Lewis Krystina B, Stacey Dawn, Carroll Sandra L, Boland Laura, Sikora Lindsey, Birnie David
School of Nursing, University of Ottawa, Ottawa, Canada.
University of Ottawa Heart Institute, Ottawa, Canada.
Pacing Clin Electrophysiol. 2016 Jul;39(7):709-22. doi: 10.1111/pace.12850. Epub 2016 Apr 29.
Every 4-7 years an implantable cardioverter defibrillator (ICD) pulse generator must be replaced surgically. This procedure is not without risk. In some cases, the risk versus benefit ratio may be against replacement. We aimed to synthesize the evidence on risks, benefits, and costs related to ICD replacement.
A systematic review was conducted using electronic databases from 2000 onward. Literature screening, quality appraisal, and data extraction were independently conducted by two reviewers. Outcomes included major and minor complications, ICD therapies, and costs, which were synthesized descriptively.
Of 1,483 citations, 17 nonrandomized studies met criteria. Median rate of major complications was 4.05% (range 0.55-7.37%) and minor complications was 3.50% (range 0.36-7.37%). Without non-ICD control groups, the true risk reduction provided by the ICD following replacement is unknown. Following ICD replacement, annualized rate of appropriate ICD therapy was 10.52% (range 2.42-75.00%). Of these, patients without therapies during their first generator life and those no longer meeting ICD criteria received appropriate therapies at nontrivial rates.
Rates of complications associated with ICD replacement are substantial. No study had nonreplacement groups, hence the true risk reduction provided by the ICD following replacement is unknown. Our analysis did not identify a subgroup at low risk of therapies following replacement. Shared discussions should occur with patients about the evidence, healthcare goals, risk tolerances, and feelings about life and death trade-offs to enable high-quality decisions about ICD replacement.
每4至7年，植入式心脏复律除颤器（ICD）脉冲发生器必须通过手术进行更换。此 procedure 并非毫无风险。在某些情况下，风险与收益比可能不利于进行更换。我们旨在综合关于ICD更换相关的风险、益处和成本的证据。
使用2000年起的电子数据库进行系统评价。文献筛选、质量评估和数据提取由两名 reviewers 独立进行。结局包括 major 和 minor 并发症、ICD治疗及成本，对其进行描述性综合分析。
在1483篇文献中，17项非随机研究符合标准。major 并发症的中位数发生率为4.05%（范围0.55 - 7.37%），minor 并发症为3.50%（范围0.36 - 7.37%）。由于没有非ICD对照组，更换后ICD所提供的真正风险降低情况未知。ICD更换后，适当ICD治疗的年化率为10.52%（范围2.42 - 75.00%）。其中，在首个发生器使用寿命期间未接受治疗的患者以及不再符合ICD标准的患者接受适当治疗的比例相当可观。
与ICD更换相关的并发症发生率较高。没有研究设置不更换组，因此更换后ICD所提供的真正风险降低情况未知。我们的分析未识别出更换后治疗风险较低的亚组。应与患者共同讨论相关证据、医疗保健目标、风险承受能力以及对生死权衡的看法，以便就ICD更换做出高质量决策。
