Medical University of South Carolina, Charleston, South Carolina.
ProMedica Toledo Hospital, Toledo, Ohio.
Heart Rhythm. 2017 Oct;14(10):1456-1463. doi: 10.1016/j.hrthm.2017.05.016. Epub 2017 May 11.
The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to reduce short- and long-term complications associated with transvenous ICD leads. Early multicenter studies included younger patients with less left ventricular systolic dysfunction and fewer comorbidities than cohorts with traditional ICD.
The purpose of this study was to characterize patient selection and the acute performance of the S-ICD in a contemporary real-world setting.
The S-ICD Post-Approval Study is a prospective registry involving 86 US centers. Patients were enrolled if they met criteria for S-ICD implantation, passed an electrocardiogram screening test, and had a life expectancy of >1 year. Analyses of descriptive statistics, Kaplan-Meier time to event, and multivariate logistic regression were performed.
The study includes 1637 patients who underwent S-ICD implantation. The cohort included 68.6% (1123/1637) male patients, and 13.4% (220/1636) were receiving dialysis for end-stage renal disease. The mean age was 52 ± 15 years, with a mean left ventricular ejection fraction of 32.0% ± 14.6%. Electrocardiogram screening was successful for at least 1, 2, or 3 vectors in 100%, 93.8%, and 51.4% of patients, respectively. Medical imaging (65.1%, 1065/1636) and general anesthesia (64.1%, 1048/16) were used in a majority of patients, and 52.2% (855/1637) were implanted with the 2-incision technique. Induced ventricular tachycardia/ventricular tachycardia was successfully converted in 98.7% (1394/1412) of patients. The 30-day complication-free rate was 96.2%. Predictors of complications included diabetes, younger age, and higher body mass index.
Contemporary US patients with S-ICD have more comorbidities than do previous cohorts with S-ICD, but they are younger with more end-stage renal disease than do patients with transvenous ICD. Implantation success is high, and short-term complication rates are acceptable.
皮下植入式心律转复除颤器（S-ICD）的开发旨在降低与经静脉 ICD 导联相关的短期和长期并发症。早期的多中心研究纳入了比传统 ICD 队列年轻、左心室收缩功能障碍更少且合并症更少的患者。
本研究旨在描述在当代真实环境下患者选择和 S-ICD 的急性表现。
S-ICD 批准后研究是一项涉及 86 个美国中心的前瞻性注册研究。如果患者符合 S-ICD 植入标准、通过心电图筛查测试且预期寿命>1 年，则可入组。进行描述性统计分析、Kaplan-Meier 时间至事件分析和多变量逻辑回归分析。
本研究纳入了 1637 例接受 S-ICD 植入的患者。该队列包括 68.6%（1123/1637）的男性患者，13.4%（220/1636）正在接受终末期肾病的透析治疗。平均年龄为 52±15 岁，平均左心室射血分数为 32.0%±14.6%。心电图筛查在至少 1、2 或 3 个向量上成功的患者比例分别为 100%、93.8%和 51.4%。大多数患者采用了医学影像学（65.1%，1065/1636）和全身麻醉（64.1%，1048/16），52.2%（855/1637）采用了两切口技术。98.7%（1394/1412）的患者成功转复诱导性室性心动过速/室性心动过速。30 天无并发症发生率为 96.2%。并发症的预测因素包括糖尿病、年龄较小和体重指数较高。
与之前的 S-ICD 队列相比，接受 S-ICD 的当代美国患者合并症更多，但比接受经静脉 ICD 的患者年轻，且终末期肾病更多。植入成功率高，短期并发症发生率可接受。
