IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING - CLINICAL INTERFACE

Transcription

1 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING - CLINICAL INTERFACE

2 Developments in Cardiovascular Medicine C.A. Nienaber and U.Sechtem (eds.): Imaging and Intervention in Cardiology ISBN G. Assmann (ed.): HDL Deficiency and Atherosclerosis ISBN N.M. van Hemel, F.H.M. Wittkampf and H. Ector (eds.): The Pacemaker Clinic of the 90's. Essentials in Brady-Pacing ISBN N. Wilke (ed.): Advanced Cardiovascular MRI of the Heart and Great Vessels ISBN M.LeWinter. H. Suga and M.W. Watkins (eds.): Cardiac Energetics: From Emax to Pressure-volume Area ISBN R.I. Siegel (ed.): Ultrasound Angioplasty ISBN D.M. Yellon and G.J. Gross (eds.): Myocardial Protection and the Katp Channel. ISBN A.V.G. Bruschke. J.H.C. Reiber. K.I. Lie and H.I.I. Wellens (eds.): Lipid Lowering Therapy and Progression of Coronary Atherosclerosis ISBN A.S.A. Abd-Elfattah and A.S. Wechsler (eds.): Purines and Myocardial Protection ISBN M. Morad, S. Ebashi, W. Trautwein and Y. Kurachi (eds.): Molecular Physiology and Pharmacology of Cardiac Ion Channels and Transporters ISBN A.M. Oto (ed.): Practice and Progress in Cardiac Pacing and Electrophysiology ISBN W.H. Birkenhager (ed.): Practical Management of Hypertension. Second Edition ISBN J.e. Chatham, J.R. Forder and J.H. McNeill(eds.):The Heart In Diabetes ISBN M. Kroll, M. Lehmann (eds.): Implantable Cardioverter Defibrillator Therapy: The Engineering-Clinical Interface ISBN

3 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR THERAPY: THE ENGINEERING - CLINICAL INTERFACE Edited by: Mark W. Kroll, PhD Vice President, Tachycardia Business Unit Pacesetter Inc., A St. Jude Medical Company Sylmar, California, USA and Michael H. Lehmann, MD Clinical Associate Professor of Medicine Wayne State University School of Medicine Director, Arrhythmia Center Sinai Hospital Detroit, Michigan, USA

4 Library of Congress Cataloging-in-Publication A C.I.P. Catalog record for this book is available from the Library of Congress ISBN ISBN (ebook) DOI / Copyright <O 1996 by Springer Science+Business Media New York Originally published by Kluwer Academic Publishers, New York in 1996 Softcover reprint ofthe hardcover Ist edition 1996 This printing is a digital duplication of the original edition. Permissions for books published in the USA: Permissions for books published in Europe: permissions@wkap.nl All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, mechanical, photo-copying, recording, or otherwise, without the prior written permis sion of the publisher, with the exception of any material supplied specifically for the purpose of being entered and executed on a computer system, for exclusive use by the purchaser of the work. Printed an acid-free paper.

5 To our parents, Irene, Bill, Betty, and Bert; our wlves, Lori and Annie; and our children, Braden, Mollie, Ryan, Chase, Jonah, David, and Ruth.

6 This book is based on information and facts believed to be accurate at the time of publication. The views of the authors do not necessarily reflect those of their employers and institutions. TRADEMARKS: The following are trademarks and registered trademarks: AICD, Ventak, Endotak, Mini, Mini AV, and PRx (Guidant Corp. - CPI); PCD, Active Can, Jewel, Jewel Plus, Marker Channel, T -Shock, AMD, and Transvene (Medtronic); Guardian, EnGuard, Sentry (Telectronics); Res-Q (Intermedics); Cadence, Cadet, TVL, and Contour (Ventritex); Defender (ELA Medical); Aegis, and Autocapture (Pacesetter); Angeflex and Hot Can (Angeion). NOTICE: The medications described in this book do not necessarily have specific approval by the US Food and Drug Administration for the situations and dosages described. The package insert for each drug should be consulted as it contains the usage as approved by the Food and Drug Administration.

7 Table of Contents CONTRIBUTING AUTHORS PREFACE XVII XXI 1 1 SUDDEN CARDIAC DEATH MASOOD AKlITAR, MD, MOHAMMAD R JAZAYERI, MD, JASBIR S SRA, MD, ZALMEN BLANCK, MD, SANJAY DESHPANDE, MD, ANWER DHALA, MD, AND KAnil AxrELL, RN Clinical Circumstances of SCD 2 Myocardial Substrates 3 Triggers for SCD 5 Management and Prevention of SCD HISTORY OF THE ICD WILLIAM S. STAEWEN, CCE AND MORTON M. MOWER, MD 3 31 THE ELECTRO PHYSIOLOGICAL EFFECTS OF DEFIBRILLATION SHOCKS 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

8 viii CONTENTS 4 DEFINING THE DEFIBRILLATION DOSAGE MARKW. KROLL, PHD, MICHAEL H. LEHMANN, MD, AND PATRICK]. 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 THE DEFIBRILLATION THRESHOLD 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 PATHWAYS FOR DEFIBRILLATION CURRENT MICHAEL]. KALLOK, PHD Two-Electrode Systems 132 Three-Electrode Systems 137 Four-Electrode Systems 140 Current Issues 141 Summary 143

9 CONTENTS ix THE DEFIBRILLATION WAVEFORM 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 THE SYSTEM c. G. "JERRY" SUPINO Ancillary Components of the System 164 The ICD as a Component of the System 167 Internal ICD System LEADS FOR THE leo 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 x CONTENTS THE BATTERY CURTIS F. HOLMES, PHD The Lithium/Vanadium Oxide System The Lithium/Silver Vanadium Oxide System Discharge Characteristics Safety and Qualification Testing Electrical Testing of Cells Performance in Devices Summary Appendix: Sizing The Battery THE HIGH VOLTAGE CAPACITOR JOEL B. ENNIS AND MARK W. KROLL, PHD Role of the Capacitor Basic Principles of Capacitor Operation Capacitor Design Fundamentals Types of Capacitors Selecting the Capacitor for the lcd Future Possibilities Summary THE PULSE GENERATOR RANDALL S. NELSON General Description Reliability Size and Weight Potential Complications Future Pulse Generators

11 CONTENTS xi HIGH POWER CIRCUITRY STAN M. BACH, JR., BSEE, MD AND PAUL MONROE, PE The Charging Circuit The Discharge Circuit THE AMPLIFIER: SENSING THE DEPOLARIZATION DENNIS A. BRUMWELL, MSBE, KAI KROLL, BSEE, AND MICHAEL H. LEHMANN, MD The Ideal Sense Circuit Amplifier Basics Electrical Filtering Automatic Gain and Threshold Control Post-Shock Sensing Final Thoughts T ACHY ARRHYTHMIA DETECTION STAN M. BACH, JR., BSEE, MD, MICHAEL H. LEHMANN, MD, AND MARK W. KROLL, PHD 303 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

12 xii CONTENTS ANTI-TACHYCARDIA PACING AND CARDIOVERSION 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 A TP 336 Low Energy Cardioversion Shocks 338 Empiric Approaches to ATP Programming 339 Complications in Tachycardia Terminating Devices IMPLANTATION: PRE-OPERATIVE EVALUATION TO DISCHARGE 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 lcd-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

13 CONTENTS xiii led INFECTION AVOIDANCE: SCIENCE, ART, DISCIPLINE RICHARD B. SHEPARD, MD AND ANDREW E. EPSTEIN, MD Lessons From the Pacemaker Experience The ICD and Infection Pre-Operative Anti-Infection Management The Operation Care After the Operation Final Thoughts SAFETY MARGINS FOR SENSING AND DETECTION: PROGRAMMING TRADEOFFS 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 407 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

14 xiv CONTENTS PATIENT FOLLOWUP SYSTEMS TEDP.ADAMS System Evaluation Capacitor Reforming Device History Evaluation Noninvasive Programmed Stimulation Reprogramming Followup Safety Considerations Remote Followup The Future Appendix: Magnet Function Table TROUBLESHOOTING SUSPECTED ICD MALFUNCTION 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 CLINICAL RESULTS RICHARDN. 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

15 CONTENTS xv SUDDEN DEATH DESPITE ICD THERAPY: 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 FUTURE CLINICAL CHALLENGES MICHAEL H. LEHMANN, MD AND MARK W. KROLL, PHD Clarification of Clinical Role of ICD Therapy Role of the Atrial ICD Optimization of Implant Techniques Reducing Regulatory Hurdles Rapid Access to Performance Information GLOSSARY 533 INDEX 553

16 Contributing Authors Ted P. Adams, MSEE Chairman & CEO St. Croix Medical Minneapolis, MN Masood Akhtar, MD Professor of Medicine Chief, Cardiovascular Disease Sec. Univ. of Wisconsin Medical School ~ i l w aclinical u k ecampus e Dlrector, Arrhythmia Services Sinai Samaritan Medical Center Director, 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 -Samari tan Milwaukee, WI Stanley M. Bach, BSEE, MD Arden Hills, MN John J. Baga, MD Clinical Assistant Prof. of Medicine Wayne State University Arrhythmia Center Sinai Hospital Detroit, MI Susan M. Blanchard, PhD North Carolina State Univ. Raleigh,NC Zalmen Blanck, MD University of Wisconsin Milwaukee Clinical Campus St. Luke's Medical Center Wisconsin Electrophysiology Gp. Milwaukee, WI Dennis A. Brumwell, MSBE Bloomington, MN cmoswizard@aol.com Randolph A.S. Cooper, MD U of Alabama at Birmingham Birmingham, AL RAC@CRML.UAB.EDU Sanjay Deshpande, MD Assistant Professor of Medicine Univ. of Wisconsin Medical School Milwaukee Clinical Campus Sinai -Samari tan Milwaukee, WI Anwer Dhala, MD Assistant Professor of Medicine Univ. of Wisconsin Medical School Milwaukee Clinical Campus Staff Electrophysiologist St. Luke's Medical Center Stephen M. Dillon, PhD Allegheny U of the Health Sciences Philadelphia, P A SDillon@IX.Netcom.com Joel B. Ennis Director of Engineering Maxwell Labs. San Diego, CA xvii

17 xviii AUTHORS Andrew W. Epstein, MD Professor of Medicine Division of Cardiovascular Disease U of Alabama at Birmingham Birmingham, AL AEpstein@Cardio.dom.UAB.EDU Richard N. Fogoros, MD Professor of Medicine Allegheny University of the Health Sciences Director, Clinical Electrophysiology Allegheny General Hospital Pittsburgh, P A Byron L. Gilman Chairman & Chief Technical Officer SurVivaLink Corporation Minneapolis, MN BGilman@Survivalin.com Wolfram Grimm, MD ZIM-Kardiologie Philipps Univ. Marourg, Germany Michael L. Hardage, MSEE Ventritex Inc. Sunnyvale, CA @Compuserve.com Curtis F. Holmes, PhD Vice President, Technology Wilson Greatbatch, Ltd. Clarence, NY CHolmes@Greatbatch.com Raymond Ideker, MD, PhD Professor of Medicine Professor of Physiology Professor of Biomedical Engineering U of Alabama at Birmingham Cardiology, Birmingham, AL REI@CRML.UAB.edu Veronica Ivan, BSEE Medtronic Inc. Mpls,MN Mohammad R Jazayeri, MD Associate Professor of Medicine Univ. of Wisconsin Medical School Milwaukee Clinical Campus Sinai-Samaritan Milwaukee, WI Douglas J. Lang, PhD Director of Therapy Research Cardiac Pacemakers Inc. St. Paul, MN Doug.Lang@Guidant.com Michael J. Kallok, PhD Angeion Corp. Plymouth, MN Kai Kroll St. Croix Medical Minneapolis, MN Kroll@StCroixMedical.com Francis E. Marchlinski, MD System Director and Section Chief Cardiac Electrophysiology Allegheny University Philadelphia, P A Paul Monroe, PE Janesville, WI Morton M. Mower, MD Cardiac Pacemakers, Inc. St. Paul, MN Randall Nelson Engineering Project Manager Angeion Corp. Plymouth, MN

18 AUTHORS xix Walter Olson, PhD Tachycardia Arrhythmia Research Sr. Research Fellow Medtronic Inc. Mpls,MN Luis A. Pires, MD Clinical Assistant Prof. of Medicine Wayne State University Arrhythmia Center Sinai Hospital Detroit, MI Mark E. Rosenthal, MD Dir. of Cardiac Electrophysiology Abington Memorial Hospital Abington, P A 215-5' Claudio D. Schuger, MD Clinical Assistant Prof. of Medicine Wayne State University Arrhythmia Center Sinai Hospital Detroit, MI Edward Shapland, PhD Chief Operating Officer EMed St. Paul, MN Richard B. Shepard, MD Professor of Surgery Division of Cardio Thoracic Surgery U Alabama at Birmingham Birmingham, AL RShepard@UAB.edu William S. Staewen, CCE Medical Engineering Consultant Venice, FL Jasbir S Sra, MD Associate Professor of Medicine Univ. of Wisconsin Medical School Milwaukee Clinical Campus Staff Electrophysiologist St. Luke's MedIcal Center Wisconsin Electrophysiology Gp. Milwaukee, WI Russell T. Steinman, MD Clinical Assistant Prof. of Medicine Wayne State University Arrhythmia Center Sinai Hospital Detroit, MI Jerry Supino Vice President Engineering Pharrnatarget, Inc. Maple Grove, MN Michael L. Sweeney VP Clinical Engineering Ventritex Inc. Sunnyvale, CA MSweeney@Ventritex.com Patrick Tchou, MD Cleveland Clinic Cleveland, OH TchouP@Cesmtp.CCF.com J. Marcus Wharton, MD Associate Professor of Medicine Director Clinical Cardiac Electrophysiology Duke University Medical Center Durham,NC Whart002@MC.Duke.edu

19 Preface THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, or "lcd," 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 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. This book 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. The highly varied backgrounds of such a diverse audience posed obvious challenges in the preparation of this volume. Given the overwhelmingly greater involvement of clinicians in the day-today management and follow-up of ICD recipients, we gave high priority to the presentation of oftentimes complex yet relevant engineering concepts in a manner that could be understandable to most clinicians. The majority of the topics covered herein relate to principles of operation of the ICD and its various subsystems with the aim of facilitating an in-depth understanding of ICD function and malfunction, independent of the specific manufactured device a patient receives. At the same time, features of specific ICD models are frequently introduced to provide practical clinical examples that are intended to complement the theoretical treatment. Topics for the mainly clinically oriented chapters are not intended to be allinclusive but rather are focused on areas that we felt deserve emphasis for the larger purpose of optimizing care of the ICD patient. The twin challenges of striking a proper balance of content and seeking clarity of technical language were compounded by the rapid pace of technologic evolution (spanning the first four generations of ICD devices) over the time period that this book was pre-

20 xxii PREFACE pared. In order to arrive at text that would meet our objectives while maintaining technologic relevance, most chapters had to undergo multiple (and, at times, substantial) revisions. We cannot thank our author colleagues enough for the patience, understanding and close collaborative support they provided, without which this book would not have been possible. In addition to the listed authors, we would like to especially thank Nabil Kanaan, PhD, Sabine Jaensch, and Sandra Crumlish for reference checking; Kathy Davis, Karen Beal, and Diane Szubeczak for superb secretarial support; and Karl Kroll for many drawings. The professional proofreading for the second printing was done by Karen Shostak, Maureen Donohue, and Sharon Irving. We thank them and apologize for being unable to use all of their suggestions due to the time constraints after the first printing sold out ahead of schedule. Finally, we are deeply grateful to our families who lovingly tolerated the countless hours of our unavailability during the course of this project. MARK W. KROLL, PHD MICHAEL H. LEHMANN, MD