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冷冻消融与射频消融治疗常见房扑后三尖瓣峡部双向传导阻滞耐久性的前瞻性随机对照研究(CRYOTIP 研究)。

Prospective randomized comparison of durability of bidirectional conduction block in the cavotricuspid isthmus in patients after ablation of common atrial flutter using cryothermy and radiofrequency energy: the CRYOTIP study.

机构信息

Department of Cardiology, Kerckhoff-Klinik, Bad Nauheim, Germany.

出版信息

Heart Rhythm. 2009 Dec;6(12):1699-705. doi: 10.1016/j.hrthm.2009.09.012. Epub 2009 Sep 11.

Abstract

BACKGROUND

Recent studies have shown that cryoablation and radiofrequency (RF) ablation are comparable with regard to success rates and safety in the treatment of common atrial flutter (AFL). Long-term success requires persistence of bidirectional conduction block (BCB) in the inferior cavotricuspid isthmus (CTI).

OBJECTIVE

The purpose of this study was to determine the persistence of BCB in a prospective randomized multicenter trial of the two ablation techniques.

METHODS

A total of 191 patients were randomized to RF ablation or cryoablation of the CTI using an 8-mm-tip catheter. In all patients, BCB was defined as the ablation end-point. Primary end-point of the study was nonpersistence of achieved BCB and/or ECG-documented relapse of common AFL within 3-month follow-up.

RESULTS

Acute success rates were 91% (83/91) in the RF group and 89% (80/90) in the cryoablation group (P = NS). Invasive follow-up after 3 months with repeated electrophysiologic study was available for 60 patients in the RF group and 64 patients in the cryoablation group. Persistent BCB could be confirmed in 85% of the RF group versus 65.6% of the cryoablation group. The primary end-point was achieved in 15% of the RF group and 34.4% of the cryoablation group (P = .014). As a secondary end-point, pain perception during ablation was significant lower in the cryoablation group (P <.001).

CONCLUSION

Persistence of BCB in patients treated with cryoablation reinvestigated after 3 months is inferior to that patients treated with RF ablation, as evidenced by the higher recurrence rate of common AFL seen in this study.

摘要

背景

最近的研究表明,冷冻消融和射频(RF)消融在治疗常见的房扑(AFL)方面成功率和安全性相当。长期成功需要在下腔静脉三尖瓣峡部(CTI)中保持双向传导阻滞(BCB)。

目的

本研究旨在确定两种消融技术的前瞻性随机多中心试验中 BCB 的持续存在。

方法

共 191 例患者随机分为 RF 消融或 CTI 使用 8mm 尖端导管的冷冻消融。在所有患者中,BCB 定义为消融终点。研究的主要终点是在 3 个月随访期间未持续存在已达到的 BCB 和/或心电图记录的常见 AFL 复发。

结果

RF 组急性成功率为 91%(83/91),冷冻消融组为 89%(80/90)(P=NS)。在 RF 组有 60 例和冷冻消融组有 64 例患者接受了 3 个月后重复电生理研究的有创随访。RF 组中 85%的患者可证实持续 BCB,而冷冻消融组中 65.6%的患者可证实持续 BCB。RF 组的主要终点为 15%,冷冻消融组为 34.4%(P=.014)。作为次要终点,冷冻消融组的消融过程中的疼痛感知明显低于 RF 组(P<0.001)。

结论

在这项研究中,冷冻消融组治疗后 3 个月复查的 BCB 持续存在率低于 RF 消融组,这表明常见 AFL 的复发率较高。

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