Department of Medicine, Medical University of South Carolina, Charleston, South Carolina.
Department of Cardiac Electrophysiology, Lexington Cardiology/Baptist Health Medical Group, Lexington, Kentucky.
Heart Rhythm. 2022 Dec;19(12):1993-2001. doi: 10.1016/j.hrthm.2022.07.031. Epub 2022 Aug 6.
Early subcutaneous implantable cardioverter-defibrillator (S-ICD) studies included atypical cohorts of patients who were younger with fewer comorbidities. Recent S-ICD studies included patient populations with more comorbidities.
The goals of this study were to determine the incidence and predictors of S-ICD-related infection over a 3-year follow-up period and to use these results to develop an infection risk score.
The S-ICD Post Approval Study is a US prospective registry of 1637 patients. Baseline demographic characteristics and outcomes with 3-year postimplantation follow-up were compared between patients with and without device-related infection. A risk score was derived from multivariable proportional hazards analysis of 22 variables.
Infection was observed in 55 patients (3.3%), with 69% of infections occurring within 90 days and a vast majority (92.7%) within 1 year of implantation. Late infections more likely involved device erosion; no infections occurred after year 2. The annual mortality rate postinfection was 0.6%/y. No lead extraction complications or bacteremia related to infection were observed. An infection risk score was created with diabetes, age, prior transvenous ICD implant, and ejection fraction as predictors. Patients with a risk score of ≥3 had an 8.8 hazard ratio (95% confidence interval 2.8-16.3) of infection compared with a 0 risk score.
Infection rates in the S-ICD Post Approval Study were similar to other S-ICD populations and not associated with systemic blood-borne infections. Late infection (>1 year) is uncommon and associated with system erosion. A high-risk infection cohort can be identified that may facilitate preventive measures.
早期皮下植入式心律转复除颤器（S-ICD）的研究纳入了一些非典型的患者群体，这些患者年龄较小且合并症较少。最近的 S-ICD 研究纳入了更多合并症患者。
本研究旨在确定 S-ICD 相关感染在 3 年随访期间的发生率和预测因素，并利用这些结果制定感染风险评分。
S-ICD 上市后研究是一项在美国开展的前瞻性注册研究，共纳入了 1637 例患者。对比了植入后 3 年的随访中有无器械相关感染患者的基线人口统计学特征和结局。采用多变量比例风险分析对 22 个变量进行分析，得出风险评分。
55 例（3.3%）患者发生了感染，其中 69%的感染发生在 90 天内，绝大多数（92.7%）发生在植入后 1 年内。迟发性感染更可能与器械侵蚀有关；2 年后未发生感染。感染后的年死亡率为 0.6%/年。未观察到与感染相关的导线取出并发症或菌血症。创建了一个感染风险评分，其中糖尿病、年龄、先前经静脉 ICD 植入和射血分数为预测因素。风险评分为≥3 的患者感染的风险比（HR）为 8.8（95%置信区间 2.8-16.3），而风险评分为 0 的患者感染风险较低。
S-ICD 上市后研究的感染率与其他 S-ICD 人群相似，且与全身性血源性感染无关。迟发性感染（>1 年）较为少见，与系统侵蚀有关。可以确定一个高风险感染队列，以便采取预防措施。
