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首页> 外文期刊>PACE: Pacing and clinical electrophysiology >A prospective, randomized evaluation of a nonthoracotomy implantable cardioverter defibrillator lead system. Endotak/PRX Investigator Group.
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A prospective, randomized evaluation of a nonthoracotomy implantable cardioverter defibrillator lead system. Endotak/PRX Investigator Group.

机译：非开胸植入式心脏复律除颤器导联系统的前瞻性随机评估。 Endotak / PRX研究人员小组。

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Nonthoractomy lead systems for ICDs have been developed that obviate the need for a thoracotomy and reduce the morbidity and mortality associated with implantation. However, an adequate DFT cannot be achieved in some patients using transvenous electrodes alone. Thus, a new subcutaneous array trial that compared the DFT obtained using monophasic shock waveforms with a single transvenous lead alone that has two defibrillating electrodes, the transvenous lead linked to a subcutaneous/submuscular patch electrode, and the transvenous lead linked to the investigational array electrode. There were 267 patients randomized to one of the three nonthoracotomy ICD lead systems. All had DFTs that met the implantation criterion of < or = 25 J. The resultant study population was 82% male and 18% female, mean age of 63 +/- 11 years. The indication for ICD implantation was monomorphic VT in 70%, VF in 19%, monomorphic VT/VF in 6%, and polymorphic VT in 4% of the patients, respectively. The mean LVEF was 0.33 +/- 0.13. The mean DFT obtained with the transvenous lead alone was 17.5 +/- 4.9 J as compared to 16.9 +/- 5.5 J with the lead linked to a patch electrode (P = NS), and 14.9 +/- 5.6 with the lead linked to the array electrode (array versus lead alone, P = 0.0001; array versus lead/patch, P = 0.007). The results of this investigation suggest that the subcutaneous array may be superior to the standard patch as a subcutaneous electrode to lower the DFT and increase the margin of safety for successful nonthoracotomy defibrillation.
机译：已开发出用于ICD的非胸腔切开术引导系统，从而无需进行开胸手术并降低与植入相关的发病率和死亡率。但是，仅使用静脉电极的某些患者无法获得足够的DFT。因此，一项新的皮下阵列试验将使用单相电击波形获得的DFT与具有两个除纤颤电极的单根静脉引线进行了比较，该静脉引线与皮下/肌肉下贴片电极相连，而静脉引线与研究阵列电极相连。共有267名患者被随机分配到三个非开胸ICD导联系统之一。所有患者的DFT均满足植入≤25 J的标准。研究人群为男性82％，女性18％，平均年龄63 +/- 11岁。 ICD植入的适应症分别是70％的单形VT，19％的VF，6％的单形VT / VF和4％的多形VT。平均LVEF为0.33 +/- 0.13。单独使用静脉引线获得的平均DFT为17.5 +/- 4.9 J，而将引线连接到贴片电极的平均DFT为16.9 +/- 5.5 J（P = NS），将引线连接到斑块电极的平均DFT为14.9 +/- 5.6。阵列电极（阵列对单独的铅，P = 0.0001;阵列对铅/贴片，P = 0.007）。这项研究的结果表明，皮下阵列可以作为皮下电极优于标准贴片，从而降低DFT并增加成功开胸除颤的安全性。

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