Gillinov A Marc, Gelijns Annetine C, Parides Michael K, DeRose Joseph J, Moskowitz Alan J, Voisine Pierre, Ailawadi Gorav, Bouchard Denis, Smith Peter K, Mack Michael J, Acker Michael A, Mullen John C, Rose Eric A, Chang Helena L, Puskas John D, Couderc Jean-Philippe, Gardner Timothy J, Varghese Robin, Horvath Keith A, Bolling Steven F, Michler Robert E, Geller Nancy L, Ascheim Deborah D, Miller Marissa A, Bagiella Emilia, Moquete Ellen G, Williams Paula, Taddei-Peters Wendy C, O'Gara Patrick T, Blackstone Eugene H, Argenziano Michael
The authors' affiliations are listed in the Appendix.
N Engl J Med. 2015 Apr 9;372(15):1399-409. doi: 10.1056/NEJMoa1500528. Epub 2015 Mar 16.
Among patients undergoing mitral-valve surgery, 30 to 50% present with atrial fibrillation, which is associated with reduced survival and increased risk of stroke. Surgical ablation of atrial fibrillation has been widely adopted, but evidence regarding its safety and effectiveness is limited.
We randomly assigned 260 patients with persistent or long-standing persistent atrial fibrillation who required mitral-valve surgery to undergo either surgical ablation (ablation group) or no ablation (control group) during the mitral-valve operation. Patients in the ablation group underwent further randomization to pulmonary-vein isolation or a biatrial maze procedure. All patients underwent closure of the left atrial appendage. The primary end point was freedom from atrial fibrillation at both 6 months and 12 months (as assessed by means of 3-day Holter monitoring).
More patients in the ablation group than in the control group were free from atrial fibrillation at both 6 and 12 months (63.2% vs. 29.4%, P<0.001). There was no significant difference in the rate of freedom from atrial fibrillation between patients who underwent pulmonary-vein isolation and those who underwent the biatrial maze procedure (61.0% and 66.0%, respectively; P=0.60). One-year mortality was 6.8% in the ablation group and 8.7% in the control group (hazard ratio with ablation, 0.76; 95% confidence interval, 0.32 to 1.84; P=0.55). Ablation was associated with more implantations of a permanent pacemaker than was no ablation (21.5 vs. 8.1 per 100 patient-years, P=0.01). There were no significant between-group differences in major cardiac or cerebrovascular adverse events, overall serious adverse events, or hospital readmissions.
The addition of atrial fibrillation ablation to mitral-valve surgery significantly increased the rate of freedom from atrial fibrillation at 1 year among patients with persistent or long-standing persistent atrial fibrillation, but the risk of implantation of a permanent pacemaker was also increased. (Funded by the National Institutes of Health and the Canadian Institutes of Health Research; ClinicalTrials.gov number, NCT00903370.).
在接受二尖瓣手术的患者中,30%至50%会出现心房颤动,这与生存率降低和中风风险增加相关。心房颤动的外科消融术已被广泛采用,但关于其安全性和有效性的证据有限。
我们将260例需要进行二尖瓣手术的持续性或长期持续性心房颤动患者随机分为两组,一组在二尖瓣手术期间接受外科消融术(消融组),另一组不进行消融(对照组)。消融组患者进一步随机分为肺静脉隔离组或双心房迷宫手术组。所有患者均进行左心耳闭合术。主要终点是6个月和12个月时无房颤(通过3天动态心电图监测评估)。
消融组在6个月和12个月时无房颤的患者比对照组更多(63.2%对29.4%,P<0.001)。接受肺静脉隔离的患者和接受双心房迷宫手术的患者在无房颤率方面无显著差异(分别为61.0%和66.0%;P=0.60)。消融组的1年死亡率为6.8%,对照组为8.7%(消融的风险比为0.76;95%置信区间为0.32至1.84;P=0.55)。与不进行消融相比,消融与更多的永久性起搏器植入相关(每100患者年分别为21.5次和8.1次,P=0.01)。在主要心脏或脑血管不良事件、总体严重不良事件或住院再入院方面,两组之间无显著差异。
对于持续性或长期持续性心房颤动患者,在二尖瓣手术中增加心房颤动消融术可显著提高1年时无房颤的发生率,但永久性起搏器植入的风险也会增加。(由美国国立卫生研究院和加拿大卫生研究院资助;ClinicalTrials.gov编号,NCT00903370。)