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三维电解剖标测系统引导下的心房颤动导管消融:来自意大利NavX心房颤动消融程序注册研究(IRON-AF)的2年随访研究

Catheter ablation of atrial fibrillation guided by a 3D electroanatomical mapping system: a 2-year follow-up study from the Italian Registry On NavX Atrial Fibrillation ablation procedures (IRON-AF).

作者信息

Forleo Giovanni B, De Martino Giuseppe, Mantica Massimo, Menardi Endrj, Trevisi Nicola, Faustino Massimiliano, Muto Carmine, Perna Francesco, Santamaria Matteo, Pandozi Claudio, Pappalardo Augusto, Mancusi Carmine, Romano Enrico, Della Bella Paolo, Tondo Claudio

机构信息

Division of Cardiology, Policlinico Universitario Tor Vergata, Viale Oxford, 81, 00133, Rome, Italy.

出版信息

J Interv Card Electrophysiol. 2013 Jun;37(1):87-95. doi: 10.1007/s10840-012-9772-4. Epub 2013 Feb 10.

Abstract

AIMS

Clinical trials have established that atrial fibrillation (AF) catheter ablation improves symptoms in appropriately selected patients. Confirmation of these results by long-term prospective observational studies is needed. This registry was created to describe the experience of 16 Italian centers with a large cohort of AF patients treated with catheter ablation guided by the NavX 3D mapping system.

METHODS

From November 2006 to May 2008, 545 consecutive patients (age 60.4 ± 9.8, 67 % male) with paroxysmal (44 %), persistent (43 %), and long-standing persistent (13 %) AF referred for catheter ablation guided by the NavX system, were included in this registry. For this paper, follow-up was censored at 24 months; however, patients are being followed in the ongoing registry.

RESULTS

Before the ablation, 80 % of patients failed to respond to at least one antiarrhythmic drug aimed at rhythm control. Pulmonary vein (PV) isolation guided by a circular mapping catheter was performed in 70 % of patients whereas non potential-guided PV encircling was performed in 30 % of patients. In 67 % of patients, additional left atrial (LA) substrate modification was performed. Image integration was performed in 9.2 % of patients. Considering a 3-month blanking period, after a single-ablation procedure, the patients had 1- and 2-year freedom from AF recurrence of 67.4 and 57.0 % (36.1 % off antiarrhythmic drugs), respectively. Cox regression analysis showed that AF recurrences during blanking (HR 2.1), and previous AF ablation (HR 3.3) were independent predictors of AF recurrences. Major procedure-related complications occurred in 53 patients (9.7 %). In 35 patients (6.7 %), a repeat procedure was performed at a median of 5 months after the initial procedure.

CONCLUSIONS

This prospective, multicenter clinical experience provides significant insights into current ablation care of patients with AF. Despite favorable outcomes, real-world complication rates appear higher than previously recognized.

摘要

目的

临床试验已证实,心房颤动(AF)导管消融可改善适当选择的患者的症状。需要长期前瞻性观察研究来证实这些结果。创建该注册研究旨在描述16个意大利中心对大量接受NavX 3D标测系统指导下导管消融治疗的AF患者的治疗经验。

方法

从2006年11月至2008年5月,本注册研究纳入了545例连续的患者(年龄60.4±9.8岁,67%为男性),这些患者患有阵发性(44%)、持续性(43%)和长期持续性(13%)AF,接受NavX系统指导下的导管消融治疗。对于本文,随访在24个月时进行截尾;然而,患者仍在正在进行的注册研究中接受随访。

结果

在消融前,80%的患者对至少一种旨在控制心律的抗心律失常药物无反应。70%的患者采用环形标测导管指导下的肺静脉(PV)隔离,而30%的患者采用非电位引导的PV环绕。67%的患者进行了额外的左心房(LA)基质改良。9.2%的患者进行了图像整合。考虑到3个月的空白期,单次消融术后,患者1年和2年无AF复发率分别为67.4%和57.0%(36.1%停用抗心律失常药物)。Cox回归分析显示,空白期AF复发(HR 2.1)和既往AF消融(HR 3.3)是AF复发的独立预测因素。主要的手术相关并发症发生在53例患者(9.7%)中。35例患者(6.7%)在初次手术后中位5个月进行了重复手术。

结论

这一前瞻性、多中心临床经验为当前AF患者的消融治疗提供了重要见解。尽管结果良好,但实际并发症发生率似乎高于先前认识到的水平。

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