BIOTRONIK ICDs Implantable Cardioverter Defibrillators Instructions
- July 6, 2024
- BIOTRONIK
Table of Contents
BIOTRONIK ICDs Implantable Cardioverter Defibrillators
Product Specifications
- Product Name: Implantable Cardioverter Defibrillator (ICD)
- Model Year: 2024
- Manufacturer: Telectronics
- Function: Prevent sudden cardiac death by delivering therapeutic shocks
Product Usage Instructions
ICD System Overview
The Implantable Cardioverter Defibrillator (ICD) is a device designed to monitor heart rhythms and deliver therapy when dangerous arrhythmias are detected.
ICD System Components
The ICD system consists of the device itself, leads that connect the device to the heart, and a programmer used by healthcare professionals to program and monitor the device.
Implantation Procedure
The implantation of an ICD is typically performed under local anesthesia. The device is placed under the skin near the collarbone, and leads are inserted into the heart to monitor and deliver therapy.
Device Programming
After implantation, the ICD needs to be programmed based on the patient’s specific condition. This includes setting detection parameters and therapy options.
Monitoring and Follow-Up
Patient’s with an ICD require regular follow-up appointments to ensure the device is functioning properly and to adjust settings if needed.
Frequently Asked Questions
- Q: How long does an ICD last?
- A: The battery life of an ICD varies but typically lasts between 5 to 10 years depending on usage.
- Q: Can I travel with an ICD?
- A: Yes, you can travel with an ICD. However, it’s recommended to inform airport security and carry your device identification card with you.
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Implantable Cardioverter Defibrillators (ICDs) Fundamentals Overview
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Objectives
· Review History of the ICD · Discuss Indications · Describe ICD Sensing &
Detection · Provide Basics of ICD Therapies & Diagnostics · Present ICD
Electrograms · Review ICD Therapy Case Studies
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ICD System Historical Milestones
· 1966 Conception · 1969 First experimental model · 1969 First transvenous
defibrillation · 1975 First animal implant · 1980 First human implant · 1982
Addition of cardioverting capability · 1985 FDA approval · 1988 First
programmable ICD implanted
Dr. Michel Mirowski 1924 – 1990
Mirowski M, Mower M, Staewen W, Tabatznick B, Mendeloff A, (1970), Standby
automatic defibrillator. An approach to prevention of sudden coronary death.
Arch Intern Med 126:158 – 161
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1980
The original ICD device (Intec) had two electrodes: · One, a spring, was
placed in the
Vena Cava · The other, a cup, designed to
conform to the cardiac apex
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1988
Telectronics developed the first ICD with an “on board” VVI pacemaker
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ICD Lead History
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3
ICD Evolution 1989 – 2000
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Today’s ICD
Bradycardia Pacing · Dual chamber and CRT Antitachycardia Pacing · Multiple
algorithms Low-Energy Cardioversion · Widely programmable High-Energy
Cardioversion · Fast charge times
· Energy waveforms Improved Algorithms · AV discrimination
· Dual chamber sensing · Detection enhancements · Hemodynamic monitoring CIED
Diagnostics · Stored electrograms · Device integrity · Remote monitoring
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The ICD Procedure In the beginning
The patient admitted AFTER surviving Sudden Cardiac Death…
· EP testing required · DFT testing routine · Sternal thoracotomy · Average 18
months battery longevity
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The ICD Procedure – Now
Patient at high risk for SCD:
· Admitted as an outpatient majority of the time · Discharged the same or next day · DFTs only performed in select patients · 8+ years battery longevity common
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ICD Indications: Primary
Primary Prevention Guidelines:
· ICD therapy is recommended to reduce total mortality by a reduction in SCD
in patients who have ischemic heart disease and whose MI was greater than 40
days ago, with EF less than 30%, NYHA II or III symptoms and optimal medical
therapy
· ICD therapy is recommended to reduce total mortality by a reduction in SCD
in patients with nonischemic cardiomyopathy, EF less than 30%, NYHA II or III
symptoms with optimal medical therapy
2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death A Report of the
American College of Cardiology/American Heart Association Task Force on
Clinical Practice Guidelines and the Heart Rhythm Society Sana M. Al-Khatib,
Michael J. Ackerman,William J. Bryant,David J. Callans,Anne B. Curtis,Barbara
J. Deal,Timm Dickfeld Michael E. Field,Gregg C. Fonarow,Anne M.
Gillis,Christopher B. Granger,Stephen C. Hammill,Mark A. Hlatky,José A.
Joglar,G. Neal KayDaniel D. Matlock,Robert J. Myerburg andRichard L. Page
Originally published1 Aug
2018https://doi.org/10.1161/CIR.0000000000000549Circulation.
2018;138:e272e391
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ICD Indications: Secondary
· Cardiac arrest due to VF or VT not due to a transient or reversible cause ·
Nonsustained VT with CAD, previous MI, left ventricular dysfunction, and
inducible VF or sustained VT
at EP study not suppressible by Class I antiarrhythmic drug · Spontaneous
sustained VT in a normal heart when alternative therapies have failed ·
Syncope of undetermined origin with clinically relevant, hemodynamically
significant sustained VT or
VF induced at EP study when drug therapy is ineffective, not tolerated or not
preferred
2017 AHA/ACC/HRS Guideline for Management of Patients With Ventricular
Arrhythmias and the Prevention of Sudden Cardiac Death A Report of the
American College of Cardiology/American Heart Association Task Force on
Clinical Practice Guidelines and the Heart Rhythm Society Sana M. Al-Khatib,
Michael J. Ackerman,William J. Bryant,David J. Callans,Anne B. Curtis,Barbara
J. Deal,Timm Dickfeld Michael E. Field,Gregg C. Fonarow,Anne M.
Gillis,Christopher B. Granger,Stephen C. Hammill,Mark A. Hlatky,José A.
Joglar,G. Neal KayDaniel D. Matlock,Robert J. Myerburg andRichard L. Page
Originally published1 Aug
2018https://doi.org/10.1161/CIR.0000000000000549Circulation.
2018;138:e272e391
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Common Diagnosis/Indications for ICD, CRT-Defibrillator Implant
Why did the patient receive the implant?
· Cardiac arrest · Ventricular tachycardia (VT) · Ventricular fibrillation
(VF) · Ischemic cardiomyopathy · Non-ischemic cardiomyopathy · Left
ventricular (LV) dysfunction due to prior myocardial infarction (MI), minimum
40 days post-MI, LV
ejection fraction (EF) < 30% with New York Heart Association (NYHA) functional
class I heart failure (HF) · Hypertrophic cardiomyopathy · Brugada syndrome ·
Catecholaminergic polymorphic VT (CPVT) with syncope · Cardiac sarcoidosis ·
Arrhythmogenic right ventricular dysplasia (ARVD) · Long QT syndrome
Courtesy of Amy Tucker, MSN, RN, CCDS Sanger Heart & Vascular Institute
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Indications for Implantable Cardioverter-Defibrillator (ICD) in Patients with
Ischemic Heart Disease (IHD) to Prevent Sudden Cardiac Death (SCD)
Patient with ischemic heart disease (IHD) with a meaningful survival >1 year
expected
Do all of the following apply?
OR Do any of the following apply?
· Low left ventricular ejection fraction (LVEF) due to IHD · 40 days post- myocardial infarction · 90 days postrevascularization
· Sudden cardiac arrest due to ventricular tachycardia (VT) or ventricular
fibrillation (VF)
· Hemodynamically unstable VT
· Stable VT*
If LVEF 35%
· NYHA class II or III HF despite guidelinedirected management and therapy
If LVEF 30%
· NYHA class I HF despite guideline-directed management and therapy
· Unexplained syncope plus inducible sustained monomorphic VT on EP study
Yes
Yes
Yes
ICD is recommended for the primary prevention of SCD
*Not due to reversible causes. Al-Khatib, S.M., et al. J Am Coll Cardiol. 10.1016/j.jacc.2017.10.052
ICD is recommended for the secondary prevention of SCD
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Sensing: Two Important Definitions
SENSITIVITY
The ability of the ICD to detect VT 100% of the time for fast arrhythmias
SPECIFICITY
The ability of the ICD to discriminate between VTs and SVTs
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Sensing
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Sensing
From ICD Sense/ Pace Leads Signal
Filter
Comp
Processed Event
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High and Low Bandpass Filters
Ignores signals <10 Hz
R Waves
Signals used by the ICD
P waves
Ignores signals greater than 40 Hz
T Waves
Noise
Baseline Drift
Myopotentials
EMI
Hz 0
10 20 30 40
80
100
1000
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ICD Signal Processing Summary
· The intra-cardiac signal is sensed and converted into an electronic signal
· The intervals between the electronic signals can then be processed by the
device
· Due to the varying amplitudes of tachyarrhythmia signals, an automatic
sensing system is needed
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Sensing: A Review
Fixed sensitivity in NSR
Pacemaker sensitivity
A fixed sensitivity setting cannot be used
with an ICD
Fixed Sensitivity with changing amplitudes
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Automatic Sensing
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A system of automatically adapting sensitivity settings is used in ICDs
50% 25%
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Automatic Sensing
The sensitivity settings are automatically “reset” to avoid inappropriate
sensing R-Waves
T-Waves Maximum sensitivity
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Detection Criteria for Fast Arrhythmias:
Rate · Programmed rate to begin detection
Specificity Discrimination · Onset detector · Stability detector · Morphology
comparison
Fibrillation Detection · Quick delivery of defibrillation therapy
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Single Chamber VT Detection
VF 300 ms 200 bpm
VT-2 342 ms 175 bpm Count 14 VT-1 428 ms 140 bpm Count 16
Sinus
= Interval
VT1 Detected
VT2 0 0 0 0 1 2 3 4 3 2 1 0 0 0 0 0 0 0 VT1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13
14 15 16
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Onset: A Hallmark of VT
· Sudden Onset is used to differentiate sinus tachycardias (normally a slow
onset), from VTs which have a rapid onset
· With Onset ON, Onset AND the Detection Counter must be satisfied before
Detection is met and therapy will be delivered
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Onset
· The increase in rate from previous average of four beats to new average of
four beats is greater than the programmed Onset
· The most recent interval falls into VT or VF zone Sudden change
Programmed VT zone
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VT Detection with Onset
VF 300 ms 200 bpm
VT-1
1
400 ms
150 bpm
Count 16
Onset 20%
Sinus
= Interval
VT1 Detected
VT1 0 0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
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Stability: Inhibit or Treat?
Stability is used to differentiate SVTs that conduct irregularly to the
ventricles (atrial fibrillation) from monomorphic VTs which are stable
· Atrial fibrillation (with high ventricular rate response) is the most common
reason for inappropriate shock
With Stability ON, Stability AND the Detection Counter must be satisfied
before Detection is met
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Stability: Inhibit or Treat?
Stability delays detection in the presence of an unstable R-R interval
· Unstable R-R decrements VT counter by 20
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Inappropriate ICD shocks were attributed to atrial fibrillation (44%),
supraventricular tachycardia (36%), and abnormal sensing (20%).(What is the
rate of inappropriate shocks from implantable cardioverter-defibrillators
(ICDs)? Updated: Oct 11, 2019 Author: Daniel M Beyerbach, MD, PhD; Chief
Editor: Jeffrey N Rottman). https://emedicine.medscape.com/article/. Visited
March 18, 2024.
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Stability
VF 300 ms 200 bpm
VT-1 400 ms 150 bpm Count 16 Stability 24ms
Sinus
= Interval
Detection continues until count fulfilled
1 2 3 45 6 7 8 0 The interval falling outside of the stability range results in the VT counter being set back to 0
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Morphology Discriminator
Compares the QRS morphology of the intrinsic ventricular beats (normal) with
those in a fast arrhythmia · MorphMatch (BIOTRONIK specific) compares far-
field signals obtained during sinus rhythm to those occurring in the VT
zone(s) · The reference QRS is updated on a beat-by-beat basis for sinus
rhythm · Once the morphology reference is created, the device can then compare
the reference QRS to the current or actual QRS · MorphMatch is programmable
OFF, ON or Monitoring
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Example
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Tiered Therapy
Fib Zone Rate
Tachy Zone Rate
Bradycardia Pacing Rate
Fib Zone
Shock Therapy
Tachy Zone No Therapy Zone
ATP, CV & Shock Therapy
No Therapy
Bradycardia Zone
Pacing Therapy
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Pain-Free Therapy ATP (Anti-Tachycardia Pacing)
· ATP is rapid pacing at a cycle length shorter than VT · ATP can terminate
reentrant VT by penetrating the circuit and depolarizing the excitable gap
which will
block reentry · Mostly effective treating monomorphic VTs · ATP can reduce
painful shocks, improve quality of life, and lengthen pulse generator life ·
“Successful termination of VT by ATP was 89% in the Pacing Fast Ventricular
Tachycardia Reduces Shock
Therapies (PainFREE Rx) study,19 81% in the PainFREE Rx II study,20 91% in the
EMPIRIC study,21 88% in the Automated Antitachycardia Pacing study,22 and 74%
in the Nippon Storm Study.23”
Laurence D. Sterns, Angelo Auricchio, Edward J. Schloss, Dan Lexcen, Luke
Jacobsen, Paul DeGroot, Amy Molan, Takashi Kurita, Antitachycardia pacing
success in implantable cardioverter-defibrillators by p atient, device, and
programming characteristics, Heart Rhythm, Volume 20, Issue 2,2023,Pages
190197,ISSN 1547-5271,https://doi.org/10.1016/j.hrthm.2022.10.015.
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Theory of ATP
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Programming ATP therapies
ATP Schemes: · Burst Number of paced beats at a set rate · Ramp Programmed
paced beats will get shorter at a set interval
Enhancements: · Add one more scheme · Scan decrement
VT Re-entry circuit
ATP must hit outside the absolute refractory period of the VT to be successful
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Start of VT
Detection window
Redetection
Redetection
Start of VT
ATP sequence 1 Tachycardia detected
Schema of an ATP therapy. https://doi.org/10.1371/journal.pone.0219533.g00
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ATP sequence 2
ATP therapy 1
ATP One Shot®
· Allows the programming of one train of ATP to treat stable, fast VT
occurring in the VF zone
· Delivery: Initial detection criterion met and meets stability criterion of
+/-12% (nonprogrammable)
· ATP is delivered immediately before charging of the shock capacitors
· Pulse amplitude of 7.5 V with pulse width of 1.5 ms, and in a VOO mode
· Shock confirmation occurs to confirm efficacy of ATP · Capacitors bleed off
the energy if confirmation criterion of
¾ slow intervals is met
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ATP One Shot®
FVT
ATP One Shot
Caps charge and confirmation
Key Points · In the presence of true VF shock delivery is immediate · Battery
longevity is not compromised due to Confirmation during charge
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VF Detection
· Single VF zone set in an ICD · VF Detection: Based on the VF Heart
Rate/Interval limit
and an X out of Y criterion (Ex: 8/12) · X/Y detection compensates for
undersensing of fine VF
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40
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VF Detection
VF 300 ms 200 bpm 8 in 12 VT-1 400 ms 150 bpm Count 16 Sinus
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VF Detection
= Interval
1
23 4 5 67 8
VF Detected
5 out of 12 6 out of 12 7 out of 12 8 out of 12
Fib Zone
Detect
1 2 3 4 5 6 7 8 9 10 11 12
Fastest 8 / 12 beats
Initiate Therapy
Charge
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ICD Diagnostics
A few added diagnostic features for ICD optimization
· Statistics · Stored IEGMs · Event counters (interval plots) · Shock times ·
Capacitor reformation (charge time)
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A clinical magnet placed on an ICD:
SUSPENDS tachyarrhythmia detection & therapies (for BIOTRONIK this is up to 8
hours while the magnet remains positioned over the ICD) A magnet placed on an
ICD will not affect pacing response Device manufacturer specific – so always
contact tech support to be sure of the effect of clinical magnet placement on
your patient’s device.
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IEGM Markers: Tell You Everything
Therapy markers include:
· Heavy black line when device charging
· Shock energy and impedance
15J
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· ATP therapy type
Ramp
· ATP optimization train
*Burst
· Pacing mode · Termination
Psh DDI
Msw DDI
Term
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Example 1: VF Detection with Shock
Detection 8/12 Termination of episode
Caps Charge 20 j Shock
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Example 2: VT Detection with successful ATP
Detection 16
ATP Burst
Termination of episode
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Example 3: ATP During VF
ATP may be very effective for FVT in the VF zone
Detection in VF 8/12
ATP
Shock termination
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Example 4: Aborted Shocks
Confirmation during charge: Another way to optimize ICD therapy
Confirmation of arrhythmia
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ICDs and Patient Education
Continuous Patient Education = Patient Engagement · Why did they have an ICD
implant?
(with a pacemaker) · Detection heart rates/therapy parameters · ATP vs a Shock
· Shock Plan · ERI
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Questions?
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© 2024 BIOTRONIK, Inc. All rights reserved. PPT_EDU_018_AHP_ICD_Fundamentals_March 2024_Final_3_7_2024
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