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Implantable Cardioverter Defibrillator Therapy: the Engineering-Clinical Interface

Mark W. Kroll; Michael Lehmann


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Product Information:
ISBN-13: 9780792343004
ISBN-10: 079234300X
Publisher: KLUWER ACADEMIC PUBLISHERS
Format: Cloth, 585 pages
Pub Date: 11/1996
Edition Number: 1




Synopsis

Technical reference on ICD technology to promote a common understanding about the engineering of the device and its clinical application, for the engineers and clinicians working with the device. 42 contributors, 41 U.S.

From the publisher:

The Implantable Cardioverter Defibrillator, or `ICD', is arguably the most technologically challenging type of therapy that physicians utilize today. At the same time, engineers who design ICDs are being called upon by clinicians to extend even further the technological envelope in the quest of building the `ideal' device. To the extent, however, that physicians who utilize ICDs are not sufficiently comfortable with, or familiar with, the engineering principles that guide ICD function, the full clinical potential of even an ideal device will not be realized. In complementary fashion, engineers require as full an appreciation as possible of the real world `boundary conditions' and clinical impact of various ICD features, if the latter are truly to be perfected. Implantable Cardioverter Defibrillator Therapy: The Engineering–Clinical Interface is intended to serve as an educational tool to foster mutual understanding and communication among physicians, engineers, and other professionals involved in ICD therapy, with the ultimate purpose of enhancing patient care.




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Additional Description

TABLE OF CONTENTS
CONTRIBUTING AUTHORS XVII
PREFACE XXI
1 SUDDEN CARDIAC DEATH 1
MASOOD AKHTAR, MD, MOHAMMAD R. JAZAYERI, MD,
JASBIR S. SRA, MD, ZALMEN BLANCK, MD, SANJAY DESHPANDE, MD,
ANWER DHALA, MD, AND KATHI AXTELL, RN
Clinical Circumstances of SCD 2
Myocardial Substrates 3
Triggers for SCD 5
Management and Prevention of SCD 11
2 HISTORY OF THE ICD 17
WILLIAM S. STAEWEN, CCE AND MORTON M. MOWER, MD
3 THE ELECTROPHYSIOLOGICAL EFFECTS OF DEFIBRILLATION SHOCKS 31
STEPHEN M. DILLON, PHD
Background 31
The Optical Recording Method 35
Electrical Defibrillation 37
Electrophysiological Effects of Shocks 41
Effects of Shocks on Cardiac Membrane Voltage 48
Electrophysiological Responses and Fibrillation 53
Conclusion 57
4 DEFINING THE DEFIBRILLATION DOSAGE 63
MARK W. KROLL, PHD, MICHAEL H. LEHMANN, MD, AND
PATRICK J. TCHOU, MD
Units of Electricity 64
Defibrillation Parameters 66
Energy as a Parameter 76
Specification of the Duration: Time, Tilt, or Both? 81
So Why Use Energy? 84
Summary 84
5 THE DEFIBRILLATION THRESHOLD 89
IGOR SINGER, MBBS AND DOUGLAS LANG, PHD
Defibrillation Success Curve and Energy Margins 89
Methods for Evaluating Energy Margins 91
Upper Limit of Vulnerability Method 108
Effects of Antiarrhythmic Drugs on Defibrillation 109
Effects of Cardiac Surgery 114
Approach to the Patient with High DFT 114
Appendix A: Margins for Threshold Protocols 117
Appendix B: Margins for Verification Protocols 120
Appendix C: Variability of DFT Measurements 122
6 PATHWAYS FOR DEFIBRILLATION CURRENT 131
MICHAEL J. KALLOK, PHD
Two-Electrode Systems 132
Three-Electrode Systems 137
Four-Electrode Systems 140
Current Issues 141
Summary 143
7 THE DEFIBRILLATION WAVEFORM 147
SUSAN M. BLANCHARD, PHD, RAYMOND E. IDEKER, MD, PHD,
RANDOLPH A.S. COOPER, MD, AND J. MARCUS WHARTON, MD
Historical Perspective 147
Monophasic Waveforms 148
Biphasic Waveforms 149
Hypotheses for the Success of Biphasic Waveforms 155
Other Waveforms 157
Summary 158
8 THE SYSTEM 163
C.G. "JERRY" SUPINO
Ancillary Components of the System 164
The ICD as a Component of the System 167
Internal ICD System 169
9 LEADS FOR THE ICD 173
RANDALL S. NELSON, BYRON L. GILMAN, J. EDWARD SHAPLAND, PHD,
AND MICHAEL H. LEHMANN, MD
Physiological Requirements and Considerations 176
Engineering Requirements and Considerations 181
Potential Complications 190
Extraction and Repair 197
Clinical Surveillance of Lead Function and Integrity 198
Future Systems 199
10 THE BATTERY 205
CURTIS F. HOLMES, PHD
The Lithium/Vanadium Oxide System 205
The Lithium/Silver Vanadium Oxide System 206
Discharge Characteristics 208
Safety and Qualification Testing 211
Electrical Testing of Cells 214
Performance in Devices 216
Summary 218
Appendix: Sizing The Battery 219
11 THE HIGH VOLTAGE CAPACITOR 223
JOEL B. ENNIS AND MARK W. KROLL, PHD
Role of the Capacitor 223
Basic Principles of Capacitor Operation 224
Capacitor Design Fundamentals 226
Types of Capacitors 228
Selecting the Capacitor for the ICD 233
Future Possibilities 237
Summary 238
12 THE PULSE GENERATOR 241
RANDALL S. NELSON
General Description 242
Reliability 246
Size and Weight 247
Potential Complications 251
Future Pulse Generators 254
13 HIGH POWER CIRCUITRY 257
STAN M. BACH, JR., BSEE, MD AND PAUL MONROE, PE
The Charging Circuit 258
The Discharge Circuit 263
14 THE AMPLIFIER: SENSING THE DEPOLARIZATION 275
DENNIS A. BRUMWELL, BSEE, KAI KROLL, BSEE, AND
MICHAEL H. LEHMANN, MD
The Ideal Sense Circuit 275
Amplifier Basics 277
Electrical Filtering 279
Automatic Gain and Threshold Control 287
Post-Shock Sensing 296
Final Thoughts 298
15 TACHYARRHYTHMIA DETECTION 303
STAN M. BACH, JR., BSEE, MD, MICHAEL H. LEHMANN, MD, AND
MARK W. KROLL, PHD
Detection Zones 305
Duration Requirements for Detection 308
Detection During and After Capacitor Charging 312
Onset Algorithms 313
Stability Algorithms 316
Combinational Detection Criteria 318
Post Therapy Detection 318
Morphology Detection 320
Clinical Caveats and Future Considerations 321
16 ANTI-TACHYCARDIA PACING AND CARDIOVERSION 325
MICHAEL L. HARDAGE AND MICHAEL B. SWEENEY
The Ideal Anti-tachycardia Device 325
History of Tachycardia Treating Devices 326
Prevention of Tachycardias by Devices 329
Termination of Tachycardias by Pacing 330
ATP Techniques 331
Clinical Effectiveness of ATP 336
Low Energy Cardioversion Shocks 338
Empiric Approaches to ATP Programming 339
Complications in Tachycardia Terminating Devices 340
17 IMPLANTATION: PRE-OPERATIVE EVALUATION TO DISCHARGE 343
WOLFRAM GRIMM, MD AND FRANCIS E. MARCHLINSKI, MD
Preimplant Evaluation 344
Implantation Using Nonthoracotomy Lead Systems 345
Implantation Using Epicardial Lead Systems 348
Assessment of Sensing and Pacing Lead Function 350
Avoidance of ICD-Pacemaker interactions 350
Defibrillation Threshold Assessment 351
Intraoperative ICD Testing and Programming 355
Predischarge Testing 357
Surgical Complications of ICD Implantation 358
Implantation in the Electrophysiology Lab 359
Generator Replacement 360
18 ICD INFECTION AVOIDANCE: SCIENCE, ART, DISCIPLINE 365
RICHARD B. SHEPARD, MD AND ANDREW E. EPSTEIN, MD
Lessons From the Pacemaker Experience 369
The ICD and Infection 365
Pre-Operative Anti-Infection Management 376
The Operation 379
Care After the Operation 384
Final Thoughts 385
19 SAFETY MARGINS FOR SENSING AND DETECTION: PROGRAMMING
TRADEOFFS 389
WALTER OLSON, PHD
Normal Sensing and Detection of Fibrillation 389
Undersensing of Ventricular Fibrillation 391
Oversensing of T-waves, Myopotentials, and Noise 395
Programming Detection Zone Boundaries 398
Detection Zone Boundaries and Algorithms 401
Consistency Plots for Three Detection Algorithms 404
Zone-Boundary Programming Tradeoffs 408
VT and VF Detection in an ICD Trial 408
Programming Time to Detection and Redetection 413
Programming Optional Stability Algorithms 414
Programming Optional Onset Algorithms 415
Programming Optional Morphology Algorithms 416
Confirmation and Synchronization 416
Episode Termination 417
Summary and Conclusions 418
20 PATIENT FOLLOWUP SYSTEMS 421
TED P. ADAMS
System Evaluation 421
Capacitor Reforming 425
Device History Evaluation 426
Noninvasive Programmed Stimulation 430
Reprogramming 431
Followup Safety Considerations 431
Remote Followup 432
The Future 432
Appendix: Magnet Function Table 433
21 TROUBLESHOOTING SUSPECTED ICD MALFUNCTION 435
MARK E. ROSENTHAL, MD, J. TODD ALDERFER, MD, AND
FRANCIS E. MARCHLINSKI, MD
Essentials of ICD Followup 435
ICD Therapy in the Absence of Severe Symptoms 438
Absent or Delayed Therapy in Patients With VT/VF 459
Failure of ICD Therapy With Documented VT/VF 465
Symptoms of VT/VF Without Noticed Shock 469
Final Note 472
22 CLINICAL RESULTS 477
RICHARD N. FOGOROS, MD
Efficacy of the ICD in Preventing Sudden Death 478
Effect of the ICD on Overall Survival 482
Quality of Life 492
The Future 494
23 SUDDEN DEATH DESPITE ICD THERAPY: 501
MICHAEL H. LEHMANN, MD, LUIS A. PIRES, MD,
WALTER H. OLSON, PHD, VERONICA IVAN, BSEE,
RUSSELL T. STEINMAN, MD, JOHN J. BAGA, MD, AND
CLAUDIO D. SCHUGER, MD
Terminal Events in ICD Patients Who Die Suddenly 501
Factors in ICD Therapy Success or "Failure" 507
Diagnosis of Tachyarrhythmic Death in ICD Patients 508
Finding the Cause of Actual or Aborted Sudden Death 516
Conclusions 519
24 FUTURE CLINICAL CHALLENGES 525
MICHAEL H. LEHMANN, MD AND MARK W. KROLL, PHD
Clarification of Clinical Role of ICD Therapy 525
Role of the Atrial ICD 528
Optimization of Implant Techniques 528
Reducing Regulatory Hurdles 529
Rapid Access to Performance Information 530
GLOSSARY 533
INDEX 553


CONTRIBUTORS
Ted P. Adams, MSEE
St. Croix Medical
Minneapolis, MN
Masood Akhtar, MD
Cardiovascular Disease Section
University of Wisconsin Medical School
Milwaukee Clinical Campus
Arrhythmia Services
Sinai Samaritan Medical Center
Clinical Electrophysiology Laboratory
St. Luke's Medical Center
Milwaukee, WI
J. Todd Alderfer, MD
Pennsylvania State University
Hershey Medical Center
Hershey, PA
Kathi Axtell, RN
Sinai-Samaritan
Milwaukee, WI
Stanley M. Bach, BSEE, MD
Arden Hills, MN
John J. Baga, MD
Wayne State University
Arrhythmia Center
Sinai Hospital
Detroit, MI
Susan M. Blanchard, PhD
North Carolina State University
Raleigh, NC
Zalmen Blanck, MD
University of Wisconsin
Milwaukee Clinical Campus
St. Luke's Medical Center
Wisconsin Electrophysiology Group
Milwaukee, WI
Dennis A. Brumwell
Bloomington, MN
Randolph A.S. Cooper, MD
Duke University
Durham, NC
Sanjay Deshpande, MD
University of Wisconsin Medical School
Milwaukee Clinical Campus
Sinai-Samaritan
Milwaukee, WI
Anwer Dhala, MD
University of Wisconsin Medical School
Milwaukee Clinical Campus
St. Luke's Medical Center
Stephen M. Dillon, PhD
Philadelphia Heart Institute
Presbyterian Medical Center
Philadelphia, PA
Joel B. Ennis
Maxwell Labs.
San Diego, CA
Richard N. Fogoros, MD
Allegheny University of the Health Sciences
Clinical Electrophysiology
Allegheny General Hospital
Pittsburgh, PA
Byron L. Gilman
SurVivaLink
Mpls, MN
Wolfram Grimm, MD
Philipps University
Marburg, Germany
Michael L. Hardage, MSEE
Ventritex Inc.
Sunnyvale, CA
Curtis F. Holmes, PhD
Technology
Wilson Greatbatch, Ltd.
Clarence, NY
Raymond Ideker, MD, PhD
University of Alabama at Birmingham
Cardiology,
Birmingham, AL
Veronica Ivan, BSEE
Medtronic Inc.
Mpls, MN
Mohammad R. Jazayeri, MD
University of Wisconsin Medical School
Milwaukee Clinical Campus
Sinai-Samaritan
Milwaukee, WI
Douglas J. Lang, PhD
Cardiac Pacemakers Inc.
St. Paul, MN
Michael J. Kallok, PhD
Angeion Corp.
Plymouth, MN
Kai Kroll
St. Croix Medical
Minneapolis, MN
Francis E. Marchlinski, MD
Cardiac Electrophysiology
Allegheny University
Philadelphia, PA
Paul Monroe, FE
Janesville, WI
Morton M. Mower, MD
Cardiac Pacemakers, Inc.
St. Paul, MN
Randall Nelson
Angeion Co.
Plymouth, MN
Walter Olson, PhD
Tachycardia Arrhythmia Research
Medtronic Inc.
Mpls, MN
Luis A. Pires, MD
Wayne State University
Arrhythmia Center
Sinai Hospital
Detroit, MI
Mark E. Rosenthal, MD
Abington Memorial Hospital
Abington, PA
Claudio D. Schuger, MD
Wayne State University
Arrhythmia Center
Sinai Hospital
Detroit, MI
Edward Shapland, PhD
Cortrak Medical Inc.
Minneapolis, MN
Richard B. Shepard, MD
Division of Cardiothoracic Surgery
University of Alabama at Birmingham
Birmingham, AL
William S. Staewen, CCE
Medical Engineering Consultant
Selbyville, DE
Jasbir S. Sra, MD
University of Wisconsin Medical School
Milwaukee Clinical Campus
St. Luke's Medical Center
Wisconsin Electrophysiology Group
Milwaukee, WI
Russell T. Steinman, MD
Wayne State University
Arrhythmia Center
Sinai Hospital
Detroit Ml
Jerry Supino
Pharmatarget
Maple Grove, MN
Michael L. Sweeney
Ventritex Inc.
Sunnyvale, CA
Patrick Tchou, MD
Cleveland Clinic
Cleveland, OH
J. Marcus Wharton, MD
Clinical Cardiac Electrophysiology
Duke University Medical Center
Durham, NC