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1 Arrhythmias and Devices Module 1. 2 Objectives Recognize typical rhythms and rhythm disorders.

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Presentation on theme: "1 Arrhythmias and Devices Module 1. 2 Objectives Recognize typical rhythms and rhythm disorders."— Presentation transcript:

1 1 Arrhythmias and Devices Module 1

2 2 Objectives Recognize typical rhythms and rhythm disorders

3 3 Arrhythmias and Devices Overview The Conduction System –Normal Conduction –Automaticity & Action Potential –Causes of Rhythm Disorders Rhythm Disorders –Categories Disorders of Impulse Formation Disorders of Impulse Conduction –Mechanisms Arrhythmia Recognition and Classification –Bradycardias –Tachycardias

4 4 Cardiac Conduction Sinus Node The Hearts Natural Pacemaker –Rate of bpm at rest Sinus Node (SA Node)

5 5 Cardiac Conduction AV Node Receives impulses from SA node Delivers impulses to the His-Purkinje System Delivers rates between bpm if SA node fails to deliver impulses Atrioventricular Node (AV Node)

6 6 Cardiac Conduction HIS Bundle Begins conduction to the ventricles AV Junctional Tissue: –Rates between bpm Bundle of His

7 7 Cardiac Conduction Purkinje Fibers Bundle Branches and Purkinje Fibers Moves the impulse through the ventricles for contraction Provides Escape Rhythm: –Rates between bpm Purkinje Network

8 8 Normal Sinus Rhythm

9 9 Impulse Formation in SA Node

10 10 Atrial Depolarization

11 11 Delay at AV Node

12 12 Conduction through Bundle Branches

13 13 Conduction through Purkinje Fibers

14 14 Ventricular Depolarization

15 15 Plateau Phase of Repolarization

16 16 Final Rapid (Phase 3) Repolarization

17 17 Normal ECG Activation This pattern of depolarization results in efficient mechanical contraction – which is the purpose – to pump blood.

18 18 Reading ECG Squares Intervals and Timing Horizontal axis – time: Each small square = 40 ms Each block = 200 ms (5 ea. 40 ms squares) Converting this to a rate in bpm: 1 min = 60,000 ms, so: 60,000/ms = bpm –60,000/600ms = 100 bpm Pacemakers and ICDs calculate intervals (ms), not in rates (bpm)

19 19 ECGs Annotation Normal Ranges in Milliseconds: PR Interval 120 – 200 ms QRS Complex 60 – 100 ms QT Interval 360 – 440 ms

20 20 Status Check This ECG shows a QRS duration of about 100 ms – a normal duration. If this represents efficient ventricular contraction… …then what effect could a QRS duration of 200 ms have on mechanical efficiency and cardiac output? Click for Answer Inefficient contraction

21 21 Status Check Match the term on the left with the description on the right P-R Interval AV Node Purkinje Network Bundle Branches Click for Answer Normally ms Escape rate is bpm Depolarizes the Ventricles Connect His bundle to Purkinje network

22 22 Weve Seen How the Normal Pattern of Conduction Occurs But: What triggers the depolarization – what causes that first cell to depolarize? If a cell depolarizes, why does it result in depolarization in other cells?

23 23 Automaticity Cardiac Cells are unique because they spontaneously depolarize Upper (SA Node) –60-80 bpm Middle (AV Junction) –40-60 bpm Lower (Purkinje Network) –20-40 bpm

24 24 Automaticity Once a pacemaker cell initiates an impulse, its neighboring cells follow suit – like dominos.

25 25 Action Potential of a Cardiac Cell 5 Phases Phase 0 –Rapid or upstroke depolarization with an influx of sodium ions into the cell Phase 1 –Early rapid repolarization with transient onward movement of potassium ions Phase 2 –Plateau Phase: Continued Influx of Sodium and slow Influx of Calcium Phase 3 –Repolarization: Potassium outflow Phase 4 –Resting Phase

26 26 Action Potential of a Cardiac Cell 5 Phases Phase 0 –Rapid or upstroke depolarization with an influx of sodium ions into the cell Phase 1 –Early rapid repolarization with transient onward movement of potassium ions Phase 2 –Plateau Phase: Continued Influx of Sodium and slow Influx of Calcium Phase 3 –Repolarization: Potassium outflow Phase 4 –Resting Phase

27 27 Action Potential of a Cardiac Cell 5 Phases Phase 0 –Rapid or upstroke depolarization with an influx of sodium ions into the cell Phase 1 –Early rapid repolarization with transient onward movement of potassium ions Phase 2 –Plateau Phase: Continued Influx of Sodium and slow Influx of Calcium Phase 3 –Repolarization: Potassium outflow Phase 4 –Resting Phase

28 28 Action Potential of a Cardiac Cell 5 Phases Phase 0 –Rapid or upstroke depolarization with an influx of sodium ions into the cell Phase 1 –Early rapid repolarization with transient onward movement of potassium ions Phase 2 –Plateau Phase: Continued Influx of Sodium and slow Influx of Calcium Phase 3 –Repolarization: Potassium outflow Phase 4 –Resting Phase

29 29 Action Potential of a Cardiac Cell 5 Phases Phase 0 –Rapid or upstroke depolarization with an influx of sodium ions into the cell Phase 1 –Early rapid repolarization with transient onward movement of potassium ions Phase 2 –Plateau Phase: Continued Influx of Sodium and slow Influx of Calcium Phase 3 –Repolarization: Potassium outflow Phase 4 –Resting Phase

30 30 Action Potential of a Cardiac Cell 5 Phases Phase 0 –Rapid or upstroke depolarization with an influx of sodium ions into the cell Phase 1 –Early rapid repolarization with transient onward movement of potassium ions Phase 2 –Plateau Phase: Continued Influx of Sodium and slow Influx of Calcium Phase 3 –Repolarization: Potassium outflow Phase 4 –Resting Phase

31 31 Action Potential of a Cardiac Cell Refractory Periods ERP - Effective Refractory Period –AKA: Absolute Refractory Period –Phases 0, 1, 2, and early Phase 3 –A depolarization cannot be initiated by an impulse of any strength RRP - Relative Refractory Period –Late Phase 2 and early Phase 3 –A strong impulse can cause depolarization, possibly with aberrancy –R on T phenomena

32 32 Causes of Rhythm Disorders Congenital Present at birth due to genetics, or conditions during the peri-natal environment Cardiac and other diseases Myocardial Infarction, high blood pressure, cardiomyopathy, valvular heart disease Acquired Medications (even anti-arrhythmic Rx), diet pills, cold remedies, illegal drugs, caffeine and/or alcohol abuse, tobacco use...

33 33 Causes of Rhythm Disorders Secondary to other conditions Hyper-Thyroid Neurocardiogenic Syncope - Hypersensitive Carotid Sinus Syndrome (CSS) - Vasovagal Syncope (VS)

34 34 Disorders of Rhythm Disorders 2 Categories Impulse Formation Impulse Conduction Abnormal Automaticity Triggered Activity

35 35 Rhythm Disorders 2 Categories Impulse Formation Abnormal Automaticity Triggered Activity Bradycardia: Abnormally slow rates usually due to disease Tachycardia: Excessively rapid rates due to ANS

36 36 Rhythm Disorders 2 Categories Impulse Formation Abnormal Automaticity Triggered Activity Depolarization occurring in Phase 3 or 4 of the action potential can trigger arrhythmias

37 37 Mechanisms of Rhythm Disorders Triggered Activity Early Afterdepolarization Potential Causes: - Low potassium blood levels - Slow heart rate - Drug toxicity (ex. Quinidine causing Torsades de Pointes type of VT) Late Afterdepolarization Potential Causes: - Premature beats - Increased calcium blood levels - Increased adrenaline levels - Digitalis toxicity

38 38 Rhythm Disorders Two Categories Impulse Formation Impulse Conduction Abnormal Automaticity Triggered Activity Slow or Blocked Conduction Reentry

39 39 Mechanisms of Rhythm Disorders Slowed or Blocked Conduction Impulse generated normally Impulse slowed or blocked as it makes its way through the conduction system

40 40 Rhythm Disorders Two Categories Impulse Formation Impulse Conduction Abnormal Automaticity Triggered Activity Slow or Blocked Conduction Reentry

41 41 Mechanisms of Rhythm Disorders Reentry Model Conduction paths are mirrored Pathway A: Slow conduction but short (fast) refractory Pathway B: Fast conduction but long (slow) refractory period

42 42 By the time the slow antegrade conduction is complete, the fast pathway is no longer refractory, allowing retrograde conduction to occur. Mechanisms of Rhythm Disorders Reentry Model A premature event occurs, which is conducted down the slow pathway. During this antegrade conduction, the fast or retrograde pathway is still refractory This circus mechanism is maintained as long as the relationship between fast and slow conduction, and fast/slow refractoriness persists. A premature event occurs, which is conducted down the slow pathway. During this antegrade conduction, the fast or retrograde pathway is still refractory.

43 43 Mechanisms of Rhythm Disorders Reentry Model These are sometimes referred to as circus tachycardias. This mechanism explains one common arrhythmia seen in the EP lab: AV node re-entrant tachycardia. Note the almost simultaneous depolarization of the atria and ventricles. V-V Intervals ms A-V Intervals ms

44 44 Terminating Reentry Spontaneous termination –Another premature beat that disturbs the underlying conduction/refractoriness relationships Pace the heart at a rate above the tachycardia rate –Abruptly stop pacing –This is how implantable cardioverter-defibrillators can stop VT without a shock (ATP)

45 45 Disorders of Bradycardia Classifications Impulse Formation Impulse Conduction

46 46 Bradycardia Classifications Impulse Formation Impulse Conduction Sinus Arrest Brady/Tachy Syndrome Sinus Bradycardia

47 47 Sinus Arrest Failure of sinus node discharge Absence of atrial depolarization Periods of ventricular asystole May be episodic as in vaso-vagal syncope, or carotid sinus hypersensitivity –May require a pacemaker

48 48 Sinus Bradycardia Sinus Node depolarizes very slowly If the patient is symptomatic and the rhythm is persistent and irreversible, may require a pacemaker

49 49 Brady/Tachy Syndrome Intermittent episodes of slow and fast rates from the SA node or atria Brady < 60 bpm Tachy > 100 bpm AKA: Sinus Node Disease –Patient may also have periods of AF and chronotropic incompetence –75-80% of pacemakers implanted for this diagnosis

50 50 Impulse Formation Impulse Conduction Sinus Arrest Brady/Tachy Syndrome Sinus Bradycardia Exit Block Bi/Trifascicular Block 1 st Degree AV Block 2 nd Degree AV Block 3 rd Degree AV Block Bradycardia Classifications

51 51 Exit Block Transient block of impulses from the SA node –Sinus Wenckebach is possible, but rare Pacing is rare unless symptomatic, irreversible, and persistent

52 52 First-Degree AV Block PR interval > 200 ms Delayed conduction through the AV Node -Example shows PR Interval = 320 ms -Not an indication for pacing -Some consider this a normal variant (not an arrhythmia)

53 53 Second-Degree AV Block – Mobitz I Progressive prolongation of the PR interval until there is failure to conduct and a ventricular beat is dropped AKA: Wenckebach block –Usually not an indication for pacing

54 54 Second-Degree AV Block – Mobitz II Regularly dropped ventricular beats –2:1 block (2 P-waves for every 1 QRS complex) –Atrial rate = 75 bpm, Ventricular rate = 42 bpm A high grade block, usually an indication for pacing –May progress to third-degree, or Complete Heart block (CHB)

55 55 Third-Degree AV Block No impulse conduction from the atria to the ventricles –Atrial rate = 130 bpm, Ventricular rate = 37 bpm –Complete A – V disassociation –Usually a wide QRS as ventricular rate is idioventricular

56 56 Fascicular Block Right bundle branch block and left anterior hemiblock Right bundle branch block and left posterior hemiblock Complete left bundle branch block

57 57 Trifascicular Block Complete block in the right bundle branch, and Complete or incomplete block in both divisions of the left bundle branch Identified by EP Study

58 58 Impulse Formation Impulse Conduction Sinus Arrest Brady/Tachy Syndrome Sinus Bradycardia Exit Block Bi/Trifascicular Block 1 st Degree AV Block 2 nd Degree AV Block 3 rd Degree AV Block Bradycardia Classifications Summary

59 59 Status Check What is the most likely rhythm disorder that might result in a patient getting a pacemaker? –Sinus node disease Sinus node disease is otherwise known as? –Brady-tachy syndrome What are some symptoms a patient might complain of? –Fatigue, shortness of breath, palpitations, inability to perform activities of daily living, vertigo, syncope, racing heart at rest, slow pulse rate Click for Answer

60 60 Status Check What are some simple diagnostic tests used to make this diagnosis? –12-lead ECG, GXT, Ambulatory ECG (Holter) Click for Answer

61 61 Terms Describing Ventricular Tachycardias Paroxysmal (may be used with VT or SVT) – Ectopic focus, sudden onset, abrupt cessation Sustained (usually used with VT) – Duration of > 30 seconds – Requires intervention to terminate Non-Sustained (usually used with VT) – At least 6 beats or < 30 seconds – Spontaneously terminates Recurrent (usually used with VT) – Occurs periodically – Periods of no tachycardia are longer than periods of tachycardia

62 62 Terms Describing Ventricular Tachycardias Monomorphic – Single focus – Complexes are similar with equal intervals Polymorphic – Multiple foci – Complexes appear different with varied intervals Incessant – Long periods of tachy, short periods of NSR

63 63 Terms Describing SVT SVTs (Supraventricular Tachycardia)originating from above the ventricles –Paroxysmal: Sudden onset and spontaneous cessation –Persistent: Requires intervention to terminate, usually >24-48 hour duration –Permanent or Chronic: Unable to terminate

64 64 Disorders of Tachycardia Classifications Impulse Formation Impulse Conduction

65 65 Tachycardia Classifications Impulse Formation Impulse Conduction Sinus Tachycardia Premature Contractions Atrial Tachycardia Accelerated Junctional Rhythm Accelerated Idioventricular Rhythm (AIVR)

66 66 Sinus Tachycardia Origin: Sinus Node Rate: bpm Mechanism: Abnormal or Hyper Automaticity (for example, exercise)

67 67 Atrial Tachycardia Origin: Atrium - Ectopic Focus Rate: >100 bpm Mechanism: Abnormal Automaticity

68 68 Premature Beats Premature Atrial Contraction (PAC) Origin: Atrium (outside the Sinus Node) Mechanism: Abnormal Automaticity Characteristics: An abnormal P-wave occurring earlier than expected, followed by compensatory pause

69 69 Origin: AV Node Junction Mechanism: Abnormal Automaticity Characteristics: A normally conducted complex with an absent P-wave, followed by a compensatory pause Premature Beats Premature Junctional Contraction (PJC)

70 70 Origin: Ventricles Mechanism: Abnormal Automaticity Characteristics: A broad complex occurring earlier than expected, followed by a compensatory pause Premature Beats Premature Ventricular Contraction (PVC)

71 71 PVC Patterns Bigeminy -Every other beat Trigeminy -Every third beat Quadrigeminy -Every fourth beat

72 72 Origin: Varies within the Ventricle Mechanism: Abnormal Automaticity Characteristics: Each premature beat changes axis; implies a different focus of origin for each beat Note: PVCs by themselves are not a predictor of VT/VF, nor do they imply the need for a defibrillator Multifocal PVC

73 73 Accelerated Junctional Rhythm Origin: AV Node or Junctional Tissue Mechanism: Abnormal Automaticity Characteristics: Occurs when AV nodal cells depolarize at a rate faster than the sinus node

74 74 Accelerated Idioventricular Rhythm Origin: Ventricle Mechanism: Abnormal Automaticity Rate: Ventricular rate >sinus rate, but

75 75 Accelerated Idioventricular Rhythm Sinus Rhythm being taken over by an Idioventricular Rhythm

76 76 Tachycardia Classifications Based on disorder Impulse Formation Impulse Conduction Sinus Tachycardia Premature Contractions Atrial Tachycardia Accelerated Junctional Rhythm Accelerated Idioventricular Rhythm (AIVR) Atrial Flutter Atrial Fibrillation AVRT/AVNRT Ventricular Tachycardia Ventricular Fibrillation

77 77 Atrial Flutter Origin: Right and Left Atrium Mechanism: Reentry, circus tachycardia, may be clockwise or counter-clockwise Rate: 250 – 400 bpm Characteristics: Rapid, regular P-waves, regular R-waves

78 78 Origin: Right and/or left atrium, pulmonary veins Mechanism: Multiple wavelets of reentry Atrial Rate: > 400 bpm Characteristics: Random, chaotic rhythm; associated with irregular ventricular rhythm Atrial Fibrillation (AF)

79 79 Atrial Fibrillation (AF)

80 80 AF Mechanism Paroxysmal: Sudden onset and spontaneous cessation Persistent: Requires intervention to terminate, usually > hour duration Permanent or Chronic: Unable to terminate AF begets AF –The more frequent the AF the more frequently it will re-occur and episodes tend to last longer

81 81 Mutifocal Atrial Tachycardia Mechanism: Abnormal Automaticity (multi-sites) Characteristics: Many depolarization waves; activation occurs asynchronously Not commonly used terms anymore, usually just called AF Other AF Mechanisms Single Foci Mechanism: Abnormal Automaticity (single- focus, usually in the Posterior Left Atrium) Characteristics: Rapid discharge; single ectopic site Parasystole – rare

82 82 Atrial Flutter vs. Atrial Fibrillation Summary of Disease Characteristics Atrial FlutterAtrial Fibrillation Atrial Rate250 to 400 bpm400 bpm Ventricular Rate/Rhythm Usually regularVaries with conduction Grossly irregular PatternSaw tooth baselineIrregular or almost flat baseline Irregularly irregular Underlying MechanismReentry via macro re- entrant circuit Typically multiple wavelet reentry

83 83 AVRT AV Re-entrant Tachycardia An SVT caused by the existence of an extra pathway from the atria to the ventricles –Extra pathway + AV Node = reentry Two Types –Orthodromic –Antidromic

84 84 Orthodromic Mechanism: Reentry Rate: bpm+ Characteristics: Extra electrical pathway to ventricles AVRT Accessory Pathway Conduction to the ventricles via the AV node (normal conduction) - then from Ventricles to the Atria via the accessory pathway. Produces narrow complex SVT.

85 85 Antidromic Mechanism: Reentry Rate: bpm+ Characteristics: Extra electrical pathway to ventricles. Wide-complex QRS. AVRT Accessory Pathway Conduction to ventricles via the accessory pathway. The impulse is then conducted retrograde to atrial via the AV node. Produces a wide-complex SVT.

86 86 Origin: A - V conduction outside the AV node. The Wolff pathway conducts faster than the AV node Mechanism: Reentry Rate: bpm – can be faster Characteristics: Short PR Interval ( 110 ms), obvious delta wave Wolff-Parkinson-White

87 87 Origin: AV Node Mechanism: Reentry Rate: bpm, faster in teenagers Characteristics: Normal QRS with absent P-waves AVNRT AV Node Re-entrant Tachycardia

88 88 AVRT vs. AVNRT AVRT –180 – 260 bpm –Narrow QRS if orthodromic –Wide QRS if antidromic –Delta wave + in SR –PR < 120 msec –1:1 Conduction AVNRT –150 – 230 bpm –Narrow QRS –Short RP –No delta waves –Initiating PR long –P-waves buried in QRS –Conduction 1:1, or 2:1 when distal block present Treatment: Ablation Rarely is a pacemaker implanted –Perhaps if AV node is injured during ablation

89 89 Tachycardia Classifications Based on disorder Impulse Formation Impulse Conduction Sinus Tachycardia Premature Contractions Atrial Tachycardia Accelerated Junctional Rhythm Accelerated Idioventricular Rhythm (AIVR) Atrial Flutter Atrial Fibrillation AVRT/AVNRT Ventricular Tachycardia Ventricular Fibrillation

90 90 Monomorphic VT Classification Based on ECG Morphology Origin: Ventricles (Single Focus) Mechanism: Reentry initiated by abnormal automaticity or triggered activity Characteristics: Rapid, wide and regular QRS. A-V disassociation

91 91 Origin: Ventricles (Wandering Single Focus) Mechanism: Reentry with movement in the circuit initiated by abnormal automaticity or triggered activity Characteristics: Wide and irregular QRS Complex that changes in axis Polymorphic VT

92 92 Origin: Ventricle Mechanism: Reentry (movement in focus) Rate: 200 – 250 bpm Characteristics: Associated with Long QT interval; QRS changes axis and morphology with alternating positive/negative complexes Torsades de Pointes Twisting of the points

93 93 Origin: Ventricle Mechanism: Multiple wavelets of reentry Characteristics: Irregular with no discrete QRS Ventricular Fibrillation (VF)

94 94 Tachycardia Classifications Summary Impulse Formation Impulse Conduction Sinus Tachycardia Premature Contractions Atrial Tachycardia Accelerated Junctional Rhythm Accelerated Idioventricular Rhythm (AIVR) Atrial Flutter Atrial Fibrillation AVRT/AVNRT Ventricular Tachycardia Ventricular Fibrillation

95 95 Status Check Identify the Rhythm Ventricular Tachycardia Sinus Bradycardia Complete Heart Block Atrial Fibrillation Ventricular Fibrillation Click for Answer

96 96 Status Check Identify the Rhythm Ventricular Tachycardia Sinus Bradycardia Complete Heart Block Atrial Fibrillation Ventricular Fibrillation Click for Answer

97 97 Status Check Identify the Rhythm Ventricular Tachycardia Sinus Bradycardia Complete Heart Block Atrial Fibrillation Ventricular Fibrillation Click for Answer

98 98 Status Check Identify the Rhythm Ventricular Tachycardia Sinus Bradycardia Complete Heart Block Atrial Fibrillation Ventricular Fibrillation Click for Answer

99 99 Status Check Ventricular Tachycardia Sinus Bradycardia Complete Heart Block Atrial Fibrillation Ventricular Fibrillation Click for Answer

100 100 Upcoming Modules The Fundamentals of Cardiac Devices Basic ConceptsElectricity and Pacemakers Applying Electrical Concepts to Pacemakers Pacemaker Basics Single and Dual Chamber Pacemaker Timing Advanced Pacemaker Operations Pacemaker Patient Follow-up Pacemaker Troubleshooting Pacemaker Automatic Features

101 101 Disclosure NOTE: This presentation is provided for general educational purposes only and should not be considered the exclusive source for this type of information. At all times, it is the professional responsibility of the practitioner to exercise independent clinical judgment in a particular situation.

102 102 Brief Statements Indications Implantable Pulse Generators (IPGs) are indicated for rate adaptive pacing in patients who ay benefit from increased pacing rates concurrent with increases in activity and increases in activity and/or minute ventilation. Pacemakers are also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony, which include various degrees of AV block to maintain the atrial contribution to cardiac output and VVI intolerance (e.g. pacemaker syndrome) in the presence of persistent sinus rhythm. Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration of 130 ms. CRT IPGs are indicated for the reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction less than or equal to 35% and a QRS duration of 130 ms. Contraindications IPGs and CRT IPGs are contraindicated for dual chamber atrial pacing in patients with chronic refractory atrial tachyarrhythmias; asynchronous pacing in the presence (or likelihood) of competitive paced and intrinsic rhythms; unipolar pacing for patients with an implanted cardioverter defibrillator because it may cause unwanted delivery or inhibition of ICD therapy; and certain IPGs are contraindicated for use with epicardial leads and with abdominal implantation. ICDs and CRT ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, and for patients who have a unipolar pacemaker. ICDs are also contraindicated for patients whose primary disorder is bradyarrhythmia.

103 103 Brief Statements (continued) Warnings/Precautions Changes in a patients disease and/or medications may alter the efficacy of the devices programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place transthoracic defibrillation paddles directly over the device. Additionally, for CRT ICDs and CRT IPGs, certain programming and device operations may not provide cardiac resynchronization. Also for CRT IPGs, Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at 65 ppm. In this mode, patients may experience loss of cardiac resynchronization therapy and / or loss of AV synchrony. For this reason, the device should be replaced prior to ERI being set. Potential complications Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional complication for ICDs and CRT ICDs is the acceleration of ventricular tachycardia. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult Medtronics website at Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

104 104 Brief Statement: Medtronic Leads Indications Medtronic leads are used as part of a cardiac rhythm disease management system. Leads are intended for pacing and sensing and/or defibrillation. Defibrillation leads have application for patients for whom implantable cardioverter defibrillation is indicated Contraindications Medtronic leads are contraindicated for the following: ventricular use in patients with tricuspid valvular disease or a tricuspid mechanical heart valve. patients for whom a single dose of 1.0 mg of dexamethasone sodium phosphate or dexamethasone acetate may be contraindicated. (includes all leads which contain these steroids) Epicardial leads should not be used on patients with a heavily infracted or fibrotic myocardium. The SelectSecure Model 3830 Lead is also contraindicated for the following: patients for whom a single dose of 40.µg of beclomethasone dipropionate may be contraindicated. patients with obstructed or inadequate vasculature for intravenous catheterization.

105 105 Brief Statement: Medtronic Leads (continued) Warnings/Precautions People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs), and accompanying leads should not receive diathermy treatment. The interaction between the implant and diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in serious injury, loss of therapy, or the need to reprogram or replace the device. For the SelectSecure Model 3830 lead, total patient exposure to beclomethasone 17,21-dipropionate should be considered when implanting multiple leads. No drug interactions with inhaled beclomethasone 17,21-dipropionate have been described. Drug interactions of beclomethasone 17,21-dipropionate with the Model 3830 lead have not been studied. Potential Complications Potential complications include, but are not limited to, valve damage, fibrillation and other arrhythmias, thrombosis, thrombotic and air embolism, cardiac perforation, heart wall rupture, cardiac tamponade, muscle or nerve stimulation, pericardial rub, infection, myocardial irritability, and pneumothorax. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation or exit block. See specific device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult Medtronics website at Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.


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