This guide summarizes the clinical evidence on the effectiveness and safety of catheter-based radiofrequency ablation (RFA) compared with anti-arrhythmic drugs (AADs) for the treatment of atrial fibrillation (AF). This guide does not address other aspects of AF treatment, including anticoagulation, rate control medications, or treatments other than RFA and AADs used to restore sinus rhythm.

Clinical Issue

Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. AF can be paroxysmal, persistent (more than 7 days), or chronic (more than 1 year). AF often causes significant symptoms, such as palpitations, shortness of breath, and fatigue, and is associated with a fivefold increased risk of stroke and approximately a twofold increased risk of death. Many people with AF can be adequately treated with drugs that control heart rate without restoring normal heart rhythm. However, for some people, rate control alone does not relieve the symptoms. Those people may benefit from therapies to restore normal cardiac rhythm. Sometimes a normal rhythm can be maintained with medications, but anti-arrhythmic drugs (AADs) can have serious side effects.

An alternative method for restoring normal cardiac rhythm is radiofrequency ablation (RFA). With RFA, a catheter is advanced into the heart and positioned in the area of an abnormal electrical circuit. On contact, the catheter tip heats the cardiac tissue using radiofrequency energy. The resulting tissue destruction prevents the abnormal electrical signals from being conducted. Several different ablation techniques are used for AF. With most techniques, the ablation targets are sites in the pulmonary veins and the left atrium.

Clinical Bottom Line

Evidence is insufficient to determine the effectiveness of RFA as first-line therapy compared with AADs.

Among patients with AF who have failed at least one course of AADs, RFA is more effective than another trial of AADs for maintaining sinus rhythm at 1 year.

Level of Confidence:

Serious complications are uncommon after RFA, but stroke and cardiac tamponade each occur in about 1 percent of cases.

Level of Confidence:

Effectiveness

Comparative Effectiveness

Table 1 summarizes the evidence on the comparative effectiveness of RFA and AADs for various outcomes. Most trials examined the effectiveness of RFA as second-line therapy; they compared RFA with AADs among patients who had failed at least one previous trial of AADs. Evidence is insufficient to determine the effectiveness of RFA as first-line therapy compared with AADs.

Table 1

Comparative effectiveness of RFA and AADs as second-line therapy for atrial fibrillation.

Factors Affecting Efficacy

Patient characteristics

Studies have examined the efficacy of RFA in subgroups of patients with AF (see Table 2). These studies show that many patient characteristics do not affect the efficacy of RFA.

Table 2

Effect of patient characteristics on RFA efficacy.

• To date, research on the benefits of left- or right-sided ablation lines in addition to standard RFA techniques is inconclusive.
• To date, research on different radiofrequency energy outputs is inconclusive.
• Research on the importance of RFA operator characteristics (e.g., clinical setting and level of experience) is limited.

Assessing Risk

Serious complications are relatively uncommon after RFA (see Table 3). Adverse events were reported in 100 studies with over 22,000 patients. Sixteen studies, with more than 4,300 patients, reported mortality rates. Five deaths were reported within 30 days after RFA. Three deaths were caused by atrioesophageal fistula, one was caused by pulmonary infection, and one was due to anaphylaxis.

Table 3

Rates of complications after RFA.

Treatment Selection

On the Horizon

Results from the Ablation Versus Anti-Arrhythmic Drug Therapy for AF (CABANA) trial should be available in late 2015 or 2016. This long-term trial of first-line therapies compares catheter ablation with either rate-control or rhythm-control drugs for reducing total mortality in patients with untreated or incompletely treated AF. Cost effectiveness and quality of life will be evaluated.

Resource for Patients

Radiofrequency Ablation for Atrial Fibrillation: A Guide for Adults is a companion to this Clinician’s Guide. It can help people talk with their health care professional about radiofrequency ablation. It provides information about:

• What atrial fibrillation is.
• Types of treatments for AF.
• Benefits and risks of rhythm-control treatments.
• Seeking advice from a health care professional about treatment options.

For More Information

For electronic copies of the consumer’s guide, this clinician’s guide, and the full systematic review, visit this Web site: www.effectivehealthcare.ahrq.gov

For free print copies call:

AHRQ Publications Clearinghouse

800-358-9295

Consumer Guide, AHRQ Pub. No. 09(10)-EHC015-A

Clinician Guide, AHRQ Pub. No. 09(10)-EHC015-3

Source

The source material for this guide is a systematic review of 120 research studies. The review, Comparative Effectiveness of Radiofrequency Catheter Ablation for Atrial Fibrillation (2009), was prepared by the Tufts Medical Center Evidence-based Practice Center. A summary of the report, including an additional analysis, was published in Ann Intern Med 2009;151:191–202. The Agency for Healthcare Research and Quality (AHRQ) funded the systematic review and this guide. The guide was developed using feedback from clinicians who reviewed preliminary drafts. The full systematic review is available at www.effectivehealthcare.ahrq.gov .

AHRQ created the John M. Eisenberg Center to make research useful for decisionmakers. This guide was written by Somnath Saha, M.D., Rachelle Nicolai, B.A., Martha Schechtel, R.N., and David Hickam, M.D., of Oregon Health & Science University.