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金-铂铱尖端导管与普通顶端导管消融三尖瓣峡部的对比:AURUM 8 研究。

Gold vs. platinum-iridium tip catheter for cavotricuspid isthmus ablation: the AURUM 8 study.

机构信息

Department of Internal Medicine, Vascular and Arrhythmia Center Rhineland-Bonn, St. Marienhospital Bonn, Academic Hospital, University of Bonn, Robert-Koch-Str. 1, 53115 Bonn, Germany.

出版信息

Europace. 2011 Jan;13(1):102-8. doi: 10.1093/europace/euq339. Epub 2010 Sep 28.

Abstract

AIMS

Gold electrodes have the theoretical advantage of creating bigger lesions than platinum-iridium (Pt-Ir) electrodes. We performed a prospective randomized study to compare the clinical efficacy of standard 8 mm Pt-Ir tip catheter (control) and 8 mm gold-tip catheters in the ablation of the cavotricuspid isthmus (CTI)-dependent atrial flutter.

METHODS AND RESULTS

A total of 463 patients undergoing CTI ablation in 19 clinical centres were randomized to receive the treatment by gold-tip or control catheter. The primary endpoint was cumulative radiofrequency (RF) application duration until achieving bidirectional CTI block. It did not differ significantly for the two catheters. The gold-tip catheter was, however, associated with a higher ablation success rate (94.3 vs. 89.0%, P = 0.042) and a substantially lower incidence of char and coagulum formation (4.8 vs. 37.9%, P < 0.001), which required exchange of 1 gold-tip (0.4%) and 10 control catheters (4.6%, P = 0.005). The gold-tip catheter delivered more mean power (52 ± 12 W) than the control catheter (48 ± 13 W, P < 0.001). Both mean and maximum temperatures measured by the thermocouple integrated in the catheter tip were statistically significantly lower in the gold (mean: 53.2 ± 4.7°C, max: 68.7 ± 6.6°C) than in the control catheter (54.3 ± 5.2 and 70.2 ± 7.0°C, respectively, P < 0.05). Fluoroscopy time, procedure duration, procedural-related complications, and arrhythmia recurrence during 6 months of follow-up did not differ between the two catheters.

CONCLUSION

Owing to a higher primary ablation success rate and reduced incidence of char/coagulum formation, gold may be preferred over Pt-Ir as electrode material for 8 mm tip catheters for CTI ablation. ClinicalTrials.gov: NCT00326001 (http://clinicaltrials.gov/ct2/show/NCT00326001).

摘要

目的

金电极在创造比铂-铱(Pt-Ir)电极更大的病变方面具有理论优势。我们进行了一项前瞻性随机研究,比较了标准 8 毫米 Pt-Ir 尖端导管(对照)和 8 毫米金尖端导管在消融三尖瓣峡部依赖型房扑中的临床疗效。

方法和结果

共有 463 例在 19 个临床中心接受三尖瓣峡部消融的患者被随机分为接受金尖端导管或对照导管治疗。主要终点是达到双向三尖瓣峡部阻滞的累积射频(RF)应用时间。两种导管之间无显著差异。然而,金尖端导管与更高的消融成功率(94.3%比 89.0%,P = 0.042)和明显更低的炭化和凝血形成发生率(4.8%比 37.9%,P < 0.001)相关,这需要更换 1 个金尖端导管(0.4%)和 10 个对照导管(4.6%,P = 0.005)。金尖端导管输送的平均功率(52 ± 12 W)高于对照导管(48 ± 13 W,P < 0.001)。热电偶集成在导管尖端测量的平均和最大温度在金(平均:53.2 ± 4.7°C,最大:68.7 ± 6.6°C)中均显著低于对照导管(54.3 ± 5.2 和 70.2 ± 7.0°C,分别,P < 0.05)。透视时间、手术时间、手术相关并发症以及 6 个月随访期间的心律失常复发,两种导管之间无差异。

结论

由于初始消融成功率更高,炭化/凝血形成发生率降低,金可能优于 Pt-Ir 作为 8 毫米尖端导管进行三尖瓣峡部消融的电极材料。ClinicalTrials.gov:NCT00326001(http://clinicaltrials.gov/ct2/show/NCT00326001)。

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