Background: An obesity-survival benefit, called the “obesity paradox,” has been variably reported in patients with heart failure (HF) and those with atrial fibrillation (AF), but inconsistencies have been observed. Objectives: The purpose of this study was to assess how the interaction between body mass index (BMI) and HF status impacts AF-related outcomes. Methods: Patients hospitalized for AF in the Get With The Guidelines-Atrial Fibrillation registry from 2013 to 2021 and linked to Medicare claims were included. Adjusted Cox proportional hazards models were used to assess the association between BMI and outcomes, stratified by HF status (no HF, HF with preserved ejection fraction, HF with mid-range ejection fraction, and HF with reduced ejection fraction). The outcomes were mortality, cardiovascular rehospitalization, thromboembolism, and myocardial infarction within 1 year. Results: In total, 21,850 patients (mean age 77 years, 42.3% male) were included: 29.5% underweight/normal (BMI<25 kg/m2), 32.0% overweight (BMI 25-29.9), and 38.5% obese (BMI ≥30). Increasing BMI was associated with lower mortality in patients without obesity and without HF (HR: 0.94 per 1 kg/m2 increase; 95% CI: 0.92 to 0.95), with HF with reduced ejection fraction (HR: 0.96; 0.93-0.99), and with HF with preserved ejection fraction/HF with mid-range ejection fraction (HR: 0.93; 0.92-0.95), while increases in BMI among patients with obesity were not associated with lower mortality (interaction P = 0.013). The risks of cardiovascular rehospitalization, thromboembolism, and myocardial infarction were not significantly different across the HF spectrum between patients with and without obesity (all interaction P > 0.05). Conclusions: Higher BMI was associated with increased survival in patients without obesity, irrespective of HF status, but not in patients with obesity and AF.

BACKGROUND:Increasingly, atrial fibrillation patients meet indications for rhythm control with catheter ablation and stroke prevention with left atrial appendage occlusion (LAAO). OBJECTIVE:To assess the frequency of both procedures and compare in-hospital safety of concomitant catheter ablation plus LAAO with cumulative patient-level risk across sequential procedures. METHODS:A retrospective analysis of Medicare fee-for-service beneficiaries with index LAAO (January 1, 2017-June 30, 2024) was conducted. Beneficiaries were classified as LAAO only, sequential ablation and LAAO (±6 months), or concomitant. Procedure utilization and in-hospital outcomes were evaluated. For the sequential cohort, events from both encounters were combined to reflect cumulative patient-level procedural risk. Inverse probability weighted logistic regression compared stroke, major bleeding, and complications between groups. RESULTS:Among 182,582 LAAO recipients, 20.9% underwent ablation during the study period; 7.7% ±6 months, including 1.5% concomitantly. Concomitant and sequential patients were clinically similar; LAAO-only patients were older with more comorbidities. After adjustment, in-hospital stroke and pericardial effusion did not differ. Major bleeding was approximately 50% lower with concomitant procedures (aOR 0.54, 95% CI, 0.42-0.69; p<0.01). Vascular complications were also lower (aOR 0.67, 95% CI, 0.47-0.94, p=0.02). CONCLUSIONS:Concomitant ablation and LAAO demonstrated comparable in-hospital stroke and pericardial effusion risk, but lower observed risks of bleeding and vascular complications compared with cumulative risk across sequential procedures, supporting single-session approach when clinically appropriate.

BACKGROUND:Care pathways for patients with atrial fibrillation (AF) are poorly understood and may influence the likelihood of guideline concordant oral anticoagulation or antiarrhythmic drug therapy and associated outcomes. METHODS:Adult patients in the Optum Clinformatics Database (2015-2023) with incident AF were identified. Care pathways, by treating clinician specialty (primary care, cardiology, electrophysiology) during each AF-related visit in the 1 year post diagnosis were examined. Cox regression models were used to assess associations between an electrophysiologist visit and AF-related treatments including antiarrhythmic drug therapy and oral anticoagulation and outcomes including AF-related hospitalizations, heart failure hospitalizations, and stroke. RESULTS:Of the 37 370 patients included, 7700 (20.6%) had a care pathway including an electrophysiologist visit. Older patients (70-79 and 80+ versus 18-49 years: hazard ratio [HR], 0.71 [95% CI, 0.64-0.78] and HR, 0.57 [95% CI, 0.51-0.63], respectively) and those with a higher CHA2DS2-VASc score (2-3 and ≥4 versus 0-1: HR, 0.79 [95% CI, 0.74-0.85] and HR, 0.76 [95% CI, 0.68-0.84], respectively) were less likely to have an electrophysiologist visit. Electrophysiologist visits were associated with a significant increase in rates of treatment with antiarrhythmic drug and oral anticoagulation. Patients aged ≥80 years with an electrophysiologist visit had significantly lower risks of stroke compared with those without an electrophysiologist visit (HR, 0.63 [95% CI, 0.42-0.95]). CONCLUSIONS:Certain demographic groups including older patients had lesser likelihood of electrophysiologist consultation, but guideline concordant care was more likely associated with electrophysiology care pathways. Electrophysiology care pathways were associated with improved outcomes especially among the groups with greatest stroke risk.

BACKGROUND AND AIMS:Pulsed field (PF) ablation is increasingly used to treat paroxysmal atrial fibrillation (PAF). FlexPulse (NCT06676072) was conducted to evaluate safety and effectiveness of a novel dual-energy, flexible-tip focal ablation catheter with radiofrequency and PF for treatment of symptomatic, drug-refractory PAF. METHODS:FlexPulse was a global, prospective, single arm, multicentre study. The ablation procedures targeted pulmonary vein isolation (PVI) and adjunctive ablation at operators' discretion. The primary safety endpoint was occurrence of pre-defined safety events within 7-days of any ablation procedure. The primary effectiveness endpoint was freedom from a composite of recurrent AF/atrial tachycardia/atrial flutter, repeat procedure, new use or escalation of class I/III AAD, and/or cardioversion through 12-months. RESULTS:Overall, 180 subjects underwent PAF ablation. Successful PVI was achieved in all participants. Additional non-PV ablations were performed in 37.2% (67/180) of subjects. The primary safety endpoint event rate was 1.7%. The primary effectiveness endpoint was 74.6% at 12-months, and freedom from documented AF/AFL/AT recurrence was 77.4% (92.6% without weekly transtelephonic monitoring). In 15 subjects who underwent repeat ablation after the blanking period, remapping indicated that 79.7% (47/59) of the PVs were durably isolated from the index procedures. Retrospective analysis found that workflows with PFA Index (PI) ≥30 and AutoMark distance up to 6 mm target had a 12-month freedom from AF/AFL/AT of 84.6%. CONCLUSIONS:In this trial, ablation with TactiFlex Duo in patients with symptomatic, drug-refractory PAF was safe and effective.

BACKGROUND AND AIMS:Stroke and systemic embolism are recognized but poorly characterized complications of atrial fibrillation (AF) and left atrial flutter (AFL) catheter ablation. Their incidence, outcomes, and procedural associations remain insufficiently defined. METHODS:Retrospective global registry was initiated by the European Heart Rhythm Association Scientific Committee. A secure database captured data from ablation centres worldwide on general AF and left AFL ablation activity, as well as detailed information on patients with symptomatic embolic events between 2017 and 2024. RESULTS:Overall, 204 centres reported 335 743 ablation procedures and 550 embolic events (incidence 0.16%). Centre-level rate ranged from 0% to 3.1%. Most events were cerebral (94%), followed by peripheral (5%), and combined (1%). Coronary air embolism accounted for 62% of all peripheral events. Intraprocedural events occurred in 93 patients (17%), within 72 h in 357 (78%) and beyond 72 h in 100 (22%); 128 cases (23%) were diagnosed after hospital discharge. Nonparoxysmal AF (0.23% vs 0.15%; P < .001), centre experience, and ablation energy source (radiofrequency, 0.16%; cryoballoon, 0.16%; pulsed field ablation, 0.25%; laserballoon, 0.88%; P < .001) were associated with embolic risk. Median NIHSS score after stroke was 4 (interquartile range, 2-9). Three-month follow-up was available for 518 patients with embolism (95%): 181 (35%) had sequelae and 16 (3%) died. CONCLUSIONS:Symptomatic embolic events are infrequent but associated with significant morbidity and mortality. Most events occur early, though a substantial proportion arise later. Higher event rates were observed with laser and possibly with pulsed field ablation. A greater centre experience was associated with a lower embolism incidence.

BACKGROUND:Atrial tachyarrhythmias frequently recur after surgical ablation and often require catheter ablation (CA). METHODS:We conducted a retrospective cohort study of patients who underwent CA for symptomatic atrial fibrillation or flutter (AF hereafter) following surgical ablation. Clinical data, including patient and surgical characteristics and results of electrophysiology testing and mapping, were recorded. Recurrence was defined as 30 s of AF, atrial flutter, or atrial tachycardia following a 3-month blanking period. RESULTS:Thirty-seven patients were included in the study (mean age 67.0 ± 9.8 years, 43% female) who underwent isolated surgical ablation (n = 5), concomitant mitral valve surgery (n = 21), aortic valve (n = 5), tricuspid valve surgery (n = 6), and/or coronary artery bypass grafting (n = 6). The mean time from surgical ablation to CA was 5.9 ± 5.1 years. Among the 37 patients, 19 (51%) experienced one or more pulmonary vein reconnections (mean 3.0 ± 1.3 veins per patient), and 15 (41%) developed mitral annular flutter. Following ablation, 12 (32%) patients developed recurrent arrhythmia by 1-year post-ablation. Age, sex, body mass index, time from surgical ablation to CA left ventricular ejection fraction < 50%, prior CA, left atrial diameter, and mitral annular flutter were not associated with recurrence. The number of pulmonary vein reconnections at the time of repeat CA was predictive of arrhythmia recurrence in subsequent follow-up (OR 2.148 [95% CI: 1.059-4.357]; p = 0.034). CONCLUSIONS:Pulmonary vein reconnection and mitral annular flutter are common recurrence mechanisms in patients with symptomatic arrhythmia recurrence following surgical ablation. The number of pulmonary vein reconnections predicts recurrent arrhythmia.

BACKGROUND:Guidelines recommend a trial of antiarrhythmic drugs before catheter ablation for persistent atrial fibrillation. Whether pulsed field ablation (PFA) may be a preferred initial treatment is unclear. METHODS:We conducted an international, randomized trial involving patients with previously untreated persistent atrial fibrillation. The patients were randomly assigned in a 2:1 ratio to receive PFA performed with a pentaspline catheter or to receive antiarrhythmic-drug therapy. An additional group of patients (PFA-assigned) underwent PFA for the analysis of the primary safety end point alone. All the patients received an insertable cardiac monitor. The primary effectiveness end point was the short-term and long-term success of treatment through 12 months. Short-term success was defined as procedural success in the PFA group and the absence of ablation during the blanking period (90 days after treatment initiation) in the antiarrhythmic-drug group. Long-term success was defined as freedom from recurrence of atrial arrhythmias, repeat ablation, or need for antiarrhythmic drugs from 90 days through 12 months (in the PFA group) and freedom from amiodarone use at any time. The primary safety end point was device- and procedure-related serious adverse events. RESULTS:At 12 months, treatment success was observed in 128 of 207 patients (Kaplan-Meier estimate, 56%; 95% confidence interval [CI], 48 to 63) in the PFA group and in 40 of 103 patients (Kaplan-Meier estimate, 30%; 95% CI, 21 to 40) in the antiarrhythmic-drug group (hazard ratio for composite treatment failure [a lack of short- and long-term success], 0.46; 95% CI, 0.33 to 0.65; P<0.001). A primary safety end-point event occurred in 13 of 257 patients (5.1%) in the combined PFA group (both randomized and PFA-assigned groups). At 12 months, serious adverse events had occurred in 45 patients (25%) in the PFA group and in 20 patients (21%) in the antiarrhythmic-drug group. CONCLUSIONS:Among patients with persistent atrial fibrillation, the risk of recurrence of atrial arrhythmia was significantly lower among those who received PFA as first-line treatment than among those who received antiarrhythmic-drug therapy. (Funded by Boston Scientific; AVANT GUARD ClinicalTrials.gov number, NCT06096337.).

BACKGROUND:Despite the use of atrial fibrillation (AF) cutoff of 30s as the standard for success in most AF clinical trials, patients consider an AF Severity Scale (AFSS) of ≤ 5 or AF duration ≤ 1 hour as treatment success. Prevalence and factors associated with these patient-defined endpoints are unknown. METHODS:We performed a cross-sectional analysis using a single-site cohort of AF patients. We report rates of patient-defined treatment success (AFSS ≤ 5 or AF burden ≤ 1 hour) and multivariable analyses to identify factors associated with either successful outcome. RESULTS:From 2019 to 2023, 2087 patients had available AFSS symptom scores and 2305 had ambulatory ECG monitoring. Of these, 862 (41%) had AFSS scores ≤5 and 1130 (49%) had AF burden ≤1 hour. After adjusted analysis, older age (OR 1.03, 95% CI 1.02-1.04, p <0.001) was associated with AFSS ≤5. Whereas female sex (OR 0.43, 95% CI 0.35-0.52, p <0.001), CKD, COPD, depression, and CHF were less likely to meet AFSS threshold. Among the AF burden cohort, age (OR 0.98, 95% CI 0.97-0.99, p <0.001), and female sex (OR 1.24, 95% CI 1.03-1.50, p=0.025) were associated with AF burden ≤ 1 hour. Unlike the AFSS cohort, medical comorbidities such as COPD and CHF, were not significantly different for meeting AF burden goal. CONCLUSION:Less than half of AF patients had AF-symptom scores or arrhythmia burdens reflecting patient-defined treatment success. Factors associated with reaching patient reported outcome goals were distinct from those associated with arrhythmia burden goals.

BACKGROUND:The safety and effectiveness of concomitant catheter ablation at the time of left atrial appendage (LAA) occlusion (LAAO) are not well characterized. OBJECTIVE:This study aimed to describe the safety and effectiveness of LAAO during concomitant ablation of atrial fibrillation (AF) with LAAO performed as a stand-alone procedure. METHODS:Patients from the Surveillance Postapproval Analysis Plan who underwent concomitant ablation and LAAO were compared with patients who underwent LAAO alone. The primary effectiveness end point was complete seal of the LAA, and the primary safety end point was the occurrence of major adverse events at 45 days. RESULTS:Among 96,968 patients, 1.9% (n = 1844) underwent concomitant ablation; these patients were younger (median 73 [quartile 1, quartile 3 68-78] vs 76 [72-82] years) and had lower CHA2DS2-VASc scores (4 [3-5] vs 5 [4-6]), previous clinically relevant bleeding (32.4% vs 56.6%), or fall risk (30.2% vs 42.2%). The most common discharge drug therapy in the concomitant AF ablation group was direct-acting oral anticoagulant plus aspirin (56.2%), followed by direct-acting oral anticoagulant alone (30.0%). Immediately after implant, patients undergoing concomitant ablation had lower rates of any residual leak (1.6% vs 3.7%; P < .001); no difference was seen at 45 days (15.7% vs 16.9%; P = .29). In-hospital major adverse events were more frequent in those undergoing LAAO with concomitant ablation than LAAO without ablation (1.9% vs 1.2%; P = .0111). In-hospital major bleeding (1.6% vs 1.0%; P = .0073) and pericardial effusion requiring intervention (0.8% vs 0.4%; P = .0108) were more frequent with combined LAAO and AF ablation. At 1 year after the procedure, the composite of all-cause mortality, stroke, or systemic embolism was less frequent in those undergoing LAAO with concomitant ablation (5.2% vs 9.3%; P < .0001). CONCLUSION:Patients undergoing concomitant AF ablation at the time of LAAO are younger and have fewer comorbidities. There was no clinically important difference in LAA seal peridevice leaks with concomitant LAAO; however, there was a higher rate of major bleeding and pericardial effusion requiring intervention.

BACKGROUND:Atrial fibrillation (AF) can lead to significant cardiovascular events and health care utilization. Continuous monitoring via insertable cardiac monitors (ICMs) and data analytics have the potential to improve care delivery. OBJECTIVE:The DEFINE Atrial Fibrillation (DEFINE AFib) study was designed to develop and evaluate novel algorithms using ICM data to predict AF-associated clinical actions (AFCAs) and guide AF management. METHODS:DEFINE AFib enrolled patients with an ICM (Reveal LINQ/LINQ II; Medtronic) and a history of AF. An Apple iPhone application collected AF-related quality of life (AFEQT) and EQ-5D data. ICM daily AF burden and Apple Watch (AW) irregular rhythm notification (IRN) data were also collected. AFCA was defined as an AF-related procedure or initiation of rate/rhythm control medication. Mutivariable logistic regression was used to identify ICM features in the last 30 days associated with first occurrence of AFCA in the next 30 days in a train and test approach (70%/30%). RESULTS:Among 864 patients (mean 69 ± 10 years; 56% male) meeting inclusion criteria, there were 8963 30-day evaluation windows that included 151 AFCAs. Area under the receiver operating characteristic curve (AUC) was 76% (train) and 70% (test). The model placed participants into high- vs low-risk AFCA groups. At the patient-level, 21% of participants crossing the high-risk threshold for their first time experienced an AFCA at a mean time of 195 ± 164 days compared with 5% in the low-risk group (AUC 65%). Increasing daily mean AF burden was associated with lower quality of life: <6 minutes (reference), 6 minutes to 5.5 hours (AFEQT -7.69; P < .001), and 5.5-12 hours (AFETQ -13.97, P < .001; ≥5.5 hours EQ-5D -0.03, P = .007). In a subanalysis of individuals with smart watch data (n = 53), the ICM model signaled high risk before AFCAs 85% of the time (AUC 57%) compared with 23% for AW IRN (P = .005; AUC 55%). CONCLUSION:DEFINE AFib transformed ICM diagnostic data to predict risk of AFCA with good discrimination, particularly compared with wearable data. These results highlight the potential advantages of ICM-based continuous monitoring for AF management and the utility of ICM prediction models that could help inform pre-emptive therapeutic strategies.

BACKGROUND:Prior analyses of trials comparing direct oral anticoagulants (DOACs) to warfarin in atrial fibrillation (AF) have not routinely incorporated patient preferences, despite substantial variation in how patients value the trade-off between outcomes such as stroke and bleeding. By applying patient-centered approaches, we aimed to provide intuitive metrics to inform shared decision-making, particularly for frail older adults for whom DOAC benefit remains controversial. METHODS:Individual-level data from 58,634 participants in four randomized controlled trials (RCTs) comparing DOACs to warfarin (A Collaboration Between Multiple Institutions to Better Investigate Non-Vitamin K Antagonist Oral Anticoagulant Use in Atrial Fibrillation; COMBINE-AF) were analyzed using two patient-centered methods. Seven clinical outcomes (death, disabling stroke, major bleeding, moderate-severity stroke, systemic embolism, clinically relevant non-major bleeding, and minor stroke) were weighted based on a prior 1028-patient preference study with all values scaled relative to death. For the weighted composite endpoint (WCE), a survival-based approach incorporated weights of initial and recurrent events to estimate event-free survival. For win statistics, outcomes were hierarchically ranked for pairwise comparisons. The primary estimand was the 2-year difference in weighted death-equivalent events per 100 patients for the WCE. The win ratio was a secondary estimand. A prespecified subgroup analysis was conducted in frail, older patients. RESULTS:In the overall cohort, compared to warfarin, DOACs were associated with a more favorable outcome (WCE: 11.74 vs. 12.85 events per 100 patients; difference, -1.11 [95% confidence interval (CI): -1.61 to -0.61]; P<0.001; win ratio 1.11 [95% CI: 1.07 to 1.15]). In the prespecified subgroup of 5913 frail participants, the difference in the WCE was +0.50 events [95% CI: -1.39 to 2.40]) with a win ratio of 0.99 [95% CI: 0.90 to 1.08]) in individuals treated with DOAC versus warfarin. CONCLUSIONS:In individuals with atrial fibrillation pooled from four RCTs, DOACs were associated with a favorable net clinical benefit compared to warfarin when evaluated using a patient-weighted composite clinical outcome. (Funded by a Fellows Supplemental Funding grant from the Duke Clinical Research Institute's Executive Director Pathway Committee.).

Background Early rhythm control improves cardiovascular outcomes in recently diagnosed atrial fibrillation (AF) patients. Whether care pathways are a tool to improve translation into clinical practice needs evaluation. Objective The Centers of Excellence Optimal Management Pathways for Atrial Fibrillation Specialty Services (COMPASS) Early Rhythm Control Treatment Care Pathway program aims to assess the utility of care pathways to increase initiation of early rhythm control, establish specialty care (cardiology/electrophysiology), and improve stroke prevention. Methods This multicenter, pre-post study of recently diagnosed patients with AF (within 12 months) was conducted at 3 different health systems (Duke University Medical Center, Cedars-Sinai Medical Center, and Texas Cardiac Arrhythmia Institute). Each center, using a set of common core elements, tailored an intervention for an Early Rhythm Control Treatment Care Pathway. Patients with AF were identified using electronic health records (EHRs) and historical control groups were defined in the year before the COMPASS program interventions. The interventions were care pathways and EHR-based protocols for AF management to coincide with a rapid access AF clinic/patient education/provider education (Duke University Medical Center), EHR-based passive best practice alert/patient education/provider education (Cedars-Sinai Medical Center), and patient/provider education (Texas Cardiac Arrhythmia Institute). Each patient had 6 months of follow-up. The primary outcome was the change in the rate of early rhythm control (antiarrhythmic drugs or catheter ablation). Secondary outcomes were changes in specialty care access (cardiology or electrophysiology visits) and guideline-concordant oral anticoagulation use. Conclusion This study will provide information on the effectiveness of care pathways to improve the quality of care for patients recently diagnosed with AF.

The TAILORED-AF trial used artificial intelligence (AI)-guided mapping to enhance catheter ablation in persistent atrial fibrillation and demonstrated reductions in recurrent atrial fibrillation, but the net clinical benefit remains unclear.