心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130907北區

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心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130907北區

  1. 1. 陽明大學附設醫院 心臟內科 黃嵩豪
  2. 2. First External Stimulation Catharina Serafin Increase in heart rate (140 bpm) Hugo von Ziemssen (1882) Stimulation: ON OFF Right Ventricle Left Ventricle
  3. 3. 1827/46 Bradycardia as cause of syncope (Adams, Stokes) 1882 First external stimulation (von Ziemssen) 1932 First external pacemaker (Hyman) 1952 External stimulation via surface electrodes (Zoll) 1958 External stimulator with transvenous lead (Furman, Robinson) 1958 First implantable PM with transvenous lead (Elmquist, Senning) Historical Milestones
  4. 4. First External Pacemaker Hyman (1932) - Clockwork generator with manual power - Transthoracic stimulation needle - Handle turn to provide induction stimulus Cardiac standstill Stimulation 120 ppm
  5. 5. Transvenous External PM Furman and Robinson (1958)
  6. 6. Wearable Pulse Generator - Around Waist (1958 )
  7. 7. First Implantable Pacemaker Senning and Elmquist (1958) Rune Elmquist Engineer at Siemens-Elema Ake Senning, Cardiac Surgeon Karolinska Hospital Stockholm
  8. 8. First Implantable Pacemaker Senning and Elmquist (1958) • 2 Transistors • Pulse 2 V / 1.5 ms • Rate 80 ppm 55 mm Ø , 16 mm thick
  9. 9. First Pacemaker Patient: Arne Larsson 1986 First Implantable Pacemaker
  10. 10. First Battery Powered PM Chardack, Greatbatch (1960) 10 Zinc-Mercury Batteries
  11. 11. First Programmable PM Chardack, Greatbatch (1963) with a screwdriver
  12. 12. Founded in 1949 as a medical equipment service company History and Background History • First external wearable pacemaker
  13. 13. Success With Implantable Pacemakers  In the United States, the first successful attempts at designing a totally implantable pacemaker were reported by Drs. William Chardack and Andrew Gage at the Veterans Administration Hospital in Buffalo, New York, and Wilson Greatbatch, an electrical engineer. The three men carried out more than two years of experimental work and testing, then published a paper about their work in 1960.  Medtronic's founders read the article with interest and soon contacted the New York researchers. Palmer Hermundslie flew his own plane to Buffalo to meet Dr. Chardack and Greatbatch, and signed a contract giving Medtronic exclusive rights to produce and market the Chardack-Greatbatch implantable pulse generator. Within two months of beginning production in late 1960, Medtronic had received orders for 50 of the $375 implantable units.  Co-founder Palmer Hermundslie often piloted his own plane to make emergency deliveries of pacemakers.  At the same time, Medtronic appointed Picker International Corporation of White Plains, New York, as its sole distributor outside the United States, exclusive of Canada. Picker's 72 foreign sales offices greatly expanded the marketing efforts of Medtronic, which had 14 sales representatives covering the United States and Canada.  In addition to the implantable pacemaker, the representatives sold seven other Medtronic products, including the Telecor, which visibly and audibly monitored heart activity; the Cardiac Sentinel, an automatic alarm that summoned aid when the patient's heart activity became critical and stimulated the heart with an electronically regulated pulse; and a Coagulation Generator, used to control bleeding during surgery without damaging nearby tissue. Dr. C. Walton Lillehei with a child who received one of the early Medtronic external pacemakers
  14. 14. Atomic Pacemaker Plutonium powered PM (1967)
  15. 15. Implantable Electronic Cardiac Devices Historical Aspects 1932 1958 1964 1970 1980’s 1994 Hyman Senning and Elmquist 1st implant of an electronic PM Mirowski Development of the 1st ICD – implant in dogs 1st report of CRT RECENTLY Furman 1st endocardiac PM Heart Failure control Home Monitoring
  16. 16. Basic Concept of Pacemaker Over view - Pacemaker System - Pacemaker Function - NBG Code - Lead Impedance - The magnet Mode & Electromagnetic Interference - Information for patient ‘s pacemaker
  17. 17. What is a pacemaker ?  A device for increaseing a slow HR  A device used primarily to correct some types of bradycardia, or slow heart rhythms.
  18. 18. Who need it ?  Indications for Pacing  Sick Sinus Syndrome  Heart Block  Post RF Ablation
  19. 19. How does it work ?  Attach the pacemaker system  Pulse generator  Sensing and Pacing leads  Make it into a circuit  Put the system into the body / under the skin and join to the heart by pacing wire  Program it’s function by the programmer
  20. 20. Pacing Systems Pulse generator Sensing and Pacing lead
  21. 21. The Pacemaker System  Patient  Lead  Pacemaker  Programmer Lead Pacemaker
  22. 22. Leads  Epicardial  Endocardial
  23. 23. Connection to Pacemaker
  24. 24. Just a Simple Lead
  25. 25. Lead System  A lead is the insulated wire used to connect the pulse generator to the cardiac tissue  The lead transmits the energy to the myocardium and relays intrinsic cardiac signals back to the sensing circuit
  26. 26. Components of a Pacing Lead Connector Proximal Ring Electrode Lead Body Active Fixation Mechanism Suture Sleeve Distal Tip Electrode
  27. 27. Fixation Mechanisms Active fixation Screw-in lead Passive fixation Tined tip Passive fixation Finned tip
  28. 28. Suture On Sutureless Epicardial Leads
  29. 29. Pacemaker Circuit Unipolar VS Bipolar
  30. 30. Bipolar Unipolar Unipolar Vs. Bipolar ++-
  31. 31. Unipolar Configuration Lead Pacemaker Unipolar Pathway - +
  32. 32. Bipolar Configuration Lead Pacemaker - + Bipolar Pathway
  33. 33. Unipolar Versus Bipolar
  34. 34. UNIPOLAR vs BIPOLAR
  35. 35. Unipolar Leads  Advantage  Smaller size  Easier to implant?  Larger spike on surface ECG  Theoretically more reliable  Disadvantages  Possibility of pocket stimulation  Possibility of myopotential inhibition  Susceptible to EMI  Susceptible to cross-talk
  36. 36. Bipolar Leads  Advantages  Torque control  Noise Rejection  Programming flexibility  No Pocket stimulation  Disadvantages  Larger Diameter  Stiffer  Small ECG Artifact in surface ECG
  37. 37. Lead Placement  Ventricular Lead  Right Ventricular Apex (RVA) or Right Ventricular Outflow Tract (RVOT)  Ventricular Bradycardia Pacing  Sensing Intrinsic Rhythm  Atrial Lead  Right Atrial Appendage or Atrial Septal Wall  Atrial Pacing  Atrial Sensing
  38. 38. Ventricular Lead Placement
  39. 39. Atrial Lead Placement  The atrial lead should be implanted on the septal wall of the atrial appendage  Once the lead is in the proper position it will have a “wagging” appearance
  40. 40. Atrial Endocardial Placement
  41. 41. Single Chamber Pacing  One Lead  One Circuit / Pacemaker  One Patient
  42. 42. Dual-Chamber Pacing
  43. 43. Basic Function  Energy  Output Parameters  Cardiac Stimulation Threshold  Impedance
  44. 44. Energy  Ohm's Law  Voltage  Current  Resistance
  45. 45. How to stimulate? Ohm´s Law: V = R x I R = V I Voltage Current = = [V] [A] The higher the voltage and the lower the resulting current the higher is the resistance.  V = Voltage, I = Current , R = Resistance
  46. 46. Voltage The difference in potential energy between two points Unit of measure = volt (V)
  47. 47. Current The rate of transfer or flow of electricity Unit of measure – milliampere (mA)
  48. 48. Resistance The opposition to the flow of electrical current through a material Unit of measure = ohm (Ω)
  49. 49. V = IR V = IR CONSTANT VOLTAGE
  50. 50. t (ms) How to stimulate? Pulse Amplitude Pulse Duration U (V) Pacemaker Pulse
  51. 51. Pacing Technology “Secret” Pacemakers do only 2 things: Pace Sense
  52. 52. Capture Definition : Cardiac depolarization and resultant contraction caused by pacemaker stimulus
  53. 53. Pacing (Stimulation) threshold  The lowest amount of energy to capture the myocardium 100 % of the time
  54. 54. How to stimulate? Pulse Duration (ms) Pulse Ampli- tude (V)
  55. 55. Pulse Duration (ms) Pulse Ampli- tude (V) How to stimulate? Rheobase - Chronaxie
  56. 56. How to stimulate? Pulse Duration (ms) Pulse Ampli- tude (V) Energy (mJ)
  57. 57. How to stimulate? E = R x I x t E = x t (Joule) V2 R Energy V = R x I V R I = E = V x x tV R
  58. 58. How to stimulate? E = x t (J) V2 R Energy How to save energy? - lower pulse amplitude (V²) - lower pulse duration - high impedance
  59. 59. Strength Duration Curve pulse width (msec) Voltagethreshold(V) Chronaxie Rheobase 2 x Rheobase Most efficient pulse width • The rheobase is the least voltage needed to depolarise the heart at an infinite pulse duration. • The chronaxie is the shortest pulse duration required to depolarise the heart at a voltage twice the rheobase.
  60. 60. Pacing Thresholds  Suggested Intraoperative Values  Atrium  Less than 1.5 Volts  Ventricular  Less than 1.0 Volts  Pacing Impedance  300-1500 Ω Depending on lead type
  61. 61. Acute To Chronic Threshold Change  Historically reported to occur between 2-8 weeks post implant  Thresholds may increase 2-5 times  Virtual Electrode - Myocardial Interface
  62. 62. Excitable Tissue Non-Excitable Tissue Virtual Electrode Electrode Chronic Electrode
  63. 63. Pacing Thresholds Hayes, D. et. al. Cardiac Pacing and Defibrillation: A Clinical Approach. Futura. Armonk, NY. 2000:7. 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 1 2 3 4 5 6 7 13 26 52 Time After Implant ChronicPacingThreshold,PulseWidth(ms) 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5 1 2 3 4 5 6 7 13 26 52 Time After Implant ChronicPacingThreshold,PulseWidth(ms) Steroid No Steriod
  64. 64. Sensing Definition: The ability of the pacemaker to sense an intrinsic electrical signal
  65. 65. Sensing  When programming sensitivity, as you lower the number you make the pacemaker more sensitive, (allow it “see” more). 1 mV 2 mV 5 mV Sensing
  66. 66. Sensing  Sensing Threshold: indicates the minimum intracardiac signal that will be sensed by the pacemaker to initiate the pacemaker response (inhibited or triggered) Sensing
  67. 67. X = programmed sensitivity Amplifier and Filter Signal processing Signal recording How to sense?
  68. 68. 0 5 10 15 20 25 1 3 5 10 30 50 100 300 1000 VES R-wave T-wave Amplitude Frequency (Hz) P-wave Myopotentials (mV) How to sense? Filtering of Intracardiac Signals
  69. 69. How to sense? Sensitivity: 2.5 mV Vs Vs 0 5 5 Intra- cardiac Signal (mV) Vs Vs Vs Vs PM Marker
  70. 70. How to sense? Sensitivity: 5.0 mV Intra- cardiac Signal (mV) PM Marker 0 5 5 Vs Vs  Undersensing
  71. 71. Sensing Thresholds  Suggested Intraoperative Values  Atrium  Greater than 2.0 mV  Ventricular  Greater than 5.0 mV
  72. 72. The NASPE/BPEG Generic (NBG) Code Position Category Letters Used Manufac- turer’s Designation Only I II III Chamber(s) Paced Chamber(s) Sensed Response to Sensing Rate modulation Multisite pacing O-None P-Simple Programmable M-Multi- Programmable C-Communicating R-Rate modulation O-None A-Atrium V-Ventricle D-Dual (A+V) S- Single (A or V) S- Single (A or V) O-None A-Atrium V-Ventricle D-Dual (A+V) O-None T-Triggered I-Inhibited D-Dual (T+I) O-None A-Atrium V-Ventricle D-Dual (A+V) IV V Version 2001
  73. 73. Insulation Break Current is escaping Decreased Resistance Increased Current Drain Pacing and sensing problems
  74. 74. Lead Fracture Current cannot reach heart Increased Resistance Decreased Current Drain Pacing and sensing problems
  75. 75. LiJ - Battery Hybrid Connectors Titanium housing Components of the PM
  76. 76. Pacemaker Programming Telemetry Antenna
  77. 77. Pacemaker Power Source Zinc-Mercury Lithium-Iodine
  78. 78. Pacemaker Power Source Zinc-Mercury Lithium-Iodine Time Time
  79. 79. Pacemaker Power Source
  80. 80. Pacemaker Power Source Pulse Amplitude and Device Longevity Battery 1.1 Ah Mode VVI VVI DDD DDD Amplitude (V) 5 2.5 5 2.5 Inhibited (µA) 11 11 12 12 Pacing V (µA) + 10 + 2,5 + 10 + 2,5 Pacing A (µA) - - + 10 + 2,5 Total (µA) 21 13,5 32 17 Longevity (yrs) 6,2 9,6 4,1 8,0
  81. 81. Lead Resistance/Impedance Changes  High Resistance  > 2500 ohms  Also called an “Open Circuit”  Chronic lead system  Fractured lead conductor coil  Acute lead system  Loss of contact between the terminal pin of the lead and the pacemaker header set screw
  82. 82.  Low Resistance  < 250 ohms  Also called “Shorted Circuit”  Insulation Break-Down  Insulation cut by suture  Degradation of the insulation  Subclavian Crush Syndrome Lead Resistance/Impedance Changes
  83. 83. Implantable Cardioverter Defibrillator Anti-tachycardia Devices
  84. 84. First graphic documentation of ventricular fibrillation ICD Evolution: 1850 Carl Ludwig (1816-1895)
  85. 85.  1st documented termination of VF with elevated current  Their work went largely unnoticed for 30 years ICD Evolution: 1899
  86. 86. • Reproduced electric current termination of VF • Done at the request of Bell telephone to address electrocution of line workers (occurring at the rate of 1000/yr) ICD Evolution: 1930 William Kouwenhoven (1886-1975)
  87. 87. What is ICD Therapy? • ICD therapy consists of pacing, cardioversion, and defibrillation therapies to treat tachyarrhythmias. ICDs also have programmable diagnostic functions. • An ICD system includes the device, and the pacing, sensing and defibrillation lead(s).
  88. 88. 1947 • First successful defibrillation of exposed human heart • Required thoracotomy ICD Evolution:
  89. 89. Early Medtronic Defibrillator 1950’s Used in open heart surgeries Applied directly to the heart ICD Evolution
  90. 90. 1970 • Patent granted for first totally implantable defibrillator • System used an intracardiac catheter and SQ patch with detection via RV pressure transducer ICD Evolution Michael Mirowski (1924-1990)
  91. 91. ICD Evolution
  92. 92. NEJM 1997;337;1576-83 Secondary Prevention of Sudden Arrhythmic Death AVID Study
  93. 93. N of Patients at Risk ICD 742 502 (0.91) 274 (0.84) 110 (0.78) 9 Conventional 490 329 (0.90) 170 (0.78) 65 (0.69) 3 Moss AJ. N Engl J Med 2002;346:877-883 ICD ConventionalP = 0.007 1.0 0.9 0.8 0.7 0.6 0.0 SurvivalProbability 0 1 2 3 4 Years 0.78 0.69 -31% Primary Prevention of Sudden Arrhythmic Death MADIT II Study
  94. 94. Cardiac Resynchronization Therapy for Heart Failure
  95. 95. Ventricular Dysynchrony and Cardiac Resynchronization • Ventricular Dysynchrony1 – Electrical: Inter- or Intraventricular conduction delays typically manifested as left bundle branch block – Structural: disruption of myocardial collagen matrix impairing electrical conduction and mechanical efficiency – Mechanical: Regional wall motion abnormalities with increased workload and stress—compromising ventricular mechanics • Cardiac Resynchronization – Therapeutic intent of atrial synchronized biventricular pacing • Modification of interventricular, intraventricular, and atrial-ventricular activation sequences in patients with ventricular dysynchrony • Complement to optimal medical therapy 1 Tavazzi L. Eur Heart J 2000;21:1211-1214
  96. 96. Prevalence of Inter- or Intraventricular Conduction Delay 1 Havranek E, Masoudi F, Westfall K, et al. Am Heart J 2002;143:412-417 2 Shenkman H, McKinnon J, Khandelwal A, et al. Circulation 2000;102(18 Suppl II): abstract 2293 3 Schoeller R, Andersen D, Buttner P, et al. Am J Cardiol. 1993;71:720-726 4 Aaronson K, Schwartz J, Chen T, et al. Circulation 1997;95:2660-2667 5 Farwell D, Patel N, Hall A, et al. Eur Heart J 2000;21:1246-1250 IVCD 15% IVCD >30% General HF Population1,2 Moderate to Severe HF Population3,4,5
  97. 97. 60% 70% 80% 90% 100% 0 60 120 180 240 300 360 Days in Trial CumulativeSurvival QRS Duration (msec) <90 90-120 120-170 170-220 >220 Wide QRS – Proportional Mortality Increase • NYHA Class II-IV patients • 3,654 ECGs digitally scanned • Age, creatinine, LVEF, heart rate, and QRS duration found to be independent predictors of mortality • Relative risk of widest QRS group 5x greater than narrowest 1 Gottipaty V, Krelis S, Lu F, et al. JACC 1999;33(2) :145 [Abstr847-4]. Vesnarinone Study1 (VEST study analysis)
  98. 98. Clinical Consequences of Ventricular Dysynchrony • Abnormal interventricular septal wall motion1 • Reduced dP/dt3,4 • Reduced pulse pressure4 • Reduced EF and CO4 • Reduced diastolic filling time1,2,4 • Prolonged MR duration1,2,4 1 Grines CL, Bashore TM, Boudoulas H, et al. Circulation 1989;79:845-853. 2 Xiao, HB, Lee CH, Gibson DG. Br Heart J 1991;66:443-447. 3 Xiao HB, Brecker SJD, Gibson DG. Br Heart J 1992;68:403-407. 4 Yu C-M, Chau E, Sanderson JE, et al. Circulation. 2002;105:438-445. Click to Start/Stop
  99. 99. Longer Shorter Relaxed Courtesy of Dr Kass, MD, Johns Hopkins University, Maryland. SEPTUM BASE APEX SEPTUM BASE Normal Dilated Cardiomyopathy APEX Left Ventricular Dysfunction Electromechanical Dyssynchrony
  100. 100. Summary of Proposed Mechanisms Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 Intraventricular Synchrony Atrioventricular Synchrony Interventricular Synchrony  LA Pressure  LV Diastolic Filling  RV Stroke Volume  LVESV  LVEDV Reverse Remodeling Cardiac Resynchronization  MR dP/dt,  EF,  CO ( Pulse Pressure)
  101. 101. Proposed Mechanisms: Improved Intraventricular Synchrony Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73 PV loop tracings at right illustrate BiV/LV pacing produces: greater stroke work (area) and increased stroke volume (width), and a reduced systolic volume 0 40 80 120 0 100 200 300 0 40 80 120 0 100 200 300 0 40 80 120 0 100 200 300 0 40 80 120 0 100 200 300 LVPressure(mmHg)LVPressure(mmHg) LV Volume (mL) LV Volume (mL) RV Apex RV Septum LV Free Wall Biventricular ----- NSR Control - - - VDD Pacing Adapted from Kass et al.
  102. 102. Proposed Mechanisms: Improved Intraventricular Synchrony Click to Start/Stop  dP/dt 1,3,4 EF1,5  Pulse Pressure 3,4  SV&CO1, 2 Improved Intraventricular Synchrony1,2  MR1  LVESV1  LA Pressure1 1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 2 Søgaard P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182 3 Kass D Chen-Huan C, Curry C, et al. Circulation 1999;99:1567-73 4 Auricchio A, Ding J, Spinelli J, et al. J Am Coll Cardiol 2002;39:1163-1169 5 Stellbrink C, Breithardt O, Franke A, et al. J Am Coll Cardiol 2001;38:1957- 65
  103. 103. Proposed Mechanisms: Improved Atrioventricular Synchrony Click to Start/Stop 1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 2 Kindermann M, Frohlig G, Doerr T, et al. Pacing Clin Electrophysiol 1997; 20(I):2453-2462 3 Breithardt O, Stellbrink C, Franke A, et al. Am Heart J 2002;143:34-44 4 Søgaard P, Kim W, Jensen H, et al. Cardiology 2001;95:173-182 Improved Atrioventricular Synchrony  LA1 Pressure  LV Diastolic Filling1,3  LVEDV1,4 Optimized AV Delay:  Isovolumic Contraction Time1,2  MR1,4
  104. 104. 1 Yu C-M, Chau E, Sanderson J, et al. Circulation 2002;105:438-445 2 Kerwin W, Botvinick E, O’Connel W, et al. JACC 2000;35:1221-7 Improved Interventricular Synchrony1,2  LV Diastolic Filling1  RV Stroke Volume1 Courtesy of Ottawa Heart Institute LV Wall Endocardium RV Septum LV Proposed Mechanisms: Improved Interventricular Synchrony
  105. 105. Achieving Cardiac Resynchronization Mechanical Goal: Atrial-synchronized bi-ventricular pacing • Transvenous Approach – Standard pacing lead in RA – Standard pacing or defibrillation lead in RV – Specially designed left heart lead placed in a left ventricular cardiac vein via the coronary sinus Right Atrial Lead Right Ventricular Lead Left Ventricular Lead
  106. 106. Cardiac Resynchronization Atrio-biventricular Pacing LVRV
  107. 107. Cleland et al, Eur Heart J 2006;27(16):1928-32 0 500 1000 1500 0 25 50 75 Days P<0.0001 Event-freeSurvival 571192321365404 889213351376409 Control CRT N of Patients at Risk Medical Therapy CRT 100 HF CF III/IV EF<0.35 QRS>130ms Cardiac Resynchronization CARE-HF Study: Overall Mortality
  108. 108. Cardiac Resynchronization CARE-HF Study: Sudden Mortality Cleland et al, Eur Heart J 2006;27(16):1928-32 CRT Medical Therapy Survival Time (days) Hazard ratio 0.54 (95% CI 0.35-0.84. P = 0.006) CRT = 32 sudden deaths (7.8%) Medical therapy = 54 sudden deaths (13.4%) 1.00 0.75 0.50 0.25 0.00 0 400 800 1200 1600
  109. 109. Cardiac Resynchronization + ICD COMPANION Study: Overall Mortality N Engl J Med 2005 CRT-D CRT TMO Sobrevidalivredeeventos(%) 19% 12% 15% N:1520

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