The Cost-Effectiveness of First-Line Cryoablation vs First-Line Antiarrhythmic Drugs in Canadian Patients With Paroxysmal Atrial Fibrillation.

BACKGROUND: The EARLY-AF (NCT02825979), STOP AF First (NCT03118518), and Cryo-FIRST (NCT01803438) randomised controlled trials (RCTs) demonstrated that cryoballoon pulmonary vein isolation reduces atrial fibrillation (AF) recurrence compared with antiarrhythmic drugs (AADs) in patients with symptomatic paroxysmal atrial fibrillation (PAF). The present study developed a cost-effectiveness model (CEM) of first-line cryoablation compared with first-line AADs for PAF, from the Canadian health care payer's perspective. METHODS: Data from the 3 RCTs were analysed to estimate key CEM parameters. The model structure used a decision tree for the first 12 months and a Markov model with a 3-month cycle length for the remaining lifetime time horizon. Costs were set at 2023 Canadian dollars, health benefits were expressed as quality-adjusted life years (QALYs), and both were discounted 3% annually. Probabilistic sensitivity analysis (PSA) considered parameter uncertainty. RESULTS: The statistical analysis estimated that first-line cryoablation generates a 47% reduction (P < 0.001) in the rate of AF recurrence, a 73% reduction in the rate of subsequent ablation (P < 0.001), and a 4.3% (P = 0.025) increase in health-related quality of life, compared with first-line AADs. The PSA indicates that an individual treated with first-line cryoablation accrues less costs (-$3,862) and more QALYs (0.19) compared with first-line AADs. Cryoablation is cost-saving in 98.4% of PSA iterations and has a 99.9% probability of being cost-effective at a cost-effectiveness threshold of $50,000 per QALY gained. Cost-effectiveness results were robust to changes in key model parameters. CONCLUSIONS: First-line cryoballoon ablation is cost-effective when compared with AADs for patients with symptomatic PAF.

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.

Cost-effectiveness of cryoballoon ablation for the management of paroxysmal atrial fibrillation.

AIMS: Cryoballoon ablation is an established treatment option for the management of patients with atrial fibrillation. We sought to evaluate the cost-effectiveness of cryoablation, compared with second-line anti-arrhythmic drug (AAD) therapy in patients with paroxysmal atrial fibrillation (PAF), from a UK payer perspective. METHODS AND RESULTS: We developed a state-transition (Markov) model to calculate the total costs and quality-adjusted life-years (QALYs) associated with cryoablation and AAD therapy in patients with PAF. A 5-year horizon was used for the base-case. Data from a recent study of cryoballoon ablation in patients with PAF were used to model short-term health outcomes and costs, together with longer term external evidence to populate subsequent time periods. Total discounted costs were £21 162 and £17 627 for the cryoballoon ablation and AAD arms, respectively. Total QALYs of 3.565 and 3.404 therefore led to an incremental cost-effectiveness ratio of £21 957 per QALY gained. Sensitivity analysis suggested that the key drivers of the results were the model time horizon, the costs of follow-up care in patients with recurrent AF, and the costs of the ablation procedure. CONCLUSION: Cryoballoon ablation provides increased quality-adjusted life expectancy compared with AAD at reasonable additional cost, representing good value for money in patients with PAF.

Cost of atrial fibrillation: invasive vs non-invasive management in 2012.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It places an enormous burden on the patients, caregivers and the society at large. As a chronic illness, AF accrues significant costs related to clinical presentation, complications and loss of productivity. Novel invasive approaches to AF promise a cure in some patients and a significant reduction in AF burden in others, but are very expensive. This paper will address the cost of conventional and invasive strategies in AF care and will review the evidence on the comparative cost effectiveness of these approaches.

Cost considerations in the management of atrial fibrillation - impact of dronedarone.

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. It is associated with significant morbidity and mortality. At the societal level, AF carries an enormous cost. Strategies aimed at reducing AF morbidity and mortality and containing the associated fiscal burden are of paramount importance. This review will discuss AF treatment strategies and economics, focusing on the impact of dronedarone, a novel antiarrhythmic agent.

Relationship between complex fractionated electrograms (CFE) and dominant frequency (DF) sites and prospective assessment of adding DF-guided ablation to pulmonary vein isolation in persistent atrial fibrillation (AF).

BACKGROUND: Sites of high DF are potential targets for AF ablation, but it is unknown if addition of DF ablation can improve procedural outcome. OBJECTIVES: We sought to (1) examine the relationship between DF sites and complex fractionated electrograms (CFE) and (2) prospectively assess the long-term outcome of adding DF ablation to pulmonary vein antral isolation (PVAI) for persistent AF. METHODS: First, 20 patients with persistent AF who underwent previous CFE-guided ablation and who had AF terminate during ablation were studied retrospectively (group I). Bipolar, 8-second electrograms were collected by a circular catheter (288 ± 86 points/map). The EnSite NavX system allows for automated display of both CFE and DF maps. Electrograms with cycle length <120 ms were considered CFE and were compared to DF sites > 8 Hz (direct inverse relationship). Sites of AF termination were related to CFE and DF sites. Based on these observations, 30 different patients (group II) with persistent AF prospectively underwent DF-guided ablation plus PVAI. They were followed every 3 months for 1 year (visit, Holter, ECG). These patients were compared to case-matched controls undergoing PVAI alone (group III). RESULTS: In group I, there was a significant, inverse correlation between DF and CFE values at each point (r =-0.24, P < 0.001). DF surface area was less than CFE area (27 ± 5 cm(2) vs 34 ± 4 cm(2) , P = 0.03). CFE sites overlapped 48 ± 27% with the DF surface area. Nonoverlapping CFE sites were contiguous to DF sites. AF termination occurred where DF and CFE overlapped, and at these sites, DF was always greater than the mean DF for the map. In group II, all DF sites above the mean value were prospectively ablated during AF. AF termination was noted in only 2/30 (7%) patients. After DF ablation, PVAI was performed and termination increased to 4/30 patients (14%). At 1 year, freedom from atrial arrhythmia > 30 seconds occurred in 57% of DF+PVAI compared to 60% in patients receiving PVAI alone (P = 0.18). CONCLUSIONS: DF and CFE regions overlap only about 50%. AF termination retrospectively occurred on overlapping CFE/DF sites where DF was above the mean. However, prospective ablation of DF sites plus PVAI resulted in low AF termination rates, and did not improve 1 year success over PVAI alone.

Is there an association between external cardioversions and long-term mortality and morbidity? Insights from the Atrial Fibrillation Follow-up Investigation of Rhythm Management study.

BACKGROUND: Cardiac electric therapies effectively terminate tachyarrhythmias. Recent data suggest a possible increase in long-term mortality associated with implantable cardioverter-defibrillator shocks. Little is known about the association between external cardioversion episodes (ECVe) and long-term mortality. We sought to assess the safety of repeated ECVe with regard to cardiovascular mortality and morbidity. METHODS AND RESULTS: We analyzed the data of the 4060 patients from the AFFIRM (Atrial Fibrillation Follow-up Investigation of Rhythm Management) trial. In particular, associations of ECVe with all-cause mortality, cardiovascular mortality, and hospitalizations after ECVe were studied. Over an average follow-up of 3.5 years, 660 (16.3%) patients died, 331 (8.2%) from cardiovascular causes. A total of 207 (5.1%) and 1697 (41.8%) patients had low ejection fraction and nonparoxysmal atrial fibrillation, respectively; 2460 patients received no ECVe, whereas 1600 experienced ≥ 1 ECVe. Death occurred in 412 (16.7%), 196 (16.5%), 39 (13.5%), and 13 (10.4%) of patients with 0, 1, 2, and ≥ 3 ECVe, respectively. There was no significant association between ECVe and mortality within any of the 4 subgroups defined by ejection fraction and atrial fibrillation type, although myocardial infarction, coronary artery bypass graft, and digoxin were significantly associated with death (estimated hazard ratios, 1.65, 1.59, and 1.62, respectively; P < 0.0001). ECVe were associated with increased cardiac hospitalization reported at the next follow-up visit (39.3% versus 5.8%; estimated odds ratio, 1.39; P < 0.0001). CONCLUSIONS: In the AFFIRM study, there was no significant association between ECVe and long-term mortality, even though ECVe were associated with increased hospitalizations from cardiac causes. Digoxin, myocardial infarction, and coronary artery bypass graft were significantly associated with mortality.

Cost of AF Ablation: Where Do We Stand?

Atrial fibrillation (AF) is a common and frequently disabling chronic condition associated with significant patient morbidity and affecting an increasing stratum of our ageing society. Direct costs related to atrial fibrillation are comprised from direct cost of medical therapy, catheter ablation, and related hospitalizations and imaging procedures, with indirect costs related to complications of the primary therapeutic strategy, management of related conditions, as well as disability and loss in quality of life related to AF. Over the last decade, catheter ablation became a promising alternative to rate and rhythm control among symptomatic AF patients. The purpose of this paper is to describe the evidence on the financial implications related to ablation based on published data and authors' experience.

Cost comparison of ablation versus antiarrhythmic drugs as first-line therapy for atrial fibrillation: an economic evaluation of the RAAFT pilot study.

INTRODUCTION: Radiofrequency ablation (RFA) has become an accepted therapy for atrial fibrillation (AF). The objective of this study was to perform an economic evaluation of RFA versus antiarrhythmic drug therapy (AAD) as first-line treatment of symptomatic paroxysmal AF. METHODS: To estimate and compare the costs of RFA versus AAD, a decision analytic model was developed using data on AF recurrence, hospitalization rates, AAD use, and treatment crossover rates derived directly from the Randomized Trial of RFA versus AAD as First-Line Treatment of Symptomatic Atrial Fibrillation (RAAFT). Resource utilization was modeled to reflect Canadian clinical practice in AF management. Unit costs of healthcare interactions were based on available Canadian government resources and published literature. Costs were assessed based on intention-to-treat. Total expected costs were computed to include initial treatment, hospital stay, physician fees, diagnostic tests, and outpatient visits. Sensitivity analyses were performed to account for the uncertainties. The study was conducted from the third party payer's perspective and costs are reported in 2005 Canadian dollars with 3% discount rate used in the analysis. RESULTS: During the 2-month blanking period following therapy selection, total average costs for RFA and AAD were $10,465 and $2,556, respectively; at 1-year follow-up, these were $12,823 and $6,053; and total 2-year cumulative total average costs were $15,303 and $14,392. Sensitivity analyses did not alter the results, suggesting the model is robust. CONCLUSIONS: RFA as first-line treatment strategy in patients with symptomatic paroxysmal AF was cost neutral 2 years after the initial procedure compared to AAD.

Cost comparison of catheter ablation and medical therapy in atrial fibrillation.

INTRODUCTION: There is emerging evidence for clinical superiority of catheter ablation over rate and rhythm control strategies in paroxysmal atrial fibrillation (PAF). The objective of this study was to compare costs related to medical therapy versus catheter ablation for PAF in Ontario (Canada). METHODS: Costs related to medical therapy in the analysis included the cost of anticoagulation, rate and rhythm control medications, noninvasive testing, physician follow-up visits, and hospital admissions, as well as the cost of complications related to this management strategy. Costs related to catheter ablation were assumed to include the cost of the ablation tools (electroanatomic mapping or intracardiac echocardiography-guided pulmonary vein ablation), hospital and physician billings, and costs related to periprocedural medical care and complications. Costs related to these various elements were obtained from the Canadian Registry of Atrial Fibrillation (CARAF), government fee schedules, and published data. Sensitivity analyses looking at a range of initial success rates (50-75%) and late attrition rates (1-5%), prevalence of congestive heart failure (CHF) (20-60%), as well as discounting varying from 3% to 5% per year were performed. RESULTS: The cost of catheter ablation ranged from $16,278 to $21,294, with an annual cost of $1,597 to $2,132. The annual cost of medical therapy ranged from $4,176 to $5,060. Costs of ongoing medical therapy and catheter ablation for PAF equalized at 3.2-8.4 years of follow-up. CONCLUSION: Catheter ablation is a fiscally sensible alternative to medical therapy in PAF with cost equivalence after 4 years.

Cost-effectiveness of catheter ablation for atrial fibrillation.

PURPOSE OF REVIEW: Catheter ablation for atrial fibrillation is a rapidly evolving field. It has been adopted at many institutions worldwide. This review compares the efficacy and cost of catheter ablation and medical therapy in atrial fibrillation patients. RECENT FINDINGS: There is emerging evidence for clinical superiority of catheter ablation over medical therapy for restoring and maintaining sinus rhythm in atrial fibrillation patients. Early analyses of costs related to catheter ablation in atrial fibrillation suggest that medical therapy and catheter ablation become cost-equivalent at about 5 years of follow-up. A recent cost-effectiveness study concluded that catheter ablation is a cost-effective alternative to medical care in younger and older patients at low and moderate risk of stroke, assuming that restoration and maintenance of sinus rhythm with ablation would have some protective effect with respect to embolic events. SUMMARY: Catheter ablation is a potentially cost-effective strategy in select patients with atrial fibrillation. Long-term randomized studies that compare it to conventional care and focus on outcomes of morbidity and mortality are necessary prior to widespread application of this technique.