https://doi.org/10.4081/monaldi.2024.3013
Reduction of inappropriate shock rate through signal filtering (smart-pass) in patients with implantable subcutaneous cardioverter-defibrillator: a systematic review and meta-analysis
Submitted: April 2, 2024
Accepted: May 19, 2024
Published: August 29, 2024
Accepted: May 19, 2024
Abstract Views: 183
PDF_EARLY VIEW: 64
Publisher's note
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Authors
Subcutaneous implantable cardioverter-defibrillators (S-ICD) are effective in protecting patients against sudden death but expose them to a higher risk of inappropriate shock (IAS). We performed a systematic search of studies published between January 2010 and December 2019 assessing IAS due to cardiac oversensing by the selection process (PRISMA) and identified 17 eligible articles. Fifteen studies were observational, and two studies were retrospective. For the meta-analysis, the final population included 6111 patients: 3356 without SMART pass (SP) filter (group 1) and 2755 with SP filter (group 2). 1614 shocks (appropriate shocks plus IAS) were registered (1245 in group 1 and 369 in group 2). The random effects meta-analysis estimated an overall IAS rate of 7.78% (95% confidence interval: 4.93-10.64) with substantial variability between studies (I square=96.05%, p<0.001). The IAS rate was 10.75% (95% confidence interval: 8.49-13.02) for group 1 and 3.61% (95% confidence interval: 1.36-5.86) for group 2 (p<0.001). Third-generation S-ICD technology with SP filters reduced the risk of cardiac signal-related IAS.
Al-Khatib SM, Stevenson WG, Ackerman MJ, et al. 2017 AHA/ACC/HRS guideline for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: Executive summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. Heart Rhythm 2018;15:e190-e252.
Burke MC, Gold MR, Knight BP, et al. Safety and efficacy of the totally subcutaneous implantable defibrillator: 2-year results from a pooled analysis of the IDE study and EFFORTLESS registry. J Am Coll Cardiol 2015;65:1605-15.
DOI: https://doi.org/10.1016/j.jacc.2015.02.047
Köbe J, Reinke F, Meyer C, et al. Implantation and follow-up of totally subcutaneous versus conventional implantable cardioverter-defibrillators: a multicenter case-control study. Heart Rhythm 2013;10:29-36.
DOI: https://doi.org/10.1016/j.hrthm.2012.09.126
Jarman JW, Lascelles K, Wong T, et al. Clinical experience of entirely subcutaneous implantable cardioverter-defibrillators in children and adults: cause for caution. Eur Heart J 2012;33:1351-9.
DOI: https://doi.org/10.1093/eurheartj/ehs017
Bardy GH, Smith WM, Hood MA, et al. An entirely subcutaneous implantable cardioverter-defibrillator. N Engl J Med 2010;363:36-44.
DOI: https://doi.org/10.1056/NEJMoa0909545
Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol 2012;60:1933-9.
DOI: https://doi.org/10.1016/j.jacc.2012.06.053
Saini A, Ellenbogen KA. Oversensing and inappropriate shock in a patient with subcutaneous implantable cardioverter defibrillator: what is the mechanism?. Pacing Clin Electrophysiol 2017;40:897-9.
DOI: https://doi.org/10.1111/pace.13105
Theuns DAMJ, Brouwer TF, Jones PW, et al. Prospective blinded evaluation of a novel sensing methodology designed to reduce inappropriate shocks by the subcutaneous implantable cardioverter-defibrillator. Heart Rhythm 2018;15:1515-22.
DOI: https://doi.org/10.1016/j.hrthm.2018.05.011
Moher D, Shamseer L, Clarke M, et al. Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement. Syst Rev 2015;4:1.
DOI: https://doi.org/10.1186/2046-4053-4-1
Slim K, Nini E, Forestier D, et al. Methodological index for non-randomized studies (minors): development and validation of a new instrument. ANZ J Surg 2003;73:712-6.
DOI: https://doi.org/10.1046/j.1445-2197.2003.02748.x
Nyaga VN, Arbyn M, Aerts M. METAPROP: stata module to perform fixed and random effects meta-analysis of proportions. Available from: https://www.gnu.org/licenses/gpl-3.0.txt.
Hunter JP, Saratzis A, Sutton AJ, et al. In meta-analyses of proportion studies, funnel plots were found to be an inaccurate method of assessing publication bias. J Clin Epidemiol 2014;67:897-903.
DOI: https://doi.org/10.1016/j.jclinepi.2014.03.003
Egger M, Davey Smith G, Schneider M, Minder C. Bias in meta-analysis detected by a simple, graphical test. BMJ 1997;315:629-34.
DOI: https://doi.org/10.1136/bmj.315.7109.629
Dabiri Abkenari L, Theuns DA, Valk SD, et al. Clinical experience with a novel subcutaneous implantable defibrillator system in a single center. Clin Res Cardiol 2011;100:737-44.
DOI: https://doi.org/10.1007/s00392-011-0303-6
Aydin A, Hartel F, Schlüter M, et al. Shock efficacy of subcutaneous implantable cardioverter-defibrillator for prevention of sudden cardiac death: initial multicenter experience. Circ Arrhythm Electrophysiol 2012;5:913-9.
DOI: https://doi.org/10.1161/CIRCEP.112.973339
Olde Nordkamp LR, Brouwer TF, Barr C, et al. Inappropriate shocks in the subcutaneous ICD: incidence, predictors and management. Int J Cardiol 2015;195:126-33.
DOI: https://doi.org/10.1016/j.ijcard.2015.05.135
Jarman JW, Todd DM. United Kingdom national experience of entirely subcutaneous implantable cardioverter-defibrillator technology: important lessons to learn. Europace 2013;15:1158-65.
DOI: https://doi.org/10.1093/europace/eut016
Brouwer TF, Yilmaz D, Lindeboom R, et al. Long-term clinical outcomes of subcutaneous versus transvenous implantable defibrillator therapy. J Am Coll Cardiol 2016;68:2047-55.
DOI: https://doi.org/10.1016/j.jacc.2016.08.044
Gold MR, Aasbo JD, El-Chami MF, et al. Subcutaneous implantable cardioverter-defibrillator Post-Approval Study: Clinical characteristics and perioperative results. Heart Rhythm 2017;14:1456-63.
DOI: https://doi.org/10.1016/j.hrthm.2017.05.016
Özkartal T, Breitenstein A, Saguner AM, et al. The subcutaneous implantable cardioverter defibrillator in daily clinical practice. Swiss Med Wkly 2017;147:w14518.
DOI: https://doi.org/10.4414/smw.2017.14518
Honarbakhsh S, Providencia R, Srinivasan N, et al. A propensity matched case-control study comparing efficacy, safety and costs of the subcutaneous vs. transvenous implantable cardioverter defibrillator. Int J Cardiol 2017;228:280-5.
DOI: https://doi.org/10.1016/j.ijcard.2016.11.017
Mithani AA, Kath H, Hunter K, et al. Characteristics and early clinical outcomes of patients undergoing totally subcutaneous vs. transvenous single chamber implantable cardioverter defibrillator placement. Europace 2018;20:308-14.
DOI: https://doi.org/10.1093/europace/eux026
Migliore F, Mattesi G, De Franceschi P, et al. Multicentre experience with the second-generation subcutaneous implantable cardioverter defibrillator and the intermuscular two-incision implantation technique. J Cardiovasc Electrophysiol 2019;30:854-64.
DOI: https://doi.org/10.1111/jce.13894
Khazen C, Magnusson P, Flandorfer J, Schukro C. The subcutaneous implantable cardioverter-defibrillator: a tertiary center experience. Cardiol J 2019;26:543-9.
DOI: https://doi.org/10.5603/CJ.a2018.0050
Liang JJ, Okamura H, Asirvatham R, et al. Comparative outcomes of subcutaneous and transvenous cardioverter-defibrillators. Chin Med J (Engl) 2019;132:631-7.
DOI: https://doi.org/10.1097/CM9.0000000000000133
Brouwer TF, Knops RE, Kutyifa V, et al. Propensity score matched comparison of subcutaneous and transvenous implantable cardioverter-defibrillator therapy in the SIMPLE and EFFORTLESS studies. Europace 2018;20:f240-8.
DOI: https://doi.org/10.1093/europace/euy083
Auricchio A, Hudnall JH, Schloss EJ, et al. Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis. Europace 2017;19:1973-80.
DOI: https://doi.org/10.1093/europace/euw415
Afzal MR, Evenson C, Badin A, et al. Role of exercise electrocardiogram to screen for T-wave oversensing after implantation of subcutaneous implantable cardioverter-defibrillator. Heart Rhythm 2017;14:1436-9.
DOI: https://doi.org/10.1016/j.hrthm.2017.06.022
Rudic B, Tülümen E, Berlin V, et al. Low prevalence of inappropriate shocks in patients with inherited arrhythmia syndromes with the subcutaneous implantable defibrillator single center experience and long-term follow-up. J Am Heart Assoc 2017;6:e006265.
DOI: https://doi.org/10.1161/JAHA.117.006265
Larbig R, Motloch LJ, Bettin M, et al. Device updates successfully reduce T wave oversensing and inappropriate shocks in subcutaneous ICD patients. Neth Heart J 2018;26:606-11.
DOI: https://doi.org/10.1007/s12471-018-1160-y
How to Cite
Santomauro, Maurizio, Mario Petretta, Carla Riganti, Mario Alberto Santomauro, Mariarosaria De Luca, Andrea Santomauro, and Antonio Cittadini. 2024. “Reduction of Inappropriate Shock Rate through Signal Filtering (smart-Pass) in Patients With Implantable Subcutaneous Cardioverter-Defibrillator: A Systematic Review and Meta-Analysis”. Monaldi Archives for Chest Disease, August. https://doi.org/10.4081/monaldi.2024.3013.
Copyright (c) 2024 The Author(s)
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
PAGEPress has chosen to apply the Creative Commons Attribution NonCommercial 4.0 International License (CC BY-NC 4.0) to all manuscripts to be published.
