背景:心房颤动(AF)是最常见的持续性心律失常。心脏复律是一种恢复正常/窦性心律的节律控制策略,并且可以通过药物(药理学)或同步电击(电复律)来实现。
目的:评估药物和电复律治疗心房颤动(AF)的疗效和安全性,房扑和房性心动过速.
方法:我们搜索了CENTRAL,MEDLINE,Embase,会议论文集引文索引-科学(CPCI-S)和三个试验寄存器(ClinicalTrials.gov,WHOICTRP和ISRCTN),2023年2月14日。
方法:我们纳入了个体患者水平的随机对照试验(RCT)。患者群体年龄≥18岁,有任何类型和持续时间的房颤,房扑或其他持续性相关房性心律失常,不是由于可逆原因而发生的。
方法:我们使用标准Cochrane方法来收集数据,并使用R中的netmeta软件包使用标准频率图理论方法进行网络荟萃分析。我们使用GRADE来评估我们在研究结果摘要中提供的证据的质量,并对确定性进行判断。我们使用风险比(RR)和95%置信区间(CI)计算差异,并使用P值对治疗进行排名。我们评估了临床和统计异质性,并对主要结果和急性手术成功的网络进行了拆分。由于担心违反传递性假设。
结果:我们包括112条RCT(139条记录),我们汇集了15,968例患者的数据。平均年龄为47~72岁,男性患者比例为38%~92%。79项试验被认为至少有一个领域存在高偏倚风险,32个没有高风险的偏向域,但至少有一个领域被归类为不确定风险,一项研究被认为是所有领域的低风险。对于阵发性房颤(35项试验),与安慰剂相比,心尖前(AA)/前后(AP)双相截断指数波形(BTE)复律(RR:2.42;95%CI1.65至3.56),奎尼丁(RR:2.23;95%CI1.49至3.34),伊布利特(RR:2.00;95%CI1.28至3.12),普罗帕酮(RR:1.98;95%CI1.67至2.34),胺碘酮(RR:1.69;95%CI1.42至2.02),索他洛尔(RR:1.58;95%CI1.08~2.31)和普鲁卡因胺(RR:1.49;95%CI1.13~1.97)可能导致在出院或研究随访结束前窦性心律维持大幅增加(证据确定性:中度)。AA/AP增量的效应大小较大,而随后的干预措施则逐渐变小。尽管证据的确定性很低,在此结果中,antazoline可能导致大幅增加(RR:28.60;95%CI1.77至461.30)。同样,低确定性证据表明氟卡尼的这一结果大幅增加(RR:2.17;95%CI1.68至2.79),vernakalant(RR:2.13;95%CI1.52至2.99),和镁(RR:1.73;95%CI0.79至3.79)。对于持续性房颤(26次试验),为电复律创建了一个网络,表明,与带补丁的APBTE增量能量相比,带补丁的APBTE最大能量(RR1.35,95%CI1.17至1.55)可能导致大幅增加,和主动加压APBTE增加的能量与贴片(RR:1.14,95%CI1.00~1.131)可能导致出院时或研究随访结束时窦性心律的维持增加(证据确定性:高).使用带桨的APBTE增量(RR:1.03,95%CI0.98至1.09;证据确定性:低)可能会导致轻微增加,和APMDS增量桨(RR:0.95,95%CI0.86至1.05;证据确定性:低)可能导致疗效略有下降。另一方面,使用补丁的APMDS增量能量(RR:0.78,95%CI0.70至0.87),带补丁的AARBW增量能量(RR:0.76,95%CI0.66至0.88),带补丁的APRBW增量能量(RR:0.76,95%CI0.68至0.86),与带补丁的APBTE增量能量相比,带补丁的AAMDS增量能量(RR:0.76,95%CI0.67至0.86)和带桨的AAMDS增量能量(RR:0.68,95%CI0.53至0.83)可能导致该结果降低(证据确定性:中等)。药物复律网络显示,与胺碘酮相比,贝普地尔(RR:2.29,95%CI1.26至4.17)和奎定(RR:1.53,(95%CI1.01至2.32)可能导致出院或研究结束时窦性心律维持大量增加(证据确定性:中度)。多非利特(RR:0.79,95%CI0.56至1.44),索他洛尔(RR:0.89,95%CI0.67至1.18),与胺碘酮相比,普罗帕酮(RR:0.79,95%CI0.50至1.25)和吡西卡尼(RR:0.39,95%CI0.02至7.01)可能导致该结果降低,但是证据的确定性很低。对于房扑(14项试验),只能为抗心律失常药物创建网络。使用安慰剂作为常见的比较器,伊布特利(RR:21.45,95%CI4.41至104.37),普罗帕酮(RR:7.15,95%CI1.27至40.10),多非利特(RR:6.43,95%CI1.38至29.91),和索他洛尔(RR:6.39,95%CI1.03至39.78)可能导致出院或研究随访结束时窦性心律的维持大幅增加(证据确定性:中度),和普鲁卡因胺(RR:4.29,95%CI0.63至29.03),氟卡尼(RR3.57,95%CI0.24~52.30)和vernakalant(RR:1.18,95%CI0.05~27.37)可能导致出院或研究结束时窦性心律维持率大幅增加(证据确定性:低).所有测试过的房扑电复律策略均具有非常高的疗效(97.9%至100%)。30天的死亡率(14例死亡)和卒中或全身性栓塞(3例)极低。关于生活质量的数据很少,临床意义不确定。没有关于心力衰竭再入院的信息。住院时间的数据很少,低质量,并且无法汇集。
结论:尽管证据质量低,本系统综述提供了有关电学和药理学策略的重要信息,以帮助患者和医师应对房颤和房扑.在评估患者合并症时,抗心律失常药物的起效和副作用与需要有镇静经验的医生相比,或麻醉支持电复律是选择复律方法时的关键方面。
Atrial fibrillation (AF) is the most frequent sustained arrhythmia. Cardioversion is a rhythm control strategy to restore normal/sinus rhythm, and can be achieved through drugs (pharmacological) or a synchronised electric shock (electrical cardioversion).
To assess the efficacy and safety of pharmacological and electrical cardioversion for atrial fibrillation (AF), atrial flutter and atrial tachycardias.
We searched CENTRAL, MEDLINE, Embase, Conference Proceedings Citation Index-Science (CPCI-S) and three trials registers (ClinicalTrials.gov, WHO ICTRP and ISRCTN) on 14 February 2023.
We included randomised controlled trials (RCTs) at the individual patient level. Patient populations were aged ≥ 18 years with AF of any type and duration, atrial flutter or other sustained related atrial arrhythmias, not occurring as a result of reversible causes.
We used standard Cochrane methodology to collect data and performed a network meta-analysis using the standard frequentist graph-theoretical approach using the netmeta package in R. We used GRADE to assess the quality of the evidence which we presented in our summary of findings with a judgement on certainty. We calculated differences using risk ratios (RR) and 95% confidence intervals (CI) as well as ranking treatments using a P value. We assessed clinical and statistical heterogeneity and split the networks for the primary outcome and acute procedural success, due to concerns about violating the transitivity assumption.
We included 112 RCTs (139 records), from which we pooled data from 15,968 patients. The average age ranged from 47 to 72 years and the proportion of male patients ranged from 38% to 92%. Seventy-nine trials were considered to be at high risk of bias for at least one domain, 32 had no high risk of bias domains, but had at least one domain classified as uncertain risk, and one study was considered at low risk for all domains. For paroxysmal AF (35 trials), when compared to placebo, anteroapical (AA)/anteroposterior (AP) biphasic truncated exponential waveform (BTE) cardioversion (RR: 2.42; 95% CI 1.65 to 3.56), quinidine (RR: 2.23; 95% CI 1.49 to 3.34), ibutilide (RR: 2.00; 95% CI 1.28 to 3.12), propafenone (RR: 1.98; 95% CI 1.67 to 2.34), amiodarone (RR: 1.69; 95% CI 1.42 to 2.02), sotalol (RR: 1.58; 95% CI 1.08 to 2.31) and procainamide (RR: 1.49; 95% CI 1.13 to 1.97) likely result in a large increase in maintenance of sinus rhythm until hospital discharge or end of study follow-up (certainty of evidence: moderate). The effect size was larger for AA/AP incremental and was progressively smaller for the subsequent interventions. Despite low certainty of evidence, antazoline may result in a large increase (RR: 28.60; 95% CI 1.77 to 461.30) in this outcome. Similarly, low-certainty evidence suggests a large increase in this outcome for flecainide (RR: 2.17; 95% CI 1.68 to 2.79), vernakalant (RR: 2.13; 95% CI 1.52 to 2.99), and magnesium (RR: 1.73; 95% CI 0.79 to 3.79). For persistent AF (26 trials), one network was created for electrical cardioversion and showed that, when compared to AP BTE incremental energy with patches, AP BTE maximum energy with patches (RR 1.35, 95% CI 1.17 to 1.55) likely results in a large increase, and active compression AP BTE incremental energy with patches (RR: 1.14, 95% CI 1.00 to 1.131) likely results in an increase in maintenance of sinus rhythm at hospital discharge or end of study follow-up (certainty of evidence: high). Use of AP BTE incremental with paddles (RR: 1.03, 95% CI 0.98 to 1.09; certainty of evidence: low) may lead to a slight increase, and AP MDS Incremental paddles (RR: 0.95, 95% CI 0.86 to 1.05; certainty of evidence: low) may lead to a slight decrease in efficacy. On the other hand, AP MDS incremental energy using patches (RR: 0.78, 95% CI 0.70 to 0.87), AA RBW incremental energy with patches (RR: 0.76, 95% CI 0.66 to 0.88), AP RBW incremental energy with patches (RR: 0.76, 95% CI 0.68 to 0.86), AA MDS incremental energy with patches (RR: 0.76, 95% CI 0.67 to 0.86) and AA MDS incremental energy with paddles (RR: 0.68, 95% CI 0.53 to 0.83) probably result in a decrease in this outcome when compared to AP BTE incremental energy with patches (certainty of evidence: moderate). The network for pharmacological cardioversion showed that bepridil (RR: 2.29, 95% CI 1.26 to 4.17) and quindine (RR: 1.53, (95% CI 1.01 to 2.32) probably result in a large increase in maintenance of sinus rhythm at hospital discharge or end of study follow-up when compared to amiodarone (certainty of evidence: moderate). Dofetilide (RR: 0.79, 95% CI 0.56 to 1.44), sotalol (RR: 0.89, 95% CI 0.67 to 1.18), propafenone (RR: 0.79, 95% CI 0.50 to 1.25) and pilsicainide (RR: 0.39, 95% CI 0.02 to 7.01) may result in a reduction in this outcome when compared to amiodarone, but the certainty of evidence is low. For atrial flutter (14 trials), a network could be created only for antiarrhythmic drugs. Using placebo as the common comparator, ibutilide (RR: 21.45, 95% CI 4.41 to 104.37), propafenone (RR: 7.15, 95% CI 1.27 to 40.10), dofetilide (RR: 6.43, 95% CI 1.38 to 29.91), and sotalol (RR: 6.39, 95% CI 1.03 to 39.78) probably result in a large increase in the maintenance of sinus rhythm at hospital discharge or end of study follow-up (certainty of evidence: moderate), and procainamide (RR: 4.29, 95% CI 0.63 to 29.03), flecainide (RR 3.57, 95% CI 0.24 to 52.30) and vernakalant (RR: 1.18, 95% CI 0.05 to 27.37) may result in a large increase in maintenance of sinus rhythm at hospital discharge or end of study follow-up (certainty of evidence: low). All tested electrical cardioversion strategies for atrial flutter had very high efficacy (97.9% to 100%). The rate of mortality (14 deaths) and stroke or systemic embolism (3 events) at 30 days was extremely low. Data on quality of life were scarce and of uncertain clinical significance. No information was available regarding heart failure readmissions. Data on duration of hospitalisation was scarce, of low quality, and could not be pooled.
Despite the low quality of evidence, this systematic review provides important information on electrical and pharmacological strategies to help patients and physicians deal with AF and atrial flutter. In the assessment of the patient comorbidity profile, antiarrhythmic drug onset of action and side effect profile versus the need for a physician with experience in sedation, or anaesthetics support for electrical cardioversion are key aspects when choosing the cardioversion method.