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新型接触力感知金标导管高能消融治疗心房颤动的初步临床经验。

First clinical experience of high-power ablation of atrial fibrillation with a novel contact force-sensing gold-tip catheter.

机构信息

Department of Internal Medicine and Cardiology, Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum, Berlin, Germany.

DZHK (German Center of Cardiovascular Research), partner site Berlin, Germany.

出版信息

Cardiol J. 2022;29(5):759-765. doi: 10.5603/CJ.a2022.0060. Epub 2022 Jun 28.

Abstract

BACKGROUND

Contact force (CF)-sensing catheters are commonly used in the field of radiofrequency (RF) ablation to treat atrial fibrillation (AF). Increasing ablation power (e.g., 50 W) has been suggested as a method to reduce procedure times whilst creating safe and lasting lesions.

METHODS

We report the first clinical evidence of a 50 W point-by-point RF ablation in 25 consecutive patients with symptomatic AF using a novel CF-sensing catheter with a gold tip (AlCath Force, Biotronik). We collected and analyzed procedural and ablation parameters. The safety and efficacy of the catheter were evaluated.

RESULTS

Altogether, 985 RF lesions in 25 patients were created with a mean number of 39.4 ± 16.3 lesions per patient. The total skin-to-skin procedure time was 116.1 ± 35.1 min, and the mean total area dose product was 10.9 ± 5.1 Gy*cm2. The mean RF time per procedure was 13.2 ± 6.6 min. The mean RF time per lesion was 20.2 ± 8.4 s. The mean CF was 15.7 ± 7.6 g. We observed a mean force time integral of 274.7 ± 11.1 gs (range: 53 to 496 gs). Acute procedural success, defined as entrance and exit block in all pulmonary veins, could be obtained in all cases. No procedure- or device-related serious adverse events were observed. No audible steam pops occurred. Optical inspection of the catheter after the procedure showed neither charring nor clotting.

CONCLUSIONS

We provide the first evidence for the safety and efficacy of 50 W ablation using the AlCath Force gold-tip catheter. These data must be supported by a larger multi-center study.

摘要

背景

在射频(RF)消融治疗心房颤动(AF)的领域中,通常使用接触力(CF)感应导管。增加消融功率(例如 50W)已被建议作为一种减少手术时间的方法,同时创建安全且持久的病变。

方法

我们报告了首例使用新型 CF 感应导管(Biotronik 的 AlCath Force)在 25 例有症状的 AF 患者中进行 50W 点到点 RF 消融的临床证据。我们收集和分析了手术和消融参数。评估了导管的安全性和有效性。

结果

在 25 例患者中总共创建了 985 个 RF 病变,每个患者的平均病变数量为 39.4 ± 16.3 个。总皮肤到皮肤的手术时间为 116.1 ± 35.1 分钟,平均总面积剂量乘积为 10.9 ± 5.1 Gy*cm2。每个手术的平均 RF 时间为 13.2 ± 6.6 分钟。每个病变的平均 RF 时间为 20.2 ± 8.4 秒。平均 CF 为 15.7 ± 7.6g。我们观察到平均力时间积为 274.7 ± 11.1 gs(范围:53 至 496 gs)。所有情况下均能获得所有肺静脉入口和出口阻滞的急性手术成功。未观察到与手术或器械相关的严重不良事件。未发生可听见的蒸汽爆裂声。手术后对导管进行光学检查,未发现碳化或凝块。

结论

我们提供了使用 AlCath Force 金尖导管进行 50W 消融的安全性和有效性的首批证据。这些数据必须得到更大的多中心研究的支持。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5964/9550336/beb6e1470095/cardj-29-5-759f1.jpg

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