Quality is considered a strategic variable by most companies, public institutions and organisations in general. This is true to the extent that, for most companies, survival in the global market is considered to be directly related to their capacity to compete in terms of quality. Both public and private health services and professional healthcare workers in those services also have a responsibility that extends beyond economic considerations due to the nature of the area in which they work: as they provide a public service, quality is an ethical requirement.
Invasive management of heart rhythm disorders by catheter ablation and device implantation has been established as the therapy of choice for a great number of cardiac arrhythmias; as a result, the number of patients referred for these procedures has increased exponentially during the last decade (see Figure 1).1 At the same time, as a consequence of the improvement and sophistication of the techniques and technological systems used, the number of complex procedures has also significantly increased. However, these procedures have an associated risk of serious complications and require fluoroscopic control, which entails additional risks for both the patient and the operating personnel. All of these considerations justify the implementation of actions to guarantee quality and create qualifications to practise these techniques in the interest of obtaining the greatest efficacy with the minimum possible risk to the patient and operating personnel. Attempts at quality improvement of electrophysiology (EP) in Europe should undergo a systematic approach incorporating various actions that probably would be best adopted in the order presented in this article.
Setting the Standards – Guidelines and Consensus Recommendations
Setting up guidelines and recommendations for clinical practice is the first and most obvious step towards improving quality and homogeneity in Europe. Much work has been carried out in the area of heart rhythm management by several scientific organisations over the years.2,3 In Europe, this matter has been addressed by the European Society of Cardiology (ESC) and, more recently, by its affiliate association, the European Heart Rhythm Association (EHRA).4–7 These organisations have produced several guidelines and consensus documents as stand-alone societies or in co-operation with other international scientific societies, and the guidelines are extensively accepted as standards of care.
Other European scientific societies, such as the European Cardiac Arrhythmia Society (ECAS), have contributed to a minor extent with other recommendation documents.5,8 Most national scientific societies of cardiology in Europe issue their own guidelines, but there is a trend towards stopping this and adopting the ESC-EHRA’s guidelines, which are translated into the local language and published together with editorials or comments discussing specific aspects of national peculiarities.9 This policy is similar to that of the transposition of European directives into the national legislation of countries belonging to the EU, with the aim of greater integration of countries.
Nevertheless, despite these initiatives, some surveys have suggested that official recommendations have limited impact on clinical practice. According to some, only 30% of physicians follow these recommendations, and many others place greater trust in the recommendations of key opinion leaders or personal opinions.10 Therefore, much work still needs to be done to disseminate and promote the use of these guidelines.
Getting the Full Picture of the Basal Situation – Registries and Surveys
Strategies aimed at improving the quality of care in Europe should start by establishing the scenario in which they have to be applied. There is little use in continuing to issue and refine guidelines and recommendations if the lay professional is not aware of or does not trust them, as discussed in the previous section of this article. In addition, the success rate of a therapeutic procedure is often drawn from multicentre trials, which are often conducted in selected centres under special conditions and with particular patient populations. These results can be different from those obtained by the average healthcare centre in its daily practice. Therefore, understanding this scenario is important for guiding decision-making as to which corrective actions may have the greatest impact in improving quality of care at the minimum cost. However, achieving this understanding is complex and often not an easy task. Daily practice is generally influenced by many factors that are not strictly scientific, such as funding, national cost-effectiveness analysis, resource constraints, habits and national/local differences in medical practice. Registries and surveys have been proposed as means to obtain such information;11 however, each of these systems has strengths and limitations that have to be recognised.
Registries are systematic collections of data about a specific problem. These data can be retrospectively or prospectively collected by scientific societies, but also by individuals and groups of investigators. They are usually left open to voluntary participation and therefore account for clinical practice in the real world. As mentioned above, they have an advantage over single-centre studies or controlled clinical trials in that they provide data on procedures and interventions performed during routine practice rather than within the protected environment of a controlled clinical trial. In addition, they aim to avoid the bias of selecting top-quality centres, which may have better results than would be expected in a regular centre. However, one of the major limitations of registries is that data are neither controlled nor subject to audit; also, participation in a registry is voluntary, which may be responsible for other biases such as low participation among centres with poorer results or lower activity.
Several registries have been published about pacemakers and implantable defibrillators in various countries of Europe.12–16 Registries on catheter ablation have also been reported, especially for southern European countries (see Table 1).17 Among these, probably the most comprehensive – in terms of both centre participation (around 90% of all practising Spanish centres) and data coverage – is the Spanish Catheter Ablation registry, which provides success and complication rates for ablation of different arrhythmia substrates of the last seven consecutive years (see Figures 1 and 2).1,18 Finally, there are also global registries supported by private companies currently being conducted into patient characteristics and atrial fibrillation management by cardiologists randomly selected in Europe and other parts of the world (the RECORD-AF registry, supported by sanofi-aventis).
Surveys are used to collect quantitative information about defined items in a selected population. Usually, they focus on opinions or factual information, depending on the purpose of the survey. Many surveys involve administering questions to individuals to canvass the opinions and practices of colleagues on a particular issue. Their main advantages are that they are easy and cheap to administer. However, they depend on the motivation, honesty, memory and ability to respond of their subjects, who may be motivated to give answers that present themselves in a favourable light.
Several important surveys have been conducted in the EP field in Europe in recent years.11 One of the most important is the Euro Heart Survey, which provides relevant information about atrial fibrillation management in Europe.19 More recently, the journal EP-Europace has introduced a new section called ‘EP wire’ that will publish the results of a series of brief surveys about specific and controversial EP topics, such as management of atrial fibrillation patients after catheter ablation.20 Private healthcare companies have also conducted surveys, for example the IMK survey at Europace 2007, supported by St Jude Medical, which produced interesting results about recently recommended practices such as cardiac resynchronisation therapy device optimisation by echocardiography at follow-up (see Figure 3).
Finally, questionnaires are series of questions and other prompts for the purpose of gathering objective information from respondents. This approach has been used by the EHRA to develop the EHRA white book, which probably provides the best available picture that can be obtained about EP resources and personnel in the different countries of Europe.21 This white book was developed by a survey conducted among key professionals and board members of the national societies of each European country.
Establishing Pathways for Common Education – Core Curriculum
Another crucial aspect for improving quality of care in EP is education. This is especially true nowadays, with the increase in indications for and number of EP procedures depicting a scenario of emerging indications, an increasing number of invasive procedures and the establishment of new practising units and professionals. These procedures require cardiologists with comprehensive knowledge of heart rhythm disorders who are trained in cardiovascular catheter manipulation, heart electrical signal recording and interpretation and device implantation and follow-up to ensure both patient safety and quality.
At present, there are many excellent educational activities across Europe, including courses and congresses organised by national and European cardiology and EP scientific societies. However, most of these activities are limited in time, are not comprehensive and are mainly theoretical, with no or little training of practical skills. Thus, it appears imperative to promote and ensure sufficient and homogeneous training and qualifications in heart rhythm management among these professionals in Europe.
There are training and accreditation programmes in some European countries,22 but co-ordination at the European level is needed because transnational co-operation is currently not well organised, resulting in the duplication of work and an inability to compare work implemented in different countries due to unnecessary methodological variations.23 In addition, the development of a uniform and consistent set of standards is desirable to facilitate qualified health services and ensure free movement across borders, both for professionals and for patients. These two reasons are even more relevant nowadays due to the development of European healthcare systems, the increasing integration of the EU and the challenges currently arising, such as increased management autonomy, inter-country invoicing and competition between healthcare centres.
For all of these reasons, the EHRA has developed a core curriculum for all European heart rhythm specialists that represents a harmonised and uniform way to ensure high standards of excellence.24,25 This core curriculum is a formal education plan for a training programme that establishes specific learning objectives and requirements for trainees, trainers and training centres. It also provides a syllabus for the subspecialty, which is a listing of subject matters that are covered in the training programme. Finally, the document details the minimum number of procedures recommended to be performed by the trainee during the training period. In addition, the levels of competence expected for a given area of a subject matter are provided using the same definitions used in the ESC Core Curriculum for the General Cardiologist,26 to which they are complementary. These levels of competence are defined as follows:
- Level I: Has experience of selecting the appropriate diagnostic modality and interpreting the results or choosing an appropriate treatment for which the patient should be referred. This level of competence does not include performing a technique.
- Level II: Has practical experience but not as an independent operator, including assisting in or performing a particular technique or procedure under the guidance of a superior.
- Level III: is able to independently perform the technique or procedure unaided.
Fostering Motivation – Research
It has long been recognised that quality in medicine can only be achieved by promoting all three main aspects of the profession: clinical practice, teaching and research. These three aspects are complementary and each fosters the other two. Research is therefore critical because it leads healthcare professionals to be motivated, active in the field and fully up-to-date with state-of-the-art science.
Research on EP in Europe has increased in recent years and more funding is available now than ever before thanks to the resources invested by national and European public administrations, scientific organisations and private companies. The EU’s Framework Programme for research and technological development deserves a special mention here.27
Recognising Excellence – Accreditation
Assessment of trainees and training programmes is essential both to guarantee a minimum level of knowledge and practical competence among trainees and to promote continuous improvement of the training programmes. Assessment methods include reports by the training programme supervisors, logbooks of procedures, written examinations and assessments of professionalism. This assessment process should result in a certification or accreditation system that does not delimit the legal capacity of professional training in this area of cardiology, but that provides objective certification of the qualifications of training personnel and training centres. Indeed, accreditation is a process resulting in a diploma/certificate indicating proficiency, and signifies granting credit or recognition or proving certitude. It is a voluntary and motivational process, and its objective is the improvement of quality. It applies to both individuals and healthcare centres that already have the appropriate authorisation from the corresponding official organisation to carry out a certain activity and, therefore, are already operational.
The implementation of such an accreditation system in EP in Europe could play an important role as an informative element when taking decisions in the case of health authorities, as well as for service professionals and users. However, until recently – with the exception of a few national initiatives (in Spain and France, for example)22 – there have not been any general accreditation systems established in Europe in the field of EP.
In 2005, the EHRA undertook the task of assessment and accreditation of professionals by verifying the credentials, logbooks and merits of candidates and holding accreditation examinations. Two accreditation processes were implemented: one for interventional EP and one for implantable cardiac rhythm devices (pacemakers and implantable cardioverter–defibrillators [ICDs]).28
The candidates had to be cardiologists, had to provide a logbook with a minimum number of procedures (100 ablations plus 100 diagnostic EP studies for interventional EP accreditation and 100 device implants for implantable device accreditation) and had to pass an examination of 120 multiple-choice questions.24 The candidates who passed the assessment process were issued a diploma/certificate indicating training excellence and proficiency, which was endorsed and accredited by the EHRA. The first EHRA accreditation exams for invasive EP and for implantable devices were held in 2005 during the Europace Congress (the EHRA’s official biannual congress) in Prague, and the first EHRA accreditation titles were issued in 2006. Since then, three other sessions (in Barcelona, Lisbon and Nice) have been held, and another session with more than 50 participants for each examination is expected during the 2009 Europace Congress in Berlin.
Raising Public Awareness and Public Resources – Public Foundations and Patient Associations
Finally, an important way to promote quality in EP in Europe is by increasing public awareness about the importance of heart rhythm disorders. This in turn often results in increasing public resources to reduce the impact of heart rhythm disease on society. This should be taken into account because between 10 and 20% of all deaths are sudden, most of them due to ventricular arrhythmias, and atrial fibrillation prevalence is around 1% in the general population. Despite these figures, heart rhythm diseases are poorly acknowledged in many European countries and their populations often pay more attention to other less prevalent diseases. The role of public foundations such as the British Heart Foundation or the Spanish Heart Foundation is very important, as they support informative and educational programmes for the general population. In addition, some patient associations have recently been created in the field of EP, such as the international Arrhythmia Alliance (A-A), and organise informative campaigns for the public. The latter organisation holds annual Arrhythmia Awareness Weeks, promoting awareness among the public and the medical profession.