Abstract 3375: Left Maze Radiofrequency Ablation During Mitral Valve Surgery For Chronic Atrial Fibrillation : A Randomized Multicenter Study (SAFIR)
Randomized studies evaluating antiarrhythmic surgery in patients with chronic atrial fibrillation undergoing mitral valve remplacement are scarce and monocentric.
Methods: The Surgery for Atrial FIbrillation tRial is a multicenter, blinded and centrally randomized study, involving 5 academic centres. Between December 2003 and January 2006 a total of 43 patients with mitral valve disease and chronic atrial fibrillation (> 6 months duration) were included. We compared valvular surgery alone (controls;n=22) and left maze radiofrequency (RFA) ablation associated with cryoablation (n=21). The main endpoint was sinus rhythm at 12 months. Secondary end-point were surgical adverse events, stroke and death during the follow-up at 6 and 12 months. The statistical analysis was performed according to the “intention to treat analysis”.
Results: Patients of both groups did not differ in terms of their baseline characteristics. Mean left atrial diameter in RFA group and in control group was 54+/6 mm versus 52+/− 7 mm, respectively. At hospital discharge, and at 6 and 12 months follow-up there were more patients with sinus rhythm in the RFA group when compare to the valve surgery alone group (76% versus 1%, p<0.0005; 65% versus 22%, p<0.0012; 95% versus 31% , p< 0.0005, respectively). Patients randomized to antiarrhythmic surgery had similar rates of post-operative complications and stroke during follow-up as control patients.
Conclusions : This study suggests that a left MAZE procedure is effective in preserving sinus rhythm at one year in patients with chronic atrial fibrillation and mitral valve disease. Long term follow-up studies are needed before this therapy can be universally recommended.