Inappropriate shocks in single-chamber and subcutaneous implantable cardioverter-defibrillators: a systematic review and meta-analysis

Angelo Auricchio, J Harrison Hudnall, Edward J Schloss, Laurence D Sterns, Takashi Kurita, Albert Meijer, Dedra H Fagan, Tyson Rogers, Angelo Auricchio, J Harrison Hudnall, Edward J Schloss, Laurence D Sterns, Takashi Kurita, Albert Meijer, Dedra H Fagan, Tyson Rogers

Abstract

Aims: Single-chamber (VR-ICD) and subcutaneous (S-ICD) implantable cardioverter-defibrillators are effective to protect patients against sudden death but expose them to higher risk of inappropriate shock (IS). We sought to quantify the annual rate and influencing factors of ISs in VR- and S-ICDs from the literature.

Methods and results: PubMed, Embase, and Cochrane Library were searched for full text articles with IS rates. Poisson distribution estimated proportion of patients with ISs; rates were annualized based on follow-up duration. Random effects meta-analysis accounted for study-to-study variation. Out of 3264 articles, 16 qualified for the meta-analysis. Across studies, 6.4% [95% confidence interval (CI) 5.1-7.9%] of patients received an IS per year. Meta-regression analyses demonstrated that IS rates were lower in more recent studies [rate ratio (RR) per year: 0.93, 95% CI: 0.87-0.98; P = 0.01] and trended lower in studies with longer follow-up (RR per year: 0.78, 95% CI: 0.60-1.01; P = 0.06). Use of S-ICDs (RR: 1.81, 95% CI: 0.86-3.81; P = 0.12) and ventricular tachycardia zone programmed on (RR: 1.13, 95% CI: 0.65-1.97; P = 0.66) were not associated with a significantly increased change in risk. The IS rate observed in one of the more recent studies was significantly lower than predicted after accounting for covariates (RR: 0.29, 95% CI: 0.14-0.60; P < 0.001).

Conclusions: A comprehensive review of the literature shows that 6.4% of patients with ICDs experienced their first IS annually. One of the 16 studies was better than predicted with the lowest reported rate (1.9%) and could not be explained by timing of the study or other covariates.

Keywords: Implantable cardioverter-defibrillator; Inappropriate shocks; Meta-analysis; Subcutaneous ICD; Sudden cardiac death.

Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2017. For permissions, please email: journals.permissions@oup.com.

Figures

Figure 1
Figure 1
PRISMA flow diagram. Diagram depicting systematic review process, following the PRISMA approach.
Figure 2
Figure 2
(A) Annualized inappropriate shock rate. Random effects Poisson meta-analysis depicting annualized inappropriate shock rate. In the model, the expected number of patients with an inappropriate shock is a function of the inappropriate shock rate and the total number of years of patient follow-up observed in the study. (B) Observed vs. predicted inappropriate shock rates. A meta-regression analysis adjusting for mean follow-up time, the middle year of enrolment, device type, and slow VT zone programming was used to calculate predicted inappropriate shock rates. Each individual study’s observed (annualized) inappropriate shock rate was compared with the predicted rate. Results are shown as relative rates.
Figure 3
Figure 3
Estimated inappropriate shock rate by middle year of patient enrolment into each given study. A meta-regression analysis of the inappropriate shock rate by study at 12 months after adjusting for calendar year and mean follow-up duration. Each bubble shows a study and the size of bubble is proportional to the inverse of the variance of the log-risk ratio.
Figure 4
Figure 4
Appropriate shock meta-analysis. Meta-analysis depicting annualized appropriate shock rate within a subgroup of the 16 studies that reported appropriate shocks.

References

    1. A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators. N Engl J Med 1997;337:1576–83.
    1. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R. et al. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure. N Engl J Med 2005;352:225–37.
    1. Moss AJ, Hall WJ, Cannom DS, Daubert JP, Higgins SL, Klein H. et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmia. Multicenter automatic defibrillator implantation trial investigators. N Engl J Med 1996;335:1933–40.
    1. Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS. et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877–83.
    1. Priori SG, Blomström-Lundqvist C, Mazzanti A, Blom N, Borggrefe M, Camm J. et al. 2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Europace 2015;17:1601–87.
    1. Peterson PN, Varosy PD, Heidenreich PA, Wang Y, Dewland TA, Curtis JP. et al. Association of single- vs dual-chamber ICDs with mortality, readmissions, and complications among patients receiving an ICD for primary prevention. JAMA 2013;309:2025–34.
    1. Goncalves J, Pereira T.. Inappropriate shocks in patients with ICDs: single chamber versus dual chamber. Arq Bras Cardiol 2013;101:141–8.
    1. Kusumoto FM, Calkins H, Boehmer J, Buxton AE, Chung MK, Gold MR. et al. HRS/ACC/AHA expert consensus statement on the use of implantable cardioverter-defibrillator therapy in patients who are not included or not well represented in clinical trials. J Am Coll Cardiol 2014;64:1143–77.
    1. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P.. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. BMJ 2009;339:b2535.
    1. Viechtbauer W. Conducting meta-analyses in R with the metafor package. J Stat Softw 2010;36:1–48.
    1. Higgins JP, Thompson SG.. Quantifying heterogeneity in a meta-analysis. Stat Med 2002;21:1539–58.
    1. Alter P, Waldhans S, Plachta E, Moosdorf R, Grimm W.. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005;28:926–32.
    1. Friedman PA, McClelland RL, Bamlet WR, Acosta H, Kessler D, Munger TM. et al. Dual-chamber versus single-chamber detection enhancements for implantable defibrillator rhythm diagnosis: the detect supraventricular tachycardia study. Circulation 2006;113:2871–9.
    1. Sacher F, Probst V, Iesaka Y, Jacon P, Laborderie J, Mizon-Gerard F. et al. Outcome after implantation of a cardioverter-defibrillator in patients with Brugada syndrome: a multicenter study. Circulation 2006;114: 2317–24.
    1. Almendral J, Arribas F, Wolpert C, Ricci R, Adragao P, Cobo E. et al. Dual-chamber defibrillators reduce clinically significant adverse events compared with single-chamber devices: results from the DATAS (Dual chamber and Atrial Tachyarrhythmias Adverse events Study) trial. Europace 2008;10:528–35.
    1. Kleemann T, Hochadel M, Strauss M, Skarlos A, Seidl K, Zahn R.. Comparison between atrial fibrillation-triggered implantable cardioverter-defibrillator (ICD) shocks and inappropriate shocks caused by lead failure: different impact on prognosis in clinical practice. J Cardiovasc Electrophysiol 2012;23:735–40.
    1. Gonzalez-Enriquez S, Rodriguez-Entem F, Exposito V, Castrillo-Bustamante C, Canteli A, Solloso A. et al. Single-chamber ICD, single-zone therapy in primary and secondary prevention patients: the simpler the better? J Interv Card Electrophysiol 2012;35:343–9.
    1. Yang JH, Byeon K, Yim HR, Park JW, Park SJ, Huh J. et al. Predictors and clinical impact of inappropriate implantable cardioverter-defibrillator shocks in Korean patients. J Korean Med Sci 2012;27:619–24.
    1. Gold MR, Ahmad S, Browne K, Berg KC, Thackeray L, Berger RD.. Prospective comparison of discrimination algorithms to prevent inappropriate ICD therapy: primary results of the Rhythm ID going head to head trial. Heart Rhythm 2012;9:370–7.
    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. Deyell MW, Qi A, Chakrabarti S, Yeung-Lai-Wah JA, Tung S, Khoo C. et al. Prognostic impact of inappropriate defibrillator shocks in a population cohort. Heart 2013;99:1250–5.
    1. Guedon-Moreau L, Lacroix D, Sadoul N, Clementy J, Kouakam C, Hermida JS. et al. A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial. Eur Heart J 2013;34:605–14.
    1. Weiss R, Knight BP, Gold MR, Leon AR, Herre JM, Hood M. et al. Safety and efficacy of a totally subcutaneous implantable-cardioverter defibrillator. Circulation 2013;128:944–53.
    1. Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G. et al. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail 2014;2:611–9.
    1. Schwab JO, Bonnemeier H, Kleemann T, Brachmann J, Fischer S, Birkenhauer F. et al. Reduction of inappropriate ICD therapies in patients with primary prevention of sudden cardiac death: DECREASE study. Clin Res Cardiol 2015;104:1021–32.
    1. Olde 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. Auricchio A, Schloss EJ, Kurita T, Meijer A, Gerritse B, Zweibel S. et al. Low inappropriate shock rates in patients with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm 2015;12:926–36.
    1. Lunati M, Proclemer A, Boriani G, Landolina M, Locati E, Rordorf R. et al. Reduction of inappropriate anti-tachycardia pacing therapies and shocks by a novel suite of detection algorithms in heart failure patients with cardiac resynchronization therapy defibrillators: a historical comparison of a prospective database. Europace 2016;18:1391–8.
    1. Moss AJ, Schuger C, Beck CA, Brown MW, Cannom DS, Daubert JP. et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012;367:2275–83.
    1. Gasparini M, Proclemer A, Klersy C, Kloppe A, Lunati M, Ferrer JB. et al. Effect of long-detection interval vs standard-detection interval for implantable cardioverter-defibrillators on antitachycardia pacing and shock delivery: the ADVANCE III randomized clinical trial. JAMA 2013;309:1903–11.
    1. Mastenbroek MH, Pedersen SS, van der Tweel I, Doevendans PA, Meine M.. Results of ENHANCED Implantable Cardioverter Defibrillator Programming to Reduce Therapies and Improve Quality of Life (from the ENHANCED-ICD Study). Am J Cardiol 2016;117:596–604.
    1. Poole JE, Johnson GW, Hellkamp AS, Anderson J, Callans DJ, Raitt MH. et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 2008;359:1009–17.
    1. Proietti R, Labos C, Davis M, Thanassoulis G, Santangeli P, Russo V. et al. A systematic review and meta-analysis of the association between implantable cardioverter-defibrillator shocks and long-term mortality. Can J Cardiol 2015;31:270–7.
    1. Boriani G, Auricchio A, Klersy C, Kirchhof P, Brugada J, Morgan J. et al. Healthcare personnel resource burden related to in-clinic follow-up of cardiovascular implantable electronic devices: a European Heart Rhythm Association and Eucomed joint survey. Europace 2011;13:1166–73.
    1. von Gunten S, Schaer BA, Yap SC, Szili-Torok T, Kuhne M, Sticherling C. et al. . Longevity of implantable cardioverter defibrillators: a comparison among manufacturers and over time. Europace 2015;18:710–7.
    1. Boersma LV. Performance and outcomes in patients with the subcutaneous implantable cardiac defibrillator through mid term follow-up: The effortless Study. Presented at the Heart Rhythm Society's Annual Scientific Sessions San Francisco, CA; May 6, 2016.
    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. Theuns DA. Evaluation of a High Pass Filter Designed to Reduce Oversensing in the S-ICD. Presented at the Heart Rhythm Society's Annual Scientific Sessions San Francisco, C;A May 5, 2016.
    1. Gold MR, Theuns DA, Knight BP, Sturdivant JL, Sanghera R, Ellenbogen KA. et al. Head-to-head comparison of arrhythmia discrimination performance of subcutaneous and transvenous ICD arrhythmia detection algorithms: the START study. J Cardiovasc Electrophysiol 2012;23:359–66.
    1. Biton Y, Huang DT, Goldenberg I, Rosero S, Moss AJ, Kutyifa V. et al. Relationship between age and inappropriate implantable cardioverter-defibrillator therapy in MADIT-RIT (Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy). Heart Rhythm 2016;13:888–93.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever