Subcutaneous versus transvenous implantable defibrillator: An updated meta-analysis

doi:10.1016/j.hrthm.2020.11.013

Heart Rhythm

Volume 18, Issue 3, March 2021, Pages 382-391

https://doi.org/10.1016/j.hrthm.2020.11.013 Get rights and content

Background

Implantable cardioverter-defibrillator (ICD) placement is a well-established therapy for prevention of sudden cardiac death. The subcutaneous implantable cardioverter-defibrillator (S-ICD) was specifically designed to overcome some of the complications related to the transvenous implantable cardioverter-defibrillator (TV-ICD), such as lead complications and systemic infections. Evidence on the comparison of S-ICD vs TV-ICD are limited.

Objective

The purpose of this study was to conduct an updated meta-analysis comparing S-ICD vs TV-ICD.

Methods

Electronic databases were searched for studies directly comparing clinical outcomes and complications between S-ICD and TV-ICD. The primary outcome was the composite of clinically relevant complications (lead, pocket, major procedural complications; device-related infections) and inappropriate shocks. Secondary outcomes included death and the individual components of the primary outcome.

Results

Thirteen studies comprising 9073 patients were included in the analysis. Mean left ventricular ejection fraction was 40% ± 10%; 30% of patients were female; and 73% had an ICD implanted for primary prevention. There was no statistically significant difference in the risk of the primary outcome between S-ICD and TV-ICD (odds ratio [OR] 0.80; 95% confidence interval [CI] 0.53–1.19). Patients with S-ICD had lower risk of lead complications (OR 0.14; 95% CI 0.06–0.29; P <.00001) and major procedural complications (OR 0.18; 95% CI 0.06–0.57; P = .003) but higher risk of pocket complications (OR 2.18; 95% CI 1.30–3.66; P = .003) compared to those with TV-ICD. No significant differences were found for the other outcomes.

Conclusion

In patients with an indication for ICD without the need for pacing, TV-ICD and S-ICD are overall comparable in terms of the composite of clinically relevant device-related complications and inappropriate shock.

Introduction

Implantable cardioverter-defibrillator (ICD) placement is a mainstay therapy for both primary and secondary prevention of sudden cardiac death.¹ However, traditional transvenous implantable cardioverter-defibrillator (TV-ICD) therapy is not free from complications, especially those related to the risk of lead failure and systemic infections.² The subcutaneous implantable cardioverter-defibrillator (S-ICD) was specifically designed to overcome these complications by reducing the need for device extractions.³ In the past years, several comparative studies that addressed both the effectiveness and the safety of S-ICD vs TV-ICD showed overall similar performances.⁴

The first head-to-head randomized controlled trial (RCT) comparing S-ICD vs TV-ICD was published recently.⁵ PRAETORIAN (Prospective Randomized Comparison of Subcutaneous and Transvenous Implantable Cardioverter Defibrillator Therapy) demonstrated that S-ICD was not inferior to TV-ICD with respect to the composite endpoint of device-related complications and inappropriate shocks.⁵ However, a higher significant risk of appropriate shocks and a trend toward an increase in noncardiovascular deaths were encountered in the S-ICD arm, thus leaving some uncertainties regarding the true equivalence of the 2 technologies.

Accordingly, the aim of the present study was to provide new insights to the debated comparison between TV-ICD and S-ICD by conducting a meta-analysis of the available clinical studies on the topic.

Section snippets

Methods

The present study was conducted following the principles of the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA).⁶

Included studies

Overall, 380 titles and abstracts were identified through database searching, and 18 full-text articles were selected and screened for potential eligibility. Thirteen studies were included in the final analysis (1 RCT, 8 observational studies with matched comparison, and 4 with unmatched comparison⁵^,8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19), for a total of 9073 patients (Figure 1). A summary of patient characteristics is given in Table 1. The risk of bias evaluation for nonrandomized

Discussion

We present the results of the largest meta-analysis comparing clinical outcomes and complications between patients implanted with S-ICD vs TV-ICD, and the first to include data from the only RCT published on the topic. The main findings of this study are that in patients with an indication for ICD without the need for pacing, the overall risk of clinically relevant complications and inappropriate shocks was not different between patients treated with S-ICD and those treated with TV-ICD.

Conclusion

In the present meta-analysis, S-ICD was confirmed to be at least as effective and safe as TV-ICD for prevention of sudden cardiac death in patients without the need for pacing. Our results show that the 2 technologies, although equally effective, are associated with different kinds of complications that must be considered when choosing between S-ICD and TV-ICD in specific patients. Additional improvements in implantation techniques, available algorithms, and programming recommendations could

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Cited by (41)

Subcutaneous Implantable Cardioverter Defibrillators in Pediatrics and Congenital Heart Disease
2023, Cardiac Electrophysiology Clinics
The need for a subsequent transvenous system in patients implanted with subcutaneous implantable cardioverter-defibrillator
2022, Heart Rhythm
The absence of pacing capabilities may reduce the appeal of subcutaneous implantable cardioverter-defibrillator (S-ICD) devices for patients at risk for conduction disorders or with antitachycardia pacing (ATP)/cardiac resynchronization (CRT) requirements. Reports of rates of S-ICD to transvenous implantable cardioverter-defibrillator (TV-ICD) system switch in real-world scenarios are limited.
The purpose of this study was to investigate the need for a subsequent transvenous (TV) device in patients implanted with an S-ICD and its predictors.
All patients implanted with an S-ICD were enrolled from the multicenter, real-world iSUSI (International SUbcutaneouS Implantable cardioverter defibrillator) Registry. The need for a TV device and its clinical reason, and appropriate and inappropriate device therapies were assessed. Logistic regression with Firth penalization was used to assess the association between baseline and procedural characteristics and the overall need for a subsequent TV device.
A total of 1509 patients were enrolled (age 50.8 ± 15.8 years; 76.9% male; 32.0% ischemic; left ventricular ejection fraction 38% [30%–60%]). Over 26.5 [13.4–42.9] months, 155 (10.3%) and 144 (9.3%) patients experienced appropriate and inappropriate device therapies, respectively. Forty-one patients (2.7%) required a TV device (13 bradycardia; 10 need for CRT; 10 inappropriate shocks). Body mass index (BMI) >30 kg/m² and chronic kidney disease (CKD) were associated with need for a TV device (odds ratio [OR] 2.57 [1.37–4.81], P = .003; and OR 2.67 [1.29–5.54], P = .008, respectively).
A low rate (2.7%) of conversion from S-ICD to a TV device was observed at follow-up, with need for antibradycardia pacing, ATP, or CRT being the main reasons. BMI >30 kg/m² and CKD predicted all-cause need for a TV device.
Concerns about the meta-analysis by Nso et al. comparing subcutaneous and transvenous implantable cardioverter defibrillator
2022, International Journal of Cardiology
Subcutaneous versus transvenous implantable defibrillator in patients with hypertrophic cardiomyopathy
2022, Heart Rhythm
Hypertrophic cardiomyopathy (HCM) is the most prevalent inherited cardiomyopathy. The implantable cardioverter-defibrillator (ICD) is important for prevention of sudden cardiac death (SCD) in patients at high risk. In recent years, the subcutaneous implantable cardioverter-defibrillator (S-ICD) has emerged as a viable alternative to the transvenous implantable cardioverter-defibrillator (TV-ICD). The S-ICD does not require intravascular access; however, it cannot provide antitachycardia pacing (ATP) therapy.
The purpose of this study was to assess the real-world incidence of ICD therapy in patients with HCM implanted with TV-ICD vs S-ICD.
We compared the incidence of ATP and shock therapies among all HCM patients with S-ICD and TV-ICD enrolled in the Boston Scientific ALTITUDE database. Cumulative Kaplan-Meier incidence was used to compare therapy-free survival, and Cox proportional hazard ratios were calculated. We performed unmatched as well as propensity match analyses.
We included 2047 patients with TV-ICD and 626 patients with S-ICD, followed for an average of 1650.5 ± 1038.5 days and 933.4 ± 550.6 days, respectively. Patients with HCM and TV-ICD had a significantly higher rate of device therapy compared to those with S-ICD (32.7 vs 14.5 therapies per 100 patient-years, respectively; P <.001), driven by a high incidence of ATP therapy in the TV-ICD group, which accounted for >67% of therapies delivered. Shock incidence was similar between groups, both in the general and the matched cohorts.
Patients with HCM and S-ICD had a significantly lower therapy rate than patients with TV-ICD without difference in shock therapy, suggesting potentially unnecessary ATP therapy. Empirical ATP programming in patients with HCM may be unbeneficial.
Longitudinal Outcomes of Subcutaneous or Transvenous Implantable Cardioverter-Defibrillators in Older Patients
2022, Journal of the American College of Cardiology
Citation Excerpt :
However, the mean age of patients enrolled in UNTOUCHED was 55.8 ± 12.4 years, limiting generalizability to older patients who may be prone to inappropriate shocks of different mechanisms. The results of the current study are consistent with that of the PRAETORIAN trial (and published meta-analyses9,10) and importantly extend the results to older individuals (mean age of patients in the current study was 72.7 ± 5.8 years). Compared with older patients who receive a TV-ICD, those with an S-ICD experience similar rates of cardiovascular hospitalization and all-cause readmission (Central Illustration).
The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking.
The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD.
The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models.
A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161).
In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients.
Comparative Assessment of Transvenous versus Subcutaneous Implantable Cardioverter-defibrillator Therapy Outcomes: An Updated Systematic Review and Meta-analysis
2022, International Journal of Cardiology
Citation Excerpt :
This meta-analysis reversed the finding from the meta-analysis by Rordorf et al. [7] that indicated a higher predisposition for pocket complications among patients with S-ICD. The findings, however, strengthened earlier results that showed a lower risk of lead complications with S-ICD than TV-ICD [7]. Our enhanced results negated previous findings that indicated a lower risk of major procedural complications in patients implanted with S-ICD.
Subcutaneous (S-ICD) and transvenous (TV-ICD) implantable cardioverter-defibrillator devices effectively reduce the incidence of sudden cardiac death in patients at a high risk of ventricular arrhythmias. This study aimed to evaluate the safe replacement of TV-ICD with S-ICD based on updated recent evidence.
We systematically searched EMBASE, JSTOR, PubMed/MEDLINE, and Cochrane Library on 30 July 2021 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
We identified 26 studies that examined 7542 (58.27%) patients with S-ICD and 5400 (41.72%) with TV-ICD. The findings indicated that, compared to patients with TV-ICD, patients with S-ICD had a lower incidence of defibrillation lead failure (odds ratio [OR], 0.12; 95% confidence interval [CI], 0.01–0.98; p = 0.05), lead displacement or fracture (OR, 0.25; 95% CI, 0.12–0.86; p = 0.0003), pneumothorax and/or hemothorax (OR: 0.22, 95% CI 0.05, 0.97, p = 0.05), device failure (OR: 0.70, 95% CI 0.51, 0.95, p = 0.02), all-cause mortality (OR: 0.44 [95% CI 0.32, 0.60], p < 0.001), and lead erosion (OR: 0.01, 95% CI 0.00, 0.05, p < 0.001). Patients with TV-ICD had a higher incidence of pocket complications than patients with S-ICD (OR, 2.13; 95% CI, 1.23–3.69; p = 0.007) and a higher but insignificant incidence of inappropriate sensing (OR, 3.53; 95% CI, 0.97–12.86; p = 0.06).
The S-ICD algorithm was safer and more effective than the TV-ICD system as it minimized the incidence of pocket complications, lead displacement or fracture, inappropriate sensing, defibrillation lead failure, pneumothorax/hemothorax, device failure, lead erosion, and all-cause mortality. Future studies should explore the scope of integrating novel algorithms with the current S-ICD systems to improve cardiovascular outcomes.

View all citing articles on Scopus

: Funding sources: The authors have no funding sources to disclose. Disclosures: Dr Rordorf received modest speaking fees from Boston Scientific and Abbott Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

¹: Dr Roberto Rordorf and Dr Matteo Casula share joint first co-authorship.

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ClinicalDevicesSubcutaneous versus transvenous implantable defibrillator: An updated meta-analysis

Background

Objective

Methods

Results

Conclusion

Introduction

Section snippets

Methods

Included studies

Discussion

Conclusion

JACC Clin Electrophysiol

transvenous implantable cardioverter-defibrillators. Int J Cardiol

J Am Coll Cardiol

Int J Cardiol

Heart Rhythm

Heart Rhythm

Heart Rhythm

Heart Rhythm

JACC Clin Electrophysiol

Heart Rhythm

Heart Rhythm

Heart Rhythm

ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death

Eur Heart J

Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

Eur Heart J

An entirely subcutaneous implantable cardioverter-defibrillator

N Engl J Med

Subcutaneous or transvenous defibrillator therapy

N Engl J Med

Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement

PLoS Med

Clinical
Devices
Subcutaneous versus transvenous implantable defibrillator: An updated meta-analysis