Department of Medicine, Emory University, School of Medicine, Atlanta, Georgia.
CorVita Science Foundation, Chicago, Illinois.
Heart Rhythm. 2020 Sep;17(9):1566-1574. doi: 10.1016/j.hrthm.2020.04.036. Epub 2020 May 4.
Patients with chronic renal disease on hemodialysis (HD) have limited vascular access and are at high risk of bacteremia. The subcutaneous implantable cardioverter-defibrillator (S-ICD) avoids vascular access, so it may be advantageous in this patient population.
The purpose of this study was to report outcomes of patients with end-stage renal disease enrolled in the multicenter S-ICD post-approval study (PAS).
S-ICD PAS patients were stratified on the basis of the presence (group 1) or absence (group 2) of HD at the time of implantation. Baseline demographic and clinical characteristics were collected. Perioperative and intermediate-term outcomes 365 days postimplantation were compared between the 2 groups.
There were 220 patients on HD (13.4%) at the time of implantation out of 1637 patients enrolled in the S-ICD PAS. Patients on HD (group 1) were older (57.4 ± 13.2 years vs 52.5 ± 15.2 years; P < .0001), more likely to be of African descent (48.6% vs 25.1%; P < .0001), and had lower ejection fraction (28.6% ± 11.3% vs 32.6% ± 14.9%; P < .0001) as compared with patients not on HD (group 2). Group 1 had more comorbidities and mortality was higher (17.4% vs 3.7%) than did group 2. The rate of complications calculated using the Kaplan-Meier estimate did not differ between the 2 groups (overall P = .9169), with a 1-year rate of 7.9% and 7.7% for groups 1 and 2, respectively. The rate of appropriate shocks was significantly higher in group 1 (Kaplan-Meier analysis, P = .0003), as was inappropriate shocks (P = .0137).
S-ICD is associated with similar adverse event rates but a higher risk of inappropriate and appropriate therapy in dialysis patients than in nondialysis patients.
接受血液透析（HD）的慢性肾病患者血管通路有限，且发生菌血症的风险较高。皮下植入式心律转复除颤器（S-ICD）无需血管通路，因此可能对该患者人群有利。
本研究旨在报告参加多中心 S-ICD 上市后批准研究（PAS）的终末期肾病患者的结局。
根据植入时是否存在（第 1 组）或不存在（第 2 组）HD，对 S-ICD PAS 患者进行分层。收集基线人口统计学和临床特征。比较两组患者植入后 365 天的围手术期和中期结局。
在 1637 名参加 S-ICD PAS 的患者中，有 220 名（13.4%）在植入时正在接受 HD。接受 HD 的患者（第 1 组）年龄较大（57.4 ± 13.2 岁比 52.5 ± 15.2 岁；P<0.0001），更可能为非裔（48.6%比 25.1%；P<0.0001），射血分数较低（28.6% ± 11.3%比 32.6% ± 14.9%；P<0.0001）。与未接受 HD 的患者（第 2 组）相比，第 1 组患者的合并症更多，死亡率更高（17.4%比 3.7%）。使用 Kaplan-Meier 估计计算的并发症发生率在两组之间没有差异（整体 P=0.9169），第 1 组和第 2 组的 1 年发生率分别为 7.9%和 7.7%。第 1 组的适当电击率明显较高（Kaplan-Meier 分析，P=0.0003），不适当电击率也较高（P=0.0137）。
S-ICD 在透析患者中的不良事件发生率相似，但与非透析患者相比，S-ICD 发生不适当和适当治疗的风险更高。
