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Background: There have been limited data examining the temporal relationship between device-derived daily activity and ventricular arrhythmias (VAs). Objective: We aimed to assess whether activity predicted VAs or VAs predicted changes in activity. Methods: The CERTITUDE registry includes over 55,000 implanted devices active on Home Monitoring. Daily data on activity are captured by a 1-axis accelerometer. Temporal changes in activity during treated VAs were analyzed using the first event and 7-day activity windows (baseline, pre-event, and postevent). Baseline period was defined as 31 to 38 days prior to VA. VAs were categorized by heart rate (≤200 beats/min, >200 beats/min) and treatment (shock or antitachycardia pacing). Differences were assessed using the binomial proportion test and case-crossover analysis. Results: A total of 5631 devices (3688 implantable cardioverter-defibrillators, 1943 cardiac resynchronization therapy defibrillators) were analyzed with a cumulative follow-up duration of 18,354 years (5.6 million days). Patients with VA events >200 beats/min with shock (n = 593) had a significant decline in activity post-VA with a median –8.7% reduction (interquartile range –24.6% to 7.3%, P < 0.001). However, there was no reduction in activity before VA events >200 beats/min (P = .690) or before or after VA events >200 beats/min with antitachycardia pacing. However, VA events ≤200 beats/min with shock had reductions in activity following the event (–5.8%, interquartile range –29.5% to 12.3%, P = .003). Case-crossover analyses confirmed lower activity rates following for VA events >200 beats/min with shock. Conclusion: In the CERTITUDE registry, we have shown a temporal decline in device-derived activity following VA events >200 beats/min and for VA events

Background: Despite clear associations between arrhythmia burden and cardiovascular risk, clinical risk scores that predict cardiovascular events do not incorporate individual-level arrhythmia characteristics from long-term continuous monitoring (LTCM). Objectives: This study evaluated the performance of risk models that use data from LTCM and patient claims for prediction of heart failure (HF) and ischemic stroke. Methods: We retrospectively analyzed features extracted from up to 14 days of LTCM electrocardiogram (ECG) data linked to patient-level claims data for 320,974 Medicare beneficiaries who underwent ZioXT ambulatory monitoring. We created predictive models for HF hospitalization, stroke hospitalization, and new-onset HF within 1 year using LASSO Cox regression for variable selection among ambulatory ECG variables and components of the CHA2DS2-VASc score. Results: A model that included components of the CHA2DS2-VASc and all ambulatory ECG variables had greater discrimination for HF hospitalization (C-statistic 0.85, 95% CI: 0.84-0.86) than the CHA2DS2-VASc (C-statistic 0.73, 95% CI: 0.72-0.74), but performed similarly to the CHA2DS2-VASc for prediction of stroke hospitalization (C-statistic 0.75 [95% CI: 0.74-0.77] vs 0.71 [95% CI: 0.70-0.72], respectively). Atrial fibrillation was associated with greater risk in the most predictive models (HF hospitalization, HR: 1.53 [95% CI: 1.35-1.72]; stroke hospitalization, HR: 1.58 [95% CI: 1.30-1.93]), and premature ventricular couplets were associated with greater risk of HF hospitalization (HR: 1.54, 95% CI: 1.43-1.65). Conclusions: The CHA2DS2-VASc performed modestly for prediction of stroke and HF events; predictive ability improved significantly with addition of LTCM ECG covariates. The presence of atrial fibrillation and ventricular ectopy on 14-day LTCM were strongly associated with HF events.

Background Shock‐reduction implantable cardioverter‐defibrillator programming (SRP) was associated with fewer therapies and improved survival in randomized controlled trials, but real‐world studies investigating SRP and associated outcomes are limited. Methods and Results The BIOTRONIK CERTITUDE registry was linked with the Medicare database. We included all patients with an implantable cardioverter‐defibrillator implanted between August 22, 2012 and September 30, 2021 in the United States. SRP was defined as programming to either a therapy rate cutoff ≥188 beats per minute or number of intervals to detection ≥30/40 for treatment. Among 6781 patients (mean 74±9 years; 27% women), 3393 (50%) had SRP. Older age, secondary prevention indication, and device implantation in the southern or western United States were associated with lower use of SRP. The cumulative incidence rate of implantable cardioverter‐defibrillator shocks was lower in the SRP group (5.1% shocks/patient year) compared with the non‐SRP group (7.2% shocks/patient year) (adjusted hazard ratio [HR], 0.83 [95% CI, 0.73–0.96]; P=0.005). Over a median follow‐up of 2.9 years, 739 deaths occurred in the SRP group and 822 deaths occurred in the non‐SRP group (adjusted HR, 0.97 [95% CI, 0.88–1.07]; P=0.569). SRP was associated with a lower all‐cause mortality among patients without ischemic heart disease compared with patients with ischemic heart disease (adjusted HR, 0.64 [95% CI, 0.48–0.87] versus adjusted HR, 1.02 [95% CI, 0.92–1.14]; Pinteraction=0.004). Conclusions Adoption of SRP is low in real‐world clinical practice. Age, clinical variables, and geographic factors are associated with use of SRP. In this study, SRP‐associated decrease in mortality was limited to patients without ischemic heart disease.

Background Days alive out of hospital (DAOH) is an objective and patient‐centered net benefit end point. There are no assessments of DAOH in clinical trials of interventions for atrial fibrillation (AF), and it is not known whether this end point is of clinical utility in these populations. Methods and Results ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) was an international double‐blind, double‐dummy randomized clinical trial that compared rivaroxaban with warfarin in patients with atrial fibrillation at increased risk for stroke. We assessed DAOH using investigator‐reported event data for up to 12 months after randomization in ROCKET AF. We assessed DAOH overall, by treatment group, and by subgroup, including age, sex, and comorbidities, using Poisson regression. The mean±SD number of days dead was 7.3±41.2, days hospitalized was 1.2±7.2, and mean DAOH was 350.7±56.2, with notable left skew. Patients with comorbidities had fewer DAOH overall. There were no differences in DAOH by treatment arm, with mean DAOH of 350.6±56.5 for those randomized to rivaroxaban and 350.7±55.8 for those randomized to warfarin (P=0.86). A sensitivity analysis found no difference in DAOH not disabled with rivaroxaban versus warfarin (DAOH not disabled, 349.2±59.5 days and 349.1 days±59.3 days, respectively, P=0.88). Conclusions DAOH did not identify a treatment difference between patients randomized to rivaroxaban versus warfarin. This may be driven in part by the low overall event rates in atrial fibrillation anticoagulation trials, which leads to substantial left skew in measures of DAOH.

Background Obstructive sleep apnea (OSA) contributes to the generation, recurrence, and perpetuation of atrial fibrillation, and it is associated with worse outcomes. Little is known about the economic impact of OSA therapy in atrial fibrillation. This retrospective cohort study assessed the impact of positive airway pressure (PAP) therapy adherence on health care resource use and costs in patients with OSA and atrial fibrillation. Methods and Results Insurance claims data for ≥1 year before sleep testing and 2 years after device setup were linked with objective PAP therapy use data. PAP adherence was defined from an extension of the US Medicare 90‐day definition. Inverse probability of treatment weighting was used to create covariate‐balanced PAP adherence groups to mitigate confounding. Of 5867 patients (32% women; mean age, 62.7 years), 41% were adherent, 38% were intermediate, and 21% were nonadherent. Mean±SD number of all‐cause emergency department visits (0.61±1.21 versus 0.77±1.55 [P=0.023] versus 0.95±1.90 [P

Abstract Background Traditional risk scores for recurrent atrial fibrillation (AF) following catheter ablation utilize readily available clinical and echocardiographic variables and yet have limited discriminatory capacity. Use of data from cardiac imaging and deep learning may help improve accuracy and prediction of recurrent AF after ablation. Methods We evaluated patients with symptomatic, drug‐refractory AF undergoing catheter ablation. All patients underwent pre‐ablation cardiac computed tomography (cCT). LAVi was computed using a deep‐learning algorithm. In a two‐step analysis, random survival forest (RSF) was used to generate prognostic models with variables of highest importance, followed by Cox proportional hazard regression analysis of the selected variables. Events of interest included early and late recurrence. Results Among 653 patients undergoing AF ablation, the most important factors associated with late recurrence by RSF analysis at 24 (+/−18) months follow‐up included LAVi and early recurrence. In total, 5 covariates were identified as independent predictors of late recurrence: LAVi (HR per mL/m2 1.01 [1.01–1.02]; p 66.7 mL/m2 and early recurrence had the highest risk of late recurrence risk compared with those with LAVi

Background: High-power, short-duration (HPSD) radiofrequency ablation (RFA) may reduce ablation time. Concerns that catheter-mounted thermocouples (TCs) can underestimate tissue temperature, resulting in elevated risk of steam pop formation, potentially limit widespread adoption of HPSD ablation. Objective: The purpose of this study was to compare the safety and efficacy of HPSD and low-power, long-duration (LPLD) RFA in the context of pulmonary vein isolation (PVI). Methods: An open-irrigated ablation catheter with a contact force sensor and a flexible-tip electrode containing a TC at its distal end (TactiFlexTM Ablation Catheter, Sensor EnabledTM, Abbott) was used to isolate the left pulmonary veins (PVs) in 12 canines with HPSD RFA (50 W for 10 seconds) and LPLD RFA (30 W for a maximum of 60 seconds). PVI was assessed at 30 minutes and 28 ± 3 days postablation. Computed tomographic scans were performed to assess PV stenosis after RFA. Lesions were evaluated with histopathology. Results: A total of 545 ablations were delivered: 252 with LPLD (0 steam pops) and 293 with HPSD RFA (2 steam pops) (P = .501). Ablation time required to achieve PVI was >3-fold shorter for HPSD than for LPLD RFA (P = .001). All 24 PVs were isolated 30 minutes after ablation, with 12/12 LPLD-ablated and 11/12 HPSD-ablated PVs still isolated at follow-up. Histopathology revealed transmural ablations for HPSD and LPLD RFA. No major adverse events occurred. Conclusion: An investigational ablation catheter effectively delivered RFA lesions. Ablation time required to achieve PVI with HPSD with this catheter was >3-fold shorter than with LPLD RFA.

Background Nonvitamin K oral anticoagulants require dose adjustment based on kidney function.The most common estimate of kidney function employed in clinical practice is estimated glomerular filtration rate (eGFR); however, product monographs recommend the use of the Cockcroft‐Gault estimated creatinine clearance (eCrCl) for dose adjustment. Methods and Results The authors included patients enrolled in the ORBIT‐AF II (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation AF II) trial. Dosing was considered inappropriate when use of eGFR resulted in a lower (undertreatment) or higher (overtreatment) dose than that recommended by the eCrCl. The primary outcome of major adverse cardiovascular and neurological events was a composite of cardiovascular death, stroke or systemic embolism, new‐onset heart failure, and myocardial infarction. Among 8727 in the overall cohort, agreement between eCrCl and eGFR was observed in 93.5% to 93.8% of patients. Among 2184 patients with chronic kidney disease (CKD), the agreement between eCrCl and eGFR was 79.9% to 80.7%. Dosing misclassification was more frequent in the CKD population (41.9% of rivaroxaban users, 5.7% of dabigatran users, and 4.6% apixaban users). At 1 year, undertreated patients in the CKD group had significantly greater major adverse cardiovascular and neurological events (adjusted hazard ratio, 2.93 [95% CI, 1.08–7.92]) compared with the group with appropriate nonvitamin K oral anticoagulants dosing (P=0.03). Conclusions The prevalence of misclassification of nonvitamin K oral anticoagulants dosing was high when using eGFR, particularly among patients with CKD. Among patients with CKD, potential undertreatment due to inappropriate and off‐label renal formulae may result in worse clinical outcomes. These findings highlight the importance of using eCrCl, and not eGFR, for dose adjustment in all patients with AF receiving nonvitamin K oral anticoagulants.

Background: Insulin use may be a better predictor of stroke risk and morbidity and mortality than diabetes in patients with atrial fibrillation (AF). Objectives: Determine if the increased risk of stroke observed in patients with AF and diabetes is restricted to those treated with insulin. Methods: We analyzed the association between diabetes and treatment and the occurrence of stroke/systemic embolism, myocardial infarction (MI), all-cause death, vascular death, composite outcomes, and bleeding risk in the ROCKET AF trial. Results: In a cohort of 14,264 patients, there were 40.3% (n = 5746) with diabetes, 5.9% (n = 842) on insulin, 18.9% (n = 2697) on oral medications, and 11.9% (n = 1703) diet-controlled. Compared to those without diabetes, patients with non–insulin-treated diabetes had increased risks of stroke (hazard ratio [HR] 1.33, 95% confidence interval [CI] 1.06–1.68), MI (HR 1.64, 95% CI 1.17–2.30), all-cause death (HR 1.26, 95% CI 1.08–1.46), vascular death (HR 1.33, 95% CI 1.11–1.60), and composite outcomes (HR 1.37, 95% CI 1.18–1.157). Patients with insulin-treated diabetes had a significantly higher risk of MI (HR 2.31, 95% CI 1.33–4.01) and composite outcomes (HR 1.57, 95% CI 1.19–2.08) compared to those without diabetes. There were no significant differences between insulin-treated and non–insulin-treated diabetes for any outcome. Conclusion: Among patients with AF and diabetes, there were no significant differences in outcomes in insulin-treated diabetes compared to non–insulin-treated diabetes.

This collaborative statement from the International Society for Holter and Noninvasive Electrocardiology/Heart Rhythm Society/European Heart Rhythm Association/Asia Pacific Heart Rhythm Society describes the current status of mobile health (''mHealth'') technologies in arrhythmia management. The range of digital medical tools and heart rhythm disorders that they may be applied to and clinical decisions that may be enabled are discussed. The facilitation of comorbidity and lifestyle management (increasingly recognized to play a role in heart rhythm disorders) and patient self-management are novel aspects of mHealth. The promises of predictive analytics but also operational challenges in embedding mHealth into routine clinical care are explored.

Background: Ablation reduces atrial fibrillation (AF) burden and improves health-related quality of life. The relationship between ablation, healthcare utilization, and AF type (paroxysmal AF [PAF] vs persistent AF [PsAF]) remains unclear. Objective: To compare changes in AF-related healthcare utilization and costs from preablation to postablation among patients with PAF and PsAF. Methods: Patients (2794 PAF, 1909 PsAF) undergoing ablation (2016–2018) were identified using the Optum database. Outcomes included inpatient admissions, emergency department (ED) visits, office visits, cardioversion, and antiarrhythmic drug (AAD) use. Costs (2018 US$) and outcomes were compared for the year before/after ablation using the McNemar test and Wilcoxon signed rank test. Results: Compared to PAF patients, PsAF patients were older (68.6 ± 9.0 years vs 67.4 ± 9.9 years, P < .0001), were less commonly female (36.3% vs 44.1%, P < .0001), and more commonly had a CHA2DS2-VASc ≥ 3(71.2% vs 62.7%, P < .0001). The 12-month postablation costs were lower for AF-specific inpatient admissions (PAF -28%, PsAF -33%), ED visits (PAF -76%, PsAF -70%), AAD prescription fills (PAF -25%, PsAF -7%), and cardioversions (PAF -59%, PsAF -55%) as compared to 12 months before ablation. Although these reductions were observed for both PAF and PsAF patients, absolute costs remained higher for PsAF. Total AF costs were higher during the 1 year after ablation vs before ablation (PAF: 11%, P < .0001; PsAF: 10%, P < .0001) owing to repeat ablation. However, in the 18-month follow-up analysis, postablation costs were overall reduced (PAF: 35%, P < .0001; PsAF: 34%, P < .0001), despite including costs from repeat ablation. Conclusion: Significant reductions in healthcare utilization and costs were observed among PAF and PsAF patients undergoing ablation. These data suggest a strategy of earlier ablation may reduce long-term healthcare utilization and costs.

Background: Diabetes mellitus (DM) is an independent risk factor for atrial fibrillation (AF). Few studies have compared clinical outcomes after catheter ablation between patients with and those without DM. Objective: The purpose of this study was to compare AF ablation outcomes in patients with and those without DM. Methods: We performed a retrospective analysis of 351 consecutive patients who underwent first-time AF ablation. Clinical outcomes included freedom from recurrent atrial arrhythmia, symptom burden (Mayo AF Symptom Inventory score), cardiovascular and all-cause hospitalizations, and periprocedural complications. Results: Patients with DM (n = 65) were older, had a higher body mass index, more persistent AF, more hypertension, and larger left atrial diameter (P

Background: Although there are considerable data on the safety of cryoablation, data on the rare but severe complication of atrioesophageal fistula (AEF) following cryoballoon ablation are limited. Objective: To report the global, user-reported incidence of AEF associated with cryoballoon ablation for the treatment of atrial fibrillation using Medtronic’s complaint database. Methods: User-reported cryoballoon ablation complications occurring between July 1, 2009, and March 31, 2019, were reviewed to identify cases of AEF. A global event rate of AEF was calculated by dividing the event count by total catheter utilization over the same period. Data on symptoms and patient sequalae were reported as available. Results: More than 500,000 Arctic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, Arctic Front Advance ST, and Arctic Front Advance Pro; Medtronic, Inc) were distributed globally during the 9.75-year study period. During this time, 18 confirmed AEF, 1 suspected AEF, and 1 pericardial esophageal fistula were identified; therefore, global incidence of AEF associated with the Arctic Front family of ablation catheters was 0.00396%. Patients most commonly presented with fever (88.2%), and initial symptoms were reported a median of 21 (interquartile range: 4–30) days after the ablation. Although rare, the development of an AEF resulted in death in 68.8% (11/16) of patients with known outcomes. Conclusions: AEF is a possible but rare complication of cryoballoon ablation with a reported frequency of 1 in every 25,000 patients treated. Awareness of the prevalence and manifestation of AEF associated with cryoballoon ablation is critical for early identification and treatment of this complication.

Abstract Background Focal impulse and rotor modulation (FIRM) can cause slowing, organization, and occasionally termination of atrial fibrillation (AF), although results have been mixed. To further characterize changes in AF during rotor ablation, we quantified morphologic and temporal activation changes following FIRM. Methods In patients undergoing FIRM ablation for AF, we retrospectively analyzed coronary sinus bipolar EGMs before and after rotor ablation, including EGM activation frequency and regularity, dominant frequency (DF), and organizational index (OI). Changes in EGM waveform morphology were determined with recurrence quantification analysis (RQA) consisting of recurrence rate (RR), determinism (DET), laminarity (LAM), average diagonal line length (L), and trapping time (TT) using Wilcoxon signed‐rank testing. Results Overall, 36 rotors from 21 patients undergoing FIRM ablation were analyzed. All morphology RQA parameters demonstrated significant organization of atrial activation after rotor ablation (RR P = .03, DET P = .005, LAM P = .03, L P = .005, TT P = .009). The organizational index also showed a significant increase after rotor ablation (P = .01), and the change in OI correlated with changes in all morphology parameters. Of the rotors, 14/36 (39%) rotors showed organizational changes in all morphology parameters and OI, and an additional 5 rotors (19/36, 53%) showed organizational changes in 4 of 5 morphology parameters and OI. Conclusions Coronary sinus EGM waveform morphologies and activation patterns are significantly altered after FIRM ablation even when there is no fibrillatory slowing. RQA morphology analysis and organizational index may impart important information regarding underlying AF organization and may be useful in quantifying the acute response to ablation.

Abstract Background Catheter ablation is an important rhythm control therapy in patients with atrial fibrillation (AF) with concomitant heart failure (HF). The objective of this study was to assess the comparative efficacy of AF ablation patients with ischemic vs nonischemic heart failure. Methods We conducted a retrospective, observational cohort study of patients with HF who underwent AF ablation. Outcomes were compared based on HF etiology and included in‐hospital events, symptoms (Mayo AF Symptom Inventory [MAFSI]), and functional status (New York Heart Association class) and freedom from atrial arrhythmias at 12 months. Results Among 242 patients (n = 70 [29%] ischemic, n = 172 [71%] nonischemic), patients with nonischemic cardiomyopathy were younger (mean age 64 ± 11.5 vs 69 ± 9.1, P = .002), more often female (36% vs 17%, P = .004), and had higher mean left‐ventricular ejection fraction (47% vs 42%, P = .0007). There were no significant differences in periprocedural characteristics, including mean procedure time (243 ± 74.2 vs 259 ± 81.8 minutes, P = .1) and nonleft atrial ablation (17% vs 20%, P = .6). All‐cause adverse events were similar in each group (15% vs 17%, P = .7). NYHA and MAFSI scores improved significantly at follow‐up and did not differ according to HF etiology (P = .5; P = .10‐1.00 after Bonferroni correction). There were no significant differences in freedom from recurrent atrial arrhythmia at 12‐months between ischemic (74%) and nonischemic patients (78%): adjusted RR 0.63, 95% confidence interval 0.33‐1.19. Conclusions Catheter ablation in patients with AF and concomitant heart failure leads to significant improvements in functional and symptom status without significant differences between patients with ischemic vs nonischemic HF etiology.

Background Guideline recommendations are the accepted reference for selection of therapies for rhythm control of atrial fibrillation (AF). This study was designed to understand physicians’ treatment practices and adherence to guidelines. Methods and Results The AIM‐AF (Antiarrhythmic Medication for Atrial Fibrillation) study was an online survey of clinical cardiologists and electrophysiologists that was conducted in the United States and Europe (N=629). Respondents actively treated ≥30 patients with AF who received drug therapy, and had received or were referred for ablation every 3 months. The survey comprised 96 questions on physician demographics, AF types, and treatment practices. Overall, 54% of respondents considered guidelines to be the most important nonpatient factor influencing treatment choice. Across most queried comorbidities, amiodarone was selected by 60% to 80% of respondents. Other nonadherent usage included sotalol by 21% in patients with renal impairment; dofetilide initiation (16%, United States only) outside of hospital; class Ic agents by 6% in coronary artery disease; and dronedarone by 8% in patients with heart failure with reduced ejection fraction. Additionally, rhythm control strategies were frequently chosen in asymptomatic AF (antiarrhythmic drugs [AADs], 35%; ablation, 8%) and subclinical AF (AADs, 38%; ablation, 13%). Despite guideline algorithms emphasizing safety first, efficacy (48%) was selected as the most important consideration for AAD choice, followed by safety (34%). Conclusions Despite surveyed clinicians recognizing the importance of guidelines, nonadherence was frequently observed. While deviation may be reasonable in selected patients, in general, nonadherence has the potential to compromise patient safety. These findings highlight an underappreciation of the safe use of AADs, emphasizing the need for interventions to support optimal AAD selection.

Background One‐quarter of all strokes are subsequent events. It is not known whether higher levels of blood glucose are associated with an increased risk of subsequent stroke after high‐risk transient ischemic attack or minor ischemic stroke. Methods and Results We performed a secondary analysis of the POINT (Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke) trial to evaluate the relationship between serum glucose hyperglycemia (≥180 mg/dL) versus normoglycemia (

Background Atrial tachyarrhythmias are common after atrial fibrillation ablation, so adjunctive antiarrhythmic drug therapy is often used. Data on the effectiveness and safety of dronedarone and sotalol after AF ablation are limited. Here, we compared health outcomes of patients who underwent an ablation and were treated with dronedarone versus sotalol. Methods and Results A comparative analysis of propensity score–matched retrospective cohorts was performed using Merative™ (formerly IBM) MarketScan Research Databases. Patients treated with dronedarone after atrial fibrillation ablation were matched 1:1 to patients treated with sotalol between January 1, 2013 and December 31, 2017. Outcomes of interest included cardiovascular hospitalization, proarrhythmia, repeat ablation, and cardioversion. This study was exempt from institutional review board review. Among 37 589 patients who underwent atrial fibrillation ablation, 2230 were treated with dronedarone and 3986 with sotalol after ablation. Propensity‐score matching resulted in 2224 patients receiving dronedarone matched 1:1 to patients receiving sotalol. Risk of cardiovascular hospitalization was lower with dronedarone versus sotalol at 3 months (adjusted hazard ratio [aHR], 0.73 [95% CI: 0.61–0.87]). 6 months (aHR, 0.73 [95% CI: 0.62–0.85] and 12 months after ablation (aHR, 0.79 [95% CI: 0.69–0.90]). Risk of repeat ablation and cardioversion generally did not differ between the 2 groups. A lower risk of proarrhythmia was associated with dronedarone versus sotalol at 3 months (aHR, 0.76 [95% CI, 0.66–0.89]), 6 months (aHR, 0.79 [95% CI, 0.70–0.91]), and 12 months (aHR, 0.84 [95% CI, 0.75–0.95]) after ablation. Conclusions These data suggest that dronedarone may be a more effective and safer alternative after ablation than sotalol.

Background Currently, little is known regarding seasonal variation for atrial fibrillation (AF) in the United States and whether quality of care for AF varies between seasons. Methods and Results The GWTG‐AFib (Get With The Guidelines–AFib) registry was initiated by the American Heart Association to enhance national guideline adherence for treatment and management of AF. Our analyses included 61 291 patients who were admitted at 141 participating hospitals from 2014 to 2018 across the United States. Outcomes included numbers of AF admissions and quality‐of‐care measures (defect‐free care, defined as a patient’s receiving all eligible measures). For quality‐of‐care measures, generalized estimating equations accounting for within‐site correlations were used to estimate odds ratios (ORs) with 95% CIs, adjusting patient and hospital characteristics. The proportion of AF admissions for each season was similar, with the highest percentage of AF admissions being observed in the fall (spring 25%, summer 25%, fall 27%, and winter 24%). Overall, AF admissions across seasons were similar, with no seasonal variation observed. No seasonal variation was observed for incident AF. There were no seasonal differences in care quality (multivariable adjusted ORs and 95% CIs were 0.93 (0.87–1.00) for winter, 1.09 (1.01–1.18) for summer, and 1.08 (0.97–1.20) for fall, compared with spring). Conclusions In a nationwide quality improvement registry, no seasonal variation was observed in hospital admissions for AF or quality of care for AF.

Background In event‐driven clinical trials, study termination is based on accrual of a target number of primary efficacy events. For noninferiority trials in which superiority is conditionally examined, the ideal cohort in which to track event accrual is unclear. We used data from the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation) trial to determine the effect of primary efficacy‐event tracking in the per‐protocol cohort during the on‐treatment period versus the intention‐to‐treat (ITT) cohort during the ITT period. Methods and Results ROCKET AF was terminated after accruing 429 primary efficacy events (stroke or systemic embolism) in the per‐protocol cohort during the on‐treatment period for noninferiority. We identified the date on which 429 events occurred in the ITT cohort during the ITT period. We performed noninferiority and superiority analyses based on hypothetical study termination on this date. ROCKET AF would have terminated 226 days earlier if events were tracked during the ITT period. Similar to the main trial findings, rivaroxaban would have met noninferiority versus warfarin for the primary efficacy end point (hazard ratio [HR], 0.77; 95% CI, 0.62–0.96; P

Summary: There is an increasing recognition of the importance of interactions between the heart and the autonomic nervous system in the pathophysiology of arrhythmias. These interactions play a role in both the initiation and maintenance of arrhythmias and are important in both atrial and ventricular arrhythmia. Given the importance of the autonomic nervous system in the pathophysiology of arrhythmias, there has been notable effort in the field to improve existing therapies and pioneer additional interventions directed at cardiac-autonomic targets. The interventions are targeted to multiple and different anatomic targets across the neurocardiac axis. The purpose of this review is to provide an overview of the rationale for neuromodulation in the treatment of arrhythmias and to review the specific treatments under evaluation and development for the treatment of both atrial fibrillation and ventricular arrhythmias. Key Words: arrhythmia, atrial fibrillation, autonomic nervous system, ganglionated plexi, neuromodulation, ventricular arrhythmias

Abstract Introduction Patient-reported outcomes (PROs) and satisfaction endpoints are increasingly important in clinical trials and may be associated with treatment adherence. In this post hoc substudy from ROCKET AF, we examined whether patient-reported satisfaction was associated with study drug discontinuation. Methods ROCKET AF (n = 14,264) compared rivaroxaban with warfarin for prevention of stroke and systemic embolism in patients with atrial fibrillation. We analyzed treatment satisfaction scores: the Anti-Clot Treatment Scale (ACTS) and Treatment Satisfaction Questionnaire for Medication version II (TSQM II). We compared satisfaction with study drug between the two treatment arms, and examined the association between satisfaction and patient-driven study drug discontinuation (stopping study drug due to withdrawal of consent, noncompliance, or loss to follow-up). Results A total of 1577 (11%) patients participated in the Patient Satisfaction substudy; 1181 (8.3%) completed both the ACTS and TSQM II 4 weeks after starting study drug. Patients receiving rivaroxaban did not experience significant differences in satisfaction compared with those receiving warfarin. During a median follow-up of 1.6 years, 448 premature study drug discontinuations occurred (213 rivaroxaban group; 235 warfarin group), of which 116 (26%) were patient-driven (52 [24%] rivaroxaban group; 64 [27%] warfarin group). No significant differences were observed between satisfaction level and rates of patient-driven study drug discontinuation. Conclusions Study drug satisfaction did not predict rate of study drug discontinuation. No significant difference was observed between satisfaction with warfarin and rivaroxaban, as expected given the double-blind trial design. Although these results are negative, the importance of PRO data will only increase, and these analyses may inform future studies that explore the relationship between drug-satisfaction PROs, adherence, and clinical outcomes. ClinicalTrials.gov NCT00403767. Funding The ROCKET AF trial was funded by Johnson & Johnson and Bayer.

Background Knowledge is scarce regarding how multimorbidity is associated with therapeutic decisions regarding oral anticoagulants (OACs) in patients with atrial fibrillation. Methods and Results We conducted a cross‐sectional study of hospitalized patients with atrial fibrillation using the Get With The Guidelines‐Atrial Fibrillation registry from 2013 to 2019. We identified patients ≥65 years and eligible for OAC therapy. Using 16 available comorbidity categories, patients were stratified by morbidity burden. A multivariable logistic regression model was used to determine the odds of receiving OAC prescription at discharge by morbidity burden. We included 34 174 patients with a median (interquartile range) age of 76 (71–83) years, 56.6% women, and 41.9% were not anticoagulated at admission. Of these patients, 38.6% had 0 to 2 comorbidities, 50.7% had 3 to 5 comorbidities, and 10.7% had ≥6 comorbidities. The overall discharge OAC prescription was high (85.6%). The prevalence of patients with multimorbidity increased from 59.7% in 2014 to 64.3% in 2019 (P trend=0.002). Using 0 to 2 comorbidities as the reference, the adjusted odds ratio (95% CI) of OAC prescription were 0.93 (0.82, 1.05) for patients with 3 to 5 comorbidities and 0.72 (0.60, 0.86) for patients with ≥6 comorbidities. In those with ≥6 comorbidities, the most common reason for nonprescription of OACs were frequent falls/frailty (31.0%). Conclusions In a contemporary quality‐of‐care database of hospitalized patients with atrial fibrillation eligible for OAC therapy, multimorbidity was common. A higher morbidity burden was associated with a lower odds of OAC prescription. This highlights the need for interventions to improve adherence to guideline‐recommended anticoagulation in multimorbid patients with atrial fibrillation.

Background Left ventricular assist devices (LVADs) generate electromagnetic interference that causes high‐frequency noise artifacts on 12‐lead ECGs. We describe the causes of this interference and potential solutions to aid ECG interpretation in patients with LVAD. Methods and Results Waveform data from ECGs performed before and after LVAD implantation were passed through a fast Fourier transform to identify LVAD‐related changes in the spectral profile. ECGs recorded in 9 patients with HeartMate II, HeartMate 3, and HeartWare LVADs were analyzed to identify the LVAD model‐specific spectral patterns. Waveform data were then passed through digital low‐pass and bandstop filters and redisplayed to evaluate the effect of filtering on LVAD‐related electromagnetic interference. The spectral profile of patients with HeartMate II and HeartMate 3 LVADs demonstrated a prominent signal at the device‐specific frequency of impeller rotation. In patients with the HeartMate 3 LVAD, 2 additional peaks were observed at the frequencies equivalent to the LVAD's artificial pulsatility rotational speeds. Patients with HeartWare devices demonstrated a prominent signal peak at a frequency equal to double their LVAD's set rotational speed. Applying a low‐pass filter to a value below the observed frequency peak from the LVAD significantly improved the waveform tracing and quality of the ECG. Applying a speed‐specific bandstop filter to remove the observed LVAD frequency peak also improved the clarity of the ECG without compromising physiological high‐frequency signal components. Conclusions LVADs create impeller rotational speed‐specific electromagnetic interference that can be ameliorated by application of low‐pass or bandstop filters to improve ECG clarity.

Background Limited data exist to guide treatment for patients with heart failure with preserved ejection fraction and atrial fibrillation, including the important decision regarding rate versus rhythm control. Methods and Results We analyzed the Get With The Guidelines—Heart Failure (GWTG‐HF) registry linked to Medicare claims data from 2008 to 2014 to describe current treatments for rate versus rhythm control and subsequent outcomes in patients with heart failure with preserved ejection fraction and atrial fibrillation using inverse probability weighted analysis. Rhythm control was defined as use of an antiarrhythmic medication, cardioversion, or AF ablation or surgery. Rate control was defined as use of any combination of β‐blocker, calcium channel blocker, and digoxin without evidence of rhythm control. Among 15 682 fee‐for‐service Medicare patients, at the time of discharge, 1857 were treated with rhythm control and 13 825 with rate control, with minimal differences in baseline characteristics between groups. There was higher all‐cause death at 1 year in the rate control compared with the rhythm control group (37.5% and 30.8%, respectively, P

Background Patient satisfaction with therapy is an important metric of care quality and has been associated with greater medication persistence. We evaluated the association of patient satisfaction with warfarin therapy to other metrics of anticoagulation care quality and clinical outcomes among patients with atrial fibrillation (AF). Methods and Results Using data from the ORBIT‐AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry, patients were identified with AF who were taking warfarin and had completed an Anti‐Clot Treatment Scale (ACTS) questionnaire, a validated metric of patient‐reported burden and benefit of oral anticoagulation. Multivariate regressions were used to determine association of ACTS burden and benefit scores with time in therapeutic international normalized ratio range (TTR; both ≥75% and ≥60%), warfarin discontinuation, and clinical outcomes (death, stroke, major bleed, and all‐cause hospitalization). Among 1514 patients with AF on warfarin therapy (75±10 years; 42% women; CHA2DS2‐VASc 3.9±1.7), those most burdened with warfarin therapy were younger and more likely to be women, have paroxysmal AF, and to be treated with antiarrhythmic drugs. After adjustment for covariates, ACTS burden scores were independent of TTR (TTR ≥75%: odds ratio, 1.01 [95% CI, 0.99–1.03]; TTR ≥60%: odds ratio, 1.01 [95% CI, 0.98–1.05]), warfarin discontinuation (odds ratio, 0.99; 95% CI, 0.97–1.01), or clinical outcomes. ACTS benefit scores were also not associated with TTR, warfarin discontinuation, or clinical outcomes. Conclusions In a large registry of patients with AF taking warfarin, ACTS scores provided independent information beyond other traditional metrics of oral anticoagulation care quality and identified patient groups at high risk for dissatisfaction with warfarin therapy.

Background Chronic kidney disease (CKD) is a common comorbidity in patients with atrial fibrillation. The presence of CKD complicates drug selection for stroke prevention and rhythm control. Methods and Results Patients enrolled in ORBIT AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) with baseline renal function and follow‐up data were included (N=9019). CKD was defined as an estimated creatinine clearance

Background There is concern that selective serotonin reuptake inhibitors (SSRIs) substantially increase bleeding risk in patients taking anticoagulants. Methods and Results We studied 737 patients taking SSRIs in the ROCKET AF (Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Embolism and Stroke Trial in Atrial Fibrillation) trial of rivaroxaban compared with warfarin for the prevention of stroke/systemic embolism in patients with atrial fibrillation. These patients were propensity score matched 1:1 to 737 patients not taking SSRIs. The primary outcome measure was major and nonmajor clinically relevant bleeding events, the principal safety outcome in ROCKET AF. Over a mean 1.6 years of follow‐up, the rate of major/nonmajor clinically relevant bleeding was 18.57 events/100 patient‐years for SSRI users versus 16.84 events/100 patient‐years for matched comparators, adjusted hazard ratio (aHR) of 1.16 (95% confidence interval [CI], 0.95–1.43). The aHRs were similar in patients taking rivaroxaban (aHR 1.11 [95% CI, 0.82–1.51]) and those taking warfarin (aHR 1.21 [95% CI, 0.91–1.60]). For the rarer outcome of major bleeding, the aHR for SSRI users versus those not taking SSRIs was 1.13 (95% CI, 0.62–2.06) for rivaroxaban; for warfarin, the aHR was higher, at 1.58 (95% CI, 0.96–2.60) but not statistically significantly elevated. Conclusions We found no significant increase in bleeding risk when SSRIs were combined with anticoagulant therapy, although there was a suggestion of increased bleeding risk with SSRIs added to warfarin. While physicians should be vigilant regarding bleeding risk, our results provide reassurance that SSRIs can be safely added to anticoagulants in patients with atrial fibrillation. Clinical Trial Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00403767.

Background Current American College of Cardiology/American Heart Association guidelines suggest that for patients with atrial fibrillation who are at low risk for stroke (CHA2DS2VASc=1) (or women with CHA2DS2VASc=2) a variety of treatment strategies may be considered. However, in clinical practice, patterns of treatment in these “low‐risk” patients are not well described. The objective of this analysis is to define thromboembolic event rates and to describe treatment patterns in patients with low‐risk CHA2DS2VASc scores. Methods and Results We compared characteristics, treatment strategies, and outcomes among patients with a CHA2DS2VASc=0, CHA2DS2VASc=1, females with a CHA2DS2VASc=2, and CHA2DS2VASc ≥2 in ORBIT‐AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) I & II. Compared with CHA2DS2VASc ≥2 patients (84.2%), those with a CHA2DS2VASc=0 (60.3%), 1 (69.9%), and females with a CHA2DS2VASc score=2 (72.4%) were significantly less often treated with oral anticoagulation (P

Background Oral anticoagulation (OAC) reduces stroke risk in atrial fibrillation, but bleeding is a frequent side effect. The decision to discontinue or modify medication regimens in response to a bleeding event may differ according to bleeding site and severity. Methods and Results We used data from a large, national outpatient registry, ORBIT‐AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation; 2010–2011), to evaluate event characteristics and OAC management following the first bleeding event occurring during follow‐up. Bleeding events were classified into 3 categories: (1) International Society of Thrombosis and Hemostasis major bleeding, (2) clinically relevant nonmajor bleeding requiring medical attention, and (3) nuisance bleeding not requiring medical attention (eg, bruising, hemorrhoidal bleeding). Of 9743 patients enrolled in ORBIT‐AF with follow‐up data, 510 (3.23/100 subject‐years) experienced a major bleed, 615 (3.90/100 subject‐years), experienced a clinically relevant nonmajor bleed, and 1558 (9.87/100 subject‐years) experienced a nuisance bleed, among first bleeds over 2 years. Nearly one third of patients (31.6%) discontinued OAC therapy following a major bleeding event, 12.7% following a clinically relevant nonmajor bleed, and 4.5% following a nuisance bleed. Compared with those who experienced a clinically relevant nonmajor or nuisance bleed, patients who experienced a major bleed were more likely to be black and female and to have a history of heart failure and stroke. Those who discontinued were more likely to have central nervous system or gastrointestinal bleeding than those who persisted on OAC therapy. Conclusions Overall, 1 in 3 patients who experienced a major bleed was no longer anticoagulated after the event. Those who discontinued OAC were more likely to have central nervous system or gastrointestinal bleeding than those who persisted on OAC.

BackgroundMineralocorticoid receptor antagonist (MRA) therapy may be beneficial to patients with atrial fibrillation (AF), but little is known about their use in patients with AF and subsequent outcomes. Methods and ResultsIn order to better understand MRA use and subsequent outcomes, we performed a retrospective cohort study of the contemporary ORBIT‐AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation) registry. AF progression and cardiovascular outcomes were compared using propensity‐matched Cox proportional hazards modeling according to MRA use at baseline and new MRA use at follow‐up versus patients with no MRA use. Among 7012 patients with nonpermanent AF, 320 patients were taking MRA at enrollment, and 416 patients initiated MRA use during follow‐up. The mean patient age was 72.5 years, 56.3% were men, and 70.4% had paroxysmal AF. Among all patients taking MRAs, 434 (59.0%) had heart failure, 655 (89.0%) had hypertension, and 380 (51.6%) had both. After adjustment, new MRA use was not associated with reduced AF progression (hazard ratio, 1.18; 95% confidence interval, 0.88–1.58; P=0.27) but showed a trend towards lower risk of stroke, transient ischemic attack, or systemic embolism (hazard ratio, 0.17; 95% confidence interval, 0.02–1.23; P=0.08). Results were similar for a comparison of new MRA users and baseline MRA users compared with nonusers. ConclusionsIn community‐based outpatients with AF, the majority of MRA use was for heart failure and hypertension. MRA use also trended towards lower adjusted stroke risk. Future studies should test the hypothesis that MRA use may decrease the risk of stroke in patients with AF.

BackgroundNon–vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice. Methods and ResultsWe analyzed data from the ORBIT‐AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients. Among 7925 AF patients receiving NOACs, we assessed patterns of use of reduced NOAC doses and associated cardiovascular and bleeding outcomes at median follow‐up of 1 year. Overall, 6636 patients (84%) received a NOAC at standard dose, which was consistent with US Food and Drug Administration labeling in 6376 (96%). Reduced NOAC dose was prescribed to 1289 (16% overall), which was consistent with Food and Drug Administration labeling in only 555 patients (43%). Compared with those whose NOAC dose was appropriately reduced, patients receiving inappropriate dose reductions were younger (median age 79 versus 84, P

BackgroundThe presence of valvular heart disease (VHD) may affect the risk of stroke and mortality in patients with atrial fibrillation (AF). Community‐based estimates of prevalence and outcomes of specific forms of VHD in patients with AF are lacking. Methods and ResultsWe examined the prevalence of VHD, anticoagulation use, mortality, stroke/transient ischemic attack, and bleeding among a community cohort of patients with AF. Significant VHD was defined as follows: (1) moderate/severe mitral stenosis or mechanical valve; (2) bioprosthetic valve, surgical repair, or balloon valvuloplasty; and (3) moderate/severe aortic regurgitation or stenosis, mitral regurgitation, or tricuspid regurgitation. Proportional hazards models were performed to test the association between VHD groups and outcomes. Among 9748 patients with AF, 2705 (27.7%) had significant VHD. Anticoagulation use was highest among patients with mitral stenosis/mechanical valve (91.8%). Compared with individuals with no significant VHD, individuals with aortic regurgitation/aortic stenosis, mitral regurgitation, or tricuspid regurgitation (hazard ratio, 1.23; 95% confidence interval, 1.07–1.42) had the highest risk of death. There were no differences in stroke or transient ischemic attack and major bleeding among individuals with and without significant VHD. Patients with AF and aortic stenosis had the highest risk of death (hazard ratio, 1.32; 95% confidence interval, 1.08–1.62). ConclusionsSignificant VHD is common among patients with AF in community practice. In a community cohort of patients with AF and CHA2DS2‐VASc score ≥2, most were anticoagulated. Individuals with AF and moderate‐to‐severe biological VHD have more comorbidities and a higher mortality risk; however, stroke and major bleeding are similar among those with and without significant VHD.

BackgroundAlthough implantation of cardiac implantable electronic devices (CIEDs) in patients receiving warfarin is well studied, limited data are available on the use of oral factor Xa inhibitors in this setting. Methods and ResultsUsing data from Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) (n=14 264), we compared baseline characteristics and clinical outcomes in patients with atrial fibrillation randomized to rivaroxaban versus warfarin who did and did not undergo CIED implantation or revision. In this post‐hoc, postrandomization, on‐treatment analysis, only the first intervention per patient was analyzed. During a median follow‐up of 2.2 years, 453 patients (242 rivaroxaban group; 211 warfarin group) underwent de novo CIED implantation (64.2%) or revision procedures (35.8%). Patients who received CIEDs were older, more likely to be male, and more likely to have past myocardial infarction, but had similar stroke risk compared to patients who did not receive CIEDs. Most patients who received a device had study drug interrupted for the procedure and did not receive bridging anticoagulation. During the 30‐day postprocedural period, 11 patients (4.55%) in the rivaroxaban group experienced bleeding complications compared with 15 (7.13%) in the warfarin group. Thromboembolic complications occurred in 3 patients (1.26%) in the rivaroxaban group and 1 (0.48%) in the warfarin group. Event rates were too low for formal hypothesis testing. ConclusionsBleeding and thromboembolic events were low in both rivaroxaban‐ and warfarin‐treated patients. Periprocedural use of oral factor Xa inhibitors in CIED implantation requires further study in prospective, randomized trials. Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00403767.

BackgroundWhether outcomes differ between sexes following treatment with pacemakers (PM), implantable cardioverter defibrillators, and cardiac resynchronization therapy (CRT) devices is unclear. Methods and ResultsConsecutive US patients with newly implanted PM, implantable cardioverter defibrillators, and CRT devices from a large remote monitoring database between 2008 and 2011 were included in this observational cohort study. Sex‐specific all‐cause survival postimplant was compared within each device type using a multivariable Cox proportional hazards model, stratified on age and adjusted for remote monitoring utilization and ZIP‐based socioeconomic variables. A total of 269 471 patients were assessed over a median 2.9 [interquartile range, 2.2, 3.6] years. Unadjusted mortality rates (MR; deaths/100 000 patient‐years) were similar between women versus men receiving PMs (n=115 076, 55% male; MR 4193 versus MR 4256, respectively; adjusted hazard ratio, 0.87; 95% CI, 0.84–0.90; P

BackgroundWe examined all‐cause mortality and long‐term thromboembolic risk (ischemic stroke, transient ischemic attack, systemic thromboembolism) in patients with and without familial atrial fibrillation (AF). Methods and ResultsUsing Danish nationwide registry data, we identified all patients diagnosed with AF (1995–2012) and divided them into those with familial AF (having a first‐degree family member with a prior AF admission) and those with nonfamilial AF. We paired those with and without familial AF according to age, year of AF diagnosis, and sex in a 1:1 match. Using cumulative incidence and multivariable Cox models, we examined the risk of long‐term outcomes. We identified 8658 AF patients (4329 matched pairs) with and without familial AF. The median age was 50 years (interquartile range 43–54 years), and 21.4% were women. Compared with nonfamilial AF patients, those with familial AF had slightly less comorbid illness but similar overall CHA2DS2‐VASc score (P=0.155). Median follow‐up was 3.4 years (interquartile range 1.5–6.5 years). Patients with familial AF had risk of death and thromboembolism similar to those with nonfamilial AF (adjusted hazard ratio 0.91 [95% CI 0.79–1.04] for death and 0.90 [95% CI 0.71–1.14] for thromboembolism). ConclusionsAlthough family history of AF is associated with increased likelihood for development of AF, once AF developed, long‐term risks of death and thromboembolic complications were similar in familial and nonfamilial AF patients.

BackgroundWhereas insurance status has been previously associated with care patterns, little is currently known about the association between Medicaid insurance and the clinical characteristics, treatment, or outcomes of patients with atrial fibrillation (AF). Methods and ResultsWe used data from adults with AF enrolled in the Outcomes Registry for Better Informed Treatment of AF (ORBIT‐AF), a national outpatient registry conducted at 176 community, multispecialty sites. The primary outcome of interest was the proportion of patients prescribed any oral anticoagulation (OAC; warfarin or novel oral anticoagulants [NOAC]). Secondary outcomes of interest included the proportion of patients prescribed NOACs (dabigatran or rivaroxaban); time in therapeutic range (TTR) for warfarin users, all‐cause mortality, stroke/systemic embolism, and major bleed. Of 10 133 patients, N=470 (4.6%) had Medicaid insurance. Medicaid patients were similarly likely to receive OAC at baseline (72.8% vs 76.3%; unadjusted P=0.079), but less likely to receive NOAC at baseline or follow‐up (12.1% vs 16.3%; unadjusted P=0.019). After risk adjustment, Medicaid status was associated with lower use of OAC at baseline among patients with high stroke risk (odds ratio [OR]=0.68; 95% CI=0.49, 0.94), but was not associated with OAC use overall (OR=0.82; 95% CI=0.61, 1.09). Among warfarin users, median TTR was lower among Medicaid patients (60% vs 68%; P

BackgroundAtrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all‐cause mortality may guide interventions. Methods and ResultsIn the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose‐adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all‐cause mortality in the 14 171 participants in the intention‐to‐treat population. The median age was 73 years, and the mean CHADS2 score was 3.5. Over 1.9 years of median follow‐up, 1214 (8.6%) patients died. Kaplan–Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all‐cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33–1.70, P

Background The characteristics of patients undergoing atrial fibrillation (AF) ablation and subsequent outcomes in community practice are not well described. Methods and Results Using the Outcomes Registry for Better Informed Treatment of Atrial Fibrillation (ORBIT‐AF), we investigated the prevalence and impact of catheter ablation of AF. Among 9935 patients enrolled, 5.3% had previous AF ablation. Patients with AF ablation were significantly younger, more frequently male, and had less anemia, chronic obstructive pulmonary disease, and previous myocardial infarction (P