Neuzner Jörg, Hohnloser Stefan H, Kutyifa Valentina, Glikson Michael, Dietze Thomas, Mabo Philippe, Vinolas Xavier, Kautzner Josef, O'Hara Gilles, Lawo Thomas, Brachmann Johannes, VanErven Liselot, Gadler Fredrik, Appl Ursula, Wang Jia, Connolly Stuart J, Healey Jeff S
Klinikum Kassel, Kassel, Germany.
Department of Cardiology, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.
J Cardiovasc Electrophysiol. 2019 Jul;30(7):1078-1085. doi: 10.1111/jce.13943. Epub 2019 Apr 22.
Dual-coil leads (DC-leads) were the standard of choice since the first nonthoracotomy implantable cardioverter/defibrillator (ICD). We used contemporary data to determine if DC-leads offer any advantage over single-coil leads (SC-leads), in terms of defibrillation efficacy, safety, clinical outcome, and complication rates.
In the Shockless IMPLant Evaluation study, 2500 patients received a first implanted ICD and were randomized to implantation with or without defibrillation testing. Two thousand and four hundred seventy-five patients received SC-coil or DC-coil leads (SC-leads in 1025/2475 patients; 41.4%). In patients who underwent defibrillation testing (n = 1204), patients with both lead types were equally likely to achieve an adequate defibrillation safety margin (88.8% vs 91.2%; P = 0.16). There was no overall effect of lead type on the primary study endpoint of "failed appropriate shock or arrhythmic death" (adjusted HR 1.18; 95% CI, 0.86-1.62; P = 0.300), and on all-cause mortality (SC-leads: 5.34%/year; DC-leads: 5.48%/year; adjusted HR 1.16; 95% CI, 0.94-1.43; P = 0.168). However, among patients without prior heart failure (HF), and SC-leads had a significantly higher risk of failed appropriate shock or arrhythmic death (adjusted HR 7.02; 95% CI, 2.41-20.5). There were no differences in complication rates.
In this nonrandomized evaluation, there was no overall difference in defibrillation efficacy, safety, outcome, and complication rates between SC-leads and DC-leads. However, DC-leads were associated with a reduction in the composite of failed appropriate shock or arrhythmic death in the subgroup of non-HF patients. Considering riskier future lead extraction with DC-leads, SC-leads appears to be preferable in the majority of patients.
自首个非开胸植入式心脏复律除颤器（ICD）问世以来，双线圈电极导线（DC导线）一直是首选标准。我们利用当代数据来确定DC导线在除颤效果、安全性、临床结局和并发症发生率方面是否比单线圈电极导线（SC导线）具有任何优势。
在无电击植入评估研究中，2500例患者首次植入ICD，并随机分为进行或不进行除颤测试的植入组。2475例患者接受了SC线圈或DC线圈电极导线（1025/2475例患者接受SC导线；41.4%）。在接受除颤测试的患者（n = 1204）中，两种电极导线类型的患者达到足够除颤安全裕度的可能性相同（88.8%对91.2%；P = 0.16）。电极导线类型对“恰当电击失败或心律失常死亡”这一主要研究终点没有总体影响（校正风险比1.18；95%置信区间，0.86 - 1.62；P = 0.300），对全因死亡率也没有影响（SC导线：5.34%/年；DC导线：5.48%/年；校正风险比1.16；95%置信区间，0.94 - 1.43；P = 0.168）。然而，在无既往心力衰竭（HF）的患者中，SC导线发生恰当电击失败或心律失常死亡的风险显著更高（校正风险比7.02；95%置信区间，2.41 - 20.5）。并发症发生率没有差异。
在这项非随机评估中，SC导线和DC导线在除颤效果、安全性、结局和并发症发生率方面没有总体差异。然而，在非HF患者亚组中，DC导线与恰当电击失败或心律失常死亡的复合结局降低相关。考虑到DC导线未来拔除风险更高，在大多数患者中SC导线似乎更可取。
