Compara'vestudyoftheCardioSecurproECGsystemwiththeEASIPhilipsM2601B

DavidTriebl,PeterKenedi,IstvanPreda,AdamSzekely,MarcusSkribek,MarkusRiemenschneiderPersonalMedSystemsFrankfurt,CentralHospitaloftheHungarianDefenceForcesBudapest

Theclinicaldiagnosisfor41measuredpaAentswasidenAcal in the ECGs measured with bothCardioSecurandPhilipsM2601B.Thesediagnosesincluded a variety of clinical paKerns includingrhythmdisorders,acuteMIandoldMI.ApaersoncorrelaAon coefficient was calculated forCardioSecur and Philips for the classical 12 leadsand was high for all measured parameters (seetable 1). The addiAonal 10 leads of CardioSecurwere not analyzed as part of the study as thePhilipsdevicedoesnotofferthisopAon.The second test, covering a technical analysisincluding waveforms and peak heights ofsimulated ECGs, revealed differences in the

heightsoftheR-andS-wave.CardioSecurshowedan absolute R peak 10% higher than the Philipsdevice (see figure 2). This difference can beexplained by the use of different filter seXngs inthedevices.ThePhilipsM2601BclearlystatesthattherecordedECGmaynotbeusedforST-segmentevaluaAon. CardioSecur uses a filter seXngcompliant with the regulatory standards to allowST-segmentevaluaAon.Consequently,adifferenceinabsolutepeakheightcanbealsoseen infigure3. Morphologically, all ECGs (paAent andsimulated) showed idenAcal orientaAon of themeasuredparameters.

Results

To assess both the technical and the medicalcomparability of the systems, the setup wasdividedintotwoprocedures,thefirsttestcoveringthe medical diagnosAc accuracy of the twosystems, the second test covering the technicalcomparability of the ECG signal, generated withthe reduced lead system. In the first test ECGmeasurements were taken from 41 individuals

with both systems. A clinical diagnosiswasmadeon these ECGs by two independent cardiologistsandtheorientaAonofthewavesP,R,TandSwereevaluated and compared. To assess the technicalwaveform of the two systems, ECGs weresimulated with an ECG simulator to ensureidenAcal electrical input on both systems. TheseECGs were simulated at frequencies between 30

and 180bpm. AddiAonally, pathological ECGpaKerns were simulated and recorded with thesystems. These waveforms were compared withrespecttomorphologyandheightoftheelectricalsignalinthestandard12leadsofthetwosystems.

Methods

AcomparaAvestudywasconductedtovalidatetheECGmeasurements of CardioSecur. CardioSecur isa tablet-based ECG system using 4 electrodes toderive a 22-channel ECG (standard 12-leads + V7-V9andVR1-VR9).ThetechnologyofCardioSecurisbasedonthecalculaAonof12leadsgainedfrom4electrodes and these are comparable to thestandard12leadECG.

AimoftheStudy

Thisstudyhasshownthattheclinical informaAonintheCardioSecurdevice is idenAcaltothe informaAonofECGsofthePhilipsM2601Bdevice.Asmalldifferenceinpeakheightsoftherawsignalarisesfromthedifferentfiltersystems.Morphologically,theorientaAonofallrecordedECGsandtheR-waveprogressionwereidenAcalinallmeasuredECGs.ThereforethediagnosAccapabiliAesof theCardioSecurdevicecanbeseenas fullycomparabletothoseof thePhilipsECG.ThepossiblebenefitsofanaddiAonal10 leads intheCardioSecurdevicewillbethesubjectoffuturestudies.

Conclusion

o  Dower,G.E.,TheECGD:aderivaAonoftheECGfromVCGleads.JournalofElectrocardiology,1984.17(2):p.189-91.o  Horacek, B.M., et al. DiagnosAc accuracy of derived compared to standard 12-lead electrocardiograms. in InternaAonal Society for Computerized Cardiology. 2000.

Yosemite,California:JournalofElectrocardiology.o  ESCGuidelinesonSTsegmentelevaAonacutemyocardialinfarcAonEuropeanHeartJournal(2012)33,2569–2619o  Comparison of standard and derived 12-lead electrocardiograms registrated by a simplified 3-lead seXngwith four electrodes for diagnosis of coronary angioplasty-

inducedmyocardialischemia.BonaventuraK,WellnhoferE,FleckE.EuropeanCardiology.2012Jul;8(3):179.

References

Figure2:AbsolutedifferencesbetweenPhilipsandCardioSecurinR-Peakamplitude.

Table 1: CorrelaAon coefficients for parameters ofCardioSecurandPhilipsover41paAents.

Figure1:ElectrodePlacementandtechnicalcomponentsofCardioSecur

Figure3:AbsoluteS-peakamplitudsforCardioSecurandPhilipsoverdiffferentfrequenciesforV1toV6.