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二尖瓣手术期间行左心房射频消融治疗持续性心房颤动:一项随机对照试验

Left atrial radiofrequency ablation during mitral valve surgery for continuous atrial fibrillation: a randomized controlled trial.

作者信息

Doukas George, Samani Nilesh J, Alexiou Christos, Oc Mehmet, Chin Derek T, Stafford Peter G, Ng Leong L, Spyt Tomasz J

机构信息

Department of Cardiac Surgery, Glenfield Hospital, University Hospitals of Leicester NHS Trust, England.

出版信息

JAMA. 2005 Nov 9;294(18):2323-9. doi: 10.1001/jama.294.18.2323.

Abstract

CONTEXT

Although left atrial radiofrequency ablation (RFA) is increasingly used for the treatment of chronic atrial fibrillation during mitral valve surgery, its efficacy to restore sinus rhythm and any resulting benefits have not been examined in the context of an adequately powered randomized trial.

OBJECTIVE

To determine whether intraoperative RFA of the left atrium increases the long-term restoration of sinus rhythm and improves exercise capacity.

DESIGN, SETTING, AND PATIENTS: Randomized, double-blind trial performed in a single UK tertiary referral center with enrollment between December 2001 and November 2003. A total of 101 patients referred for mitral valve surgery with at least 6 months' history of uninterrupted atrial fibrillation were assessed for eligibility; 97 were enrolled. Patients were followed up for 12 months.

INTERVENTION

Patients were randomly assigned to undergo mitral valve surgery and RFA of the left atrium (n = 49) or mitral valve surgery alone (controls; n = 48).

MAIN OUTCOME MEASURES

The primary outcome measure was presence of sinus rhythm at 12 months; secondary measures were patient functional status and exercise capacity (assessed by shuttle-walk test), left atrial contractility, and left atrial and left ventricular dimension and function and plasma levels of B-type natriuretic peptide.

RESULTS

At 12 months, sinus rhythm was present in 20 (44.4%) of 45 RFA patients and in 2 (4.5%) of 44 controls (rate ratio, 9.8; 95% CI, 2.4-86.3; P<.001). Restoration of sinus rhythm in the RFA group was accompanied by a greater improvement in mean (SD) shuttle-walk distance compared with controls (+94 [102] m vs +48 [82] m; P = .003) and a greater reduction in the plasma level of B-type natriuretic peptide (-104 [87] fmol/mL vs -51 [82] fmol/mL; P = .03). Patients randomized to receive RFA had similar rates of postoperative complications and deaths as control patients.

CONCLUSIONS

Radiofrequency ablation of the left atrium during mitral valve surgery for continuous atrial fibrillation significantly increases the rate of sinus rhythm restoration 1 year postoperatively, improving patient exercise capacity. On the basis of its efficacy and safety, routine use of RFA of the left atrium during mitral valve surgery may be justified.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT00238706.

摘要

背景

尽管左心房射频消融术(RFA)越来越多地用于二尖瓣手术期间慢性心房颤动的治疗,但在一项样本量充足的随机试验背景下,其恢复窦性心律的疗效及任何由此产生的益处尚未得到检验。

目的

确定术中左心房射频消融术是否能提高窦性心律的长期恢复率并改善运动能力。

设计、地点和患者:在英国一家三级转诊中心进行的随机双盲试验,于2001年12月至2003年11月期间招募患者。共有101例因二尖瓣手术前来就诊且有至少6个月持续性心房颤动病史的患者接受了资格评估;97例患者入组。对患者进行了12个月的随访。

干预措施

患者被随机分配接受二尖瓣手术及左心房射频消融术(n = 49)或单纯二尖瓣手术(对照组;n = 48)。

主要结局指标

主要结局指标为12个月时窦性心律的存在情况;次要指标为患者功能状态和运动能力(通过往返步行试验评估)、左心房收缩力、左心房和左心室大小及功能以及B型利钠肽血浆水平。

结果

12个月时,45例接受射频消融术的患者中有20例(44.4%)恢复窦性心律,44例对照组患者中有2例(4.5%)恢复窦性心律(率比为9.8;95%可信区间为2.4 - 86.3;P <.001)。与对照组相比,射频消融术组恢复窦性心律的同时,平均(标准差)往返步行距离改善更大(+94 [102] m对+48 [82] m;P =.003),B型利钠肽血浆水平降低幅度更大(-104 [87] fmol/mL对-51 [82] fmol/mL;P =.03)。随机接受射频消融术的患者术后并发症和死亡发生率与对照组患者相似。

结论

二尖瓣手术期间对持续性心房颤动患者进行左心房射频消融术可显著提高术后1年窦性心律恢复率,改善患者运动能力。基于其疗效和安全性,二尖瓣手术期间常规使用左心房射频消融术可能是合理的。

试验注册

ClinicalTrials.gov标识符:NCT00238706。

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