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

BACKGROUND: Randomized studies evaluating left atrial radiofrequency ablation (RFA) in patients with persistent atrial fibrillation undergoing mitral valve surgery are scarce and monocentric. AIM: To evaluate the efficacy of left atrial RFA concomitant with mitral valve surgery to restore and maintain sinus rhythm.
METHODS: 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.
RESULTS: 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 discharge (72.7% vs 4.8%; p<0.005), 3-month follow-up (85.7% vs 23.8%; p<0.01) and 12-month follow-up (95.2% vs 33.3%; p<0.005). The patients in the RFA group had similar rates of postoperative complications and stroke during follow-up as those in the control group.
CONCLUSIONS: This multicentre study suggests that left atrial RFA is effective and safe in patients with chronic atrial fibrillation and mitral valve disease.

RCT Entities:   Population Interventions Outcomes