Abstract：
The implantable cardioverter-defibrillator (ICD) was designed to detect and treat ventricular arrhythmias, which account for nearly half of all cardiovascular fatalities. Transvenous ICD (TV-ICD) complications were reduced by introducing subcutaneous ICD (S-ICD). S-ICD can be implanted using a three (3IT)- or two (2IT)-incision technique. This systematic review and meta-analysis was conducted to compare the 3IT to the 2IT.
We searched medical electronic databases of Cochrane Central, Embase, PubMed, Scopus, and Web of Science (WOS) from the study\'s inception until March 8, 2023. We compared 2IT and 3IT techniques of S-ICDs in terms of procedural, safety, and efficacy outcomes. We used Review Manager software for the statistical analysis. We calculated the risk ratio (RR) with its 95% confidence interval (CI) for dichotomous variables; and the mean difference with its 95% CI for continuous variables. We measured the heterogeneity using the chi-squared and I-squared tests. If the data were heterogeneous, the random-effect (RE) model was applied; otherwise, the fixed-effect model (FE) was used.
We included three retrospective observational studies of 2076 patients, 1209 in the 2IT group and 867 in the 3IT. There was no statistically significant difference in erosion after S-ICD when 2IT compared with 3IT (RR = 0.27, 95% CI: [0.07, 1.02]; P = .05) (I2 = 0%, P = .90). There was no difference in risk of infection, lead dislocation, or inappropriate shock with either incision technique (RR = 0.78, 95% CI: [0.48, 1.29]; P = .34) (I2 = 0%, P = .71) and (RR = 0.37, 95% CI: [0.02, 8.14]; P = .53) (I2 = 66%, P = .05) respectively. Our meta-analysis showed that the efficacy of both techniques is comparable; Appropriate shock (RR = 0.94, 95% CI: [0.78, 1.12]; P = .48) (I2 = 0%, P = .81) and first shock efficacy (RR = 0.89, 95% CI: [0.44, 1.82]; P = .76) (I2 = 0%, P = .87).
2IT and 3IT of S-ICD have comparable efficacy and complication rates; however, the 3IT exposes patients to an additional incision without any additional benefits. These findings may provide clinicians with a simpler method for subcutaneous ICD implantation and likely result in improved cosmetic outcomes. Before the 2IT technique can be considered the standard of care, randomized controlled trials (RCTs) must be conducted to assess its long-term safety and efficacy.
We searched medical electronic databases of Cochrane Central, Embase, PubMed, Scopus, and Web of Science (WOS) from the study\'s inception until March 8, 2023. We compared 2IT and 3IT techniques of S-ICDs in terms of procedural, safety, and efficacy outcomes. We used Review Manager software for the statistical analysis. We calculated the risk ratio (RR) with its 95% confidence interval (CI) for dichotomous variables; and the mean difference with its 95% CI for continuous variables. We measured the heterogeneity using the chi-squared and I-squared tests. If the data were heterogeneous, the random-effect (RE) model was applied; otherwise, the fixed-effect model (FE) was used.
We included three retrospective observational studies of 2076 patients, 1209 in the 2IT group and 867 in the 3IT. There was no statistically significant difference in erosion after S-ICD when 2IT compared with 3IT (RR = 0.27, 95% CI: [0.07, 1.02]; P = .05) (I2 = 0%, P = .90). There was no difference in risk of infection, lead dislocation, or inappropriate shock with either incision technique (RR = 0.78, 95% CI: [0.48, 1.29]; P = .34) (I2 = 0%, P = .71) and (RR = 0.37, 95% CI: [0.02, 8.14]; P = .53) (I2 = 66%, P = .05) respectively. Our meta-analysis showed that the efficacy of both techniques is comparable; Appropriate shock (RR = 0.94, 95% CI: [0.78, 1.12]; P = .48) (I2 = 0%, P = .81) and first shock efficacy (RR = 0.89, 95% CI: [0.44, 1.82]; P = .76) (I2 = 0%, P = .87).
2IT and 3IT of S-ICD have comparable efficacy and complication rates; however, the 3IT exposes patients to an additional incision without any additional benefits. These findings may provide clinicians with a simpler method for subcutaneous ICD implantation and likely result in improved cosmetic outcomes. Before the 2IT technique can be considered the standard of care, randomized controlled trials (RCTs) must be conducted to assess its long-term safety and efficacy.
摘要：
背景：植入式心脏复律除颤器（ICD）旨在检测和治疗室性心律失常，占所有心血管死亡人数的近一半。通过引入皮下ICD（S-ICD）减少了经静脉ICD（TV-ICD）并发症。S-ICD可以使用三(3IT)或二(2IT)切口技术植入。进行了系统评价和荟萃分析，以比较3IT和2IT。
方法：我们搜索了CochraneCentral的医疗电子数据库，Embase,PubMed,Scopus,和WebofScience（WOS）从研究开始到2023年3月8日。我们从程序上比较了S-ICD的2IT和3IT技术，安全,和疗效结果。我们使用ReviewManager软件进行统计分析。我们计算了二分变量的95％置信区间（CI）的风险比（RR）；以及连续变量的95％CI的平均差。我们使用卡方检验和I方检验测量了异质性。如果数据是异构的，应用随机效应(RE)模型；否则，使用固定效应模型(FE)。
结果：我们纳入了2076例患者的三项回顾性观察研究，2IT组中的1209和3IT组中的867。与3IT相比，2IT时S-ICD后的侵蚀差异无统计学意义（RR=0.27，95％CI：[0.07，1.02]；P=0.05）（I2=0％，P=.90）。感染的风险没有差异，铅位错,或任何一种切口技术不当休克(RR=0.78,95%CI:[0.48,1.29];P=.34)(I2=0%,P=.71）和（RR=0.37，95%CI：[0.02，8.14]；P=.53）（I2=66%，分别为P=.05)。我们的荟萃分析表明，两种技术的功效是可比的；适当的休克（RR=0.94，95％CI：[0.78，1.12]；P=0.48）（I2=0％，P=0.81）和首次休克疗效（RR=0.89，95%CI：[0.44，1.82]；P=0.76）（I2=0%，P=.87）。
结论：S-ICD的2IT和3IT具有相当的疗效和并发症发生率；然而，3IT将患者暴露于额外的切口而没有任何额外的益处。这些发现可能为临床医生提供一种更简单的皮下ICD植入方法，并可能导致改善的美容效果。在2IT技术被认为是护理标准之前，必须进行随机对照试验(RCTs)以评估其长期安全性和有效性.
方法：我们搜索了CochraneCentral的医疗电子数据库，Embase,PubMed,Scopus,和WebofScience（WOS）从研究开始到2023年3月8日。我们从程序上比较了S-ICD的2IT和3IT技术，安全,和疗效结果。我们使用ReviewManager软件进行统计分析。我们计算了二分变量的95％置信区间（CI）的风险比（RR）；以及连续变量的95％CI的平均差。我们使用卡方检验和I方检验测量了异质性。如果数据是异构的，应用随机效应(RE)模型；否则，使用固定效应模型(FE)。
结果：我们纳入了2076例患者的三项回顾性观察研究，2IT组中的1209和3IT组中的867。与3IT相比，2IT时S-ICD后的侵蚀差异无统计学意义（RR=0.27，95％CI：[0.07，1.02]；P=0.05）（I2=0％，P=.90）。感染的风险没有差异，铅位错,或任何一种切口技术不当休克(RR=0.78,95%CI:[0.48,1.29];P=.34)(I2=0%,P=.71）和（RR=0.37，95%CI：[0.02，8.14]；P=.53）（I2=66%，分别为P=.05)。我们的荟萃分析表明，两种技术的功效是可比的；适当的休克（RR=0.94，95％CI：[0.78，1.12]；P=0.48）（I2=0％，P=0.81）和首次休克疗效（RR=0.89，95%CI：[0.44，1.82]；P=0.76）（I2=0%，P=.87）。
结论：S-ICD的2IT和3IT具有相当的疗效和并发症发生率；然而，3IT将患者暴露于额外的切口而没有任何额外的益处。这些发现可能为临床医生提供一种更简单的皮下ICD植入方法，并可能导致改善的美容效果。在2IT技术被认为是护理标准之前，必须进行随机对照试验(RCTs)以评估其长期安全性和有效性.
