Subcutaneous implantable cardioverter‐defibrillator in primary and secondary prevention of sudden cardiac death: A meta‐analysis

Abstract

Background Subcutaneous implantable cardioverter‐defibrillator (S‐ICD) is gaining in popularity for primary and secondary prevention of sudden cardiac death. The objective was to evaluate the safety and clinical effectiveness of the S‐ICD for prevention of sudden cardiac death compared to transvenous cardioverter‐defibrillator (TV‐ICD). Methods A systematic review with meta‐analyses was performed. The electronic databases MEDLINE, EMBASE, SCI, and Cochrane Central Register of Controlled Trials were consulted in March 2018 with no restrictions on publication date. Predefined criteria were used to determine inclusion of studies and to assess their methodologic quality. Results Ten longitudinal‐observational studies with comparison group presenting moderate methodologic flaws were included (N = 7820). The combination of results indicates that health‐related quality of life is not significantly different between S‐ICD and TV‐ICD groups (Physical health: MD = 2.90; 95% CI = −3.88, 9.68/Mental health: MD = 0.13; 95% CI = −2.11, 2.37). Mortality occurred in 4.4% of S‐ICD patients and 5.9% of TV‐ICD patients died (OR = 0.79; 95% CI = 0.50, 1.24). The incidence of infections (OR = 1.79; 95% CI = 0.93, 3.43) and inappropriate shocks (OR = 1.28, 95% CI = 0.91, 1.78) is not significantly different between both groups. The S‐ICD reduces complications related to electrodes/leads (OR = 0.13, 95% CI = 0.05, 0.29) and has lower electrodes/leads movement compared with TV‐ICD (OR = 0.26; 95% CI 0.10, 0.67). In contrast, pneumothorax is more likely in TV‐ICD than S‐ICD (OR = 0.17; 95% CI = 0.03, 0.97). Conclusions S‐ICD reduces electrodes/leads movement, electrodes/leads related complications, and pneumothorax. Our study did not demonstrate a statistically significant difference in mortality, health‐related quality of life, and infection rate between S‐ICD and TV‐ICD.

Diagnosis and management of subcutaneous implantable cardioverter‐defibrillator infections based on process mapping

“…A meta‐analysis that included five case‐control studies demonstrated similar ICD infection rates for subcutaneous versus TV devices 20 . More recently, a meta‐analysis that included the same five case‐control studies and five additional series was published 21 and yielded similar results to the initial meta‐analysis. However, in a subsequent review 22 that included seven observational investigations that pooled data, the incidence rate ratio suggested that ICD infection was more prevalent in patients with subcutaneous versus TV‐ICD.…”

Clinical outcomes of subcutaneous vs. transvenous implantable defibrillator therapy in a polymorbid patient cohort

“…Although the reported studies questioned the appropriateness of ICD implantations in patients with CCI > 5 ( 39 , 40 ) or even > 4 ( 42 ), the high survival rates observed in our study cohort (in contrast to the predicted survival rates by the CCI score) suggest that it would have been arguable to withhold ICD implantation from these young but polymorbid patients. Another reason for the encouraging clinical performance could have been S-ICD implantation per se, as this technique reduces electrode movement, lead-related complications and procedural complications like pneumothorax therefore reducing morbidity in total ( 38 , 44 ). Consequently, our results might add value to the discussion about the guideline's class III indication for ICD-implantation in patients with a life expectancy of < 1 year ( 8 , 9 ), which is very often difficult to assess and define in clinical practice.…”

Lead Macrodislodgement of a Subcutaneous Implantable Cardioverter-Defibrillator Results in a Reel Problem

“…S-ICDs are an alternative to TV-ICDs to avoid complications related to venous access, intracardiac leads, and infection. Pertaining to LMD, in a recent meta-analysis, S-ICDs had significantly less risk of lead-related complications and lead-related movement compared to TV-ICDs ( 7 ). Although its risk is lower, reel syndrome can alter the sensed vectors and result in inappropriate device shocks in S-ICD patients.…”