Arrhythmias and Devices Module 1 1 Objectives • Recognize typical rhythms and rhythm disorders 2 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 3 Cardiac Conduction Sinus Node Sinus Node (SA Node) • The Heart’s ‘Natural Pacemaker’ – Rate of 60-100 bpm at rest 4 Cardiac Conduction AV Node Atrioventricular Node (AV Node) • Receives impulses from SA node • Delivers impulses to the His-Purkinje System • Delivers rates between 40-60 bpm if SA node fails to deliver impulses 5 Cardiac Conduction HIS Bundle Bundle of His • Begins conduction to the ventricles • AV Junctional Tissue: – Rates between 40-60 bpm 6 Cardiac Conduction Purkinje Fibers Purkinje Network Bundle Branches and Purkinje Fibers • Moves the impulse through the ventricles for contraction • Provides ‘Escape Rhythm’: – Rates between 20-40 bpm 7 Normal Sinus Rhythm 8 Impulse Formation in SA Node 9 Atrial Depolarization 10 Delay at AV Node 11 Conduction through Bundle Branches 12 Conduction through Purkinje Fibers 13 Ventricular Depolarization 14 Plateau Phase of Repolarization 15 Final Rapid (Phase 3) Repolarization 16 Normal ECG Activation This pattern of depolarization results in efficient mechanical contraction – which is the purpose – to pump blood. 17 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) 18 ECGs Annotation Normal Ranges in Milliseconds: • PR Interval 120 – 200 ms • QRS Complex 60 – 100 ms • QT Interval 360 – 440 ms 19 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 20 Status Check Match the term on the left with the description on the right Click for Answer • P-R Interval • AV Node • Purkinje Network • Bundle Branches Escape rate is 40-60 bpm Connect His bundle to Purkinje network Normally 120-200 ms Depolarizes the Ventricles 21 We’ve 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? 22 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 23 Automaticity Once a pacemaker cell initiates an impulse, its neighboring cells follow suit – like dominos. 24 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 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 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 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 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 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 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 31 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... 32 Causes of Rhythm Disorders Secondary to other conditions • Hyper-Thyroid • Neurocardiogenic Syncope - Hypersensitive Carotid Sinus Syndrome (CSS) - Vasovagal Syncope (VS) 33 Rhythm Disorders 2 Categories Impulse Formation • Abnormal Automaticity Disorders of • Triggered Activity Impulse Conduction 34 Rhythm Disorders 2 Categories Impulse Formation • Abnormal Automaticity Bradycardia: Abnormally slow rates usually due to disease Tachycardia: Excessively rapid rates due to ANS • Triggered Activity 35 Rhythm Disorders 2 Categories Impulse Formation • Abnormal Automaticity • Triggered Activity Depolarization occurring in Phase 3 or 4 of the action potential can trigger arrhythmias 36 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 37 Rhythm Disorders Two Categories Impulse Formation • Abnormal Automaticity • Triggered Activity Impulse Conduction • Slow or Blocked Conduction • Reentry 38 Mechanisms of Rhythm Disorders Slowed or Blocked Conduction • Impulse generated normally • Impulse slowed or blocked as it makes its way through the conduction system 39 Rhythm Disorders Two Categories Impulse Formation • Abnormal Automaticity • Triggered Activity Impulse Conduction • Slow or Blocked Conduction • Reentry 40 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 41 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. refractory By the time the slow antegrade conduction is complete, the fast pathway is no longer refractory, allowing retrograde conduction to occur. This “circus” mechanism is maintained as long as the relationship between fast and slow conduction, and fast/slow refractoriness persists. 42 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. A-V Intervals ms V-V Intervals ms Note the almost simultaneous depolarization of the atria and ventricles. 43 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) 44 Bradycardia Classifications Impulse Formation Disorders of Impulse Conduction 45 Bradycardia Classifications • Sinus Arrest Impulse Formation • Sinus Bradycardia • Brady/Tachy Syndrome Impulse Conduction 46 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 47 Sinus Bradycardia • Sinus Node depolarizes very slowly • If the patient is symptomatic and the rhythm is persistent and irreversible, may require a pacemaker 48 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 49 Bradycardia Classifications • Sinus Arrest Impulse Formation • Sinus Bradycardia • Brady/Tachy Syndrome Impulse Conduction • Exit Block • 1st Degree AV Block • 2nd Degree AV Block • 3rd Degree AV Block • Bi/Trifascicular Block 50 Exit Block • Transient block of impulses from the SA node – Sinus Wenckebach is possible, but rare • Pacing is rare unless symptomatic, irreversible, and persistent 51 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) 52 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 53 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) 54 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 55 Fascicular Block Right bundle branch block and left posterior hemiblock Right bundle branch block and left anterior hemiblock Complete left bundle branch block 56 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 57 Bradycardia Classifications Summary • Sinus Arrest Impulse Formation • Sinus Bradycardia • Brady/Tachy Syndrome Impulse Conduction • Exit Block • 1st Degree AV Block • 2nd Degree AV Block • 3rd Degree AV Block • Bi/Trifascicular Block 58 Status Check Click for Answer • 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 59 Status Check • What are some simple diagnostic tests used to make this diagnosis? – 12-lead ECG, GXT, Ambulatory ECG (Holter) Click for Answer 60 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 61 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 62 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 63 Tachycardia Classifications Impulse Formation Disorders of Impulse Conduction 64 Tachycardia Classifications • Sinus Tachycardia • Atrial Tachycardia Impulse Formation • Premature Contractions • Accelerated Junctional Rhythm • Accelerated Idioventricular Rhythm (AIVR) Impulse Conduction 65 Sinus Tachycardia • Origin: Sinus Node • Rate: 100-180 bpm • Mechanism: Abnormal or Hyper Automaticity (for example, exercise) 66 Atrial Tachycardia •Origin: Atrium - Ectopic Focus •Rate: >100 bpm •Mechanism: Abnormal Automaticity 67 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 68 Premature Beats Premature Junctional Contraction (PJC) • Origin: AV Node Junction • Mechanism: Abnormal Automaticity • Characteristics: A normally conducted complex with an absent P-wave, followed by a compensatory pause 69 Premature Beats Premature Ventricular Contraction (PVC) • Origin: Ventricles • Mechanism: Abnormal Automaticity • Characteristics: A broad complex occurring earlier than expected, followed by a compensatory pause 70 PVC Patterns Bigeminy - Every other beat Trigeminy - Every third beat Quadrigeminy - Every fourth beat 71 Multifocal PVC • 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 72 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 73 Accelerated Idioventricular Rhythm • Origin: Ventricle • Mechanism: Abnormal Automaticity • Rate: Ventricular rate >sinus rate, but <VT • Characteristic: May dominate and take over the underlying rhythm 74 Accelerated Idioventricular Rhythm Sinus Rhythm being taken over by an Idioventricular Rhythm 75 Tachycardia Classifications Based on disorder • Sinus Tachycardia • Atrial Tachycardia Impulse Formation • Premature Contractions • Accelerated Junctional Rhythm • Accelerated Idioventricular Rhythm (AIVR) Impulse Conduction • Atrial Flutter • Atrial Fibrillation • AVRT/AVNRT • Ventricular Tachycardia • Ventricular Fibrillation 76 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 77 Atrial Fibrillation (AF) • 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 78 Atrial Fibrillation (AF) 79 AF Mechanism • Paroxysmal: Sudden onset and spontaneous cessation • Persistent: Requires intervention to terminate, usually > 24-48 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 80 Other AF Mechanisms Mutifocal Atrial Tachycardia • Mechanism: Abnormal Automaticity (multi-sites) • Characteristics: Many depolarization waves; activation occurs asynchronously Not commonly used terms anymore, usually just called “AF” Single Foci • Mechanism: Abnormal Automaticity (singlefocus, usually in the Posterior Left Atrium) • Characteristics: Rapid discharge; single ectopic site • Parasystole – rare 81 Atrial Flutter vs. Atrial Fibrillation Summary of Disease Characteristics Atrial Flutter Atrial Fibrillation Atrial Rate 250 to 400 bpm 400 bpm Ventricular Rate/Rhythm Usually regular Varies with conduction Pattern Saw tooth baseline Grossly irregular Irregular or almost flat baseline “Irregularly irregular” Underlying Mechanism Reentry via macro reentrant circuit Typically multiple wavelet reentry 82 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 83 AVRT Orthodromic • Mechanism: Reentry • Rate: 180 - 260 bpm+ • Characteristics: Extra electrical pathway to ventricles 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. 84 AVRT Antidromic • Mechanism: Reentry • Rate: 180 - 260 bpm+ • Characteristics: Extra electrical pathway to ventricles. Wide-complex QRS. 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. 85 Wolff-Parkinson-White • Origin: A - V conduction outside the AV node. The Wolff pathway conducts faster than the AV node • Mechanism: Reentry • Rate: 180-260 bpm – can be faster • Characteristics: Short PR Interval (< 120 ms), wide QRS (> 110 ms), obvious delta wave 86 AVNRT AV Node Re-entrant Tachycardia • Origin: AV Node • Mechanism: Reentry • Rate: 150 - 230 bpm, faster in teenagers • Characteristics: Normal QRS with absent P-waves 87 AVRT vs. AVNRT • AVRT • AVNRT – 180 – 260 bpm – 150 – 230 bpm – Narrow QRS if orthodromic – Narrow QRS – Wide QRS if antidromic – Short RP – Delta wave + in SR – No delta waves – PR < 120 msec – Initiating PR long – 1:1 Conduction – P-waves buried in QRS Treatment: • – Conduction 1:1, or 2:1 when distal block present Ablation • Rarely is a pacemaker implanted – Perhaps if AV node is injured during ablation 88 Tachycardia Classifications Based on disorder • Sinus Tachycardia • Atrial Tachycardia Impulse Formation • Premature Contractions • Accelerated Junctional Rhythm • Accelerated Idioventricular Rhythm (AIVR) Impulse Conduction • Atrial Flutter • Atrial Fibrillation • AVRT/AVNRT • Ventricular Tachycardia • Ventricular Fibrillation 89 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 90 Polymorphic VT • 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 91 Torsades de Pointes “Twisting of the points” • 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 92 Ventricular Fibrillation (VF) • Origin: Ventricle • Mechanism: Multiple wavelets of reentry • Characteristics: Irregular with no discrete QRS 93 Tachycardia Classifications Summary • Sinus Tachycardia • Atrial Tachycardia Impulse Formation • Premature Contractions • Accelerated Junctional Rhythm • Accelerated Idioventricular Rhythm (AIVR) Impulse Conduction • Atrial Flutter • Atrial Fibrillation • AVRT/AVNRT • Ventricular Tachycardia • Ventricular Fibrillation 94 Status Check Identify the Rhythm • Ventricular Tachycardia Click for Answer • Sinus Bradycardia • Complete Heart Block • Atrial Fibrillation • Ventricular Fibrillation 95 Status Check Identify the Rhythm • Ventricular Tachycardia Click for Answer • Sinus Bradycardia • Complete Heart Block • Atrial Fibrillation • Ventricular Fibrillation 96 Status Check Identify the Rhythm • Ventricular Tachycardia Click for Answer • Sinus Bradycardia • Complete Heart Block • Atrial Fibrillation • Ventricular Fibrillation 97 Status Check Identify the Rhythm • Ventricular Tachycardia Click for Answer • Sinus Bradycardia • Complete Heart Block • Atrial Fibrillation • Ventricular Fibrillation 98 Status Check • Ventricular Tachycardia Click for Answer • Sinus Bradycardia • Complete Heart Block • Atrial Fibrillation • Ventricular Fibrillation 99 Upcoming Modules • The Fundamentals of Cardiac Devices • Basic Concepts—Electricity 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 100 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. 101 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. 102 Brief Statements (continued) Warnings/Precautions • Changes in a patient’s disease and/or medications may alter the efficacy of the device’s 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 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. 103 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. 104 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 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com. Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. 105