Department of Cardiology/Rythmology, hospices civils de Lyon, hôpital cardiologique Louis-Pradel, CHU Louis-Pradel, avenue du Doyen-Lépine, Lyon cedex 03, France.
Arch Cardiovasc Dis. 2009 Nov;102(11):769-75. doi: 10.1016/j.acvd.2009.08.010. Epub 2009 Nov 17.
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 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.
This multicentre study suggests that left atrial RFA is effective and safe in patients with chronic atrial fibrillation and mitral valve disease.
评价持续性心房颤动患者行二尖瓣手术时行左心房射频消融（RFA）的随机研究很少且为单中心研究。
评估左心房 RFA 联合二尖瓣手术恢复和维持窦性心律的疗效。
SAFIR 是一项多中心、双盲、中心随机研究，涉及 4 所大学医院。2002 年 12 月至 2005 年 9 月，纳入 43 例二尖瓣疾病合并长期持续性心房颤动（持续时间>6 个月）患者。我们比较了单纯瓣膜手术（n=22）或联合左心房 RFA（n=21）。主要终点是 12 个月时无心律失常复发的窦性心律。次要终点是手术不良事件、心房颤动复发、卒中和术后 3 个月和 12 个月的超声心动图测量。基于意向治疗原则对疗效标准进行分析。
RFA 组主要终点的发生率显著高于对照组（分别为 12/21 例患者[57%] vs 1/22 例患者[4%]；p=0.004）。RFA 组窦性心律患者多于对照组，出院时（72.7% vs 4.8%；p<0.005）、术后 3 个月（85.7% vs 23.8%；p<0.01）和 12 个月（95.2% vs 33.3%；p<0.005）。RFA 组患者在随访期间的术后并发症和卒中和对照组相似。
这项多中心研究表明，对于慢性心房颤动和二尖瓣疾病患者，左心房 RFA 是有效且安全的。
