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采用新型实时三维标测技术的电生理引导下非阵发性心房颤动消融的临床转归:前瞻性随机试验结果。

Clinical Outcome of Electrophysiologically Guided Ablation for Nonparoxysmal Atrial Fibrillation Using a Novel Real-Time 3-Dimensional Mapping Technique: Results From a Prospective Randomized Trial.

机构信息

From the Department of Arrhythmology and Electrophysiology (C.P., G.C., G.V., M.C., L.G., F.L., V.S.), Department of Cardiac Surgery (L.M.), and Heart Failure Unit (M.G.), IRCCS Policlinico San Donato, San Donato Milanese, Italy; and Abbott, Sylmar, Los Angeles, CA (J.O.M., W.L., L.M., K.R.).

出版信息

Circ Arrhythm Electrophysiol. 2018 Mar;11(3):e005904. doi: 10.1161/CIRCEP.117.005904.

DOI:10.1161/CIRCEP.117.005904
PMID:29535136
Abstract

BACKGROUND

Clinical outcomes after ablation of persistent atrial fibrillation remain suboptimal. Identification of AF drivers using a novel integrated mapping technique may be crucial to ameliorate the clinical outcome.

METHODS AND RESULTS

Persistent AF patients were prospectively enrolled to undergo high-density electrophysiological mapping to identify repetitive-regular activities (RRas) before modified circumferential pulmonary vein (PV) ablation. They have been randomly assigned (1:1 ratio) to ablation of RRa followed by modified circumferential PV ablation (mapping group; n=41) or modified circumferential PV ablation alone (control group; n=40). The primary end point was freedom from arrhythmic recurrences at 1 year. In total, 81 persistent AF patients (74% male; mean age, 61.7±10.6 years) underwent mapping/ablation procedure. The regions exhibiting RRa were 479 in 81 patients (5.9±2.4 RRa per patient): 232 regions in the mapping group (n=41) and 247 in the control group (n=40). Overall, 185 of 479 (39%) RRas were identified within the PVs, whereas 294 of 479 (61%) in non-PV regions. Mapping-guided ablation resulted in higher arrhythmia termination rate when compared with conventional strategy (25/41, 61% versus 12/40, 30%; <0.007). Total radiofrequency duration (=0.38), mapping (=0.46), and fluoroscopy times (=0.69) were not significantly different between the groups. No major procedure-related adverse events occurred. After 1 year, 73.2% of mapping group patients were free from recurrences versus 50% of control group (=0.03).

CONCLUSIONS

Targeted ablation of regions showing RRa provided an adjunctive benefit in terms of arrhythmia freedom at 1-year follow-up in the treatment of persistent AF. These findings might support a patient-tailored strategy in subjects with nonparoxysmal AF and should be confirmed by additional larger, randomized, multicenter studies.

CLINICAL TRIAL REGISTRATION

URL: https://www.clinicaltrials.gov. Unique identifier NCT02571218.

摘要

背景

持续性房颤消融后的临床转归仍不理想。使用新的整合映射技术识别房颤驱动灶可能对于改善临床转归至关重要。

方法和结果

前瞻性纳入持续性房颤患者,行高密度电生理标测以识别改良环肺静脉消融前的重复规则活动(RRas)。患者被随机(1:1 比例)分为消融 RRas 后行改良环肺静脉消融(标测组;n=41)或仅行改良环肺静脉消融(对照组;n=40)。主要终点为 1 年时无心律失常复发。共 81 例持续性房颤患者(74%为男性;平均年龄 61.7±10.6 岁)接受了标测/消融治疗。81 例患者中有 479 个部位存在 RRas(每个患者 5.9±2.4 个 RRas):标测组 232 个部位(n=41),对照组 247 个部位(n=40)。总的来说,479 个 RRas 中有 185 个(39%)位于肺静脉内,而 294 个(61%)位于肺静脉外。与传统策略相比,标测指导下消融可提高消融终止率(25/41,61%比 12/40,30%;<0.007)。两组间射频总时间(=0.38)、标测时间(=0.46)和透视时间(=0.69)无显著差异。无主要与操作相关的不良事件发生。1 年后,标测组 73.2%的患者无复发,而对照组为 50%(=0.03)。

结论

在持续性房颤的治疗中,针对存在 RRas 的部位进行消融可在 1 年随访时提供心律失常转复方面的附加获益。这些发现可能支持对非阵发性房颤患者采用个体化治疗策略,还需要更多的大型、随机、多中心研究来证实。

临床试验注册

网址:https://www.clinicaltrials.gov。唯一标识符 NCT02571218。

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