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心房颤动的消融治疗:基于证据的分析。

Ablation for atrial fibrillation: an evidence-based analysis.

出版信息

Ont Health Technol Assess Ser. 2006;6(7):1-63. Epub 2006 Mar 1.

Abstract

OBJECTIVE

To review the effectiveness, safety, and costing of ablation methods to manage atrial fibrillation (AF). The ablation methods reviewed were catheter ablation and surgical ablation.

CLINICAL NEED

Atrial fibrillation is characterized by an irregular, usually rapid, heart rate that limits the ability of the atria to pump blood effectively to the ventricles. Atrial fibrillation can be a primary diagnosis or it may be associated with other diseases, such as high blood pressure, abnormal heart muscle function, chronic lung diseases, and coronary heart disease. The most common symptom of AF is palpitations. Symptoms caused by decreased blood flow include dizziness, fatigue, and shortness of breath. Some patients with AF do not experience any symptoms. According to United States data, the incidence of AF increases with age, with a prevalence of 1 per 200 people aged between 50 and 60 years, and 1 per 10 people aged over 80 years. In 2004, the Institute for Clinical Evaluative Sciences (ICES) estimated that the rate of hospitalization for AF in Canada was 582.7 per 100,000 population. They also reported that of the patients discharged alive, 2.7% were readmitted within 1 year for stroke. One United States prevalence study of AF indicated that the overall prevalence of AF was 0.95%. When the results of this study were extrapolated to the population of Ontario, the prevalence of AF in Ontario is 98,758 for residents aged over 20 years. Currently, the first-line therapy for AF is medical therapy with antiarrhythmic drugs (AADs). There are several AADs available, because there is no one AAD that is effective for all patients. The AADs have critical adverse effects that can aggravate existing arrhythmias. The drug selection process frequently involves trial and error until the patient's symptoms subside.

THE TECHNOLOGY

Ablation has been frequently described as a "cure" for AF, compared with drug therapy, which controls AF but does not cure it. Ablation involves directing an energy source at cardiac tissue. For instance, radiofrequency energy uses heat to burn tissue near the source of the arrhythmia. The purpose is to create a series of scar tissue, so that the aberrant electrical pathways can no longer exist. Because the pulmonary veins are the predominant source of AF initiation, the primary goal of ablation is to isolate the pulmonary veins from the left atria through the creation of a conduction block. There are 2 methods of ablation: catheter ablation and surgical (operative) ablation. Radiofrequency energy is most commonly used for ablation. Catheter ablation involves inserting a catheter through the femoral vein to access the heart and burn abnormal foci of electrical activity by direct contact or by isolating them from the rest of the atrium. The surgical ablation is performed minimally invasively via direct visualization or with the assistance of a special scope for patients with lone AF.

REVIEW STRATEGY

In March 2006, the following databases were searched: Cochrane Library International Agency for Health Technology Assessment (first quarter 2006), Cochrane Database of Systematic Reviews (first quarter 2006), Cochrane Central Register of Controlled Trials (first quarter 2006), MEDLINE (1966 to February 2006), MEDLINE In-Process and Other Non-indexed Citations (1966 to March 1, 2006), and EMBASE (1980 to 2006 week 9). The Medical Advisory Secretariat also searched Medscape on the Internet for recent reports on trials that were unpublished but that were presented at international conferences. In addition, the Web site Current Controlled Trials (www.controlled-trials.com) was searched for ongoing trials investigating ablation for atrial fibrillation. Search terms included: radiofrequency ablation, catheter ablation and atrial fibrillation.

SUMMARY OF FINDINGS

Sixteen RCTs were identified that compared ablation methods in patients with AF. Two studies were identified that investigated first-line therapy for AF or atrial flutter. Seven other studies examined patients with drug-refractory, lone AF; and the remaining 7 RCTs compared ablation plus heart surgery to heart surgery alone in patients with drug-refractory AF and concomitant heart conditions. First-line Catheter Ablation for Atrial Fibrillation or Atrial Flutter Both studies concluded that catheter ablation was associated with significantly improved long-term freedom from arrhythmias and quality of life compared with medical therapy. These studies included different patient populations (those with AF in one pilot study, and those with atrial flutter in the other). Catheter ablation as first-line treatment is considered experimental at this time. Catheter Ablation Versus Medical Therapy in Patients With Drug-Refractory, Lone Atrial Fibrillation In this review, catheter ablation had success rates (freedom from arrhythmia) that ranged from 42% to 90% (median, 74%) in patients with drug-refractory, lone AF. All 3 of the RCTs comparing catheter ablation to medical therapy in patients with drug-refractory, lone AF found a significant improvement in terms of freedom from arrhythmia over a minimum of 12 months follow-up (P<.05). Ablation Plus Heart Surgery Versus Heart Surgery Alone in Patients With Atrial Fibrillation It is clear that patients with drug-refractory AF who are undergoing concomitant heart surgery (usually mitral valve repair or replacement) benefit significantly from surgical ablation, in terms of long-term freedom from AF, without substantial additional risk compared to open heart surgery alone. This group of patients represents about 1% of the patients with atrial fibrillation, thus the majority of the burden of AF lies within the patients with lone AF (i.e. those not requiring additional heart surgery).

CONCLUSION

Catheter ablation appears to be an effective treatment for patients with drug-refractory AF whose treatment alternatives are limited. Ablation technology is continually evolving with increasing success rates associated with the ablation procedure.

摘要

目的

回顾用于治疗心房颤动(AF)的消融方法的有效性、安全性及成本。所回顾的消融方法包括导管消融和外科消融。

临床需求

心房颤动的特征是心率不规则,通常较快,这限制了心房有效地将血液泵入心室的能力。心房颤动可以是原发性诊断,也可能与其他疾病相关,如高血压、心肌功能异常、慢性肺部疾病和冠心病。房颤最常见的症状是心悸。由血流减少引起的症状包括头晕、疲劳和呼吸急促。一些房颤患者没有任何症状。根据美国的数据,房颤的发病率随年龄增长而增加,50至60岁人群中每200人中有1人患病,80岁以上人群中每10人中有1人患病。2004年,临床评估科学研究所(ICES)估计,加拿大房颤的住院率为每10万人582.7例。他们还报告说,在存活出院的患者中,2.7%在1年内因中风再次入院。一项美国房颤患病率研究表明,房颤的总体患病率为0.95%。将该研究结果推算至安大略省人口,安大略省20岁以上居民中房颤患病率为98758人。目前,房颤的一线治疗是使用抗心律失常药物(AADs)进行药物治疗。有几种AADs可供选择,因为没有一种AADs对所有患者都有效。AADs有严重的不良反应,可加重现有的心律失常。药物选择过程通常需要反复试验,直到患者症状缓解。

技术

与控制房颤但不能治愈的药物治疗相比,消融常被描述为房颤的“治愈”方法。消融涉及将能量源指向心脏组织。例如,射频能量利用热量烧灼心律失常源头附近的组织。目的是形成一系列瘢痕组织,使异常电通路不再存在。由于肺静脉是房颤起始的主要来源,消融的主要目标是通过形成传导阻滞将肺静脉与左心房隔离。有两种消融方法:导管消融和外科(手术)消融。射频能量最常用于消融。导管消融是通过股静脉插入导管进入心脏,通过直接接触或与心房其他部分隔离来烧灼异常电活动灶。对于孤立性房颤患者,外科消融通过直接可视化或在特殊内镜辅助下进行微创操作。

综述策略

2006年3月,检索了以下数据库:Cochrane图书馆国际卫生技术评估机构(2006年第一季度)、Cochrane系统评价数据库(2006年第一季度)、Cochrane对照试验中心注册库(2006年第一季度)、MEDLINE(1966年至2006年2月)、MEDLINE在研及其他未索引引文(1966年至2006年3月1日)和EMBASE(1980年至2006年第9周)。医学咨询秘书处还在互联网上搜索了Medscape,以获取关于未发表但在国际会议上发表的试验的最新报告。此外,在网站Current Controlled Trials(www.controlled-trials.com)上搜索了正在进行的关于房颤消融治疗的试验。检索词包括:射频消融、导管消融和心房颤动。

研究结果总结

确定了16项比较房颤患者消融方法的随机对照试验(RCT)。确定了2项研究一线治疗房颤或心房扑动的试验。其他7项研究观察了药物难治性孤立性房颤患者;其余7项RCT比较了药物难治性房颤合并心脏疾病患者接受消融加心脏手术与单纯心脏手术的效果。房颤或心房扑动的一线导管消融两项研究均得出结论,与药物治疗相比,导管消融与长期无心律失常和生活质量显著改善相关。这些研究纳入了不同的患者群体(一项试点研究中的房颤患者和另一项研究中的心房扑动患者)。目前,导管消融作为一线治疗被认为是试验性的。药物难治性孤立性房颤患者的导管消融与药物治疗比较在本综述中,药物难治性孤立性房颤患者的导管消融成功率(无心律失常)在42%至90%之间(中位数为74%)。在药物难治性孤立性房颤患者中,所有3项比较导管消融与药物治疗的RCT均发现,在至少12个月的随访中,无心律失常方面有显著改善(P<0.05)。房颤患者消融加心脏手术与单纯心脏手术比较显然,正在接受心脏手术(通常是二尖瓣修复或置换)的药物难治性房颤患者,从外科消融中显著获益,在长期无房颤方面,与单纯心脏直视手术相比,没有实质性的额外风险。这组患者约占房颤患者的1%,因此,房颤的大部分负担在于孤立性房颤患者(即那些不需要额外心脏手术的患者)。

结论

对于治疗选择有限的药物难治性房颤患者,导管消融似乎是一种有效的治疗方法。消融技术不断发展,消融手术的成功率不断提高。

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