Long-term efficacy and safety of radiofrequency ablation combined with left atrial appendage occlusion in the treatment of non-valvular atrial fibrillation
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摘要: 目的 评估射频消融联合左心耳封堵治疗非瓣膜性心房颤动(房颤)的长期有效性及安全性。方法 纳入2019年1月—2021年12月在云南大学附属医院心内科接受介入治疗的非瓣膜性房颤患者，分为射频消融联合左心耳封堵手术组(一站式组，77例)、单纯左心耳封堵组(单封堵组，62例)及单纯射频消融组(单消融组，96例)。将一站式组患者临床基线资料、围手术期资料及随访资料，分别与单封堵组及单消融组比较，以评估一站式手术治疗非瓣膜性房颤在消融及封堵两方面的长期有效性及安全性。结果 一站式组手术时间长于单封堵组和单消融组(P < 0.001)。一站式组发生1例心包积液及1例血管穿刺并发症，与单封堵组及单消融组比较差异无统计学意义。一站式组与单封堵组在即刻封堵成功率、残余分流、左心耳形态、封堵器压缩比方面差异无统计学意义；一站式组与单消融组在即刻消融成功率、消融策略方面差异无统计学意义。随访期间，一站式组与单封堵组停抗凝药物、残余分流、器械相关性血栓发生情况差异无统计学意义；一站式组与单消融组停抗心律失常药物、再发房性心律失常、重复消融事件发生情况差异无统计学意义；一站式组观察到2例缺血事件及2例出血事件，与单封堵组及单消融组比较差异无统计学意义。结论 射频消融联合左心耳封堵治疗非瓣膜性房颤具有长期有效性及安全性，对比分次手术，一站式手术的消融及封堵疗效与单消融和单封堵相当，并未显著增加围手术期并发症及随访期间不良事件发生率。Abstract: Objective To evaluate the long-term efficacy and safety of radiofrequency ablation combined with left atrial appendage occlusion in the treatment of non-valvular atrial fibrillation.Methods Patients with non-valvular atrial fibrillation who received interventional treatment in the Department of Cardiology of the Affiliated Hospital of Yunnan University from January 2019 to December 2021 were divided into a radiofrequency ablation combined with left atrial appendage occlusion group(one-stop group, n=77), a simple left atrial appendage occlusion group(single occlusion group, n=62), and a simple radiofrequency ablation group(single ablation group, n=96). The clinical baseline data, perioperative data, and follow-up data of patients in the one-stop group were compared with those in the single occlusion and single ablation groups, respectively, to evaluate the long-term effectiveness and safety of one-stop surgery in the treatment of non-valvular atrial fibrillation in terms of ablation and occlusion.Results The operation time of the one-stop group was longer than those of the single occlusion group and the single ablation group(P < 0.001). One case of pericardial effusion and one case of vascular puncture complications occurred in the one-stop group; this was not significantly different from the single occlusion and single ablation groups. There was no significant difference in terms of immediate occlusion success rate, residual shunt, left atrial appendage shape, and occluder compression ratio between the one-stop group and the single occlusion group. There was no significant difference in immediate ablation success rate and ablation strategy between the one-stop group and the single ablation group. During the follow-up period, there was no statistical difference in the occurrence of anticoagulant withdrawal, residual shunt, and device-related thrombosis between the one-stop group and the single occlusion group. There was no statistical difference in stopping antiarrhythmic drugs, recurrent atrial arrhythmia and repeated ablation events between the one-stop group and the single ablation group. There were two cases of ischemic events and two cases of bleeding events observed in the one-stop group. However, there was no notable difference observed between the one-stop group, the single occlusion group, and the single ablation group.Conclusion Radiofrequency ablation combined with left atrial appendage occlusion in the treatment of non-valvular atrial fibrillation has long-term effectiveness and safety. Compared with the fractional operation, one-stop operation has the same ablation and occlusion effect as single ablation and single occlusion, and does not significantly increase the incidence of perioperative complications and adverse events during follow-up.
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图 1 一站式组缺血栓塞事件和出血事件预测发生率与实际发生率对比
Figure 1. Predicted and actual incidence of ischemic embolism and bleeding events
表 1 一站式组、单消融组及单封堵组基线资料
Table 1. General data
例(%), X±S, M(P25, P75) 项目 一站式组(77例) 单消融组(96例) 单封堵组(62例) P1值 P2值 男性 50(64.9) 58(60.4) 31(50.0) 0.542 0.076 年龄/岁 68.5±7.0 66.8±7.4 70.1±9.0 0.128 0.071 BMI /(kg/m2) 25.1±3.8 24.6±3.5 24.0±3.9 0.444 0.098 持续性房颤 44(57.1) 43(44.8) 39(62.9) 0.106 0.491 高血压史 55(71.4) 56(58.3) 48(77.4) 0.074 0.423 糖尿病史 22(28.6) 16(16.7) 17(27.4) 0.060 0.881 冠心病史 21(27.3) 16(16.7) 17(27.4) 0.091 0.985 心衰 30(39.0) 25(26.0) 32(51.6) 0.070 0.136 卒中/TIA/TE史 30(39.0) 13(13.5) 26(41.9) < 0.001 0.722 左心房直径/mm 42.0±7.0 40.1±6.1 43.8±6.6 0.057 0.116 LVEF/% 64.0(57.0，69.0) 63.0(59.0，67.8) 64.0(57.0，67.0) 0.598 0.403 CHA2DS2-VASC评分 4.0(3.0，5.0) 2.0(1.0，2.0) 4.0(3.0，5.0) < 0.001 0.239 HAS-BLED评分 3.0(2.0，3.0) 1.0(1.0，2.0) 2.0(2.0，3.0) < 0.001 0.157 P1值为一站式组与单消融组比较，P2值为一站式组与单封堵组比较。 
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表 2 一站式组与单消融组围手术期及随访资料
Table 2. Perioperative and follow-up data
例(%), M(P25, P75) 项目 一站式组(77例) 单消融组(96例) P值 消融方式 仅PVI 30(39.0) 43(44.8) 0.440 PVI+附加消融 47(61.0) 53(55.2) 0.440 手术时间/min 160.0(132.5，192.5) 127.5(105.0，151.5) < 0.001 成功消融 76(98.7) 96(100.0) 0.445 围手术期并发症 心包积液 1(1.3) 1(1.0) 1.000 血管穿刺并发症 1(1.3) 3(3.1) 0.775 随访情况 随访时间/月 26.0(19.0，31.0) 32.5(21.0，41.0) < 0.001 停抗心律失常药物 62(80.5) 72(75.0) 0.388 再发房性心律失常 17(22.1) 18(18.8) 0.588 重复消融 5(6.5) 10(10.4) 0.362 缺血事件 2(2.6) 2(2.1) 1.000 出血事件 2(2.6) 1(1.0) 0.847
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表 3 一站式组与单封堵组围手术期及随访资料
Table 3. Perioperative and follow-up data
例(%), M(P25, P75) 项目 一站式组(77例) 单纯封堵组(62例) P值 左心耳最大开口/mm 24.0(22.0，26.0) 24.0(21.0，27.0) 0.507 左心耳形态 菜花状 42(54.5) 36(58.1) 0.678 鸡翅状 29(37.7) 19(30.6) 0.387 仙人掌状 4(5.2) 5(8.1) 0.736 风向袋状 2(2.6) 2(3.2) 1.000 封堵器规格/mm 27.0(27.0，30.0) 27.0(24.0，33.0) 0.929 封堵器压缩比/% 18.5(16.7，20.4) 18.3(16.7，20.0) 0.716 即刻成功封堵 77(100.0) 61(98.4) 0.446 残余分流 无分流 70(90.9) 55(88.7) 0.882 分流≤5 mm 7(9.1) 6(9.7) 0.882 手术时间/min 160.0(132.5，192.5) 75.0(58.8，100.0) < 0.001 围术期并发症 心包积液 1(1.3) 1(1.6) 1.000 血管穿刺并发症 1(1.3) 1(1.6) 1.000 随访情况 随访时间/月 26.0(19.0，31.0) 27.0(18.8，33.5) 0.148 停抗凝药物 76(98.7) 60(96.8) 0.849 3个月封堵器分流 无分流 69(89.6) 54(87.1) 0.771 分流≤5 mm 8(10.4) 7(11.3) 0.771 分流>5 mm 0 1(1.6) 0.771 DRT形成 0 2(3.2) 0.197 随访期缺血事件 2(2.6) 1(1.6) 1.000 随访期出血事件 2(2.6) 0 0.574
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