The maze procedure in treating atrial fibrillation

Findings by SBU Alert

Version: 1

Technology and target group

Atrial fibrillation is a common disorder that impairs cardiac function and increases the risk for thrombosis. Primarily, medication is used to treat the disorder, but surgery becomes an option if medication or other non-pharmacological treatment alternatives are insufficient. The Maze procedure is an open surgical intervention that can be used to treat particularly severe cases of atrial fibrillation. Eleven incisions are strategically placed in both atria and are sutured to create a labyrinth (Maze) that is intended to direct electrical impulses to the appropriate areas of the heart. The target group is comprised of patients with very severe problems, and where other treatment methods have failed to normalize cardiac rhythm. In Sweden, it is estimated that between 50 and 100 patients annually would be candidates for treatment.

Patient benefit

No randomized controlled studies have assessed the benefits of the Maze procedure. However, results have been reported from followup studies of 1476 patients who have undergone the Maze procedure. In followups ranging between 1 and 10 years, permanent sinus rhythm was restored in 75 percent to 100 percent of the patients. One study reported on quality of life in 49 patients prior to and 6 months following the Maze procedure. The results were compared to an average population and showed that the patients quality of life was significantly lower before the operation, but 6 months after surgery it was comparable to the average population. As with all open thoracic surgery, the Maze procedure involves risks for severe complications such as hemorrhaging, infections, and myocardial infarction. Different studies have reported that mortality in conjunction with surgery varies between 1 percent and nearly 5 percent.

Economic aspects

The Maze procedure has not been assessed from a health economics standpoint. Costs for the procedure are comparable to coronary artery surgery, ie, between 175 000 and 225 000 SEK. This would imply an annual cost ranging between 10 and 20 million SEK in Sweden if the method were to be used routinely in health care.

Scientific evidence

There is moderate* scientific documentation on the patient benefits and risks of the Maze procedure. There is no* scientific documentation on the cost effectiveness of the method. Knowledge about the method remains insufficient, and further studies of the benefits and risks are needed. In compliance with the principles of ethical research, patients must be adequately informed of the scientific evidence about the procedure before they decide to accept this option.

*This assessment by SBU Alert uses a 4-point scale to grade the quality and evidence of the scientific documentation. The grades indicate: (1) good, (2) moderate, (3) poor, or (4) no scientific evidence on the subject.

This summary is based on a report prepared at SBU in collaboration with Assoc. Prof. Per Blomström, Uppsala University Hospital, Uppsala. It has been reviewed by Assoc. Prof. Rolf Nordlander, Södersjukhuset, Stockholm.

The complete report is available only in Swedish.

Alert is a joint effort by the Swedish Council on Technology Assessment in Health Care (SBU), the Medical Products Agency, the National Board of Health and Welfare, and the Federation of Swedish County Councils.

References

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