Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes From the MANIFEST-PF Registry.

BACKGROUND: Pulsed field ablation is a novel nonthermal cardiac ablation modality using ultra-rapid electrical pulses to cause cell death by a mechanism of irreversible electroporation. Unlike the traditional ablation energy sources, pulsed field ablation has demonstrated significant preferentiality to myocardial tissue ablation, and thus avoids certain thermally mediated complications. However, its safety and effectiveness remain unknown in usual clinical care. METHODS: MANIFEST-PF (Multi-National Survey on the Methods, Efficacy, and Safety on the Post-Approval Clinical Use of Pulsed Field Ablation) is a retrospective, multinational, patient-level registry wherein patients at each center were prospectively included in their respective center registries. The registry included all patients undergoing postapproval treatment with a multielectrode 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF) between March 1, 2021, and May 30, 2022. The primary effectiveness outcome was freedom from clinical documented atrial arrhythmia (AF/atrial flutter/atrial tachycardia) of ≥30 seconds on the basis of electrocardiographic data after a 3-month blanking period (on or off antiarrhythmic drugs). Safety outcomes included the composite of acute (<7 days postprocedure) and latent (>7 days) major adverse events. RESULTS: At 24 European centers (77 operators) pulsed field ablation was performed in 1568 patients with AF: age 64.5±11.5 years, female 35%, paroxysmal/persistent AF 65%/32%, CHA2DS2-VASc 2.2±1.6, median left ventricular ejection fraction 60%, and left atrial diameter 42 mm. Pulmonary vein isolation was achieved in 99.2% of patients. After a median (interquartile range) follow-up of 367 (289-421) days, the 1-year Kaplan-Meier estimate for freedom from atrial arrhythmia was 78.1% (95% CI, 76.0%-80.0%); clinical effectiveness was more common in patients with paroxysmal AF versus persistent AF (81.6% versus 71.5%; P=0.001). Acute major adverse events occurred in 1.9% of patients. CONCLUSIONS: In this large observational registry of the postapproval clinical use of pulsed field technology to treat AF, catheter ablation using pulsed field energy was clinically effective in 78% of patients with AF.

Validation of a machine learning algorithm to identify pulmonary vein isolation during ablation procedures for the treatment of atrial fibrillation: results of the PVISION study.

AIMS: Pulmonary vein isolation (PVI) is the cornerstone of ablation for atrial fibrillation. Confirmation of PVI can be challenging due to the presence of far-field electrograms (EGMs) and sometimes requires additional pacing manoeuvres or mapping. This prospective multicentre study assessed the agreement between a previously trained automated algorithm designed to determine vein isolation status with expert opinion in a real-world clinical setting. METHODS AND RESULTS: Consecutive patients scheduled for PVI were recruited at four centres. The ECGenius electrophysiology (EP) recording system (CathVision ApS, Copenhagen, Denmark) was connected in parallel with the existing system in the laboratory. Electrograms from a circular mapping catheter were annotated during sinus rhythm at baseline pre-ablation, time of isolation, and post-ablation. The ground truth for isolation status was based on operator opinion. The algorithm was applied to the collected PV signals off-line and compared with expert opinion. The primary endpoint was a sensitivity and specificity exceeding 80%. Overall, 498 EGMs (248 at baseline and 250 at PVI) with 5473 individual PV beats from 89 patients (32 females, 62 ± 12 years) were analysed. The algorithm performance reached an area under the curve (AUC) of 92% and met the primary study endpoint with a sensitivity and specificity of 86 and 87%, respectively (P = 0.005; P = 0.004). The algorithm had an accuracy rate of 87% in classifying the time of isolation. CONCLUSION: This study validated an automated algorithm using machine learning to assess the isolation status of pulmonary veins in patients undergoing PVI with different ablation modalities. The algorithm reached an AUC of 92%, with both sensitivity and specificity exceeding the primary study endpoints.

Current management of atrial fibrillation in routine practice according to the last ESC guidelines: an EHRA physician survey-how are we dealing with controversial approaches?

AIMS: Although guidelines for the management of atrial fibrillation (AF) are regularly published, many controversial issues remain, limiting their implementation. We aim to describe current clinical practice among European Heart Rhythm Association (EHRA) community according to last guidelines. METHODS AND RESULTS: A 30 multiple-choice questionnaire covering the most controversial topics related to AF management was distributed through the EHRA Research Network, National Societies, and social media between January and February 2023. One hundred and eighty-one physicians responded the survey, 61% from university hospitals. Atrial fibrillation screening in high-risk patients is regularly performed by 57%. Only 42% has access to at least one programme aiming at diagnosing/managing comorbidities and lifestyle modifications, with marked heterogeneity between countries. Direct oral anticoagulants are the preferred antithrombotic (97%). Rhythm control is the preferred strategy in most AF phenotypes: symptomatic vs. asymptomatic paroxysmal AF (97% vs. 77%), low vs. high risk for recurrence persistent AF (90% vs. 72%), and permanent AF (20%). I-C drugs and amiodarone are preferred while dronedarone and sotalol barely used. Ablation is the first-line therapy for symptomatic paroxysmal AF (69%) and persistent AF with markers of atrial disease (57%) and is performed independently of symptoms by 15%. In persistent AF, 68% performs only pulmonary vein isolation and 32% also additional lesions. CONCLUSION: There is marked heterogeneity in AF management and limited accordance to last guidelines in the EHRA community. Most of the discrepancies are related to the main controversial issues, such as those related to AF screening, management of comorbidities, pharmacological treatment, and ablation strategy.

Utilization of and perceived need for simulators in clinical electrophysiology: results from an EHRA physician survey.

AIMS: Simulator training has been recently introduced in electrophysiology (EP) programmes in order to improve catheter manipulation skills without complication risks. The aim of this study is to survey the current use of EP simulators and the perceived need for these tools in clinical training and practice. METHODS AND RESULTS: A 20-item online questionnaire developed by the Scientific Initiatives Committee of the European Heart Rhythm Association (EHRA) in collaboration with EHRA Digital Committee was disseminated through the EHRA Scientific Research Network members, national EP groups, and social media platforms. Seventy-four respondents from 22 countries (73% males; 50% under 40 years old) completed the survey. Despite being perceived as useful among EP professionals (81%), EP simulators are rarely a part of the institutional cardiology training programme (20%) and only 18% of the respondents have an EP simulator at their institution. When available, simulators are mainly used in EP to train transseptal puncture, ablation, and mapping, followed by device implantation (cardiac resynchronization therapy [CRT], leadless, and conduction system pacing [CSP]). Almost all respondents (96%) believe that simulator programmes should be a part of the routine institutional EP training, hopefully developed by EHRA, in order to improve the efficacy and safety of EP procedures and in particular CSP 58%, CRT 42%, leadless pacing 38%, or complex arrhythmia ablations (VT 58%, PVI 45%, and PVC 42%). CONCLUSION: This current EHRA survey identified a perceived need but a lack of institutional simulator programme access for electrophysiologists who could benefit from it in order to speed up the learning curve process and reduce complications of complex EP procedures.

Design and deployment of the STEEER-AF trial to evaluate and improve guideline adherence: A cluster-randomised trial by the European Society of Cardiology and European Heart Rhythm Association.

AIMS: To describe the rationale, design, delivery and baseline characteristics of STEEER-AF (Stroke prevention and rhythm control Treatment: Evaluation of an Educational programme of the European Society of Cardiology [ESC] in a cluster-Randomised trial in patients with Atrial Fibrillation). METHODS & RESULTS: STEEER-AF is a pragmatic trial designed to objectively and robustly determine whether guidelines are adhered to in routine practice, and evaluate a targeted educational programme for healthcare professionals. Seventy centres were randomised in 6 countries (France, Germany, Italy, Poland, Spain and United Kingdom; 2022-2023). STEEER-AF centres recruited 1732 patients with a diagnosis of atrial fibrillation (AF), with mean age 68.9 years (SD 11.7), CHA2DS2-VASc score 3.2 (SD 1.8) and 647 (37%) women. 843 patients (49%) were in AF and 760 (44%) in sinus rhythm at enrolment. Oral anticoagulant therapy was prescribed in 1,543 patients (89%), with the majority receiving direct oral anticoagulants (1,378; 89%). Previous cardioversion, antiarrhythmic drug therapy or ablation was recorded in 836 patients (48.3%). 551 patients (31.8%) were currently receiving an antiarrhythmic drug, and 446 (25.8%) were scheduled to receive a future cardioversion or ablation. The educational programme engaged 195 healthcare professionals across centres randomised to the intervention group, consisting of bespoke interactive online learning and reinforcement activities, supported by national expert trainers. CONCLUSION: The STEEER-AF trial was successfully deployed across six European countries to investigate guideline adherence in real-world practice, and evaluate if a structured educational programme for healthcare professionals can improve patient-level care. REGISTRATION: Clinicaltrials.gov NCT04396418.

Comparing pulsed field electroporation and radiofrequency ablation for the treatment of paroxysmal atrial fibrillation: design and rationale of the BEAT PAROX-AF randomized clinical trial.

AIMS: Using thermal-based energy sources [radiofrequency (RF) energy/cryo energy] for catheter ablation is considered effective and safe when performing pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (AF). However, treatment success remains limited and complications can occur due to the propagation of thermal energy into non-target tissues. We aim to compare pulsed field ablation (PFA) with RF ablation in terms of efficacy and safety for patients with drug-resistant paroxysmal AF. METHODS AND RESULTS: The BEAT PAROX-AF trial is a European multicentre, superiority, open-label randomized clinical trial in two parallel groups. A total of 292 participants were recruited in 9 high-volume European clinical centres in 5 countries. Patients with paroxysmal AF were randomized to PFA (FARAPULSE Endocardial Ablation System©, Boston Scientific) or RF using the CLOSE protocol with contact force sensing catheter (SmartTouch© catheter and CARTO© Biosense Webster). The primary endpoint will be the 1-year recurrence of atrial arrhythmia, and the major secondary safety endpoint will be the occurrence of acute (<7 days) procedure-related serious adverse events, or pulmonary vein stenosis, or atrio-oesophageal fistula up to 12 months. Additionally, five sub-studies investigate the effect of PFA on oesophageal safety, cerebral lesions, cardiac autonomic nervous system, durability of PVI as assessed during redo ablation procedures, and atrial and ventricular function. The study began on 27 December 2021 and concluded recruitment on 17 January 2024. Results will be available in mid-2025. CONCLUSION: The BEAT PAROX-AF trial aims to provide critical insights into the optimal treatment approach for patients with paroxysmal AF.

Practical guide on left atrial appendage closure for the non-implanting physician: an international consensus paper.

A significant proportion of patients who suffer from atrial fibrillation (AF) and are in need of thromboembolic protection are not treated with oral anticoagulation or discontinue this treatment shortly after its initiation. This undertreatment has not improved sufficiently despite the availability of direct oral anticoagulants which are associated with less major bleeding than vitamin K antagonists. Multiple reasons account for this, including bleeding events or ischaemic strokes whilst on anticoagulation, a serious risk of bleeding events, poor treatment compliance despite best educational attempts, or aversion to drug therapy. An alternative interventional therapy, which is not associated with long-term bleeding and is as effective as vitamin K anticoagulation, was introduced over 20 years ago. Because of significant improvements in procedural safety over the years, left atrial appendage closure, predominantly achieved using a catheter-based, device implantation approach, is increasingly favoured for the prevention of thromboembolic events in patients who cannot achieve effective anticoagulation. This management strategy is well known to the interventional cardiologist/electrophysiologist but is not more widely appreciated within cardiology or internal medicine. This article introduces the devices and briefly explains the implantation technique. The indications and device follow-up are more comprehensively described. Almost all physicians who care for adult patients will have many with AF. This practical guide, written within guideline/guidance boundaries, is aimed at those non-implanting physicians who may need to refer patients for consideration of this new therapy, which is becoming increasingly popular.

2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation.

In the last three decades, ablation of atrial fibrillation (AF) has become an evidence-based safe and efficacious treatment for managing the most common cardiac arrhythmia. In 2007, the first joint expert consensus document was issued, guiding healthcare professionals involved in catheter or surgical AF ablation. Mounting research evidence and technological advances have resulted in a rapidly changing landscape in the field of catheter and surgical AF ablation, thus stressing the need for regularly updated versions of this partnership which were issued in 2012 and 2017. Seven years after the last consensus, an updated document was considered necessary to define a contemporary framework for selection and management of patients considered for or undergoing catheter or surgical AF ablation. This consensus is a joint effort from collaborating cardiac electrophysiology societies, namely the European Heart Rhythm Association, the Heart Rhythm Society, the Asia Pacific Heart Rhythm Society, and the Latin American Heart Rhythm Society .

A worldwide survey on incidence, management, and prognosis of oesophageal fistula formation following atrial fibrillation catheter ablation: the POTTER-AF study.

AIMS: Oesophageal fistula represents a rare but dreadful complication of atrial fibrillation catheter ablation. Data on its incidence, management, and outcome are sparse. METHODS AND RESULTS: This international multicentre registry investigates the characteristics of oesophageal fistulae after treatment of atrial fibrillation by catheter ablation. A total of 553 729 catheter ablation procedures (radiofrequency: 62.9%, cryoballoon: 36.2%, other modalities: 0.9%) were performed, at 214 centres in 35 countries. In 78 centres 138 patients [0.025%, radiofrequency: 0.038%, cryoballoon: 0.0015% (P < 0.0001)] were diagnosed with an oesophageal fistula. Peri-procedural data were available for 118 patients (85.5%). Following catheter ablation, the median time to symptoms and the median time to diagnosis were 18 (7.75, 25; range: 0-60) days and 21 (15, 29.5; range: 2-63) days, respectively. The median time from symptom onset to oesophageal fistula diagnosis was 3 (1, 9; range: 0-42) days. The most common initial symptom was fever (59.3%). The diagnosis was established by chest computed tomography in 80.2% of patients. Oesophageal surgery was performed in 47.4% and direct endoscopic treatment in 19.8% and conservative treatment in 32.8% of patients. The overall mortality was 65.8%. Mortality following surgical (51.9%) or endoscopic treatment (56.5%) was significantly lower as compared to conservative management (89.5%) [odds ratio 7.463 (2.414, 23.072) P < 0.001]. CONCLUSION: Oesophageal fistula after catheter ablation of atrial fibrillation is rare and occurs mostly with the use of radiofrequency energy rather than cryoenergy. Mortality without surgical or endoscopic intervention is exceedingly high.

Use of instant messaging in electrophysiological clinical practice in Latin America: a LAHRS survey.

AIMS: Instant messaging (IM) platforms are a prominent component of telemedicine and a practical tool for sharing clinical data and counselling. Purpose of the survey was to inquire about the use of IM, the platforms used, frequency, recipients, and contents in Latin America region. METHODS AND RESULTS: An online survey was sent to medical community via newsletter and social media channels. The survey consisted in 22 questions, in Spanish and Portuguese, collected on SurveyMonkey. A total of 125 responders from 13 Latin-American countries (79% male, mean age 46.1 ± 9.7 years) completed the survey. Most of the responders declared that they send (88.8%) and receive (97.6%) clinical data through IM apps. Most senders declare that they anonymize clinical data before sending (71.0 ± 38.3%), but that the data received is anonymized only in 51.4 ± 33.5%. The most common tests shared with other physicians were 12-lead electrocardiograms (99.2%), followed by Holter recordings (68.0%) and tracings from electrophysiological studies (63.2%). The majority (55.2%) said that are unaware of legal data protection rules in their countries. CONCLUSIONS: IM apps are used by medical professionals worldwide to share and discuss clinical data and are preferred to many other methods of data sharing and are often used to share many different types of clinical data. They are perceived as a fast and easy way of communication, but medical professionals should be aware of the appropriate use of IM to prevent legal and privacy issues.

Two-year outcomes of leadless vs. transvenous single-chamber ventricular pacemaker in high-risk subgroups.

AIMS: This study compares clinical outcomes between leadless pacemakers (leadless-VVI) and transvenous ventricular pacemakers (transvenous ventricular permanent-VVI) in subgroups of patients at higher risk of pacemaker complications. METHODS AND RESULTS: This study is based on the Micra Coverage with Evidence Development (CED) study. Patients from the Micra CED study were considered in a high-risk subgroup if they had a diagnosis of chronic kidney disease Stages 4-5 (CKD45), end-stage renal disease, malignancy, diabetes, tricuspid valve disease (TVD), or chronic obstructive pulmonary disease (COPD) 12 months prior to pacemaker implant. A pre-specified set of complications and reinterventions were identified using diagnosis and procedure codes. Competing risks models were used to compare reinterventions and complications between leadless-VVI and transvenous-VVI patients within each subgroup; results were adjusted for multiple comparisons. A post hoc comparison of a composite outcome of reinterventions and device complications was conducted. Out of 27 991 patients, 9858 leadless-VVI and 12 157 transvenous-VVI patients have at least one high-risk comorbidity. Compared to transvenous-VVI patients, leadless-VVI patients in four subgroups [malignancy, HR 0.68 (0.48-0.95); diabetes, HR 0.69 (0.53-0.89); TVD, HR 0.60 (0.44-0.82); COPD, HR 0.73 (0.55-0.98)] had fewer complications, in three subgroups [diabetes, HR 0.58 (0.37-0.89); TVD, HR 0.46 (0.28-0.76); COPD, HR 0.51 (0.29-0.90)) had fewer reinterventions, and in four subgroups (malignancy, HR 0.52 (0.32-0.83); diabetes, HR 0.52 (0.35-0.77); TVD, HR 0.44 (0.28-0.70); COPD, HR 0.55 (0.34-0.89)] had lower rates of the combined outcome. CONCLUSION: In a real-world study, leadless pacemaker patients had lower 2-year complications and reinterventions rates compared with transvenous-VVI pacing in several high-risk subgroups. TRIAL REGISTRATION: ClinicalTrials.gov ID NCT03039712.

Cardiac pacing and lead devices management: 25 years of research at EP Europace journal.

AIMS: Cardiac pacing represents a key element in the field of electrophysiology and the treatment of conduction diseases. Since the first issue published in 1999, EP Europace has significantly contributed to the development and dissemination of the research in this area. METHODS: In the last 25 years, there has been a continuous improvement of technologies and a great expansion of clinical indications making the field of cardiac pacing a fertile ground for research still today. Pacemaker technology has rapidly evolved, from the first external devices with limited longevity, passing through conventional transvenous pacemakers to leadless devices. Constant innovations in pacemaker size, longevity, pacing mode, algorithms, and remote monitoring highlight that the fascinating and exciting journey of cardiac pacing is not over yet. CONCLUSION: The aim of the present review is to provide the current 'state of the art' on cardiac pacing highlighting the most important contributions from the Journal in the field.

Conduction system pacing in everyday clinical practice: EHRA physician survey.

With the increasing interest in conduction system pacing (CSP) over the last few years and the inclusion of this treatment modality in the current guidelines, our aim was to provide a snapshot of current practice across Europe. An online questionnaire was sent to physicians participating in the European Heart Rhythm Association research network as well as to national societies and over social media. Data on previous experience with CSP, current indications, preferred tools, unmet needs, and perceptions for the future are reported and discussed.

Rhythm monitoring, success definition, recurrence, and anticoagulation after atrial fibrillation ablation: results from an EHRA survey.

Atrial fibrillation (AF) is a major challenge for the healthcare field. Pulmonary vein isolation is the most effective treatment for the maintenance of sinus rhythm. However, clinical endpoints for the procedure vary significantly among studies. There is no consensus on the definition of recurrence and no clear roadmap on how to deal with recurrences after a failed ablation. The purpose of this study was to perform a survey in order to show how clinicians currently approach this knowledge gap. An online survey, supported by the European Heart Rhythm Association (EHRA) Scientific Initiatives Committee, was conducted between 1 April 2022 and 8 May 2022. An anonymous questionnaire was disseminated via social media and EHRA newsletters, for clinicians to complete. This consisted of 18 multiple-choice questions regarding rhythm monitoring, definitions of a successful ablation, clinical practices after a failed AF ablation, and the continuance of anticoagulation. A total of 107 replies were collected across Europe. Most respondents (82%) perform routine monitoring for AF recurrences after ablation, with 51% of them preferring a long-term monitoring strategy. Cost was reported to have an impact on the choice of monitoring strategy. Self-screening was recommended by most (71%) of the respondents. The combination of absence of symptoms and recorded AF was the definition of success for most (83%) of the respondents. Cessation of anticoagulation after ablation was an option mostly for patients with paroxysmal AF and a low CHA2DS2-VASc score. The majority of physicians perform routine monitoring after AF ablation. For most physicians, the combination of the absence of symptoms and electrocardiographic endpoints defines a successful result after AF ablation.

Contemporary management of ventricular electrical storm in Europe: results of a European Heart Rhythm Association Survey.

Electrical storm (ES) is a predictor of mortality, and its treatment is challenging. Moreover, not all potential therapeutic strategies are available in all hospitals, and a standardized approach among European centres is lacking. The aim of this European Heart Rhythm Association (EHRA) survey was to assess the current management of patients with ES both in the acute and post-acute phases in 102 different European centres. A 20-item online questionnaire was sent out to the EHRA Research Network Centres. The median number of patients with ES treated annually per centre is 10 (IQR 5-15). The possibility of using autonomic modulation (e.g. percutaneous stellate ganglion block or thoracic epidural anaesthesia) for the acute ES treatment is available in only 29.3% of the centres. Moreover, although over 80% of centres perform ventricular tachycardia ablation, this procedure is available 24/7 in only 16.5% of the hospitals. There is a significant heterogeneity among centres regarding the availability of AADs and their use before deciding to proceed with a non-AAD strategy; specifically, 4.4% of centres use only one drug, 33.3% use two drugs, and 12.2% >two drugs, while about 50% of the centres decide based on individual patient's characteristics. Regarding the type of AADs used for the acute and post-acute management of ES patients, important variability is reported depending upon the underlying heart disease. Most patients considered for percutaneous ablation have structural heart disease. Only 46% of centres refer patients to psychological counselling after ES.

Long-term outcomes of left atrial appendage isolation using cryoballoon in persistent atrial fibrillation.

AIMS: There is an increasing trend evaluating the role of non-pulmonary vein (PV) triggers to improve ablation outcomes in persistent atrial fibrillation (AF) as pulmonary vein isolation (PVI) strategy alone has modest outcomes. We investigated the long-term safety and efficacy of left atrial appendage isolation (LAAi) in addition to PVI using cryoballoon (CB) in persistent AF. METHODS AND RESULTS: In this multicentre retrospective analysis, we included a total of 193 persistent AF patients (mean age: 60 ± 11 years, 50.3% females) who underwent PVI and LAAi using CB. Baseline and follow-up data including electrocardiography (ECG), 24 h Holter ECGs, and echocardiography were recorded for all patients. Atrial tachyarrhythmia (ATa) recurrence was defined as the detection of AF, atrial flutter, or atrial tachycardia (≥30 s) after a 3-month blanking period. At a median follow-up of 55 (36.5-60.0) months, 85 (67.9%) patients with PVI + LAAi were in sinus rhythm after the index procedure. Ischaemic stroke/transient ischemic attack occurred in 14 (7.2%) patients at a median of 24 (2-53) months following catheter ablation. Multivariate regression analysis revealed heart failure with preserved ejection fraction [hazard ratio (HR) 2.29, 95% confidence interval (CI) 1.04-5.02; P = 0.038], male gender (HR 0.53, 95% CI 0.29-0.96; P = 0.037), and LA area (HR 1.04, 95% CI 0.53-1.32; P = 0.023) as independent predictors of ATa recurrence. CONCLUSION: Our findings demonstrated that the LAAi + PVI strategy using CB had acceptable long-term outcomes in patients with persistent AF. Systemic thrombo-embolic events are an important concern throughout the follow-up, which were mostly observed in case of non-adherence to anticoagulants.

Major gaps in the information provided to patients before implantation of cardioverter defibrillators: a prospective patient European evaluation.

AIMS: Information provided to patients prior to implantable cardioverter-defibrillator (ICD) insertion and their participation in the decision-making process are crucial for understanding ICD function and accepting this lifelong therapy. The aim of this study is to evaluate the extent to which different aspects related to ICD and quality of life were transmitted to patients prior to ICD implantation. METHODS AND RESULTS: Prospective, multicenter European study with an online questionnaire initiated by the European Heart Rhythm Association. The questionnaire was filled-in directly and personally by the ICD patients who were invited to participate. A total of 1809 patients (majority in their 40s-70s, with 624 women, 34.5%) from 10 European countries participated in the study. The median time from first ICD implantation was 5 years (interquartile range 2-10). Overall, 1155 patients (71.5%) felt optimally informed at the time of device implantation, however many respondents received no information about ICD-related complications (n = 801, 49.6%), driving restrictions (n = 718, 44.5%), and possibility of end-of-life ICD deactivation (n = 408, 25.4%). Of note, women were less frequently involved in the decision-making process than men (47.3% vs. 55.9%, P = 0.003) and reported to be less often optimally informed before ICD implantation than men (61.2% vs. 76.8%, P < 0.001). More women mentioned the desire to have learned more about ICD therapy and the benefit/risk balance (45.4% vs. 33.7% of men; P < 0.001). CONCLUSIONS: This patient-based evaluation provides alarming findings on the lack of information provided to patients prior ICD implantation, particularly for women.

Prevention of venous thromboembolism in right heart-sided electrophysiological procedures: results of an European Heart Rhythm Association survey.

Limited data are available regarding venous thromboembolism (VTE), specifically deep vein thrombosis (DVT) and pulmonary embolism (PE), following right-sided ablations and electrophysiological (EP) studies. Compared to left-sided procedures, no guidelines on antithrombotic management strategies for the prevention of DVT and PE are available. The main purpose of the present European Heart Rhythm Association (EHRA) survey is to report the current management of right-sided EP procedures, focusing on anticoagulation and prevention of VTE. An online survey was conducted using the EHRA infrastructure. A total of 244 participants answered a 19-items questionnaire on the periprocedural management of EP studies and right-sided catheter ablations. The right femoral vein is the most common access for EP studies and right-sided procedures. An ultrasound-guided approach is employed by more than 2/3 of respondents. Intravenous heparin is not commonly given by the majority of participants. About 1/3 of participants (34%) routinely prescribe VTE prophylaxis during (mostly aspirin and low molecular weight heparin) and 1/4 of respondents (25%) commonly prescribe VTE prophylaxis after discharge (mostly aspirin). Of note, respectively 13% and 9% of participants observed at least one DVT and one PE related to right-sided ablation or EP study within the last year in their center. The present survey shows that only a minority of operators routinely gives intraprocedural intravenous heparin and prescribes VTE prophylaxis after right-sided EP procedures. Compared to left-sided procedures like atrial fibrillation (AF) ablation, there are no consistent systematic antithrombotic management strategies.

Occupational radiation exposure of electrophysiology staff with reproductive potential and during pregnancy: an EHRA survey.

AIMS: Electrophysiology (EP) is a growing field in cardiology, with an increasing involvement of young people. Nevertheless, concerns about radiation exposure and its impact on reproduction and pregnancy may discourage the choice of an EP career. The study is aimed at investigating the level of awareness and main sources of concern about the effects of radiation on reproductive potential and pregnancy, exploring the safety measures adopted in different EP labs, and verifying the adherence to the current guidelines. METHODS AND RESULTS: An online survey was conducted using the European Heart Rhythm Association (EHRA) infrastructure from April to June 2022. A total of 252 EP personnel (42% women) participated, from 50 countries and different professional roles. Most participants expressed concerns regarding the effects of radiation on reproductive capacity (67.1%) and offspring diseases (68.2%). Only 37.9% of participants were aware of the EHRA 2017 consensus document about occupational radiation exposure. Most participants (80.9%) considered that occupational radiation during pregnancy is not safe. EP female staff were not allowed to work in the EP lab during pregnancy in 48.1% of cases. Zero-fluoroscopy was the preferred choice to continue working in the EP lab during pregnancy. CONCLUSION: EP staff, including both men and women, have concerns about the effects of radiation on reproductive capacity. Despite the recommendations issued by international bodies, implementation of the policies regarding pregnancy and occupational radiation exposure is heterogeneous. Zero-fluoroscopy is the preferred approach to ensure safety during pregnancy in the EP lab.

Impact of peri-procedural management of direct oral anticoagulants on pocket haematoma after cardiac electronic device implantation: the StimAOD multicentre prospective study.

AIMS: The study aims to investigate the impact of direct oral anticoagulant (DOAC) management on the incidence of pocket haematoma in patients undergoing pacemaker or implantable cardioverter-defibrillator implantation. METHODS AND RESULTS: All consecutive patients receiving DOAC and undergoing cardiac electronic device implantation were included in a large multicentre prospective observational study (NCT03879473). The primary endpoint was clinically relevant haematoma within 30 days after implantation. Overall, 789 patients were enrolled [median age 80 (IQR 72-85) years old, 36.4% women, median CHA2DS2-VASc score 4 (IQR 0-8)], of which 632 (80.1%) received a pacemaker implantation. Antiplatelet therapy was combined with DOAC in 146 patients (18.5%). Direct oral anticoagulants (DOACs) were interrupted 52 (IQR 37-62) h before the procedure and resumed 31 (IQR 21-47) h later. Ninety-six percent of the patients had at least 12 h DOAC interruption before the procedure, and 78% had at least 12 h DOAC interruption after the procedure. Overall, anticoagulation was interrupted for 72 (IQR 48-96) h. Pre- or post-procedural heparin bridging was used in 8.2% and 3.9%, respectively. Timing of DOAC interruption of resumption was not associated with clinically relevant haematoma. Clinically relevant haematoma occurred in 26 patients (3.3%), and thromboembolic events occurred in 5 patients (0.6%). CONCLUSION: In this large real-life registry where most patients had DOAC interruption, clinically relevant haematoma was rare. Despite DOAC interruption and high CHA2DS2-VASc score, thromboembolic events occurred seldomly, highlighting that bleeding exceeds thromboembolic risk in this peri-procedural period. Future research is needed to identify risk factors for clinically relevant haematoma and meaningfully guide clinicians in optimizing DOAC management.