Subcutaneous Implantable Cardioverter Defibrillator: A Contemporary Overview
Abstract
:1. Introduction
2. Subcutaneous ICD: What We Know So Far
2.1. Pre-Implant Screening
2.2. Implant Technique
2.3. Inappropriate Shocks
2.4. Infections
2.5. Lead Complications
2.6. Appropriate Therapies
3. Indications for S-ICD Implant
4. Particular Set of Patients according to the Underlying Cardiomyopathy
4.1. Hypertrophic Cardiomyopathy
4.2. Brugada Syndrome, Long QT Syndrome and Arrhythmogenic Right Ventricular Cardiomyopathy
4.3. Congenital Heart Disease
5. Future Perspectives
6. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study | Year | Type | Aim of Study | Primary Endpoints | Secondary Endpoints | Results |
---|---|---|---|---|---|---|
IDE (Investigational Device Exemption) Trial [15] | 2013 | Prospective, non-randomized, multicenter clinical study | Safety and effectiveness of S-ICD | -Shock effectiveness in converting induced VF in conversion test -Complication-free Rate at 180 days | // | -100% VF conversion rate at 180 days -92–99% complications-free rate at 180 days |
EFFORTLESS (Evaluation of factors impacting clinical outcome and cost effectiveness of the S-ICD) Registry [13] | 2017 | Prospective, non-randomized, multicenter observational registry | Early, mid- and long-term clinical effectiveness | -Complication-free rate at 30 days -Complication-free rate at 360 days -Inappropriate shocks-free rate for AF/SVT | // | -97% complication-free rate at 30 days -94% complication-free rate at 360 days -7% inappropriate shock rate (94% oversensed episodes) |
S-ICD post approval Study [14] | 2017 | Prospective, non-randomized, multicenter registry | Safety and effectiveness of S-ICD | -Complication-free rate at 60 months -Shock effectiveness in converting spontaneous VT/VF at 60 months | -Electrode-related complications-free rate at 60 months -First shock effectiveness i converting induced and spontaneous VT/VF at 60 months | -96.2% complication- free rate at 30 days -98.7% successful conversion rate of induced VT/VF at 60 months |
PRAETORIAN (Prospective randomized comparison of subcutaneous and transvenous implantable cardioverter defibrillator therapy) Study [11] | 2020 | Prospective, randomized, international, controlled trial | Comparison of safety and effectiveness in TV-ICD and S-ICD (non-inferiority) | -Adverse event rate at 48 months | -MACE, appropriate and inappropriate shocks, time to successful therapy, first shock conversion efficacy, implant procedure time, hospitalization rate, fluoroscopy time, cardiac (pre)-syncope events, cross over to the other arm, cardiac decompensation at 48 months -Quality of life at 30 months | -No difference in overall and arrhythmic mortality -Four times lead-related complications rate in TV -ICD -Two times infection rate in TV-ICD -No difference in complications rate in 4 years -No difference in inappropriate shock rate |
UNTOUCHED (Understanding outcomes with the S-ICD in primary prevention patients with low ejection fraction) Study [10] | 2021 | Prospective, non-randomized, multinational trial | Safety and effectiveness of S-ICD | -Inappropriate shocks free rate at 18 months | -Freedom from system and procedure related complication at 30 days -All cause shock free rate at 18 months | -95.9% inappropriate shock-free rate at 18 months -90.6% all-cause shock-free rate at 18 months -92.7% complications-free rate at 18 months |
ATLAS (Avoid transvenous leads in appropriate subjects) Trial [12] | 2022 | Prospective, randomized, multicenter controlled study | Comparison of safety and effectiveness in TV-ICD and S-ICD (superiority) | -Lead-related complications at 6 months -Other complications at 6 months | -Late device-related complications after 6 months -Arrhythmic deaths, visits, inappropriate shocks, all-cause mortality, economic analysis, patients acceptance after 6 months | -12 times lead-related complications in TV-ICD |
TV-ICD | S-ICD | |
---|---|---|
Pre-implant Screening | Not needed | Needed |
Implant Technique | Transvenous | Subcutaneous |
Sedation | Local | Deep/general anesthesia |
Fluoroscopy | Needed | Not needed |
Electrocardiogram | Intracavitary ECG | 12-lead ECG |
Inappropriate shocks | SVT | T oversensing, myopotential, discrimination error |
Anti-tachycardia pacing | Possible | Not possible |
SHOCK threshold | 5–30 J | 80 J |
Infections | Systemic infections | Pocket infections |
Lead complications | Dislocations/fractures; tricuspid regurgitation, pericardial effusion or pericarditis, cardiac perforation | Lead movement/suboptimal lead position |
Indications | Pitfalls |
---|---|
Indication for ICD when pacing for bradycardia, cardiac resynchronization or ATP is not needed | Disease progression with need for anti-bradycardia pacing, cardiac resynchronization or enhancement of antiarrhythmic medical therapy |
Congenital heart disease | Frequent development of conduction system disfunction overtime |
Anatomical barriers to IV-ICD implantation (i.e., venous occlusion) | Aesthetic defect in thin women |
History of IV lead infection | Only defibrillation therapy provided |
Immunocompromised individuals | Large surgical wound, need for large disinfection area |
Hemodialysis | \\ |
Young patients | Aesthetic defect, contact sports forbidden |
Ion channelopathies | Polymorphic or monomorphic VTs not treatable |
Hypertrophic cardiomyopathy | Increased risk of T oversensing |
Dilated cardiomyopathy | Usually manifested with VTs of variable cardiac frequency (slower VTs not treated by the device) |
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Guarracini, F.; Preda, A.; Bonvicini, E.; Coser, A.; Martin, M.; Quintarelli, S.; Gigli, L.; Baroni, M.; Vargiu, S.; Varrenti, M.; et al. Subcutaneous Implantable Cardioverter Defibrillator: A Contemporary Overview. Life 2023, 13, 1652. https://doi.org/10.3390/life13081652
Guarracini F, Preda A, Bonvicini E, Coser A, Martin M, Quintarelli S, Gigli L, Baroni M, Vargiu S, Varrenti M, et al. Subcutaneous Implantable Cardioverter Defibrillator: A Contemporary Overview. Life. 2023; 13(8):1652. https://doi.org/10.3390/life13081652
Chicago/Turabian StyleGuarracini, Fabrizio, Alberto Preda, Eleonora Bonvicini, Alessio Coser, Marta Martin, Silvia Quintarelli, Lorenzo Gigli, Matteo Baroni, Sara Vargiu, Marisa Varrenti, and et al. 2023. "Subcutaneous Implantable Cardioverter Defibrillator: A Contemporary Overview" Life 13, no. 8: 1652. https://doi.org/10.3390/life13081652