The AngelMed Guardian® System in the Detection of Coronary Artery Occlusion: Current Perspectives

Syed Hassan Abbas Kazmi, Sudarshana Datta, Gerald Chi, Tarek Nafee, Megan Yee, Akshun Kalia, Sadaf Sharfaei, Fahimehalsadat Shojaei, Sabawoon Mirwais, C Michael Gibson, Syed Hassan Abbas Kazmi, Sudarshana Datta, Gerald Chi, Tarek Nafee, Megan Yee, Akshun Kalia, Sadaf Sharfaei, Fahimehalsadat Shojaei, Sabawoon Mirwais, C Michael Gibson

Abstract

Total ischemic time, which specifies the time from the onset of chest pain to initiation of reperfusion during percutaneous coronary intervention, consists of two intervals: symptom to door time and door to balloon time. A door to balloon time of 90 mins or less has become a quality-of-care metric in the management of ST elevation myocardial infarction (STEMI). While national efforts made by the American College of Cardiology (ACC) and American Heart Association (AHA) have curtailed in-hospital door to balloon time over the years, a reduction in pre-hospital symptoms to door time presents a challenge in modern interventional Cardiology. Early and complete revascularization has been associated with improved clinical outcomes in MI and strategies that may help reduce symptom to door time, and thus the total ischemic time, are crucial. Rapidly evolving ST-segment changes commonly develop prior to ischemia-related symptom onset, and are detectable even in patients with clinically unrecognized silent MIs. Therefore, a highly intelligent ischemia detection system that alerts patients of ST segment deviation may allow for rapid identification of acute coronary occlusion. The AngelMed Guardian® System is a cardiac activity monitoring and alerting system designed for rapid identification of intracardiac ST-segment changes among patients at a high risk for recurrent ACS events. This article reviews the clinical studies evaluating the design, safety and efficacy of the AngelMed Guardian System and discusses the clinical implications of the device.

Keywords: ST elevation myocardial infarction; acute coronary syndrome; electrocardiography; ischemia monitoring; myocardial infarction.

Conflict of interest statement

Dr C. Michael Gibson reports grants, personal fees from Angel Medical, during the conduct of the study. The authors report no other conflicts of interest in this work.

© 2020 Kazmi et al.

Figures

Figure 1
Figure 1
AngelMed Guardian® system device design and components.
Figure 2
Figure 2
Implantable medical device (IMD) and external medical device (EXD).
Figure 3
Figure 3
Timeline for the clinical studies of the AngelMed Guardian® system.

References

    1. Writing GM, Mozaffarian D, EJ B, et al. Executive summary: heart disease and stroke statistics–2016 update: a report from the American Heart Association. Circulation. 2016;133:447–454. doi:10.1161/CIR.0000000000000366
    1. Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics-2017 update: a report from the American Heart Association. Circulation. 2017;135:e146–e603.
    1. Sheifer SE, Manolio TA, Gersh BJ. Unrecognized myocardial infarction. Ann Intern Med. 2001;135:801–811. doi:10.7326/0003-4819-135-9-200111060-00010
    1. Faxon D, Lenfant C. Timing is everything: motivating patients to call 9-1-1 at onset of acute myocardial infarction. Circulation. 2001;104:1210–1211. doi:10.1161/circ.104.11.1210
    1. De Luca G, Suryapranata H, Ottervanger JP, Antman EM. Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts. Circulation. 2004;109:1223–1225. doi:10.1161/01.CIR.0000121424.76486.20
    1. De Luca G, Suryapranata H, Zijlstra F, et al. Symptom-onset-to-balloon time and mortality in patients with acute myocardial infarction treated by primary angioplasty. J Am Coll Cardiol. 2003;42:991–997. doi:10.1016/S0735-1097(03)00919-7
    1. Hasche ET, Fernandes C, Freedman SB, Jeremy RW. Relation between ischemia time, infarct size, and left ventricular function in humans. Circulation. 1995;92:710–719. doi:10.1161/01.CIR.92.4.710
    1. Liem AL, van ‘t Hof AW, Hoorntje JC, de Boer MJ, Suryapranata H, Zijlstra F. Influence of treatment delay on infarct size and clinical outcome in patients with acute myocardial infarction treated with primary angioplasty. J Am Coll Cardiol. 1998;32:629–633. doi:10.1016/S0735-1097(98)00280-0
    1. Gersh BJ, Stone GW, White HD, Holmes DR Jr. Pharmacological facilitation of primary percutaneous coronary intervention for acute myocardial infarction: is the slope of the curve the shape of the future? JAMA. 2005;293:979–986. doi:10.1001/jama.293.8.979
    1. Reimer KA, Lowe JE, Rasmussen MM, Jennings RB. The wavefront phenomenon of ischemic cell death. 1. Myocardial infarct size vs duration of coronary occlusion in dogs. Circulation. 1977;56:786–794. doi:10.1161/01.CIR.56.5.786
    1. Brown AL, Mann NC, Daya M, et al. Demographic, belief, and situational factors influencing the decision to utilize emergency medical services among chest pain patients. Rapid Early Action for Coronary Treatment (REACT) study. Circulation. 2000;102:173–178. doi:10.1161/01.CIR.102.2.173
    1. Meischke H, Ho MT, Eisenberg MS, Schaeffer SM, Larsen MP. Reasons patients with chest pain delay or do not call 911. Ann Emerg Med. 1995;25:193–197. doi:10.1016/S0196-0644(95)70323-3
    1. Chew DP, Moliterno DJ, Herrmann HC. Present and potential future paradigms for the treatment of ST-segment elevation acute myocardial infarction. J Invasive Cardiol. 2002;14(Suppl A):3A–20A.
    1. Sekulic M, Hassunizadeh B, McGraw S, David S. Feasibility of early emergency room notification to improve door-to-balloon times for patients with acute ST segment elevation myocardial infarction. Catheter Cardiovasc Interv. 2005;66:316–319. doi:10.1002/(ISSN)1522-726X
    1. Fischell TA, Fischell DR, Fischell RE, et al. Potential of an intracardiac electrogram for the rapid detection of coronary artery occlusion. Cardiovasc Revasc Med. 2005;6:14–20. doi:10.1016/j.carrev.2005.05.002
    1. Varriale P, Niznik J. Unipolar ventricular electrogram in the diagnosis of right ventricular ischemic injury. Pacing Clin Electrophysiol. 1978;1:335–341. doi:10.1111/pace.1978.1.issue-3
    1. Taylor DM, Garewal D, Carter M, Bailey M, Aggarwal A. Factors that impact upon the time to hospital presentation following the onset of chest pain. Emerg Med Australas. 2005;17:204–211. doi:10.1111/emm.2005.17.issue-3
    1. Goldberg RJ, Steg PG, Sadiq I, et al. Extent of, and factors associated with, delay to hospital presentation in patients with acute coronary disease (the GRACE registry). Am J Cardiol. 2002;89:791–796. doi:10.1016/S0002-9149(02)02186-0
    1. Crumlish CM, Bracken J, Hand MM, Keenan K, Ruggiero H, Simmons D. When time is muscle. Am J Nurs. 2000;100:26–33. doi:10.1097/00000446-200001000-00032.
    1. McNamara RL, Wang Y, Herrin J, et al. Effect of door-to-balloon time on mortality in patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2006;47:2180–2186. doi:10.1016/j.jacc.2005.12.072
    1. Wilson JH, Rath R, Glaser R, Panke T. Severe hemolysis after incomplete mitral valve repair. Ann Thorac Surg. 1990;50:136–137. doi:10.1016/0003-4975(90)90108-I
    1. Gibson CM, Pride YB, Frederick PD, et al. Trends in reperfusion strategies, door-to-needle and door-to-balloon times, and in-hospital mortality among patients with ST-segment elevation myocardial infarction enrolled in the National Registry of Myocardial Infarction from 1990 to 2006. Am Heart J. 2008;156:1035–1044. doi:10.1016/j.ahj.2008.07.029
    1. Furman MI, Dauerman HL, Goldberg RJ, Yarzebski J, Lessard D, Gore JM. Twenty-two year (1975 to 1997) trends in the incidence, in-hospital and long-term case fatality rates from initial Q-wave and non-Q-wave myocardial infarction: a multi-hospital, community-wide perspective. J Am Coll Cardiol. 2001;37:1571–1580. doi:10.1016/S0735-1097(01)01203-7
    1. Fox KA, Steg PG, Eagle KA, et al. Decline in rates of death and heart failure in acute coronary syndromes, 1999–2006. JAMA. 2007;297:1892–1900. doi:10.1001/jama.297.17.1892
    1. DeVon HA, Hogan N, Ochs AL, Shapiro M. Time to treatment for acute coronary syndromes: the cost of indecision. J Cardiovasc Nurs. 2010;25:106–114. doi:10.1097/JCN.0b013e3181bb14a0
    1. Gibson CM. Time is myocardium and time is outcomes. Circulation. 2001;104:2632–2634. doi:10.1161/circ.104.22.2632
    1. Kannel WB. Silent myocardial ischemia and infarction: insights from the Framingham Study. Cardiol Clin. 1986;4:583–591. doi:10.1016/S0733-8651(18)30577-0
    1. Davis TME, Fortun P, Mulder J, Davis WA, Bruce DG. Silent myocardial infarction and its prognosis in a community-based cohort of Type 2 diabetic patients: the Fremantle Diabetes Study. Diabetologia. 2004;47:395–399. doi:10.1007/s00125-004-1344-4
    1. Luepker RV, Raczynski JM, Osganian S, et al. Effect of a community intervention on patient delay and emergency medical service use in acute coronary heart disease: the Rapid Early Action for Coronary Treatment (REACT) Trial. JAMA. 2000;284:60–67. doi:10.1001/jama.284.1.60
    1. Canto JG, Shlipak MG, Rogers WJ, et al. Prevalence, clinical characteristics, and mortality among patients with myocardial infarction presenting without chest pain. JAMA. 2000;283:3223–3229. doi:10.1001/jama.283.24.3223
    1. Hollenberg NK. Controversies in cardiovascular care: silent myocardial ischemia. Complicat Card Patient. 1987;1:24–30.
    1. Sanchis-Gomar F, Perez-Quilis C, Leischik R, Lucia A. Epidemiology of coronary heart disease and acute coronary syndrome. Ann Transl Med. 2016;4:256. doi:10.21037/atm
    1. Kannel WB, Dannenberg AL, Abbott RD. Unrecognized myocardial infarction and hypertension: the Framingham Study. Am Heart J. 1985;109:581–585. doi:10.1016/0002-8703(85)90566-6
    1. Brennan P. Coronary heart disease in the medical research council trial of treatment of mild hypertension. Medical Research Council Working Party on Mild Hypertension. Br Heart J. 1988;59:364–378. doi:10.1136/hrt.59.3.364.
    1. DeLuca AJ, Kaplan S, Aronow WS, et al. Comparison of prevalence of unrecognized myocardial infarction and of silent myocardial ischemia detected by a treadmill exercise sestamibi stress test in patients with versus without diabetes mellitus. Am J Cardiol. 2006;98:1045–1046. doi:10.1016/j.amjcard.2006.05.026
    1. Niakan E, Harati Y, Rolak LA, Comstock JP, Rokey R. Silent myocardial infarction and diabetic cardiovascular autonomic neuropathy. Arch Intern Med. 1986;146:2229–2230. doi:10.1001/archinte.1986.00360230169023
    1. Nesto RW, Watson FS, Kowalchuk GJ, et al. Silent myocardial ischemia and infarction in diabetics with peripheral vascular disease: assessment by dipyridamole thallium-201 scintigraphy. Am Heart J. 1990;120:1073–1077. doi:10.1016/0002-8703(90)90118-H
    1. Kwong RY, Sattar H, Wu H, et al. Incidence and prognostic implication of unrecognized myocardial scar characterized by cardiac magnetic resonance in diabetic patients without clinical evidence of myocardial infarction. Circulation. 2008;118:1011–1020. doi:10.1161/CIRCULATIONAHA.107.727826
    1. Prevalence of unrecognized silent myocardial ischemia and its association with atherosclerotic risk factors in noninsulin-dependent diabetes mellitus. Milan Study on Atherosclerosis and Diabetes (MiSAD) Group. Am J Cardiol. 1997;79:134–139. doi:10.1016/S0002-9149(96)00699-6.
    1. Burgess DC, Hunt D, Li L, et al. Incidence and predictors of silent myocardial infarction in type 2 diabetes and the effect of fenofibrate: an analysis from the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. Eur Heart J. 2010;31:92–99. doi:10.1093/eurheartj/ehp377
    1. Pride YB, Tung P, Mohanavelu S, et al. Angiographic and clinical outcomes among patients with acute coronary syndromes presenting with isolated anterior ST-segment depression: a TRITON-TIMI 38 (trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with prasugrel-thrombolysis in myocardial infarction 38) substudy. JACC Cardiovasc Interv. 2010;3:806–811. doi:10.1016/j.jcin.2010.05.012
    1. Boden WE, Kleiger RE, Gibson RS, et al. Electrocardiographic evolution of posterior acute myocardial infarction: importance of early precordial ST-segment depression. Am J Cardiol. 1987;59:782–787. doi:10.1016/0002-9149(87)91091-5
    1. McAlister FA, Quan H, Fong A, Jin Y, Cujec B, Johnson D. Effect of invasive coronary revascularization in acute myocardial infarction on subsequent death rate and frequency of chronic heart failure. Am J Cardiol. 2008;102:1–5. doi:10.1016/j.amjcard.2008.02.089
    1. Kerr JH. Symposium on anaesthetic equipment. Warning devices. Br J Anaesth. 1985;57:696–708. doi:10.1093/bja/57.7.696
    1. Block FE Jr., Nuutinen L, Ballast B. Optimization of alarms: a study on alarm limits, alarm sounds, and false alarms, intended to reduce annoyance. J Clin Monit Comput. 1999;15:75–83. doi:10.1023/A:1009992830942
    1. Hedley-Whyte J Standardization of interface design for medical devices: international electrotechnical commission and international organization for standardization medical alarm systems. Proceedings of the Human Factors and Ergonomics Society Annual Meeting; 2000: SAGE Publications Sage CA: Los Angeles, CA p. 215–218.
    1. Kerr JH, Hayes B. An “alarming” situation in the intensive therapy unit. Intensive Care Med. 1983;9:103–104. doi:10.1007/BF01772574
    1. Morris RW, Montano SR. Response times to visual and auditory alarms during anaesthesia. Anaesth Intensive Care. 1996;24:682–684. doi:10.1177/0310057X9602400609
    1. Edworthy J, Hellier E. Fewer but better auditory alarms will improve patient safety. BMJ Qual Saf. 2005;14:212–215. doi:10.1136/qshc.2004.013052
    1. Edworthy J, Hellier E. Alarms and human behaviour: implications for medical alarms. Br J Anaesth. 2006;97:12–17. doi:10.1093/bja/ael114
    1. Wogalter MS, Young SL. Behavioural compliance to voice and print warnings. Ergonomics. 1991;34:79–89. doi:10.1080/00140139108967290
    1. Wogalter MS, Conzola VC, Smith-Jackson TL. Research-based guidelines for warning design and evaluation. Appl Ergon. 2002;33:219–230. doi:10.1016/S0003-6870(02)00009-1
    1. Simons EC, Feigenblum DY, Nemirovsky D, Simons GR. Alert tones are frequently inaudible among patients with implantable cardioverter-defibrillators. Pacing Clin Electrophysiol. 2009;32:1272–1275. doi:10.1111/pace.2009.32.issue-10
    1. Zhang Y, Szolovits P. Patient-specific learning in real time for adaptive monitoring in critical care. J Biomed Inform. 2008;41:452–460. doi:10.1016/j.jbi.2008.03.011
    1. Hay WW Jr., Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients. J Perinatol. 2002;22:360–366. doi:10.1038/sj.jp.7210740
    1. Zhang Y. Real-time development of patient-specific alarm algorithms for critical care. Conf Proc IEEE Eng Med Biol Soc. 2007;2007:4351–4354. doi:10.1109/IEMBS.2007.4353300
    1. Epstein AE, Abraham WT, Bianco NR, et al. Wearable cardioverter-defibrillator use in patients perceived to be at high risk early post-myocardial infarction. J Am Coll Cardiol. 2013;62:2000–2007. doi:10.1016/j.jacc.2013.05.086
    1. Olgin JE, Pletcher MJ, Vittinghoff E, et al. Wearable cardioverter-defibrillator after myocardial infarction. N Engl J Med. 2018;379:1205–1215. doi:10.1056/NEJMoa1800781
    1. Tachinardi U, de Sa Rebelo M, de Magalhaes Oliveira PP Jr., Pilon PE. Real time information from bedside monitors as part of a web-based patient record. Proc AMIA Symp. 2001;691–695.
    1. DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med. 2003;349:1836–1847. doi:10.1056/NEJMra035432
    1. Brodie BR, Gersh BJ, Stuckey T, et al. When is door-to-balloon time critical? Analysis from the HORIZONS-AMI (Harmonizing Outcomes with Revascularization and Stents in Acute Myocardial Infarction) and CADILLAC (Controlled Abciximab and Device Investigation to Lower Late Angioplasty Complications) trials. J Am Coll Cardiol. 2010;56:407–413. doi:10.1016/j.jacc.2010.04.020
    1. Crossley GH, Brinker JA, Reynolds D, et al. Steroid elution improves the stimulation threshold in an active-fixation atrial permanent pacing lead. A randomized, controlled study. Model 4068 Investigators. Circulation. 1995;92:2935–2939. doi:10.1161/01.CIR.92.10.2935
    1. Mond HG, Stokes KB. The steroid-eluting electrode: a 10-year experience. Pacing Clin Electrophysiol. 1996;19:1016–1020. doi:10.1111/pace.1996.19.issue-7
    1. Vogel B, Claessen BE, Arnold SV, et al. ST-segment elevation myocardial infarction. Nat Rev Dis Primers. 2019;5:39. doi:10.1038/s41572-019-0090-3
    1. Gibson CM, Holmes D, Mikdadi G, et al. Implantable cardiac alert system for early recognition of ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2019;73:1919–1927. doi:10.1016/j.jacc.2019.01.014
    1. Watanabe T, Hirooka K, Furukawa Y, et al. Continuous ST-monitoring function of implantable cardioverter defibrillator detects silent ischemia in patients with coronary artery disease. J Am Heart Assoc. 2018;7:e009332.
    1. Tajrishi FZ, Chitsazan M, Chitsazan M, Shojaei F, Gunnam V, Chi G. Smartwatch for the detection of atrial fibrillation. Crit Pathw Cardiol. 2019;18:176–184. doi:10.1097/HPC.0000000000000192
    1. Halcox JPJ, Wareham K, Cardew A, et al. Assessment of remote heart rhythm sampling using the AliveCor heart monitor to screen for atrial fibrillation: the REHEARSE-AF study. Circulation. 2017;136:1784–1794. doi:10.1161/CIRCULATIONAHA.117.030583
    1. Chan PH, Wong CK, Pun L, et al. Head-to-head comparison of the AliveCor heart monitor and microlife WatchBP office AFIB for atrial fibrillation screening in a primary care setting. Circulation. 2017;135:110–112. doi:10.1161/CIRCULATIONAHA.116.024439
    1. Reed MJ, Grubb NR, Lang CC, et al. Multi-centre randomised controlled trial of a smart phone-based event recorder alongside standard care versus standard care for patients presenting to the emergency department with palpitations and pre-syncope - the IPED (Investigation of Palpitations in the ED) study: study protocol for a randomised controlled trial. Trials. 2018;19:711.
    1. Gibson CM, Guimarães V, John MS, et al. Magnitude and duration of intracardiac ST-segment changes for confirmed clinical events: first in-man experience. J Am Coll Cardiol. 2012;59:E414. doi:10.1016/S0735-1097(12)60415-X
    1. Hopenfeld B, John MS, Fischell DR, Medeiros P, Guimarães HP, Piegas LS. The Guardian: an implantable system for chronic ambulatory monitoring of acute myocardial infarction. J Electrocardiol. 2009;42:481–486. doi:10.1016/j.jelectrocard.2009.06.017

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe