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冷冻消融与射频能量消融用于房室结折返性心动过速(CYRANO 研究):一项大型多中心前瞻性随机试验的结果。

Cryoablation versus radiofrequency energy for the ablation of atrioventricular nodal reentrant tachycardia (the CYRANO Study): results from a large multicenter prospective randomized trial.

机构信息

Deutsches Herzzentrum München, Lazarettstrasse 36, D-80636 Munich, Germany.

出版信息

Circulation. 2010 Nov 30;122(22):2239-45. doi: 10.1161/CIRCULATIONAHA.110.970350. Epub 2010 Nov 15.

Abstract

BACKGROUND

Cryoablation has emerged as an alternative to radiofrequency catheter ablation (RFCA) for the treatment of atrioventricular (AV) nodal reentrant tachycardia (AVNRT). The purpose of this prospective randomized study was to test whether cryoablation is as effective as RFCA during both short-term and long-term follow-up with a lower risk of permanent AV block.

METHODS AND RESULTS

A total of 509 patients underwent slow pathway cryoablation (n=251) or RFCA (n=258). The primary end point was immediate ablation failure, permanent AV block, and AVNRT recurrence during a 6-month follow-up. Secondary end points included procedural parameters, device functionality, and pain perception. Significantly more patients in the cryoablation group than the RFCA group reached the primary end point (12.6% versus 6.3%; P=0.018). Whereas immediate ablation success (96.8% versus 98.4%) and occurrence of permanent AV block (0% versus 0.4%) did not differ, AVNRT recurrence was significantly more frequent in the cryoablation group (9.4% versus 4.4%; P=0.029). In the cryoablation group, procedure duration was longer (138±54 versus 123±48 minutes; P=0.0012) and more device problems occurred (13 versus 2 patients; P=0.033). Pain perception was lower in the cryoablation group (P<0.001).

CONCLUSIONS

Cryoablation for AVNRT is as effective as RFCA over the short term but is associated with a higher recurrence rate at the 6-month follow-up. The risk of permanent AV block does not differ significantly between cryoablation and RFCA. The potential benefits of cryoenergy relative to ablation safety and pain perception are counterbalanced by longer procedure times, more device problems, and a high recurrence rate.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00196222.

摘要

背景

冷冻消融术已成为治疗房室(AV)结折返性心动过速(AVNRT)的替代方法,优于射频导管消融术(RFCA)。本前瞻性随机研究的目的是测试冷冻消融术在短期和长期随访中是否与 RFCA 一样有效,且永久性 AV 阻滞的风险较低。

方法和结果

共有 509 例患者接受了慢径路冷冻消融术(n=251)或 RFCA(n=258)。主要终点是 6 个月随访时即刻消融失败、永久性 AV 阻滞和 AVNRT 复发。次要终点包括程序参数、器械功能和疼痛感知。冷冻消融组比 RFCA 组达到主要终点的患者更多(12.6%对 6.3%;P=0.018)。虽然即刻消融成功率(96.8%对 98.4%)和永久性 AV 阻滞发生率(0%对 0.4%)无差异,但冷冻消融组 AVNRT 复发更常见(9.4%对 4.4%;P=0.029)。在冷冻消融组中,手术时间更长(138±54 分钟对 123±48 分钟;P=0.0012),器械问题更多(13 例对 2 例;P=0.033)。冷冻消融组疼痛感知较低(P<0.001)。

结论

AVNRT 的冷冻消融术在短期疗效与 RFCA 相当,但在 6 个月随访时复发率较高。冷冻消融术和 RFCA 之间永久性 AV 阻滞的风险无显著差异。冷冻能量相对于消融安全性和疼痛感知的潜在益处被手术时间延长、器械问题更多和高复发率所抵消。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00196222。

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