Multicentre experience with the second‐generation subcutaneous implantable cardioverter defibrillator and the intermuscular two‐incision implantation technique

Abstract

Introduction:The recently developed second-generation subcutaneous implantable cardioverter defibrillator (S-ICD) and the intermuscular two-incision implantation technique demonstrate potential favorable features that reduce inappropriate shocks and complications. However, data concerning large patient populations are lacking.The aim of this multicentre prospective study was to evaluate the safety and outcome of second-generation S-ICD using the intermuscular two-incision technique in a large population study. Methods and Results:The study population included 101 consecutive patients (75% male; mean age, 45 ± 13 years) who received second-generation S-ICD (EMBLEM; Boston Scientific, Marlborough, MA) implantation using the intermuscular twoincision technique as an alternative to the standard implantation technique. Twenty nine (29%) patients were implanted for secondary prevention. Twenty four (24%) patients had a previously implanted transvenous ICD. All patients were implanted without any procedure-related complications. Defibrillation testing was performed in 80 (79%) patients, and ventricular tachycardia was successfully converted at less than or equal to 65 J in 98.75% (79/80) of patients without pulse generator adjustments.During a median follow-up of 21 ± 10 months, no complications requiring surgical revision or local or systemic device-related infections were observed. Ten patients Disclosures: None.(9.9%) received appropriate and successful shocks for ventricular arrhythmias. Three (2.9%) patients experienced inappropriate shocks due to oversensing the cardiac signal (n = 1), noncardiac signal (n = 1), and a combination of both cardiac and noncardiac signals (n = 1), with one patient requiring device explantation. No patients required device explantation due to antitachycardia pacing indications.Conclusions: According to our multicentre study, second-generation S-ICD implanted with the intermuscular two-incision technique is an available safe combination and appears to be associated with a low risk of complications, such as inappropriate shocks. K E Y W O R D S implantable cardioverter defibrillator, intermuscular technique, subcutaneous implantable cardioverter defibrillator, two-incision technique 1 | INTRODUCTION Current guidelines state that the subcutaneous implantable cardioverter defibrillator (S-ICD) represents a therapeutic option for patients at highrisk of sudden cardiac death, in whom pacing or cardiac resynchronization therapy is not required. 1 The recent development of an entirely S-ICD constitutes a major evolution of defibrillator technology, and there has been consistent clinical evidence regarding its safety. 2-4 The standard S-ICD implantation technique requires three incisions and the placement of a midaxillary pulse generator under subcutaneous tissue. However, various alternative implantation techniques have been explored, 3 including the intermuscular two-incision technique. 4-6 New techniques may reduce complications such as erosion while improving the esthetic appeal of the puls...

Serratus anterior plane block in subcutaneous implantable cardioverter defibrillator implantation: A case‐control analysis

“…In our series, all patients tested were cardioverted with 65 J. This finding confirms a previous experience on the implantation of second‐generation S‐ICDs by means of the two‐incision inter‐muscular technique, and well compares with previous studies involving conventional subcutaneous implantation, in which cardioversion success ranged from 91.2% to 92.7% at 65 J …”

Primary Results From the Understanding Outcomes With the S-ICD in Primary Prevention Patients With Low Ejection Fraction (UNTOUCHED) Trial

“…This approach shortens procedural time, does not increase implantation complications, and is rapidly growing in use. 18 , 23 , 28 The IAS rate using the 2-incision technique was still low enough to meet the study’s performance requirement. Although early postimplant IAS has been reported with the 2-incision technique, presumably because of air along the electrode tract, 29 other mechanisms to explain the higher rate of IAS associated with eliminating the sternal incision are likely involved.…”

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

“…IAS rates were not found to be significantly different between the two‐ and three‐incision groups in the Brouwer study, 7 and a low IAS rate of 2.8% was found over the 21‐month follow‐up in the Migliore study 12 . In contrast, IAS in the UNTOUCHED trial 10 recently demonstrated an association to 2IT, with 18 month rate of 4.9% versus the 2.5% in those patients implanted with 3IT.…”

“…However, infection numbers from this PAS study also reveal no statistical difference in infection of either device system. Migliore, et al 12 reports no device‐related infections in a study of 101 patients implanted with the 2IT and intermuscular implant, with an average follow‐up of 21 months.…”