Chlorhexidine vs Povidone-Iodine Alcohol Solutions for Cardiac Implantable Electronic Devices: A Prospective Randomized Study.

Studies on surgical-site infections show conflicting results regarding the use of alcohol-based povidone-iodine vs chlorhexidine for skin antisepsis, especially as CRT implantation remains insufficiently studied.

关于手术部位感染的研究显示，使用酒精基聚维酮碘与氯己定进行皮肤消毒的结果存在冲突，特别是作为CRT植入的研究仍然不足。

This study sought to compare the effectiveness of 2% alcohol-based chlorhexidine with that of 4-phase povidone-iodine-alcohol skin preparation in preventing local or systemic infections after cardiac resynchronization therapy device implantation, and to assess the impact on other major cardiovascular events and treatment-related adverse effects over 24 months.

本研究旨在比较2%含酒精氯己定与4阶段聚维酮碘-酒精皮肤准备在预防心脏再同步治疗装置植入后局部或系统性感染方面的有效性，并评估其在24个月内对其他主要心血管事件和治疗相关不良反应的影响。

Methods

In this randomized, multicenter, open-label trial with blinded outcome adjudication, patients undergoing CRT (implantation, upgrade, or replacement) pacemaker, or defibrillator implantation were assigned 1:1 to receive skin antisepsis with either 2% alcoholic chlorhexidine or alcoholic povidone-iodine.

在这项随机、多中心、开放标签试验中，对结果进行盲法评定，接受心脏再同步治疗（植入、升级或更换）起搏器或除颤器植入的患者按1:1的比例分配，分别接受2%酒精型氯己定或酒精型聚维酮碘的皮肤消毒处理。

Randomization was conducted centrally using an interactive web-response system, with stratification according to trial center.

随机分组是通过交互式网络响应系统进行的，根据试验中心进行分层。

The primary outcome was local or systemic infection related to the device over a 24-month follow-up period.

主要结果是在24个月的随访期间，与设备相关的局部或系统性感染。

The secondary outcomes were major cardiovascular events and noninfectious side effects.

次要结果是主要心血管事件和非感染性副作用。

Results

From April 2013 to December 2018, 2,272 patients were randomized to the chlorhexidine (n = 1,143) or the povidone-iodine group (n = 1,129).

从2013年4月到2018年12月，共有2,272名患者被随机分配到氯己定组（n = 1,143）或聚维酮碘组（n = 1,129）。

Median age was 72 years; 75.1% were men.

中位年龄为72岁；75.1%为男性。

Device-related infections occurred in 2.9% of the chlorhexidine group and 3.9% of the povidone-iodine group (adjusted subhazard ratio: 0.75; 95% CI: 0.48-1.20; P = 0.23).

在氯己定组中，与设备相关的感染发生率为2.9%，而在聚维酮碘组中为3.9%（调整后亚风险比：0.75；95% 置信区间：0.48-1.20；P = 0.23）。

Major cardiovascular events occurred in 31.5% and 31.3% of patients, respectively (subhazard ratio: 1.01; 95% CI: 0.87-1.17).

主要心血管事件分别发生在31.5%和31.3%的患者中（亚风险比：1.01；95%置信区间：0.87-1.17）。

Noninfectious local side effects occurred in 12.9% vs 13.3%.

非感染性局部副作用分别发生在12.9%和13.3%的患者中。

Conclusions

The study did not demonstrate a significant reduction in infection rates with alcoholic chlorhexidine compared with alcoholic povidone-iodine in patients undergoing cardiac resynchronization device implantation.

该研究未显示使用酒精氯己定与使用酒精聚维酮碘相比，在接受心脏再同步化设备植入的患者中感染率有显著降低。

Both antiseptics showed similar rates of major infectious and noninfectious events.

两种抗菌剂显示出主要感染和非感染事件的相似发生率。

Further research is needed to optimize infection prevention strategies in this population.

需要进一步研究以优化这一人群的感染预防策略。

(Comparison of Alcoholic Chlorhexidine 2% Versus Alcoholic Povidone Iodine for Infections Prevention With Cardiac Resynchronization Therapy Device Implantation [CHLOVIS]; NCT01841242).

(比较2%酒精氯己定与酒精聚维酮碘在心脏再同步化治疗装置植入感染预防中的效果[CHLOVIS]; NCT01841242)。