– Report examines comparative effectiveness of established and emerging strategies for rhythm control and stroke prevention in patients with the common heart arrhythmia –

Boston, Mass., September 30, 2010 – A comprehensive appraisal of the management options for the irregular heartbeat called atrial fibrillation (AF) released last week details the comparative clinical effectiveness and value of several strategies for restoring rhythm control and preventing stroke in patients with AF.  The report – prepared by the Institute for Clinical and Economic Review (ICER), a leader in comparative effectiveness research based at the Massachusetts General Hospital’s Institute for Technology Assessment – examined evidence on established approaches, such as anti-arrhythmic drugs and catheter ablation; newer techniques such as surgical ablation; and emerging strategies.

AF is the most common cardiac arrhythmia in the U.S. population, with over 2 million people suffering from the condition.  AF can be asymptomatic but it may also be associated with shortness of breath, difficulty with exercise, palpitations, general fatigue, dizziness, and confusion.  Importantly, AF is the second-leading cause of stroke, after atherosclerosis; the risk of stroke among those with AF is estimated to be fivefold higher than in patients without this disorder.  Therefore, clinicians’ approaches to AF management involve two strategies: controlling the arrhythmia and preventing stroke.

“There are several recent innovations in the treatment of AF patients that have both created difficulty for patients and clinicians trying to choose the right strategy, and presented payers with challenges as they attempt to make policies that support appropriate care,” said Steven Pearson, MD, ICER’s President.  “Not only does our report help to synthesize the existing evidence, but it also frames the key evidence gaps that should help set research goals for the future.”

ICER’s research concluded that catheter ablation following a course of treatment with an anti-arrhythmic drug, while more costly, was substantially more effective at maintaining a normal heart rhythm than an anti-arrhythmic drug alone.  Dronedarone, a newer anti-arrhythmic drug, was found to have both comparable effectiveness and comparable costs as compared to amiodarone, a commonly used anti-arrhythmic drug.  However, ICER’s review found the evidence on the effectiveness of surgical ablation to be insufficient to make a determination of comparative clinical effectiveness or comparative value.  For all of the interventions examined, there was far less information available on older, sicker patients, therefore ICER was not able to make any determination about comparative effectiveness in those populations.

“Our report highlights the areas where there is a lack of quality evidence on the effectiveness of several strategies employed to manage atrial fibrillation and prevent stroke,” said Dan Ollendorf, MPH, ICER’s Chief Review Officer.  “By conducting this comprehensive analysis, we hope that patients and clinicians will have more information at their disposal to make decisions about the treatment pathways for atrial fibrillation patients.  ”

The full report and associated appendices with detailed information on the results of ICER’s work are available online.

About ICER

The Institute for Clinical and Economic Review (ICER) is an independent non-profit research institute that produces reports analyzing the evidence on the effectiveness and value of drugs and other medical services. ICER’s reports include evidence-based calculations of prices for new drugs that accurately reflect the degree of improvement expected in long-term patient outcomes, while also highlighting price levels that might contribute to unaffordable short-term cost growth for the overall health care system.

ICER’s reports incorporate extensive input from all stakeholders and are the subject of public hearings through three core programs: the California Technology Assessment Forum (CTAF), the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC), and the New England Comparative Effectiveness Public Advisory Council (New England CEPAC). These independent panels review ICER’s reports at public meetings to deliberate on the evidence and develop recommendations for how patients, clinicians, insurers, and policymakers can improve the quality and value of health care. For more information about ICER, please visit ICER’s website.


Sarah K. Emond
Institute for Clinical and Economic Review