Ablation Versus Antiarrhythmic Drug Therapy Research Articles

Catheter ablation versus antiarrhythmic drug therapy for sustained ventricular tachycardia in patients with hypertrophic cardiomyopathy.

Ventricular tachycardia (VT) is the primary cause of sudden cardiac death in patients with hypertrophic cardiomyopathy (HCM). However, the strategy for VT treatment in HCM patients remains unclear. This study is aimed to compare the effectiveness of catheter ablation versus antiarrhythmic drug (AAD) therapy for sustained VT in patients with HCM. A total of 28 HCM patients with sustained VT at 4 different centers between December 2012 and December 2021 were enrolled. Twelve underwent catheter ablation (ablation group) and sixteen received AAD therapy (AAD group). The primary outcome was VT recurrence during follow-up. Baseline characteristics were comparable between two groups. After a mean follow-up of 31.4 ± 17.5 months, the primary outcome occurred in 35.7% of the ablation group and 90.6% of the AAD group (hazard ratio [HR], 0.29 [95%CI, 0.10-0.89]; P = 0.021). No differences in hospital admission due to cardiovascular cause (25.0% vs. 71.0%; P = 0.138) and cardiovascular cause-related mortality/heart transplantation (9.1% vs. 50.6%; P = 0.551) were observed. However, there was a significant reduction in the composite endpoint of VT recurrence, hospital admission due to cardiovascular cause, cardiovascular cause-related mortality, or heart transplantation in ablation group as compared to that of AAD group (42.9% vs. 93.7%; HR, 0.34 [95% CI, 0.12-0.95]; P = 0.029). In HCM patients with sustained VT, catheter ablation reduced the VT recurrence, and the composite endpoint of VT recurrence, hospital admission due to cardiovascular cause, cardiovascular cause-related mortality, or heart transplantation as compared to AAD.

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.

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.

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)

Cost-effectiveness of ablation of ventricular tachycardia in ischaemic cardiomyopathy: limitations in the trial evidence base

ObjectiveCatheter ablation is an important treatment for ventricular tachycardia (VT) that reduces the frequency of episodes of VT. We sought to evaluate the cost-effectiveness of catheter ablation versus antiarrhythmic drug...

P3816Cost-effectiveness of ventricular tachycardia catheter ablation: limitations in the current trial evidence base

Abstract Introduction Randomised clinical trials (RCTs) have suffered from criticisms including a lack of generalisability as well as a lack of cost-effectiveness analysis of the different interventions being studied. Such analyses are used by organisations including the UK's National institute for Health and Care Excellence (NICE) to inform system-level decisions regarding which treatments are funded. There is the potential for a growing chasm to exist between what is the latest innovation in cardiology and what can be afforded. Purpose To evaluate the cost-effectiveness of ventricular tachycardia (VT) catheter ablation versus anti-arrhythmic drug (AAD) therapy in ischemic heart disease. Methods A decision-analytic Markov model was used to calculate the costs and health outcomes of catheter ablation or AAD treatment of VT for a hypothetical cohort of patients with ischaemic cardiomyopathy andan implantable cardioverter defibrillator (ICD). Model inputs where informed using RCT-level evidence [Table 1] wherever possible. Costs were calculated from a UK perspective. Results Catheter ablation vs. AAD therapy had an incremental cost-effectiveness ratio (ICER) of £144,150 (€161,448) per quality adjusted life year (QALY) gained, over a five-year time horizon. The ICER for a ten-year time horizon was £75,074 (€84,083) and £69,986 (€78,384) over the cohort's lifetime. Using probabilistic sensitivity analyses to account for model parameter uncertainty, the likelihood of catheter ablation being cost-effective was only 11%, assuming a willingness to pay threshold of £30,000 used by the NICE [Figure 1]. Table 1. Summary of RCT level source data used to inform Markov model inputs Name of trial SMASH VT VTACH SMS CALYPSO VANISH VISTA Sample size 128 110 111 27 259 118 Mean age 67 66 67 64 68 66 Control AAD AAD AAD AAD AAD Clinical ablation Intervention Ablation Ablation Ablation Ablation Ablation Substrate ablation Length of follow up 22 months 24 months 28 months 6 months 28 months 12 months Mortality (%) 11% [AAD] 7% [AAD] 19% [AAD] 14% [AAD] 28% [AAD] 15% [C-ablation] vs. vs. vs. vs. vs. vs. 9% [Ablation] 10% [Ablation] 17% [Ablation] 15% [Ablation] 27% [Ablation] 9% [S-Ablation] Readmission (%) 19% [AAD] 55% [AAD] 44% [AAD] 50% [AAD] 31% [AAD] 32% [C-ablation] vs. vs. vs. vs. vs. vs. 12% [S-ablation] 6% [Ablation] 33% [Ablation] 39% [Ablation] 38% [Ablation] 25% [Ablation] Cost-effectiveness acceptability curve Conclusion Catheter ablation of VT is unlikely to be cost-effective compared with AAD therapy alone in patients with ischaemic cardiomyopathy implanted with an ICD based on pooled trial evidence. However, better designed studies incorporating detailed and more frequent quality of life assessment are needed to advise health policy in this field and to provide more informed cost-effectiveness analyses. Acknowledgement/Funding NIHR Academic Clinical Fellowship

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.

Resource use and clinical outcomes in patients with atrial fibrillation with ablation versus antiarrhythmic drug treatment

BackgroundThe objective of our study was to compare resource use and clinical outcomes among atrial fibrillation (AF) patients who underwent catheter ablation versus antiarrhythmic drug (AAD) treatment.MethodsA retrospective cohort design using the Clinical Practice Research Data-Hospital Episode Statistics linkage data from England (2008–2013) was used. Patients undergoing catheter ablation treatment for AF were indexed to the date of first procedure. AAD patients with at least two different AAD drugs were indexed to the first fill of the second AAD. Patients were matched using 1:1 propensity matching. Primary endpoints including inpatient and outpatient visits were compared between ablation and AAD cohorts in the 4 months-1 year period after index. Secondary endpoints including heart failure, stroke, cardioversion, mortality, and a composite outcome were compared for the 4 months-3 years post-index period in the two groups. Cox-proportional hazards models were estimated for clinical outcomes comparison.ResultsA total of 558 patients were matched in the two groups for resource utilization comparison. The average number of cardiovascular (CV)-related outpatient visits in the 4–12 months post-index period were significantly lower in the ablation group versus the AAD group (1.76 vs 3.57, p < .0001). There was no significant difference in all-cause and CV-related inpatient visits and all-cause outpatient visits among the two groups. For secondary endpoints comparison, 615 matched patients in each group emerged. Ablation patients had 38% lower risk of heart failure (hazard ratio [HR] 0.62, p = 0.0318), 50% lower risk of mortality (HR 0.50, p = 0.0082), and 43% lower risk of experiencing a composite outcome (HR 0.57, p = 0.0009) as compared to AAD treatment cohort.ConclusionAF ablation was associated with significantly lower CV-related outpatient visits, and lower risk of heart failure and mortality versus AAD therapy.

Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) Trial: Study Rationale and Design

The Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA,NCT00911508)(1) trial is testing the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of eliminating atrial fibrillation (AF) is superior to current state-of-the-art pharmacologic therapy. This international 140-center clinical trial was designed to randomize 2200 patients to a strategy of catheter ablation versus state-of-the-art rate or rhythm control drug therapy. Inclusion criteria include: 1) age> 65, or ≤65 with≥ 1 risk factor for stroke, 2) documented AF warranting treatment, and 3) eligibility for both catheter ablation and≥ 2 anti-arrhythmic or≥ 2 rate control drugs. Patients were followed every 3 to 6 months (median 4 years) and underwent repeat trans-telephonic monitoring, Holter monitoring, and CT/MR in a subgroup of patient studies to assess the impact of treatment on AF recurrence and atrial structure.With 1100 patients in each treatment arm, CABANA is projected to have 90% power for detecting a 30% relative reduction in the primary composite endpoint of total mortality, disabling stroke, serious bleeding, or cardiac arrest. Secondary endpoints include total mortality; mortality or cardiovascular hospitalization; a combination of mortality, stroke, hospitalization for heart failure or acute coronary artery events; cardiovascular death alone; and heart failure death, as well as AF recurrence, quality of life, and cost effectiveness. At a time when AF incidence is rising rapidly, CABANA will provide critical evidence with which to guide therapy and shape health care policy related to AF for years to come.

Cost-effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy for the Treatment of Atrial Fibrillation: A Canadian Perspective.

Background: Atrial fibrillation (AF) affects approximately 350,000 Canadians and has an estimated annual economic burden exceeding $800 million dollars. Anti-arrhythmic drug (AAD) therapy and catheter ablation (CA) are the two common treatments for paroxysmal AF. However, the upfront costs of CA are quite substantial. Objective: The objective of this study was to assess the cost-effectiveness of CA compared to AAD for AF based on community practice. Methods: A Markov simulation model was developed for a hypothetical cohort of 55-year-old patients with paroxysmal AF and a low stroke risk. Patients received either CA or AAD. Costs and quality-adjusted life years (QALYs) were computed over lifetime, 10-year, and 5-year time horizons. Model inputs were obtained from a large, prospectively collected, single-center Canadian registry and augmented with the published literature, using Canadian cost estimates for disease states. Threshold values of $25,000, $50,000, and $100,000 per QALY, respectively, were used to determine cost-effectiveness. All costs were expressed in 2012 Canadian dollars. Results: The incremental cost-effectiveness ratio for CA versus AAD therapy was $1,228, $22,879, and $63,647 for the lifetime, 10-year, and 5-year time horizons, respectively. Over a lifetime horizon, the probability of achieving cost-effectiveness was 100% for all 3 cost per QALY thresholds. The 10-year probability of achieving cost-effectiveness was 74%, 100%, and 100% at the $25,000, $50,000, and $100,000 thresholds, respectively. The 5-year probability of achieving cost-effectiveness was 0%, 0.9%, and 100% at the 3 cost per QALY thresholds. Results were most sensitive to time horizon, probability of repeat AF ablation, and stroke rate. Conclusions: From the perspective of the Canadian Healthcare system, CA is a potentially cost-effective treatment compared to AAD therapy in a low stroke risk population using real-world data when examining a time horizon of greater than 5 years.

Radiofrequency Ablation Versus Antiarrhythmic Drug Therapy for AtrialFibrillation: Meta-Analysis of Quality of Life, Morbidity, and Mortality.

The aim of this study was to perform a collaborative meta-analysis of published and unpublished quality-of-life, morbidity, and mortality data from randomized controlled trial comparisons of radiofrequency ablation (RFA) and antiarrhythmic drug therapy (AAD) in symptomatic atrial fibrillation. RFA is superior to AAD in decreasing recurrences of atrial fibrillation, but the effects on other clinical outcomes are not well established. The primary investigators of eligible randomized controlled trials were invited to contribute standardized outcome data. Random-effects summary estimates were calculated as standardized mean differences and risk ratios with 95% confidence intervals for continuous and binary outcomes, respectively. Fixed effects were used in subgroup analyses. Twelve randomized controlled trials (n= 1,707 patients) were included. RFA led to greater improvements in436-Item Short Form Health Survey areas and the symptom frequency score from baseline to 3 months. In all quality-of-life metrics, there was a trend toward diminution of the differences between the 2 approaches with follow-up. There were 7of 866 (5 in a study using phased RFA) and 0 of 704 strokes in the RFA and AAD arms, respectively (p=0.02, Fisher exact test). Bleeding and mortality events were not significantly different between the 2 arms. Therewas high heterogeneity for hospitalizations, with decreased hospitalization risk with RFA when it was not first-line therapy (risk ratio: 0.34; 95% confidence interval: 0.24 to 0.46) and increased risk as first-line therapy (risk ratio: 1.22; 95% confidence interval: 1.03 to 1.45). RFA demonstrates an early but nonsustained superiority over AAD for the improvement of quality of life.There are no obvious differences in other clinical outcomes, and the periprocedural stroke risk is non-negligible.

PMD69 Cost-Effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy for the Treatment of Atrial Fibrillation in the UK

PMD69 Cost-Effectiveness of Catheter Ablation Versus Antiarrhythmic Drug Therapy for the Treatment of Atrial Fibrillation in the UK

Silent Cerebral Embolism During Catheter Ablation of Atrial Fibrillation

Radiofrequency catheter ablation is recommended with increasing frequency as part of a treatment regimen for both paroxysmal and persistent forms of symptomatic atrial fibrillation (AF), largely because of the relatively poor efficacy of antiarrhythmic medications1 and trials showing improvement in quality of life and reduction in AF in selected patients.2 The ongoing Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial is a randomized, multicenter study currently enrolling up to 3000 patients to test whether a treatment strategy of left atrial catheter ablation for the purpose of eliminating AF will be superior to current medical therapy for reducing total mortality in patients with AF.3 For catheter ablation to be superior, procedural complications need to be minimized. Article see p 1667 Catheter ablation for AF is infrequently associated with clinically apparent thromboembolism. Cappato et al4 reported a 0.94% incidence of stroke or transient ischemic attack in a worldwide survey of AF ablation, and Scherr et al5 reported a 1.4% incidence overall with a higher incidence in patients with CHADS2 score ≥2 or prior transient ischemic attack. In a study at the Brigham and Women's Hospital, we observed a 0.7% incidence of stroke or transient ischemic attack.6 It is important to recognize that the incidence of asymptomatic embolic events may …

A Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Paroxysmal Atrial Fibrillation: The APAF Study

A Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Paroxysmal Atrial Fibrillation: The APAF Study

A Randomized Trial of Circumferential Pulmonary Vein Ablation Versus Antiarrhythmic Drug Therapy in Paroxysmal Atrial Fibrillation: The APAF Study

We compared ablation strategy with antiarrhythmic drug therapy (ADT) in patients with paroxysmal atrial fibrillation (PAF). Atrial fibrillation (AF) ablation strategy is superior to ADT in patients with an initial history of PAF, but its role in patients with a long history of AF as compared with ADT remains a challenge. One hundred ninety-eight patients (age, 56 +/- 10 years) with PAF of 6 +/- 5 years' duration (mean AF episodes 3.4/month) who had failed ADT were randomized to AF ablation by circumferential pulmonary vein ablation (CPVA) or to the maximum tolerable doses of another ADT, which included flecainide, sotalol, and amiodarone. Crossover to CPVA was allowed after 3 months of ADT. By Kaplan-Meier analysis, 86% of patients in the CPVA group and 22% of those in the ADT group who did not require a second ADT were free from recurrent atrial tachyarrhythmias (AT) (p < 0.001); a repeat ablation was performed in 9% of patients in the CPVA group for recurrent AF (6%) or atrial tachycardia (3%). At 1 year, 93% and 35% of the CPVA and ADT groups, respectively, were AT-free. Ejection fraction, hypertension, and age independently predicted AF recurrences in the ADT group. Circumferential pulmonary vein ablation was associated with fewer cardiovascular hospitalizations (p < 0.01). One transient ischemic attack and 1 pericardial effusion occurred in the CPVA group; side effects of ADT were observed in 23 patients. Circumferential pulmonary vein ablation is more successful than ADT for prevention of PAF with few complications. Atrial fibrillation ablation warrants consideration in selected patients in whom ADT had already failed and maintenance of sinus rhythm is desired. (A Controlled Randomized Trial of CPVA Versus Antiarrhythmic Drug Therapy in for Paroxysmal AF: APAF/01; http://clinicaltrials.gov/ct/show; NCT00340314).