Impact of SMART Pass filter in patients with ajmaline-induced Brugada syndrome and subcutaneous implantable cardioverter-defibrillator eligibility failure: results from a prospective multicentre study

Giulio Conte, Fabio Cattaneo, Carlo de Asmundis, Paola Berne, Alessandro Vicentini, Mehdi Namdar, Antonio Scalone, Catherine Klersy, Maria Luce Caputo, Andrea Demarchi, Tardu Özkartal, Francesca Salghetti, Gavino Casu, Ilaria Passarelli, Stefano Mameli, Dipen Shah, Haran Burri, Gaetano De Ferrari, Pedro Brugada, Angelo Auricchio, Giulio Conte, Fabio Cattaneo, Carlo de Asmundis, Paola Berne, Alessandro Vicentini, Mehdi Namdar, Antonio Scalone, Catherine Klersy, Maria Luce Caputo, Andrea Demarchi, Tardu Özkartal, Francesca Salghetti, Gavino Casu, Ilaria Passarelli, Stefano Mameli, Dipen Shah, Haran Burri, Gaetano De Ferrari, Pedro Brugada, Angelo Auricchio

Abstract

Aims: Ajmaline challenge can unmask subcutaneous implantable cardioverter-defibrillator (S-ICD) screening failure in patients with Brugada syndrome (BrS) and non-diagnostic baseline electrocardiogram (ECG). The efficacy of the SMART Pass (SP) filter, a high-pass filter designed to reduce cardiac oversensing (while maintaining an appropriate sensing margin), has not yet been assessed in patients with BrS. The aim of this prospective multicentre study was to investigate the effect of the SP filter on dynamic Brugada ECG changes evoked by ajmaline and to assess its value in reducing S-ICD screening failure in patients with drug-induced Brugada ECGs.

Methods and results: The S-ICD screening with conventional automated screening tool (AST) was performed during ajmaline challenge in subjects with suspected BrS. The S-ICD recordings were obtained before, during and after ajmaline administration and evaluated by the means of a simulation model that emulates the AST behaviour with and without SP filter. A patient was considered suitable for S-ICD if at least one sensing vector was acceptable in all tested postures. A sensing vector was considered acceptable in the presence of QRS amplitude >0.5 mV, QRS/T-wave ratio >3.5, and sense vector score >100. Of the 126 subjects (mean age: 42 ± 14 years, males: 61%, sensing vectors: 6786), 46 (36%) presented with an ajmaline-induced Brugada type 1 ECG. Up to 30% of subjects and 40% of vectors failed the screening during the appearance of Brugada type 1 ECG evoked by ajmaline. The S-ICD screening failure rate was not significantly reduced in patients with Brugada ECGs when SP filter was enabled (30% vs. 24%). Similarly, there was only a trend in reduction of vector-failure rate attributable to the SP filter (from 40% to 36%). The most frequent reason for screening failure was low QRS amplitude or low QRS/T-wave ratio. None of these patients was implanted with an S-ICD.

Conclusion: Patients who pass the sensing screening during ajmaline can be considered good candidates for S-ICD implantation, while those who fail might be susceptible to sensing issues. Although there was a trend towards reduction of vector sensing failure rate when SP filter was enabled, the reduction in S-ICD screening failure in patients with Brugada ECGs did not reach statistical significance.

Clinical trial registration: https://ichgcp.net/clinical-trials-registry/NCT04504591" title="See in ClinicalTrials.gov">NCT04504591.

Keywords: Brugada syndrome; Eligibility; SMART Pass; Screening; Subcutaneous implantable cardioverter-defibrillator; Sudden cardiac death.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Subcutaneous implantable cardioverter-defibrillator screening failure rates before and after ajmaline challenge in patients with BrS (N = 46). BrS, Brugada syndrome.
Figure 3
Figure 3
Proportion of failure from logistic multivariable model (panel A: vector level; panel B: patient level).
Figure 4
Figure 4
Causes of vector screening failure (without SP filter). SP, SMART Pass.
Figure 5
Figure 5
Different Automated Screening Tool outcomes depending on if signal was SP filtered (red) in two patients with ajmaline-induced Brugada type 1 ECG (PASS, panel A; FAIL: panel B). The blue/green dots are associated to R wave peaks while red/pink dots relate to T-wave peaks and are used by the simulation model to compute QRS amplitudes and R–T ratio. The dots are associated with the absolute values of the peaks. ECG, electrocardiogram; SP, SMART Pass.

References

    1. Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J. et al. ESC guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: the task force for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the Europe. Europace 2015;17:1601–87.
    1. Knops RE, Olde Nordkamp LRA, Delnoy PHM, Boersma LVA, Kuschyk J, El-Chami MF, et al.; PRAETORIAN Investigators. Subcutaneous or transvenous defibrillator therapy. N Engl J Med 2020;383:526–36.
    1. Gold MR, Lambiase PD, El-Chami MF, Knops RE, Aasbo JD, Bongiorni MG. et al. Primary results from the understanding outcomes with the S-ICD in primary prevention patients with low ejection fraction (UNTOUCHED) trial. Circulation 2020;143:7–17.
    1. Conte G, Sieira J, Ciconte G, de Asmundis C, Chierchia GB, Baltogiannis G. et al. Implantable cardioverter-defibrillator therapy in Brugada syndrome: a 20-year single-center experience. J Am Coll Cardiol 2015;65:879–88.
    1. Sacher F, Probst V, Maury P, Babuty D, Mansourati J, Komatsu Y. et al. Outcome after implantation of a cardioverter-defibrillator in patients with Brugada syndrome: a multicenter study-part 2. Circulation 2013;128:1739–47.
    1. Auricchio A, Hudnall JH, Schloss EJ, Sterns LD, Kurita T, Meijer A. et al. Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis. Europace 2017; 19:1973–80.
    1. Rordorf R, Casula M, Pezza L, Fortuni F, Sanzo A, Savastano S. et al. Subcutaneous versus transvenous implantable defibrillator: an updated meta-analysis. Heart Rhythm 2021;18:382–91.
    1. Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA. 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.
    1. Casu G, Silva E, Bisbal F, Viola G, Merella P, Lorenzoni G. et al. Predictors of inappropriate shock in Brugada syndrome patients with a subcutaneous implantable cardiac defibrillator. J Cardiovasc Electrophysiol 2021;32:1704–11.
    1. Brisben AJ, Burke MC, Knight BP, Hahn SJ, Herrmann KL, Allavatam V. et al. A new algorithm to reduce inappropriate therapy in the S-ICD system. J Cardiovasc Electrophysiol 2015;26:417–23.
    1. EMBLEM S-ICD, EMBLEM MRI S-ICD User’s Manual. Boston Scientific Corporation: MN, USA, 2015.
    1. Zeb M, Curzen N, Allavatam V, Wilson D, Yue A, Roberts P. et al. Sensitivity and specificity of the subcutaneous implantable cardioverter defibrillator pre-implant screening tool. Int J Cardiol 2015;195:205–9.
    1. Sakhi R, Yap SC, Michels M, Schinkel AFL, Kauling RM, Roos-Hesselink JW. et al. Evaluation of a novel automatic screening tool for determining eligibility for a subcutaneous implantable cardioverter-defibrillator. Int J Cardiol 2018;272:97–101.
    1. Conte G, Kawabata M, de Asmundis C, Taravelli E, Petracca F, Ruggiero D. et al. High rate of subcutaneous implantable cardioverter-defibrillator sensing screening failure in patients with Brugada syndrome: a comparison with other inherited primary arrhythmia syndromes. Europace 2018;20:1188–93.
    1. Conte G, Regoli F, Moccetti T, Auricchio A.. Subcutaneous implantable cardioverter-defibrillator and drug-induced Brugada syndrome: the importance of repeat morphology analysis during ajmaline challenge. Eur Heart J 2016;37:1498.
    1. Olde Nordkamp LRA, Conte G, Rosenmöller BRAM, Warnaars JLF, Tan HL, Caputo ML. et al. Brugada syndrome and the subcutaneous implantable cardioverter-defibrillator. J Am Coll Cardiol 2016;68:665–6.
    1. Özkartal T, Auricchio A, Conte G.. Ajmaline infusion during automated screening in Brugada syndrome and spontaneous Type 1 electrocardiogram unmasks non-suitability for subcutaneous implantable cardioverter-defibrillator. Eur Heart J 2019;40:1888–9.
    1. Brugada P. The variability of the electrocardiogram in Brugada syndrome: implications for subcutaneous implantable cardioverter-defibrillator candidacy. Rev Port Cardiol 2020;40:39–40.
    1. Oide Nordkamp LR, Brouwer TF, Barr C, Theuns DA, Boersma LV, Johansen JB. et al. Inappropriate shocks in the subcutaneous ICD: incidence, predictors and management. Int J Cardiol 2015;195:126–33.
    1. Burke MC, Gold MR, Knight BP, Barr CS, Theuns DAMJ, Boersma LVA. 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.
    1. Olde Nordkamp LR, Dabiri Abkenari L, Boersma LV, Maass AH, de Groot JR, van Oostrom AJ. et al. The entirely subcutaneous implantable cardioverter-defibrillator: initial clinical experience in a large Dutch cohort. J Am Coll Cardiol 2012;60:1933–9.
    1. Lambiase P, Eckardt L, Theuns DA, Betts TR, Kyriacou AL, Duffy E. et al. Evaluation of subcutaneous implantable cardioverter-defibrillator performance in patients with ion channelopathies from the EFFORTLESS cohort and comparison with a meta-analysis of transvenous ICD outcomes. Heart Rhythm 2020;1:326–35.
    1. Rudic B, Tülümen E, Berlin V, Röger S, Stach K, Liebe 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.
    1. Theuns DAMJ, Brouwer TF, Jones PW, Allavatam V, Donnelley S, Auricchio A. 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.
    1. Wilson DG, Zeb M, Veldtman G, Dimitrov BD, Morgan JM.. Left and right parasternal sensing for the S-ICD in adult congenital heart disease patients and normal controls. Pacing Clin Electrophysiol 2016;39:282–90.
    1. Okamura H, McLeod CJ, DeSimone CV, Webster TL, Bonnichsen CR, Grogan M. et al. Right parasternal lead placement increases eligibility for subcutaneous implantable cardioverter defibrillator therapy in adults with congenital heart disease. Circ J 2016;80:1328–35.

Source: PubMed

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