The use of imaging for electrophysiological and devices procedures: a report from the first European Heart Rhythm Association Policy Conference, jointly organized with the European Association of Cardiovascular Imaging (EACVI), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology.

Implantations of cardiac devices therapies and ablation procedures frequently depend on accurate and reliable imaging modalities for pre-procedural assessments, intra-procedural guidance, detection of complications, and the follow-up of patients. An understanding of echocardiography, cardiovascular magnetic resonance imaging, nuclear cardiology, X-ray computed tomography, positron emission tomography, and vascular ultrasound is indispensable for cardiologists, electrophysiologists as well as radiologists, and it is currently recommended that physicians should be trained in several imaging modalities. There are, however, no current guidelines or recommendations by electrophysiologists, cardiac imaging specialists, and radiologists, on the appropriate use of cardiovascular imaging for selected patient indications, which needs to be addressed. A Policy Conference on the use of imaging in electrophysiology and device management, with representatives from different expert areas of radiology and electrophysiology and commercial developers of imaging and device technologies, was therefore jointly organized by European Heart Rhythm Association (EHRA), the Council of Cardiovascular Imaging and the European Society of Cardiac Radiology (ESCR). The objectives were to assess the state of the level of evidence and a first step towards a consensus document for currently employed imaging techniques to guide future clinical use, to elucidate the issue of reimbursement structures and health economy, and finally to define the need for appropriate educational programmes to ensure clinical competence for electrophysiologists, imaging specialists, and radiologists.

Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform. Report of a policy conference of the European Society of Cardiology.

The European Commission announced in 2008 that a fundamental revision of the medical device directives is being considered in order to clarify and strengthen the current legal framework. The system for testing and approving devices in Europe was established >20 years ago as a 'New Approach' to a previously little-regulated industry. It is recognized by many that the regulatory system has not kept pace with technological advances and changing patterns of medical practice. New legislation will be drafted during 2011, but medical experts have been little involved in this important process. This context makes it an opportune time for a professional association to advise from both clinical and academic perspectives about changes which should be made to improve the safety and efficacy of devices used in clinical practice and to develop more appropriate systems for their clinical evaluation and post-marketing surveillance. This report summarizes how medical devices are regulated and it reviews some serious clinical problems that have occurred with cardiovascular devices. Finally, it presents the main recommendations from a Policy Conference on the Clinical Evaluation of Cardiovascular Devices that was held at the European Heart House in January 2011.

Determinants of geographic variations in implantation of cardiac defibrillators in the European Society of Cardiology member countries--data from the European Heart Rhythm Association White Book.

AIMS: Sudden cardiac death (SCD) is a major health concern in developed countries. Many studies have demonstrated the efficacy of implantable cardioverter defibrillator (ICD) therapy in the prevention of SCD and total mortality reduction. However, the high individual costs and the reimbursement policy may limit widespread ICD utilization. METHODS AND RESULTS: This study analyzed the temporal and the geographical trends of the ICD implantation rate. Data were gathered from two editions of the European Heart Rhythm Association (EHRA) White Books published in 2008 and 2009. The analysis revealed significant differences in the rates of ICD implantation per million capita between the countries, but the median implantations was constantly increasing. The number of ICD implantations correlated with gross domestic product (GDP), GDP per capita, expenditure on health, life expectancy, and the number of implanting centres. CONCLUSION: There are great number of differences in the ICD-implanting rates between EHRA member countries, consequent to the increase in the number of ICD implantations. The ICD implantation rates are related to national economic status and healthcare expenses.

An international survey of physician and patient understanding, perception, and attitudes to atrial fibrillation and its contribution to cardiovascular disease morbidity and mortality.

AIMS: Atrial fibrillation (AF) is not always perceived as a serious health threat, but is the most common sustained arrhythmia, with a major impact on morbidity, mortality, and patient quality of life (QoL). A survey was undertaken to examine the level of understanding, perception, and attitudes of the cardiovascular risks associated with AF. METHODS AND RESULTS: The AF AWARE group (an international coalition of organizations with an interest in AF) conducted an international quantitative survey in 11 countries in 2009, to investigate patients' (n = 825) and cardiologists' (n = 810) perceptions of AF, preferences for communicating information on AF and burden of AF. Both patients and physicians considered AF life-threatening (55 and 43%, respectively). Physicians were more concerned about the risk of stroke and hospitalizations than patients, whereas patients were most concerned about death risk. One in four patients felt unable to explain AF and >33% were worried or fearful about their disease. Many physicians (51%) wanted more patient information with >60% viewing available information as poor/difficult to find. Hospital specialists and GPs were identified as key information sources for patients. Most patients (83%) reported symptoms, yet 75% claimed to be satisfied with AF therapies. Atrial fibrillation patients, often with associated diseases, made an average of nine visits per year to their doctors, who consider AF difficult and time consuming to manage. Patients and physicians rated the QoL impact of AF as moderate to high. CONCLUSIONS: A comprehensive international patient and professional information and support programme on AF is needed to improve management and consequently health outcomes.

Tracing the European course of cardiac resynchronization therapy from 2006 to 2008.

Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006-2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized.

Cost-effectiveness of atrial fibrillation catheter ablation.

Radiofrequency catheter ablation has become an established treatment option for the management of patients with atrial fibrillation (AF). Although the concept of a rhythm control strategy devoid of the adverse events related to antiarrhythmic treatment seems highly attractive, further steps are needed in order to improve our understanding of the underlying pathophysiology, refine our ablative techniques, and increase our therapeutic efficacy. Furthermore, the increased cost of AF catheter ablation combined with the substantial number of potential candidates also mandates the evaluation of this invasive treatment through a cost-effectiveness prism. In the present review, we recapitulate the existing evidence pertaining to cost-effectiveness of AF catheter ablation as well as the shortcomings, peculiarities, and distinctive aspects of such a cost-to-benefit analysis.

Extracellular matrix alterations in patients with paroxysmal and persistent atrial fibrillation: biochemical assessment of collagen type-I turnover.

OBJECTIVES: We investigated whether the serum markers of collagen turnover differed in various forms of atrial fibrillation (AF) and in sinus rhythm (SR) in humans. BACKGROUND: Structural alterations and fibrosis have been implicated in the generation and perpetuation of AF. METHODS: Serum C-terminal propeptide of collagen type-I (CICP), C-terminal telopeptide of collagen type-I (CITP), matrix metalloproteinase-1, and tissue inhibitor of matrix metalloproteinases-1 were measured as markers of collagen synthesis and degradation in 70 patients with AF and 20 healthy control subjects in SR. RESULTS: C-terminal propeptide of collagen type-I and CITP were significantly higher in AF patients than in control subjects (91 +/- 27 ng/ml vs. 67 +/- 11 ng/ml, p < 0.001 and 0.38 +/- 0.20 ng/ml vs. 0.25 +/- 0.08 ng/ml, p < 0.001, respectively). Persistent AF patients had higher levels of CICP (105 +/- 28 ng/ml vs. 80 +/- 21 ng/ml, p < 0.001), but not CITP, compared with those with paroxysmal AF. Patients with persistent AF had lower levels of matrix metalloproteinase-1 but increased levels of tissue inhibitor of matrix metalloproteinases-1 compared with patients with paroxysmal AF (11.90 +/- 4.79 ng/ml vs. 14.98 +/- 6.28 ng/ml, p = 0.03 and 155 +/- 45 ng/ml vs. 130 +/- 38 ng/ml, p < 0.001, respectively). Tissue inhibitor of matrix metalloproteinases-1 levels were significantly lower in control subjects compared with those in both paroxysmal and persistent AF patients (102 +/- 15 ng/ml vs. 130 +/- 38 ng/ml vs. 155 +/- 45 ng/ml, respectively, p < 0.001). CONCLUSIONS: Serum markers of collagen type-I turnover differed significantly between patients with AF and SR. Furthermore, these markers also differed significantly between paroxysmal and persistent AF patients, suggesting that the intensity of the extracellular synthesis and degradation of collagen type-I may be related to the burden or type of AF.