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. 2025 Apr 11;41(2):e70063.
doi: 10.1002/joa3.70063. eCollection 2025 Apr.

Long-term safety and efficacy of subcutaneous implantable cardioverter-defibrillator compared with transvenous implantable cardioverter-defibrillator in propensity score-matched patients from Japan

Yuki Konno  1 , Shingo Sasaki  1   2   3 , Yuji Ishida  1 , Yuichi Toyama  1 , Kimitaka Nishizaki  1 , Takahiko Kinjo  1 , Taihei Itoh  1 , Masaomi Kimura  3 , Kazufumi Kato  1 , Toshihiro Iwasaki  1 , Hitoshi Umezaki  1 , Shun Hirosawa  1 , Hirofumi Tomita  1   2   3   4
Affiliations

Long-term safety and efficacy of subcutaneous implantable cardioverter-defibrillator compared with transvenous implantable cardioverter-defibrillator in propensity score-matched patients from Japan

Yuki Konno et al. J Arrhythm. .

Abstract

Background: Subcutaneous implantable cardioverter-defibrillator (S-ICD) has been reported to be non-inferior to transvenous ICD (TV-ICD) in terms of device-related complications and inappropriate shock (IAS). We aimed to evaluate the long-term clinical outcomes of S-ICD compared with TV-ICD in Japanese patients.

Methods: We studied 315 consecutive patients (TV-ICD, 167; S-ICD, 148) who underwent ICD implantation. A propensity score matching analysis was performed to select patient subgroups for comparison (104 patients in each group). Clinical outcomes, including appropriate and inappropriate ICD therapy, procedure- and lead-related complications, and mortality, were compared between the two groups.

Results: During follow-up (median, 1458 [interquartile range, 1353-1572] days), the cumulative incidence of appropriate shock therapy was 9.6% and 8.7% in the S-ICD and TV-ICD groups, respectively (p = 0.94). Although the S-ICD group tended to have a higher IAS than the TV-ICD group (5.8% vs. 1.9%), the difference was not significant (p = 0.19). Conversely, the cumulative incidence of procedural and lead-related complications was significantly lower in the S-ICD group (2.9% vs. 9.6%, p = 0.02). Notably, lead-related complications were more common in the TV-ICD group (p = 0.05). There was no difference in all-cause mortality between the two groups (p = 0.75), and heart failure exacerbation was the most common cause of death in both groups.

Conclusions: In propensity score-matched Japanese patients with S-ICD, the cumulative incidence of appropriate shock and mortality was comparable to those with TV-ICD. There was no significant difference in the rate of IAS. Notably, patients with S-ICD had fewer lead-related complications than those with TV-ICD.

Keywords: Japanese; defibrillation; inappropriate shock; oversensing; subcutaneous implantable cardioverter‐defibrillator.

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Conflict of interest statement

Dr. Masaomi Kimura is an associate professor of the Department of Advanced Management of Cardiac Arrhythmias, which is an endowment Department supported by Medtronic Japan Co., Ltd., Japan Lifeline Co., Ltd., and Fukuda Denshi Kita‐Tohoku Hanbai Co., Ltd. Dr. Shingo Sasaki received a research grant from Boston Scientific Japan Co., Ltd. and is a concurrent associate professor of the Department of Advanced Management of Cardiac Arrhythmias and the Department of Cardiac Remote Management System, which is an endowment Department supported by BIOTRONIK Japan Co., Ltd. Dr. Hirofumi Tomita received a research grant from Abbott Medical Japan LLC. and is a concurrent professor of the Department of Advanced Management of Cardiac Arrhythmias, the Department of Cardiac Remote Management System, and the Department of Advanced Therapeutics for Cardiovascular Diseases, which is an endowment Department supported by Boston Scientific Japan Co. Other authors have no relevant disclosures.

Figures

FIGURE 1
FIGURE 1
Underlying heart diseases in patients with (A) subcutaneous implantable cardioverter‐defibrillator (S‐ICD) and those with (B) transvenous implantable cardioverter defibrillator (TV‐ICD). ARVC, arrhythmogenic right ventricular cardiomyopathy; CAD, coronary artery disease; DCM, dilated cardiomyopathy; ERS, early repolarization syndrome; HCM, hypertrophic cardiomyopathy; IVF, idiopathic ventricular fibrillation; IVT, idiopathic ventricular tachycardia; LQTS, long QT syndrome; MI, myocardial infarction; NICM, non‐ischemic cardiomyopathy; TOF, tetralogy of Fallot; VHD, valvular heart disease.
FIGURE 2
FIGURE 2
Underlying heart diseases in patients with (A) subcutaneous implantable cardioverter‐defibrillator (S‐ICD) and those with (B) transvenous implantable cardioverter defibrillator (TV‐ICD) after propensity score matching. ARVC, arrhythmogenic right ventricular cardiomyopathy; CAD, coronary artery disease; DCM, dilated cardiomyopathy; ERS, early repolarization syndrome; HCM, hypertrophic cardiomyopathy; IVF, idiopathic ventricular fibrillation; IVT, idiopathic ventricular tachycardia; LQTS, long QT syndrome; MI, myocardial infarction; NICM, non‐ischemic cardiomyopathy; TOF, tetralogy of Fallot; VHD, valvular heart disease.
FIGURE 3
FIGURE 3
Kaplan–Meier plot of (A) appropriate therapy (ATP and shocks), (B) appropriate shocks, (C) inappropriate therapy (ATP and shocks), and (D) inappropriate shocks.
FIGURE 4
FIGURE 4
Kaplan–Meier plot of (A) all complications, (B) lead‐related complications, and (C) survival.
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