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德国激光心脏除颤器取出登记研究:GALLERY。

The GermAn Laser Lead Extraction RegistrY: GALLERY.

机构信息

Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, University Hospital Eppendorf, Martinistr. 52, 20246 Hamburg, Germany.

Department of Cardiac Surgery, Kerckhoff-Klinik, Bad Nauheim, Germany.

出版信息

Europace. 2022 Oct 13;24(10):1627-1635. doi: 10.1093/europace/euac056.

Abstract

AIMS

The GermAn Laser Lead Extraction RegistrY: GALLERY is a retrospective, national multicentre registry, investigating the safety and efficacy of laser lead extraction procedures in Germany.

METHODS AND RESULTS

Twenty-four German centres that are performing laser lead extraction have participated in the registry. All patients, treated with a laser lead extraction procedure between January 2013 and March 2017, were consecutively enrolled. Safety and efficacy of laser lead extraction were investigated. A total number of 2524 consecutive patients with 6117 leads were included into the registry. 5499 leads with a median lead dwell time of 96 (62-141) months were treated. The mean number of treated leads per patient was 2.18 ± 1.02. The clinical procedural success rate was 97.86% and the complete lead removal was observed in 94.85%. Additional extraction tools were used in 6.65% of cases. The rate of procedural failure was 2.14% with lead age  ≥10 years being its only predictor. The overall complication rate was 4.32%, including 2.06% major and 2.26% minor complications. Procedure-related mortality was 0.55%. Female sex and the presence of abandoned leads were predictors for procedure-related complications. The all-cause in-hospital mortality was 3.56% with systemic infection being the strongest predictor, followed by age ≥75 years and chronic kidney disease.

CONCLUSION

In the GALLERY, a high success- and low procedure-related complication rates have been demonstrated. In multivariate analysis, female sex and the presence of abandoned leads were predictors for procedure-related complications, while the presence of systemic infection, age ≥75 years, and chronic kidney disease were independent predictors for all-cause mortality.

摘要

目的

德国激光心脏导线拔除登记研究(GALLERY)是一项回顾性的全国多中心登记研究,旨在调查德国激光心脏导线拔除术的安全性和疗效。

方法和结果

参与该登记研究的 24 家德国中心正在进行激光心脏导线拔除术。2013 年 1 月至 2017 年 3 月期间,连续纳入接受激光心脏导线拔除术的所有患者。研究调查了激光心脏导线拔除术的安全性和疗效。该登记研究共纳入 2524 例连续患者和 6117 根导线。5499 根导线的中位导线留置时间为 96(62-141)个月。每位患者的平均治疗导线数为 2.18±1.02。临床操作成功率为 97.86%,完全拔除率为 94.85%。在 6.65%的病例中使用了额外的拔除工具。操作失败率为 2.14%,其唯一预测因素为导线年龄≥10 年。总的并发症发生率为 4.32%,其中 2.06%为主要并发症,2.26%为次要并发症。与操作相关的死亡率为 0.55%。女性和存在废弃导线是与操作相关并发症的预测因素。全因院内死亡率为 3.56%,其中全身感染是最强的预测因素,其次是年龄≥75 岁和慢性肾脏病。

结论

在 GALLERY 中,高成功率和低操作相关并发症发生率得到了证明。多变量分析显示,女性和存在废弃导线是操作相关并发症的预测因素,而全身感染、年龄≥75 岁和慢性肾脏病是全因死亡率的独立预测因素。

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