Cantillon Daniel J, Ha Kieu, Styperek Robert, Jumrussirikul Pitayadet, Mirro Michael, Wong Wilson, Wilkoff Bruce L
Section of Cardiac Electrophysiology and Pacing, Heart and Vascular Institute, The Cleveland Clinic Foundation, Cleveland, Ohio, USA.
Pacing Clin Electrophysiol. 2013 Jul;36(7):855-62. doi: 10.1111/pace.12130. Epub 2013 Apr 25.
Current implantable cardioverter defibrillators (ICDs) employ two or three low- and high-voltage lead connectors, adding complexity and bulk, sometimes resulting in incorrect connections and adverse events. The SJ4 study evaluates the performance of a novel integrated single-lead DF4 connection system by characterizing lead measurements, handling characteristics, and outcomes.
Patients with standard guidelines-based ICD indications were enrolled and implanted with a St. Jude Medical™ DF4 system (St. Jude Medical, Sylmar, CA, USA; right ventricular high-voltage DF4 lead models 7120Q, 7121Q, 7122Q, or 7170Q with compatible ICD). Device electrical measurements, handling characteristics, and any adverse events were collected at implant and during each scheduled 6-month follow-up.
Among 1,701 patients (65 ± 13 years, 72% male, left ventricular ejection fraction 29 ± 12%) enrolled at 58 centers, there were 1,697 successful implants (99.8% implant success; ICD; n = 999, cardiac resynchronization therapy-defibrillator n = 698). Implanting physicians reported that implantation of the DF4 lead was normal or easier than normal in 94% of cases with successful implant. These patients have been followed for 1.7 ± 0.5 years with a maximum follow-up of 2.5 years. The complication rate was 0.017 per patient year of follow-up (95% confidence interval: 0.013-0.023), which included abnormal defibrillation impedance, elevated pacing thresholds, failure to detect ventricular tachycardia/ventricular fibrillation, lead dislodgement, lead fracture, loss of capture, and lead perforation. There were no set screw-related complications at implant or during follow-up.
The DF4 system overall performed very well with few complications at implant and in follow-up.
当前的植入式心脏复律除颤器（ICD）使用两个或三个低电压和高电压导联连接器，增加了复杂性和体积，有时会导致连接错误和不良事件。SJ4研究通过对导联测量、操作特性和结果进行表征，评估了一种新型集成单导联DF4连接系统的性能。
纳入符合基于标准指南的ICD适应症的患者，并为其植入圣犹达医疗™DF4系统（美国加利福尼亚州西尔玛市圣犹达医疗公司；右心室高电压DF4导联型号7120Q、7121Q、7122Q或7170Q以及兼容的ICD）。在植入时以及每次预定的6个月随访期间收集设备的电测量数据、操作特性和任何不良事件。
在58个中心纳入的1701例患者（年龄65±13岁，男性占72%，左心室射血分数29±12%）中，有1697例成功植入（植入成功率99.8%；ICD；n = 999，心脏再同步治疗除颤器n = 698）。植入医生报告，在94%的成功植入病例中，DF4导联的植入正常或比正常情况更容易。这些患者已随访1.7±0.5年，最长随访时间为2.5年。随访期间每位患者每年的并发症发生率为0.017（95%置信区间：0.013 - 0.023），包括除颤阻抗异常、起搏阈值升高、未能检测到室性心动过速/心室颤动、导联脱位、导联断裂、夺获失败和导联穿孔。在植入时或随访期间没有与固定螺钉相关的并发症。
DF4系统总体表现良好，植入时和随访期间并发症较少。
