The clinical effect of arrhythmia monitoring after myocardial infarction (BIO-GUARD|MI):study protocol for a randomized controlled trial

Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk, Poul Erik Bloch Thomsen, Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk, Poul Erik Bloch Thomsen

Abstract

Background: The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac devices means that physicians receive an early warning in cases of new-onset arrhythmias. While remote monitoring has been suggested to increase survival in heart failure patients with implantable defibrillators, trials using ICMs for continuous electrocardiographic monitoring of cardiac arrhythmias in the postmyocardial infarction setting have shown that patients who experienced cardiac arrhythmias such as atrial fibrillation, bradycardia, and ventricular tachyarrhythmia have an increased risk of major adverse cardiac events.

Methods: The Biomonitoring in patients with preserved left ventricular function after diagnosed myocardial infarction (BIO-GUARD-MI) study is designed to investigate and clarify whether the incidence of major adverse cardiac events can be decreased by early detection and treatment of cardiac arrhythmias using an ICM in patients after myocardial infarction. In addition, the study will allow us to describe the interplay between baseline characteristics, arrhythmias, and clinical events to improve the treatment of this high-risk patient population. The study will enroll and randomize a cohort of high-risk postmyocardial infarction patients with CHA2DS2-VASc score ≥ 4 and left ventricular ejection fraction > 35% to an ICM or conventional treatment. Physicians are provided with suggestions on how to respond to ICM-documented arrhythmias. An estimated 1400 patients will be enrolled and followed until 372 primary endpoints have occurred. In this paper, we describe the literature and rationale behind the design and interventions towards new-onset arrhythmias, as well as future perspectives and limitations for the use of ICMs.

Discussion: Remote monitoring may improve clinical outcome if it uncovers conditions with low symptom burden which cause or indicate an increased risk. A simple and easily implementable response to the information is important. Cardiac arrhythmias frequently start as asymptomatic, shorter lasting, and nightly events. The BIO-GUARD-MI trial represents the first attempt to simplify the response to the rather complex nature of heart arrhythmias.

Trial registration: Clinical Trials, NCT02341534 . Registered on 19 January 2015.

Keywords: CHADS-VASC score; Cardiac arrhythmia; Implantable cardiac monitor; Major adverse cardiac event; Myocardial infarction.

Conflict of interest statement

CJ, PS, SB and PEBT have received honoraria and travel support in the context of this study. SB has received consultancy honoraria from Biotronik. JS and SM are employees of Biotronik.

Figures

Fig. 1
Fig. 1
BIO-GUARD-MI flow diagram. AV atrioventricular, CEMB central electrocardiogram monitoring board, ICD implantable cardioverter-defibrillator, ICM implantable cardiac monitor, TIA transient ischemic attack, VF ventricular fibrillation, VT ventricular tachycardia
Fig. 2
Fig. 2
SPIRIT figure. ICM implantable cardiac monitor

References

    1. Botkin NF, Spencer FA, Goldberg RJ, Lessard D, Yarzebski J, Gore JM. Changing trends in the long-term prognosis of patients with acute myocardial infarction: a population-based perspective. Am Heart J. 2006;151:199–205. doi: 10.1016/j.ahj.2005.03.016.
    1. Yeh RW, Sidney S, Chandra M, Sorel M, Selby JV, Go AS. Population trends in the incidence and outcomes of acute myocardial infarction. N Engl J Med. 2010;362:2155–2165. doi: 10.1056/NEJMoa0908610.
    1. Chan MY, Sun JL, Newby LK, Shaw LK, Lin M, Peterson ED, et al. Long-term mortality of patients undergoing cardiac catheterization for ST-elevation and non-ST-elevation myocardial infarction. Circulation. 2009;119:3110–3117. doi: 10.1161/CIRCULATIONAHA.108.799981.
    1. Garcia-Garcia C, Subirana I, Sala J, Bruguera J, Sanz G, Valle V, et al. Long-term prognosis of first myocardial infarction according to the electrocardiographic pattern (ST elevation myocardial infarction, non-ST elevation myocardial infarction and non-classified myocardial infarction) and revascularization procedures. Am J Cardiol. 2011;108:1061–1067. doi: 10.1016/j.amjcard.2011.06.003.
    1. Alzuhairi KS, Sogaard P, Ravkilde J, Gislason GH, Kober L, Torp-Petersen C. Incidence and outcome of first myocardial infarction according to gender and age in Denmark over a 35-year period (1978–2012) Eur Heart J - Qual Care Clin Outcomes. 2015;1:72–78. doi: 10.1093/ehjqcco/qcv016.
    1. Waks JW, Buxton AE. Risk stratification for sudden cardiac death after myocardial infarction. Annu Rev Med. 2018;69:147–164. doi: 10.1146/annurev-med-041316-090046.
    1. Bloch Thomsen PE, Jons C, Raatikainen MJ, Moerch JR, Hartikainen J, Virtanen V, et al. Long-term recording of cardiac arrhythmias with an implantable cardiac monitor in patients with reduced ejection fraction after acute myocardial infarction: the Cardiac Arrhythmias and Risk Stratification After Acute Myocardial Infarction (CARISMA) study. Circulation. 2010;122:1258–1264. doi: 10.1161/CIRCULATIONAHA.109.902148.
    1. Huikuri HV, Raatikainen MJP, Moerch-Joergensen R, Hartikainen J, Virtanen V, Boland J, et al. Prediction of fatal or near-fatal cardiac arrhythmia events in patients with depressed left ventricular function after an acute myocardial infarction. Eur Heart J. 2009;30:689–698. doi: 10.1093/eurheartj/ehn537.
    1. Jons C, Raatikainen P, Gang UJ, Huikuri HV, Joergensen RM, Johannesen A, et al. Autonomic dysfunction and new-onset atrial fibrillation in patients with left ventricular systolic dysfunction after acute myocardial infarction: a CARISMA substudy. J Cardiovasc Electrophysiol. 2010;21:983–990. doi: 10.1111/j.1540-8167.2010.01795.x.
    1. Gang UJ, Jons C, Jorgensen RM, Abildstrom SZ, Messier MD, Haarbo J, et al. Risk markers of late high-degree atrioventricular block in patients with left ventricular dysfunction after an acute myocardial infarction: a CARISMA substudy. Europace. 2011;13:1471–1477. doi: 10.1093/europace/eur165.
    1. Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, et al. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014;384:583–590. doi: 10.1016/S0140-6736(14)61176-4.
    1. Hindricks G, Varma N, Kacet S, Lewalter T, Søgaard P, Guédon-Moreau L, et al. Daily remote monitoring of implantable cardioverter-defibrillators: insights from the pooled patient-level data from three randomized controlled trials (IN-TIME, ECOST, TRUST) Eur Heart J. 2017;38:1749–1755. doi: 10.1093/eurheartj/ehx015.
    1. Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, et al. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006;355:2395–2407. doi: 10.1056/NEJMoa066139.
    1. Fox KM. Efficacy of perindopril in reduction of cardiovascular events among patients with stable coronary artery disease: randomised, double-blind, placebo-controlled, multicentre trial (the EUROPA study) Lancet. 2003;362:782–788. doi: 10.1016/S0140-6736(03)14974-4.
    1. Yusuf S, Sleight P, Pogue J, Bosch J, Davies R, Dagenais G. Effects of an angiotensin-converting-enzyme inhibitor, ramipril, on cardiovascular events in high-risk patients. The Heart Outcomes Prevention Evaluation Study Investigators. N. Engl. J Med. 2000;342:145–153.
    1. Antoni ML, Hoogslag GE, Boden H, Liem SS, Boersma E, Fox K, et al. Cardiovascular mortality and heart failure risk score for patients after ST-segment elevation acute myocardial infarction treated with primary percutaneous coronary intervention (data from the Leiden MISSION! Infarct Registry) Am J Cardiol. 2012;109:187–194. doi: 10.1016/j.amjcard.2011.08.029.
    1. el-Sherif N, Denes P, Katz R, Capone R, Mitchell LB, Carlson M, Reynolds-Haertle R. Definition of the best prediction criteria of the time domain signal-averaged electrocardiogram for serious arrhythmic events in the postinfarction period. The Cardiac Arrhythmia Suppression Trial/Signal-Averaged Electrocardiogram (CAST/SAECG) Substudy Investigators. J Am Coll Cardiol. 1995;25:908–914. doi: 10.1016/0735-1097(94)00504-J.
    1. Gehi AK, Stein RH, Metz LD, Gomes JA. Microvolt T-wave alternans for the risk stratification of ventricular tachyarrhythmic events: a meta-analysis. J Am Coll Cardiol. 2005;46:75–82. doi: 10.1016/j.jacc.2005.03.059.
    1. Exner DV, Kavanagh KM, Slawnych MP, Mitchell LB, Ramadan D, Aggarwal SG, et al. Noninvasive risk assessment early after a myocardial infarction the REFINE study. J Am Coll Cardiol. 2007;50:2275–2284. doi: 10.1016/j.jacc.2007.08.042.
    1. Brateanu A. Heart rate variability after myocardial infarction: what we know and what we still need to find out. Curr Med Res Opin. 2015;31:1855–1860. doi: 10.1185/03007995.2015.1086992.
    1. Saliba W, Gronich N, Barnett-Griness O, Rennert G. Usefulness of CHADS2 and CHA2DS2-VASc scores in the prediction of new-onset atrial fibrillation: a population-based study. Am J Med. 2016;129:843–849. doi: 10.1016/j.amjmed.2016.02.029.
    1. Jacobs V, May HT, Bair TL, Crandall BG, Cutler M, Day JD, et al. The impact of risk score (CHADS2 versus CHA2DS2-VASc) on long-term outcomes after atrial fibrillation ablation. Heart Rhythm. 2015;12:681–686. doi: 10.1016/j.hrthm.2014.12.034.
    1. Ntaios G, Lip GYH, Makaritsis K, Papavasileiou V, Vemmou A, Koroboki E, et al. CHADS2, CHA2S2DS2-VASc, and long-term stroke outcome in patients without atrial fibrillation. Neurology. 2013;80:1009–1017. doi: 10.1212/WNL.0b013e318287281b.
    1. Larsen TB, Lip GYH, Skjøth F, Due KM, Overvad K, Hvilsted RL. Added predictive ability of the CHA2DS2VASc risk score for stroke and death in patients with atrial fibrillation: the prospective Danish Diet, Cancer, and Health cohort study. Circ Cardiovasc Qual Outcomes. 2012;5:335–342. doi: 10.1161/CIRCOUTCOMES.111.964023.
    1. Ruwald AC, Gang U, Thomsen PE, Jorgensen RM, Ruwald MH, Huikuri HV, Jons C. The predictive value of CHADS(2) risk score in post myocardial infarction arrhythmias—a Cardiac Arrhythmias and RIsk Stratification after Myocardial infArction (CARISMA) substudy. Int J Cardiol. 2014;173:441–446. doi: 10.1016/j.ijcard.2014.03.010.
    1. Morgan JM, Kitt S, Gill J, McComb JM, Ng GA, Raftery J, et al. Remote management of heart failure using implantable electronic devices. Eur Heart J. 2017;38:2352–2360. doi: 10.1093/eurheartj/ehx227.
    1. Husser D, Christoph Geller J, Taborsky M, Schomburg R, Bode F, Nielsen JC, et al. Remote monitoring and clinical outcomes: details on information flow and workflow in the IN-TIME study. Eur Heart J Qual Care Clin Outcomes. 2019;5:136–144. doi: 10.1093/ehjqcco/qcy031.
    1. Piorkowski C, Busch M, Nölker G, Schmitt J, Roithinger FX, Young G, et al. Clinical evaluation of a small implantable cardiac monitor with a long sensing vector. Pacing Clin Electrophysiol. 2019;42:1038–1046. doi: 10.1111/pace.13728.
    1. Søgaard P, Behrens S, Konyi A, Taborsky M, Christiansen PD, Jacobsen PK, et al. Transmission and loss of ECG snapshots: remote monitoring in implantable cardiac monitors. J Electrocardiol. 2019;56:24–28. doi: 10.1016/j.jelectrocard.2019.06.005.
    1. Nielsen PB, Larsen TB, Gorst-Rasmussen A, Skjøth F, GYH L. β-Blockers in atrial fibrillation patients with or without heart failure: association with mortality in a nationwide cohort study. Circ Heart Fail. 2016;9:e002597. doi: 10.1161/CIRCHEARTFAILURE.115.002597.
    1. Zhang H, Yuan X, Zhang H, Chen S, Zhao Y, Hua K, et al. Efficacy of long-term β-blocker therapy for secondary prevention of long-term outcomes after coronary artery bypass grafting surgery. Circulation. 2015;131:2194–2201. doi: 10.1161/CIRCULATIONAHA.114.014209.
    1. Lin T-T, Chiang J-Y, Liao M-T, Tsai C-T, Hwang JJ, Chiang F-T, et al. Primary prevention of atrial fibrillation with beta-blockers in patients with end-stage renal disease undergoing dialysis. Sci Rep. 2015;5:17731. doi: 10.1038/srep17731.
    1. Ulimoen SR, Enger S, Carlson J, Platonov PG, Pripp AH, Abdelnoor M, et al. Comparison of four single-drug regimens on ventricular rate and arrhythmia-related symptoms in patients with permanent atrial fibrillation. Am J Cardiol. 2013;111:225–230. doi: 10.1016/j.amjcard.2012.09.020.
    1. Kotecha D, Calvert M, Deeks JJ, Griffith M, Kirchhof P, Lip GY, et al. A review of rate control in atrial fibrillation, and the rationale and protocol for the RATE-AF trial. BMJ Open. 2017;7:e015099. doi: 10.1136/bmjopen-2016-015099.
    1. Gorenek B, Bax J, Boriani G, Chen S-A, Dagres N, Glotzer TV, et al. Device-detected subclinical atrial tachyarrhythmias: definition, implications and management—a European Heart Rhythm Association (EHRA) consensus document, endorsed by Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS) and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE) Europace. 2017;19:1556–1578. doi: 10.1093/europace/eux163.
    1. Sethi NJ, Feinberg J, Nielsen EE, Safi S, Gluud C, Jakobsen JC. The effects of rhythm control strategies versus rate control strategies for atrial fibrillation and atrial flutter: asystematic review with meta-analysis and trial sequential analysis. PLoS One. 2017;12:e0186856. doi: 10.1371/journal.pone.0186856.
    1. Marrouche NF, Brachmann J, Andresen D, Siebels J, Boersma L, Jordaens L, et al. Catheter ablation for atrial fibrillation with heart failure. N Engl J Med. 2018;378:417–427. doi: 10.1056/NEJMoa1707855.
    1. Prabhu S, Taylor AJ, Costello BT, Kaye DM, McLellan AJA, Voskoboinik A, et al. Catheter ablation versus medical rate control in atrial fibrillation and systolic dysfunction: the CAMERA-MRI study. J Am Coll Cardiol. 2017;70:1949–1961. doi: 10.1016/j.jacc.2017.08.041.
    1. Aksnes TA, Flaa A, Strand A, Kjeldsen SE. Prevention of new-onset atrial fibrillation and its predictors with angiotensin II-receptor blockers in the treatment of hypertension and heart failure. J Hypertens. 2007;25:15–23. doi: 10.1097/01.hjh.0000254378.26607.1f.
    1. Proietti M, Romiti GF, Olshansky B, Lip GYH. Systolic blood pressure visit-to-visit variability and major adverse outcomes in atrial fibrillation: the AFFIRM study (Atrial Fibrillation Follow-Up Investigation of Rhythm Management) Hypertension. 2017;70:949–958. doi: 10.1161/HYPERTENSIONAHA.117.10106.
    1. Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt O-A, et al. 2013 ESC guidelines on cardiac pacing and cardiac resynchronization therapy: the task force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA) Eur Heart J. 2013;34:2281–2329. doi: 10.1093/eurheartj/eht150.
    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 JID - 0255562. 1996;335:1933–1940. doi: 10.1056/NEJM199612263352601.
    1. Zaman S, Narayan A, Thiagalingam A, Sivagangabalan G, Thomas S, Ross DL, Kovoor P. Long-term arrhythmia-free survival in patients with severe left ventricular dysfunction and no inducible ventricular tachycardia after myocardial infarction. Circulation. 2014;129:848–854. doi: 10.1161/CIRCULATIONAHA.113.005146.
    1. Zang M, Zhang T, Mao J, Zhou S, He B. Beneficial effects of catheter ablation of frequent premature ventricular complexes on left ventricular function. Heart. 2014;100:787–793. doi: 10.1136/heartjnl-2013-305175.
    1. Lakkireddy D, Di Biase L, Ryschon K, Biria M, Swarup V, Reddy YM, et al. Radiofrequency ablation of premature ventricular ectopy improves the efficacy of cardiac resynchronization therapy in nonresponders. J Am Coll Cardiol. 2012;60:1531–1539. doi: 10.1016/j.jacc.2012.06.035.
    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: the task force for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death of the European Society of Cardiology (ESC). Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC) Eur Heart J. 2015;36:2793–2867. doi: 10.1093/eurheartj/ehv316.
    1. McDonnell ME. Telemedicine in complex diabetes management. Curr Diab Rep. 2018;18:42. doi: 10.1007/s11892-018-1015-3.
    1. Tucker KL, Sheppard JP, Stevens R, Bosworth HB, Bove A, Bray EP, et al. Self-monitoring of blood pressure in hypertension: a systematic review and individual patient data meta-analysis. PLoS Med. 2017;14:e1002389. doi: 10.1371/journal.pmed.1002389.
    1. Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014;68:369–378. doi: 10.1111/ijcp.12345.
    1. Givertz MM, Stevenson LW, Costanzo MR, Bourge RC, Bauman JG, Ginn G, Abraham WT. Pulmonary artery pressure-guided management of patients with heart failure and reduced ejection fraction. J Am Coll Cardiol. 2017;70:1875–1886. doi: 10.1016/j.jacc.2017.08.010.
    1. Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, et al. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011;123:1873–1880. doi: 10.1161/CIRCULATIONAHA.111.018473.
    1. Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, et al. Telemonitoring in patients with heart failure. N Engl J Med. 2010;363:2301–2309. doi: 10.1056/NEJMoa1010029.
    1. Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan B-A, et al. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018;392:1047–1057. doi: 10.1016/S0140-6736(18)31880-4.

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