{"title":"Antibacterial Envelope Prevents Cardiac Implantable Electronic Device Infections: The Largest Asia Real World Data.","authors":"Ching-Fen Chang, Wen-De Tang, Yin-Huei Chen, Chiung-Ray Lu, Wei-Hsin Chung, Cheng-Li Lin, Hung-Pin Wu, You-Cheng Chang, Pei-Chi Hung, Kuan-Cheng Chang, Yen-Nien Lin","doi":"10.6515/ACS.202505_41(3).20250107A","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cardiac implantable electronic device (CIED) infection is a serious complication of CIED therapy and has been associated with increased morbidity, mortality, and healthcare costs. The use of an absorbable antibiotic-eluting envelope (TYRX<sup>TM</sup>, Medtronic, Minneapolis, US) has been reported to reduce the risk of CIED infection without increasing the risk of additional complications. To investigate the real-world efficacy in Taiwanese patients, we retrospectively reviewed the outcomes of CIED patients with and without the use of an envelope.</p><p><strong>Methods: </strong>A total 456 patients underwent CIED procedure from January 2022 to June 2023, including initial implantation, generator replacement, upgrade, or revision. There were 154 patients in the envelope group and 302 patients in the control group, all of whom received our standard infection prophylaxis care. Patient demographics and CIED complications during serial clinical follow-ups were analyzed.</p><p><strong>Results: </strong>Both groups demonstrated comparable characteristics including age, sex, body mass index, CIED type, and left ventricular ejection fraction. More of the envelope group were receiving dialysis (Envelope vs. Control: 13.6% vs. 7.0%, p = 0.015), anticoagulant therapy (Envelope vs. Control: 35.7% vs. 27.5%, p = 0.048), and had a longer procedure time (Envelope vs. Control: 83.4 ± 40.3 vs. 70.4 ± 31.7 minutes, p = 0.0002). CIED-related infections occurred in none of the envelope patients and 4 of the control patients (0% vs. 1.3%, p = 0.19; Kaplan-Meier estimate 0% vs. 2.02%, hazard ratio: 0.24, 95% confidence interval: 0.03-2.03, p = 0.19). Two patients reported allergic reactions to the envelope.</p><p><strong>Conclusions: </strong>The envelope group had a higher risk of CIED infections but similar infection rate , compared with the control group. However, the envelope group had a slightly longer procedure time and possibly an increased risk of allergic reaction.</p>","PeriodicalId":6957,"journal":{"name":"Acta Cardiologica Sinica","volume":"41 3","pages":"314-322"},"PeriodicalIF":1.8000,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12099244/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Acta Cardiologica Sinica","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.6515/ACS.202505_41(3).20250107A","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Cardiac implantable electronic device (CIED) infection is a serious complication of CIED therapy and has been associated with increased morbidity, mortality, and healthcare costs. The use of an absorbable antibiotic-eluting envelope (TYRXTM, Medtronic, Minneapolis, US) has been reported to reduce the risk of CIED infection without increasing the risk of additional complications. To investigate the real-world efficacy in Taiwanese patients, we retrospectively reviewed the outcomes of CIED patients with and without the use of an envelope.
Methods: A total 456 patients underwent CIED procedure from January 2022 to June 2023, including initial implantation, generator replacement, upgrade, or revision. There were 154 patients in the envelope group and 302 patients in the control group, all of whom received our standard infection prophylaxis care. Patient demographics and CIED complications during serial clinical follow-ups were analyzed.
Results: Both groups demonstrated comparable characteristics including age, sex, body mass index, CIED type, and left ventricular ejection fraction. More of the envelope group were receiving dialysis (Envelope vs. Control: 13.6% vs. 7.0%, p = 0.015), anticoagulant therapy (Envelope vs. Control: 35.7% vs. 27.5%, p = 0.048), and had a longer procedure time (Envelope vs. Control: 83.4 ± 40.3 vs. 70.4 ± 31.7 minutes, p = 0.0002). CIED-related infections occurred in none of the envelope patients and 4 of the control patients (0% vs. 1.3%, p = 0.19; Kaplan-Meier estimate 0% vs. 2.02%, hazard ratio: 0.24, 95% confidence interval: 0.03-2.03, p = 0.19). Two patients reported allergic reactions to the envelope.
Conclusions: The envelope group had a higher risk of CIED infections but similar infection rate , compared with the control group. However, the envelope group had a slightly longer procedure time and possibly an increased risk of allergic reaction.
背景:心脏植入式电子装置(CIED)感染是CIED治疗的严重并发症,与发病率、死亡率和医疗费用增加有关。据报道,使用可吸收的抗生素洗脱包膜(TYRXTM,美敦力,明尼阿波利斯,美国)可降低CIED感染的风险,而不会增加其他并发症的风险。为了研究台湾患者的实际疗效,我们回顾性地回顾了使用和不使用包膜的CIED患者的结果。方法:从2022年1月到2023年6月,共有456例患者接受了CIED手术,包括初始植入、发电机更换、升级或翻修。包膜组154例,对照组302例,均接受我们标准的感染预防护理。分析连续临床随访期间患者人口统计学特征及CIED并发症。结果:两组表现出可比性特征,包括年龄、性别、体重指数、CIED类型和左心室射血分数。包膜组接受透析治疗的患者较多(包膜组vs对照组:13.6% vs 7.0%, p = 0.015),接受抗凝治疗的患者较多(包膜组vs对照组:35.7% vs 27.5%, p = 0.048),手术时间较长(包膜组vs对照组:83.4±40.3 vs 70.4±31.7分钟,p = 0.0002)。包膜组患者中无一例发生cied相关感染,对照组患者中有4例发生cied相关感染(0%对1.3%,p = 0.19;Kaplan-Meier估计0% vs 2.02%,风险比:0.24,95%置信区间:0.03-2.03,p = 0.19)。两名患者报告对信封有过敏反应。结论:与对照组相比,包膜组CIED感染风险较高,但感染率相近。然而,包膜组的手术时间稍长,过敏反应的风险可能增加。
期刊介绍:
Acta Cardiologica Sinica welcomes all the papers in the fields related to cardiovascular medicine including basic research, vascular biology, clinical pharmacology, clinical trial, critical care medicine, coronary artery disease, interventional cardiology, arrythmia and electrophysiology, atherosclerosis, hypertension, cardiomyopathy and heart failure, valvular and structure cardiac disease, pediatric cardiology, cardiovascular surgery, and so on. We received papers from more than 20 countries and areas of the world. Currently, 40% of the papers were submitted to Acta Cardiologica Sinica from Taiwan, 20% from China, and 20% from the other countries and areas in the world. The acceptance rate for publication was around 50% in general.