The potential of artificial intelligence to revolutionize health care delivery, research, and education in cardiac electrophysiology.

The field of electrophysiology (EP) has benefited from numerous seminal innovations and discoveries that have enabled clinicians to deliver therapies and interventions that save lives and promote quality of life. The rapid pace of innovation in EP may be hindered by several challenges including the aging population with increasing morbidity, the availability of multiple costly therapies that, in many instances, confer minor incremental benefit, the limitations of healthcare reimbursement, the lack of response to therapies by some patients, and the complications of the invasive procedures performed. To overcome these challenges and continue on a steadfast path of transformative innovation, the EP community must comprehensively explore how artificial intelligence (AI) can be applied to healthcare delivery, research, and education and consider all opportunities in which AI can catalyze innovation; create workflow, research, and education efficiencies; and improve patient outcomes at a lower cost. In this white paper, we define AI and discuss the potential of AI to revolutionize the EP field. We also address the requirements for implementing, maintaining, and enhancing quality when using AI and consider ethical, operational, and regulatory aspects of AI implementation. This manuscript will be followed by several perspective papers that will expand on some of these topics.

Inter-atrial septal balloon dilation to facilitate intracardiac echocardiography guided left atrial appendage occlusion.

INTRODUCTION: Percutaneous left atrial appendage occlusion (LAAO) is traditionally performed under general anesthesia with trans-esophageal echocardiography guidance. Intracardiac echo (ICE)-guided LAAO closure is increasing in clinical use. The ICE catheter is crossed into LA via interatrial septum (IAS) after the septum is dilated with LAAO delivery sheath. This step can be time-consuming and requires significant ICE catheter manipulation, which increases the risk of cardiac perforation. Pre-emptive septal balloon dilation can potentially help with ICE advancement in the LA. We sought to evaluate the effect of pre-dilation of the IAS with an 8 mm balloon on the ease of crossing the ICE catheter, fluoroscopy time for crossing, and overall procedure time. METHODS: The Piedmont LAAO registry was used to identify consecutive patients who underwent LAAO. The initial 25 patients in whom balloon dilation of the IAS was performed served as the experimental cohort, and the 25 consecutive patients before that in whom balloon dilation was not performed served as controls. In the experimental group, after a trans-septal puncture, the sheath was retracted to the right atrium with a guidewire still in the LA. An 8 × 40 mm Evercoss™ over the wire balloon was inflated across the IAS. The ICE catheter was then crossed into the LA using the fluoroscopic landmark of the guide wire and the ICE imaging. The sheath was then advanced along the ICE catheter via the transseptal puncture (TSP) and the procedure continued. Follow-up compputed tomography imaging was obtained at 4-8 weeks. RESULTS: Each group consisted of 25 patients. There were no significant differences in baseline characteristics. All procedures were performed successfully under conscious sedation and ICE guidance. There was a significant reduction in the overall procedure time, fluoroscopy time, and time for transseptal puncture to ICE in LA. There was no difference in the size of the acute residual interatrial shunt, as measured via ICE, or the size and presence of iatrogenic ASD at follow-up. CONCLUSION: Balloon dilation of TSP is safe and is associated with increased efficiency in ICE-guided LAAO procedures.

Expedited loading with intravenous sotalol is safe and feasible-primary results of the Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry.

BACKGROUND: Loading of oral sotalol for atrial fibrillation requires 3 days, frequently in the hospital, to achieve steady state. The Food and Drug Administration approved loading with intravenous (IV) sotalol through model-informed development, without patient data. OBJECTIVE: We present results of the first multicenter evaluation of this recent labeling for IV sotalol. METHODS: The Prospective Evaluation Analysis and Kinetics of IV Sotalol (PEAKS) Registry was a multicenter observational registry of patients undergoing elective IV sotalol load for atrial arrhythmias. Outcomes, measured from hospital admission until first outpatient follow-up, included adverse arrhythmia events, efficacy, and length of stay. RESULTS: Of 167 consecutively enrolled patients, 23% were female; the median age was 68 (interquartile range, 61-74) years, and the median CHA2DS2-VASc score was 3 (interquartile range, 2-4). Overall, 99% were admitted for sotalol initiation (1% for dose escalation), with a target oral sotalol dose of either 80 mg twice daily (85 [51%]) or 120 mg twice daily (78 [47%]); 62 patients (37%) had an estimated creatinine clearance ≤90 mL/min. On presentation, 40% of patients were in sinus rhythm, whereas 26% underwent cardioversion before sotalol infusion. In 2 patients, sotalol infusion was stopped for bradycardia or hypotension. In 6 patients, sotalol was discontinued before discharge because of QTc prolongation (3), bradycardia (1), or recurrent atrial arrhythmia (2). The mean length of stay was 1.1 days, and 95% (n = 159) were discharged within 1 night. CONCLUSION: IV sotalol loading is safe and feasible for atrial arrhythmias, with low rates of adverse events, and yields shorter hospitalizations. More data are needed on the minimal duration required for monitoring in the hospital.

Atrial fibrillation ablation in heart failure patients: Where do we stand in 2023? - State of the art review.

Atrial fibrillation (AF) and heart failure are common overlapping cardiovascular disorders. Despite important therapeutic advances over the past several decades, controversy persists about whether a rate control or rhythm control approach constitutes the best option in this population. There is also considerable debate about whether antiarrhythmic drug therapy or ablation is the best approach when rhythm control is pursued.  A brief historical examination of the literature addressing this issue will be performed. An analysis of several important clinical outcomes observed in the prospective, randomized studies, which have compared AF ablation to non-ablation treatment options, will be discussed. This review will conclude with recommendations to guide clinicians on the status of AF ablation as a treatment option when considering management options in heart failure patients with atrial fibrillation.

Expert Consensus on Comprehensive Early Rhythm Control in Addition to Guideline-Based Care for Atrial Fibrillation: A Modified Delphi Survey.

Atrial fibrillation (AF) practice guidelines recommend a rhythm-control strategy to improve symptoms and quality of life, noting the side effects of antiarrhythmic drugs and catheter ablation. Emerging evidence indicates that comprehensive early rhythm control with antiarrhythmic drugs or catheter ablation is associated with a lower risk of adverse cardiovascular outcomes versus the usual care. Using an online modified Delphi survey approach, perspectives and expert consensus among electrophysiologists were examined through a series of ranking and likelihood questions around treatment decision-making on (1) the use of comprehensive early rhythm-control strategies in patients with AF based on guidelines and emerging research and (2) treatment selection factors. A panel of 17 electrophysiologists reached a consensus on using early rhythm control (median 90, interquartile range 14) based on the view that early intervention improved cardiovascular outcomes (mean rank 1.6 of 3, 82% within 1 SD) and symptoms (1.8 of 3, 41%). AF-related symptoms were identified as the most important in making a treatment initiation decision (1.1 of 7, 88%), followed by AF type (2.5 of 7, 82%). Participants were most likely to initiate treatment at AF symptom onset (median 80; interquartile range 6). In making treatment selection decisions, participants ranked short-term/long-term safety (1.9 of 7, 88%) and efficacy (1.8 of 7, 53%) as the top 2 considerations. In conclusion, experts were in favor of early rhythm control; however, additional research is needed to address the role that early rhythm-control strategies play in current AF treatment management algorithms.

Introduction: Early Diagnosis and Appropriate Treatment of Atrial Fibrillation.

Atrial fibrillation (AF), the most common sustained arrhythmia, represents a significant burden to patients and healthcare systems. Many patients with AF are asymptomatic and often undiagnosed. Improved detection methods and surveillance have resulted in recognition of asymptomatic and subclinical AF, providing earlier diagnosis. The recent EAST-AFNET 4 and Korean studies have demonstrated early rhythm control (ERC) with antiarrhythmic drugs (AADs) or ablation in patients with AF improves outcomes. The EARLY AF and STOP AF First studies have shown that ERC using ablation can slow AF progression. In the following videos, the authors discuss the evolving AF landscape, with an emphasis on the benefits of early diagnosis and treatment. Historic rate versus rhythm control studies and their limitations are reviewed, followed by recent studies that support the use of ERC alongside usual care including rate control. Discussion of ERC treatment includes the selection of appropriate AADs based on safety, when to choose ablation as first-line therapy, and the complementary use of ablation and AADs. The authors summarize the current guidelines for the use of AADs to treat AF, highlighting the importance of concordance with those guidelines. Patient cases are used to relate the contents of the videos to clinical practice and are supplemented with discussion of the importance of shared decision-making involving the patient in treatment decisions. It is anticipated that this digital publication will enable cardiologists and primary care providers to recognize when early treatment of AF will improve patient outcomes, and to empower them to initiate that treatment accordingly.

Chapter 3: Evidence for the Use of Early Rhythm Control to Prevent Atrial Fibrillation Progression.

This chapter reviews atrial fibrillation (AF) progression and its associated mechanisms, including comorbidities and AF as contributors to atrial myopathy, and atrial myopathy as a contributing factor to AF progression. In addition, the chapter discusses the concept of comorbidities and atrial myopathy as synergistic contributors to adverse outcomes, the notion of "AF begets AF," and the consequences of AF burden if left untreated. Clinical trials evaluating outcomes with antiarrhythmic drugs (AADs) compared with placebo have demonstrated efficacy, but also reveal a possible proarrhythmic and mortality risk if AAD selection is not appropriate and patients are not correctly identified based on risk factors and comorbidities. Data from ATHENA, the first and only trial to demonstrate that an AAD (dronedarone) can reduce cardiovascular (CV) hospitalizations in people with AF, are reviewed, along with studies reporting on the use of catheter ablation versus AADs for AF rhythm control. Finally, recent data showing a reduction in major adverse outcomes if rhythm control is initiated early are summarized, including results from the EAST-AFNET 4 trial, as well as confirmatory results from several large "real-world" trials. Chapter 3 is summarized as follows.

Chapter 4: Evidence for the Early Use of Ablation and AADs Post-Ablation.

Both catheter ablation and antiarrhythmic drugs (AADs) are effective treatments for atrial fibrillation (AF) and can be used individually or as complementary treatments. This chapter discusses the use of ablation for early rhythm control in AF, and the use of AADs post-ablation. Decisions on which therapeutic approach to pursue should be based on shared decision-making with the patient. The chapter reviews data from the CABANA trial, in which the intent-to-treat (ITT) analysis failed to show superiority for ablation versus AADs. Statistical significance was achieved, however, when using the pre-specified per-protocol and pre-treatment analyses. The discussion addresses the fact that data analysis was complicated by several factors: (1) not all members of the group assigned to ablation actually received ablation; (2) the AAD arm included rate control treatment without the use of AADs; (3) there were a large number of crossovers from the AAD arm to the ablation arm; and (4) many ablation-treated participants also used AADs. Results from the CABANA trial showed that ablation was better at preventing AF recurrence than AADs alone. Data from the STOP AF and EARLY AF trials that support the observation of ablation being superior to AADs alone for the reduction of recurrent AF are also reviewed. Many patients who undergo catheter ablation for AF either continue to use or need to restart AADs following ablation. This combination therapy is used by up to 40-50% of people at 1-year post ablation, as is clearly demonstrated by the results from the trials discussed above, in addition to those from the 5A trial, the POWDER AF trial, the AMIO-CAT trial, and a substantial meta-analysis. All these trials are reviewed in this chapter, noting that a variety of differences exist between the randomized clinical trials, including in ablation procedures, follow-up periods, physician experience, and AADs. Chapter 4 is summarized as follows.

Chapter 5: Guideline Recommendations: Which AAD and for Whom?

This chapter discusses the American College of Cardiology/American Heart Association/ Heart Rhythm Society (AHA/ACC/HRS) and European Society of Cardiology (ESC) guidelines for atrial fibrillation (AF) management with particular focus on antiarrhythmic drug (AAD) selection and the identification of individuals for whom AAD treatment is appropriate. Discussion includes AAD indications, when to start an AAD, choosing among AADs, how to minimize proarrhythmic risk, how to determine efficacy, and the use of adjuvant interventions. The indications for all AADs are based on safety; the current AHA/ACC/HRS and ESC guidelines state that the choice of AAD is based on the presence or absence of structural heart disease (SHD), coronary artery disease, or heart failure (HF), with further recommendations in the ESC guidelines based on HF type (e.g., HF with reduced ejection fraction [HFrEF] versus HF with preserved ejection fraction [HFpEF]). The chapter closes with a discussion of the lack of consistent use of guideline-directed care, with a review of supportive data from the recently reported AIM-AF survey-a multinational survey on AF management that involved both cardiologists and electrophysiologists. In AIM-AF, inappropriate drug selection in terms of suitable candidate selection and drug choice occurred with all types of drugs and in most patient groups. Most notable was the overuse of amiodarone in patients without SHD, and the widespread use of sotalol, including its use in patients with HFrEF. Chapter 5 is summarized as follows.

Chapter 6: AAD Use in Different Patient Populations, and a Patient-Centric Approach to Optimal Patient Management.

Associated with longer life expectancy, greater survival of patients with cardiovascular disorders, and increased use of wearable and insertable/implantable devices capable of detection, the frequency of atrial fibrillation (AF) diagnosis is increasing. This chapter describes two representative patient cases that were used to enable a discussion of the evaluation and management of AF in different scenarios. One patient is young and healthy with paroxysmal AF but no major comorbidities (though there is a family history of AF). The other is older with multiple complicating comorbidities. These cases sparked an active discussion among the panelists that demonstrated not only the multitude of considerations when choosing the optimal therapy for each individual, but also the individualistic differences in biases and styles that can exist between experts in the field. The results of these discussions revealed agreement that.

Chapter 1: The Evolving Atrial Fibrillation Landscape: Importance of Early Diagnosis and Treatment.

Chapter 1 begins with data that show the rising prevalence of atrial fibrillation (AF), which is increasing in tandem with the growing number of older adults, increased survival of people who have cardiovascular (CV) disorders, and the expanding use of wearable and insertable/implantable devices capable of detection. Together, these increases will result in healthcare providers seeing more patients with AF who present at earlier stages of the disease. The panel discussion covers information regarding symptoms that are common to patients with AF as well as information about the important adverse outcomes that may occur in patients with AF, including heart failure, hospitalization, thromboembolism, and death. Notably, these events may reflect either the comorbidities commonly underlying AF, AF itself, or a combination of these conditions. The chapter also introduces the four pillars of therapy-"upstream therapy," rate control, rhythm control, and embolic prevention-with an emphasis on early rhythm control as being optimal. Chapter 1 is summarized as follows.

Chapter 2: Rate Versus Rhythm Control.

Atrial fibrillation (AF) is a potentially serious health risk, both because of its symptoms and because of its association with an increased risk for heart failure, hospitalization, thromboembolism, and death. Chapter 2 discusses selection of appropriate treatments and when to initiate these therapies. Older trials focused on comparing rate versus rhythm control treatment options for AF. It is now recognized that both rate and rhythm control are important and can be used together. This chapter reviews the historical, pivotal rate versus rhythm control trials that failed to show any overall survival benefit of rhythm over rate control, as well as the trials' now-recognized limitations with respect to modern therapy. In addition, an in-depth discussion of the more recent trials of antiarrhythmic drugs (AAD) and ablation techniques (which have become available since the original rate versus rhythm trials were performed) is included. These updated trials show that when applied to patient- and disease-specific situations, rhythm control can reduce the risk for mortality and hospitalization. The chapter also reviews the guidelines that have been developed to achieve these goals. Chapter 2 is summarized as follows: (1) Rate control is needed (at rest and during exertion) to reduce rate-related symptoms when rhythm control is ineffective or incomplete and to prevent a tachycardia-induced cardiomyopathy. (2) Previous trials with pharmacological therapy alone comparing rate versus rhythm control using the AADs available at that time failed to show any overall survival benefit of rhythm control over rate control. (3) These earlier trials had many methodological limitations and enrolled participants who did not have access to modern therapies. (4) Newer therapies, including those for stroke prevention, dronedarone (the latest approved AAD), and AF ablation, have improved the safety and efficacy of rhythm control strategies.

Device-detected atrial fibrillation in a large remote-monitored cohort: implications for anticoagulation and need for new pathways of service delivery.

BACKGROUND: Remote monitoring (RM) can facilitate early detection of subclinical and symptomatic atrial fibrillation (AF), providing an opportunity to evaluate the need for stroke prevention therapies. We aimed to characterize the burden of RM AF alerts and its impact on anticoagulation of patients with device-detected AF. METHODS: Consecutive patients with a cardiac implantable electronic device, at least one AF episode, undergoing RM were included and assigned an estimated minimum CHA2DS2-VASc score based on age and device type. RM was provided via automated software system, providing rapid alert processing by device specialists and systematic, recurrent prompts for anticoagulation. RESULTS: From 7651 individual, 389,188 AF episodes were identified, 3120 (40.8%) permanent pacemakers, 2260 (29.5%) implantable loop recorders (ILRs), 987 (12.9%) implantable cardioverter defibrillators, 968 (12.7%) cardiac resynchronization therapy (CRT) defibrillators, and 316 (4.1%) CRT pacemakers. ILRs transmitted 48.8% of all AF episodes. At twelve-months, 3404 (44.5%) AF < 6 min, 1367 (17.9%) 6 min-6 h, 1206 (15.8%) 6-24 h, and 1674 (21.9%) ≥ 24 h. A minimum CHA2DS2-VASc score of 2 was assigned to 1704 (63.1%) of the patients with an AF episode of ≥ 6 h, 531 (31.2%) who were not anticoagulated at 12-months, and 1031 (61.6%) patients with an AF episode duration of ≥ 24 h, 290 (28.1%) were not anticoagulated. CONCLUSIONS: Despite being intensively managed via RM software system incorporating cues for anticoagulation, a substantial proportion of patients with increased stroke risk remained unanticoagulated after a device-detected AF episode of significant duration. These data highlight the need for improved clinical response pathways and an integrated care approach to RM. TRIAL REGISTRATION: Australian New Zealand Clinical Trial Registry: ACTRN12620001232921.

COVID-19 and Cardiac Arrhythmias: a Contemporary Review.

Purpose of Review: A significant proportion of patients infected by the severe acute respiratory syndrome-coronavirus (SARS-CoV2) (COVID-19) also have disorders affecting the cardiac rhythm. In this review, we provide an in-depth review of the pathophysiological mechanisms underlying the associated arrhythmic complications of COVID-19 infection and provide pragmatic, evidence-based recommendations for the clinical management of these conditions. Recent Findings: Arrhythmic manifestations of COVID-19 include atrial arrhythmias such as atrial fibrillation or atrial flutter, sinus node dysfunction, atrioventricular conduction abnormalities, ventricular tachyarrhythmias, sudden cardiac arrest, and cardiovascular dysautonomias including the so-called long COVID syndrome. Various pathophysiological mechanisms have been implicated, such as direct viral invasion, hypoxemia, local and systemic inflammation, changes in ion channel physiology, immune activation, and autonomic dysregulation. The development of atrial or ventricular arrhythmias in hospitalized COVID-19 patients has been shown to portend a higher risk of in-hospital death. Summary: Arrhythmic complications from acute COVID-19 infection are commonly encountered in clinical practice, and COVID-19 patients with cardiac complications tend to have worse clinical outcomes than those without. Management of these arrhythmias should be based on published evidence-based guidelines, with special consideration of the acuity of COVID-19 infection, concomitant use of antimicrobial and anti-inflammatory drugs, and the transient nature of some rhythm disorders. Some manifestations, such as the long COVID syndrome, may lead to residual symptoms several months after acute infection. As the pandemic evolves with the discovery of new SARS-CoV2 variants, development and use of newer anti-viral and immuno-modulator drugs, and the increasing adoption of vaccination, clinicians must remain vigilant for other arrhythmic manifestations that may occur in association with this novel but potentially deadly disease.

Heart Rhythm Society Atrial Fibrillation Centers of Excellence Study: A survey analysis of stakeholder practices, needs, and barriers.

BACKGROUND: An integrated, coordinated, and patient-centered approach to atrial fibrillation (AF) care delivery may improve outcomes and reduce cost. OBJECTIVE: The purpose of this study was to gain a better understanding from key stakeholder groups on current practices, needs, and potential barriers to implementing optimal integrated AF care. METHODS: A series of comprehensive questionnaires were designed by the Heart Rhythm Society Atrial Fibrillation Centers of Excellence (CoE) Task Force to conduct surveys with physicians, advanced practice professionals, patients, and hospital administrators. Data collected focused on the following areas: access to care, stroke prevention, education, AF quality improvement, and AF CoE needs and barriers. Survey responses were collated and analyzed by the Task Force. RESULTS: The surveys identified 5 major unmet needs: (1) Standardized protocols, order sets, or care pathways in the emergency department or inpatient setting were uncommon (36%-42%). (2) All stakeholders agreed stroke prevention was a top priority; however, prior bleeding or risk of bleeding was the most frequent barrier for initiation. (3) Patients indicated that education on modifiable causes, AF-related complications, and lowering stroke risk is most important. (4) Less than half (43%) of the health care systems track patients with AF or treatment status. Patients reported that stroke and heart failure prevention and access to procedures were priority areas for an AF CoE. The most common barriers to implementing AF CoE identified by clinicians were administrative support (69%) and cost (52%); administrators reported physical space (43%). CONCLUSION: On the basis of the findings of this study, the Task Force identified high priority areas to develop initiatives to aid the implementation of AF CoE.

Physician antibiotic hydration preferences for biologic antibacterial envelopes during cardiac implantable device procedures.

Background: Cardiac implantable electronic device (CIED) infection is a potentially serious complication of CIED procedures. Infection risk mitigation includes using guideline-recommended pre-operative intravenous antibacterial prophylaxis (IV ABX). The use of antibiotic-eluting CIED envelopes has also been shown to reduce infection risk. The relationship between and potential benefits associated with guideline-recommended IV ABX in combination with antibacterial envelopes have not been characterized. Methods: Biologic envelopes made from non-crosslinked extracellular matrix (ECM) were implanted into 1,102 patients receiving CIEDs. The implanting physician decided patient selection for using a biologic envelope and envelope hydration solution. Observational data was analyzed on IV ABX utilization rates, antibacterial envelope usage, and infection outcomes. Results: Overall compliance with IV ABX was 96.6%, and most patients received a biologic envelope hydrated in antibiotics (77.1%). After a mean follow-up of 223 days, infection rates were higher for sites using IV ABX <80% of the time vs. sites using ≥80% (5.6% vs. 0.8%, p = 0.008). Physicians demonstrated preference for hydration solutions containing gentamicin in higher-risk patients, which was found by multivariate analysis to be associated with a threefold reduction in infection risk (OR 3.0, 95% CI, 1.0-10.0). Conclusion: These findings suggest that use of antibiotics, particularly gentamicin, in biologic envelope hydration solution may reduce infection risk, and use of antibacterial envelopes without adjunct IV ABX may not be sufficient to reduce CIED infections. Clinical trial registration: [https://clinicaltrials.gov/], identifier [NCT02530970].

Ending Gender Inequality in Cardiovascular Clinical Trial Leadership: JACC Review Topic of the Week.

Women are under-represented as leaders of cardiovascular randomized controlled trials, representing 1 in 10 lead authors of cardiovascular trials published in high-impact journals. Although the proportion of cardiovascular specialists who are women has increased in recent years, the proportion of cardiovascular clinical trialists who are women has not. This gap, underpinned by systemic sexism, has not been adequately addressed. The benefits of diverse randomized controlled trial leadership extend to patients and professionals. In this position statement, we present strategies adopted by some organizations to end gender inequality in research leadership. We offer an actionable roadmap for early-career researchers, scientists, academic institutions, professional societies, trial sponsors, and journals to follow, with the goal of harnessing the strength of women and under-represented groups as research leaders and facilitating a just culture in the cardiovascular clinical trial enterprise.