Evidence for long-term AF ablation efficacy lacking

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Treating atrial fibrillation (AF) with radiofrequency (RF) ablation is gaining widespread acceptance despite gaps in comparative evidence to show its effectiveness.

The FDA earlier this year approved the first two RF ablation catheters for treating AF, but acknowledged a lack of evidence in the technology's capbility to reduce the risk of stroke. It recommended, therefore, that patients should continue taking blood thinners.

The FDA is not the only government agency to have scrutinized RF ablation for AF. A report funded by the Agency for Healthcare Research and Quality (AHRQ) found evidence to support ablation’s efficacy for up to one year compared with drugs, but noted the lack of longer term evidence. AHRQ confirmed the FDA’s assessment, noting that the effect of ablation on stroke risk is unknown.

AHRQ also reported that little evidence suggests the effectiveness of ablation as a first-line therapy.

The cardiovascular community has a similar situation with coronary CT angiography (CCTA) for chest pain patients. Adoption of the technique was rapid among early supporters, but without the evidence of its effectiveness compared with commonly used tests, payors were hesitant to reimburse. Many cardiologists got involved in studies and trials to help prove the efficacy of CCTA. There is still no national reimbursement policy, but providers have more evidence to help persuade their private payors to reimburse for CCTA, which they are doing with increasing frequency.

Another study featured in this Electrophysiology portal adds to the evidence that RF ablation is effective in the short term, up to one year. Researchers from Tufts found the procedure beneficial in younger patients with good cardiac function as a second-line approach. This review of the literature found that ablation improved the quality of life, compared with drugs alone. Ablation, however, did not reduce stroke risk compared with drugs.

Much more research needs to be conducted to assess the efficacy of ablation in AF patients, including those who are older, have more serious cardiac conditions and in women. It seems the FDA is on the right track, approving the first two RF catheter ablation systems for AF, and the AHRQ has laid out the present state of the research. It is now up to the EP community to continue to gather evidence-based data to help answer the questions surrounding this topic.

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Lastly, if you have a comment or report to share about any aspect of cardiovascular imaging, please contact me at the address below. I look forward to hearing from you.

Chris Kaiser, Editor
ckaiser@cardiovascularbusiness.com