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Randomized Controlled Trial
. 2015 Apr 9;372(15):1399-409.
doi: 10.1056/NEJMoa1500528. Epub 2015 Mar 16.

Surgical ablation of atrial fibrillation during mitral-valve surgery

Collaborators, Affiliations
Randomized Controlled Trial

Surgical ablation of atrial fibrillation during mitral-valve surgery

A Marc Gillinov et al. N Engl J Med. .

Abstract

Background: Among patients undergoing mitral-valve surgery, 30 to 50% present with atrial fibrillation, which is associated with reduced survival and increased risk of stroke. Surgical ablation of atrial fibrillation has been widely adopted, but evidence regarding its safety and effectiveness is limited.

Methods: We randomly assigned 260 patients with persistent or long-standing persistent atrial fibrillation who required mitral-valve surgery to undergo either surgical ablation (ablation group) or no ablation (control group) during the mitral-valve operation. Patients in the ablation group underwent further randomization to pulmonary-vein isolation or a biatrial maze procedure. All patients underwent closure of the left atrial appendage. The primary end point was freedom from atrial fibrillation at both 6 months and 12 months (as assessed by means of 3-day Holter monitoring).

Results: More patients in the ablation group than in the control group were free from atrial fibrillation at both 6 and 12 months (63.2% vs. 29.4%, P<0.001). There was no significant difference in the rate of freedom from atrial fibrillation between patients who underwent pulmonary-vein isolation and those who underwent the biatrial maze procedure (61.0% and 66.0%, respectively; P=0.60). One-year mortality was 6.8% in the ablation group and 8.7% in the control group (hazard ratio with ablation, 0.76; 95% confidence interval, 0.32 to 1.84; P=0.55). Ablation was associated with more implantations of a permanent pacemaker than was no ablation (21.5 vs. 8.1 per 100 patient-years, P=0.01). There were no significant between-group differences in major cardiac or cerebrovascular adverse events, overall serious adverse events, or hospital readmissions.

Conclusions: The addition of atrial fibrillation ablation to mitral-valve surgery significantly increased the rate of freedom from atrial fibrillation at 1 year among patients with persistent or long-standing persistent atrial fibrillation, but the risk of implantation of a permanent pacemaker was also increased. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00903370.).

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Conflict of interest statement

No other potential conflict of interest relevant to this article was reported.

Figures

Figure 1
Figure 1. Freedom from Atrial Fibrillation
Freedom from atrial fibrillation was defined as the absence of the condition at both 6 months and 12 months, as assessed by means of 3-day Holter monitoring. MVS denotes mitral-valve surgery, and PVI pulmonary-vein isolation.
Figure 2
Figure 2. Time-to-Event Curves for Death and Composite Cardiac End Point
The composite end point of major cardiac or cerebrovascular adverse events included death, stroke, hospitalization for heart failure, worsening heart failure (as defined by an increase of one or more classes in the New York Heart Association classification), or mitral-valve reintervention. Tick marks represent patients with censored data.

Comment in

References

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