Strickberger S A, Hummel J D, Daoud E, Niebauer M, Williamson B D, Man K C, Horwood L, Schmittou A, Kalbfleisch S J, Langberg J J
Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor 18109-0022.
Circulation. 1994 Aug;90(2):868-72. doi: 10.1161/01.cir.90.2.868.
Traditional lead systems for implantable cardioverter defibrillators (ICDs) require a thoracotomy for placement. Nonthoracotomy lead systems are available and are usually implanted by an electrophysiologist and a surgeon. The purpose of this study was to prospectively evaluate the safety and efficacy of ICD implantation with a nonthoracotomy lead system by electrophysiologists.
A consecutive series of 100 patients (mean age, 61 +/- 13 years, +/- SD) underwent ICD implantation with a nonthoracotomy lead system while intubated and under general anesthesia. Seventy-seven patients had coronary artery disease, 15 had idiopathic cardiomyopathy, 6 had miscellaneous heart disease, and 2 had structurally normal hearts. The mean ejection fraction was 0.29 +/- 0.13. Sixty-eight patients had suffered a cardiac arrest, and 32 had had ventricular tachycardia or syncope. All patients except 9 underwent electrophysiological testing and had failed 1 +/- 1 drug trials before ICD implantation. Three types of nonthoracotomy lead systems were used. The nonthoracotomy lead with an ICD was successfully implanted in 96 patients (96%). Of the unsuccessful implants, 1 patient did not have venous access, the passive fixation lead in 1 would not remain lodged, 1 had elevated defibrillation thresholds, and 1 developed a hemopneumothorax while venous access was being obtained. The mean defibrillation threshold was 17 +/- 6 J. The mean procedure duration was 161 +/- 57 minutes. When a subcutaneous patch was used (n = 58), the procedure duration was 189 +/- 5 minutes, and when a subcutaneous patch was not required (n = 40), the procedure lasted 123 +/- 37 minutes (P < .0001). Patients remained in the hospital 4.5 +/- 4.1 days after implantation, with no procedure-related deaths. Acute complications occurred in 10 patients; 2 had lead dislodgments, 1 with previous abdominal surgery had his abdominal cavity entered (without other complications) while the ICD pocket was being made, 1 had postoperative heart failure, 1 developed a large hematoma when anticoagulation therapy was initiated, 3 required reintubation because of excessive anesthesia, 1 developed superficial cellulitis, and 1 developed a hemopneumothorax secondary to a lacerated subclavian vein. During 6 +/- 3 months of follow-up, 2 patients developed lead fractures.
(1) Electrophysiologists can implant an ICD with a nonthoracotomy lead system safely and with a high success rate; (2) use of a subcutaneous patch correlates with longer procedure durations; and (3) special precautions should be taken in patients with previous abdominal surgery.
传统的植入式心脏复律除颤器（ICD）导联系统需要开胸植入。非开胸导联系统已有应用，通常由电生理学家和外科医生植入。本研究的目的是前瞻性评估电生理学家使用非开胸导联系统植入ICD的安全性和有效性。
连续100例患者（平均年龄61±13岁，±标准差）在插管全身麻醉下接受非开胸导联系统的ICD植入。77例患者患有冠状动脉疾病，15例患有特发性心肌病，6例患有其他心脏病，2例心脏结构正常。平均射血分数为0.29±0.13。68例患者曾发生心脏骤停，32例曾发生室性心动过速或晕厥。除9例患者外，所有患者均接受了电生理检查，且在ICD植入前1±1次药物试验失败。使用了三种类型的非开胸导联系统。带ICD的非开胸导联成功植入96例患者（96%）。植入失败的患者中，1例没有静脉通路，1例被动固定导联无法固定，1例除颤阈值升高，1例在获取静脉通路时发生血气胸。平均除颤阈值为17±6J。平均手术时间为161±57分钟。使用皮下贴片时（n = 58），手术时间为189±5分钟，不使用皮下贴片时（n = 40），手术持续123±37分钟（P <.0001）。患者植入后住院4.5±4.1天，无手术相关死亡。10例患者发生急性并发症；2例导联移位，1例曾接受腹部手术，在制作ICD囊袋时腹腔被打开（无其他并发症），1例术后发生心力衰竭，1例开始抗凝治疗时出现大血肿，3例因麻醉过量需要重新插管，1例发生浅表蜂窝织炎，1例因锁骨下静脉撕裂继发血气胸。在6±3个月的随访期间，2例患者发生导联骨折。
（1）电生理学家可以安全地使用非开胸导联系统植入ICD，成功率高；（2）使用皮下贴片与手术时间延长相关；（3）既往有腹部手术史的患者应采取特殊预防措施。
