions has a table showing whether new oral anticoagulants (NOACs) are contraindicated, safe, or require consideration for dose adjustment in combination with concomitant drugs. Compliance with NOACs is essential and an entire chapter is devoted to practical tips. Other chapters cover patients with renal dysfunction, coronary heart disease (the problem of combined treatment with antiplatelets), and stroke. Bleeding risk is discussed in two chapters. The first recommends what to do in case of an overdose without bleeding. The second makes recommendations on what to do in case of bleeding, which is somewhat dependent on the type of NOAC. We go farther than the anticoagulation companies can go in their information, giving advice as practical as possible including ranking of measures and dosages of coagulation factors for instance, says Heidbuchel. We have incomplete data but bleedings occur and it s unfair not to provide physicians with guidance. Surgical intervention is another topic, with a subsection on ablation for atrial fibrillation (AF), an area with conflicting evidence in the literature. Some studies show more bleeding or thrombo-embolisms peri-procedurally than with vitamin K antagonists while others show similar safety profiles. The guide will also be available on the EHRA pages of the European Society of Cardiology website where the recommendations can be updated dynamically as new studies are published. A pocket version of the guide will be published and slide sets will be downloadable for teaching purposes. Throughout the project the EHRA writing group has been in contact with the medical advisers at the NOAC companies. Sometimes we deliberately go beyond or a little bit against SmPCs that s our responsibility but they collaborated magnificently with us, to make sure that the scientific validity of the text is as high as possible, says Heidbuchel. Published on behalf of the European Society of Cardiology. All rights reserved. & The Author For permissions please journals.permissions@oup.com

2 792 CardioPulse App review Cardiac device challenge Pro: a new interactive cardiology training tool An innovative iphone and ipad App for cardiology has been produced by two cardiologists The digital face of medicine has grown by leaps and bounds over the last several years, now dominating every aspect of clinical care from online electronic health records to phone-based medical calculators. It is only natural, then, that medical training would soon become a beneficiary of this digital revolution. Digital training materials can indeed be much more than simply searchable textbooks; they can integrate diverse sources and types of data, create interactive learning environments, offer customizable self-assessments, and link to supplemental data. Jan Steffel, MD and David Hürlimann, MD have taken this idea and applied it to advanced cardiac device training for future electrophysiologists with their new application, Cardiac Device Challenge Pro. In many ways, electrophysiology devices represent the perfect opportunity for this type of training tool, with cases requiring analysis of a wide array of digital and graphical information. Cardiac Device Challenge Pro, available in both iphone and ipad formats, tackles key issues with pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy devices in a quiz-based format. Each question is presented as a case scenario with a rich set of interactive features. A sample question on atrial tachycardia (AT) in a patient with an ICD, for example, supplements the case with a complete device history, shows a zoomable and scrollable image of the Medtronic AT/AF event printout, displays the device interrogation summary, and even includes a PA/lateral chest X-ray to confirm lead locations. The software also offers multiple ways for individuals to engage with these questions. Starting users can navigate through the questions in a tutor mode, attempting each question individually and reviewing the answer and discussion immediately after. More advanced users can create mock examinations and assess their performance at the end of the exam. Questions can be filtered by device, manufacturer, and difficulty level, ranging from basic to significantly more advanced questions. The current iteration of the application is fully functional, if a little aesthetically rough around the edges and free to try with four included sample questions. Another 50 questions are available for purchase within the app itself, and the authors are continuing to add content, with another 50 questions scheduled to be released by the end of the year and more still in development. Cardiac Device Challenge Pro represents the future of training tools. Its interactive, filterable, rich database of challenging questions, along with detailed, insightful answers, and explanations, will allow a wide range of healthcare professionals to learn about a variety of advanced cardiac devices. Their target audience board-certified practitioners looking to brush up on their knowledge, fellows learning device material for the first time, and Registered Nurses, Nurse Practitioners, and technicians working daily with these devices would be well-served by taking this interactive tool for a spin.

3 CardioPulse 793 Digoxin increases deaths in patients with atrial fibrillation A medication used for decades is cause for concern in new study Digoxin, a drug that has been used worldwide for centuries to treat heart disease, is associated with a significant increase in deaths in patients with atrial fibrillation (AF), according to results from a study published online Wednesday 28 November 2012 in the European Heart Journal. 1 Foxglove flower Digoxin, originally extracted from the foxglove plant (digitalis), increases force of contraction of cardiomyocytes and helps maintain a more regular rhythm. It is commonly used in AF patients, and those with heart failure. However, it can be problematic to use successfully, as there is a narrow dose range at which it is effective and beyond which, it can be dangerous. High levels of digoxin in the blood have been correlated with an increased death rate in patients. Researchers led by Samy Claude Elayi, associate professor of medicine at the Gill Heart Institute, University of Kentucky, USA, analysed data from 4060 AF patients who had enrolled in the landmark Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial, in order to determine the relationship between digoxin and deaths in this group of patients. They found that digoxin was associated with a 41% increase in deaths from any cause, after controlling for other medications and risk factors and that an increase in deaths occurred regardless of gender or the presence or absence of underlying heart failure. Digoxin was also associated with a 35% increase in deaths from cardiovascular causes, and a 61% increase in deaths from arrhythmias. Prof. Elayi said: These results mean that among AF patients taking digoxin compared to those not on digoxin in the AFFIRM trial, within five years one additional patient out of six will die from any cause, one additional patient out of eight will die from cardiovascular causes, and one additional patient out of 16 will die from arrhythmias. These findings call into question the widespread use of digoxin in patients with AF, particularly when used for controlling AF rate in a similar way as in the AFFIRM trial. Until now, there have been limited data on the use of digoxin in AF patients. Digoxin in AF patients has hardly been studied, said Prof. Elayi. The main prospective randomized controlled trials available with digoxin were performed in patients with heart failure and sinus rhythm, excluding AF patients. As a result of these findings, the authors conclude in their paper: Our study underscores the importance of reassessing the role of digoxin in the contemporary management of AF in patients with or without HF. Prof. Elayi said: These findings mean that physicians should try to first control a patient s heart rate by using alternatives such as, beta-blockers or calcium channel blockers; if digoxin is used, use a low dose with careful clinical follow-up, evaluate potential drug interactions when starting new medications, and monitor digoxin levels. Patients should be aware of potential toxicity and see their physicians immediately in specific clinical situations, for instance, if they experience palpitations or syncope, as these may precede arrhythmic death. The researchers say that the mechanism by which digoxin increases deaths among patients is unclear. Deaths from classic cardiovascular causes, whether due to arrhythmia or not, can partly but not entirely explain it. This suggests there must be some additional mechanism that remains to be identified, said Prof. Elayi. He concluded There is a need for further studies of the drug s use, particularly in systolic heart failure patients and AF patients that would in theory, benefit the most from digoxin. Andros Tofield Reference 1. Whitbeck MG et al. Increased mortality among patients taking digoxin-analysis: analysis from the AFFIRM study. Eur Heart J doi: /eurheartj/ehs348. Published online ahead of print 27 November 2012.

4 794 CardioPulse EURObservational research programme: atrial fibrillation general registry pilot phase Prof. Gregory Y.H. Lip outlines the criteria of this important new registry on AF Introduction Given the advances in atrial fibrillation (AF) management and the availability of new ESC Guidelines, there is a need for the systematic collection of contemporary data regarding the management and treatment of AF in the member ESC countries. It is now nearly 10 years since the last European registry of AF management which was undertaken (as part of the EuroHeart survey programme 1 ), and a new registry is needed. The EuroHeart survey clearly showed great heterogeneity in the management of patients with AF, with major implications for outcomes, especially stroke prevention. 1,2 Many other analyses from the EuroHeart survey on AF have been published (including the initial validations of the CHA 2 DS 2 -VASc and HAS-BLED scores], making important contributions to our knowledge and understanding of this common arrhythmia. 3,4 New guidelines on the management of AF have recently been published by the ESC, 5,6 but it remains unclear how often clinicians adhere to them. A survey of AF management under the EORP programme would enable a timely assessment of uptake of the new ESC Guidelines, allow monitoring of implementation and uptake of catheter ablation, new antithrombotic drugs and new antiarrhythmic agents, and would inform about outcomes related to guideline-adherent management of AF, cost and health economics, and quality of life. This data set could also be compared with published data from other recent AF surveys (some funded by industry, some still on-going) in Europe (AF-NET, ATRIUM, Record-AF, Realise-AF, GARFIELD, and GLORIA-AF). Objectives The main objectives of this EORP-AF registry are as follows: To obtain contemporary information on the occurrence of AF-related complications in Europe. To assess whether the diagnostic work-up of AF complies with current ESC Guidelines (2010 Guidelines and their focussed update). To evaluate appropriateness of treatment in the different subsets of AF in relation to the current ESC Guidelines on AF. To evaluate the management of comorbidities associated with AF in light of the respective treatment guidelines. To evaluate mortality and morbidity in relation to therapeutic decisions. To describe the use of new antiarrhythmic therapy options such as catheter ablation and newly available antiarrhythmic drugs. To evaluate the health-related quality of life and its changes over 1 year of AF patients. To assess progression of AF from paroxysmal (self-terminating) to persistent (non-self-terminating) AF, and risk factors for the progression. Screening and inclusion of patients The registry population will comprise consecutive in- and outpatients with AF presenting to cardiologists in participating ESC countries. Consecutive patients will be screened at the time of their presentation to a cardiologist (hospital or medical centre), and potential patients will be approached to obtain written informed consent. Patients with the primary or secondary diagnosis of AF have to be included. While it is anticipated that most investigators will be hospitalbased cardiologists, recruitment by private office-based cardiologists is allowed (given the different healthcare systems in different countries) if follow-up of patients is deemed feasible by the private cardiologist. Furthermore, all patients admitted for catheter ablation, initiation of drug therapy, or cardioversion (electrical or pharmacological) have also to be included. Patients are officially enrolled in the EORP-AF only if an ECG diagnosis (12-lead ECG, 24-h Holter, etc.) confirming AF has been made. The qualifying episode of AF should have occurred within the last year, and the patient need not be in AF at the time of enrolment. Follow-up This would be performed at (initially) 1 Year (which may be repeated annually). Data will be collected on a separate follow-up form, at 1 year after inclusion. The patient survival status will first be established by contacting physicians or community registration. Where patients are deceased, the mode of death will be determined using the following classification: cardiovascular (sudden and non-sudden), noncardiovascular, or unknown. Where patients are alive, follow-up data concerning morbidity (that is, complications including embolic events, congestive heart failure, or other major events) and some drug therapies (e.g. persistence with antithrombotic drugs) will be collected either through telephonic interview or by sending a questionnaire and by checking hospital records and/or other medical information systems.

5 CardioPulse 795 Duration of the registry For the initial phase ( pilot phase or Phase 1), it is anticipated that 3000 patients will be enrolled from 12 countries (for a broad representation of ESC member countries), with a recruitment of a minimum of 20 consecutive patients and will take a maximum of 4 months to complete in individual centres. Chosen investigator sites are a broad mix of tertiary and general hospitals, with and without surgery or interventions. Obviously, this period could vary between centres, and therefore data collection in each separate centre continues at least until the target number of patients has been achieved. The registry was commenced in early 2012, with individual centres commencing at different time points to facilitate data collection. The number of patients per centre, and number of centres involved in each country have been agreed upon in advance, in consultation with the national co-ordinators who have knowledge of clinical practices specific to each country. Follow-up will be performed by the local investigator, initially at 1 year, and annually thereafter for 2 further years for Phase 1 (a total of 4 years). It is anticipated that a long-term survey (Phase 2) will ultimately be undertaken, based on observations and logistics learnt in Phase 1. Patients included in Phase 1 could ultimately be continued into Phase 2 for the long-term cohort study. Executive committee References 1. Nieuwlaat R, Capucci A, Camm AJ, Olsson SB, Andresen D, Davies DW, Cobbe S, Breithardt G, Le Heuzey JY, Prins MH, Lévy S, Crijns HJ. European Heart Survey Investigators. Atrial fibrillation management: a prospective survey in ESC member countries: the Euro Heart Survey on Atrial Fibrillation. Eur Heart J 2005;26: Nieuwlaat R, Capucci A, Lip GY, Olsson SB, Prins MH, Nieman FH, López-Sendón J, Vardas PE, Aliot E, Santini M, Crijns HJ. Euro Heart Survey Investigators. Antithrombotic treatment in real-life atrial fibrillation patients: a report from the Euro Heart Survey on Atrial Fibrillation. Eur Heart J 2006;27: Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the Euro Heart Survey on Atrial Fibrillation. Chest 2010; 137: Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS- BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010;138: Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohnloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010; 31: Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P. ESC Committee for Practice Guidelines-CPG; Document Reviewers focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation developed with the special contribution of the European Heart Rhythm Association. Europace 2012;14: CardioPulse contact: Andros Tofield, Managing Editor. docandros@bluewin.ch