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

• Published in: Archives of cardiovascular diseases Vol. 102; no. 11; pp. 769 - 775
• Main Authors: Chevalier, Philippe, Leizorovicz, Alain, Maureira, Pablo, Carteaux, Jean-Pierre, Corbineau, Hervé, Caus, Thierry, DeBreyne, Brigitte, Mabot, Philippe, Dechillou, Christian, Deharo, Jean-Claude, Barry, Serge, Touboul, Paul, Villemot, Jean-Pierre, Obadia, Jean-François
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier Masson SAS 01.11.2009; Elsevier; Elsevier/French Society of Cardiology
• Subjects: Ablation par courant de radiofréquence; Aged; Atherosclerosis (general aspects, experimental research); Atrial Fibrillation; Atrial Fibrillation - complications; Atrial Fibrillation - diagnostic imaging; Atrial Fibrillation - physiopathology; Atrial Fibrillation - surgery; Bioengineering; Biological and medical sciences; Blood and lymphatic vessels; Cardiac dysrhythmias; Cardiac Surgical Procedures; Cardiac Surgical Procedures - adverse effects; Cardiology and cardiovascular system; Cardiology. Vascular system; Cardiovascular; Catheter Ablation; Catheter Ablation - adverse effects; Computer Science; Double-Blind Method; Engineering Sciences; Female; Fibrillation atriale; France; Heart; Heart Valve Diseases; Heart Valve Diseases - complications; Heart Valve Diseases - diagnostic imaging; Heart Valve Diseases - physiopathology; Heart Valve Diseases - surgery; Human health and pathology; Humans; Internal Medicine; Life Sciences; Male; Medical sciences; Middle Aged; Mitral Valve; Mitral Valve - diagnostic imaging; Mitral Valve - physiopathology; Mitral Valve - surgery; Mitral valve disease; Other treatments; Prospective Studies; Radiofrequency ablation; Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects); Recurrence; Signal and Image processing; Stroke; Stroke - etiology; Time Factors; Treatment Outcome; Treatment. General aspects; Tumors; Ultrasonography; Valvulpathie mitrale; SAFIR; atrial fibrillation; Ablation par courant de radiofréquence; AF; Valvulpathie mitrale; RFA; radiofrequency ablation; Surgery for atrial fibrillation trial; Mitral valve disease; Fibrillation atriale; Atrial fibrillation; Radiofrequency ablation; Mitral valve; Arrhythmia; Ultrasonic treatment; Instrumentation therapy; Thermal ablation; Cardiovascular disease; Left atrium; Radiofrequency; Excitability disorder; Prospective; Randomization; Heart disease; Surgery; Clinical trial; Cardiology; Current
• ISSN: 1875-2136; 1875-2128
• DOI: 10.1016/j.acvd.2009.08.010

Summary 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.