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

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          Abstract

          Aims

          Subcutaneous-implantable cardiac defibrillators (S-ICDs) are used increasingly to prevent sudden cardiac death in young patients. This study was set up to gain insight in the indications for S-ICD, possible complications, and their predictors and follow-up results.

          Methods and results

          A multicentre, observational, retrospective, non-randomized, standard-of-care registry on S-ICD outcome in young patients with congenital heart diseases (CHDs), inherited arrhythmias (IAs), idiopathic ventricular fibrillation (IVF), and cardiomyopathies (CMPs). Anthropometry was registered as well as implantation technique, mid-term device-related complications, and incidence of appropriate/inappropriate shocks (IASs). Data are reported as median (interquartile range) or mean ± standard deviation. Eighty-one patients (47% CMPs, 20% CHD, 21% IVF, and 12% IA), aged 15 (14–17) years, with body mass index (BMI) 21.8 ± 3.8 kg/m 2, underwent S-ICD implantation (primary prevention in 59%). This was performed with two-incision technique in 81% and with a subcutaneous pocket in 59%. Shock and conditional zones were programmed at 250 (200–250) and 210 (180–240) b.p.m., respectively. No intraoperative complications occurred. Follow up was 19 (6–35) months: no defibrillation failure occurred, 17% of patients received appropriate shocks, 13% of patients received IAS (supraventricular tachycardias 40%, T-wave oversensing 40%, and non-cardiac oversensing 20%). Reprogramming, proper drug therapy, and surgical revision avoided further IAS. Complications requiring surgical revision occurred in 9% of patients, with higher risks in patients with three-incision procedures [hazard ratio (HR) 4.3, 95% confidence interval (95% CI) 0.5–34, P = 0.038] and BMI < 20 (HR 5.1, 95% CI 1–24, P = 0.031).

          Conclusion

          This multicentre European paediatric registry showed good S-ICD efficacy and safety in young patients. Newer implantation techniques and BMI > 20 showed better outcome.

          Graphical Abstract

          Graphical Abstract

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          Most cited references20

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

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            Safety and Efficacy of the Totally Subcutaneous Implantable Defibrillator: 2-Year Results From a Pooled Analysis of the IDE Study and EFFORTLESS Registry.

            The entirely subcutaneous implantable cardioverter-defibrillator (S-ICD) is the first implantable defibrillator that avoids placing electrodes in or around the heart. Two large prospective studies (IDE [S-ICD System IDE Clinical Investigation] and EFFORTLESS [Boston Scientific Post Market S-ICD Registry]) have reported 6-month to 1-year data on the S-ICD.
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              Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator

              Most inappropriate shocks from the subcutaneous implantable cardioverter-defibrillator (S-ICD) are caused by cardiac oversensing. A novel sensing methodology, SMART Pass (SP; Boston Scientific Corporation, Natick, MA), aims to reduce cardiac oversensing.
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                Author and article information

                Contributors
                Journal
                Europace
                Europace
                europace
                Europace
                Oxford University Press (US )
                1099-5129
                1532-2092
                February 2023
                15 September 2022
                15 September 2022
                : 25
                : 2
                : 460-468
                Affiliations
                Paediatric Cardiology and Cardiac Arrhythmia/Syncope Unit, Department of Paediatric Cardiology and Cardiac Surgery, Bambino Gesù Children’s Hospital IRCCS , Rome, Italy
                Department of Paediatric Cardiology, Amsterdam University Medical Centers , Amsterdam, The Netherlands
                Laboratory of Experimental Medicine and Paediatrics, University of Antwerp , Antwerp, Belgium
                Department of Paediatric Cardiology Hopital Necker-Enfants Malades , Paris, France
                Hopital Marie Lannelongue-M3C, GHPSJ, Université Paris Descartes , Paris, France
                Department of Paediatric Cardiology, Heart Centre Leipzig, University of Leipzig, Leipzig , Germany
                Department of Paediatric Cardiology and Congenital Heart Defects, Medical University of Gdansk, Gdansk , Poland
                Gottsegen National Cardiovascular Center , Budapest, Hungary
                Heart Surgery Team, Department of Paediatric Cardiology and Cardiac Surgery, Bambino Gesù Children’s Hospital IRCCS , Rome, Italy
                Paediatric Cardiology and Cardiac Arrhythmia/Syncope Unit, Department of Paediatric Cardiology and Cardiac Surgery, Bambino Gesù Children’s Hospital IRCCS , Rome, Italy
                Department of Paediatric Cardiology Hopital Necker-Enfants Malades , Paris, France
                Department of Paediatric Cardiology, Heart Centre Leipzig, University of Leipzig, Leipzig , Germany
                Department of Cardiology and Electrotherapy, Medical University of Gdansk, Gdansk , Poland
                Gottsegen National Cardiovascular Center , Budapest, Hungary
                Department of Paediatric Cardiology, Amsterdam University Medical Centers , Amsterdam, The Netherlands
                Department of Paediatrics, Antwerp University Hospital , Edegem, Belgium
                Department of Paediatric Cardiology, Amsterdam University Medical Centers , Amsterdam, The Netherlands
                Department of Paediatric Cardiology, Leiden University Medical Center , Leiden, The Netherlands
                Paediatric Cardiology and Cardiac Arrhythmia/Syncope Unit, Department of Paediatric Cardiology and Cardiac Surgery, Bambino Gesù Children’s Hospital IRCCS , Rome, Italy
                Author notes
                Corresponding author. Tel: +39 06 68593354; fax: +39 06 68594841. E-mail address: mstefano.silvetti@ 123456opbg.net

                Conflict of interest: M.K. received consultant fees from Boston Scientific. R.E.K. is a consultant for Boston Scientific. All remaining authors have declared no conflicts of interest.

                Author information
                https://orcid.org/0000-0001-9284-5972
                https://orcid.org/0000-0002-2315-9925
                https://orcid.org/0000-0001-9934-6746
                https://orcid.org/0000-0001-9760-1977
                https://orcid.org/0000-0001-7012-6133
                https://orcid.org/0000-0002-9064-6651
                https://orcid.org/0000-0002-3100-2493
                https://orcid.org/0000-0001-9676-8994
                https://orcid.org/0000-0002-3472-2883
                https://orcid.org/0000-0001-9328-6295
                https://orcid.org/0000-0003-1888-373X
                Article
                euac162
                10.1093/europace/euac162
                9935000
                36107451
                cbf72a4d-96dd-48de-a486-f7f4191bb772
                © The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 19 April 2022
                : 04 August 2022
                Page count
                Pages: 9
                Categories
                Clinical Research
                AcademicSubjects/MED00200
                Eurheartj/1
                Eurheartj/4
                Eurheartj/7

                Cardiovascular Medicine
                implantable cardioverter defibrillator,subcutaneous-icd,paediatric age,congenital heart disease,icd complications

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