Pulsed field ablation (PFA) is an emerging technology for the treatment of atrial fibrillation (AF), for which pre-clinical and early-stage clinical data are suggestive of some degree of preferentiality to myocardial tissue ablation without damage to adjacent structures. Here in the MANIFEST-17K study we assessed the safety of PFA by studying the post-approval use of this treatment modality. Of the 116 centers performing post-approval PFA with a pentaspline catheter, data were received from 106 centers (91.4% participation) regarding 17,642 patients undergoing PFA (mean age 64, 34.7% female, 57.8% paroxysmal AF and 35.2% persistent AF). No esophageal complications, pulmonary vein stenosis or persistent phrenic palsy was reported (transient palsy was reported in 0.06% of patients; 11 of 17,642). Major complications, reported for ~1% of patients (173 of 17,642), were pericardial tamponade (0.36%; 63 of 17,642) and vascular events (0.30%; 53 of 17,642). Stroke was rare (0.12%; 22 of 17,642) and death was even rarer (0.03%; 5 of 17,642). Unexpected complications of PFA were coronary arterial spasm in 0.14% of patients (25 of 17,642) and hemolysis-related acute renal failure necessitating hemodialysis in 0.03% of patients (5 of 17,642). Taken together, these data indicate that PFA demonstrates a favorable safety profile by avoiding much of the collateral damage seen with conventional thermal ablation. PFA has the potential to be transformative for the management of patients with AF.

Aims: The true incidence of life-threatening ventricular tachyarrhythmic events and the risk of sudden cardiac death in the early stage of peripartum cardiomyopathy (PPCM) are still unknown. We aimed to assess the usefulness of the wearable cardioverter/defibrillator (WCD) to bridge a potential risk for life-threatening arrhythmic events in patients with early PPCM, severely reduced left ventricular ejection fraction (LVEF) and symptoms of heart failure. Methods and results: Twelve consecutively admitted women with PPCM were included in this single-centre, prospective observational study between September 2012 and September 2013. Patients with LVEF ≤35% were considered to use the WCD for 3 months or even 6 months when considered necessary for LVEF recovery. Nine of the 12 women had a severely reduced LVEF (mean 18.3%) at the time of study enrolment; seven women received a WCD, while two patients refused to wear a WCD. During a median WCD follow-up of 81 days (range 25–345 days), we observed a total of four events of ventricular fibrillation with appropriate and successful WCD shocks in three of the seven women receiving a WCD. No syncope or sudden arrhythmic deaths occurred in women not using the WCD during a median follow-up of 12 months (range 5–15 months). All women showed impressive improvement of LVEF during follow-up. Conclusion: PPCM patients with severely reduced LVEF have an elevated risk for ventricular tachyarrhythmias early after diagnosis. Therefore, use of the WCD should be considered in all women with early-stage PPCM and severely reduced LVEF during the first 6 months after initiation of heart failure therapy.

The possibilities and implementation of wearable cardiac monitoring beyond atrial fibrillation are increasing continuously. This review focuses on the real-world use and evolution of these devices for other arrhythmias, cardiovascular diseases and some of their risk factors beyond atrial fibrillation. The management of nonatrial fibrillation arrhythmias represents a broad field of wearable technologies in cardiology using Holter, event recorder, electrocardiogram (ECG) patches, wristbands and textiles. Implementation in other patient cohorts, such as ST-elevation myocardial infarction (STEMI), heart failure or sleep apnea, is feasible and expanding. In addition to appropriate accuracy, clinical studies must address the validation of clinical pathways including the appropriate device and clinical decisions resulting from the surrogate assessed.

Aims: Recent trial data demonstrate beneficial effects of active rhythm management in patients with atrial fibrillation (AF) and support the concept that a low arrhythmia burden is associated with a low risk of AF-related complications. The aim of this document is to summarize the key outcomes of the 9th AFNET/EHRA Consensus Conference of the Atrial Fibrillation NETwork (AFNET) and the European Heart Rhythm Association (EHRA). Methods and results: Eighty-three international experts met in Münster for 2 days in September 2023. Key findings are as follows: (i) Active rhythm management should be part of the default initial treatment for all suitable patients with AF. (ii) Patients with device-detected AF have a low burden of AF and a low risk of stroke. Anticoagulation prevents some strokes and also increases major but non-lethal bleeding. (iii) More research is needed to improve stroke risk prediction in patients with AF, especially in those with a low AF burden. Biomolecules, genetics, and imaging can support this. (iv) The presence of AF should trigger systematic workup and comprehensive treatment of concomitant cardiovascular conditions. (v) Machine learning algorithms have been used to improve detection or likely development of AF. Cooperation between clinicians and data scientists is needed to leverage the potential of data science applications for patients with AF. Conclusions: Patients with AF and a low arrhythmia burden have a lower risk of stroke and other cardiovascular events than those with a high arrhythmia burden. Combining active rhythm control, anticoagulation, rate control, and therapy of concomitant cardiovascular conditions can improve the lives of patients with AF.

Aims: Artificial intelligence (AI) has the potential to transform cardiac electrophysiology (EP), particularly in arrhythmia detection, procedural optimization, and patient outcome prediction. However, a standardized approach to reporting and understanding AI-related research in EP is lacking. This scientific statement aims to develop and apply a checklist for AI-related research reporting in EP to enhance transparency, reproducibility, and understandability in the field. Methods and results: An AI checklist specific to EP was developed with expert input from the writing group and voted on using a modified Delphi process, leading to the development of a 29-item checklist. The checklist was subsequently applied to assess reporting practices to identify areas where improvements could be made and provide an overview of the state of the art in AI-related EP research in three domains from May 2021 until May 2024: atrial fibrillation (AF) management, sudden cardiac death (SCD), and EP lab applications. The EHRA AI checklist was applied to 31 studies in AF management, 18 studies in SCD, and 6 studies in EP lab applications. Results differed between the different domains, but in no domain reporting of a specific item exceeded 55% of included papers. Key areas such as trial registration, participant details, data handling, and training performance were underreported (<20%). The checklist application highlighted areas where reporting practices could be improved to promote clearer, more comprehensive AI research in EP. Conclusion: The EHRA AI checklist provides a structured framework for reporting AI research in EP. Its use can improve understanding but also enhance the reproducibility and transparency of AI studies, fostering more robust and reliable integration of AI into clinical EP practice.

Commercially available health technologies such as smartphones and smartwatches, activity trackers and eHealth applications, commonly referred to as wearables, are increasingly available and used both in the leisure and healthcare sector for pulse and fitness/activity tracking. The aim of the Position Paper is to identify specific barriers and knowledge gaps for the use of wearables, in particular for heart rate (HR) and activity tracking, in clinical cardiovascular healthcare to support their implementation into clinical care. The widespread use of HR and fitness tracking technologies provides unparalleled opportunities for capturing physiological information from large populations in the community, which has previously only been available in patient populations in the setting of healthcare provision. The availability of low-cost and high-volume physiological data from the community also provides unique challenges. While the number of patients meeting healthcare providers with data from wearables is rapidly growing, there are at present no clinical guidelines on how and when to use data from wearables in primary and secondary prevention. Technical aspects of HR tracking especially during activity need to be further validated. How to analyse, translate, and interpret large datasets of information into clinically applicable recommendations needs further consideration. While the current users of wearable technologies tend to be young, healthy and in the higher sociodemographic strata, wearables could potentially have a greater utility in the elderly and higher-risk population. Wearables may also provide a benefit through increased health awareness, democratization of health data and patient engagement. Use of continuous monitoring may provide opportunities for detection of risk factors and disease development earlier in the causal pathway, which may provide novel applications in both prevention and clinical research. However, wearables may also have potential adverse consequences due to unintended modification of behaviour, uncertain use and interpretation of large physiological data, a possible increase in social inequality due to differential access and technological literacy, challenges with regulatory bodies and privacy issues. In the present position paper, current applications as well as specific barriers and gaps in knowledge are identified and discussed in order to support the implementation of wearable technologies from gadget-ology into clinical cardiology.