Comparing atrial fibrillation guidelines: Focus on stroke prevention, bleeding risk assessment and oral anticoagulant recommendations.

Clinical practice in atrial fibrillation (AF) patient management is constantly evolving. In the past 3 years, various new AF guidelines or focused updates have been published, given this rapidly evolving field. In 2019, the American College of Cardiology/American Heart Association published a focused update of the 2014 guidelines. In 2020, both the European Society of Cardiology and the Canadian Cardiovascular Society released their new guidelines. Finally, the most recent guidelines were those published in 2021 by the Asian Pacific Heart Rhythm Society, which updates their 2017 version and the 2021 National Institute for Health and Care Excellence (NICE) guidelines. In the present narrative review, we compare these guidelines, emphasizing similarities and differences in the following mainstay elements of patient care: thromboembolic risk assessment, oral anticoagulants (OACs) prescription, bleeding risk evaluation, and integrated patient management. A formal evaluation of baseline thromboembolic and bleeding risks and their reassessment during follow-up is evenly recommended, although some differences in using risk stratification scores. OACs prescription is highly encouraged where appropriate, and prescription algorithms are broadly similar. The importance of an integrated and multidisciplinary approach to patient care is emerging, aiming to address several different aspects of a multifaceted disease.

Performance-based risk-sharing arrangements for devices and procedures in cardiac electrophysiology: an innovative perspective.

There is an increasing pressure on demonstrating the value of medical interventions and medical technologies resulting in the proposal of new approaches for implementation in the daily practice of innovative treatments that might carry a substantial cost. While originally mainly adopted by pharmaceutical companies, in recent years medical technology companies have initiated novel value-based arrangements for using medical devices, in the form of 'outcomes-based contracts', 'performance-based contracts', or 'risk-sharing agreements'. These are all characterized by linking coverage, reimbursement, or payment for the innovative treatment to the attainment of pre-specified clinical outcomes. Risk-sharing agreements have been promoted also in the field of electrophysiology and offer the possibility to demonstrate the value of specific innovative technologies proposed in this rapidly advancing field, while relieving hospitals from taking on the whole financial risk themselves. Physicians deeply involved in the field of devices and technologies for arrhythmia management and invasive electrophysiology need to be prepared for involvement as stakeholders. This may imply engagement in the evaluation of risk-sharing agreements and specifically, in the process of assessment of technology performances or patient outcomes. Scientific Associations may have an important role in promoting the basis for value-based assessments, in promoting educational initiatives to help assess the determinants of the learning curve for innovative treatments, and in promoting large-scale registries for a precise assessment of patient outcomes and of specific technologies' performance.

Burden of disease and costs of infections associated with cardiac implantable electronic devices.

INTRODUCTION: Infections are complications of Cardiac Implantable Electronic Device (CIED) procedures, associated with high mortality (20-25% at 1 year), long hospitalizations (23-30 days), and high costs for health-care systems (often higher than 30.000 €). The incidence rates are around 1-4%. Prevention strategies appear to be the best approach for minimizing the occurrence of CIED infections, but in real-world, the recommendations for the best practices are not always followed. Among the recommended preventive measures, the antibacterial envelope has proven to be effective in reducing CIED-related infections. AREAS COVERED: Published studies investigate the role of antibacterial envelopes in infection prevention and the use of infection risk scores to select high-risk patients undergoing CIED implantation/replacement who can benefit from additional preventive measures. EXPERT OPINION: A proficient selection of the best candidates for the antibacterial envelope can be the basis for reducing the healthcare system's costs, in line with the principles of cost-effectiveness. Risk scores have been developed to select patients at high risk of CIED infections and their use appears simple and more complete than individual factors alone. Among them, the PADIT score seems to be effective in selecting patients eligible for antibacterial envelope insertion, with a good cost-effectiveness profile.

Prevalence, management and impact of chronic obstructive pulmonary disease in atrial fibrillation: a systematic review and meta-analysis of 4,200,000 patients.

AIM: Prevalence of chronic obstructive pulmonary disease (COPD) in atrial fibrillation (AF) patients is unclear, and its association with adverse outcomes is often overlooked. Our aim was to estimate the prevalence of COPD, its impact on clinical management and outcomes in patients with AF, and the impact of beta-blockers (BBs) on outcomes in patients with COPD. METHODS AND RESULTS: A systematic review and meta-analysis was conducted according to international guidelines. All studies reporting the prevalence of COPD in AF patients were included. Data on comorbidities, BBs and oral anticoagulant prescription, and outcomes (all-cause death, cardiovascular (CV) death, ischaemic stroke, major bleeding) were compared according to COPD and BB status. Among 46 studies, pooled prevalence of COPD was 13% [95% confidence intervals (CI) 10-16%, 95% prediction interval 2-47%]. COPD was associated with higher prevalence of comorbidities, higher CHA2DS2-VASc score and lower BB prescription [odds ratio (OR) 0.77, 95% CI 0.61-0.98]. COPD was associated with higher risk of all-cause death (OR 2.22, 95% CI 1.93-2.55), CV death (OR 1.84, 95% CI 1.39-2.43), and major bleeding (OR 1.45, 95% CI 1.17-1.80); no significant differences in outcomes were observed according to BB use in AF patients with COPD. CONCLUSION: COPD is common in AF, being found in 13% of patients, and is associated with increased burden of comorbidities, differential management, and worse outcomes, with more than a two-fold higher risk of all-cause death and increased risk of CV death and major bleeding. Therapy with BBs does not increase the risk of adverse outcomes in patients with AF and COPD.

Infections associated with cardiac electronic implantable devices: economic perspectives and impact of the TYRX™ antibacterial envelope.

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems.

The Euro Heart Survey and EURObservational Research Programme (EORP) in atrial fibrillation registries: contribution to epidemiology, clinical management and therapy of atrial fibrillation patients over the last 20 years.

Management of atrial fibrillation (AF) may be challenging in clinical practice. Given the complexity of AF patients and the continuous advances in AF clinical management, there is a need for standardized programmes aimed at collecting so-called 'real-world clinical practice data' regarding the epidemiology, diagnostic/therapeutic/management practices and assessing adherence to guidelines. Over the past 20 years, the number of registries and surveys based on real-world AF patients has been dramatically increased. In Europe, based on the Euro Heart Survey (EHS) and the EURObservational Research Programme (EORP), a large series of studies based on these prospective, observational, large-scale multicentre registries on AF have been published. This narrative review gives an overview of these two projects on AF led by the European Society of Cardiology, focusing mainly on the contribution that these studies have provided to AF management and patient outcomes. Both the EHS and the EORP registries have collected a large amount of data regarding contemporary clinical practice, and despite some limitations, mainly related to their observational nature, these registries have contributed to our knowledge and clinical management of AF patients.

Driving restriction in patients with cardiac implantable electronic devices: an overview of worldwide regulations.

Introduction: It is common belief that driving with an implantable cardioverter defibrillator (ICD)/pacemaker (PM) might be associated with sudden cardiac incapacitation, road traffic accidents, and chance to harm to self and others. On the other hand, the ability to drive is highly valuable in the modern era, representing a cornerstone of daily living and employment. National regulations try to balance the right to drive of ICD/PM patients and the risk they pose to public safety, but rules for granting them a driving license are considerably different worldwide. For the same subset of patients driving restrictions may vary between 1 week and 1 year depending on the local law.Areas covered: In this article we systematically review driving restrictions in ICD/PM patients in 16 countries all over the world, highlighting their differences and analyzing data from the literature that underlie their formulation.Expert opinion: Current regulations are mainly based on historical data that do not take into account improvements in ICD/PM technologies and driving environment, which have made driving with an ICD/PM is substantially safe. Newer studies and updated regulatory documents are warranted to set the best driving restrictions and reach homogeneity worldwide.