Porterfield J G, Porterfield L M, Levine J H, Luceri R M, Hsia H H
Am J Cardiol. 1996 Mar 15;77(8):586-90. doi: 10.1016/s0002-9149(97)89311-3.
This prospective multicenter study was conducted under the Food and Drug Administration Investigational Device Exemption to evaluate the safety and efficacy of the combination of the Cadence implantable defibrillator (Ventritex, Inc.) and 60-series Endotak C leads (Cardiac Pacemakers, Inc.). Implantation was attempted in 148 patients with hemodynamically compromising ventricular tachycardia or fibrillation (VF), or with pace-terminable ventricular tachycardia. The system was successfully implanted in 97% of patients, with 96% of implants in a transvenous-lead-alone configuration. At implantation, the defibrillation threshold was 455 +/- 94 V (14 +/- 6 J) for lead-alone patients and 532 +/- 40 V (19 +/- 3 J) for those requiring a subcutaneous patch. VF conversion efficacy was reconfirmed in patients who underwent a 3-month chronic induction study. The system successfully detected all 763 induced arrhythmias and terminated 99.5% of them; after system modification, successful conversion was demonstrated in the 2 patients who initially had induced episodes requiring external defibrillation (1 lead revision; 1 reprogramming). All spontaneous episodes were terminated with an implantable-cardioverter defibrillator. Postshock VF redetection times were significantly shorter than initial detection times (4.5 +/- 1.8 seconds detection, 2.1 +/- 0.7 seconds redetection; p<0.0001). During an 8-month mean follow-up (range 1 to 31 months), 2 unwitnessed deaths were classified as sudden cardiac deaths, and 11 patients experienced a total of 12 complications, none of which was associated with the Cadence-Endotak combination.
本前瞻性多中心研究是在食品药品监督管理局的研究器械豁免下进行的，旨在评估Cadence植入式除颤器（Ventritex公司）与60系列Endotak C导线（心脏起搏器公司）组合的安全性和有效性。对148例有血流动力学障碍的室性心动过速或心室颤动（VF）或可被起搏器终止的室性心动过速患者尝试进行植入。该系统在97%的患者中成功植入，96%的植入采用仅经静脉导线的配置。植入时，仅使用导线的患者除颤阈值为455±94 V（14±6 J），需要皮下贴片的患者为532±40 V（19±3 J）。在接受3个月慢性诱发研究的患者中再次确认了VF转复疗效。该系统成功检测到所有763次诱发的心律失常，并终止了其中的99.5%；在系统改进后，最初有诱发发作需要体外除颤的2例患者（1例导线修订；1例重新编程）实现了成功转复。所有自发发作均通过植入式心律转复除颤器终止。电击后VF重新检测时间明显短于初始检测时间（检测时间4.5±1.8秒，重新检测时间2.1±0.7秒；p<0.0001）。在平均8个月的随访期间（范围1至31个月），2例未目击死亡被归类为心源性猝死，11例患者共出现12例并发症，均与Cadence-Endotak组合无关。
