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Page 1: LASERS IN CARDIOVASCULAR MEDICINE AND SURGERY ...978-1-4613-1489-9/1.pdf · Institute De Cardiologie De Quebec 2725 Chemin Ste-Foy, Sainte-Foy Province de Quebec Canada Enrico Barbieri,

LASERS IN CARDIOVASCULAR MEDICINE AND SURGERY: FUNDAMENTALS

AND TECHNIQUES

Page 2: LASERS IN CARDIOVASCULAR MEDICINE AND SURGERY ...978-1-4613-1489-9/1.pdf · Institute De Cardiologie De Quebec 2725 Chemin Ste-Foy, Sainte-Foy Province de Quebec Canada Enrico Barbieri,

Developments tn Cardiovascular Medicine

Reiber, J .H.C., Serruys, P. W., Slager, C.].: Quantitative coronary and left ventricular cineangiography. ISBN 0-89838-760-4. DICM 51

Fagard, R.H., Beksert, I.E., eds.: Sports cardiology. ISBN 0-89838-782-5. DICM 52 Reiber,J.H.C., Serruys, P.W., eds.: State of the art in quancitative coronary arteriography. ISBNO-89838-804-X. DICM 53 Roelandt, J., ed.: Color doppler flow imaging. ISBN 0-89838-806-6. DICM 54 van der Wall. E.E., ed.: Noninvasive imaging of cardiac metabolism. ISBN 0-89838-812-0. DICM 55 Liebman, J., Plonsey, R., Rudy, Y., eds.: Pediatric and fundamental electrocardiography. ISBN 0-89838-815-5. DICM 56 Higler, H., Hombach, V., eds.: Invasive cardiovascular therapy. ISBN 0-89838-818-X. DICM 57 Serruys, P. W., Meester, G. T., eds.: Coronary angioplasty: a controlled model for ischemia. ISBN 0-89838-819-8. DIeM 58 Tooke, J .E., Smaje, L.H., eds.: Clinical investigation of the microcirculation. ISBN 0-89838-833- 3. DICM 59 van Dam, Th., van Oosterom, A., eds.: Electrocardiographic body surface mapping. ISBN 0-89838-834-1. DICM 60 Spencer, M.P., ed.: Ultrasonic diagnosis of cerebrovascular disease. ISBN 0-89838-836-8. DICM 61 Legaro, M.]., ed.: The stressed heart. ISBN 0-89838-849-X. DICM 62 Safar, M.E., ed.: Arterial and venous systems in essential hypertension. ISBN 0-89838-857-0. DICM 63 Roelandt, J., ed.: Digital techniques in echocardiography. ISBN 0-89838-861-9. DICM 64 Dhalla, N.S., Singal, P.K., Beamish, R.E., eds.: Pathophysiology of heart disease. ISBN 0-89838-864-3. DICM 65 Dhalla, N.S., Pierce, G.N., Beamish, R.E., eds.: Heart function and metabolism. ISBN 0-89838-865-1. DICM 66 Dhalla, N.S., Innes, I.R., Beamish, R.E., eds.: Myocardial ischemia. ISNB 0-89838-866-X. DICM 67 Beamish, R.E., Panagia, V., Dhalla, N.S., eds.: Pharmacological aspects of heart disease. ISBN 0-89838-867 -8. DICM 68 Ter Keurs, H.E.D.]., Tyberg, J. V., eds.: Mechanics of the circulation. ISBN 0-89838-870-8. DICM 69 Sideman, S., Beyar, R., eds.: Activation metabolism and perfusion of the heart. ISBN 0-89838-871-6. DICM 70 Aliot, E., Lazzara, R., eds.: Ventricular tachycardias. ISBN 0-89838-881- 3. DICM 71 Schneeweiss, A., Schettler, G.: Cardiovascular drug therapy in the elderly. ISBN 0-89838-883-X. DICM 72 Chapman, J. V., Sgalambro, A., eds.: Basic concepts in doppler echocardiography. ISBN 0-89838-888-0. DICM 73 Chien, S., Dormandy, J., Ernst. E., Matrai, A., eds.: Clinical hemorheology. ISBN 0-89838-807 -4. DICM 74 Morgantoth, J., Moore, E. Neil, eds.: Congestive heart failure. ISBN 0-89838-955-0. DICM 75 Heintzen, P.H., Bursch, J.H., eds.: Progress in digital angiocardiography. ISBN 0-89838-965-8. DICM 77 Scheinman, M., ed.: Catheter ablation of cardiac arrhythmias. ISBN 0-89838-967 -4. DICM 78 Spaan, J.A.E., Bruschke, A. V.G., Gittenberger, A.C., eds.: Coronary circulation. ISBN 0-89838-978-X. DICM 79 Bayes de Luna, A., ed.: Therapeutics in cardiology. ISBN 0-89838-981-X. DICM 81 Visser, c., Kan, G., Meltzer, R., eds.: Echocardiography in coronary artery disease. ISBN 0-89838-979-8. DIeM 80 Singal, P.K., ed.: Oxygen radicals in the pathophysiology of heart disease. ISBN 0-89838-375-7. DICM 86 Iwata, H., Lombardini, J.B., Segawa, T., eds:: Taurine and the heart. ISBN 0-89838- -. DICM 93 Mirvis, D.M., ed.: Body surface electrocardiographic mapping. ISBN 0-89838-983 -6. DICM 82 Morganroth, J., Moore, E.N., eds.: Silent myocardial ischemia. ISBN 0-89838- 380-3. DICM 88

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LASERS IN CARDIOV ASCULAR

MEDICINE AND SURGERY:

FUNDAMENTALS AND TECHNIQUES

Edited by

George S. Abela, M. D. UNIVERSITY OF FLORIDA GAINESVILLE, FLORIDA

Kluwer Academic Publishers

BOSTON DORDRECHT LONDON

Page 4: LASERS IN CARDIOVASCULAR MEDICINE AND SURGERY ...978-1-4613-1489-9/1.pdf · Institute De Cardiologie De Quebec 2725 Chemin Ste-Foy, Sainte-Foy Province de Quebec Canada Enrico Barbieri,

DISTRIBUTORS

for North America:

Kluwer Academic Publishers 101 Philip Drive Assinippi Park

Norwell, Massachusetts 02061 USA

fur all other countries:

Kluwer Academic Publishers Group Distribution Centre Post Office Box 322

3300 AH Dordrecht, THE NETHERLANDS

Library of Congress Cataloging-in-Publication Data

Lasers in cardiovascular medicine and surgery: fundamentals and techniques 1 edited by George S. Abela.

p. cm.-(Developments in cardiovascular medicine, DICM 103) Includes bibliographical references. ISBN-13: 978-1-4612-8801-5 1. Cardiovascular system-Laser surgery. 2. Laser angioplasty.

I. Abela, George S. II. Series: Developments in cardiovascular medicine; v. 103.

(DNLM: 1. Cardiovascular Diseases-therapy. 2. Laser Surgery. 3. Lasers-therapeutic use. 4. Vascular Surgery. WI DE997VME v. 1031 WG 170 L3431

DE997VME v. 103/WG 170 L3431 RD598.35.L37L37 1990 617.4' 13059-dc20 DNLM/DLC for Library of Congress 89-19854

CIP

Copyright 1990 by Kluwer Academic Publishers Soffcover reprint of the hardcover 1 st edition 1990

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,

photocopying, recording, or otherwise, without the prior written permission of the publisher, Kluwer Academic Publishers, 101 Philip Drive, Assinippi Park,

Norwell, Massachusetts 02061.

ISBN-I3: 978-1-4612-8801-5 e-ISBN-13: 978-1-4613-1489-9 001: 10.1007/978-1-4613-1489-9

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CONTENTS

Contributing Authors Vll

Preface Xl

George S. Abela

Foreword X111

C. Richard Conti

I. HISTORICAL BACKGROUND 1

1. The History and Development of the Medical Laser 3 Leon Goldman

2. Historical Background, Development, and Future Trends of Lasers in Cardiovascular Disease 9 George S. Abela

II. LASER PHYSICS IN MEDICAL APPLICATIONS 19

3. Laser Physics and its Relevance to Applications in Medicine 21 jimjohnson

4. Laser Sources for Angioplasty 31 Robert F. Bonner, Paul D. Smith, Louis G. Prevosti, Antonio Bartorelli, Yaron Almagor, and Martin B. Leon

5. The Excimer Laser-Tissue Interactions and Early Clinical Results 45 Frank W . Cross, and Timothy j. Bowker

6. Laser Physics and Thermal Properties 59 AI Welch, Martinj.C. van Gemert, and Wai-Fung Cheong

7. Thermal Analysis of Laser Ablation of Cardiovascular Tissue 73 Massoud Motamedi, Gerald L. LeCarpentier, jorgeH. Torres, andAJ. Welch

8. Light Distribution, Optical Properties, and Cardiovascular Tissues 93 Martinj.C. van Gernert, AI Welch, Steven L. jacques, Wai-Fung Cheong, and Willem M. Star

III. EXPERIMENTAL STUDIES: LASER­TISSUE INTERACTION, PROTODYNAMIC THERAPY, SPECTROSCOPY, ELECTROPHYSIOLOGY 111

9. Immediate and Chronic Effects of Laser Angioplasty 113 George S. Abela

10. Photosensitizer-Enhanced Laser Angioplasty 143 G. Michael Vincent, George S. Abela and Enrico Barbieri

11. Laser-Induced Arterial Fluorescence Spectroscopy 153 Lawrence I. Decklebaum

12. Laser Balloon Angioplasty: Experimental In-Vivo and In-Vitro Studies 167 j. Richard Spears, I. Nigel Sinclair, and Ronald D.jenkins

13. Laser Catheter Ablation of Arrhythmias 189 AnneB. Curtis, G. Michael Vincent and George S. Abela

IV. LASER DELIVERY SYSTEMS 201

14. Optical Fibers 203 Stephan E. Friedl, Biqing Ye and George S. Abela

15. Laser Angioplasty with Optically Modified Fiber Tips 209 Cornelius Borst, Rudolf M. Verdaasdonk, and Rienk Rienks

v

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VI CONTENTS

16. Catheter Systems for Laser Angioplasty 229 GeorgeS. Abela, andGeraldR. Barbeau

V. CLINICAL EXPERIENCE WITH LASER ANGIOPLASTY 255

17. Clinical Experience with Laser Angioplasty 257 Gerald R. Barbeau and George S. Abela

18. Laser Recanalization and Treatment of Peripheral Atherosclerosis: A Vascular Surgeon's Perspective 27 3 james M. SeegerandGeorgeS. Abela

19. Intraoperative Use of the Laser for Coronary Artery Disease 283 james]. Livesay

20. Laser Thermal Angioplasty with an Argon-Laser-Heated, Metallic-Capped Fiber optic 291 Timothy A. Sanborn

21. Laser Angioplasty Using a Special Sapphire-Tip Catheter: Preliminary Clinical Trial 301 j. Louis Fourier, and M. Bertrand

22. Laser Angioplasty: New Modalities 307 Herbert j. Geschwind

23. Evaluation, Treatment, and Care of the Laser Angioplasty Patient: A Nursing Perspective 315 Sharonjablonski

VI. ADDITIONAL CLINICAL EXPERIENCE WITH OTHER CARDIOVASCULAR LASER APPLICATIONS 325

24. Laser Modification of the Myocardium for the Treatment of Cardiac Arrhythmias: Background, Current Results, and Future Possibilities 327 Robert H. Svenson, Laszlo Littmann,john]. Gallagher, jay Selle, Samuel Zimmern, john Fedor, Marie-Claire Marroum, Kathleen Seifert, George P. Tatsis, and Kathy Linder

25. Laser Endarterectomy 347 john Eugene, Yvon Baribeau, and Michael W. Berns

26. Vascular Tissue Bonding Using Laser Energy 361 Rodney A. White, George Kopchok, and Geoffrey White

27. Percutaneous Laser Myoplasty for Treatment of Hypertrophic Cardiomyopathy 373 Dov Gal, Douglas Losordo, andjeffrey M. Isner

28. Direct Myocardial Revascularization: Preliminary Experience 385 Mahmood Mirhoseini and Mary M. Cayton

VII. ANGIOSCOPY AND ULTRASOUND GUIDANCE 397

29. Percutaneous Cardiovascular Angioscopy 399 Yasumi Uchida

30. Angioscopy of Congenital Cardiac Lesions 411 Michel Sargin

31. Intravascular Ultrasound Imaging 423 john A. Mallery, jonathan M. Tobis, james M. Gessert, james M. Griffith, Michael W. Berns, and Walter L. Henry

VIII. INDUSTRIAL, REGULATORY AND POPULATION ANALYSIS 437

32. Safety and Effectiveness in Clinical Trials Involving Lasers: Food and Drug Administration

33.

34.

Perspective 439 Richard P. Felten, and Lynne A. Reamer

Market Trends and Business Considerations 449 Stephen M. Fry

The Acceptance of Percutaneous Transluminal Angioplasty and Laser Angioplasty 459 john Abele

Glossary Index

465 469

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CONTRIBUTING AUTHORS

George S. Abela, M.D. Associate Professor of Medicine Director, Cardiovascular Laser Laboratory Department of Medicine/Cardiology University of Florida Gainesville, FL 32610 USA

John E. Abele, Ph .D. Co-Chairman Boston Scientific Corporation 480 Pleasant St . Watertown, MA 02172 USA

Yaron Almagor, M.D. Research Fellow Cardiology Branch Heart, Lung and Blood Instituce NIH Building 10 Bethesda, MD 20892 USA

Gerald R. Barbeau, M.D. Associate Clinical Professor Institute De Cardiologie De Quebec 2725 Chemin Ste-Foy, Sainte-Foy Province de Quebec Canada

Enrico Barbieri, M.E. Fulbright Scholar Institute of Cardiology of the University of Verona Verona, Italy

Yvon Baribeau, M.D. 717 Bay St. #902 Toronto, Onrario M15G2J9, Canada

Antonio Bartorelli, M.D. Research Fellow Cardiology Branch NHLBI NIH Bethesda, MD 20892 USA

Michael W. Berns, M.D. Professor of Surgery Developmental & Cell Biology Director, Beckman Laser Institute University of California, Irvine 101 The City Drive Orange, CA 92668 USA

Michael E. Bertrand, M.D. Professor and Chief Service de Cardiologie B et Hemodynamic H6pital Cardiologique Centre Hospitalier Regional et Universitaire de Lille

Boulevard du Professor J . Leclercq 59037 Lille Cedex France

Robert F. Bonner, Ph.D. Physicist National Institutes of Health Electrical and Electronic Engineering of Biomedical Engineering and Instrumentation Branch Division of Research Service 9000 Rockville Pike Bldg. 13, Rm 3W13 Bethesda, MD 20892 USA

Cornelius Borst, M.D. Professor of Experimental Cardiology Academisch Ziekenhuis Utrecht Cathari j nesingel 3511 GV Utrecht The Netherlands

Timothy J. Bowker, MA Clinical Lecturer The Cardiothoracic Institute The Brompton Hospital Fulham Road London United Kingdom

Mary M. Cayton, R.N. Clinical Specialist Cardiovascular Surgery Clinical Specialist Laser Surgery St. Luke's Medical Center Heart and Lung Institute of Wisconsin Laser Research Laboratory Clement Zablocki Veterans Administration Medical Center Milwaukee, Wisconsin USA

Wai-Fung Cheong, Ph .D. Biomedical Engineering Program The University of Texas at Austin Austin, TX 78712 USA

Anne B. Curtis, M.D. Associate Professor Director of Electrophysiology BoxJ-277 JHMHC College of Medicine University of Florida Gainesville, Florida 32610 USA

Frank W . Cross, M.D. Senior Surgical Registrar 7 Millers Way Horsford Norwich, Norfolk NR 103 DV United Kingdom

Vll

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V1l1 CONTRIBUTING AUTHORS

Lawrence 1. Decklebaum, M.D. Assistant Professor of Medicine Yale University School of Medicine Director, Cardiac Catheterization Lab West Spring Street West Haven, CT 06516 USA

John Eugene, M.D. Associate Professor of Surgery University of California, Irvine 23451 Madison Street, Ste. 160 Torrance, CA 90505 USA

John Fedor, M.D. Medical Director, Cardiac Rehabilitation Program Laser and Applied Technologies Laboratory Sanger Clinic 1960 Randolph Road Charlotte, NC 28232-2861 USA

Richard P. Felten Research Chemist Food and Drug Administration Center for Devices and Radiological Health 12709 Twinbrook Parkway Rockville, MD 20857 USA

Jean-Louis Fourrier, M.D. Chef de Clinique Universite de Lille Service de Cardiologique de Lille Boulevard du Professeur J. Leclerccq 59037 Lille Cedex France

Stephan E. Friedl, ME.E. Department of Medicine/Cardiology University of Florida BoxJ-277 JHMHC Gainesville, Florida 32610 USA

StephenM. Fry, Ph.D. President, Strategic Business Development, Inc. P.O. Box 1155 Hanalei Kauai, Hawaii 96714 USA

DovGal, D.V.M. St. Elizabeth's Hospital of Boston Departments of Biomedical Research and Medicine

(Cardiology) 736 Cambridge Street Boston, MA 02135 USA

JohnJ. Gallagher, M.D. Director, Electrophysiology Services, Lasers and Applied

Technologies Laboratory Sanger Clinic 1960 Randolph Road Charlotte, NC 28207 USA

Herbert 1. Geschwind, M.D. Director Cardiac Catheterization Laboratory

Service D' explorations Fonctionnelles Inserm U 138 C.H. U. Henri-Modor 51, Ave. Du Marechal De Lattre de

Tassigny 94010 Creteil France

James M. Gessert Display Systems Engineer InterTherapy, Inc. Costa Mesa, CA USA

James M. Griffith, Ph.D. Director, Research & Development InterTherapy, Inc Costa Mesa, CA USA

Leon Goldman, M.D. Professor Emeritus University of Cincinnati Laser Consultant Naval Hospital, San Diego 7811 Eads Ave. #304 LaJolla, CA 92037 USA

Walter 1. Henry, M.D. Professor of Medicine Vice Chancellor, Health Sciences and Dean, California College of Medicine University of California, Irvine USA

Jeffery Isner, M.D. Professor of Medicine and Pathology Tufts University School of Medicine Chief, Cardiovascular Research St. Elizabeth's Hospital of Boston 736 Cambridge Street Boston, MA02135 USA

Sharon Jablonski, RN Clinical Research Nurse 500-110 Ave. N., #506 St. Petersburg, FL 33716 USA

Stephen 1. Jacques, Ph.D. Wellman Laboratory of Photo medicine Department of Dermatology Massachusetts General Hospital Boston, MA 02114 USA

Ronald D. Jenkins, M.D. Fellow, Cardiology Division Charles A. Dana Research Institute and Harvard Thorndike Laboratory of Beth Israel Hospital Department of Medicine Cardiovascular Division Beth Israel Hospital Harvard Medical School Boston, MA 02115 USA

Jim Johnson, Ph.D. President, Photon Dynamics Ltd., Inc.

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CONTRIBUTING AUTHORS

4722 Arrow Rd. Orlando, FL 32806 USA

George Kopchok, B.S. Harbor/UCLA Medical Center 1000 W. Carson Street Torrance, CA 90502 USA

GeraldL. LeCarpentier, M.S. Graduate Student University of Texas Engineering Science Building, Room 639 Austin, TX 78712

Martin B. Leon, M.D. Senior Investigator and Co-Director of the Cardiac

Catheterization Laboratory Cardiology Branch Heart, Lung and Blood Institute Building 10 Room 7315 Bethesda, MD 20892 USA

Kathy Linder, M.S. Laser and Applied Technologies Laboratory Sanger Clinic 1960 Randolph Road Charlotte, NC 28207 USA

Lazlo l.ittmann, M.D. Director of Electrophysiology Research Carolina Heart Institute P.O. Box 32861 Charlotte, NC 28232 USA

JamesJ. Livesay, M.D. Associate in Cardiovascular Surgery Texas Heart Institute and Attending Surgeon St. Lukes Episcopal Hospital Clinical Associate Professor of Surgery at Houston Houston, Texas 77225 USA

Douglas Losordo, M.D. Departments of Biomedical Research and Medicine

(Cardiology) 736 Cambridge Street Boston, MA02135 USA

JohnA. Mallery, M.D. Assistant Adjunct Professor of Medicine Acting Director, Coronary Care Unit Cardiology/Surgery Liaison University of California, Irvine USA

Marie-Clair Marroum, M.D. Laser and Applied Technologies Laboratory Sanger Clinic 1960 Randolph Road Charlotte, NC 28207 USA

Mahmood Mirhoseini, M.D. Assistant Clinical Professor

Cardiac Thoracic Surgery Medical College of Wisconsin Laser Research Laboratory 2722 W. Oklahoma Ave. Milwaukee, Wisconsin 53215 USA

Massoud Motamedi, Ph.D. Assistant Professor of Internal Medicine Wayne State University Engineering Director of the Cardiac Laser Program Louis Elliman Research Building 421 East Canfield St. Detroit, Michigan 48201 USA

Louis G. Prevosti, M.D. Research Associate National Institutes of Health 12900 Lake Ave. Suite 526 Lakewood, Ohio 44107

Lynne Reamer Division of Cardiovascular Devices Bureau of Medical Devices Food and Drug Administration 1390 Piccard Dr. Rockville, MD 20850 USA

Rienk Rienks, M.D. Academisch Ziekenhuis Utrecht Heart-Lung Institute Utrecht Department of Cardiology Room 62.002 Catharijnesingel 101 3511 GV Utrecht The Netherlands

Timoth A. Sanborn, M.D. Associate Professor of Medicine Mt. Sinai School of Medicine Director, Interventional Cardiology Research and Laser

Angioplasty Program Mt. Sinai Hospital 1 G. 1. Levy Place Box 1030 New York, NY 10029 USA

Mikhail Sargin, M.D. Senior Research Scientist Dept. of Cardiac Surgery A. V. Vishnevsky Institute of Surgery Serpukhovskaya 27 St. Moscow, USSR

James M. Seeger, M.D. Associate Professor of Medicine Chief, Vascular Surgery Veterans Administration Medical Center Box]-286 ]HMHC College of Medicine University of Florida Gainesville, Florida 32610 USA

IX

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x CONTRIBUTING AUTHORS

Kathleen Seifert , M.S. Laser and Applied Technologies Laboratory Carolinas Heart Institute Post Office Box 32861 Charlotte, NC 28232 USA

Jay Selle, M.D. Chief, Vascular Surgical Service Department of Thoracic Cardiac and Vascular Surgery Laser and Applied Technologies Laboratory Sanger Clinic 1960 Randolph Road Charlotte, NC 28207 USA

I. Nigel Sinclair, M.D. Department of Medicine Cardiology Section The Sir Charles Gardner Hospital Perth, Australia

Paul D. Smith, Ph.D. Cardiology Branch Bldg. 13, Room 3W13 NIH Bethesda, MD 20892 USA

RichardJ. Spears, M.D. Associate Professor of Internal Medicine Wayne State University School of Medicine Director, Cardiac Laser Program Harper Hospital Louis Elliman Research Building 421 East Canfield Sf. Detroit, Michigan 48201 USA

Willem M. Star, Ph.D. Department of Clinical Physics Dr. Daniel den Hoed Cancer Centre Rotterdam The Netherlands

Robert H. Svenson, M.D. Medical Director, Laser Program Sanger Clinic 1960 Randolph Road Charlotte, NC 28207 USA

George P. Tatsis, B.S. Associate Director, Laser Porgram Laser and Applied Technologies Laboratory Carolinas Heart Institute Post Office Box 32861 Charlotte, NC 28232 USA

Jonathan M. Tobis, M.D. Associate Professor of Medicine Acting Chief, Division of Cardiology Director, Cardiac Catheterization Lab University of California, Irvine Medical Center Bldg. 53 101 City Drive S. Orange, CA 92668 USA

Jorge H. Torres, M.D. Graduate Student

University of Texas Engineering Science Building, Room 639 Austin, TX 78712

Yasumi Uchida, M.D. Associate Professor of Medicine Head Section Cardiology 2nd Division of Internal Medicine Ohno 3-1739-8 Ichikawa City Chiba Prefecture Japan

MartinJ.C. van Gernert, Ph.D. Head, Laser Center Academic Hospital at the University of Amsterdam Academic Medical Center Mei bergdreef 9 1105 AZ Amsterdam Zuidoost The Netherlands

RudolfM. Verdaasdonk, M.Sc. Heart-Lung Institute Department of Cardiology University Hospital Utrecht The Netherlands

G. Michael Vincent, M.D. Associate Professor of Medicine Chairman, Department of Medicine LOS Hospital 8th Avenue and C street Salt Lake City, UT 84143 USA

A. J . Welch, Ph.D. Marion E. Forsman Centennial Professor Professor, Electronic Computer and Biomedical

Engineering University of Texas Engineering Science Building, Room 639

Rodney A. White, M.D. Associate Professor of Surgery Chief, Vascular Surgery Harbor/UCLA Medical Center 1000 W. Carson St. Torrance, CA 90502 USA

Geoffrey H. White, M.D. Assistant Professor of Surgery Harbor/UCLA Medical Center 1000 W . Carson St. Torrance, CA 90502 USA

Biqing Ye Associate Professor Shanghai Institute of Optics and Fine Mechanics Chinese Academy of Sciences P.O. Box 8211 Shanghai, P.R. China

Samuel Zimmern, M.D. Director Pacemaker Program Sanger Clinic 1960 Randolph Road Charlotte, NC 28207 USA

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PREFACE

Following the advent of percutaneous balloon angioplasty, interventional cardiovascular pro­cedures have become of great interest to the cardiologist, radiologist, and cardiovascular surgeon. One of the most extensively explored alternatives to bypass surgery is laser-mediated angioplasty. The fascination with laser radia­tion has greatly contributed to its popularity, but has also burdened it with unrealistic ex­pectations. Many commercial laser systems are available to the clinician and the researcher, which often makes the choice of a laser system difficult and confusing. Also the method of us­ing these systems often seems to be ambiguous, and patient selection and lesion choice for treatment are not well defined.

This book attempts to describe the most up­to-date technology and procedural approaches of laser angioplasty using the various laser systems. In order to accomplish this, several sections have been developed to address these specific issues. A group of nationally and internationally recog­nized authors have contributed to this book to provide the widest possible experience in the field.

Part I (Chapters 1-2) provides a historical background and future projection for lasers in the cardiovascular field.

Part II serves as an introduction to lasers, with a description of the various types and functions. This basic science background has several chapters (3 - 5) oriented for the beginner in the field. Chapters 6-8 provide a more advanced discussion for researchers who are involved in the basic science of laser-tissue interaction.

Part III (Chapters 9-13) summarizes the experimental work done in laser angioplasty. This includes the immediate and chronic effects on arterial tissue, plaque photosensitization for enhanced ablation as well as fluorescence char­acteristics for plaque detection. Also experi­mental results of the laser balloon angioplasty and use of the laser for His-bundle ablation are discussed.

Part IV (Chapters 14-16) describes the vari­ous fibers and catheter systems that have been de-

vel oped and are available for clinical use, as well as those that are still in investigational phases. Clinical case reports are presented by expert in­vestigators on the use of various catheter systems in the coronary and peripheral circulation.

Part V (Chapters 17-23) is the most up-to­date review of the clinical experience with vari­ous laser delivery systems. There is an emphasis on patient selection, criteria for lesion choice, and follow-up data. A detailed description of laser recanalization techniques is presented for the various systems in the clinical setting. Chapters 17, 20, 21, and 22, describe percu­taneous laser angioplasty techniques, while Chapters 18 and 19 describe intraoperative surgical applications. Chapter 23 provides a unique experience on the nursing care, manage­ment, screening and follow-up of the laser­treated patient.

Part VI (Chapters 24-28) describes other possible applications of lasers in the cardiovas­cular area. Clinical experience in electrophysi­ology for arrhythmia foci ablation is presented; also specific surgical applications such as endar­terectomy, and arterial welding are described. Myocardial effects are evaluated for the treat­ment of cardiomyopathy. Also, a more futuristic concept is explored, in which direct myocardial revascularization is used to treat ischemia in areas that are potentially viable but without vascular of perfusion.

Part VII (Chapters 29- 31) discusses the use of angioscopy and ultrasound for diagnosis of atherosclerotic and thrombotic occlusions illus­trated by color plates during acute myocardial infarction. Both these techniques can be used as a method to guide laser angioplasty. Addi­tionall y, special applications of angioscopy for the evaluation of congenital heart disease are presented.

Part VIII (Chapters 32- 34) describes the im­pact of laser technology on the medical com­munity with respect to safety considerations and future trends. A closing chapter describes the historical evolution of the field of interventional cardiovascular instrumentation.

An attempt is made in this book to address

XI

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Xli PREFACE

inrerests of various specialists involved in the use of laser technology. These include primarily the cardiovascular physician and researcher. Also, attention is given to nurses who are involved in the care and management of patients undergoing cardiovascular laser treatment.

A final message is to emphasize safety. Analysis of the future direction of this field is provided for individuals interested in the long­term viability of laser technology and its appli­cations. After reading this book, one should

have a better understanding of lasers and a clearer view of how and when laser devices can be used safely in the cardiovascular system.

Great thanks is due to the contributors of this book as much of the work presented is original. It is the earnest dedication of these physicians, scientists, and engineers that has brought a simple idea to reality.

George S. Abela Editor

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FOREWORD

I have been asked by Dr. Abela to write an introduction to Lasers in Cardiovascular Medicine and Surgery. Dr. Abela is a personal friend of mine and a fellow member of the Division of Cardiology at the University of Florida College of Medicine. Thus, I have been able to observe at close range his progress in the area of laser research for the past 9 years.

In 1980 Dr. Abela, then a Fellow in Car­diology at the University of Florida, approached me about the possibility of using the laser to recanalize vascular obstructions. At that time, nonsurgical revascularization of ischemic myo­cardium was a reality because balloon coronary angioplasty and intracoronary streptokinase ad­ministration had been performed successfully in many patients. In this milieu, Dr. Abela and a few others were stimulated to search for other possible techniques to clear intravascular ob­structions. Over the years, many clinicians have become interested in the use of the laser to treat cardiovascular and peripheral vascular disease. Many of those individuals are authoring chapters in this textbook.

Some of the early workers in this field include Ginsburg and associates at Stanford, who re­canalized a femoral arterial occlusion using the argon laser; Geschwind and colleagues in France, who reduced a vascular stenosis in the peripheral circulation; Choy and coworkers, who success­fully recanalized five occluded coronary arteries at the time of bypass surgery; and Livesay and colleagues at the Texas Heart Institute, who recanalized 16 coronary arteries using a hand­held CO2 "gun" at the time of coronary artery surgery. During the time that these preliminary experiences were being reported, numerous in­vestigations were taking place in animal models of vascular obstruction.

More recently, Cumberland, Abela, and others have performed revascularization proce­dures in the peripheral circulation using the laser and adjunctive balloon angioplasty, when necessary. Thus, the field has moved rather rapidly from in-vitro and in-vivo experiments in animals, to a few experiments in humans, to clinically applicable use of the laser, to re-

canalization of vascular obstructions in the peri­pheral circulation of humans.

Other potential applications for the use of laser energy in patients with cardiovascular dis­ease include HIS-bundle and arrhythmia focus ablation in patients with uncontrolled arrhyth­mias, septal myectomy in patients with hyper­trophic cardiomyopathy, creation of therapeutic shunts such as an ASD in patients with heart disease requiring mixing, recanalization of therapeutic shunts that have thrombosed (e.g., Blalock-Taussig shunts), and relief of valve obstruction. However, much work is needed to improve these methods from a technical stand­point. Three potential problems exist: thrombo­sis, embolization, and perforation of the vessel or the myocardium. From studies in animals, it seems unlikely that thrombosis will be a prob­lem. Healing occurs normally, as does reendo­thelialization of a blood-vessel wall. Distal embolization may occur, but this problem is unlikely to be serious. In contrast, perforation still remains an important problem, especially if a technique using the percutaneous approach is used in the coronary circulation. In the peri­pheral circulation, perforation of an artery, al­though serious, would not be as life threatening as coronary artery perforation, from which peri­cardial tamponade can result with catastrophic consequences.

In my view, to minimize the problem of per­foration, effort must be made to 1) develop new methods to control the position of the optical fiber within the blood vessel, 2) define the energy ranges required to vaporize plaques, 3) control the direction of the emitted laser beam more precisely, and 4) possibly develop photo­sensitizing agents that localize plaque and de­crease energy requirements for plaque ablation.

The development of laser techniques should be similar to that of balloon angioplasty, i. e., a careful, stepwise approach in which investiga­tors study effects and gather experience by using the technique in the peripheral circulation. When this information has been obtained, re­ported, and confirmed, other vascular beds can be studied. Time will allow investigators to

XIII

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XIV FOREWORD

understand the potential hazards of the techni­que and to gain confidence.

I remain optimistic that the laser will reach its full potential and be applicable to the coron­ary circulation of humans. While I doubt that it will replace balloon angioplasty or coronary artery bypass surgery, I believe it will be an adjunct to these well-established procedures.

C. Richard Conti, M.D. Palm Beach-Martin Co. Heart Assoc. Eminent Scholar (Cardiology) Professor of Medicine Director, Division of Cardiovascular Medicine University of Florida Gainesville, Florida

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ACKNOWLEDGMENT

This book would have never made the deadline without the help of the following people. Thanks to Gerald R. Barbeau, Fellow in cardiology, for his patient review of many of the chapters; to

Stephan E. Friedl, Scientist-Engineer, for pre-

paration of the glossary; to Cindy Jordan and Cindy Puckett, for their expert typing skills; and to Christine R. Finnegan, for editing and proofing the manuscript.

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Dedication

I would like to dedicate this work to my wife Sonia, to Albert Abela and

to my aunt Nelly without whose support and patience this work could not have been done. I would also like

to thank my teachers and my colleagues, whose contributions have

made this work possible.

George S. Abela