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Atrial fibrillation ablation leads to long-term improvement of quality of life and reduced utilization of healthcare resources |
Goldberg A, Menen M, Mickelsen S, MacIndoe C, Binder M, Nawman R, West G, Kusumoto F M |
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Record Status This is a critical abstract of an economic evaluation that meets the criteria for inclusion on NHS EED. Each abstract contains a brief summary of the methods, the results and conclusions followed by a detailed critical assessment on the reliability of the study and the conclusions drawn. Health technology The ablation of focal triggers by radiofrequency catheter was examined. No further details of the technology itself were provided.
Economic study type Cost-effectiveness analysis.
Study population The study population comprised patients referred for radiofrequency catheter ablation for drug refractory atrial fibrillation.
Setting The setting was secondary care. The economic study was carried out in Albuquerque, USA.
Dates to which data relate The effectiveness data were collected for patients referred to the medical centre between June 1996 and June 1997. The cost information was collected for the same time period. The price year was 2001.
Source of effectiveness data The effectiveness data were derived from a single study.
Link between effectiveness and cost data The costing was carried out prospectively on the same patient sample as that used for the effectiveness data.
Study sample The patient sample comprised 33 of the 64 patients referred to Lovelace Medical Centre between June 1996 and June 1997, who then underwent an electrophysiology study and radiofrequency catheter ablation. The authors did not discuss the power of the study to detect significant differences. The study sample was representative of the study population at the centre involved. No patients were reported to have refused to participate or been excluded. The average age of the study group was 51 (+/- 18) years (range: 18 - 79). There were 10 women and 23 men.
Study design The analysis used a case series study that was conducted in a single centre. The patients were compared at baseline, and at one and three years. The authors reported that there was no loss to follow-up. The patients completed the SF-36 questionnaires during their baseline evaluation or over the phone with a blinded observer. The authors did not report any other blinding.
Analysis of effectiveness All of the patients participating in the study were included in the analysis. The primary outcome was the perceived health and quality of life of the patients, as measured using SF-36 questionnaires. The other outcomes were whether the patients were arrhythmia free, were asymptomatic or had minimal symptoms on drug therapy, or whether they developed chronic atrial fibrillation despite ablation and drug therapy. The authors also assessed whether the patients developed symptomatic coronary artery disease, congestive heart failure or other structural heart disease, and whether there was any evidence of pulmonary vein stenosis. The quantity of complaints arising from palpitations and dizziness was also recorded. No adjustments for confounding factors was reported.
Effectiveness results After the 3-year follow-up, 27 patients were arrhythmia free, 4 were asymptomatic or had minimal symptoms on drug therapy, and 2 had developed chronic atrial fibrillation despite ablation and drug therapy.
No patients developed coronary artery disease, congestive heart failure or other structural heart disease.
No evidence of pulmonary vein stenosis was found.
Complaints of palpitations were found to have decreased significantly after ablation at the 3-year follow-up. Prior to ablation there were 74 (+/- 33) episodes/week, whereas post ablation there were 3 (+/- 2) episodes/week.
Complaints of dizziness were also found to have decreased at the 3-year follow-up. Prior to ablation there were 22 (+/- 14) episodes/week, whereas post ablation there were 1 (+/- 2) episodes/week.
At the 1-year follow-up ablation was associated with significant improvements in several domains of the SF-36, (p<0.05). The domains showing improvement were physical functioning, role physical, general health, vitality, social function, role emotion and mental health. At the 3-year follow-up the scores in these domains remained significantly higher than at baseline. However, the quality of life scores were generally lower at the 3-year than at the 1-year follow-up.
Clinical conclusions The authors concluded that ablation was associated with a significant decrease in disease-related symptoms at the 3-year follow-up. It was also associated with an improvement in the quality of life.
Measure of benefits used in the economic analysis There was no summary measure of health benefit. The study was therefore classified as a cost-consequences analysis.
Direct costs The authors did not report any discounting of the costs. The costs were calculated for the three years before ablation, and the three years after, in order to estimate an average cost per year pre- and post ablation. Hence, discounting was relevant. Discounting would also have been appropriate since the costs were estimated over more than two years. The authors observed procedural, hospital and billing records for all patients. These covered medications, emergency room visits, hospitalisations and visits to the clinic. The cost of ablation was estimated as the sum of the chargeable goods, facility costs (including employee salaries, service and rental contracts, and capital equipment depreciation) and a fixed proportion of the professional fee. Although not explicitly stated, the costs appear to have been estimated from the perspective of the hospital and were derived from actual data. The price year was 2001.
Statistical analysis of costs The costs were treated in a stochastic manner.
Indirect Costs The indirect costs were not measured.
Sensitivity analysis No sensitivity analysis was reported.
Estimated benefits used in the economic analysis See the 'Effectiveness Results' section.
Cost results The cost of health care utilisation was $1,920 (+/- 889) per year before ablation $87 (+/- 68) per year after ablation, (p<0.05).
The average procedural cost of ablation was $17,173 (+/- 2,466).
It was unclear whether the costs of any complications were included in these cost estimates.
Synthesis of costs and benefits Consistent with the cost-consequences classification of this study, the costs and benefits were not combined.
Authors' conclusions Radiofrequency catheter ablation improves the quality of life and health care resource utilisation in selected patients with drug refractory atrial fibrillation.
CRD COMMENTARY - Selection of comparators The authors compared treatment with ablation of focal triggers to no treatment for patients with atrial fibrillation. It was not clear from the study which alternative represented current practice in the authors' setting. You should decide if they are valid comparators in your setting.
Validity of estimate of measure of effectiveness The authors aimed to evaluate the long-term effects of radiofrequency catheter ablation of focal triggers of atrial fibrillation on the quality of life. The study design, a case series, required an implicit assumption that the baseline measure of the outcome was taken to be the outcome of no treatment at the specified periods of follow-up. The authors did not justify this. Consequently, there is a high potential for performance bias and it cannot be said that the results related to a difference between treatment and "do nothing". The study sample was representative of the study population at the centre involved, as it included all patients receiving treatment for atrial fibrillation within a specific setting.
Validity of estimate of measure of benefit There was no summary measure of benefit. The analysis was therefore categorised as a cost-consequences analysis.
Validity of estimate of costs The costs were estimated from the perspective of the hospital and all the relevant cost categories were included. Some quantities, such as the quantity of hospitalisations and clinical visits, were reported separately from the overall cost of treatment. The price year was reported, which helps the generalisability of the results. Resource use was observed directly from the study, but no statistical analysis was conducted to assess the impact of uncertainty. The authors discussed the intuition of their cost findings, providing an explanation for the high cost of ablation. A brief summary of the initial costs versus the longer run cost-savings of ablation was also given. It may have been useful had the authors estimated the post-treatment life expectancy required for the treatment to generate net cost-savings.
Other issues The authors made appropriate comparisons of their findings with those from other studies, one of which had shown improvements in quality of life over a 60-week follow-up. The authors addressed the issue of generalisability to other settings, reporting that a randomised study would be required to determine whether the results could be generalised. The authors do not appear to have presented their results selectively. The study enrolled patients with atrial fibrillation who underwent treatment and this was reflected in the authors' conclusions. The authors reported a number of limitations. First, the use of a case-series rather than a randomised study. Second, the evolution of radiofrequency ablation techniques rendering the results applicable for only a short period of time. Finally, the health care system perspective adopted for the economic analysis.
Implications of the study The authors did not make any recommendations for policy or practice in relation to the treatment. However, they did express the need for future randomised trials to fully evaluate the outcomes associated with the treatment.
Bibliographic details Goldberg A, Menen M, Mickelsen S, MacIndoe C, Binder M, Nawman R, West G, Kusumoto F M. Atrial fibrillation ablation leads to long-term improvement of quality of life and reduced utilization of healthcare resources. Journal of Interventional Cardiac Electrophysiology 2003; 8(1): 59-64 Other publications of related interest Gerstenfeld EP, Guerra P, Sparks PB, et al. Clinical outcome after radiofrequency catheter ablation of focal atrial fibrillation triggers. Journal of Cardiovascular Electrophysiology 2001;12:724-35.
Bubien RS, Knotts-Dolson SS, Plumb VJ, Kay GN. Effect of radiofrequency catheter ablation on health-related quality of life and activities of daily living in patients with recurrent arrhythmias. Circulation 1996;94:1585-91.
Fitzpatrick AP, Kourouyan HD, Siu A, et al. Quality-of-life and outcomes after radiofrequency His-bundle catheter ablation and permanent pacemaker implantation: impact of treatment in paroxysmal and established atrial fibrillation. American Heart Journal 1996;131:499-507.
Indexing Status Subject indexing assigned by NLM MeSH Adolescent; Adult; Aged; Atrial Fibrillation /economics /surgery; Catheter Ablation /economics; Costs and Cost Analysis; Echocardiography; Electrocardiography, Ambulatory; Electrophysiologic Techniques, Cardiac; Female; Follow-Up Studies; Health Resources /standards /utilization; Hospitalization /economics; Humans; Male; Middle Aged; New Mexico; Postoperative Complications /economics /etiology /physiopathology; Quality of Life /psychology; Recurrence; Reoperation; Stroke Volume /physiology; Time; Treatment Outcome; Ventricular Dysfunction, Left /economics /surgery AccessionNumber 22003000419 Date bibliographic record published 31/12/2003 Date abstract record published 31/12/2003 |
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