Asundexian versus Apixaban in Patients with Atrial Fibrillation.

BACKGROUND: Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding. METHODS: In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 1:1 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism. The primary safety objective was to determine whether asundexian is superior to apixaban with respect to major bleeding events. RESULTS: A total of 14,810 randomly assigned patients were included in the intention-to-treat population. The mean (±SD) age of the patients was 73.9±7.7 years, 35.2% were women, 18.6% had chronic kidney disease, 18.2% had a previous stroke or transient ischemic attack, 16.8% had received oral anticoagulants for no more than 6 weeks, and the mean CHA2DS2-VASc score (range, 0 to 9, with higher scores indicating a greater risk of stroke) was 4.3±1.3. The trial was stopped prematurely at the recommendation of the independent data monitoring committee. Stroke or systemic embolism occurred in 98 patients (1.3%) assigned to receive asundexian and in 26 (0.4%) assigned to receive apixaban (hazard ratio, 3.79; 95% confidence interval [CI], 2.46 to 5.83). Major bleeding occurred in 17 patients (0.2%) who received asundexian and in 53 (0.7%) who received apixaban (hazard ratio, 0.32; 95% CI, 0.18 to 0.55). The incidence of any adverse event appeared to be similar in the two groups. CONCLUSIONS: Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time. (Funded by Bayer; OCEANIC-AF ClinicalTrials.gov number, NCT05643573; EudraCT number, 2022-000758-28.).

Factors associated with stellate ganglion block success in recurrent ventricular arrhythmias.

AIMS: One treatment option for refractory ventricular arrythmias is stellate ganglion block (SGB). We examined differences in SGB success by patient and arrhythmia characteristics and predictors of successful SGB. METHODS AND RESULTS: This was a multicenter analysis of patients treated for refractory ventricular arrythmias in the Czech Republic and the United States. The primary outcome was absence of ventricular arrythmias at 24 h post SGB. SGB effectiveness was examined according to aetiology of cardiomyopathy, arrhythmia type, laterality of SGB, presence of inotropes, and presence of mechanical circulatory support. Binary logistic regression was used to examine variables associated with the primary outcome. In total there were 117 patients with refractory ventricular arrythmias treated with SGB. Overall, the mean age was 63.5 ± 11.0 years, majority of patients were male (94.0%), White (87.2%), and had an implantable cardioverter defibrillator in situ (70.1%). There were no differences in efficacy of SGB based on aetiology of cardiomyopathy (P = 0.623), arrhythmia type (0.852), laterality of block (P = 0.131), and presence of inotropes (P = 0.083). Multivariable analysis demonstrated that increased age was associated with decreased odds of SGB success (odds ratio: 0.96, confidence interval: 0.92-0.99, P = 0.039) whereas increased left ventricular ejection fraction trended towards increased odds of SGB success (odds ratio: 1.05, confidence interval: 0.995-1.11, P = 0.077). CONCLUSIONS: In this multicentre experience, SGB was similarly effective despite the aetiology of cardiomyopathy, type of arrhythmia, laterality, and inotropic or mechanical support. SGB was less effective for the suppression of ventricular arrythmias at 24 h for the elderly.

Discordant Treatment Goals for Patients With Atrial Fibrillation and Clinical Trials Metrics.

BACKGROUND: Most clinical trials define successful atrial fibrillation (AF) treatment as no AF episodes longer than 30 seconds. Yet, there has been minimal study of how patients define successful treatment and whether their perspectives align with trial outcomes. OBJECTIVES: Survey patients with AF to identify: 1) what aspect of AF is most important to address (frequency, duration, or severity of AF episodes); 2) what AF burden would be considered acceptable to consider treatment successful; and 3) to establish patient preferences for successful treatment thresholds for a validated patient-reported outcome (PRO) score. METHODS: We surveyed patients receiving active care for AF at a single tertiary care center modeled after the Toronto AF Severity Scale (AFSS). The survey consisted of current and "successful treatment" AF frequency, burden, and symptom domains; and baseline socioeconomic information. RESULTS: Of 7,000 invitations, 852 individuals completed the survey (12% response) with a mean age of 65 ± 13 years, 36.5% were female, and they had a mean CHA2DS2-VAsc score of 2.9 ± 1.9. Overall, 114 (13%) selected a decrease in AF episode duration as their top treatment priority, 505 (59%) episode frequency, and 230 (27%) episode severity. Overall, 207 (24%) patients would only consider a treatment successful if they never had AF again, whereas 645 (76%) patients considered success to be fewer AF episodes. A total of 341 (40%) patients would only consider a treatment successful if AF episodes lasted less than a few minutes, whereas 509 (60%) patients would accept AF episodes lasting >30 minutes. An AFSS symptom score ≤5 was considered a good outcome by 80% of respondents. CONCLUSIONS: Patients prioritize decreased AF frequency over improvements in severity or duration, and an AFSS ≤5 would be a reasonable outcome of AF treatment. Most patients would consider treatment successful if they had more than 1 AF episode lasting longer than 30 seconds. Future clinical trial design should consider patients' perspectives when designing outcomes.

Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion.

BACKGROUND: The prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. OBJECTIVES: This study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. METHODS: The authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. RESULTS: Among 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. CONCLUSIONS: In real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin.

Ineffective cardiac resynchronization pacing is associated with poor outcomes in a nationwide cohort analysis.

BACKGROUND: Delivery of cardiac resynchronization therapy (CRT) requires left ventricular myocardial capture to achieve clinical benefits. OBJECTIVE: We sought to determine whether ineffective pacing affects survival. METHODS: Ineffective ventricular pacing (VP) was defined as the difference between the percentage of delivered CRT (%VP) and the percentage of EffectivCRT in CRT devices. Using the Optum de-identified electronic health record data set and Medtronic CareLink data warehouse, we identified patients implanted with applicable devices with at least 30 days of follow-up. Kaplan-Meier and Cox proportional hazards models assessed the effect of %VP and % ineffective VP on survival. RESULTS: Among 7987 patients with 2.1 ± 1.0 years of follow-up, increasing ineffective VP was associated with decreasing survival: the highest observed survival was in the quartile with <0.08% ineffective VP and the lowest survival was in the quartile with >1.47% ineffective VP (85.1% vs 75.7% at 3 years; P < .001). As expected, patients with more than the median %VP of 97.7% had better survival than did patients with <97.7% VP (84.2% vs 77.8%; P < .001). However, patients who had >97.7% VP but >2% ineffective VP had similar survival to patients with <97.7% VP but ≤2% ineffective VP (81.6% vs 79.4%; P = .54). A multivariable Cox proportional hazards model demonstrated that <97.7% VP (adjusted hazard ratio 1.29; 95% confidence interval 1.14-1.46; P < .001) and >2% ineffective VP (hazard ratio 1.35; 95% confidence interval 1.18-1.54; P < .001) were both significantly associated with decreased survival. CONCLUSION: Ineffective VP is associated with decreased survival. In addition to maximizing the percentage of delivered CRT pacing, every effort should be made to minimize ineffective VP.

Predictors of Shock-Reduction Programming and Its Impact on Implantable Cardioverter-Defibrillator Therapies and Mortality: The CERTITUDE Registry.

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.

Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry.

BACKGROUND: PINNACLE FLX (Protection Against Embolism for Nonvalvular AF Patients: Investigational Device Evaluation of the WATCHMAN FLX LAA Closure Technology) demonstrated improved outcomes and low incidence of adverse events with the WATCHMAN FLX device in a controlled setting. The National Cardiovascular Disease Registry's Left Atrial Appendage Occlusion Registry was utilized to assess the safety and effectiveness of WATCHMAN FLX in contemporary clinical practice in the United States. METHODS: The WATCHMAN FLX Device Surveillance Post Approval Analysis Plan used data from the Left Atrial Appendage Occlusion registry to identify patients undergoing WATCHMAN FLX implantation between August 2020 and September 2022. The key safety end point was defined as all-cause death, ischemic stroke, systemic embolism, or device or procedure-related events requiring open cardiac surgery or major endovascular intervention between device implantation and hospital discharge. Major adverse events were reported at hospital discharge, 45 days, and 1 year. RESULTS: Among 97 185 patients in the Left Atrial Appendage Occlusion registry undergoing WATCHMAN FLX, successful implantation occurred in 97.5% (n=94 784) of patients. The key safety end point occurred in 0.45% of patients. At 45 days post-procedure, all-cause death occurred in 0.81% patients, ischemic stroke in 0.23%, major bleeding in 3.1%, pericardial effusion requiring intervention in 0.50%, device-related thrombus in 0.44%, and device embolism in 0.04% patients. No peri-device leak was observed in 83.1% of patients at 45 days. At 1 year, the rate of all-cause death was 8.2%, the rate of any stroke was 1.5% (ischemic stroke, 1.2%), and major bleeding occurred in 6.4% of patients. CONCLUSIONS: In a large contemporary cohort of patients with the WATCHMAN FLX device, the rates of implant success and clinical outcomes through 1 year were comparable with the PINNACLE FLX study, demonstrating that favorable outcomes achieved in the pivotal approval study can be replicated in routine clinical practice.

Appropriate and inappropriate ICD shocks in patients with LVADs: Prevalence, associated factors, and etiologies.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) shocks are a common complication after left ventricular assist device (LVAD) implantation; however, data on their frequency and causes are limited. OBJECTIVE: The purpose of this study was to define the incidence, programming, patient characteristics, and factors associated with appropriate and inappropriate ICD shocks in persons with LVADs. METHODS: We performed a retrospective review at Duke University Hospital of all LVAD recipients implanted between January 1, 2013, to June 30, 2019, with a preexisting ICD. ICD shocks were adjudicated by the treating physician and a second reviewer for the purpose of this study. RESULTS: Among 421 patients with an ICD in situ undergoing LVAD implant, 147 (33.9%) had at least 1 shock after LVAD implantation. Among 134 patients with complete device history, a total of 330 shock episodes occurred: 255 (77.3%) appropriate and 75 (22.7%) inappropriate. Etiologies for inappropriate shocks included supraventricular tachycardia (n = 66 [20.0%]), physiological oversensing (n = 1 [0.3%]), and nonphysiological oversensing (n = 8 [2.4%]) including LVAD electromagnetic interference (n = 1 [0.3%]). ICD programming with shorter detection delay (P <.001) and absence of antitachycardia pacing programming (P = .001) in high-rate zones was seen more commonly in inappropriate shock than appropriate shock. CONCLUSIONS: The rate of inappropriate shocks in LVAD recipients is very high and most often is due to supraventricular arrhythmias. LVAD electromagnetic interference is a rare cause of ICD shock. Implementation of current consensus American Heart Association recommendations for LVAD programming with long detection delays and high rate cutoffs may help prevent inappropriate ICD shocks.

Association between COVID-19 vaccination and atrial arrhythmias in individuals with cardiac implantable electronic devices.

INTRODUCTION: The impact of mRNA-based coronavirus disease-2019 (COVID-19) vaccines on atrial arrhythmias (AA) and ventricular arrhythmias incidence is unknown. METHODS: BIOTRONIK Home Monitoring data and Medicare Claims data were utilized to identify individuals implanted with a cardiac implantable electronic device (CIED) between 2010 and 2020 who received one or more doses of COVID-19 vaccine in 2021. The burden of AA (%) in the 3 months postvaccination was compared to those noted in the preceding 3 months using the Wilcoxon signed rank test. Sub-analyses comparing the effects of the influenza vaccine against the COVID-19 vaccine were also evaluated for individuals who received the influenza vaccine in 2020. A 1:1 propensity score match comparison between COVID-19 vaccine and non-vaccinated patients was also performed. RESULTS: First and second doses of the COVID-19 vaccine were administered to 7757 and 6579 individuals with a CIED (age 76.2 ± 9.0 years, 49% males), respectively. While a small but statistically significant increase in the burden of AA was noted in the 3 months postvaccination compared to the preceding 3 months after the first dose of the COVID-19 vaccine (0.43 ± 9.04%, p = .028) a similar rise in AA was found following the influenza vaccine and for matched patients who did not receive the COVID-19 vaccine. No significant difference in device therapies was seen pre- and postvaccination. CONCLUSIONS: Though we report a small but significant increase in the number of CIED-detected AAs following vaccination for COVID-19 over a 3-month window, we believe these results correlate more with time and the progressive nature of AF rather than the vaccine itself. While these data should not dissuade from the use of these vaccines, increased vigilance and prompt treatment of AF is required for high-risk groups, specifically males over 70 years of age, following vaccination.

Effect of implantable loop recorder-based continuous rhythm monitoring on incident atrial fibrillation and stroke: An updated systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: In patients with a history of stroke or those at high risk for developing stroke, a continuous rhythm monitoring strategy using an implantable loop recorder (ILR) is often performed to screen for atrial fibrillation (AF). OBJECTIVES: The purpose of this study was to perform a systematic review (MEDLINE and EMBASE) including randomized controlled trials comparing ILR-based continuous rhythm monitoring vs usual care in patients with a history of stroke or patients at high risk for developing stroke. METHODS: A meta-analysis was performed, and aggregate risk ratio (RR) and risk difference (RD) with 95% confidence interval (CI) were calculated. RESULTS: Four randomized controlled trials with 7237 patients (ILR 2114, non-ILR 5123) were included. ILR vs non-ILR was associated with increased detection of incident AF (RR 3.88; 95% CI 2.23-6.75; P <.00001; number needed to treat [NNT] = 7.7; I2 = 61%), increased appropriate initiation of anticoagulation (RR 2.29; 95% CI 2.07-2.55; P <.00001; NNT = 6.7; I2 = 0), and a 25% lower risk of developing stroke (RR 0.75; 95% CI 0.59-0.95]; P = .02; NNT = 100; I2 = 0%). In patients with history of stroke there was no difference in the risk of developing incident stroke (RR 0.83; 95% CI 0.61-1.14]; P = .25; I2 = 0%). CONCLUSION: Our meta-analysis showed that screening for AF with ILR is associated with increased detection of AF and increased initiation of appropriate anticoagulation therapy in patients with a history of stroke or those with risk factors for stroke. The benefit of stroke risk reduction with ILR remains unclear, and future studies focused on the inclusion of patients without a history of stroke are needed to elucidate this uncertainty.

Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion.

BACKGROUND: Procedure volumes are associated with outcomes for many cardiovascular procedures, leading to guidelines on minimum volume thresholds for certain procedures; however, the volume-outcome relationship with left atrial appendage occlusion is poorly understood. As such, we sought to determine the relationship between hospital and physician volume and WATCHMAN left atrial appendage occlusion procedural success overall and with the new generation WATCHMAN FLX device. METHODS: We performed an analysis of WATCHMAN procedures (January 2019 to October 2021) from the National Cardiovascular Data Registry LAAO Registry. Three-level hierarchical generalized linear models were used to assess the adjusted relationship between procedure volume and procedural success (device released with peridevice leak <5 mm, no in-hospital major adverse events). RESULTS: Among 87 480 patients (76.2±8.0 years; 58.8% men; mean CHA2DS2-VASc score, 4.8±1.5) from 693 hospitals, the procedural success rate was 94.2%. With hospital volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (odds ratio [OR], 0.66 [CI, 0.57-0.77]) and Q2 (OR, 0.78 [CI, 0.69-0.90]) but not Q3 (OR, 0.95 [CI, 0.84-1.07]). With physician volume Q4 (greatest volume) as the reference, the likelihood of procedural success was significantly less among Q1 (OR, 0.72 [CI, 0.63-0.82]), Q2 (OR, 0.79 [CI, 0.71-0.89]), and Q3 (OR, 0.88 [CI, 0.79-0.97]). Among WATCHMAN FLX procedures, there was attenuation of the volume-outcome relationships, with statistically significant but modest absolute differences of only ≈1% across volume quartiles. CONCLUSIONS: In this contemporary national analysis, greater hospital and physician WATCHMAN volumes were associated with increased procedure success. The WATCHMAN FLX transition was associated with increased procedural success and less heterogeneity in outcomes across volume quartiles. These findings indicate the importance of understanding the volume-outcome relationship for individual left atrial appendage occlusion devices.

Machine Learning of Cardiac Anatomy and the Risk of New-Onset Atrial Fibrillation After TAVR.

BACKGROUND: New-onset atrial fibrillation (NOAF) occurs in 5% to 15% of patients who undergo transfemoral transcatheter aortic valve replacement (TAVR). Cardiac imaging has been underutilized to predict NOAF following TAVR. OBJECTIVES: The objective of this analysis was to compare and assess standard, manual echocardiographic and cardiac computed tomography (cCT) measurements as well as machine learning-derived cCT measurements of left atrial volume index and epicardial adipose tissue as risk factors for NOAF following TAVR. METHODS: The study included 1,385 patients undergoing elective, transfemoral TAVR for severe, symptomatic aortic stenosis. Each patient had standard and machine learning-derived measurements of left atrial volume and epicardial adipose tissue from cardiac computed tomography. The outcome of interest was NOAF within 30 days following TAVR. We used a 2-step statistical model including random forest for variable importance ranking, followed by multivariable logistic regression for predictors of highest importance. Model discrimination was assessed by using the C-statistic to compare the performance of the models with and without imaging. RESULTS: Forty-seven (5.0%) of 935 patients without pre-existing atrial fibrillation (AF) experienced NOAF. Patients with pre-existing AF had the largest left atrial volume index at 76.3 ± 28.6 cm3/m2 followed by NOAF at 68.1 ± 26.6 cm3/m2 and then no AF at 57.0 ± 21.7 cm3/m2 (P < 0.001). Multivariable regression identified the following risk factors in association with NOAF: left atrial volume index ≥76 cm2 (OR: 2.538 [95% CI: 1.165-5.531]; P = 0.0191), body mass index <22 kg/m2 (OR: 4.064 [95% CI: 1.500-11.008]; P = 0.0058), EATv (OR: 1.007 [95% CI: 1.000-1.014]; P = 0.043), aortic annulus area ≥659 mm2 (OR: 6.621 [95% CI: 1.849-23.708]; P = 0.004), and sinotubular junction diameter ≥35 mm (OR: 3.891 [95% CI: 1.040-14.552]; P = 0.0435). The C-statistic of the model was 0.737, compared with 0.646 in a model that excluded imaging variables. CONCLUSIONS: Underlying cardiac structural differences derived from cardiac imaging may be useful in predicting NOAF following transfemoral TAVR, independent of other clinical risk factors.

A leadless ventricular pacemaker providing atrioventricular synchronous pacing in the real-world setting: 12-Month results from the Micra AV post-approval registry.

BACKGROUND: Advances in leadless pacemaker technology have enabled accelerometer-based atrioventricular (AV) synchronous pacing by sensing atrial mechanical contraction. OBJECTIVE: The purpose of this study was to report the performance of the Micra AV leadless pacemaker from the worldwide Micra AV post-approval registry (PAR) through 12 months. METHODS: The Micra AV PAR is a prospective, single-arm, observational registry designed to assess the safety and effectiveness of Micra AV in a real-world setting. For the present interim analysis, major complications and system revisions through 12 months were summarized and compared to a historical cohort of 2667 patients implanted with a transvenous dual-chamber pacing system. RESULTS: The device was successfully implanted in 796 of 801 patients (99.4%) at 97 centers in 19 countries. Micra AV patients were older (74.1 years vs 71.1 years; P < .0001) with a higher incidence of renal disease (22.3% vs 9.8%; P < .0001) compared with transvenous dual-chamber patients. Through 12 months, the major complication rate was 3.7% in Micra AV patients compared with 8.8% in transvenous dual-chamber patients (hazard ratio 0.42; 95% confidence interval 0.28-0.61; P < .001). The system revision rate was 1.5% in Micra AV patients compared with 5.5% for transvenous dual-chamber patients (hazard ratio 0.25; 95% confidence interval 0.13-0.47; P < .001); this reduction was largely driven by the absence of lead dislodgments requiring revision. The median AV synchrony index was 79.4% (interquartile range 65.2%-86.4%) in patients paced >90%. CONCLUSION: The Micra AV leadless pacemaker was implanted with a high rate of success in patients with multiple comorbidities, with a significantly lower rate of complications and system revisions through 12 months compared to a historical cohort of patients with transvenous dual-chamber pacemakers.

Association Between Sleep Apnea Treatment and Health Care Resource Use in Patients With Atrial Fibrillation.

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<0.001]), all-cause hospitalizations (0.19±0.69 versus 0.24±0.72 [P=0.002] versus 0.34±1.16 [P<0.001]), and cardiac-related hospitalizations (0.06±0.26 versus 0.09±0.41 [P=0.023] versus 0.10±0.44 [P=0.004]) were significantly lower in adherent versus intermediate and nonadherent patients, as were all-cause inpatient costs ($2200±$8054 versus $3274±$12 065 [P=0.002] versus $4483±$16 499 [P<0.001]). All-cause emergency department costs were significantly lower in adherent and intermediate versus nonadherent patients ($499±$1229 and $563±$1292 versus $691±$1652 [P<0.001 and P=0.002], respectively). CONCLUSIONS: These data suggest clinical and economic benefits of PAP therapy in patients with concomitant OSA and atrial fibrillation. This supports the value of diagnosing and managing OSA and highlights the need for strategies to enhance PAP adherence in this population.

Assessment of Days Alive Out of Hospital as a Possible End Point in Trials of Stroke Prevention for Atrial Fibrillation: A ROCKET AF Analysis.

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.

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

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

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

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

Prognostic Impact of Sinus Rhythm in Atrial Fibrillation Patients: Separating Rhythm Outcomes From Randomized Strategy Findings From the CABANA Trial.

BACKGROUND: Clinically detected atrial fibrillation (AF) is associated with a significant increase in mortality and other adverse cardiovascular events. Since the advent of effective methods for AF rhythm control, investigators have attempted to determine how much these adverse prognostic AF effects could be mitigated by the restoration of sinus rhythm (SR) and whether the method used mattered. METHODS: The CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) randomized 2204 AF patients to ablation versus drug therapy, of which 1240 patients were monitored in follow-up using the CABANA ECG rhythm monitoring system. To assess the prognostic benefits of SR, we performed a prespecified analysis using Cox survival modeling with heart rhythm as a time-dependent variable and randomized treatment group as a stratification factor. RESULTS: In the 1240 patient study cohort, 883 (71.2%) had documented AF at some point during their postblanking follow-up. Among the 883 patients, 671 (76.0%) experienced AF within the first year of postblanking follow-up, and 212 (24.0%) experienced their first AF after ≥1 year of postblanking follow-up. The primary CABANA end point (death, disabling stroke, serious bleeding, or cardiac arrest) occurred in 95 (10.8%) of the 883 patients with documented AF and in 29 (8.1%) of the 357 patients with no AF recorded during follow-up. In multivariable time-dependent analysis, the presence of SR (compared with non-SR) was associated with a significantly reduced risk of the primary end point (adjusted hazard ratio, 0.57 [95% CI, 0.38-0.85]; P=0.006; independent of treatment strategy [ablation versus drugs]). Corresponding results for all-cause mortality were adjusted hazard ratio of 0.59 [95% CI, 0.35-1.01]; P=0.053). CONCLUSIONS: In patients in the CABANA trial with detailed long-term rhythm follow-up, increased time in SR was associated with a clinically consequential decrease in mortality and other adverse prognostic events. The predictive value of SR was independent of the therapeutic approach responsible for reducing the burden of detectable AF. REGISTRATION: URL: https://clinicaltrials.gov; Unique Identifier: NCT00911508.