Two-incision versus three-incision implantation technique of subcutaneous implantable cardioverter defibrillator: Systematic review and meta-analysis of 2076 patients.

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.