Department of Clinical Electrophysiology & Cardiac Pacing, Centro Cardiologico Monzino, IRCCS, Via Carlo Parea 4, 20138 Milan, Italy.
Department of Cardiology, Johns Hopkins University, Baltimore, USA.
Europace. 2024 May 2;26(5). doi: 10.1093/europace/euae115.
Women have been historically underrepresented in implantable cardioverter-defibrillator (ICD) trials. No data on sex differences regarding subcutaneous ICDs (S-ICD) carriers have been described. Aim of our study was to investigate sex-related differences among unselected S-ICD recipients.
Consecutive patients enrolled in the multicentre, international i-SUSI registry were analysed. Comparisons between sexes were performed using a 1:1 propensity matching adjusted analysis for age, body mass index (BMI), left ventricular function, and substrate. The primary outcome was the rate of appropriate shocks during follow-up. Inappropriate shocks and other device-related complications were deemed secondary outcomes. A total of 1698 patients were extracted from the i-SUSI registry; 399 (23.5%) were females. After propensity matching, two cohorts of 374 patients presenting similar baseline characteristics were analysed. Despite similar periprocedural characteristics and a matched BMI, women resulted at lower risk of conversion failure as per PRAETORIAN score (73.4% vs. 81.3%, P = 0.049). Over a median follow-up time of 26.5 [12.7-42.5] months, appropriate shocks were more common in the male cohort (rate/year 3.4% vs. 1.7%; log-rank P = 0.049), while no significant differences in device-related complications (rate/year: 6.3% vs. 5.8%; log-rank P = 0.595) and inappropriate shocks (rate/year: 4.3% vs. 3.1%; log-rank P = 0.375) were observed. After controlling for confounders, sex remained significantly associated with the primary outcome (aHR 1.648; CI 0.999-2.655, P = 0.048), while not resulting predictor of inappropriate shocks and device-related complications.
In a propensity-matched cohort of S-ICD recipients, women are less likely to experience appropriate ICD therapy, while not showing higher risk of device-related complications.
ClinicalTrials.gov Identifier: NCT0473876.
女性在植入式心脏复律除颤器 (ICD) 试验中历来代表性不足。尚未描述皮下 ICD（S-ICD）携带者的性别差异数据。我们的研究目的是调查未选择的 S-ICD 受者的性别相关差异。
对多中心国际 i-SUSI 注册研究中的连续患者进行了分析。使用年龄、体重指数 (BMI)、左心室功能和基质的 1:1 倾向匹配调整分析比较了性别间的差异。主要结局是随访期间适当电击的发生率。不适当的电击和其他与设备相关的并发症被认为是次要结局。从 i-SUSI 登记处提取了 1698 例患者；其中 399 例（23.5%）为女性。在进行倾向匹配后，分析了两组具有相似基线特征的 374 例患者。尽管围手术期特征相似且 BMI 匹配，但女性根据 PRAETORIAN 评分发生转换失败的风险较低（73.4%比 81.3%，P=0.049）。在中位数为 26.5[12.7-42.5]个月的随访期间，男性组更常见适当电击（发生率/年 3.4%比 1.7%；对数秩 P=0.049），而设备相关并发症（发生率/年：6.3%比 5.8%；对数秩 P=0.595）和不适当电击（发生率/年：4.3%比 3.1%；对数秩 P=0.375）无显著差异。在校正混杂因素后，性别仍与主要结局显著相关（aHR 1.648；99%CI 0.999-2.655，P=0.048），而不是不适当电击和设备相关并发症的预测因素。
在 S-ICD 受者的倾向匹配队列中，女性发生适当 ICD 治疗的可能性较低，而设备相关并发症的风险并未增加。
ClinicalTrials.gov 标识符：NCT0473876。
