Chang Ching-Fen, Tang Wen-De, Chen Yin-Huei, Lu Chiung-Ray, Chung Wei-Hsin, Lin Cheng-Li, Wu Hung-Pin, Chang You-Cheng, Hung Pei-Chi, Chang Kuan-Cheng, Lin Yen-Nien
Division of Cardiovascular Medicine, Department of Internal Medicine, China Medical University Hospital, China Medical University.
Division of Endocrinology and Metabolism, Department of Internal Medicine, China Medical University Hospital, China Medical University.
Acta Cardiol Sin. 2025 May;41(3):314-322. doi: 10.6515/ACS.202505_41(3).20250107A.
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, 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.
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.
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.
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.
心脏植入式电子设备（CIED）感染是CIED治疗的一种严重并发症，与发病率、死亡率和医疗费用增加相关。据报道，使用可吸收抗生素洗脱包膜（TYRX，美敦力公司，美国明尼阿波利斯）可降低CIED感染风险，且不增加其他并发症风险。为研究其在台湾患者中的实际疗效，我们回顾性分析了使用和未使用该包膜的CIED患者的结局。
2022年1月至2023年6月，共有456例患者接受了CIED手术，包括初次植入、发生器更换、升级或修复。包膜组有154例患者，对照组有302例患者，所有患者均接受了我们的标准感染预防护理。分析了患者的人口统计学特征以及系列临床随访期间的CIED并发症情况。
两组在年龄、性别、体重指数、CIED类型和左心室射血分数等方面表现出相似的特征。包膜组更多患者接受透析治疗（包膜组与对照组：13.6%对7.0%，p = 0.015）、抗凝治疗（包膜组与对照组：35.7%对27.5%，p = 0.048），且手术时间更长（包膜组与对照组：83.4±40.3分钟对70.4±31.7分钟，p = 0.0002）。包膜组患者无一发生CIED相关感染，对照组有4例（0%对1.3%，p = 0.19；Kaplan-Meier估计值0%对2.02%，风险比：0.24，95%置信区间：0.03 - 2.03，p = 0.19）。有2例患者报告对包膜过敏。
与对照组相比，包膜组CIED感染风险更高，但感染率相似。然而，包膜组手术时间略长，且可能存在过敏反应风险增加的情况。
