Outcomes of two versus three incision techniques: Results from the subcutaneous ICD post‐approval study

Abstract

Background Traditionally, implantation of the subcutaneous implantable cardioverter defibrillator (S‐ICD) requires incisions near the lateral chest wall, the xyphoid, and the superior sternal region (three‐incision technique [3IT]). A two‐incision technique (2IT) avoids the superior incision and has been shown to be a viable alternative in small studies with limited follow‐up. Objectives To report on the long‐term safety and efficacy of the 2IT compared to the 3IT procedure in a large patient cohort. Methods Patients enrolled in the S‐ICD post approval study (PAS) were stratified by procedural technique (2IT vs. 3IT). Baseline demographics, comorbidities and procedural outcomes were collected. Complications and S‐ICD effectiveness in treating ventricular arrhythmias through an average 3‐year follow‐up period were compared. Results Of 1637 patients enrolled in the S‐ICD PAS, 854 pts (52.2%) were implanted using the 2IT and 782 were implanted using the 3IT (47.8%). The 2IT became more prevalent over time, increasing from 40% to 69% of implants (Q1–Q4). Mean procedure time was shorter with 2IT (69.0 vs. 86.3 min, p < .0001). No other differences in outcomes were observed between the two groups, including rates of infection, electrode migration, inappropriate shocks and first shock efficacy for treating ventricular arrhythmias. Conclusion In this large cohort of patients implanted with an S‐ICD and followed for 3 years the 2IT was as safe and effective as the 3IT while significantly reducing procedure time.

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

“…This hypothesis did not align with our findings, which revealed no statistically significant difference between the two groups in lead dislocation, inappropriate shocks, defibrillation test failure, and first shock efficacy. Our findings match the results of previous studies by El Chami et al., Stuijt et al., and Brouwer et al 17,18,21 . Brouwer et al 21 .…”

“…The omitted incision also carries a low anatomical risk as it is far from any neurovascular structures. 17 A previous study reported 4 of 7 infections to occur in the xiphoid incision. 5 Therefore, the findings of our meta-analysis reflect a real effect, as the upper parasternal incision does not carry a high risk of infection.…”

“…This is possible because the third omitted incision is superficial. The omitted incision also carries a low anatomical risk as it is far from any neurovascular structures 17 . A previous study reported 4 of 7 infections to occur in the xiphoid incision 5 .…”

“…Studies have established that the procedural duration of the 2IT is shorter than its counterpart; thus, it may reduce the risk of infection. [17][18][19] Physicians may also find the 2IT of better value than the 3IT; More than 60% of physicians choose the 2IT when deciding. 20 However, the safety profile of the 2IT is not yet well-established.…”

The SIDECAR project: S-IcD registry in European paediatriC and young Adult patients with congenital heaRt defects

“…This latter finding has been related to distal lead malposition, due to its migration in absence of a suture or to an improper placement in absence of direct visualization by the implanting physician. However, another study 16 demonstrated that the two techniques did not show significant differences in terms of mortality rates, shock efficacy, defibrillation testing, IASs, and surgical wound complications, but the two-incision technique shortened procedural times.…”