Italian Multicenter Clinical Experience with Endocardial Defibrillation: Acute and Long‐Term Results in 307 Patients
Italian Multicenter Clinical Experience with Endocardial Defibrillation: Acute and Long‐Term Results in 307 Patients
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意大利多中心心内膜除颤临床经验：307 名患者的急性和长期结果
DOI：
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发表时间：
1995
期刊：
影响因子：
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通讯作者：
G. Gasparini
中科院分区：
文献类型：
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作者：
A. Raviele;G. Gasparini
本研究介绍了 307 名恶性室性快速心律失常患者（267 名男性，平均年龄 57.5 岁，205 名患有冠状动脉疾病，平均左心室射血分数 33.3%）的急性和长期结果，这些患者在意大利 37 个中心尝试使用 CPI Endotak 导线系统进行经静脉 ICD 植入。最终有 306 名（99.7%）患者完成了经静脉 ICD 植入。其中包括 19 名在植入时具有高（低于植入设备输出能量 < 10 J）除颤阈值 (DFT) 的受试者。 164 名患者 (53%) 仅植入心内膜导线，而 142 名患者还接受了 SQ 贴片或 SQ 阵列。植入时的平均 DFT（并非总是降压 DFT）为 16.9 ± 5.7 焦耳；双相电击为 15.3 ± 5.2 焦耳，单相电击为 19.6 ± 5.4 焦耳； P<0.0001。在接受双相电击测试的患者中，有较高比例的患者可以在具有足够安全裕度的情况下进行植入，而无需额外的 SQ 贴片或 SQ 阵列（分别为 98% 和 81%）。无围手术期死亡发生。在平均 14.5 ± 10.2 个月的随访期间，140 名患者 (52%) 接受了至少一次适当的电击。 26% 的事件中观察到不适当的电击。 1 年和 3 年猝死精算发生率分别为 2% 和 4%，总死亡发生率分别为 10% 和 20%。 4 名患者（1.4%）发生囊袋感染，需要 ICD 移植；11 名患者（3.6%）发生心内膜导线脱位。两名患者 (0.3%) 出现传感引脚断开，六名患者 (2.3%) 出现引线绝缘断裂。这项意大利多中心试验的结果表明，GPl Endotak 导联系统是一种简单、安全、可靠的心内膜除颤系统。与心外膜导线相比，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了相似的功效。
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 GPl 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.