Cost effectiveness of focal impulse and rotor modulation guided ablation added to pulmonary vein isolation for atrial fibrillation.

BACKGROUND: Although ablation with focal impulse and rotor modulation (FIRM), as an adjunct to pulmonary vein isolation (PVI), has been shown to decrease atrial fibrillation (AF) recurrence, cost-effectiveness has not been assessed. OBJECTIVE: We aimed to evaluate the cost effectiveness of FIRM-guided ablation when added to PVI in a mixed AF population. METHODS AND RESULTS: We used a Markov model to estimate the costs, quality-adjusted survival, and cost effectiveness of adding FIRM ablation to PVI. AF recurrence rates were based on 3-year data from the CONFIRM trial. Model inputs for event probabilities and utilities were obtained from literature review. Costs were based on Medicare reimbursement, wholesale acquisition costs, and literature review. Three-year total costs FIRM+PVI versus PVI alone were $27,686 versus $26,924. QALYs were 2.338 versus 2.316, respectively, resulting in an incremental cost-effectiveness ratio (ICER) of $34,452 per QALY gained. Most of the cost (65-81%) was related to the index ablation procedure. Lower AF recurrence generated cost offsets of $4,266, primarily due to a reduced need for medications and repeat ablation. Probabilistic sensitivity analysis demonstrated ICER below $100,000/QALY in 74% of simulations. CONCLUSION: Based on data from the CONFIRM study, the addition of FIRM to PVI does have the potential to be cost-effective due to higher quality-adjusted life years and lower follow-up costs. Value is sensitive to the incremental reduction in AF recurrence, and FIRM may have the greatest economic value in patients with greater AF symptom severity. Results from ongoing randomized trials will provide further clarity.

Ablation of paroxysmal atrial fibrillation using a second-generation cryoballoon catheter or contact-force sensing radiofrequency ablation catheter: A comparison of costs and long-term clinical outcomes.

INTRODUCTION: Although noninferiority of cryoballoon ablation (CBA) and radiofrequency catheter ablation for antral pulmonary vein isolation (APVI) has been reported in patients with paroxysmal atrial fibrillation (PAF), it is not clear whether contact force sensing (CF-RFA) and CBA with the second-generation catheter have similar procedural costs and long-term outcomes. The objective of this study is to compare the long-term efficacy and cost implications of CBA and CF-RFA in patients with PAF. METHODS AND RESULTS: A first APVI was performed in 146 consecutive patients (age: 63 ± 10 years, men: 95 [65%], left atrial diameter: 42 ± 6 mm) with PAF using CBA (71) or CF-RFA (75). Clinical outcomes and procedural costs were compared. The mean procedure time was significantly shorter with CBA than with CF-RFA (98 ± 39 vs. 158 ± 47 minutes, P < 0.0001). Despite a higher equipment cost in the CBA than the CF-RFA group, the total procedure cost was similar between the two groups (P = 0.26), primarily driven by a shorter procedure duration that resulted in a lower anesthesia cost. At 25 ± 5 months after a single ablation procedure, 51 patients (72%) in the CBA, and 55 patients (73%) in the CF-RFA groups remained free from atrial arrhythmias without antiarrhythmic drug therapy (P = 0.84). CONCLUSIONS: The procedure duration was approximately 60 minutes shorter with CBA than CF-RFA. The procedural costs were similar with both approaches. At 2 years after a single procedure, CBA and CF-RFA have similar single-procedure efficacies of 72-73%.

Evaluation of a pharmacist-managed amiodarone monitoring program.

BACKGROUND: Because of the potential for serious adverse effects, patients treated with amiodarone must be carefully screened and routinely monitored for potential liver, thyroid, and pulmonary toxicity. However, laboratory and pulmonary monitoring rates have been found to be substantially lower than recommended in guidelines, including those of the North American Society of Pacing and Electrophysiology (NASPE, 2007). OBJECTIVE: To (a) assess rates of laboratory monitoring of liver, thyroid, and pulmonary function and adverse events in a pharmacist-managed amiodarone monitoring program compared with usual care in an integrated health care system and (b) estimate return on investment (ROI) from this intervention. METHODS: This retrospective cohort study used clinic and enrollment data to identify those patients in the pharmacist-managed program and usual care who received at least 100 days of amiodarone therapy with the first prescription for amiodarone (index) from June 1, 2007, through May 31, 2009 (index date). Laboratory test monitoring was recorded at baseline (up to 6 months before the index date), from 1-6 months after the index date, 7-12 months after the index date, and at any time during the year (months 1-12). Alanine aminotransferase (ALT) was evaluated for liver function. Thyroid-stimulating hormone (TSH) and, for patients with abnormal TSH ( less than 0.4 micro international units [uIU] per mL or greater than 4.0 uIU per mL), free thyroxine (T4) were evaluated for thyroid function. Rates of pulmonary function testing (PFT) were measured by the diffusion capacity of carbon monoxide tests (DLCO) and annual chest x-rays (CXR); electrocardiograms were not counted. Monitoring rates were compared using Pearson chi-square tests, and logistic regression was used to compare the odds of testing (ALT, TSH, T4, CXR, PFT) between the 2 groups at any time during the year after the index date. Concomitant uses of amiodarone with high-dose statins and of amiodarone with digoxin were compared using Pearson chi-square tests. Hospitalizations and emergency room (ER) visits during the 12-month follow-up period were counted for (a) interstitial lung disease; (b) rhabdomyolysis for patients who received amiodarone with high-dose statins (either lovastatin greater than 40 mg per day or greater than 20 mg per day of simvastatin or atorvastatin); and (c) for patients with abnormal digoxin, ALT, TSH, or T4 levels, if the hospitalization occurred within 2 days of the abnormal laboratory value. RESULTS: There were 2,292 patients who received at least 100 days of amiodarone therapy and met the other inclusion criteria, of whom 181 patients (7.9%) were in the pharmacist-managed group and 2,111 received usual care. There were 90 (49.7%) new amiodarone users in the pharmacist-managed group and 990 (46.9%) in usual care. The 2 groups had similar demographic characteristics except race, with more whites and fewer African Americans, Asians, and Hispanics in usual care. Laboratory monitoring rates for ALT, TSH, and T4 were significantly higher in the pharmacist-managed group than usual care at the first and second 6 months and at baseline for ALT and TSH but not T4. Baseline CXR rates were significantly higher for the pharmacist-managed group than usual care (59.1% vs. 49.3%; P=0.011). Few patients in either group received PFT tests at baseline, 6.6% versus 3.6% (P=0.042). After controlling for covariates (age, gender, race, new vs. continuing use, and comorbidities), pharmacist-managed patients were significantly more likely to have at least 1 ALT test within the year after the index prescription (odds ratio [OR]=3.13, 95% CI=1.12-8.71), as well as a TSH test (OR=8.13, 95% CI=3.27-20.21) and T4 (OR=2.51, 95% CI=1.67-3.75). PFTs were also more likely to be given to these patients (OR=5.89, 95% CI=3.86-8.99). A higher percentage of patients in the pharmacist-managed group than in usual care were taking a high-dose statin during the 12-month follow-up period (47.5% vs. 36.2%, P=0.003), but of those patients, a greater proportion were switched to another statin (14.0% [n=12] vs. 7.5% [n=57], P=0.037) or a lower dose (9.3% [n=8] vs. 3.9% [n=30], P=0.022). Six patients in the usual care group (0.79% of patients on high-dose statins) developed rhabdomyolysis, and 5 (0.24% of all patients in usual care) had an admission for interstitial lung disease. The proportions of patients using amiodarone and digoxin concomitantly were similar in the 2 groups (35.9% vs. 31.3%, P=0.197). Among patients with abnormal laboratory results for ALT, TSH, and T4, or digoxin, there were 2 all-cause hospitalizations and 1 ER visit in the pharmacist-managed group and 34 all-cause hospitalizations and 18 ER visits in the usual care group during the follow-up year. Assuming that all hospitalizations and ER visits incurred in the usual care group were avoid- able, approximately $2.14 could be saved for every dollar spent on the pharmacist-managed amiodarone monitoring program. CONCLUSIONS: Pharmacist management of patients treated with amiodarone was associated with improved monitoring of recommended laboratory tests and PFTs.

Applying health economics for policy decision making: do devices differ from drugs?

Medical devices pose unique challenges for economic evaluation and associated decision-making processes that differ from pharmaceuticals. We highlight and discuss these challenges in the context of cardiac device therapy, based on a systematic review of relevant economic evaluations. Key challenges include practical difficulties in conducting randomized clinical trials, allowing for a 'learning curve' and user characteristics, accounting for the wider organizational impacts of introducing new devices, and allowing for variations in product characteristics and prices over time.

[Cost-benefit analysis of concomitant atrial fibrillation management in Spain]. / Análisis de coste-utilidad del manejo de la fibrilación auricular concomitante en España.

OBJECTIVES: Atrial fibrillation (AF) is the most common arrhythmia in clinical practice; this disorder is a risk factor for stroke and is associated with substantial morbidity and mortality. Our objective was to develop a cost-utility analysis of the different treatment alternatives in patients aged 40 years old or more with concomitant AF with valve disease in Spain, from the National Health System perspective. METHODS: An economic evaluation through a Markov model with four health states (sinus rhythm, AF, dependent stroke, death) was developed to simulate the evolution of a cohort of 1,000 patients receiving each treatment alternative in addition to mitral valve surgery (drug therapy, surgical ablation and catheter ablation). The time horizon was 5 years, with a cycle length of 3 months. Data on costs and effects were obtained from the published literature and expert opinion and were discounted at 3.5%. A sensitivity analysis was developed to determine the robustness of the results. RESULTS: The quality-adjusted life years (QALY) gained were 3.29, 3.89, and 3.83, respectively, for the alternatives of no ablation, surgical ablation and catheter ablation. The costs per patient were 5,770euro, 10,034euro and 11,289euro, respectively. The surgical ablation cost/QALY rate compared with no ablation was 7,145euro. Surgical ablation was dominant versus catheter ablation. The probabilistic sensitivity analysis showed that the results were robust. CONCLUSIONS: Surgical ablation is a cost-effective treatment option in patients with concomitant AF, with a cost-effectiveness ratio under the efficiency threshold commonly accepted in Spain.

Incidence and economic burden of suspected adverse events and adverse event monitoring during AF therapy.

OBJECTIVE: Rhythm- and rate-control therapies are an essential part of atrial fibrillation (AF) management; however, the use of existing agents is often limited by the occurrence of adverse events. The aim of this study was to evaluate suspected adverse events and adverse event monitoring, and associated medical costs, in patients receiving AF rhythm-control and/or rate-control therapy. RESEARCH DESIGN AND METHODS: This retrospective cohort study used claims data from the Integrated Healthcare Information Systems National Managed Care Benchmark Database from 2002-2006. Patients hospitalized for AF (primary diagnosis), and who had at least 365 days' enrollment before and after the initial (index) AF hospitalization, were included in the analysis. Suspected AF therapy-related adverse events and function tests for adverse event monitoring were identified according to pre-specified diagnosis codes/procedures, and examined over the 12 months following discharge from the index hospitalization. Events/function tests had to have occurred within 90 days of a claim for AF therapy to be considered a suspected adverse event/adverse event monitoring. RESULTS: Of 4174 AF patients meeting the study criteria, 3323 received AF drugs; 428 received rhythm-control only (12.9%), 2130 rate-control only (64.1%), and 765 combined rhythm/rate-control therapy (23.0%). Overall, 50.1% of treated patients had a suspected adverse event and/or function test for adverse event monitoring (45.5% with rate-control, 53.5% with rhythm-control, and 61.2% with combined rhythm/rate-control). Suspected cardiovascular adverse events were the most common events (occurring in 36.1% of patients), followed by pulmonary (6.1%), and endocrine events (5.9%). Overall, suspected adverse events/function tests were associated with mean annual per-patient costs of $3089 ($1750 with rhythm-control, $2041 with rate control, and $6755 with combined rhythm/rate-control). LIMITATIONS: As a retrospective analysis, the study is subject to potential selection bias, while its reliance on diagnostic codes for identification of AF and suspected adverse events is a source of potential investigator error. A direct cause-effect relationship between suspected adverse events/function tests and AF therapy cannot be confirmed based on the claims data available. CONCLUSIONS: The incidence of suspected adverse events and adverse event monitoring during AF rhythm-control and/or rate-control therapy is high. Costs associated with adverse events and adverse event monitoring are likely to add considerably to the overall burden of AF management.

Curative catheter ablation in atrial fibrillation and typical atrial flutter: systematic review and economic evaluation.

OBJECTIVES: To determine the safety, clinical effectiveness and cost-effectiveness of radio frequency catheter ablation (RCFA) for the curative treatment of atrial fibrillation (AF) and typical atrial flutter. DATA SOURCES: For the systematic reviews of clinical studies 25 bibliographic databases and internet sources were searched in July 2006, with subsequent update searches for controlled trials conducted in April 2007. For the review of cost-effectiveness a broad range of studies was considered, including economic evaluations conducted alongside trials, modelling studies and analyses of administrative databases. REVIEW METHODS: Systematic reviews of clinical studies and economic evaluations of catheter ablation for AF and typical atrial flutter were conducted. The quality of the included studies was assessed using standard methods. A decision model was developed to evaluate a strategy of RFCA compared with long-term antiarrhythmic drug (AAD) treatment alone in adults with paroxysmal AF. This was used to estimate the cost-effectiveness of RFCA in terms of cost per quality-adjusted life-year (QALY) under a range of assumptions. Decision uncertainty associated with this analysis was presented and used to inform future research priorities using the value of information analysis. RESULTS: A total of 4858 studies were retrieved for the review of clinical effectiveness. Of these, eight controlled studies and 53 case series of AF were included. Two controlled studies and 23 case series of typical atrial flutter were included. For atrial fibrillation, freedom from arrhythmia at 12 months in case series ranged from 28% to 85.3% with a weighted mean of 76%. Three RCTs suggested that RFCA is more effective than long-term AAD therapy in patients with drug-refractory paroxysmal AF. Single RCTs also suggested superiority of RFCA over electrical cardioversion followed by long-term AAD therapy and of RFCA plus AAD therapy over AAD maintenance therapy alone in drug-refractory patients. The available RCTs provided insufficient evidence to determine the effectiveness of RFCA beyond 12 months or in patients with persistent or permanent AF. Adverse events and complications were generally rare. Mortality rates were low in both RCTs and case series. Cardiac tamponade and pulmonary vein stenosis were the most frequently recorded complications. For atrial flutter, freedom from arrhythmia at 12 months in case series ranged from 85% to 92% with a weighted mean of 88%. Neither of the atrial flutter RCTs reported freedom from arrhythmia at 12 months. One RCT found a statistically significant benefit favouring ablation over AADs in terms of freedom from arrhythmia at a mean follow-up of 22 months. A second RCT reported a more modest effect favouring ablation in terms of freedom from atrial flutter at follow-up in older patients (mean age 78 years) after their first episode of flutter. In the atrial flutter case series, mortality was rare and the most frequent complications were atrioventricular block and haematomas. Complications in the RCTs were similar, except for those events likely to have been caused by AAD therapy (e.g. thyroid dysfunction). The review of cost-effectiveness evidence found one relevant study, which from a UK NHS perspective had a number of important limitations. The base-case analysis in the decision model demonstrated that if the quality of life benefits of RFCA are maintained over the remaining lifetime of the patient then the cost-effectiveness of RFCA appears clear. These findings were robust over a wide range of alternative assumptions, being between 7763 and 7910 pounds per additional QALY with very little uncertainty. If the quality of life benefits of RFCA are assumed to be maintained for no more than 5 years, cost-effectiveness of RFCA is dependent on a number of factors. Estimates of cost-effectiveness that explored the influence of these factors ranged from 23,000 to 38,000 pounds per QALY. CONCLUSIONS: RFCA is a relatively safe and efficacious procedure for the therapeutic treatment of AF and typical atrial flutter. There is some randomised evidence to suggest that RFCA is superior to AADs in patients with drug-refractory paroxysmal AF in terms of freedom from arrhythmia at 12 months. RFCA appears to be cost-effective if the observed quality of life benefits are assumed to continue over a patient's lifetime. However, there remain uncertainties around longer-term effects of the intervention and the extent to which published effectiveness findings can be generalised to 'typical' UK practice. All catheter ablation procedures for the treatment of AF or atrial flutter undertaken in the UK should be recorded prospectively and centrally and measures to increase compliance in recording RFCA procedures may be needed. This would be of particular value in establishing the long-term benefits of RFCA and the true incidence and impact of any complications. Collection of appropriate quality of life data within any such registry would also be of value to future clinical and cost-effectiveness research in this area. Any planned multicentre RCTs comparing RFCA against best medical therapy for the treatment of AF and/or atrial flutter should be conducted among 'non-pioneering' centres using the techniques and equipment typically employed in UK practice and should measure relevant outcomes.

Radiofrequency catheter ablation of supraventricular tachycardia in children and adolescents : feasibility and cost-effectiveness in a low-income country.

The objective of this study is to provide results and costs of catheter ablation in children and adolescents in a low-income country. Reports from first-world countries have demonstrated the cost-effectiveness of radiofrequency catheter ablation (RFCA) compared to medical treatment of supraventricular tachycardia (SVT). The study included 28 patients younger than 18 years of age with SVT in a pediatric cardiology unit in Guatemala. All patients underwent RFCA. Clinical outcome and cost-effectiveness of RFCA compared to continued medical treatment were the end points. Twenty-four patients had successful ablation (85.7%). Mean age at RFCA was 11.42 +/- 3.49 years. Three patients underwent a second ablation, increasing the success rate to 96.4%. One remaining patient is awaiting a second procedure. At a mean follow-up of 13.69 +/- 7.16 months, all 27 patients who had a successful ablation remained in sinus rhythm. Mean cost per procedure was 4.9 times higher than that of medical treatment. However, the estimated cost of catheter ablation equal that of medical therapy after 5.1 years and is 3.4 times less after 20 years. Radiofrequency catheter ablation of SVT in children and adolescents is safe and cost-effective compared to medical therapy. Resources must be judiciously allocated, especially in low-income countries, to treat the largest number of pediatric patients.

Amiodarone for ACLS: a critical evaluation.

Years ago, William Osler taught physicians, "Be not the first nor the last to adopt a therapy." This continues to be sage advice. Clinicians should be cautious in considering the use of amiodarone in a field setting for cardiac arrest until studies clearly show a benefit over drugs currently in use. The endpoint of the only cardiac arrest study available shows improved survival when amiodarone is combined with other drugs over placebo until the patient gets to the emergency department, but is not a comparison with other current drugs nor had any effect on long-term survival or functioning neurologic status. As previously cited, amiodarone was comparable with bretylium in treating recurrent VT/VF in one controlled study. Further study of this and other ACLS drugs is imperative. In summary, amiodarone should be reclassified as either a class indeterminate agent when used alone ("no harm but no benefit ... evidence insufficient to support final class decision") or a class IIb agent ("acceptable and useful ... supported by fair to good evidence") when used in addition to other therapies in the treatment of ventricular fibrillation and pulseless ventricular tachycardia. There is not sufficient evidence to move amiodarone to first-line therapy in the "out-of-hospital" cardiac arrest. This evidence may be available in the future and would then change this recommendation.

Are implantable cardioverter- defibrillators cost-effective?

Sudden cardiac deaths account for a large number of cardiovascular deaths, and ventricular tachyarrhythmias are implicated in many of these. In survivors of sudden cardiac deaths and other selected groups of patients, implantable cardioverter-defibrillators (ICDs) have been shown to have significant survival benefits in randomized controlled trials. The incremental costs for each extra year of survival conferred by ICDs were compared to the cost of antiarrhythmic drug therapy in some of these trials. In patients with nonsustained ventricular tachycardia with low ejection fraction (< 35%) and inducible sustained ventricular tachycardia on programmed electrical stimulation (nonsuppressible by procainamide), the incremental costs of ICD therapy amounted to $27,000 per life-year saved, compared with drug therapy. These costs may be acceptable increments for adaptation of the new technology in view of the definite survival advantage conferred by ICDs. Evolving technology may further reduce these costs by development of better devices with longer battery life.

Cost-effective strategies in the acute management of atrial fibrillation.

Atrial fibrillation is the most common sustained arrhythmia likely to be encountered in clinical practice. It is associated with significant morbidity and mortality. The treatment of patients with atrial fibrillation can be complex and costly, especially when patients are hospitalized for acute management of this arrhythmia. In this review, we summarize current approaches to the acute management of atrial fibrillation with an emphasis on the most cost-effective approaches. We review acute methods of heart rate control and cardioversion, including pharmacologic and other minimally invasive strategies. We believe that the most cost-effective approaches may require the use of standardized clinical pathways. This may help to ensure that patients with acute atrial fibrillation receive the most effective and efficient care.