Zhu Yeqian, Dong Yan, Chen Qiushi, Jiang Li, He Yuan, Yadav Nishant, Cao Kejiang, Zhang Fengxiang
Section of Pacing and Electrophysiology, Division of Cardiology, The First Affiliated Hospital with Nanjing Medical University, Guangzhou Road 300, Nanjing 210029, China.
Europace. 2025 Aug 4;27(8). doi: 10.1093/europace/euaf176.
This prospective randomized controlled trial investigated the comparative efficacy and safety of circumferential pulmonary vein isolation (CPVI) combined with modified linear ablation (CPVI-MLA) vs. standalone CPVI in patients with long-standing persistent atrial fibrillation (LSPAF).
In this single-centre pilot trial, 134 LSPAF patients were randomized to the CPVI-MLA (n = 67) or CPVI-only (n = 67) groups. The CPVI-MLA protocol integrated four components: (i) ethanol infusion targeting the ligament of Marshall; (ii) complete CPVI; (iii) extended lesion sets (posterior wall isolation, dual isthmus ablation); and (iv) substrate modification [left atrial intima adjoining coronary sinus (LAI-CS) and superior vena cava isolation (SVCI)]. A 24 h Holter monitoring was performed at the 1st, 3rd, and 6th month follow-up visits, with 7-day Holter monitoring at the 12th month follow-up visit. The primary endpoint was freedom from atrial tachyarrhythmias (≥ 30 s) after the initial 3-month blanking period post-index procedure, without antiarrhythmic drugs. After a mean follow-up of 14.5 ± 9.1 months, 76.1% (51/67) in the CPVI-MLA group and 65.7% (44/67) in the CPVI-only group achieved the primary endpoint (P = 0.32). However, the CPVI-MLA group demonstrated significantly higher atrial fibrillation (AF)-free survival rate (91.0 vs. 76.1%, P = 0.049), while atrial tachycardia/atrial flutter-free survival rates were comparable (83.5 vs. 88.1%, P = 0.45). The CPVI-MLA strategy required longer ablation time (68.6 ± 12.3 vs. 49.4 ± 10.3 min, P < 0.001) and fluoroscopy exposure (14.9 ± 9.8 vs. 9.3 ± 6.7 min, P < 0.001). Serious adverse events were rare and similar between groups (1.5 vs. 0%, P = 1.00).
In patients with LSPAF, the CPVI-MLA strategy significantly improved freedom from AF compared with CPVI alone, although it did not improve overall sinus rhythm maintenance rate. This strategy may offer a refined approach for complex AF ablation, warranting further validation in larger trials.
本前瞻性随机对照试验研究了环肺静脉隔离(CPVI)联合改良线性消融(CPVI-MLA)与单纯CPVI治疗长期持续性心房颤动(LSPAF)患者的疗效和安全性比较。
在这项单中心试点试验中,134例LSPAF患者被随机分为CPVI-MLA组(n = 67)或单纯CPVI组(n = 67)。CPVI-MLA方案包括四个部分:(i)靶向Marshall韧带的乙醇注入;(ii)完全CPVI;(iii)扩展消融区域(后壁隔离、双峡部消融);(iv)基质改良[毗邻冠状窦的左心房内膜(LAI-CS)和上腔静脉隔离(SVCI)]。在第1、3和6个月的随访中进行24小时动态心电图监测,在第12个月的随访中进行7天动态心电图监测。主要终点是在索引手术后最初3个月的空白期后,无抗心律失常药物情况下无房性快速心律失常(≥30秒)。平均随访14.5±9.1个月后,CPVI-MLA组76.1%(51/67)和单纯CPVI组65.7%(44/67)达到主要终点(P = 0.32)。然而,CPVI-MLA组的无房颤生存率显著更高(91.0%对76.1%,P = 0.049),而无房性心动过速/房扑生存率相当(83.5%对88.1%,P = ?0.45)。CPVI-MLA策略需要更长的消融时间(68.6±12.3对49.4±10.3分钟,P < 0.001)和透视暴露时间(14.9±9.8对9.3±6.7分钟,P < 0.001)。严重不良事件很少见,且两组之间相似(1.5%对0%,P = 1.00)。
在LSPAF患者中,与单纯CPVI相比,CPVI-MLA策略显著提高了无房颤率,尽管它没有提高总体窦性心律维持率。该策略可能为复杂房颤消融提供一种优化方法,值得在更大规模试验中进一步验证。 (注:原文中“P = ?0.45”可能有误,这里按原文翻译)