心房颤动射频消融术中食管保护策略的比较疗效：随机试验的系统评价与网状荟萃分析。
完整摘要 · 中文译文
背景：食管热损伤仍然是心房颤动（AF）射频导管消融术的一项具有临床意义的并发症，内镜下检出的食管病变（EDELs）在高达10-15%的病例中发生，而心房-食管瘘具有高死亡率。已提出多种保护策略；然而，其比较疗效仍不确定。 方法：我们开展了一项系统评价和网络荟萃分析，评估AF消融期间食管保护策略的随机对照试验。检索了PubMed、Web of Science、Scopus和ClinicalTrials.gov，检索时间自建库至2026年8月7日。纳入接受射频消融的成年患者的平行组随机试验。主要结局为EDEL的发生率。采用频率学随机效应网络荟萃分析，并使用P评分评估治疗排序。分别使用Cochrane RoB 2和CINeMA框架评估偏倚风险和证据确定性。 结果：系统评价纳入25项随机对照试验，涉及约2，500例患者。12项试验涉及1，077例患者，纳入连通网络荟萃分析。与无专门保护相比，机械食管偏移联合管腔内食管温度监测（LET）具有最有利的点估计值（OR，0.27；95% CI，0.02-3.05），并获得最高的P评分（0.861）。排序图估计其排名第一的概率为58%。可视化引导的策略 结果也显示有利的点估计值（OR，0.48；95% CI，0.08-3.09），而单独使用LET和主动冷却未显示EDEL的显著减少。直接比较中，机械偏移联合LET与单传感器LET相比显著降低了EDEL的比值比（OR，0.13；95% CI，0.04-0.41）。七项涉及990例患者的随机试验显示，高功率与标准功率消融之间与EDEL无显著关联（OR，1.19；95% CI，0.56-2.54），未观察到异质性（I² = 0%）。网络异质性为中度（I² = 46.9%），无显著证据表明存在网络不一致性或发表偏倚。 结论：没有任何单一食管保护策略能完全消除房颤消融期间的热损伤风险。机械食管偏移联合LET显示出最有利的总体排名，而可视化引导策略也显示出潜在有益的迹象。相比之下，单独使用LET或冷却未能可靠降低EDEL发生率。然而，由于试验样本量小且依赖替代终点，对证据的总体信心受到限制。需要更大规模的当代试验来确认临床获益并评估对罕见但灾难性并发症的影响。 临床试验编号：不适用。
完整摘要 · 英文原文
BACKGROUND: Esophageal thermal injury remains a clinically significant complication of radiofrequency catheter ablation for atrial fibrillation (AF), with endoscopically detected esophageal lesions (EDELs) occurring in up to 10-15% of cases and atrio-esophageal fistula carrying high mortality. Multiple protective strategies have been proposed; however, their comparative efficacy remains uncertain. METHODS: We conducted a systematic review and network meta-analysis of randomized controlled trials evaluating esophageal protection strategies during AF ablation. PubMed, Web of Science, Scopus, and ClinicalTrials.gov were searched from inception through August 7, 2026. Parallel-group randomized trials in adult patients undergoing radiofrequency ablation were included. The primary outcome was incidence of EDEL. A frequentist random-effects network meta-analysis was performed, with treatment hierarchy assessed using P-scores. Risk of bias and certainty of evidence were evaluated using the Cochrane RoB 2 and CINeMA frameworks, respectively. RESULTS: Twenty-five randomized controlled trials involving approximately 2,500 patients were included in the systematic review. Twelve trials involving 1,077 patients contributed to the connected network meta-analysis. Mechanical esophageal deviation combined with luminal esophageal temperature monitoring (LET) had the most favorable point estimate compared with no dedicated protection (OR, 0.27; 95% CI, 0.02-3.05) and achieved the highest P-score (0.861). The rankogram estimated a 58% probability of ranking first. Visualization-guided strategies also showed a favorable point estimate (OR, 0.48; 95% CI, 0.08-3.09), whereas LET alone and active cooling did not demonstrate significant reductions in EDEL. Directly, mechanical deviation plus LET significantly reduced the odds of EDEL compared with single-sensor LET (OR, 0.13; 95% CI, 0.04-0.41). Seven randomized trials involving 990 patients showed no significant association between higher- versus standard-power ablation and EDEL (OR, 1.19; 95% CI, 0.56-2.54), with no observed heterogeneity (I² = 0%). Network heterogeneity was moderate (I² = 46.9%), with no significant evidence of network inconsistency or publication bias. CONCLUSIONS: No single esophageal protection strategy completely eliminates the risk of thermal injury during AF ablation. Mechanical esophageal deviation combined with LET demonstrated the most favorable overall ranking, while visualization-guided strategies also showed a potentially beneficial signal. In contrast, LET or cooling alone did not reliably reduce EDEL incidence. However, overall confidence in the evidence is constrained by small trial samples and reliance on surrogate outcomes. Larger, contemporary trials are needed to confirm clinical benefits and assess the impact on rare but catastrophic complications. CLINICAL TRIAL NUMBER: Not Applicable.