脉冲场消融治疗持续性和长程持续性心房颤动的疗效、安全性及策略调整因素：一项系统综述和荟萃分析。
完整摘要 · 中文译文
背景：脉冲场消融（PFA）越来越多地应用于持续性心房颤动（PerAF）和长程持续性心房颤动（LSPAF）。既往针对混合房颤人群的综述提示其在手术效率和食管安全性方面可能具有优势，但专门针对 PerAF/LSPAF 的长期节律结局以及后壁或扩大基质策略价值的证据仍然有限，且各研究在消融径线组合、终点定义和对照类型方面存在较大异质性。 方法：我们检索了 PubMed、Web of Science、Embase、Cochrane Library 和 Scopus，检索截止日期为 2026 年 4 月 18 日，并于 2026 年 8 月进行了更新验证检索。由于临床和方法学异质性较大，正式的成对汇总分析仅限于至少有两项临床同质性较高的头对头研究支持其比较的情形；单项研究比较采用叙述性综合，策略层面的结局则通过对精确计数队列进行单臂比例荟萃分析加以探讨。在可获得时优先采用停用抗心律失常药物（off-AAD）后的结局。证据确定性采用 GRADE 方法进行评级。 结果：共纳入 22 项研究（约 3,100 例患者）。在一项仅有的两项头对头比较（380 例患者，研究权重不均衡且消融径线组合不同：仅肺静脉隔离 vs. 肺静脉隔离加后壁隔离）的探索性汇总分析中，PFA 的 12 个月房性心律失常复发率低于冷冻球囊消融[风险比 [RR] 0.71，95% 置信区间 [CI] 0.51-0.9 8；GRADE证据确定性：极低]；这最好被视为一个初步信号。在主要并发症方面，PFA与冷冻球囊之间未观察到有统计学可检测的差异[风险差（RD）0.00，95% CI -0.02至0.02]，反映的是未能证明存在差异，而非证实等效。与射频消融（RR 0.65，95% CI 0.45-0.94）和混合汇聚消融（RR 1.11，95% CI 0.67-1.86）的单研究比较产生了方向性不一致的结果，仅作叙述性呈现。探索性、非比较性的单臂分析得出，PVI加后壁队列的12个月无房性心律失常合并发生率为66.0%（95% CI 55.5%-75.2%；I²=79.0%），超出肺静脉/扩展基质队列为82.6%（95% CI 76.3%-87.5%；I 2 = 0%）；这些估计值来自不同的非随机化队列，仅用于生成假设。 结论：当前证据提示PFA在PerAF/LSPAF中具有良好的有效性和安全性，但所有关键结局的确定性为低至极低。与冷冻球囊消融相比更低的复发率是一个令人鼓舞但初步的信号，需要在具有统一消融病灶组的充分效能随机试验中加以确认。扩展基质策略是否能改善结局，无法从当前非比较性数据中确定。未来研究应采用标准化的停用AAD终点、统一的心律监测，并按心房肌病负荷和PFA平台进行分层。 系统综述注册：标识符INPLASY202640082；doi：10.37766/inplasy2026.4.0082。
完整摘要 · 英文原文
BACKGROUND: Pulsed field ablation (PFA) is increasingly applied in persistent atrial fibrillation (PerAF) and long-standing persistent atrial fibrillation (LSPAF). Previous reviews of mixed AF populations suggested potential advantages in procedural efficiency and esophageal safety, but PerAF/LSPAF-specific evidence on long-term rhythm outcomes and on the value of posterior wall or extended substrate strategies remains limited, with substantial heterogeneity in lesion sets, endpoint definitions, and comparator types. METHODS: We searched PubMed, Web of Science, Embase, Cochrane Library, and Scopus through April 18, 2026, with an updated verification search performed in August 2026. Because of clinical and methodological heterogeneity, formal pairwise pooling was restricted to comparisons supported by at least two clinically homogeneous head-to-head studies; single-study comparisons were synthesized narratively, and strategy-level outcomes were explored with single-arm proportion meta-analysis of exact-count cohorts. Off-antiarrhythmic drug (off-AAD) outcomes were prioritized when available. Certainty of evidence was rated using the GRADE approach. RESULTS: Twenty-two studies (approximately 3,100 patients) were included. In an exploratory pooled analysis of the only two available head-to-head comparisons (380 patients, with imbalanced study weights and different lesion sets: PVI-only vs. PVI plus posterior wall isolation), PFA was associated with lower 12-month atrial arrhythmia recurrence than cryoballoon ablation [risk ratio [RR] 0.71, 95% confidence interval [CI] 0.51-0.98; GRADE certainty: very low]; this is best regarded as a preliminary signal. No statistically detectable difference in major complications was observed between PFA and cryoballoon [risk difference (RD) 0.00, 95% CI -0.02 to 0.02], reflecting absence of a demonstrable difference rather than proven equivalence. Single-study comparisons against radiofrequency ablation (RR 0.65, 95% CI 0.45-0.94) and hybrid-convergent ablation (RR 1.11, 95% CI 0.67-1.86) yielded directionally discordant results and are presented narratively. Exploratory, non-comparative single-arm analyses yielded pooled 12-month freedom from atrial arrhythmia of 66.0% (95% CI 55.5%-75.2%; I²=79.0%) for PVI plus posterior wall cohorts and 82.6% (95% CI 76.3%-87.5%; I 2 = 0%) for beyond-PV/extended substrate cohorts; these estimates derive from different, non-randomized cohorts and are hypothesis-generating only. CONCLUSIONS: Current evidence suggests favorable efficacy and safety of PFA in PerAF/LSPAF, but certainty is low to very low for all key outcomes. The lower recurrence vs. cryoballoon ablation is an encouraging but preliminary signal requiring confirmation in adequately powered randomized trials with uniform lesion sets. Whether extended substrate strategies improve outcomes cannot be determined from current non-comparative data. Future studies should apply standardized off-AAD endpoints, uniform rhythm monitoring, and stratification by atrial myopathy burden and PFA platform. SYSTEMATIC REVIEW REGISTRATION: identifier INPLASY202640082; doi: 10.37766/inplasy2026.4.0082.