Raviele A, Gasparini G
Division of Cardiology, Umberto I Hospital, Mestre-Venice, Italy.
Pacing Clin Electrophysiol. 1995 Mar;18(3 Pt 2):599-608. doi: 10.1111/j.1540-8159.1995.tb02570.x.
This study presents the acute and long-term results of 307 patients (267 men, mean age 57.5 years, 205 suffering from coronary artery disease, mean left ventricular ejection fraction 33.3%) with malignant ventricular tachyarrhythmias who underwent attempted transvenous ICD implantation with the CPI Endotak lead system in 37 Italian centers. Transvenous ICD implantation was ultimately accomplished in 306 (99.7%) patients. These included 19 subjects with high (< 10 J below output energy of implanted device) defibrillation threshold (DFT) at implant. One hundred sixty-four patients (53%) were implanted with the endocardial lead alone, while 142 also received an SQ patch or SQ array. The mean DFT (not always step-down DFT) at implant was 16.9 +/- 5.7 joules; 15.3 +/- 5.2 joules with biphasic shock and 19.6 +/- 5.4 joules with monophasic shock; P < 0.0001. A significantly higher percentage of patients tested with a biphasic shock could be implanted with adequate safety margin and without an additional SQ patch or SQ array (98% and 81%, respectively). No perioperative deaths occurred. During the mean follow-up of 14.5 +/- 10.2 months, 140 patients (52%) received at least one appropriate shock. An inappropriate shock was observed in 26% of episodes. The 1- and 3-year actuarial incidence of sudden death was 2% and 4%, respectively, and that of total death was 10% and 20%, respectively. A pocket infection requiring ICD explantation occurred in 4 patients (1.4%) and an endocardial lead dislodgment in 11 patients (3.6%). Two patients (0.3%) showed a sensing pin disconnection and six patients (2.3%) had a lead insulation break. The results of this Italian multicenter trial indicate that the CPI Endotak lead system is a simple, safe, and reliable system for endocardial defibrillation. When compared to epicardial leads, it clearly reduces the perioperative mortality and morbidity, while maintaining a similar efficacy in preventing sudden death and terminating ventricular arrhythmias.
本研究呈现了307例（267例男性，平均年龄57.5岁，205例患有冠状动脉疾病，平均左心室射血分数33.3%）恶性室性心律失常患者在意大利37个中心接受使用CPI Endotak导联系统尝试经静脉植入式心脏除颤器（ICD）的急性和长期结果。306例（99.7%）患者最终成功完成经静脉ICD植入。其中包括19例植入时除颤阈值（DFT）较高（低于植入设备输出能量10 J以下）的患者。164例（53%）患者仅植入心内膜导联，而142例还接受了皮下贴片或皮下阵列。植入时的平均DFT（并非总是逐步降低的DFT）为16.9±5.7焦耳；双相电击时为15.3±5.2焦耳，单相电击时为19.6±5.4焦耳；P<0.0001。接受双相电击测试的患者中，能够以足够安全裕度植入且无需额外皮下贴片或皮下阵列的比例显著更高（分别为98%和81%）。围手术期无死亡发生。在平均14.5±10.2个月的随访期间，140例（52%）患者至少接受了一次恰当电击。26%的发作观察到不恰当电击。1年和3年猝死的精算发生率分别为2%和4%，总死亡的精算发生率分别为10%和20%。4例患者（1.4%）发生需要取出ICD的囊袋感染，11例患者（3.6%）发生心内膜导联脱位。2例患者（0.3%）出现感知针断开，6例患者（2.3%）有导联绝缘破损。这项意大利多中心试验的结果表明，CPI Endotak导联系统是一种用于心内膜除颤的简单、安全且可靠的系统。与心外膜导联相比，它明显降低了围手术期死亡率和发病率，同时在预防猝死和终止室性心律失常方面保持相似的疗效。
