心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130914中區
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心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130914中區

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心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130914中區 心臟植入性電子儀器(CIED )之歷史”CIED Overview “_20130914中區 Presentation Transcript

  • History and Overview of Cardiac Implantable Electronic Devices Allied Professional Training, THRS 07th, 14th, 21st, Sep, 2013
  • Contents  Brief of cardiac pacing  Overview of battery and generator  Lead technology  Pacemaker Mode and NBG code
  • ECG history 王叔和 (201- 280BC) : 脈經 Hippocrates (460 – 375 BC): “Those who suffer from frequent and strong faints without any manifest cause die suddenly” Dr. William Harvey (1578-1657) 1774AD : first external electric stimulation of heart 1882AD :Dr.Von Ziemssen decscribed 42 (46) y/o female with chest tumor, Stimulated her heart using electric current and could change her heart rate at will
  • 1887AD : The physiologist Augustus Desire’ recorded the first human surface electrocardiogram Willem Einthoven (1860 – 1927),He initially indicated the four observed deflections with the characters A, B, C, D but later adopted the middle characters of the alphabeth: P, Q, R, S and T 1942:The extremity bipolar electrode system (the standard electrocardiogram lead system) was expanded in 1933 by F. N. Wilson who introduced the unipolar chest wall electrode ECG history
  • Cardiac Pacing 1928: Mark Lidwell: Pacing to save life of a infant in cardiac arrest 1932: Hyman Pacemaker “artificial pacemaker” 1940 Hoop pacemaker 1950 Zoll Pacemaker : 1st catheter electrode 1957 Bakken’s Pacemaker
  • History of Pacemaker 1958, Siemens-Elema In 1994 Siemens sold its entire pacemaker business to the American company St. Jude Medical Arne Larsson
  • Indications and CIED Products • Pacemaker • Single chamber pacemaker • Dual chamber pacemaker Bradycardia • ICD (Implantable cardiovertor defibrillator) • Single chamber ICD • Dual Chamber ICD Ventricular Tachycardia/Ventricular Fibrillation • CRT-P • CRT-D Congestive Heart Failure
  • Pacemaker
  • Modern Pacemaker  Fully programmable dual chamber pacing  Rate response to activity and metabolic changes  Telemetry of pacer function  Incorporated algorithms to respond to change in intrinsic rhythms  Store patients arrhythmic events
  • Pacing System +
  • Fundamentals of Electricity  Ohm’s Law U = I X R U = Voltage (Volt, V) I = Current (Ampere, A) R = Resistance ( Ohm, ) 6 V I = 6 / 3 = 2 A 12 V I = 12 / 6 = 2 A 3 6
  • Pacing Impedance Insulation Defect <250 Ohm Normal Pacing Impedance 300 Ohm~1500 Ohm Lead fracture >1500 Ohm
  • Battery Energy  Energy, W= U X I X t W = U x I x t W= U2 x t R I = U R 2X output voltage 4X Energy
  • Pacemaker Components Connector Electric component Battery
  • Lithium Battery Battery Technology Li-I battery 3,0 [V] [Ah] Lithiumiodine Phase 1 Phase 2 Phase 3 30 µA 2,0 1.8 V 1,0 0 1 2 3 4
  • A Specialized Battery – Quasar (QMR)  Uses Lithium on the anode and both Silver Vanadium Oxide (SVO) and polycarbonmonofluoride (CFx) on the cathode  SVO for fast movement of ions  Lithium and CFx to approximate pacer battery characteristic  Current collector- collect ions formed by chemical reaction & transport them to battery terminal & to the device
  • Battery Capacity and Longevity
  • How pacemaker works  Pacing : Amplitude (V), Pulse width (ms) Capture Noncapture Pulse Width (ms) PulseAmplitude(V)
  • How Pacemaker works  Sensing T-wave P- or R-wave Myopotentials 8 mV 0,2 mV1 mV Band pass filter
  • How Pacemaker Works  Sensing- Choosing sensitivity 23 Sensitivity 5.0 mV Sensitivity 1.0 mV Sensitivity 10.0 mV
  • 24 Considerations in Sensitivity Programming  To make the device more sensitive (to pick up signals it might be missing), lower the mV setting  To make the device less sensitive (to avoid detecting non- cardiac signals), increase the mV setting  Sensitivity should  Pick up low-amplitude cardiac signals  Avoid very low-amplitude non-cardiac signals
  • Timing Cycles  Base rate (Lower rate limit)  Refractory Absolute Refractory Period Relative or Noise Sampling Period Alert Period
  • I II III IV V Chamber(s) Paced Chamber(S) Sensed Mode(s) of Response Progammable Functions Antitachyca rdia Functions V=Ventricle V=Ventricle T=Triggered R=Rate Modulable O=None A=Atrium A=Atrium I=Inhibited C=Cpmmunicating P=Paced D=Dual (A&V) D=Dual (A&V) D=Dual M=Multiprogramm able S=Shocks O=None O=None O=None P=Simple Programmable D=Dual O= None THE NBG CODE
  • 27 Mode Selection Considerations  Status of Atrial Rhythm  Intrinsic vs. Paced  Presence of Atrial Tachyarrhythmias:  Acute/Chronic  Status of AV Conduction  Normal Slowed Blocked  Presence of Chronotropic Incompetence Single Chamber ? Dual Chamber ? Rate Modulation?
  • Pacing Lead  Unipolar-Large Antenna • Large spike • More sensitive to interference • Pectoral muscle stimulation • More susceptible to EMI • Smaller lead diameter  Bipolar • Small spike • More sensitive to intrinsic cardiac signals • No myopotential inhibition • EMI protected • Less crosstalk Cathod “-” Anode “+” Anode “+” Cathod “-” Unipolar Bipolar
  • Pacing Lead  Passive lead  Tined lead  Active lead  Screwed lead
  • 31SJM internal use ONLY Steroid Delivery  MCRD steroid  (Monolithic Controlled Release Delivery)  < 1 mg Dexamethasone Sodium Phosphate 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0 4 8 12 16 20 52 l l l ll l l l l l l lll ll l ll l l l Amplitude (Volt) Weeks With steroid
  • Myocardial and Epicardial Leads  Leads applied directly to the heart  Fixation mechanisms include:  Epicardial stab-in  Myocardial screw-in  Suture-on
  • Magnet Reed Switch Magnet are need for test: Asynchronous mode DOO/AOO/VOO Magnet rate could indicate battery longevity, eg. Magnet rate is 99 at BOL, 85 at ERI
  • SJM internal use ONLY Magnet for Troubleshooting  When a magnet is applied:  Pacing rate increases  Newer device 98.5 ppm (5000 series devices)  Older SJM devices (pre Affinity) programmed rate  BOL = magnet rate = 98.6 ppm / 2.75 volts  ERI = magnet rate = 86.3 ppm / 2.5 volts  EOL = magnet rate = 68.0 ppm / 2.2 volts  Device reverts to asynchronous mode  DDD >> DOO  VVI >> VOO  AAI >> AOO  AV delay decreases 125  If you don’t get any pacing?  Could be an ICD or the pacer is at EOS  Check CXR for ID
  • ICD
  • History of the AICD  1969 - Dr. Mirowski and Dr. Morton Mower begin collaborating and develop the first experimental model Milestones
  • History of AICD Therapy  1975 - The first device is implanted and tested in an animal  1980 - The first patient is implanted with an AICD device Milestones
  • Whats Inside an ICD?
  • ICD Leads-DF1 and IS-1 Two DF-1, One IS-1 DF-1 (Shock)IS-1 (Pace/ Sense)
  • 40 DF4 Development History  Project began in 2004  Originally designed on Epic+ device  Built on Atlas II+ HF, Promote (non-RF), and Riata ST for testing  Extensive testing done on this system  No failures at two times maximum voltage (1500V)  First submissions September 2007
  • Dual Coil Lead Proximal Shock Electrode Distal Shock Electrode Hot Can Single Coil Lead Cold Can
  • Dual coil v.s. Single coil Dual Coil Single Coil Pro Lower DFT Higher DFT Con Difficult to remove May easier to remove
  • ICD Modules Special Functions Measurements Electrogram and Data Storage Reversion Classification Sensing Induction Therapy
  • PVT Detection - Fixed Gain/ Sensitivity NSR
  • Automatic Sensitivity Control (ASC) Automatic Sensitivity Tracking GAIN FILTER COMP THRESHOLD Sensed EventFrom Sense/Pace Leads Threshold adjusts + and - to adapt to the signal
  • Defib with slow VT and Fast VT Tach B (Fast VT) (ATP and CV Shocks) Treatment 375 ms (160 bpm) Sinus Tach A (Slow VT) (ATP and CV Shocks) Fib (Shock) Non-Treatment Treatment Treatment 500 ms (120 bpm) 300 ms (200 bpm) >500 ms (<120 bpm) No therapy SVT discrimination, VT therapy deliver when VT indicated VF therapy deliver
  • AF/AFl + Morphology, Stability ( AVA) VT/ VF Treat VT w/ 1:1 retro AF + VT AFl + VT Treat AF/AFl Inhibit ST, AT, 1:1 SVT Inhibit Treat Isolated VT + Morphology Onset Sinus Tach AV Int Atrial CL Ventricular CL Dual Chamber Sensing: Rate Branch + Additional SVT Criteria
  • Therapy Anti-tachycardia pacing (ATP)
  • Therapy High Voltage shock  Uses of High Voltage Therapy  To terminate:  Ventricular Tachycardia  Ventricular Fibrillation Thanks, I needed that!
  • Q: How do you manage a patient with multiple shocks?  Appropriate therapy  Ischemia  CHF  Electrolytes  Beta blockers  Procainamide  Amiodarone  Inappropriate Therapy  Noise  EMI  Inappropriate programming  Increased rate cutoff settings for 1 zone, 2 zone and 3 zone programming  Longer detection intervals for 2 zone and 3 zone programming  Optimized SVT discriminator settings for VR, DR and CRT-D  ATP as the first therapy in all zones (including ATP while charging in VF zone)  VT and SVT override settings programmed to off epoisodes of sustained VT/VF in 24 hrs = “Storm”
  • Magnet in ICD  Off Detection, No therapy will be delivered
  • CRT (Cardiac Resynchronization Therapy)
  • 53 Ventricular Resynchronization with CRT Pacing @ left lateral free wall in addition to right side Symmetric lateral and septal wall conduction & contraction More efficient pump
  • 54 Synchrony More work done with less effort & increased efficiency!
  • 55 Coronary Sinus approach Right Atrial Lead Right Ventricular Lead Left Lateral Free wall LV Lead Optimal LV Lead Placement
  • Venograms and LV Lead Placement LAO AP RAO Align to CS OS/ Middle Vein Anterior Lateral Posterior Right Basal Mid Apical
  • Final LV Lead Position RAO Good lateral position
  • Final LV Lead Position LAO Good lateral position
  • CIED revolution MRI conditional Device Leadless pacemaker ……