Left atrial radiofrequency ablation during mitral valve surgery: a prospective randomized multicentre study (SAFIR)

Archives of Cardiovascular Diseases
Philippe ChevalierJean-François Obadia

Abstract

Randomized studies evaluating left atrial radiofrequency ablation (RFA) in patients with persistent atrial fibrillation undergoing mitral valve surgery are scarce and monocentric. To evaluate the efficacy of left atrial RFA concomitant with mitral valve surgery to restore and maintain sinus rhythm. The SAFIR is a multicentre, double-blinded, centrally randomized study involving four university hospitals. Between December 2002 and September 2005, 43 patients with mitral valve disease and long-standing, persistent atrial fibrillation (duration>6 months) were included. We compared valvular surgery alone (n=22) or with left atrial RFA (n=21). The main endpoint was sinus rhythm at 12 months without recurrence of arrhythmia during follow-up. Secondary endpoints were surgical adverse events, atrial fibrillation relapses, stroke and echocardiographic measurements after three and 12 months' follow-up. Analyses of the efficacy criteria were performed on an intention-to-treat basis. The primary endpoint occurred significantly more often in the RFA group than in the control group (respectively, 12/21 patients [57%] vs 1/22 patients [4%]; p=0.004). There were more patients with sinus rhythm in the RFA group than in the control group at disc...Continue Reading

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