CONTENTS Introduction ‘The Normal Heart and Its Electrical System .... Indications for Cardiac Pacing, Patient Assessment Implantable Cardiac Pacemakers. The Evolution of Cardiac Pacemakers. Pacing Code Mode Selection ae Effect of Pacing on Cardiac Output Patient Care and Follow-up Pacing Value Suggested Reading... ‘Common Patient Questions . GlossaryINTRODUCTION Due to advances in medical technology over the past 35 years, pacing the heart with an implantable cardiac pacemaker is an effective, life-enhancing treatment for patients with certain types of cardiac rhythm disturbances. The evolving nature of pacing technology creates changes in the indications for pacing, the types of pacemakers available for patients, and the follow-up care required for these patients. This brochure is an up-to-date, overview of cardiac pacing for pri- mary care physicians and other clinical staff who provide health care for the pacemaker patient. The fundamentals of cardiac pac- ing are provided, with an emphasis on practical considerations for the evaluation, management, and follow-up care of today’s pace- maker patient.THE NORMAL HEART AND ITS ELECTRICAL SYSTEM The integrity of the heart's electrical system is critical for a normal cardiac rhythm and the normal function of pumping blood throughout the body. This electrical system involves the origin and conduction of electrical impulses in the heart The heart’s normal electrical impulse originates in the SA (sino- atrial) node in the right atrium, then spreads throughout both atria and stimulates atrial contraction. (See Figure 1.) The electrical signal passes to the ventricles through the AV (atrioventricular) node, which delays the signal approximately 1/10 second to allow ventricular filling. Left Ventricle Left Atrium Right Atrium Sinoatial (SA) Node Atrioventricular (AV) Node Bundle of His Loft Bundle Branch Right Bundle Branch Right Ventrcle Purkinje Fibers ) Figure 1 The Normal Heart and Its Electrical SystemThe Bundle of His and right and left bundle branches (specialized conductive tissue within the ventricular septum) relay the impulse to Purkinje fibers, which form an extensive network within the heart muscle tissue. The Purkinje fibers simultaneously transmit the signal throughout both ventricles, stimulating ventricular con- traction, The electrical activity of the heart can be recorded as a waveform on the ECG (electrocardiogram). (See Figure 2.) PR+ i —nrenvat FOS 40 ms INTERVALS Figure 2 ECG Waveform of the Heart s Electrical Activity P= atrial contraction (depolarization) QRS = ventricular contraction (depolarization) T = ventricular repolarizationINDICATIONS FOR CARDIAC PACING Cardiac pacing is indicated when there is a significant malfunction of the heart's electrical system, usually involving the SA node and/or AV conduction pathways. The result may be a slow, fast, or irregular heart rhythm. Delays, blocks, irregularities, re-entry and other malfunctions in the electrical system may affect the heart’s pumping ability, and may lead to a decrease in cardiac output. Any or all of the follow- ing transient or persistent symptoms or conditions may result: Syncope Pulsations in the neck Dizziness Seizures Fatigue Exercise intolerance Shortness of breath Confusion Palpitations Congestive heart failure Tightness in the chest A correlation of the symptoms mentioned above to an arrhythmia ‘onan ECG strip is essential to conclude that pacing is indicated. The two major categories of pacing indications are sinoatrial dys- function and AV block. The indications that follow are general guidelines. CONTRAINDICATIONS FOR CARDIAC PACING There are no known contraindications to the use of ventricular pacing as a therapeutic modality for the control of heart rate. The patient’s age and medical condition, however, may indicate the particular pacing system and implantation procedure used by the physician,SINOATRIAL DYSFUNCTION Abbreviations and Guidelines DESCRIPTION: A dysfunction of the SA node or atria that affects for ECG Interpretation impulse formation or conduction. Cardiac arrhythmias due to sinoatrial dysfunction are often transient and may not be present bpm = beats per minute every time the patient is examined. Types of sinoatrial ms = milliseconds dysfunction are: Sinus bradycardia WSinus bradyeardia less than 60 bpm. Sinus tachycardia = mSinus arrest more than 100 bpm Sinus pause (SA exit block) Normal PR interval = cardia- less than 200 ms & Bradycardia-tachycardia Normal ORS width ~ @ Atrial flutter or fibrillation Tess than 120. ms @ Chronotropic incompetence NOTE: Descriptions and ECG examples of the above conditions follow. Common symptoms and conditions are listed for each dis- order. However, each condition that is listed is neither inclusive nor limited to these symptoms and may be associated with other non-specific complaints. [SINUS BRADYCARDIA: Persistent slow rate from the SA node. | Rate = 55 bpm [PR interval = 180:ms ae Figure 3 Common symptoms: Dizziness, fatigue, shortness of breath, palpitations, and confusion. Is a pacemaker indicated for sinus bradycardia? | Yes, when symptoms can be attributed to the arrhythmia,SINUS ARRES Rate = 75 bpm PR interval = 180:ms Note: 2.8:second arrest vansient lack of impulses from the SA node. Figure 4 Common symptoms: Syncope, dizziness, fatigue, shortness of breath, palpitations, seizures, and confusion. Is a pacemaker indicated for sinus arrest? Yes, when symptoms can be attributed to the arrhythmia. SINUS BRADYCARDIA WITH SINUS PAUSE (SA exit block): Transient blockage of impulses from the SA node. Rate = 52 bpm PR interval = 200 ms Note: 2.1-second pause Figure 5 ‘Common symptoms: Syncope, dizziness, fatigue, shortness of breath, palpitations, seizures, and confusion. Is a pacemaker indicated for sinus pause? ‘Yes, when symptoms can be attributed to the arrhythmia,BRADYCARDIA-TACHYCARDIA: Intermittent episodes of slow and fast rates from the SA node or atria Brady rate = 57 bpm Tachy rate = 120 bpm Figure 6 ‘Common symptoms: Syncope, dizziness, shortness of breath, palpitations, tight- ness in the chest, pulsations in the neck, seizures, exercise intolerance, confusion, and fatigue. Is a pacemaker indicated for bradycardia-tachycardia? | Yes, when symptoms can be attributed to the arrhythmia. ATRIAL FLUTTER: Transient or persistent fast atrial rate. Atrial flutter is 250 to 350 beats per mintite (lpm). Atrial fibrillation is dver 350 bpm. (See Figure 8.) Ventricular rate = 33 bpm Atrial rate = 300 bpm. Figure 7 ‘Common symptoms: Syncope, dizziness, shortness of breath, palpitations, seizures, and congestive heart failure. Is a pacemaker indicated for atrial flutter or fibrillation? Yes, when symptoms can be attributed to the arrhythmia,ATRIAL FIBRILLATION: Atrial fibrillation is over 350 bpm. Ventricular rate = irregular Atrial rate = over 350 bpm Figure 8 ‘Common symptoms: Syncope, dizziness, shortness of breath, palpitations, seizures, and congestive heart failure. (CHRONOTROPIC COMPETENCE/INCOMPETENCE: Inappropriate variation of heart rate in response to activity, drugs, or emotions. The normal chronotropic response to activity is a quick rise in heart rate, a steady rate during activity, and a slow fall in heart rate after activity. Patient with Normal Variation of Patient with Abnormal Variation of Heart Rate in Response to Activity Heart Rate in Response to Acti (Chronotropic Competence) (Chronotropic Incompetence) Quick Stabs Start sativiy Time acivty Aatvty Time etry Figure 9 |Common symptoms: Exercise intolerance. Is a pacemaker indicated for chronotropic incompetence? Yes, when symptoms can be attributed to the rhythm disturbance.ATRIOVENTRICULAR BLOCK (AV BLOCK) DESCRIPTION: A block in AV conduction may originate in the AV node, the Bundle of His, right or left bundle branches, or the Purkinje fibers. Types of AV block are: im First-degree AV block mSecond-degree AV block (types I and II) Third-degree (complete) AV block NOTE: Descriptions and ECG examples of the above conditions follow. FIRST-DEGREE AV BLOCK: AV conduction is delayed, but no impulses from the atria are actually blocked enroute to the ventricles. The PR interval is prolonged (>200 ms), and patients are usually asymptomatic. Rate = 79 bpm PR interval = 360 ms Figure 10 ‘Common symptoms: This is usually discovered before symptoms are apparent. Is a pacemaker indicated for first-degree AV block? Rarely.TYPE I SECOND-DEGREE AV BLOCK, MOBITZ I (WENCKEBACH): Some impulses are dropped while others are conducted. Patients may be symptomatic. There are two types of second-degree AV block: This AV block exhibits a progressive prolongation of conduction (PR interval), until a ventricular beat is dropped (R-wave). Ventricular rate = irregular 100 bpm. srogressively longer until final P-wave does not elicit a QRS response Figure 11 Common symptoms: Dizziness, confusion, intolerance of exercise and palpitations. Is a pacemaker indicated for type I second-degree AV block (Mobitz 1)? Yes, but only when symptoms are present. 10TYPE II SECOND-DEGREE AV BLOCK, MOBITZ Il: This AV block regularly drops ventricular beats. Dropping every other beat is 2:1 block; dropping every third beat is 3:1 block, etc. 2:1 Block (2 P-waves to 1 QRS complex) Ventricular rate = 60 bpm Atrial rate = 120 bpm Figure 12, ‘Common symptoms: Syncope, dizziness, shortness of breath, and palpitations. Is a pacemaker indicated for type II second-degree AV block (Mobitz ID? Yes, even if symptoms are absent, because this condition is unstable and may rapidly progress to third-degree AV block. THIRD-DEGREE (COMPLETE) AV BLOCK: No impulses travel from the atria to the ventricles. An independent site (ectopic foci) im the conduction systemt or ventricles usually takes over and maintains a heart rate of 20 to 40 beats per minute. Third-degree AV block may be an acquired or congenital condition. Ventricular rate = 37 bpm Atrial rate = 130 bpm Figure 13 ‘Common symptoms: Syncope, dizziness, shortness of breath, fatigue, palpitations and exercise intolerance. Is a pacemaker indicated for third-degree AV block? Yes, in most cases. TePATIENT ASSESSMENT The evaluation of patients with cardiac arrhythmias typically includes HISTORY PHYSICAL mECG LIFESTYLE ASSESSMENT Additional tests may include a(n): GRADED TREADMILL TEST—to determine exercise tolerance. Some arrhythmias only occur upon exercise or may change from rest to exercise. i AMBULATORY ECG MONITORING—to document transient arrhythmias. ELECTROPHYSIOLOGY STUDY—to assist diagnosis in difficult cases. The frequency and severity of symptoms is a key consideration in determining the need for a pacemaker. NOTE: For patients with syncope, dizziness, seizures, or confusion, the evaluation may include an EEG (electroencephalogram) and neurological exam to rule out possible neurological causes. Other cardiovascular conditions, such as orthostatic hypotension, may also cause syncope 12IMPLANTABLE CARDIAC PACEMAKERS BASIC COMPONENTS OF A PACEMAKER SYSTEM. ‘A pacemaker system consists of a pulse generator, one or two leads (a catheter with insulated wire), and an electrode at the tip of the lead. (See Figure 14.) Pulse Generator Connection ‘Outlet (insulated Wire) Lead 4 ace Tp Figure 14 Pacemaker System The pulse generator houses a battery, electronic circuitry, and lead connector. The pulse generator produces a pacing impulse (an elec- trical signal), and the lead carries the impulse to the heart. Most pacemaker systems also sense electrical activity from the heart, and respond by either sending a pacing impulse to the heart (triggering) or not sending a pacing impulse to the heart (inhibition). NOTE: This publication deals only with permanent, implantable pacemakers, not with temporary, external pacemakers. 13A pacemaker system may be single- or dual-chamber: A single-chamber pacemaker system uses one lead, which may go to either the right atrium or right ventricle. An ECG of single- chamber, ventricular pacing is shown in Figure 15. Note the ven- tricular pacing spikes. A dual-chamber pacemaker system uses two leads, one going to the right atrium and the other to the right ventricle. An ECG of dual-chamber pacing is shown in Figure 16. Note atrial and ven- tricular pacing spikes. Figure 15 ECG of single-chamber pacemaker with ventricular pacing spikes (arrow). Note pacemaker inhibition (sixth QRS complex) by the heart's intrinsic ventricular contraction. Figure 16 ECG of duai-chamber pacemaker with atrial and ventricular pacing spikes (arro%s). 14Single- and dual-chamber pacemaker systems may be either unipo- lar or bipolar: WA unipolar pacemaker system uses a lead with one wire and one electrode (located at the tip). Electrical activity from a pacing stimulus returns to the pulse generator through chest tissues to complete the electrical circuit. A bipolar pacemaker system uses a lead with two wires and two electrodes—one electrode at the tip and another (a ring electrode) about two inches from the tip. Electrical activity from a pacing, stimulus returns to the pulse generator via the second wire in the lead to complete the electrical circuit. NOTE: Unipolar pacing systems are more susceptible to electrical interference, because they are more sensitive to electrical signals that originate outside the heart, such as from the contraction of skeletal muscles in the chest. This is called myopotential sensing, Bipolar pacing systems eliminate myopotential sensing Allsingle- and dual-chamber pacemakers can provide a fixed rate at which they pace the heart. Some pacemakers also offer one oF more rate responsive modes: WA Fixed Rate Pacemaker paces the heart at a predetermined rate and does not fluctuate or adjust according to the patient’s chang- ing metabolic demand. A Rate Responsive Pacemaker detects and measures physiologic or physical parameters that correlate with metabolic demand. Sensors are used to detect these parameters. Then, by processing the electrical signal derived from the measurement of these para- meters, the pacemaker adjusts the rate it paces the heart.THE EVOLUTION OF CARDIAC PACEMAKERS Pacemaker technology has undergone several major advances over the past 35 years. Each advancement has provided significant improvements in the quality of life for pacemaker patients. Today, cardiac pacemakers are available that closely mimic the natural rhythm of the heart. Late 1950s: Asynchronous, Fixed-Rate Pacemakers Early single-chamber pacemakers paced the ventricle at a fixed rate (usually 70 to 80 beats per minute), independently of the heart's intrinsic rhythm. Because the heart and the implantable pacemaker were operating independently, the pacing was called “asynchro- nous.” Mid 1960s: Demand Pacemakers The next generation of single-chamber pacemakers introduced pac- ing the heart on “demand,” ie. only when the heart does not beat on ts own. If the heart beats on its own, the pacemaker is inhibited (does not send a pacing impulse to the heart). Further progress has incorporated many programmable features into demand pacemak- ers. This type of pacemaker has been used for the majority of pace- maker patients during the past 20 years. Early 1980s: Dual-Chamber Pacemakers Dual-chamber pacemakers use two leads—one in the right atrium. and one in the right ventricle, Because of their ability to pace and sense in the atrium and ventricle, dual-chamber pacemakers can maintain AV synchrony. In addition to demand pacing, dual- chamber pacemakers are capable of varying the heart rate by sens- ing or “tracking” atrial activity and then pacing the ventricle. A dual-chamber pacemaker often enables people to enjoy a higher quality life, because it can provide AV synchrony and access to the patient’s own heart rate reserves. (This access brings little or no benefit if the patient is chronotropically incompetent.) 16Mid 1980s: Sensor-Driven, Rate-Responsive The latest innovation in pacemakers is sensor-driven, rate-respon- sive pacing. This new technology varies the heart rate according to bodily needs. (See Figure 17.) One type of sensor-driven, rate- responsive pacemaker available today varies the heart rate by sens- ing pressure waves generated by physical activity. Rate-responsive pacing mimics the heart’s normal rhythm, and enables patients to participate in more activities. This type of pacing is available in single-chamber and dual-chamber devices. Adjusting Heart Rate To Activity Normal Heart Rate prone — Rate Responsive Pacing — Fixed Rate Pacing Wiking 100: Heart Rate DAILY ACTIVITIES Figure 17 Rate-Responsive Pacemakers Vary Heart Rate According to Bodily Needs Future Pacemakers Researchers are currently investigating other sensor-driven, rate- responsive technologies that can vary the heart rate by sensing core body temperature, pH, pCO>, mixed venous O> saturation, respira- tory rate, stroke volume, QT interval, and various pressure parame- ters. Future generations of pacing systems will increasingly utilize new sensors, singly and in combination, to enhance hemodynamics and quality of lite.OTHER ADVANCES IN PACING LEADS: Leads have become slimmer, more flexible, more durable, with extended longevity due to advances in design and materials. Tines or screw-in tips provide reliable intracardiac lead fixation. Steroid-eluting leads provide minimal inflammation and scar for- mation at the fixation site and use less of the battery's energy. Platinized lead tips use a surface area, reducing the size of the lead tip. BATTERIES: Batteries are now smaller and more efficient due to advances in battery chemistry. Most of today’s pacemakers contain lithium-iodide batteries, which are designed to last a number of years. Actual longevity depends on the type of pacemaker and how it is programmed to pace the heart. Because the battery is per- manently seaied inside the pacemaker, the entire pacemaker is, replaced when the battery runs down, BUILT-IN SAFETY FEATURES: Built-in filters protect pacemakers from electrical interference from most devices, motors, and appli- ances encountered in daily life, including microwave ovens. Security devices at airports and libraries should not cause any interference to the normal operation of the pacemaker; however, they may detect metal in the pacemaker. In this situation, pace- maker wearers may present an identification card indicating they have a pacemaker. PACEMAKER PROGRAMMABILITY AND TELEMETRY: Pace- maker programmability enables physicians to adjust pacing therapy during and after the pacemaker implant. Programmable features may include the pacing rate, pacing mode (see “Pacing, Code” on page 20), AV interval, upper rate, lower rate, voltage (amplitude) of atrial and /or ventricular pacing stimuli, duration (pulse width) of atrial and/or ventricular pacing stimuli, and sen- sitivity levels for sensing cardiac potentials. EVENT COUNTERS: Event counters are used to monitor cardiac activity and help the physician evaluate and optimize the pace- maker's particular rate responsive therapy. Event counters are pro- grammed to have the pacemaker record data such as the following: a) the number of paced and /or sensed (intrinsic) events in a given time frame, b) the rate at which these events occur, and when’ applicable, c) the percent of recorded events that are paced. The event counter information may be displayed visually on a pro- grammer or printed report. 18PROGRAMMER INTERFACES: New programmer interfaces are available with increased technological capabilities. Just as the new technology of leads and pacemakers have evolved, so have the new programmer interfaces, making what seems like complex technology easy to learn and easy to use. Telemetry may provide measurements for many of the pace- maker’s programmable parameters, as well as other parameters such as battery voltage. To aid ECG interpretation, some of today’s pacemakers aiso have telemetry that indicates when the pace- maker is pacing and sensing. (See Figure 18.) Figure 18 ECGs of a Dual-Chamber Pacemaker with Marker Channel"™ Telemetry NOTE: The two ECGs above show normal dual-chamber pacing. The Marker Channel™ notations below the ECGs indicate pacemaker function. KEY FOR MARKER CHANNEL™ NOTATIONS: trial pace trial sense trial refractory sense VP = ventricular pace VS = ventricular sense ventricular refractory sense 19PACING CODE ‘A. code has been developed to describe the function of single- and dual chamber pacemakers This code Is comprise of five posl- tions, arranged in sequence. Various letters are used for each posi- tion to describe a pacemaker function or characteristic. Only one letter is used per position. The combination of these letters is called a pacing mode. For a summary of the pacemaker code, see Table 1. Examples of pacing modes follow. Code Positions! 1 u ML Vv. v v v T P P 8 i A A 1 M s 4 D D D ic D 3 ° ° ° ° ° 6 R Table 1 Five-Position Code for Pacemaker Function CODE POSITIONS 1=Chamber(s) paced I= Chamber(s) sensed III = Response to sensed event IV = Programmability features \V = Antitachyarrhythmia functions CODE LETTERS jons 1, I, I, 1V Position V Ventricle Atrium Atrium and ventricle (dual) None ‘Trigger pacing Inhibit pacing Programmability of rate and /or output Multiprogrammability of rate, output, sensitivity, mode, etc. ‘Communicating R= Rate modulation (sensor-driven rate response) 20Examples of Single-Chamber Pacing Mode: * Pace Se & & & ® Pace and sense WI Paces and senses in the ventri- cle. A sensed beat inhibits the pacing stimulus (demand pac- ing), wR Same as VVI but also provides sensor-driven rate response in the ventricle (rate-responsive pacing). AAI Paces and senses in the atrium, A sensed beat inhibits the pac- ing stimulus (demand pacing). Used in patients without AV block. Provides AV synchrony. AAIR Same as AAI, but also provides sensor-driven rate response in the atrium. ® Examples of Dual-Chamber Pacing Modes: © Rate-responsive pacing (sensor-driven) and sense bpp Paces and senses in both chambers. A sensed beat in the ventricle inhibits both the ventricular and atrial pacing stimuli. A sensed beat in the atrium inhibits the atrial pacing stimulus and triggers a ventric- ular pacing stimulus after a programmed AV interval Provides AV synchrony, even if AV block occurs. Provides rate response by sensing intrinsic atrial activity (P-waves generated by the SA node) and pacing the ventricle at the same rate. DDDR ‘Same as DDD, but also pro- vides sensor-driven rate response according to the change in metabolic demand. aMODE SELECTION The following chart provides guidelines for selecting optimal pac- ing therapy based on today’s pacemaker technology. (See Table 2.) There are three goals of optimal pacing therapy: To relieve symptoms through the restoration of cardiac output. To restore a patient's quality of life and ability to resume normal activities. To maximize the patient's longevity. ‘SYMPTOMATIC BRADYCARDIA ‘Can he atm be sensed (0, porsisont ‘and paced rolably ata foritaton, Inexctabe aim) win wi 1s AV conduction prosenty adequate? (2.9,.compete or transient AV book) 1s $A node function presently adequate? NO 1s SA node function Present adequate? Yes AAIR DpDR Sect DDR DoIR® fordoccous AIR, Songs oR Table 2 Guidelines for Selecting Optimal Pacing TherapyEFFECT OF PACING ON CARDIAC OUTPUT Pacing ultimately benefits a patient and relieves symptoms because it restores a healthy heart rhythm and may increase cardiac output. factors influence the heart's ability to increase cardiac rate (beats per minute) and WM stroke volume (amount of blood pumped by one beat) By definition, cardiac output (CO) equals rate (R) times stroke volume (SV): CO=Rxsv In the average healthy person, cardiac output may increase 5 to 6 times from rest to maximum activity. Heart rate may increase by a factor of 3 and stroke volume by a factor of 2 for an overall increase of 3 x 2 = 6. The increase in stroke volume is largely due to the heart's ability to fill more fully and to increase its force of con- traction. AV synchrony affects stroke volume through its contribu- tion to ventricular filling, an especially important issue for patients with left ventricular dysfunction. At low heart rates (resting, upright position), ventricular pacing, provides similar cardiac output as does AV sequential pacing, though the latter is often preferred for its apparently greater effec- tiveness in reducing atrial arrhythmias and its greater reduction in symptoms for some patients. At intermediate heart rates (moderate activity), contractility and rate provide an increasingly important contribution to cardiac out- put. At high heart rates (strenuous activity), rate is by far the most important contributing factor to increasing cardiac output. 23Large increases in cardiac output during activity have been demonstrated only in pacing systems that increase rate. During activity, rate-responsive pacing (VVIR) has been shown to increase cardiac output 45% to 80% and improve work capacity 23% to 70%, compared to demand VVI pacing, Table 3 shows which types of pacing provide rate response and /or AV synchrony. Type of Rate AV Pacing Response Synchrony WI no no wiR yes no AAI no. AAIR yes DpD. not DDDR yes *Unless patient is chronotropically competent. Table 3 Pitysiologic Benefits of Pacing 24@ PATIENT CARE AND FOLLOW-UP PACEMAKER IMPLANTATION PROCEDURE Nearly all pacemaker implants utilize a lateral transvenous approach (by using a subclavian introducer or cephalic vein cut- down) to insert the lead into the heart. A small subcutaneous pocket for the pulse generator is usually made inferior to the clavi- cle. The implant procedure is relatively simple, usually performed under local anesthetic, and lasts about one hour. (See Figure 19.) Figure 19 Transvenous Approach for Pacemaker Implantation Patients usually stay in the hospital one or two days after a pace- maker implant. Upon returning home, pacemaker wearers resume ‘most daily activities within a few days or weeks. OPTIMAL PACING THERAPY Optimal pacing therapy begins with pacemaker implantation Follow-up of pacemaker patients on a regular basis is essential to ensure that the proper parameter settings have been selected, the hemodynamics are good, and that the patient is free of symptoms. Regular follow-up allows a physician to do everything possible to preserve the quality of his or her patient's life and minimize the progression of cardiac disease. 25Consistent follow-up allows the physician to monitor disease pro- gression. Many patients may only begin with a sinus node dy function where an occasional sinus pause occurs. Sinus pauses can progress into bradycardia and could include chronotropic incom- petence, which might progress into brady or tachycardia leading to paroxysmal atrial fibrillation and eventually chronic atrial fibril- lation. If this patient is properly followed, the pacing therapy will be adjusted to take into account the disease progression, preserv- ing the quality and longevity of the patient's life. PACEMAKER SYSTEM FOLLOW-UP For follow-up monitoring of pacemaker function, patients may either return to the doctor's office, a clinic, or a hospital. Frequency of monitoring varies, depending on the type of pace- maker, the patient's condition, and the length of time after the implant. A typical pacing system follow-up schedule is: Single-chamber pacemakers ‘Ist month — every 2 weeks 2nd through 36th month — every 8 weeks Beyond 36th month — every 4 weeks Dual-chamber pacemakers Ast month — every 2 weeks 2nd through 6th month — every 4 weeks 7th through 36th month — every 8 weeks Beyond 36th month — every 4 weeks (Guch schedules may vary by local practice.) TROUBLESHOOTING Pacemakers are very reliable, with an industry-wide, five-year sur- vival rate of over 95% for lithium-iodide pacemakers, It is important to evaluate the pacemaker system to prevent prob- Jems that might develop during cardiac pacing, including: Loss of capture: The pacemaker fails to stimulate the heart to contract. Undersensing: Failure of the pacemaker to sense electrical activity (P-waves and R-waves) in the heart. May cause the pacemaker to emit inappropriately timed pacing stimuli. 26Oversensing: The pacemaker senses electrical activity from an inappropriate source, such as skeletal muscle (myopotential sensing), electromagnetic interference (EMI), T-waves, or the other heart chamber (crosstalk). May cause the pacemaker to inhibit (not pace) or revert to asynchronous pacing, Primary physicians can help monitor a pacemaker patient between visits with the pacing follow-up physician. The following symp- toms require further examination to determine if there is an inap- propriate lead / pacemaker function or some other cause: Stimulation of the diaphragm or pectoral muscle Resumption of some or all original symptoms W Chest pain (not angina) exacerbated by inspiration Inflammation or infection in the pacemaker pocket site Pacemaker migration Ifa lead problem is suspected, chest x-rays, ECGs and other diag- nostic tools (such as pacemaker telemetry) may be used to help identify problems such as dislodgement, fractures, deformities at the electrode tip or ligature site, and improper connection to the generator. Possible causes for loss of capture, undersensing, and oversensing are: —lead dislodgment —lead insulation break —lead wire fracture — electrical circuit failure — battery depletion — pacemaker /lead connector problems — pacing /sensing parameters programmed too low or too high — electrolyte imbalance — exit block at the lead fixation site (loss of capture) — drug effects Changes in drug therapy or regimen can have an effect on thresh- olds. However, not all drugs will affect changes in threshold and the effects on each patient will vary, Ant-arthythmics, beta block- ers, beta adrenergics, diuretics and hormones may increase the threshold, indicating an increase in the amplitude or pulse width needed. Glucocorticosteroids and alpha_adrenergics may decrease the threshold, indicating a smaller amplitude or pulse width may be sufficient. It is important to remember that if a patient is taken off drugs, a reverse effect on the thresholds will typically occur. 27PACEMAKER REPLACEMENT Most pacemakers have a built-in indicator called the elective replacement indicator (ERI), to signal when the battery is approaching depletion. The pacemaker is designed to continue operating for several months to allow adequate time to schedule a replacement operation. Replacement is usually performed under local anesthesia. The pacemaker pocket is opened, and the entire pulse generator is replaced with a new one. A new lead may or may not be required. Depending on the patient's health status, the new pacemaker may not be of the same type as the one being, replaced, During a follow-up visit to a pacing specialist, it is important that the pacemaker is interrogated by use of telemetry to read the elec- tive replacement indicator. The ERI may appear without the patient experiencing symptoms or showing ECG evidence of an arrhythmia. Depending upon the manufacturer and the device, pacemakers reflect the depletion of battery capacity in many different ways. Some indicators first display gradual or stepwise declines in the pacing rate observed when an external magnet is applied to the pacemaker, while others experience automatic pacing mode changes that are designed for energy conservation. Increasing the pulse width is one way that some Medtronic pace- makers indicate ERI. By delivering a constant energy per pulse and maintaining a safety margin over the patient's threshold, the patient's ECG strip will reflect the pulse width stretching, indicat- ing a replacement should be made. After the ERI is indicated, the pacemaker will continue to operate for several months to allow adequate time for a replacement operation.PACING VALUE ‘Asa medical treatment, cardiac pacing offers significant immediate and long-term patient benefits, For most patients with complete AV block, the pacemaker restores near normal life expectancy, instead of probable death within one year. Many patients with other rhythm disorders benefit from pacemakers, in that the disruptive symptoms associated with their condition are minimized throughout their future. Rate-responsive technologies have and will continue to allow pacemaker patients to lead full, active lives. The exciting news is that pacing technology continues to progress at an astonishing rate to provide pacemaker patients with a higher quality of life. The future is brighter than ever for these patients. 29SUGGESTED READING SUGGESTED BIBLIOGRAPHY Barold S and Mugica J, eds. New Perspectives in Cardiac Pacing. Mount Kisco, NY: Futura Publishing; 1988:229-254. Barold $ and Mugica J, eds. New Perspectives in Cardiac Pacing. Series 2 and 3, Mount Kisco, NY: Futura Publishing; 1991:163-202. Bourgeois I, Sutton R. The Foundations of Cardiac Pacing, Pt.[: An Mlustrated Practical Guide to Basic Pacing. Mount Kisco, NY: Futura Publishing; 1991. Eisenhauer A. Kloner R, ed. The guide to cardiology: pacemaker therapy. Cardiovascular Review and Reports. May 1991; 12(5)42-44,47- 50,55-56,58 Ellenbogen K. Cardiac Pacing. Boston: Blackwell Scientific Publications, 1992. Furman S, Hayes D, Holmes D. A Practice of Cardiac Pacing. 3rd ed, Mount Kisco, NY: Futura Publishing; 1992. Hayes D. Advances in pacing therapy for bradycardia. Int J Cardiol. Aug 1991; 32(2):183-196. Hayes D, Osborn J. Giuliani ER, Fuster V, Gersh B], et al, eds. Cardiology: Fundamentals and Practice. 2nd ed. St. Louis, Mo: Mosby Year Book; 1990:1014-1079, Morgan JM, Joseph SP, Bahri AK, et al. Choosing the pacemaker; a rational approach to the use of modern pacemaker technology. Eur Heart J. 1990;11(8):753-764. Moses H, Taylor G, Schneider J, et al. A Practical Guide to Cardiac Pacing. 3rd ed. Boston, Mass: Little, Brown and Company; 1991. ‘Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Committee on Pacemaker Implantation). Guidelines for implantation of cardiac devices. Circulation. July 1991; 84(1):455-467. 30SUGGESTED PERIODICALS European Journal of Cardiac Pacing. EBM Erdmann-Brenger GMbH, P.O. Box 81 02 25, Gleiwitzer Str. 43, D-8000 Munchen 81, Germany. Herz-Schrittmacher. EBM Erdmann-Brenger GMbH, P.O. Box 81 02 25, Gleiwitzer Str. 43, D-8000 Munchen 81, Germany, Journal of Electrophysiology. An official publication of the North American Society of Pacing and Electrophysiology. Futura Publishing Company, Inc., 295 Main Street, P.O. Box 330, Mount Kisco, NY 10549 New Trends in Arrhythmias. John Libby, CIC s.tl., Via L. Spallanzani 11-00161 Roma, Italy. PACE—Pacing and Clinical Electrophysiology. Futura Publishing Company, Inc., 295 Main Street, P.O. Box 330, Mount Kisco, NY 10549, ‘StimuCoeur. College Francais de Stimulation Cardique, C.H.U. Rangueil, 31054 Toulouse cedex, France. 31COMMON PATIENT QUESTIONS Can the pacemaker and its electrical signal be felt? Pacemaker wearers can feel the pacemaker under the skin. However, the insulated wire leading to the heart and the electrical signal cannot be felt. Patients may be able to feel a small part of the wire just where it connects to the pacemaker. ‘Are pacemakers for people who have had a heart attack? Pacemakers are for people who have abnormal heart rhythms. A heart attack may cause an abnormal heart rhythm, so some people who have had a heart attack may need a pacemaker. Most people who wear pacemakers have never had a heart attack. Wearing a pacemaker does not increase the risk of having a heart attack. What if the patient's heart problem changes after the implant operation? Even though patients feel much better and can resume daily activi- ties after receiving a pacemaker, the underlying physical problem in the heart usually does not significantly change over the years. If it does, most of today’s pacemakers can be adjusted by telemetry or “remote control” with no additional surgery. Sometimes a dif- ferent pacemaker may need to be implanted. How often are pacemakers checked? ‘The pacemaker is checked during the implant operation and usually again before the patient leaves the hospital. Patients may return to the clinic a few times each year for follow-up care. Many patients have their pacemaker checked at home over the tele- phone. Patients may also take their pulse daily to check the pace- maker rate. How long does a pacemaker last? Today’s pacemakers are very reliable, lasting up to 10 years or more. Actual longevity depends on the type of pacemaker and how it is programmed to pace the heart. When the battery begins to run down, itis time to replace the pacemaker. (The pacemaker provides a warning well in advance of this.) Because the battery is permanently sealed inside the pacemaker, the entire pacemaker is replaced. The lead may or may not be changed. Will security devices like those used in airports and libraries interfere with the pacemaker? These security devices should not cause electrical interference with a pacemaker, but they may detect the metal in the pacemaker. Pacemaker wearers can obtain a medical identification card to indicate they have a pacemaker. 32,How long does the implant procedure last and what is involved? Most pacemaker implantation procedures take less than an hour. The patient is put under local anesthesia, a small incision is made in the upper chest, the leads are fed and guided by fluoroscopy through the subclavian or the cephalic vein into the appropriate chambers and plugged into the pacemaker. What is the average recovery like after the implantation? ‘The amount of time it takes for a patient to recover is dependent upon his or her physical condition. The patient will experience some soreness around the pocket area for the first week. It takes most patients 2 to 3 weeks before they can resume normal activi- ties. Is there any equipment or electrical devices that would interfere with a pacemaker? Pacemakers have built-in features to protect them from almost all common electrical devices encountered in daily life, including microwave ovens and airport security detectors. Heavy industrial equipment such as arc welding or large engines emit strong electri- cal signals and should be avoided. Asa rule of thumb, if a patient should start to feel dizzy around certain types of heavy equipment, have them walk away from it immediately. How often should a patient be followed by his or her doctor? Follow-up schedules will vary from patient to patient and will be set according to the discretion of the doctor. It is very important that follow-up is performed on a regular and consistent basis. What should I do if a patient's original symptoms return? IF the original symptoms should return, have the patient check his orher pulse rate and contact a doctor. Will pacemakers take the place of medications? Pacemakers are not a substitute for medications. However, pace- maker implantation may be accompanied by a change in medica- tion, and thus it is important for the patient to adhere to his or her doctor's instructions. Do medications affect pacemakers? Some medications may affect the heart's electrical behavior and thus may affect pacing therapy. Some of these are fairly common alis. The suggested bibliography contains books that dis- cuss this in greater detail. 33GLOSSARY NOTE: Not all of the following terms are used in this booklet; however, they may be useful in discussions with pacing specialis Amplitude—The maximum absolute value attained by an electri- cal waveform, or any quantity that varies periodically. Pacemaker amplitudes express the value of the potential difference (in volts) or the current flow (in amperes). Pacemaker output pulses have typically averaged 5 volts and 10 milliamps. Arrhythmia—Any rhythm in the heart that falls outside the accepted norm with respect to rate, regularity, and propagation sequence of the depolarization wave. Atrioventricular (A-V) Node—A small section of specialized neu- romuscular cells located in the posterior portion of the right atrium. This tissue is the normal conduction pathway for impuls originating in the atria to reach the ventricles, AV Interval—The period of time between an atrial event (sensed or paced) and a paced ventricular event in a dual-chamber pace- maker, AV Synchrony—The activation sequence of the heart in which the atria contract first and then, after an appropriate delay, the ventri- cles, Dual-chamber pacemakers are designed to stimulate the heart ina similar sequence. Battery—One or more cells, usually chemical, that serve as a source of electrical power. The chemical used as the anode in the majority of pacemaker cells is lithium, which is combined with another chemical that serves as the cathode, e.g,, iodine. The inter- action of the chemicals usually results in a voltage potential and current flow. Bipolar—Having two poles, or electrodes, both of which are locat- ed externally to the pulse generator, usually in the heart. For ‘example, a bipolar pacing lead has two electrodes: a small tip elec- trode through which the heart is usually stimulated, and a ring electrode, located several millimeters proximal to the tip electrode which completes the electrical circuit. During pacing, the current flow is between these two electrodes. These two electrodes also serve to sense spontaneous heart activity. Bradycardia—A slow heart rate; sometimes arbitrarily defined as a rate under 60 beats per minute, but better defined as a rate that is, too slow to be physiologically appropriate for the person and/or activity.Capture—Depolarization of the atria and /or ventricles by an elec- trical stimulus delivered by an artificial pacemaker. One-to-one capture occurs when each electrical stimulus causes a correspond ing depolarization. (See "Stimulation Threshold.”) Chronotropic Incompetence—Inability of the heart to increase its, rate appropriately in response to increased demand for cardiac output, Conduction—The passage of an electrical charge. In electro- physiology, the term refers to the active propagation of a depolar- ization wave in the heart, Depolarization—The sudden change in electrical potential from negative to slightly positive which occurs during Phase 0 of the action potential. The term also refers to the same phenomenon occurring across a large mass of tissue, e.g., the ventricles of the heart. In the heart, depolarization usually results in a contraction. Dual-Chamber Pacing—Pacing in both the atria and the ventricles to artificially restore the natural contraction sequence of the heart. Also called “physiologic” pacing. Electrocardiogram (ECG or EKG)—A graphic representation of the electrical activity of the heart as detected by electrodes, cus~ tomarily affixed to the skin. Electrode(s)—That portion of an electric conductor through which the current enters or leaves. In pacing, the term refers to the unin- sulated conductive portion(s) of a pacing lead or the unipolar implantable pulse generator’s casing which makes electrical con- tact with tissue. Electrogram (EGM)—In pacing, the recording of the cardiac wave- forms as taken at the lead (electrode) site within the heart. Electrograms may be transmitted from implanted pacemakers by telemetry End-of-Life (EOL)—The point at which a pacemaker signals that it should be replaced because its battery is nearing depletion. [For example, Medtronic pacemakers use a decrease in pacing rate as a major indicator of this event. To further assist the physician in determining when the pacemaker should be replaced, newer model Medtronic pacemakers have a two stage end-of-life indica~ tor: Imminent Elective Replacement (signaling that replacement time is approaching) and Flective Replacement (signaling that pulse generator replacement should be scheduled as soon as prac- ticable.)]Event Counters—A feature of some pacemakers that allows recording of intrinsic and paced electrical events in the heart, Exit Block—Failure of a pacemaker to capture the heart because the stimulation threshold exceeds the output of the pacemaker. Fibrillation—An unsynchronized quivering or twitching in the myocardium such that no effective pumping occurs. Flutter—A rapid but regular atrial rhythm of 250-350 bpm or ven- tricular rhythm of 200-300 bpm. Classified as an arrhythmia; not to be confused with fibrillation, which is chaotic rhythm, Heart Block—A condition in which impulses are not conducted in the normal fashion from the atria to the ventricles. A form of arrhythmia caused by damage or disease processes somewhere in the cardiac conduction system. Common types of block include the following: First Degree Block—A condition in the conduction system in which there is a prolonged interval (more than 200 ms or 2 sec.) between the atrial and ventricular depolarizations. Second Degree Block—A blockage of some (but not all) impulses traveling from the atria to the ventricles. It can take two forms. Mobitz Type I—also known as the Wenckebach phenomenon—is the successive prolongation of the P-R inter- val until one P-wave does not elicit a QRS response. Mobitz. ‘Type Il block occurs when occasional P-waves are blocked from the ventricles, Third Degree Block (Complete Heart Block)—A condition in which all impulses from the atria are blocked. In this condi- tion, an ectopic focus in the ventricles usually takes over. Impedance—The total opposition that a circuit presents to an alternating electrical current. Impedance and resistance are often used as equivalent terms in pacing, though in a strict engineering sense this is not accurate. Implantable Pulse Generator (IPG)—Refers to a pacemaker that is used for permanent pacing and is placed inside a pocket under the skin; the leads are positioned in or on the heart. Impulse—The term frequently used to describe the electrical stim- ulus delivered by a pacemaker, Lead (Also Wire, Catheter)—In a pacemaker system, the lead has three components: the wire or wires which carry electrical signals to and from the heart, a connector pin, and simulating /sensing electrode(s). The conducting wire is insulated with materials such as polyurethane or silicone rubber. 36Steroid Eluting Lead—Term used to describe an implanted lead that elutes an anti-inflammatory drug through the electrode. Use of the drug maintains relatively low pacing thresholds. Lower Rate—In atrial tracking dual-chamber pacemakers (DDD), the programmed rate at which the pacemaker will pace the heart in the absence of intrinsic cardiac activity. Marker Channel"—A feature of some pacemakers which is designed to simplify ECG interpretation by identifying—via telemetry—when and in which chamber pacing and /or sensing occurs, Myopotentials—A term used to describe electric signals that origi- nate in body muscles; these signals may be sensed by the pace- maker and falsely interpreted as depolarizations. Oversensing—Inhibition of a pacemaker by events other than those which the pacemaker was designed to sense, e.g., myopoten- tials, electromagnetic interferences, T-waves, crosstalk, ete. Pacemaker, External—Any pulse generator intended to be worn outside the body, used for temporary pacing. Pacing Mode—Describes the manner in which the cardiac pace- maker provides artificial rate and rhythm support in the presence of arrhythmias. Pacing modes can be identified by the NBG Code. Parameters—In pacing, a term quantifying the operational vari- ables which determine the pacemaker’s behavior. These include: pacing rate, pulse width, A-V interval, refractory periods, etc. Pulse Generator—That portion of the pacing system that produces periodic electrical pulses and contains the power supply and elec- tronic circ’ Pulse Width—The duration of the pacing pulse expressed in milliseconds. Also called pulse duration. P-Wave—The electrocardiographic representation of atrial depo- larization, QRS Complex—Commonly referred to as the R-wave. The elec- trocardiographic waveform produced by a ventricular depolariza- tion. Rate Responsive Pacing—Artificial pacing in which pacemakers change pacing rate in response to detected changes in the body (parameters) to mect metabolic demand for increased circulation. snsors are used to detect these parameters. 37Repolarization—The recovery process of excitable tissue (muscles or nerves) following depolarization. This causes the T-wave (ven- tricular repolarization) on an ECG. R-Wave—See “QRS Complex.” Sensing Threshold—The minimum atrial or ventricular intracar- diac signal amplitude required to inhibit or trigger a demand pace- maker. Expressed in millivolts. Sensitivity—The degree to which a pacemaker is responsive to levels of electrical activity in the heart. See “Sensing Threshold.” Sick Sinus Syndrome—A broad term to describe abnormalities in the S-A node which result in slow, or irregular, heart rates or inter- mittent cessation of nodal activity. Sino-atrial Node—A small knot of cells located on the posterior wall of the upper right atrium. The heart's natural pacemaker. Syncope—Fainting, loss of consciousness or dizziness due toa transient disturbance of cardiac rhythm (arrhythmia), cardiac con- duction (heart block), or neurovascular tone. ‘Tachycardia—Rapid beating of the heart, usually defined as a rate cover 100 beats per minute. Telemetry—The transmission of signals or data from one electronic unit to another by radio waves or other means. In pacing, this refers to the ability of the pacemaker to send information to the programmer, e.g., programmed status, real-time measurements and signals. Temporary Pacing—See “Pacemaker, External.” Threshold—The minimum electrical stimulus needed to consis- tently elicit a cardiac depolarization. It can be expressed in terms of amplitude (volts, milliamps), pulse width (milliseconds), or energy (microjoules). ‘T-Wave—The electrocardiographic representation of the repolar- ization of the ventricles. Undersensing—Failure of the pacemaker to sense the P-wave or R-wave; may cause the pacemaker to emit inappropriately timed impulses, Unipolar—Having one pole, or electrode, located externally to the pulse generator. In unipolar pacing systems, there are two. electrodes, but only one is in or on the heart; the other electrode, the indifferent electrode, is usually the metal shield of the pulse generator. 38Upper Rate—In atrial tracking dual-chamber pacemakers (DDD), a programmed limit to the rate at which the ventricles are paced in response to atrial activity. Thus, 1:1 tracking will prevail until the upper rate limit is exceeded; at this point the pacemaker will slow its rate of ventricular pacing to avoid tachycardia, by the Wenckebach operation, 2:1 block, etc. 39World Headquarters Madtrone, Ine. 70 Medtronic Parkway [Minneapolis MN'S5432-S604 Usa Tel (763) S'4-4000 Fare (763) 54-4879 wwwemedtronie.com Medtronic USA, ne. Tolefee:1(800) 328-2518 (24-hour technical support for pysclans ard medal professionals) Europe Medtronic international Trading Siri Route du Molau 31 (Hells) Tolochenaz Switzerland | “Tek (4120802 7000 Fase (4120) 802 7900 ‘worw.medtronie.com ‘canada Medtronic of Canada Lid. 6733 Kitimat Road ‘Mesissauga, Ontario LIN 193 Canada Tel (605) 826-¢020 Fax: (805) 426-6620 ‘ol-free| (800) 268-5346 Asie Pacific SE ei 16/F Manulife Plaza Se een ee ee Pees Latin America Medloric USA, ine Doral Corporate Center 3730 NW 87th Avenue Suite 700, ‘Mia FL 33178 Usa Tel (305) $00-9328, Fax: (786) 709-4244 warwmedirorie com