VERITAS Adult and Pediatric Resting ECG Physicians Guide Rev B1

Copyright © 2009 by Mortara Instrument, Inc. 7865 N. 86th Street Milwaukee, Wisconsin 53224

This document contains confidential information that belongs to Mortara Instrument, Inc. No part of this document may be transmitted, reproduced, used, or disclosed outside of the receiving organization without the express written consent of Mortara Instrument, Inc. Mortara is a registered trademark of Mortara Instrument, Inc. VERITAS is a trademark of Mortara Instrument, Inc. PRECAUTIONS: Some Mortara products are not equipped with the pediatric resting ECG interpretation feature. Refer to user manual for proper instructions and precautions pertaining to equipment use.

TABLE OF CONTENTS RHYTHM STATEMENTS Rhythm Statements and Modifiers (UNIPRO)...3 Rhythm Statements...3 Modifiers ...4 Modifiers Used with Atrial Fibrillation...4 Modifiers Used with Atrial Flutter...4 Rhythm Statements and Modifiers (UNIPRO 32)...5 Rhythm Statements...5 Modifiers ...5 Modifiers Used with Atrial Fibrillation...5 Modifiers Used with Atrial Flutter...5

ADULT CRITERIA Arm Lead Reversal and Dextrocardia ...7 Wolff-Parkinson-White ...8 Atrial Enlargement ...9 Axis Deviation...9 Low Voltage ...10 S1-S2-S3 Pattern ...10 Pulmonary Disease ...11

ADULT CONDUCTION ABNORMALITIES Right Bundle Conduction ...13 Left Bundle Conduction ...14 Non Specific Conduction Abnormality ...16

ADULT HYPERTROPHY Right Ventricular Hypertrophy...17 Left Ventricular Hypertrophy...18

ADULT MYOCARDIAL INFARCT Myocardial Infarct Discussion...21 Anterior Infarct...22 Septal Infarct ...24 Anteroseptal Infarct ...25 Lateral Infarct ...26 Anterolateral Infarct ...27 Inferior Infarct ...28 Inferior Infarct with Posterior Extension...29 Infarct Suppressions ...29

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TABLE OF CONTENTS

ADULT ST ELEVATION ST Segment Elevation ...31 Early Repolarization ...31 Pericarditis...32 Anterior and Septal Epicardial Injury...33 Lateral Epicardial Injury...35 Inferior Epicardial Injury...36

ADULT ST DEPRESSION ST Depression ...37

ADULT T WAVE ABNORMALITIES T Wave Abnormality, Ischemia...39 T Wave Abnormality, Nonspecific...41

ADULT BRUGADA Brugada ...43

ADULT REFERENCE SUMMARY Bradycardia and Tachycardia Age Table ...45 Analysis Program Testing Method ...45 Classification of Diagnostic Statements ...45 List of Main Categories for A and B Type Statements...48 Chart 1, Sensitivity, Specificity and Predictive Accuracies, Rhythm Criteria...50 Chart 2, Sensitivity, Specificity and Predictive Accuracies, Contour Criteria ...51 Rhythm Criteria, Mortara Instrument ECG Analysis Program ...52 Table 1, Rhythm Criteria ...53 Table 2, Contour Criteria...55 Supplement to Tables 1 and 2...56 Definitions ...57

PEDIATRIC CRITERIA Arm Lead Reversal and Dextrocardia ...59 Wolff-Parkinson-White ...59 Atrial Enlargement ...60 Axis Deviation...60

PEDIATRIC CONDUCTION ABNORMALITIES Right Bundle Conduction ...61 Left Bundle Conduction ...61 Ventricular Conduction Delay...62

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TABLE OF CONTENTS

PEDIATRIC HYPERTROPHY Right Ventricular Hypertrophy...63 Left Ventricular Hypertrophy...66

PEDIATRIC ST SEGMENT ABNORMALITIES ST Segment Elevation ...69 ST Segment Depression ...69

PEDIATRIC T WAVE ABNORMALITIES T Wave Abnormality, Ischemia...71

PEDIATRIC TRICUSPID ATRESIA Tricuspid Atresia ...75

PEDIATRIC ENDOCARDIAL CUSHION DEFECT Endocardial Cushion Defect...77

PEDIATRIC ATRIAL SEPTAL DEFECT Atrial Septal Defect ...79

PEDIATRIC QT INTERVAL ABNORMALITIES QT Prolongation ...81 QT Shortening ...81

PEDIATRIC BRUGADA Brugada ...83

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TABLE OF CONTENTS

PEDIATRIC REFERENCE SUMMARY Age Tables...85 QRS Axis for Age ...85 QRS Duration for Age...85 Prolonged PR Duration, Bradycardia, and Tachycardia for Age ...85 V6 R/S Amplitude Ratio for Age ...85 V1/V3R R/S Amplitude Ratio for Age...85 VERITAS Pediatric Resting ECG Interpretation Evaluation ...86 Rhythm Statements and Modifiers, Performance Measures...87 Rhythm Statements and Modifiers, Database Results ...88 Contour Criteria Statements, Performance Measures...89 Contour Criteria Statements and Modifiers, Database Results...90 Hypertrophy Performance Measures ...91

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PREFACE

PREFACE This guide describes the criteria that the Mortara Instrument VERITAS™ Adult and Pediatric Resting ECG Interpretation algorithm utilizes to analyze and provide interpretive statements for 12-lead ECGs. Adult criteria are considered for patient ages 16 years and older. Adult descriptions are detailed in the first sections of this guide. Pediatric criteria are considered for patient ages 15 years and younger. Pediatric descriptions are detailed in the last sections of this guide. Interpretive statements have two components, the actual interpretive text, and the optional reason statement, which immediately follows in each statement in this Physician’s Guide and provides a synopsis of the principle criteria used to reach the specified conclusion. The intention is to provide these reason statements where users find them helpful. They can be omitted on all ECGs via a setup function on the electrocardiograph. Interpretation of all ECGs proceeds in the sequence of the criteria listing. Ordinarily the last valid statement or conclusion reached within a given section supplants all prior statements. A condition statement follows each interpretive statement. Conditions and their meanings are listed in the table below: Condition

Meaning

Normal ECG

Normal

Atypical ECG

An unusual pattern has been observed but has no specific significance.

Borderline ECG

Criteria have limited specificity or prognostic significance or where only minimal criteria are met.

Abnormal ECG

Abnormal

Abnormal Rhythm ECG

Abnormal Rhythm

No Further Interpretation Possible

Upon detecting the phenomenon in question, no further useful interpretation of the record is possible.

No Condition Associated

Used with statement prefixes and suffixes.

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PREFACE

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RHYTHM STATEMENTS Rhythm Statements and Modifiers (UNIPRO)* Rhythm statements describe the predominant rhythm in the 10 seconds of analyzed data. A modifier, listed after the rhythm statements, may also be added to more accurately describe the type of rhythm. Rhythm Statements Sinus Tachycardia Sinus Rhythm Sinus Bradycardia Atrial Tachycardia Atrial Rhythm Atrial Bradycardia

(abnormal P axis)

Junctional Tachycardia Junctional Rhythm Junctional Bradycardia

(superior P axis and Short PR)

Supraventricular Tachycardia Supraventricular Rhythm Supraventricular Bradycardia

(narrow QRS, regular RR, no P)

Undetermined (regular) rhythm Atrial fibrillation Atrial flutter Electronic ventricular pacemaker

*Electrocardiograph is programmed with the UNIPRO communication protocol.

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RHYTHM STATEMENTS

Modifiers ...with (marked) sinus arrhythmia ...with first degree AV block ...with short PR interval ...with second degree AV block, Mobitz Type (I, II) ...with (occasional/frequent) ventricular premature complexes ...with (occasional/frequent) ectopic premature complexes ...with (occasional/frequent) atrial premature complexes ...with (occasional/frequent) supraventricular premature complexes ...in a pattern of bigeminy ...with marked rhythm irregularity, possible non-conducted PAC, SA block, AV block, or sinus pause. Modifiers Used with Atrial Fibrillation ...with (rapid/slow) ventricular response ...with AV block Modifiers Used with Atrial Flutter ...with aberrant conduction or ventricular premature complexes ...cannot rule out atrial flutter (Regular rate near 150) ...electronic (atrial/ventricular) pacemaker ...contour analysis based on intrinsic rhythm ...intermittent Wolff-Parkinson-White pattern

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RHYTHM STATEMENTS

Rhythm Statements and Modifiers (UNIPRO 32)** Rhythm statements describe the predominant rhythm in the 10 seconds of analyzed data. A modifier, listed after the rhythm statements, may also be added to more accurately describe the type of rhythm. Rhythm Statements Sinus Tachycardia Sinus Rhythm Sinus Bradycardia Atrial Tachycardia Atrial Rhythm Atrial Bradycardia

(abnormal P axis)

Junctional Tachycardia Junctional Rhythm Junctional Bradycardia

(superior P axis and Short PR)

Supraventricular Tachycardia Supraventricular Rhythm Supraventricular Bradycardia

(narrow QRS, regular RR, no P)

Undetermined (regular) rhythm Atrial fibrillation Atrial flutter Criteria for limits of Tachycardia, Bradycardia as well as PR intervals for age are included in the Pediatric Reference Summary. Modifiers ...with AV block ...with prolonged PR interval for age ...with (occasional/frequent) ventricular premature complexes ...with (occasional/frequent) ectopic premature complexes ...with (occasional/frequent) atrial premature complexes ...with (occasional/frequent) supraventricular premature complexes ...in a pattern of bigeminy ...with marked rhythm irregularity, possible non-conducted PAC, SA block, AV block, or sinus pause. Modifiers Used with Atrial Fibrillation ...with (rapid/slow) ventricular response ...with AV block Modifiers Used with Atrial Flutter ...with aberrant conduction or ventricular premature complexes ...cannot rule out atrial flutter ...electronic (atrial/ventricular) pacemaker ...contour analysis based on intrinsic rhythm ...intermittent Wolff-Parkinson-White pattern **Electrocardiograph is programmed with the UNIPRO 32 communication protocol.

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RHYTHM STATEMENTS

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ADULT CRITERIA Arm Lead Reversal and Dextrocardia Criteria IF No Q in lead I and R amplitude < 150uV in lead I or Q amplitude > 0 in lead I and P axis > 90 and PR duration ≥ 110 ms and QRS axis > 90 If above criteria are met and R amplitude < 500 µV in lead V6 and Maximum S amplitude > Maximum R amplitude in lead V6 and P amplitude < 20 µV in lead V6 and P' amplitude < -20 µV in lead V6

THEN PRINT “Arm leads reversed” REASON: Inverted P & QRS in lead I

PRINT “Dextrocardia” REASON: Inverted P & QRS in V6

Rationale Simultaneously negative P and QRS contours in lead ‘I’ are unlikely in a properly recorded ECG. If, in addition, the QRS has a Qr (or rSr') configuration, the most probable explanation is that the arm leads are reversed or dextrocardia is present. If lead V6 has a typical upright configuration, arm lead reversal is more likely: otherwise, dextrocardia is the remaining plausible explanation. Although the reason statement for both lead reversal and dextrocardia mentions only the inverted P & QRS, the requirement of Qr/rSr' morphology is important to distinguish these cases from pulmonary disease and right ventricular hypertrophy patterns, where rS configurations are the norm. (Further separation from the latter is ensured by the requirement of an inverted P.)

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ADULT CRITERIA

Wolff-Parkinson-White SKIP TEST IF The test for coupled P wave to QRS is negative or PR duration > 170 ms or QRS duration < 100 ms or Heart rate > 120 BPM or QRS duration > 200 ms or PR duration > 100 ms and QRS duration > 160 ms Criteria IF

THEN

PR duration < 140 ms

PRINT “Atypical Wolff-Parkinson-White Pattern”

and Delta wave is present in 2 leads Delta wave is present in 2 leads

PRINT “Type A Wolff-Parkinson-White Pattern”

and R amplitude > S amplitude in V1 QRS area ratio ≥ 0.6 in 2 leads of I/V5/V6 and R duration > 30 ms in V2 or Delta wave is present in 2 leads and PR duration is < 140 ms and R amplitude ≤ S amplitude in V1

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PRINT “Type B Wolff-Parkinson-White Pattern”

ADULT CRITERIA

Atrial Enlargement Criteria IF Heart rate < 120 and P amplitude > 250 µV in any 1 of leads II/III/aVF/V1/V2 Heart rate < 120 and P amplitude > 300 µV in any 1 of leads II/III/aVF/V1/V2 P' amplitude < -100 µV in V1 or V2 and negative P wave area ≥ 400 µV/ms in the same lead P' amplitude < -150 µV in V1 or V2 and negative P wave area ≥ 600 µV/ms in the same lead

THEN PRINT “Possible right atrial enlargement” REASON: 0.25 mV P wave PRINT “Right atrial enlargement” REASON: 0.3 mV P wave PRINT “Possible left atrial enlargement” REASON: -0.1 mV P wave in V1/V2 PRINT “Left atrial enlargement” REASON: -0.15 mV P wave in V1/V2

Rationale The criteria are the customary ones. For those records meeting only minimal criteria, the qualifier “possible” is used to convey this information. Right atrial enlargement is not “read” for rates of 120 or above, because it is unclear whether increased P amplitude at elevated rates should be attributed to enlargement.

Axis Deviation Criteria IF QRS axis < -20

THEN PRINT “Moderate Left axis deviation”

QRS axis < -30

REASON: QRS axis < -20 PRINT “Abnormal Left axis deviation”

QRS axis > 90

REASON: QRS axis < -30 PRINT “Moderate Right axis deviation”

QRS axis > 100

REASON: QRS axis > 90 PRINT “Abnormal Right axis deviation”

The total net QRS amplitude in leads I, II, and III is < 33% of the total QRS deflection in leads I, II, and III.

REASON: QRS axis > 100 PRINT “Indeterminate axis”

Rationale The criteria are more or less conventional. Borderline cases are characterized by the use of the term “moderate.” (Axis deviation statements are omitted when subsequently identified diagnostic categories may be regarded as the probable cause of the axis deviation.) Whenever the net amplitude is a small fraction of the total QRS deflection in each lead, the measurement of axis is lacking in meaning. The term “indeterminate axis” is used to convey this information.

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ADULT CRITERIA

Low Voltage SKIP TEST IF QRS duration ≥ 120 ms Criteria IF Total QRS deflection < 500 µV in all limb leads

THEN PRINT “Low QRS voltage in limb leads”

Total QRS deflection < 1000 µV in all V leads

REASON: QRS deflection < 0.5 mV in limb leads PRINT “Low QRS voltage in chest leads”

If both of the above are true

REASON: QRS deflection < 1.0 mV in chest leads PRINT “Low QRS voltage” REASON: QRS deflection < 0.5/1.0 mV in limb/chest leads

S1-S2-S3 Pattern Criteria IF

THEN

S amplitude > 300 µV in I

PRINT “S1-S2-S3 pattern, consistent with pulmonary disease, RVH, or normal variant”

and S amplitude > 400 µV in II and S amplitude > 700 µV in III or S amplitude > R amplitude in leads I, II & III and S amplitude > 200 µV in leads I, II & III and the test for R' is negative in any of these leads and age > 15

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ADULT CRITERIA

Pulmonary Disease SKIP TEST IF QRS duration ≥ 120 ms Criteria The test for pulmonary disease is based on counting how many of its typical characteristics are present. One point is awarded for each of • Right atrial enlargement • QRS axis < -30 • QRS axis > 90 • QRS axis is indeterminate • S1-S2-S3 pattern • Low voltage in limb leads • Low voltage in chest leads Three points are awarded if QRS net amplitude is negative in lead V5 and the R (and R') amplitude in V6 < 500 µV. IF Cumulative points > 3

THEN PRINT “Consistent with pulmonary disease”

Rationale There is room to doubt whether sufficient ECG criteria exist to diagnose pulmonary disease. However, if at least 4 (from a list of 8 distinct) features common to pulmonary disease are present, then the comment “consistent with” seems prudent.

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ADULT CRITERIA

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ADULT CONDUCTION ABNORMALITIES Right Bundle Conduction Criteria IF R amplitude > 100 µV in V1 & V2 and R duration > 20 ms in V1 and V2

THEN PRINT “RsR' (QR) in V1/V2 consistent with right ventricular conduction delay”

and no S in V1 or V2 or R' amplitude > 100 µV in V1 & V2 and R' duration > 20 ms in V1 & V2 and no S' in V1 or V2 Either of the above is true

PRINT “Incomplete right bundle branch block”

and QRS duration > 90 ms

REASON: 90+ ms QRS duration, terminal R in V1/V2, 40+ ms S in I/aVL/V4/V5/V6

and QRS duration < 120 ms and S duration ≥ 40 ms in any 2 leads of I/aVL/V4/V5/V6 QRS duration ≥ 120 ms

PRINT “Right bundle branch block”

and S duration ≥ 40 ms in any 2 leads of I/aVL/V4/V5/V6

REASON: 120+ ms QRS duration, upright V1, 40+ ms S in I/aVL/V4/V5/V6

and R duration < 100 ms in any 4 leads of I/aVL/V4/V5/V6 and QRS area > 0 in V1 and V1 does not terminate in S or S' or QRS duration > 105 ms and S duration ≥ 60 ms in any 3 leads of I/aVL/V4/V5/V6 and R duration > 60 ms in V1 and QRS area > 0 in V1 The test for right bundle branch block is positive and R amplitude > 1500 µV in V1 and QRS axis > 110

PRINT “Right bundle branch block plus possible Right Ventricular Hypertrophy” REASON: RBBB, 1.5 mV R in V1, RAD

Rationale Right bundle branch conduction abnormalities exhibit anterior and rightward directed terminal forces. The rightward force should be noticeably prolonged. Thus, in addition to QRS conducting time criteria, tests are included for a widened terminal R wave in V1 and widened terminal S waves in at least two of the lateral leads. Conventional criteria require QRS widths in excess of 0.12 seconds for bundle branch block. However, very wide lateral S waves, a wide R in an upright V1, and QRS duration > 105 ms will also be read as right bundle branch block by most interpreters. This is the basis of the second portion of the complete right bundle branch block test. Specific criteria for right bundle branch block + right ventricular hypertrophy are also included.

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ADULT CONDUCTION ABNORMALITIES

Left Bundle Conduction Criteria IF

THEN

QRS duration > 105 ms

PRINT “Incomplete left bundle branch block”

and QRS net amplitude < 0 in V1 & V2

REASON: 105+ ms QRS duration, 80+ ms Q/S in V1/V2

S duration ≥ 80 ms in V1 & V2 and no Q is present in 2 leads of I/V5/V6

no Q and 60+ ms R in I/aVL/V5/V6

and R duration ≥ 60 ms in 2 leads of I/aVL/V5/V6 QRS axis ≤ -45

PRINT “Left anterior fascicular block”

and R amplitude > Q amplitude in I & aVL

REASON: QRS axis ≤ -45, QR in I, RS in II

and a Q is present in I and S or S' amplitude > R amplitude in II The test for S1-S2-S3 is negative, and the test for PRINT “Left posterior fascicular block” Pulmonary Disease is negative REASON: QRS axis > 109, inferior Q and QRS axis ≥ 110 and R amplitude > Q amplitude in III & aVF and a Q is present in III & aVF The test for Incomplete Left Bundle Branch Block is positive and QRS area ratio > 0.25 in I or V6 and R duration ≥ 100 ms in 1 lead of I/aVL/V6 and QRS duration ≥ 160 ms or QRS duration ≥ 140 ms and the average R duration > 85 ms in I/aVL/V6 or QRS duration ≥ 120 ms and the average R duration > 85 ms in I/aVL/V6 and QRS area ratio > 0.4 in 2 leads of I/aVL/V6

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PRINT “Left bundle branch block” REASON: 120+ ms QRS duration, 80+ ms Q/S in V1/V2, 85+ ms R in I/aVL/V6