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双腔与单腔除颤器用于心源性猝死的一级预防:埋藏式自动复律除颤器-初级预防注册研究的长期随访。

Dual- vs. single-chamber defibrillators for primary prevention of sudden cardiac death: long-term follow-up of the Défibrillateur Automatique Implantable-Prévention Primaire registry.

机构信息

CHU Michallon, Grenoble, France.

Clinique Pasteur, Toulouse, France.

出版信息

Europace. 2017 Sep 1;19(9):1478-1484. doi: 10.1093/europace/euw230.

Abstract

AIMS

Implantable cardioverter defibrillators (ICDs) are an effective primary prevention of sudden cardiac death. We examined whether dual-chamber (DC) ICDs confer a greater benefit than single-chamber (SC) ICDs, and compared the long-term outcomes of recipients of each type of device implanted for primary prevention.

METHODS AND RESULTS

Between 2002 and 2012, the DAI-PP registry consecutively enrolled 1258 SC- and 1280 DC-ICD recipients at 12 French medical centres. The devices were interrogated at 4- to 6-month intervals during outpatient visits, with a focus on the therapies delivered. The study endpoints were incidence of appropriate therapies, ICD-related morbidity, and deaths from all and from specific causes. The mean age of the SC- and DC-ICD recipients was 59 ± 12 and 62 ± 11 years, respectively (P< 0.0001). The distribution of genders, New York Heart Association functional classes and glomerular filtration rates, and the rates of ischaemic vs. dilated cardiomyopathies and of defibrillation tests at implant, were similar in both study groups. The rates of periprocedural complications were 12.1% in the DC- vs. 8.8% in the SC-ICD groups (P= 0.008). Over a mean follow-up of 3.1 ± 2.2 years, pulse generators were replaced in 21.9% of the DC- vs. 13.6% of the SC-ICD group (P< 0.0001). The proportions of patients treated with ≥1 appropriate therapies (24.7 vs. 23.8%) and ≥1 inappropriate shocks (8.4 vs. 7.8%), and all-cause mortality (12.4 vs. 13.2%) were similar in both groups.

CONCLUSION

In this large registry of ICD implanted for primary prevention, DC-ICDs were associated with higher rates of peri-implant complications and generator replacements, whereas the survival and rates of inappropriate shocks were similar in both groups.

CLINICAL TRIAL NUMBER

NCT#01992458.

摘要

目的

植入式心脏复律除颤器(ICD)是预防心源性猝死的有效手段。本研究旨在探讨双腔(DC)ICD 与单腔(SC)ICD 相比,能否为患者带来更大获益,并比较两种 ICD 用于一级预防的长期预后。

方法和结果

2002 年至 2012 年,DAI-PP 注册研究连续纳入了 12 家法国医学中心的 1258 例 SC-ICD 植入患者和 1280 例 DC-ICD 植入患者。在门诊随访中,每 4-6 个月对装置进行一次程控,重点关注所实施的治疗。研究终点包括适当治疗的发生率、ICD 相关并发症发生率和全因死亡率、特定原因死亡率。SC-ICD 组和 DC-ICD 组患者的平均年龄分别为 59±12 岁和 62±11 岁(P<0.0001)。两组患者的性别分布、纽约心脏协会心功能分级、肾小球滤过率、缺血性心肌病与扩张型心肌病的比例以及植入时的除颤测试率相似。DC-ICD 组围术期并发症发生率为 12.1%,SC-ICD 组为 8.8%(P=0.008)。在平均 3.1±2.2 年的随访中,DC-ICD 组中有 21.9%的脉冲发生器需要更换,而 SC-ICD 组为 13.6%(P<0.0001)。两组患者接受≥1 次适当治疗(24.7% vs. 23.8%)和≥1 次不适当电击(8.4% vs. 7.8%)的比例以及全因死亡率(12.4% vs. 13.2%)均相似。

结论

在这项用于一级预防的 ICD 植入的大型注册研究中,DC-ICD 与更高的围术期并发症发生率和脉冲发生器更换率相关,而两组患者的存活率和不适当电击率相似。

临床试验编号

NCT01992458。

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