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最小化或最大化消融策略以实现阵发性心房颤动的肺静脉隔离:一项前瞻性多中心随机对照试验(Minimax 研究)。

A minimal or maximal ablation strategy to achieve pulmonary vein isolation for paroxysmal atrial fibrillation: a prospective multi-centre randomized controlled trial (the Minimax study).

机构信息

Alfred Heart Centre, Alfred Hospital, Melbourne, VIC, Australia Baker IDI Heart and Diabetes Institute, 75 Commercial Road, Melbourne, VIC 3004, Australia Department of Cardiology, Royal Melbourne Hospital, Parkville, VIC, Australia Department of Medicine, University of Melbourne, Parkville, VIC, Australia.

Alfred Heart Centre, Alfred Hospital, Melbourne, VIC, Australia Baker IDI Heart and Diabetes Institute, 75 Commercial Road, Melbourne, VIC 3004, Australia.

出版信息

Eur Heart J. 2015 Jul 21;36(28):1812-21. doi: 10.1093/eurheartj/ehv139. Epub 2015 Apr 28.

Abstract

AIMS

Pulmonary vein isolation (PVI) is the cornerstone of catheter ablation of atrial fibrillation (AF). The intervenous ridge (IVR) may be incorporated into ablation strategies to achieve PVI; however, randomized trials are lacking. We performed a randomized multi-centre international study to compare the outcomes of (i) circumferential antral PVI (CPVI) alone (minimal) vs. (ii) CPVI with IVR ablation to achieve individual PVI (maximal).

METHODS AND RESULTS

Two hundred and thirty-four patients with paroxysmal AF underwent CPVI and were randomized to a minimal or maximal ablation strategy. The primary outcome of recurrent atrial arrhythmia was assessed with 7-day Holter monitoring at 6 and 12 months. PVI was achieved in all patients. Radiofrequency ablation time was longer in the maximal group (46.6 ± 14.6 vs. 41.5 ± 13.1 min; P < 0.01), with no significant differences in procedural or fluoroscopy times. At mean follow-up of 17 ± 8 months, there was no difference in freedom from AF after a single procedure between a minimal (70%) and maximal ablation strategy (62%; P = 0.25). In the minimal group, ablation was required on the IVR to achieve electrical isolation in 44%, and was associated with a significant reduction in freedom from AF (57%) compared with the minimal group without IVR ablation (80%; P < 0.01).

CONCLUSION

There was no statistically significant difference in freedom from AF between a minimal and maximal ablation strategy. Despite attempts to achieve PVI with antral ablation, IVR ablation is commonly required. Patients in whom antral isolation can be achieved without IVR ablation have higher long-term freedom from AF (the Minimax study; ACTRN12610000863033).

摘要

目的

肺静脉隔离(PVI)是导管消融治疗心房颤动(AF)的基石。静脉嵴(IVR)可被纳入消融策略中以实现 PVI;然而,目前缺乏随机试验。我们进行了一项随机、多中心国际研究,比较了(i)单纯环肺静脉消融(CPVI)(最小)与(ii)CPVI 联合 IVR 消融以实现个体 PVI(最大)的结果。

方法和结果

234 例阵发性 AF 患者接受 CPVI,并随机分为最小或最大消融策略组。通过 6 个月和 12 个月的 7 天 Holter 监测评估复发性房性心律失常的主要结局。所有患者均实现了 PVI。最大组的射频消融时间更长(46.6 ± 14.6 比 41.5 ± 13.1 分钟;P < 0.01),但手术或透视时间无显著差异。在平均 17 ± 8 个月的随访中,最小(70%)和最大消融策略(62%)之间单次手术的 AF 无复发率无差异(P = 0.25)。在最小组中,为实现电隔离,有 44%的患者需要在 IVR 上进行消融,与无 IVR 消融的最小组(80%)相比,AF 无复发率显著降低(57%;P < 0.01)。

结论

最小和最大消融策略之间的 AF 无复发率无统计学差异。尽管尝试通过窦房消融实现 PVI,但通常需要 IVR 消融。在无需 IVR 消融即可实现窦房隔离的患者中,长期 AF 无复发率更高(Minimax 研究;ACTRN12610000863033)。

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