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Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

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Page 1: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Marquette™ 12SL Algorithm

Connected Clinical Excellence

Page 2: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Clinical decision support for your ECGSince its introduction in 1980 the MarquetteTM 12SL ECG analysis program has been consistently refined and improved in order to offer our customers the best possible clinically validated decision support to achieve faster accurate diagnosis.

• Exceedscurrentstandards1 for 12- and 15-lead measurements and analysis

• Providesaccurate,validatedmeasurementsofheartrate,axis, intervals,anddurations

• Offersautomatedsecondopinionminimizingtimespent over-reading ECGs

• OffersECGanalysisincludingthoseforatrialarrhythmias,pace detection,andQTmeasurement

• OffersquickqualitycheckofECGs(Hook-upadvisor)

• Offersgenderandage-drivencriteriaforacuteMI;utilizedin pre-hospital defibrillators to identify clinically significant changes andexpeditepatientcareintime-criticalenvironments

• Dedicatedpaediatriccriteria

• SupportingdecisionsonECGacrossthecarecontinuum

19861980 1991 2000 2004 2006 2011

Serial Comparison

PaediatricAnalysis

Gender-specificcriteria

Hookup Advisor

Right Ventricular Involvement

PaceStatementsAcute Coronary

Syndrome

2003

QT Algorithm

Page 3: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Serial Comparison Paediatric Analysis

TheMarquetteSerialComparisonProgramindicateschanges in the ECG from the previous ECG of the samepatient.Itutilizesinterpretivestatements, ECG measurements and waveform comparison techniquestomaximizeaccuracyinthedetection of clinically significant changes. Serial comparison requires the MUSE ECG management system.

Benefit: • Consistentvalidated1 analysis and comparison ensures reproducibility and objectivity for increased efficiency in the process.

Children are not the same as adults and neitheraretheirECGs.Increasedrightventricularsize,increasedheartrateandnarrowercomplexeswouldleadtodifferent interpretation in an adult ECG. Totakethisintoaccount,ifanageoflessthan 16 years is entered the Marquette 12SL program employs paediatric criteria. Inadditionthepossibilitytoapply15leads allows different positions to cater for the differences in paediatric anatomy.

Benefit: • Accuratepaediatricspecificmeasure- ment and interpretation validated by independent study with over 1.100 paediatric ECGs.1

12 Age groups applied to ECG analysis

Less than one day old

At least a day old but not more than 2 days

3 to 6 days old

1to3weeksold

1 to 2 months old

3 to 5 months old

6 to 11 months old

1 to 2 years old

3 to 4 years old

5 to 7 years old

8 to 11 years old

12 to 15 years old

19861980 1991

Serial Comparison

PaediatricAnalysis

Page 4: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Gender-specific criteria

Justlikechildren,adultmenandwomenarealsodifferentandthisdifferenceextendstotheECG.Marquette 12SL with Gender- Specific interpretation applies criteria for evaluating the ST segment and T-waveoftheECGwaveform,improvingsensitivitytoacute myocardial infarction in women and enhancing diagnostic confidence.

Benefit: • Improvesthesensitivityfordetectionofacuteanterior MIfrom42%to48%inwomenunder60yearsofage.2

• 25%relativeimprovementindetectionofacute inferiorMIinwomenunder60yearsofagewithout sacrificing the high specificity already maintained by the program.3

2000

Gender-specificcriteria

2003

QT Algorithm

QT Algorithm

ItiswellrecognizedthattheidentificationofprolongedQTisimportant as the condition can result in serious arrhythmia and SuddenCardiacDeath.4However,itcanbedifficulttomeasureQTaccuratelyduetofactorssuchasECGnoise,difficultydefiningtheendoftheTwave,andrequiringcorrectionsforheartrate.GEhasconcentrateditseffortsinhelpingtominimizethesechallengesthroughtheMarquette12SLprogram.TheQTismeasuredfromamediancomplexreducingtheinfluenceofnoise,itisalsomeasuredfrom global fiducial points from all 12 simultaneous leads.

Benefit: • Consistent,reproducableandaccuratemeasurementand interpretation

• OffersmultipleQTcorrectionfactorsincludingBazett, Framingham,andFridericiaSTEMI/ACS

Byusingallleadsofthemediancomplextodefinetheendofventricularrepolarization, Marquette12SLoffersaccuracyandconsistencyinQTmeasurement

Page 5: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Right Ventricular Involvement (RVI)

RightVentricularInvolvement(RVI)isassociatedwithasignificantlygreaterriskofin-hospitalmortalityandmajor in-hospital complications.5FollowingtheAHA/ACCstandards6 Marquette 12SL will call out from the regular 12-lead ECG that RV involvement should be considered.

Benefit: • Reducedriskofdeathshockandarrythmiasthrough improved diagnosis on the 15-lead ECG on the basis of an ST-segment elevation in the right precordial leads(e.g.leadV4R)7

• Marquette12SLisguidingtheuseronwhento considerRVIandapply15-leads

• Validatedonamulti-sitedatabaseofover1.300 chest pain ECGs.

Becausetreatmentofinfarctionmay vary with right ventricular involvement,recordingofadditionalright-sided precordial leads during acuteinferiorwall,leftventricularinfarction is recommended. Routi-nerecordingoftheseleads,intheabsenceofacuteinferiorinfarction,is not recommended. (Circulation2007).8

Superior Vena Cava

Acute Marginal

Artery

Right Coronary

Artery

Left Anterior Descending Artery

Left Main Coronary Artery

Aorta

Pulmonary Trunk

Right Coronary Thrombus

2004 2006

Hookup Advisor

Right Ventricular Involvement

Hookup Advisor

MarquetteHookupAdvisorenableshighquality ECGs by measuring impedance plus the signal quality of the ECG leads.

• Theeasytounderstandred-yellow-greensignal indicates the quality of the ECG. • TheHookupadvisornotonlytakesskincontact throughimpedanceintoconsideration,butalso looksattheECGsignalandelectrodemotion ornoisecomingfrommovement,ACor muscle tremor.

Benefit: • Thesystemindicatesthecauseofinterference, so that the root cause can be eliminated without using higher filters.

Page 6: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Pace Statements

Bipolarpacinghasleadtoareductionofpulseamplitudes and width.9 Therefore it is necessary to detectpacemakerpulsesatasamplingratethatismuchgreaterthanisrequiredforconventionalECGanalysis.InconjunctionwiththeCAMHD,GE’shigh-definitionECGacquisitionmodule,theMarquette12SLprogramisableto identify a biventricular paced rhythm.

• Thepacemakerannotationchannelwillthenbe shown in the MUSETM ECG management system

• Validationofpacemakerdetectioninthree different studies1

Benefit: • Marquette12SLprovidesanalysisfordetecting bi-ventricularpacemakers,identifyingtheunderlying rhythm,inadditiontothechamber(s)beingpaced

Acute Coronary Syndrome (ACS) Tool

The Marquette 12SL ACS tool* increases sensitivity for ST-ElevatedMIorAcuteIschemiainpatientssuspectedof having an acute cardiac event. The tool heavily weighs the finding of ST elevation with reciprocal ST depression. This is a very important and highly-specific indicator of STEMIandACSthathasbeenfoundto“identifypatientswho stand to benefit most from early interventional strategies.”10 Astudyevaluatedonover1,900clinicallycorrelatedECGs1 from patients suspected of having ACS showed that the ACS tool:

Benefit: • Improvedthesensitivityofemergencyphysicians’ interpretation of acute myocardial infarction by 50%andcardiologists’interpretationsby26%, with no loss of specificity11

• Improvedthesensitivityofemergency physicians’acuteischemicsyndrome interpretationby53%while maintaining a specificity of91%11

2011

PaceStatementsAcute Coronary

Syndrome

Page 7: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Recommendations of filtering• ToavoiddistortionoftheSTsegmentthelow-frequencycut-offshouldbe nohigherthan0.67Hzin“auto”mode,or0.05Hzin“manual”mode.8 • Topreventthelossofhighfrequencyinformationthehighfrequency cutoffshouldbenolowerthan150Hzinadultsandadolescents.8

Benefit: • HookupAdvisorwilllistthecauseofinterferenceisindicatedtoremove root-cause potentially avoiding the need of filtering

• Flexiblefiltersettingsallowpermanentandad-hockchangestofilter if needed

ECG Recording - why quality matters...The outcome of the ECG measurement and interpretation improve with the quality of the ECG recording and processing. ThereforetheAHA/ACCestablishedECGstandardsandrecommendationstoimprovetheaccuracyandusefulnessoftheECGinpractice.12

Recommendations on electrode positioning• ElectrodesmustbepositionedinaccordancewithAHArecommendations. Ifanyoftheelectrodeneedtobesitedinnon-standardpositionsthe recording must be labelled with this information to avoid misinterpretation of altered ECG waveforms.12,13,14

Benefit: • Hook-upadvisorindicatesthequalityoftheECGwith an easy-to-understand red-yellow-green signal

• Suspectarmleadreversalsareindicated,butnot considered in the interpretation

• Toolsandtrainingmaterialssupportcorrectpositioning

More than

300,000,000ECGs are recorded in Europe every year.15

TheECGisaquick,non-invasiveprocedure that many patients undergo as the first test!

Page 8: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Clinically validated ECG measurement and interpretationThe IEC Standard 60601-2-25:201116 defines the validation requirements:

Measurement accuracy

• Rhythminterpretationaccuracymustbetestedonatleast1.500ECGs, 100 with Afib

Diagnosticinterpretationaccuracy • Accuracymustbevalidatedvianon-ECGdata • Performanceinformationshallbedisclosedinaccompanyingdocuments andreadilyavailabletocustomerswhowanttoknowtheinformation

The Marquette 12SL ECG analysis program is continually refined through the following processes1:

• Regularclinicalinput–continuousinputisgatheredfromsomeofthe world’stopconsultingcardiologistsandphysicians.

• Clinicallycorrelateddatabases–GEutilizesdifferentdatabasesduring the development and validation processes to enhance program accuracy.

• Beyondclinically-correlateddatabasesGEmeasuresitsanalysis programperformanceonalargedatabaseofECGs(>50,000). This process challenges the program with multiple diseases and varying degrees of abnormality. ECGs with changed analysis results due to program modification can be further investigated with expertconfirmation.

Benefit:

• Improvedprogramaccuracy,whichhelpsclinicianstoimprovepatientcare.

Marquette 12SL

Disclosure of Accuracy/ Confirmation1

ICE60601-2-51inproductspecification-performance standard for ECG analysis

Measurement Accuracy via CSE database

Stabiliy of measurements in presence of noise - CSE recordings

Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist,includesatleast100ECGswithartrialfibrillation

Accuracy of conduction abnormalities by cardiologist

AccuracyofLVH,RVH,oldinfarctionviaCSEdatabase(NEJM1991)

STEMIconfirmedbycardiacenzymes&clinicaloutcome

Acute ischemia via longitudinal clinical outcome

AccuracyofQTmeasurementbycorelabanddrugdosage

Independentevaluation:articleswhereinventor/vendor is not an author

>30

Page 9: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

Connected Clinical Excellence

MAC 600 Electrocardiograph

MAC 800 Electrocardiograph

MAC 2000 Electrocardiograph

CardioSoftDiagnosticSystem

MAC 3500 Electrocardiograph

MAC5500HD Electrocardiograph

CARESCAPEMonitor

SEER 12 Holterrecorder

Page 10: Marquette 12SL Algorithm · Rhythm interpretation accuracy on over 1.500 ECGs by cardio-logist, includes at least 100 ECGs with artrial fibrillation Accuracy of conduction abnormalities

www.gehealthcare.com

GEHealthcareprovidestransformationalmedicaltechnologiesand services that are shaping a new age of patient care.

Ourbroadexpertiseinmedicalimagingandinformationtechnologies,medicaldiagnostics,patientmonitoringsystems,drugdiscovery,biopharmaceuticalmanufacturingtechnologies,performanceimprovementandperformancesolutions services help our customers to deliver better care to more people around the world at a lower cost.

Inaddition,wepartnerwithhealthcareleaders,strivingtoleverage the global policy change necessary to implementa successful shift to sustainable healthcare systems.

Imagination at work

GEHealthcare P.O.Box900, FIN-00031GE,Finland GEDirectUnitedKingdom:+44(0)8000329201

©2016GeneralElectricCompany–Allrightsreserved.

GeneralElectricCompanyreservestherighttomakechangesinspecificationsandfeaturesshownherein, or discontinue the product described at any time without notice or obligation.

GE,GEMonogram,Imaginationatwork,Marquette,MUSE,MAC,CardioSoftandCARESCAPEaretrademarks of General Electric Company.

GEHealthcare,adivisionofGeneralElectricCompany.

JB39052XE04/2016

References:

1 Marquette™12SL™ECGAnalysisProgramPhysician’sGuide2036070-006RevisionC,2010, 2012 General Electric Company

2 Wright,R.S.,et.al.“WomenwithAcuteAnteriorMyocardialInfarctionHaveLessPrecordial STElevationThanMenIndependentofAgeofPresentation.”JAmCollCardiol.37(2001):361A.

3 Xue,J.,et.al.“ANewMethodtoIncorporateAgeandGenderIntotheCriteriafortheDetection ofAcuteInferiorMyocardialInfarction.”JElectrocardiol.34(4)(Part2)(Oct2001):229-234.

4 Al-KhatibSM,et.al.,WhatCliniciansShouldKnowAbouttheQTIntervall,Jama2003; 289(16):2120-2127.

5 Zehender,M.,etal.(1993).“Rightventricularinfarctionasanindependentpredictorof prognosisafteracuteinferiormyocardialinfarction.”NEnglJMed

6 AntmanEM,AnbeDT,ArmstrongPW,BatesER,GreenLA,HandM,etal.ACC/AHAguidelines for the management of patients with ST-elevation myocardial infarction: a report of the AmericanCollegeofCardiology/AmericanHeartAssociationTaskForceonPractice Guidelines(CommitteetoRevisethe1999GuidelinesfortheManagementofPatientswith AcuteMyocardialInfarction).Circulation.2004;Aug31;110(9):e82-292.

7 “PatientswithinferiorMIwhoalsohaveRVmyocardialinvolvementareatincreasedrisk ofdeath,shockandarrhythmias.”Mehta,S.R.,etal.(2001). “Impactofrightventricularinvolvementonmortalityandmorbidityinpatientswithinferior myocardial infarction.” J Am Coll Cardiol

8 KligfieldP,GettesLS,BaileyJJ,ChildersR,DealBJ,HancockEW,etal.Recommendations fortheStandardizationandInterpretationoftheElectrocardiogram.PartI:The ElectrocardiogramandItsTechnology.AScientificStatementFromtheAmericanHeart AssociationElectrocardiographyandArrhythmiasCommittee,CouncilonClinicalCardiology; theAmericanCollegeofCardiologyFoundation;andtheHeartRhythmSociety.Endorsedby theInternationalSocietyforComputerizedElectrocardiology.Circulation.2007Feb23.

9 Improvedpacemakerplusedetection:clinicalevaluationofanewhigh-bandwith electrocardiographicsystem.JElectrocardiol,2011.

10 Otto,L.A.andT.P.Aufderheide,EvaluationofSTsegmentelevationcriteriafortheprehospital electrocardiographic diagnosis fo acute myocardial infarction. AnnEmergMed,1994.23(1):p.17-24.

11 Xue,J.,etal.,Addedvalueofnewacutecoronarysyndromecomputeralgorithmfor interpretationofprehospitalelectrocardiograms.JElectrocardiol,2004.37Suppl:p.233-9.

12 RecommendationsfortheStandardizationandInterpretationoftheElectrocardiogram,Paul Kligfield,MD,FAHA,FACC;LeonardS.Gettes,MD,FAHA,FACC;JamesJ.Bailey,MD;Rory Childers,MD;BarbaraJ.Deal,MD,FACC;E.WilliamHancock,MD,FACC;GerardvanHerpen, MD,PhD;JanA.Kors,PhD;PeterMacfarlane,DSc;DavidM.Mirvis,MD,FAHA;OllePahlm,MD, PhD;PenttiRautaharju,MD,PhD;GalenS.Wagner,MD,2007bytheAmericanHeartAssocia- tion,Inc.,theAmericanCollegeofCardiologyFoundation,andtheHeartRhythmSociety

13 KossmanCE,BrodyDA,BurchGE,HechtH,JohnstonFD,KayC,LepeschkinE,PipbergerHV, BauleG,BersonAS,BrillerSA,GeselowitzDB,HoranLG,SchmittOH.Recommendationsfor standardizationofleadsandofspecificationsforinstrumentsinelectrocardiographyand vectorcardiography.Circulation1967;35:583-601.

14 PipbergerHE,ArzbaecherRC,BersonAS.AmericanHeartAssociationCommitteeon Electrocardiography:recommendationsforstandardizationofleadsandofspecificationsfor instrumentsinelectrocardiographyandvectorcardiography.Circulation1975;52:11-31.

15 WorldHealthOrganisation(1981)RegionalOfficeforEurope.UsesoftheElectrocardiogram. ReportonaWHOstudy;CopenhagenEUROReportsandStudies37(projectICP/ATH003). WHO,Geneva

16 IEC60601-2-25:2011Medicalelectricalequipment-Part2-25:Particularrequirementsfor the basic safety and essential performance of electrocardiographs

*The12SLACSalgorithmisnotavailableinallGEHealthcareECGdevices. ContactyourGEHealthcareRepresentativeformoredetails.