Research & Literature

CardioSecur Research

We participate in investigator-initiated clinical trials as part of our “CardioSecur Trials” program. Pertinent results are listed below. For more information about this program, visit our clinical trial homepage.

  • CardioSecur adds value in the management of patients with cardiac disease1.
  • CardioSecur shows >99% agreement in presence or absence of ischemia compared to a standard ECG (0 false negatives, 1 false positive)2.
  • CardioSecur demonstrated 100% concordance with respect to localisation of myocardial ischemia compared to a standard ECG2.
  • The clinical information provided by, and diagnostic capabilities of CardioSecur, are identical to that of the EASI Philips M2601B ECG device3.

Supporting Literature


About the CardioSecur Technology

The 12-lead electrocardiogram (ECG) is the gold standard for the detection of myocardial ischemia. This is classically recorded with 10 electrodes. The EASI lead system is an alternative to the conventional method—it was described by Dower et al. in the 1980’s and resorting to vector-electrocardiography uses only 5 electrodes (4 recording + 1 grounding) to derive 12 leads.4,5,6 The agreement between the EASI derived 12-lead ECG and the standard 12-lead ECG has been shown in many reviewed studies7-17.

CardioSecur’s technology is based upon the EASI standard, additionally removing the grounding electrode to allow for the registration of a derived 12-lead ECG using only 4 electrodes. The agreement of the modified CardioSecur setting has been clinically proven and published2,3.

  • EASI and standard 12-lead ECGs are comparable for multiple cardiac diagnoses8,12,14.
  • Derived ECGs are less susceptible to positional QRS changes than a standard ECG13.
  • The EASI-derived 12-lead ECG is comparable to a standard 12-lead ECG for detecting ischemia 9,10,15,16.
  • ST-segment depression detected by the EASI-derived ECG is very similar to that detected by a standard ECG with a sensitivity and specificity for detection of myocardial ischemia at least equal to that of the standard ECG17.
  • EASI is similar to a Mason-Likar ECG regarding susceptibility for baseline wander and is less susceptible to myoelectric noise11.

For more detailed information and sources about the technology, see our Study Library.

Benefit of additional leads

When an infarction is suspected and the 12-lead ECG is inconclusive, guidelines from the European Society of Cardiology recommend recording additional leads (V7-V9, VR3-VR4),18,19. CardioSecur is the only mobile ECG to implement this guideline into practice without the need to reattach electrodes which can be limited by time, resources, and patient factors. Including additional leads can lead to improved diagnosis and treatment.

  • Using posterior leads in patients presenting with symptoms suspicious for heart attack reveals more patients with posterior myocardial infarction who benefit from early reperfusion treatment20.
  • Posterior chest leads should be routinely recorded in patients with suspected myocardial infarction and non-diagnostic, routine electrocardiograms21.
  • Isolated ST changes in leads V7-V9 and VR3-VR9 for the first time identifies patients with acute posterior wall myocardial infarction. Early identification of these patients is important for adequate triage and treatment of patients with ischemic chest pain without ST changes on a standard 12-lead ECG22.
  • The use of a 22-lead ECG has the potential to substantially reduce unnecessary “rule-out MI” admissions23.
Treatment Delay & Importance of Early Treatment

“Time is muscle.” CardioSecur Active was developed to help private users monitor their heart health on their own, helping them to receive treatment faster, and save more heart muscle. CardioSecur Pro brings a more comprehensive ECG to the patient, allowing for more rapid diagnosis.

  • Only 11% of myocardial infarction patients receive intervention within the “golden hour”24, nearly 90% are too late.
  • Energy reserves of the heart muscle typically only last for 20-60 minutes before necrosis of muscle tissue occurs22.
  • Mortality increases by 7.5% for every 30 minutes that elapse before a patient with an ST-Elevation Myocardial Infarction (STEMI) is recognized and treated25.
  • More than 90% of patients know that a heart attack can be deadly; however, 43% who suspected a heart attack still called for help too late (>1 hour later)26.
  • Survival rates for heart attack improve if treatment begins within 1 hour; however, most patients are admitted to the hospital 2.5-3 hours after symptoms begin27.
Impact of Coronary Artery Disease

Cardiovascular disease is responsible for more than half of all deaths across the European region29, with Coronary Artery Disease (CAD) being the leading cause of death worldwide29.

  • Approximately 1 American will die every minute from a coronary event30.
  • CAD is first detected via a heart attack in 62% of men and 45% of women24
  • CAD is the single most frequent cause of death worldwide (12.8% of deaths, >7 million people yearly)28
  • The lifetime risk of developing CHD after 40 years of age is 49% for men and 32% for women25.
Sources

1 Van Langehove G and Schwagten B. The Revealing timely ECG changes Decreases the likelihood of Undesirable Cardiac Events-Trial (REDUCE-Trial). Poster presented at ESC Congress 2014: Barcelona.

2 Bonaventura K, Wellnhofer E, and Fleck E. Comparison of standard and derived 12-lead electrocardiograms registrated by a simplified 3-lead setting with four electrodes for diagnosis of coronary angioplasty-induced myocardial ischemia. European Cardiology, 2012 Jul; 8(3): 179.

3 Triebl D, Kenedi P, Preda I, et al. Comparative study of the CardioSecur pro ECG system with the EASI Philips M2601B. Personal MedSystems Frankfurt, Central Hospital of the Hungarian Defence Forces Budapest. Abstract presented eCardiology Congress 2016: Berlin.

4Dower, GE. The ECGD: a derivation of the ECG from VCG leads. Journal of Electrocardiology, 1984. 17(2):189-91.

5Dower, GE, Machado HB and Osborne JA. On deriving the electrocardiogram from vectorcadiographic leads. Clinical Cardiology, 1980. 3(2):87-95.

6Dower, GE, Zakush A, Nazzal SB, et al. Deriving the 12-lead electrocardiogram from four (EASI) electrodes. Journal of Electrocardiology, 1988. 21 Suppl:182-7.

7Horacek, BM, Warren JW, Stovicek P and Feldman CL. Diagnostic accuracy of derived compared to standard 12-lead electrocardiograms. Journal of Electrocardiology, 2000. 33 Suppl:155-60.

8Drew, BJ, Pelter MM, Wung SF, et al. Accuracy of the EASI 12-lead electrocardiogram compared to the standard 12-lead electrocardiogram for diagnosing multiple cardiac abnormalities. Journal of Electrocardiology, 1999. 32:38-47.

9Drew, BJ, Adams MG, Pelter MM, Wung SF, and Caldwell MA. Comparison of standard and derived 12-lead electrocardiograms for diagnosis of coronary angioplasty-induced myocardial ischemia. American Journal of Cardiology, 1997. 79(5):639-44.

10Rautaharju, PM, Zhous SH, Hancock EW, et al. Comparability of 12-lead ECGs derived from EASI leads with standard 12-lead ECGs in the classification of acute myocardial ischemia and old myocardial infarction. Journal of Electrocardiology, 2002. 35 Suppl:35-9.

11Welinder A, Sörnmo L, Field DQ, et al. Comparison of signal quality between EASI and Mason-Likar 12-lead electrocardiograms during physical activity. American Journal of Critical Care, 2004. 13(3):228-234.

12Drew BJ, Scheinman MM, and Evans GT, Jr. Comparison of a vectorcardiographically derived 12-lead electrocardiogram with the conventional electrocardiogram during wide QRS complex tachycardia, and its potential application for continuous bedside monitoring. American Journal of Cardiology, 1992. 69(6):612-8.

13Adams, MG. and Drew BJ. Body position effects on the ECG: implication for ischemia monitoring. Journal of Electrocardiology, 1997. 30(4):285-91.

14Drew, BJ, Pelter MM, Brodnick DE, et al. Comparison of a new reduced lead set ECG with the standard ECG for diagnosing cardiac arrhythmias and myocardial ischemia. Journal of Electrocardiology, 2002. 35 Suppl:13-21.

15Wehr G, Peters RJ, Khalife K, et al. A vector-based, 5-electrode, 12-lead monitoring ECG (EASI) is equivalent to conventional 12-lead ECG for diagnosis of acute coronary syndromes. J Electrocardiology, 2006 Jan;39(1):22-8.

16Sejersten M, Wagner GS, Pahlm O, et al. Detection of acute ischemia from the EASI-derived 12-lead electrocardiogram and from the 12-lead electrocardiogram acquired in clinical practice. J Electrocardiology, 2007 Apr;40(2):120-6.

17Feldman CL, MacCallum G, and Hartley LH. Comparison of the standard ECG with the EASIcardiogram for ischemia detection during exercise monitoring. Computers in Cardiology, 1997. Lund pp. 343-345.

18Ibanez B, James S, Agewall S, et al. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC), European Heart Journal, Volume 39, Issue 2, 7 January 2018, Pages 119-177, https://doi.org/10.1093/eurheartj/ehx393.

19Roffi M, Patrono C, Collet J, et al. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC), European Heart Journal, Volume 37, Issue 3, 14 January 2016, Pages 267–315, https://doi.org/10.1093/eurheartj/ehv320.

20Van Gorselen EOF, Verheugt FWA, Meursing BTJ, and Ophuis AJM. Posterior Myocardial Infarction: the dark side of the moon. Neth Heart Journal, 2007 Jan;15(1):16-21.

21Agarwal JB, Khaw K, Aurignac F, and LoCurto A. Importance of posterior chest leads in patients with suspected myocardial infarction, but nondiagnostic, routine 12-lead electrocardiogram. American Journal of Cardiology, 1999 Feb;83(3):323-6.

22Matezky S, Freinmark D, Feinberg MS, et al. Acute myocardial infarction with isolated ST-segment elevation in posterior chest leads V7-9: „hidden“ ST-segment elevations revealing acute posterior infarction. Journal of the American College of Cardiology, 1999 Sep;34(3):748-53.

23Justis DL and Hession WT. Accuracy of 22-lead ECG Analysis for diagnosis of acute myocardial infarction and coronary artery disease in the emergency department: a comparison with 12-lead ECG. Annals of Emergency Medicine, 1992 Jan;21(1):1-9.

24Schneider H, Weber F, and Nienaber C. Die Therapie des Herzinfarkts. Published in Herzinfarkt: Unvermeidbares Schicksal? Nov 2005. Deutsche Herzstiftung e.V.

25De Luca G, Suryapranata H, Ottervanger JP, and Antman EM. Time delay to treatment and mortality in primary angioplasty for acute myocardial infarction: every minute of delay counts. Circulation, 2004 Mar 16;109(10):1223-5.

26Becker HJ. Herzinfarkt: ein Wettlauf mit der Zeit. Published in Herzinfarkt: Unvermeidbares Schicksal? Nov 2005. Deutsche Herzstiftung e.V.

27 Dracup K, et al. Acute coronary syndrome: what do patients know? Arch Intern Med. 2008;168:1049–1054.

28WHO Data and Statistics, accessed 12.01.2018 from: http://www.euro.who.int/en/health-topics/noncommunicable-diseases/cardiovascular-diseases/data-and-statistics.

29WHO Fact Sheet, updated June 2011. http://www.who.int/mediacentre/factsheets/fs310/en/index.html.

30Veronique LR, Go AS, Lloyd-Jones DM, et al. Heart Disease and Stroke Statistics- 2011 Update. A Report from the American Heart Association. Circulation, 2011 Feb 1;123(4): 318-e209. Accessed from http://circ.ahajournals.org/content/123/4/e18.long.

31Lloyd-Jones DM, Nam BH, D’Agonistino RB, et al. Parental Cardiovascular disease as a risk factor for cardiovascular disease in middle-aged adults: a prospective study of parents and offspring. JAMA, 2004. 291:2204-2211.

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