Drug Therapy For Atrial Fibrillation Research Articles

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

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. 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. 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). 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. URL: https://clinicaltrials.gov; Unique Identifier: NCT00911508.

Regional Differences in Outcomes with Ablation Versus Drug Therapy for Atrial Fibrillation: Results from the CABANA Trial

The finding of unexpected variations in treatment benefits by geographic region in international clinical trials raises complex questions about the interpretation and generalizability of trial findings. We observed such geographical variations in outcome and in the effectiveness of atrial fibrillation (AF) ablation versus drug therapy in the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. This paper describes these differences and investigates potential causes. The examination of treatment effects by geographic region was a prespecified analysis. CABANA enrolled patients from 10 countries, with 1,285 patients at 85 North American (NA) sites and 919 at 41 non-NA sites. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Death and first atrial fibrillation recurrence were secondary endpoints. At least 1 primary endpoint event occurred in 157 patients (12.2%) from NA and 33 (3.6%) from non-NA sites over a median 54.9 and 40.5 months of follow-up, respectively (NA/non-NA adjusted hazard ratio (HR) 2.18, 95% confidence interval (CI) 1.48-3.21, P < .001). In NA patients, 78 events occurred in the ablation and 79 in the drug arm, (HR 0.91, 95% CI 0.66, 1.24) while 11 and 22 events occurred in non-NA patients (HR 0.51, 95% CI 0.25,1.05, interaction P = .154). Death occurred in 53 ablation and 51 drug therapy patients in the NA group (HR 0.96, 95% CI 0.65,1.42) and in 5 ablation and 16 drug therapy patients in the non-NA group (HR 0.32, 95% CI 0.12,0.86, interaction P = .044). Adjusting for baseline regional differences or prognostic risk variables did not account for the regional differences in treatment effects. Atrial fibrillation recurrence was reduced by ablation in both regions (NA: HR 0.54, 95% CI 0.46, 0.63; non-NA: HR 0.44, 95% CI 0.30, 0.64, interaction P = .322). In CABANA, primary outcome events occurred significantly more often in the NA group but assignment to ablation significantly reduced all-cause mortality in the non-NA group only. These differences were not explained by regional variations in procedure effectiveness, safety, or patient characteristics. ClinicalTrials.gov Identifier: NCT0091150; https://clinicaltrials.gov/study/NCT00911508.

Abstract 13528: Sex Differences in Healthcare Resource Utilization in Patients With Atrial Fibrillation Receiving Dronedarone versus Sotalol Following Ablation

Introduction: Patterns of anti-arrhythmic drug therapy for atrial fibrillation (AF) treatment and outcomes may differ by sex. Dronedarone has shown clinical benefit vs sotalol post-ablation in males and females with AF; however, the impact of these drugs on healthcare resource utilization (HCRU) remains unknown among sex subgroups. Methods: We conducted two retrospective, observational cohort analyses using IBM MarketScan® data (Jan 2012-Mar 2020) in adult male and female patients with AF who received dronedarone or sotalol post-ablation. Patients were required to have had 12 months’ available pre-ablation data; follow-up ended at the earliest of health-plan disenrollment, death or end of data availability (Dec 2020). Prevalence (per 100 patient-years [PY]) during the post-ablation period was calculated for all-cause HCRU (hospitalizations; emergency room [ER] visits; outpatient office visits; other outpatient services). Patients receiving sotalol were propensity score matched 1:1 to patients receiving dronedarone and outcomes were compared using univariate generalized linear models with Poisson distribution. Results: In females (n=460 per cohort ; age at ablation: ~64 years; mean follow-up: ~29 months; prior heart failure: ~14.6%; mean Charlson comorbidity index [CCI]: ~0.8), post-ablation prevalence of ER visits, outpatient office visits, and other outpatient services were significantly lower with dronedarone than sotalol (Table). In males (n=1112 per cohort; age at ablation: ~60 years; mean follow-up: ~29 months; prior heart failure: ~12%; mean CCI: ~0.8), post-ablation prevalence of hospitalizations was significantly lower with dronedarone than sotalol, but other HCRU measures were similar. Conclusions: In females post-AF ablation, dronedarone was generally associated with lower HCRU than sotalol. In males, dronedarone was associated with lower hospitalization prevalence than sotalol, but other HCRU was similar.

USE OF POINT-OF-CARE ULTRASONOGRAPHY (POCUS) TO PREVENT DILTIAZEM-INDUCED CARDIOGENIC SHOCK

USE OF POINT-OF-CARE ULTRASONOGRAPHY (POCUS) TO PREVENT DILTIAZEM-INDUCED CARDIOGENIC SHOCK

Cost-Effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy in Atrial Fibrillation: The CABANA Randomized Clinical Trial.

In the CABANA trial (Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation), catheter ablation did not significantly reduce the primary end point of death, disabling stroke, serious bleeding, or cardiac arrest compared with drug therapy by intention-to-treat, but did improve the quality of life and freedom from atrial fibrillation recurrence. In the heart failure subgroup, ablation improved both survival and quality of life. Cost-effectiveness was a prespecified CABANA secondary end point. Medical resource use data were collected for all CABANA patients (N=2204). Costs for hospital-based care were assigned using prospectively collected bills from US patients (n=1171); physician and medication costs were assigned using the Medicare Fee Schedule and National Average Drug Acquisition Costs, respectively. Extrapolated life expectancies were estimated using age-based survival models. Quality-of-life adjustments were based on EQ-5D-based utilities measured during the trial. The primary outcome was the incremental cost-effectiveness ratio, comparing ablation with drug therapy on the basis of intention-to-treat, and assessed from the US health care sector perspective. Costs in the first 3 months averaged $20 794±SD 1069 higher with ablation compared with drug therapy. The cumulative within-trial 5-year cost difference was $19 245 (95% CI, $11 360-$27 170) and the lifetime mean cost difference was $15 516 (95% CI, -$2963 to $35,512) higher with ablation than with drug therapy. The drug therapy arm accrued an average of 12.5 life-years (LYs) and 10.7 quality-adjusted life-years (QALYs). For the ablation arm, the corresponding estimates were 12.6 LYs and 11.0 QALYs. The incremental cost-effectiveness ratio was $57 893 per QALY gained, with 75% of bootstrap replications yielding an incremental cost-effectiveness ratio <$100 000 per QALY gained. With no quality-of-life/utility adjustments, the incremental cost-effectiveness ratio was $183 318 per LY gained. Catheter ablation of atrial fibrillation was economically attractive compared with drug therapy in the CABANA Trial overall at present benchmarks for health care value in the United States on the basis of projected incremental QALYs but not LYs alone.

The 2020 ESC atrial fibrillation guidelines for atrial fibrillation catheter ablation, CABANA, and EAST.

Prior randomised clinical trials (RCTs) have suggested that rhythm control offers no benefit compared to accepting AF and instituting rate control in terms of all-cause mortality, CV mortality and sudden death; as a consequence, the ESC AF guidelines have recommended rhythm control for reducing AF-related symptoms and improving quality of life. The Early Treatment of Atrial Fibrillation for Stroke Prevention Trial (EAST-AFNET 4) evaluated whether a more up-to-date rhythm control management strategy provides a benefit in mortality or stroke rates while the Catheter Ablation vs Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial evaluated whether catheter ablation was better than drug therapy in preventing a composite of death, disabling stroke, serious bleeding or cardiac arrest. This document critically reviews the recommendations of the 2020 ESC guidelines for the management of AF in the light of these two landmark trials, both of which have underlined the safety of contemporary rhythm control treatment. Considering the safety of the different strategies in modern AF treatment, a personalized approach taking into account the specific patient profile and preferences of the individual patient is needed.

Pharmacological Management of Atrial Fibrillation: A Century of Expert Opinions in Cecil Textbook of Medicine.

Advances in drug therapy for atrial fibrillation (AF) have had a significant impact on the quality of life of a substantial majority of affected persons, which has contributed to a remarkable decrease in the frequency and severity of thromboembolic complications, hospitalizations, and mortality. What are the milestones of the changes in the expert approach to the pharmacological management of AF in the past century? To determine the changes in the experts' approach to the management of AF, as presented in a widely used textbook in the United States. The chapters presenting the management of AF in the 26 editions of Cecil Textbook of Medicine published from 1927 through 2020. AF was consistently described in Cecil Textbook of Medicine as the most common sustained arrhythmia in adults. The authors emphasized its thromboembolic complications and potential for hemodynamic deterioration. Rate control with digitalis and rhythm control with quinidine were the standard in 1927. The pharmacological advances have focused on atrioventricular nodal blocking for rate control, conversion to and maintenance of sinus rhythm, and preventive anticoagulation. The first new class of drugs for rate control was beta-adrenergic receptor blockers, starting with propranolol which was introduced in 1979, followed by the calcium channel blocker verapamil in 1988. Rhythm control with amiodarone, a potassium channel blocker, has been recommended since 2004, and the sodium channel blockers propafenone and flecainide became part of standard therapy in 2008. Anticoagulation with warfarin was recommended starting in 2000, followed by the introduction of direct thrombin inhibitor in 2012 and factor Xa inhibitors in 2016. The pharmacological management of AF was unchanged for more than 50 years (1927-1979), a period during which the devastating effects of thromboembolic complications were not addressed. The major therapeutic advance is represented by preventive anticoagulation with the newer, safer, and more user-friendly direct thrombin and factor Xa inhibitors.

Association Between Age and Outcomes of Catheter Ablation Versus Medical Therapy for Atrial Fibrillation: Results From the CABANA Trial.

Observational data suggest that catheter ablation may be safe and effective to treat younger and older patients with atrial fibrillation. No large, randomized trial has examined this issue. This report describes outcomes according to age at entry in the CABANA trial (Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). Patients with atrial fibrillation ≥65 years of age, or <65 with ≥1 risk factor for stroke, were randomly assigned to catheter ablation versus drug therapy. The primary outcome was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Secondary outcomes included all-cause mortality, the composite of mortality or cardiovascular hospitalization, and recurrence of atrial fibrillation. Treatment effect estimates were adjusted for baseline covariables using proportional hazards regression models. Of 2204 patients randomly assigned in CABANA, 766 (34.8%) were <65 years of age, 1130 (51.3%) were 65 to 74 years of age, and 308 (14.0%) were ≥75 years of age. Catheter ablation was associated with a 43% reduction in the primary outcome for patients <65 years of age (adjusted hazard ratio [aHR], 0.57 [95% CI, 0.30-1.09]), a 21% reduction for 65 to 74 years of age (aHR, 0.79 [95% CI, 0.54-1.16]), and an indeterminate effect for age ≥75 years of age (aHR, 1.39 [95% CI, 0.75-2.58]). Four-year event rates for ablation versus drug therapy across age groups, respectively, were 3.2% versus 7.8%, 7.8% versus 9.6%, and 14.8% versus 9.0%. For every 10-year increase in age, the primary outcome aHR increased (ie, less favorable to ablation) an average of 27% (interaction P value=0.215). A similar pattern was seen with all-cause mortality: for every 10-year increase in age, the aHR increased an average of 46% (interaction P value=0.111). Atrial fibrillation recurrence rates were lower with ablation than with drug therapy across age subgroups (aHR 0.47, 0.58, and 0.49, respectively). Treatment-related complications were infrequent for both arms (<3%) regardless of age. We found age-based variations in clinical outcomes for catheter ablation compared with drug therapy, with the largest relative and absolute benefits of catheter ablation in younger patients. No prognostic benefits for ablation were seen in the oldest patients. No differences were found by age in treatment-related complications or in the relative effectiveness of catheter ablation in preventing recurrent atrial arrhythmias. URL: https://www. gov; Unique identifier: NCT00911508.

Ablation Versus Drug Therapy for Atrial Fibrillation in Racial and Ethnic Minorities

BackgroundRhythm control strategies for atrial fibrillation (AF), including catheter ablation, are substantially underused in racial/ethnic minorities in North America. ObjectivesThis study sought to describe outcomes in the CABANA trial as a function of race/ethnicity. MethodsCABANA randomized 2,204 symptomatic participants with AF to ablation or drug therapy including rate and/or rhythm control drugs. Only participants in North America were included in the present analysis, and participants were subgrouped as racial/ethnic minority or nonminority with the use of National Institutes of Health definitions. The primary endpoint was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. ResultsOf 1,280 participants enrolled in CABANA in North America, 127 (9.9%) were racial and ethnic minorities. Compared with nonminorities, racial and ethnic minorities were younger with median age 65.6 versus 68.5 years, respectively, and had more symptomatic heart failure (37.0% vs 22.0%), hypertension (92.1% vs 76.8%, respectively), and ejection fraction <40% (20.8% vs 7.1%). Racial/ethnic minorities treated with ablation had a 68% relative reduction in the primary endpoint (adjusted hazard ratio [aHR]: 0.32; 95% confidence interval [CI]: 0.13-0.78) and a 72% relative reduction in all-cause mortality (aHR: 0.28; 95% CI: 0.10-0.79). Primary event rates in racial/ethnic minority and nonminority participants were similar in the ablation arm (4-year Kaplan-Meier event rates 12.3% vs 9.9%); however, racial and ethnic minorities randomized to drug therapy had a much higher event rate than nonminority participants (27.4% vs. 9.4%). ConclusionAmong racial or ethnic minorities enrolled in the North American CABANA cohort, catheter ablation significantly improved major clinical outcomes compared with drug therapy. These benefits, which were not seen in nonminority participants, appear to be due to worse outcomes with drug therapy. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508).

Acute Lung Injury Associated With Perioperative Amiodarone Therapy—Navigating the Challenges in Diagnosis and Management

AMIODARONE IS an antiarrhythmic that commonly is indicated in the cardiothoracic surgical intensive care unit for the management of atrial fibrillation. 1 Boons J Van Biesen S Fivez T et al. Mechanisms, prevention and treatment of atrial fibrillation after cardiac surgery: A narrative review [epub ahead of print]. J Cardiothorac Vasc Anesth. 2021; (Accessed June 14th 2021)https://doi.org/10.1053/j.jvca.2020.11.030 Abstract Full Text Full Text PDF PubMed Scopus (2) Google Scholar ,2 Zimetbaum P. Antiarrhythmic drug therapy for atrial fibrillation. Circulation. 2012; 125: 381-389 Crossref PubMed Scopus (153) Google Scholar Acute lung injury associated with amiodarone exposure is a rare but life-threatening syndrome that may complicate perioperative management. 3 Feduska ET Thoma BN Torjman MC et al. Acute amiodarone pulmonary toxicity. J Cardiothorac Vasc Anesth. 2021; 35: 1485-1494 Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar This case conference presents a complex clinical scenario that included acute pulmonary toxicity in the setting of amiodarone therapy for atrial fibrillation. The subsequent expert commentaries explore the diagnostic and management options for this pharmacologic complication in light of the recent literature.

Antiarrhythmic drug therapy for atrial fibrillation

Antiarrhythmic drug therapy for atrial fibrillation

Association Between Sex and Treatment Outcomes of Atrial Fibrillation Ablation Versus Drug Therapy: Results From the CABANA Trial.

Among patients with atrial fibrillation (AF), women are less likely to receive catheter ablation and may have more complications and less durable results. Most information about sex-specific differences after ablation comes from observational data. We prespecified an examination of outcomes by sex in the 2204-patient CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). CABANA randomized patients with AF age ≥65 years or <65 years with ≥1 risk factor for stroke to a strategy of catheter ablation with pulmonary vein isolation versus drug therapy with rate/rhythm control agents. The primary composite outcome was death, disabling stroke, serious bleeding, or cardiac arrest, and key secondary outcomes included AF recurrence. CABANA randomized 819 (37%) women (ablation 413, drug 406) and 1385 men (ablation 695, drug 690). Compared with men, women were older (median age, 69 years versus 67 years for men), were more symptomatic (48% Canadian Cardiovascular Society AF Severity Class 3 or 4 versus 39% for men), had more symptomatic heart failure (42% with New York Heart Association Class ≥II versus 32% for men), and more often had a paroxysmal AF pattern at enrollment (50% versus 39% for men) (P<0.0001 for all). Women were less likely to have ancillary (nonpulmonary vein) ablation procedures performed during the index procedure (55.7% versus 62.2% in men, P=0.043), and complications from treatment were infrequent in both sexes. For the primary outcome, the hazard ratio for those who underwent ablation versus drug therapy was 1.01 (95% CI, 0.62-1.65) in women and 0.73 (95% CI, 0.51-1.05) in men (interaction P value=0.299). The risk of recurrent AF was significantly reduced in patients undergoing ablation compared with those receiving drug therapy regardless of sex, but the effect was greater in men (hazard ratio, 0.64 [95% CI, 0.51-0.82] for women versus hazard ratio, 0.48 [95% CI, 0.40-0.58] for men; interaction P value=0.060). Clinically relevant treatment-related strategy differences in the primary and secondary clinical outcomes of CABANA were not seen between men and women, and there were no sex differences in adverse events. The CABANA trial results support catheter ablation as an effective treatment strategy for both women and men. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT00911508.

Ablation Versus Drug Therapy for Atrial Fibrillation in Heart Failure: Results From the CABANA Trial.

In patients with heart failure and atrial fibrillation (AF), several clinical trials have reported improved outcomes, including freedom from AF recurrence, quality of life, and survival, with catheter ablation. This article describes the treatment-related outcomes of the AF patients with heart failure enrolled in the CABANA trial (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation). The CABANA trial randomized 2204 patients with AF who were ≥65 years old or <65 years old with ≥1 risk factor for stroke at 126 sites to ablation with pulmonary vein isolation or drug therapy including rate or rhythm control drugs. Of these, 778 (35%) had New York Heart Association class >II at baseline and form the subject of this article. The CABANA trial's primary end point was a composite of death, disabling stroke, serious bleeding, or cardiac arrest. Of the 778 patients with heart failure enrolled in CABANA, 378 were assigned to ablation and 400 to drug therapy. Ejection fraction at baseline was available for 571 patients (73.0%), and 9.3% of these had an ejection fraction <40%, whereas 11.7% had ejection fractions between 40% and 50%. In the intention-to-treat analysis, the ablation arm had a 36% relative reduction in the primary composite end point (hazard ratio, 0.64 [95% CI, 0.41-0.99]) and a 43% relative reduction in all-cause mortality (hazard ratio, 0.57 [95% CI, 0.33-0.96]) compared with drug therapy alone over a median follow-up of 48.5 months. AF recurrence was decreased with ablation (hazard ratio, 0.56 [95% CI, 0.42-0.74]). The adjusted mean difference for the AFEQT (Atrial Fibrillation Effect on Quality of Life) summary score averaged over the entire 60-month follow-up was 5.0 points, favoring the ablation arm (95% CI, 2.5-7.4 points), and the MAFSI (Mayo Atrial Fibrillation-Specific Symptom Inventory) frequency score difference was -2.0 points, favoring ablation (95% CI, -2.9 to -1.2). In patients with AF enrolled in the CABANA trial who had clinically diagnosed stable heart failure at trial entry, catheter ablation produced clinically important improvements in survival, freedom from AF recurrence, and quality of life relative to drug therapy. These results, obtained in a cohort most of whom had preserved left ventricular function, require independent trial verification. Registration: URL: https://www.clinicaltrials.gov/ct2/show/NCT00911508; Unique identifier: NCT0091150.

Revisiting Antiarrhythmic Drug Therapy for Atrial Fibrillation: Reviewing Lessons Learned and Redefining Therapeutic Paradigms.

Since the clinical use of digitalis as the first pharmacological therapy for atrial fibrillation (AF) 235 years ago in 1785, antiarrhythmic drug therapy has advanced considerably and become a cornerstone of AF clinical management. Yet, a preventive or curative panacea for sustained AF does not exist despite the rise of AF global prevalence to epidemiological proportions. While multiple elevated risk factors for AF have been established, the natural history and etiology of AF remain incompletely understood. In the present article, the first section selectively highlights some disappointing shortcomings and current efforts in antiarrhythmic drug therapy to uncover reasons why AF is such a clinical challenge. The second section discusses some modern takes on the natural history of AF as a relentless, progressive fibro-inflammatory “atriomyopathy.” The final section emphasizes the need to redefine therapeutic strategies on par with new insights of AF pathophysiology.

Does Catheter Ablation Lower the Long-Term Risk of Stroke and Mortality in Patients with Atrial Fibrillation? A Concise Review of the Current State of Knowledge.

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide and carries a significant risk of morbidity and mortality. Multiple trials have highlighted the benefit of catheter ablation over medical therapy in restoring sinus rhythm and improving quality of life. Whether it reduces long-term risk of stroke and mortality is still unclear.We performed a literature search using the PubMed database to review the current state of knowledge regarding the long-term outcomes of stroke and mortality in ablated patients compared to patients who receive medical therapy. Our review mainly consisted of recent randomized controlled trials and large observational studies. Results from large observational studies show that catheter ablation significantly reduces the risk of stroke in high-risk patients and mortality compared to medical therapy. However, randomized controlled trials have only demonstrated a mortality benefit in patients with comorbid systolic heart failure. In patients with paroxysmal AF, ablation therapy significantly limits the progression to persistent AF and has a higher efficacy in restoring sinus rhythm. Maintenance of sinus rhythm is the most important factor associated with lower long term risk of stroke and mortality.Large randomized controlled trials similar to the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial are still needed to clarify whether catheter ablation is superior over medical therapy in improving the long-term outcomes of stroke and mortality.

Recurrence of Atrial Fibrillation After Catheter Ablation or Antiarrhythmic Drug Therapy in the CABANA Trial

BackgroundThe CABANA (Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation) trial randomized 2,204 patients with atrial fibrillation (AF) to catheter ablation or drug therapy. Analysis by intention-to-treat showed a nonsignificant 14% relative reduction in the primary outcome of death, disabling stroke, serious bleeding, or cardiac arrest. ObjectivesThe purpose of this study was to assess recurrence of AF in the CABANA trial. MethodsThe authors prospectively studied CABANA patients using a proprietary electrocardiogram recording monitor for symptom-activated and 24-h AF auto detection. The AF recurrence endpoint was any post–90-day blanking atrial tachyarrhythmias lasting 30 s or longer. Biannual 96-h Holter monitoring was used to assess AF burden. Patients who used the CABANA monitors and provided 90-day post-blanking recordings qualified for this analysis (n = 1,240; 56% of CABANA population). Treatment comparisons were performed using a modified intention-to-treat approach. ResultsMedian age of the 1,240 patients was 68 years, 34.4% were women, and AF was paroxysmal in 43.0%. Over 60 months of follow-up, first recurrence of any symptomatic or asymptomatic AF (hazard ratio: 0.52; 95% confidence interval: 0.45 to 0.60; p < 0.001) or first symptomatic-only AF (hazard ratio: 0.49; 95% confidence interval: 0.39 to 0.61; p < 0.001) were both significantly reduced in the catheter ablation group. Baseline Holter AF burden in both treatment groups was 48%. At 12 months, AF burden in ablation patients averaged 6.3%, and in drug-therapy patients, 14.4%. AF burden was significantly less in catheter ablation compared with drug-therapy patients across the 5-year follow-up (p < 0.001). These findings were not sensitive to the baseline pattern of AF. ConclusionsCatheter ablation was effective in reducing recurrence of any AF by 48% and symptomatic AF by 51% compared with drug therapy over 5 years of follow-up. Furthermore, AF burden was also significantly reduced in catheter ablation patients, regardless of their baseline AF type. (Catheter Ablation vs Anti-arrhythmic Drug Therapy for Atrial Fibrillation Trial [CABANA]; NCT00911508)

P421Efficacy of radiofrequency ablation and drug therapy of atrial fibrillation in patients with heart failure

Abstract Objective to compare the efficacy of radiofrequency ablation (RFA) and drug therapy in patients with atrial fibrillation (AFib) and heart failure (HF) within 12-month follow-up. Materials and methods 130 patients (men-75%, average age-62.8 ± 11.8 years) with AFib and HF with left ventricular ejection fraction (LVEF)&amp;lt;50% were included in a prospective study. In 107 (82%) of the included patients, intermediate LVEF was detected (40-49%). At the time of inclusion, paroxysmal AFib (PaAFib) was recorded in 60 (46%) of patients and persistent AFib (PeAFib) in 70 (54%). AFib RFA was performed in 65 patients, 65 patients continued to receive optimal antiarrhythmic therapy. Prior to the intervention and after 12 months, all patients underwent transthoracic echocardiography and quality of life (QoL) assessment using the SF-36 questionnaire. Results the freedom from AFib within 12 months follow-up period was registred in 49 (75%) of patients in the RFA group and 26 (40%) in the drug therapy group. After 12 month follow-up period we revealed increase of LVEF (p &amp;lt; 0.001), decrease of anteroposterior size (p &amp;lt;0.001) and volume (p &amp;lt; 0.001) of left atrium (LA), improvement of mental (p = 0.008) and physical (p = 0.048) health components according to the SF-36 questionnaire in the RFA group. In the group of drug rhythm control, after 12 months there was only the improvement of mental (p = 0.006) and physical p = 0.016) health components and it was much less than in RFA group (р&amp;lt;0.001). Similar results were received in patients who were free from Afib within 12 months in both groups. Conclusions in patients with AFib and HF with LVEF &amp;lt; 50%, restoration and maintenance of sinus rhythm using RFA was accompanied by an increase in LVEF, decrease of LA size, and an improvement of QoL. In the group of drug therapy, there was a lower freedom from AFib and there was the slight improvement only in QoL.

Prevalence and Progression of Cognitive Impairment in Atrial Fibrillation Patients after Treatment with Catheter Ablation or Drug Therapy.

Purpose In atrial fibrillation (AF) patients, the effect of catheter ablation or drug therapy on cognition is currently not well investigated. Therefore, we prospectively evaluated AF patients who were either treated 'with drug therapy or underwent catheter ablation for the prevalence and progression of cognitive impairment (CI). Methods Randomized participants of the CABANA trial (catheter ablation versus antiarrhythmic drug therapy for atrial fibrillation) and the CASTLE-AF (catheter ablation versus standard conventional treatment in patients with left ventricular dysfunction and atrial fibrillation) study were assessed twice within 6 months by Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE) in our institution. Results Forty-five patients from both trials were investigated, and twenty-eight patients received catheter ablation, whereas seventeen patients received drug therapy for rhythm or rate control. The mean age of the twenty-one CABANA trial patients (AF group) was 68.8 ± 7.0 years and of the twenty-four CASTLE-AF study patients (AF/HF group) was 66.8 ± 8.1 years, respectively. Mean time from ablation/randomization to the first interview was 16.8 ± 11 months in the AF group and 28.3 ± 18.4 months in the AF/HF group, respectively. All patients investigated were classified as cognitively impaired with mean cutoff scores <24 by MoCA. Overall, we could not detect significant differences in medically treated versus catheter ablation patients within both groups in mean MMSE or MoCA scores between the first and the second interview (p > 0.09). Moreover, patients who received catheter ablation did not show statistically significant differences in the prevalence or progression of cognitive impairment compared to patients who were treated medically, neither within the two groups nor between AF and AF/HF patients (p > 0.05). Conclusions Prevalence of cognitive impairment in AF patients with comorbidities is substantial. However, in this preliminary prospective study, no apparent impact of AF pretreatment on the prevalence and course of cognitive impairment could be observed.

Radiofrequency Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation: Meta-analysis of Safety and Efficacy.

Radiofrequency ablation (RFA) and antiarrhythmic drugs (AADs) are the main treatments used for atrial fibrillation (AF). In recent years, a number of articles comparing the 2 treatments have begun to emerge. Though, the influence of follow-up time in the meta-analysis was not considered in these articles. However, more recently, large-scale clinical trial articles have included follow-up with the patients up to 5 years after treatment. Therefore, the aim of this study was to assess the impact of variable follow-up times on the recurrence of AF by observing both the short-term and long-term efficacy and safety of catheter ablation and AADs for the treatment of AF. The primary investigators of eligible randomized controlled trials were invited to contribute standardized outcome data. Random effect summary estimates were calculated as standardized mean differences and odds ratios with 95% confidence intervals for continuous and binary outcomes. In this study, 9 randomized controlled trials (n = 1542 patients) were included. The rate of recurrence of AF with no limit on follow-up time, >12 months, >18 months, >24 months, >30 months, and approximately 36 months was compared. Furthermore, the gap between the RFA and AAD groups in the recurrence rate of AF was found to decrease inversely to follow-up time. When the follow-up time reached 24 months, the difference between RFA and AAD was relatively stable with an odds ratio of 0.45 (95% confidence interval: 0.32-0.62). Overall, RFA decreased adverse events in the remaining trials; however, AAD performed better in terms of safety and had fewer adverse events with RFA usually causing more serious complications. RFA is more advantageous in terms of recurrence rate of AF than drug therapy. In addition, the analysis suggests that this effect persists during long-term follow-up; however, these benefits appear to decrease with longer follow-up time. Finally, AAD performed better in terms of safety and had fewer adverse events.

Atrial fibrillation ablation in practice: assessing CABANA generalizability.

The Catheter Ablation vs. Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial aimed to assess the impact of ablation on morbidity and mortality. This observational study was conducted in parallel to CABANA to assess trial generalizability. Using a large US administrative database, we identified 183760 patients with atrial fibrillation (AF) treated with ablation or medical therapy (antiarrhythmic or rate control drugs) between 1 August 2009 and 30 April 2016 (CABANA enrolment period). Propensity score weighting was used to balance patients treated with ablation (N = 12032) or medical therapy alone (N = 171728) on 90 dimensions. Ablation was associated with a reduction in the composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest [hazard ratio (HR) 0.75, 95% confidence interval (CI) 0.70-0.81; P < 0.001]. The majority of patients (73.8%) were potentially trial eligible; among whom the risk reduction associated with ablation was greatest (HR 0.70, 95% CI 0.63-0.77; P < 0.001). Among the 3.8% of patients who failed to meet the inclusion criterion, i.e. patients under 65 years without stroke risk factors, the event rates were low and there was no significant relationship with ablation (HR 0.67, 95% CI 0.29-1.56; P = 0.35). Among the 22.4% patients who met at least one of the trial exclusion criteria, there was a lesser but statistically significant reduction associated with ablation (HR 0.85, 95% CI 0.75-0.95; P = 0.01). In routine clinical care, ablation was associated with a reduction in the primary CABANA composite endpoint of all-cause mortality, stroke, major bleeding, and cardiac arrest, particularly in patients who were eligible for the trial.