Why the study?
Does subcutaneous implantable defibrillator therapy reduce complications compared to transvenous implantable defibrillator therapy in patients requiring ICDs?
Does subcutaneous implantable defibrillator therapy reduce complications compared to transvenous implantable defibrillator therapy in patients requiring ICDs?
S-ICD is associated with significantly fewer lead complications compared to TV-ICD, with similar rates of infection, device failure, and overall inappropriate therapy.
Positions S-ICD as a safer alternative for avoiding lead-related morbidity; reinforces current guidelines.
Background: The subcutaneous ICD (S-ICD) was developed to minimize complications related to conventional transvenous ICD (TV-ICD). Direct comparison of clinical outcomes between the two devices has been limited by varying patient characteristics and definitions of complications with no randomized trials completed comparing these systems. Purpose: To overcome this paucity in the current literature, we conducted the first meta-analysis to summarize and compare clinical outcomes between S-ICD and TV-ICD. Methods: We systematically reviewed studies in PUBMED, EMBASE databases and secondary referencing sources. Studies meeting criteria were included in the meta-analysis. Baseline characteristics and outcome data of both S-ICD and TV-ICD groups were appraised and analyzed. A random-effects model was used to derive odds ratio (OR) with 95% confidence interval. Results: Six studies met inclusion criteria. Baseline characteristics were similar between the S-ICD and TV-ICD groups. Lead complications were less in the S-ICD group compared to the TV-ICD group (OR 0.13 [0.05,0.34]). The infection rate was similar between the S-ICD and TV-ICD group (OR 0.66 [0.27, 1.60]). There were no differences in system or device failures between groups (OR 0.94 [0.37, 2.41]). Overall, inappropriate therapy (T-wave over-sensing, SVT, episodes of inappropriate sensing) was similar between the two groups (OR 0.81 [0.48,1.36]). However, the nature of inappropriate therapy was different between the S-ICD and the TV-ICD groups. Inappropriate therapies in the TV-ICD group were primarily due to supra-ventricular tachycardia (SVT); whereas inappropriate shocks in S-ICD were mostly episodes of over-sensing (sensing of noise, T-wave over-sensing). Both devices appear to perform equally well with respect to appropriate shocks.
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Ray et al. (2017) studied this question.
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