Guide to Prosthetic Cardiac Valves

Guide to Prosthetic Cardiac Valves

Edited by Dryden Morse, Robert M. Steiner, and Javier Fernandez

With Contributions by V.O. Bjork J.M. Dunn J. Fernandez S. Flicker W.S. Frankl S. Gabbay L. Gonzalez-Lavin M.N. Kotler J .Y. Kresh S.G. Meister G.S. Mintz D. Morse LP. Panidis F.J. Schoen R.M. Steiner N.M. Wolf

With 204 halftone illustrations in 301 parts and 78 line illustrations

Springer-V er lag New York Berlin Heidelberg Tokyo

Dryden Morse, M.D., Deborah Heart and Lung Center, Browns Mills, New Jersey, 08015, U.S.A.

Robert M. Steiner, M.D., Professor of Radiology, Department of Radiology, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, U.S.A.

Javier Fernandez, M.D., Deborah Heart and Lung Center, Browns Mills, New Jersey 08015, U.s.A.

Library of Congress Cataloging in Publication Data Main entry under title: Guide to prosthetic cardiac valves.

Includes bibliographies and index. 1. Heart valve prosthesis. I. Morse, Dryden P.

(Dryden Phelps), 1924- II. Steiner, Robert M. III. Fernandez, Javier. [DNLM: 1. Heart Valve Prosthesis-instrumentation. 2. Pacemaker, Artificial-instrumentation. WG 26 G946] RD598.G79 1985 617' .412 85-9952

@ 1985 by Springer-Verlag New York Inc. Sofcover reprint of the hardcover I st edition 1985

All rights reserved. No part of this book may be translated or reproduced in any form without written permission from Springer-Verlag, 175 Fifth Avenue, New York, New York 10010, USA.

The use of general descriptive names, trade names, trademarks, etc., in this publication, even if the former are not especially identified, is not to be taken as a sign that such names, as understood by the Trade Marks and Merchandise Marks Act, may accordingly be used freely by anyone.

While the advice and information in this book are believed to be true and accurate at the date of going to press, neither the authors nor the editors nor the publisher can accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein.

Typeset by Kingsport Press, Kingsport, Tennessee

9 8 7 6 5 432 1

ISBN- 13: 978-1-4612-9562-4 DOl: 10.1007/978-1-4612-5096-8

e-ISBN-13: 978-1-4612-5096-8

Foreword: Recent Improvements Tissue Valves

. In

The field of valvular heart replacement has evolved during the last two decades to a level where valve substitutes are highly reliable. From the outset this field divided sharply into two main approaches: mechanical prostheses and biological tissue valves. Both methods have taken signifi­cant steps forward toward the ultimate goal of the "ideal valve substi­tute." However, each still falls short of that goal.

Mechanical prostheses, although available in all shapes and materials, continue to have gradients in small valve sizes and the perennial problem of thromboembolism. Anticoagulants are mandatory for the rest of the patient's life when using any of these prostheses, which introduces the inherent risk of anticoagulant-related hemorrhage. Durability is sup­posed to be their "forte," and in general this has been true, regarding the device itself. But all of us involved in this field have seen patients die from complications of thromboembolism or anticoagulant-related hemorrhage with a perfectly intact and functional prosthesis.

Biological tissue valves have diverged in several directions, with re­spect to the tissue used and to the supporting apparatus, while retaining the common characteristic of simulating the native (aortic) valve. The original method of implanting a "free-hand" homograft aortic valve (1,2) continues to be very reliable in the aortic position, although there are some shortcomings as to availability and durability. The initial uncertain­ties have dissipated to some extent, as long-term follow-up studies have repeatedly shown excellent hemodynamics without valve gradients and no thromboembolism, even without anticoagulant therapy (3,4). Homo­graft valve preparation, namely sterilization and storage, has signifi­cantly influenced durability (5,6). Fresh antibiotic-sterilized homograft valves show less degenerative changes, hence, greater durability (6). Due to the cumbersome process of valve procurement, deep-freezing tech­niques to -90°C have been developed; the long-term superiority of this method over antibiotic-sterilized valves preserved in nutrient medium at 4°C for 4-8 weeks is yet to be determined.

Due to the problems of supply of homograft valves and the strong belief in the advantages of biological tissue for heart valve replacement, xenograft valves were the logical step forward (7) after a short trial with autologous fascia lata.

Availability and reliability have established the porcine (8,9) xenobio­prosthesis as the most commonly used tissue valve. By attaching the

vi Foreword: Recent Improvements in Tissue Valves

valve to a frame (a necessary step due to the inherent anatomical features of the porcine valve) a hybrid type of device was produced. This has shown advantages, namely, commercial availability and good hemody­namic function in the larger sizes. Disadvantages, however, include a significant incidence of thromboembolic complications (10). This finding is even more conspicuous when compared with the free-hand homograft aortic valve and other xenobioprostheses (11). They have also shown a significant incidence of degenerative changes, namely, late calcification recognized 6-8 years after implantation (12).

An alternative device, the man-made bovine pericardial valve has im­proved some of the features of the porcine xenobioprostheses (13). The larger effective orifice allows for better hemodynamics and a signifi­cantly lower incidence of thromboembolism (11). The durability of this xenobio prosthesis is being evaluated after an 8-year experience in this country (14) and a 15-year experience in the United Kingdom (15).

The most important factors in the overall performance of the hybrid (porcine and bovine pericardial) valves are: valve design, type of valve tissue, and process of preparation. Valve design dictates the hydraulic and hemodynamic function and, to a degree, determines the thrombogen­icity of a given valve. The tissue utilized and the pressure applied to it during fabrication dictates, to a certain extent, the durability of each device, as does the methods of sterilization and stabilization. Along these lines, several modifications have taken place with porcine valves in the past few years. Improvements in the type of frame and mounting tech­niques, as well as in the methods of preparation, appear promising for the newer Carpentier-Edwards and the Tascon porcine valves. The bovine pericardial valve has been modified to have a lower profile. A different approach to its construction is being developed to avoid the well-known "abrasion lesion" which has been identified as the initial step for calcifica­tion and tissue disruption. The addition of surfactants and other chemi­cal methods to decrease the incidence of calcification is being tested with several of the xenobioprostheses. With these modifications one can expect an improved valve substitute with a lower incidence of thrombo­embolism and better hemodynamic features as well as increased dura­bility.

For the homograft valve, the methods of procurement and sterilization will playa major role in future durability. The application of surfactants during sterilization and/or the addition of immunosuppressive drugs ei­ther to the valve per se or to the recipient should improve long-term function.

One other approach in the field of biological tissue valves that should be considered (again) is the use of autologous pulmonary valves for aortic valve replacement. This method, originally devised by D. N. Ross (16), has proven to be reliable with excellent valve durability (17). The au­thor has had experience with this approach and the long-term follow­up results corroborate the experience reported by D. N. Ross and associ­ates (18).

In summary, recent improvements in the quality of the available tissue valves leads to hope for further steps forward in the development of "the ideal valve substitute."

References vii

References

1. Ross DN: Homograft replacement of the aortic valve. Lancet 2:487,1962.

2. Barrett-Boyes B: Homograft aortic valve replacement in aortic incompetence and stenosis. Thorax 19:131, 1964.

3. Thompson R, Yacoub M: The use of "fresh" unstented homograft valves for replacement of the aortic valve: analysis of 8 years' experience. J Thorac Cardiovasc Surg 79:896, 1980.

4. Penta A, Qureshi S, Radley-Smith R, Yacoub M: Patient status 10 or more years after fresh homograft replacement of aortic valves. Circulation (Part II) 70:1-182, 1984.

5. Gonzalez-Lavin L, Al-Janabi N, Lockey E, Ross DN: Fibroblast viability in antibiotic treated valves. N Z Med J 77:36, 1973.

6. Gonzalez-Lavin L, O'Connell T: Mitral valve replacement with viable aortic homograft valves. Ann Thorac Surg 6:592, 1973.

7. Binet JP, Duran CG, Carpentier A, Langlois J: Heterologous aortic valve transplantation. Lancet 2:1275, 1965.

8. Davila JC, Magilligan DJ Jr, Lewis JW Jr: Is the Hancock porcine valve the best cardiac valve substitute today? Ann Thorac Surg 26:303, 1978.

9. Oyer PE, Miller DC, Stinson EB, Shumway NE: Clinical durability of the Hancock porcine bioprosthetic valve. J Thorac Cardiovasc Surg, 80:824, 1980.

10. Gonzalez-Lavin L, Chi S, Blair TC, Lewis B, Daughters G: Thromboembolism and bleeding after mitral valve replacement with porcine valves: Influence of thromboembolic risk factors. J Surg Res 36:508, 1984.

11. Gonzalez-Lavin L, Tandon AP, Chi S, Blair TC, McFadden PM, Lewis B, Daughters G: The risk of thromboembolism and hemorrhage following mitral valve replacement: A comparative analysis between the porcine xenograft valve and the Ionescu-Shiley bovine pericardial valve. J Thorac Cardiovasc Surg 87:340, 1984.

12. Magilligan DJ Jr, Lewis JW Jr, Jara FM: Spontaneous degeneration of por­cine bioprosthetic valves, Annals of Thoracic Surgery, 30:259, 1980.

13. Ionescu MI, Tandon AP, Mary DAS, Adid A: Heart valve replacement with the Ionescu-Shiley pericardial xenograft. J Thorac Cardiovasc Surg 73:31, 1977.

14. Gonzalez-Lavin L, Chi S, Johnson D, Lewis B: Eight-year experience with the standard Ionescu Shiley pericardial valve in the aortic position. Interna­tional Symposium on Cardiac Bioprosthesis, London, 21-23 May, 1985.

15. Ionescu MI, Silverton NP: Long term durability of the pericardial valve. International Symposium on Cardiac Bioprosthesis, London, 21-23 May, 1985.

16. Ross DN: Replacement of aortic and mitral valves with pulmonary autografts. Lancet 2:956, 1967.

17. Gonzalez-Lavin L, Geens M, Somerville J, Ross DN: Autologous pulmonary valve replacement of the diseased aortic valve. Circulation 42:781, 1970.

18. Robles A, Vaughn M, Lau JK, Bodnar E, Ross DN: Long term assessment of aortic valve replacement with autologous pulmonary valves. Ann Thorac Surg 39:238, 1985.

Browns Mills, New Jersey April,1985

Lorenzo Gonzalez-Lavin, M.D.

Preface

Weare entering an especially prolific era in reporting and publishing clinical experiences with cardiac valve replacement. A voluminous litera­ture on this subject is already in existence, emanating from clinicians, surgeons, bioengineers, and other scientists. Additionally, information presented at heart valve symposia in the form of bound collections reaches the shelves of the medical book stores every year. This activity reflects the dynamic state of cardiac valve technology, highlighted by the introduction each year of new valve designs that often utilize new materials.

As a result, the authors recognized the need to update their book The Pacemaker and Valve Identification Guide, separating the contents into two volumes dealing with pacemakers* and cardiac valve technology. For this Guide to Prosthetic Cardiac Valves, we have gathered a group of recognized authorities in the field, all of whom have contributed in­depth analysis in their areas of expertise. New material dealing with the preoperative and postoperative care ofthe heart valve patient, pathol­ogy of cardiac valves, bioengineering problems of cardiac valve technol­ogy, and separate chapters on valve implantation in children and ultra­sonography have been added. Chapter 3, "The Radiology of Prosthetic Heart Valves," we feel will be particularly helpful to the physician in identifying a prosthetic valve and revealing the most likely complica­tions. Chapter 10 is an atlas with descriptions to supply the reader with the essential features of the various prostheses when he or she is faced with a new patient bearing an implanted cardiac valve. (This situation arises frequently because of the mobility of our population.) When a late complication such as stroke affects a patient with an artificial heart valve, the attending physician must try to determine the cause of the complication and decide whether it is valve related or due to some other cause, so that appropriate medical or surgical therapeutic measures may be taken.

The chapter describing the various surgical techniques of cardiac valve replacement is designed to give important background information on postoperative complications that may have their inception in the operat­ing room. Material related to valves that have not been fully approved by the Food and Drug Administration and that are classified as investiga-

• A Guide to Cardiac Pacemakers, F. A. Davis Company, Philadelphia, Pennsylvania, 1983.

x Preface

tional devices and bioengineering data on heart valves are included to make the book more "durable," since many ofthese devices are promising and may soon be introduced from trial series into general clinical prac­tice.

The purpose of this book is to be a useful and practical reference source for cardiologists, internists, radiologists, surgeons, emergency room physicians, and others who deal with patients suffering from valvu­lar heart disease.

We would like to acknowledge the generous cooperation and assistance of valve manufacturers who have supplied us with photographs, dia­grams, and other printed information about their valves. We wish partic­ularly to thank Dr. Jerry Stone of Springer-Verlag New York Inc. for his editorial help and patience.

Contents

Foreword Lorenzo Gonzalez-Lavin v Preface ix Contributors xv

1 The Development of Artificial Heart Valves: Introduction and Historical Perspective 1 Viking 0. Bjork

2 The Evaluation of Patients for Prosthetic Valve Implantation 5

3

William S. Frankl

Mitral Stenosis 5 Rheumatic Mitral Regurgitation 12 Nonrheumatic Mitral Regurgitation 17 Combined Mitral Stenosis and Regurgitation 21 Aortic Stenosis 23 Aortic Regurgitation 28 Combined Aortic Stenosis and Regurgitation 35 Combined Mitral and Aortic Valve Disease 36 Tricuspid Valve Disease 37 Pulmonic Valve Disease 40 Summary 41 References 41

The Radiology of Prosthetic Heart Valves Robert M. Steiner and Stephanie Flicker

Preoperative Patient Selection 53 Postoperative Evaluation 54

53

Radiographic Identification of Prosthetic Valves 55 Radiographic Evaluation Following Valve Replacement 55 Complications of Prosthetic Valves 65 Magnetic Resonance Imaging 75 Summary 75 References 75

xii Contents

4 Ultrasonography of Cardiac Valves 79

5

Gary S. Mintz, Morris N. Kotler, and Ioannis P. Panidis

Noninvasive Techniques 79 Mechanical Prostheses 81 Bioprostheses 95 Left Ventricular Dysfunction 97 References 99

Surgical Aspects of Valve Implantation Javier Fernandez

Types of Artificial Heart Valves 103 Complications of Valve Substitutes 152

101

Technical Principles of Valve Replacement 158 References 171

6 Postoperative Management of Patients with Implanted Valvular

7

8

Prostheses 179 Steven G. Meister and Nelson M. Wolf

Early Postoperative Management 179 Long-Term Management of Patients with Valvular Prostheses 185 References 188

Prosthetic Cardiac Valves in Children Jeffrey M. Dunn

The Mitral Valve in Children 191 The Aortic Valve in Children 193 The Pulmonary Valve in Children 199 The Tricuspid Valve in Children 201

191

The Choice of Prosthetic Valves for Children 202 Prosthetic Valves in Children-An Overview 207 Acknowledgment 207 Bibliography 207

Pathology of Cardiac Valve Replacement Frederick J. Schoen

Early Postoperative Pathology 209 Late Pathologic Features 211 Prosthesis-Associated Complications Analysis of Explanted Specimens Acknowledgment 232 References 232

212 230

209

9 Bioengineering of Mechanical and Biological Heart Valve Substitutes 239 Shlomo Gabbay and J. Yasha Kresh

Dynamic Valve Motion Analysis 239 In Vitro Hydrodynamic Characteristics 244 Results 247 Discussion 251

10

Acknowledgment 253 References 253 Appendix-Theory 254

Cardiac Valve Identification Atlas and Guide Dryden Morse and Robert M. Steiner

Coratomic 258 Cutter 264 Edwards 274 Daggett 293 Hancock 294 Hemex Scientific 298 Medical Engineering 301 Medical Incorporated 302 Medtronic 306 Mitral Medical 308 Pemco 310 St. Jude Medical 312 Sao Paulo Heart Institute 314 Shiley 315 Sutter 344 Valve Research 346

Index 347

Contents xiii

257

Contributors

Viking O. Bjork, M.D., Professor Emeritus, Karolinska Institute, Stock­holm Sweden; Chief, Cardiac Research, Eisenhower Medical Center and Heart Institute of the Desert, Rancho Mirage, California, U.S.A.

Jeffrey M. Dunn, M.D., Chief, Pediatric Cardiac Surgery, St. Christo­pher's Hospital for Children, Philadelphia, Pennsylvania; Associate Professor of Surgery, Temple University, Philadelphia, Pennsylvania, U.S.A.

Javier Fernandez, M.D., Clinical Associate Professor of Surgery, Rutgers Medical School, New Brunswick, New Jersey, and Temple Univer­sity Health and Science Center, Philadelphia, Pennsylvania; Attending Surgeon, Deborah Heart and Lung Center, Browns Mills, New Jersey, U.S.A.

Stephanie Flicker, M.D., Clinical Assistant Professor of Radiology, Thomas Jefferson University, Philadelphia, Pennsylvania; Chairman, De­partment of Radiology, Deborah Heart and Lung Center, Browns Mills, New Jersey, U.s.A.

William S. Frankl, M.D., Professor of Medicine and Co-Director, Likoff Cardiovascular Institute of Hahnemann University, Philadelphia, Penn­sylvania, U.S.A.

Shlomo Gabbay, M.D., Clinical Assistant Professor of Surgery; Director, Section of Research and Artificial Internal Organs, Division ofCardiotho­racic Surgery at New Jersey Medical School and East Orange Veterans Medical Center, The University of Medicine and Dentistry of New Jer­sey-New Jersey Medical School, Newark, New Jersey, U.S.A.

Lorenzo Gonzalez-Lavin, M.D., Chairman, Department of Surgery, Debo­rah Heart and Lung Center, Browns Mills, New Jersey; Professor Coter­minus, Department of Surgery, University of Medicine and Dentistry­Rutgers Medical School, New Brunswick, New Jersey, U.S.A.

Morris N. Kotler, M.D., Professor of Medicine, Temple University, Phila­delphia, Pennsylvania; Chief of Cardiology, Albert Einstein Medical Cen­ter, Philadelphia, Pennsylvania, U.S.A.

xvi Contributors

J. Yasha Kresh, PH.D., Research Associate Professor of Surgery; Di­rector of Research, Division of Cardiothoracic Surgery, Department of Surgery, Thomas Jefferson University, Philadelphia, Pennsylvania, U.S.A.

Steven G. Meister, M.D., Professor of Medicine; Director, Cardiovascular Division, Medical College of Pennsylvania, Philadelphia, Pennsylvania, U.S.A.

Gary S. Mintz, M.D., Associate Professor of Medicine and Diagnostic Ra­diology; Director, Cardiac Ultrasound Laboratory, Likoff Cardiovascular Institute of Hahnemann University, Philadelphia, Pennsylvania, U.S.A.

Dryden Morse, M.D., Assistant Professor of Thoracic Surgery, Rutgers Medical School, New Brunswick, New Jersey; Attending Thoracic and Cardiovascular Surgeon, Deborah Heart and Lung Center, Browns Mills, New Jersey, U.S.A.

Ioannis P. Panidis, M.D., Associate Professor of Medicine and Associate Director, Cardiac Ultrasound Laboratory, LikoffCardiovascular Institute of Hahnemann University, Philadelphia, Pennsylvania, U.S.A.

Frederick J. Schoen, M.D., PH.D., Associate Professor of Pathology, Har­vard Medical School; Director, Cardiac Pathology Laboratory, Brigham and Women's Hospital, Boston, Massachusetts, U.S.A.

Robert M. Steiner, M.D., Professor of Radiology; Associate Professor of Medicine; Director, Thoracic Radiology, Thomas Jefferson University, Philadelphia, Pennsylvania; Consultant in Radiology, Deborah Heart and Lung Center, Browns Mills, New Jersey, U.S.A.

Nelson M. Wolf, M.D., Professor of Medicine; Director, Cardiac Catheter­ization Laboratory, Medical College of Pennsylvania, Philadelphia, Pennyslvania, U.s.A.