Contrast Media: Safety Issues and ESUR Guidelines

161 Pages·2006·1.37 MB·English

by  Peter Aspelin MD, Marie-France Bellin MD, Jarl Å. Jakobsen MD, Judith A. W. Webb MD (auth.), Henrik S. Thomsen MD (eds.)

Contents I
MEDICAL RADIOLOGY
Diagnostic Imaging
Editors:
A. L. Baert, Leuven
K. Sartor, Heidelberg
Contents III
H. S. Thomsen (Ed.)
Contrast Media
Safety Issues and
ESUR Guidelines
With Contributions by
P. Aspelin · M.-F. Bellin · R. W. F. Geenen · J. Å. Jakobsen · G. P. Krestin · S. K. Morcos · R. Oyen
J. M. Raine · F. Stacul · H. S. Thomsen · A. J. van der Molen · J. A. W. Webb
Foreword by
A. L. Baert
With 2 Figures and 27 Tables
123
IV Contents
Henrik S. Thomsen, MD
Professor, Department of Diagnostic Radiology 54E2
Copenhagen University Hospital at Herlev
Herlev Ringvej 75
DK-2730 Herlev
Denmark
Medical Radiology · Diagnostic Imaging and Radiation Oncology
Series Editors: A. L. Baert · L. W. Brady · H.-P. Heilmann · M. Molls · K. Sartor
Continuation of Handbuch der medizinischen Radiologie
Encyclopedia of Medical Radiology
Library of Congress Control Number: 2005925776
ISBN 3-540-20448-2 Springer Berlin Heidelberg New York
ISBN 978-3-540-20448-0 Springer Berlin Heidelberg New York
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Contents V
Foreword
For more than 10 years the ESUR contrast media safety committee has been providing
radiologists with the latest information and updates on the adverse effects and risks of
contrast media. The recommendations and guidelines from this committee have gen-
erated great interest and are now universally recognized for their high scientifi c value.
They are based on solid scientifi c research, objective data and comprehensive, inde-
pendent literature analysis. The long-standing and extensive personal clinical expertise
of each of the committee members constitute the base for authoritative statements on
many controversial issues regarding the correct use of contrast agents in clinical radi-
ology.
As a comprehensive work, this book covers not only the classic iodinated contrast
media and barium preparations, but also the more recent MR and US contrast agents.
Indeed, this work brings together an immense volume of data and invaluable specifi c
information, originally scattered throughout the literature but now available in one
publication.
I most sincerely congratulate H. S. Thomsen and all contributing authors for this
outstanding volume, which deserves to become the standard reference in the fi eld.
I am confi dent that it will be of great interest for radiologists and referring physicians
in their daily practice.
Leuven Albert L. Baert
Contents VII
Preface
The European Society of Urogenital Radiology established its Contrast Media Safety
Committee in 1994. Over the years it has consisted of between 12 and 14 members, the
majority of whom are experts in the fi eld of contrast media research. There is currently
one member from the scientifi c section of each of the pharmaceutical companies pro-
ducing contrast agents (Bracco, Italy; GE Healthcare Diagnostics, USA; Guerbet, France;
Schering, Germany). Although the members of the committee have diverse views the
Contrast Media Safety Committee works as one group for the good of patients. The
committee benefi ts from the wealth of knowledge on contrast agents brought to it by
the representatives of the pharmaceutical companies. However, the rules of the Contrast
Media Safety Committee forbid any commercial promotion and the committee deals
with all types of contrast agents based purely on objective analysis, sound scientifi c data,
well documented clinical experience and clinical common sense. Disagreement within
the committee is discussed rationally and without commercial infl uence. All contrast
media are referred to by their generic names, except when the generic name is confusing
(e.g. ultrasound contrast agents). After 11 years of work the committee has covered all
the topics of clinical importance regarding the safe use of contrast media. The current
book is mainly a collection of this work together with a few new chapters. The chap-
ters have been prepared by the individual authors based on their original papers (see
Appendix) when applicable and an up to date review of the literature. Some chapters
are new and have never been published as papers by the committee. The chapters have
not been circulated among or discussed by the members of the committee and have
been edited by myself. In the appendix the latest version of the ESUR guidelines agreed
at the meeting of the committee in Copenhagen, February 2005, is presented.
The ESUR guidelines have been well received by the radiological community. They
are frequently cited in the literature. They have been incorporated into the protocols
of many departments all over the world. They are also used by the health authorities in
many countries as a reference for good radiological practice. Several of the guidelines
have been translated into languages other than English, for example Spanish, Russian
and Japanese.
I am sure the readers will agree that this book offers an invaluable, unique, practical
and unparalleled resource dealing with safety issues related to radiographic, MR and
ultrasound contrast media, and that it will ultimately benefi t patients.
It has been a great honor for me to serve as chairman of this prestigious commit-
tee for 9 years. Special mention goes to the secretary of committee, Dr. Sameh Morcos,
whose close cooperation has always been highly productive and inspirational. Without
his energy and enthusiasm we would never have accomplished what we have. Also, the
past and current members of the committee deserve sincere thanks for their continu-
VIII Contents
ing involvement and for the outstanding discussions at the annual committee meeting.
Despite disagreements we have always reached a consensus. A special thank you goes to
Dr. Judith Webb, who has not only participated actively in our work but has also ensured
that our manuscripts were published in correct English. Dr. Webb has revised the English
throughout this book and I am most grateful for her outstanding and continuous sup-
port. We also thank Professor Albert L. Baert, Editor-in-Chief of European Radiology
and Editor-in-Chief of this book series, as well as Springer-Verlag for their immediate
endorsement and support of the book.
Finally, I wish to thank my family, especially my wife Pia, for allowing me to invest so
many hours of family time in this project.
Herlev, Denmark Henrik S. Thomsen
Contents IX
Contents
1 Classifi cation and Terminology
Peter Aspelin, Marie-France Bellin, Jarl Å. Jakobsen,
and Judith A. W. Webb. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2 Off-Label Use – Legal Aspects
June M. Raine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Section I: General Adverse Reactions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
3 Prevention of Acute Reactions
Judith A. W. Webb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
4 Management of Acute Adverse Reactions to Contrast Media
Henrik S. Thomsen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5 Late Adverse Reactions to Intravascular Iodinated Contrast Media
Fulvio Stacul. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Section II: Renal Adverse Eff ects. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
6 Reducing the Risk of Contrast Media Induced Nephrotoxicity
Henrik S. Thomsen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
7 Dialysis and Contrast Media
Sameh K. Morcos. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
8 Non-Insulin Dependent Diabetes and Contrast Media
Henrik S. Thomsen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Section III: Other Adverse Eff ects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
9 Iodinated and Gadolinium Contrast Media During Pregnancy and Lactation
Judith A. W. Webb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
10 Effects on Blood and Endothelium
Peter Aspelin, Fulvio Stacul, and Sameh K. Morcos . . . . . . . . . . . . . . . . . . . . . . 65
11 Effects on Iodinated Contrast Media on Thyroid Function
Aart J. van der Molen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
X Contents
12 Pulmonary Effects of Radiographic Contrast Media
Sameh K. Morcos. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
13 Phaeocromocytoma
Judith A. W. Webb . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
14 Contrast Media: Interactions with Other Drugs and Clinical Tests
Sameh K. Morcos. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
15 Contrast Medium Extravasation Injury
Jarl Å. Jakobsen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
Section IV: MR Contrast Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
16 Non-tissue Specifi c Extra Cellular MR Contrast Media
Remy W. F. Geenen and Gabriel P. Krestin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
17 Gadolinium Contrast Media for Radiographic Examinations
Henrik S. Thomsen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113
18 Safety of MR Liver Specifi c Contrast Media
Marie-France Bellin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
Section V: Ultrasonographic Contrast Media . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129
19 Safety of Ultrasound Contrast Agents
Raymond Oyen. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
Section VI: Barium Preparations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
20 Safety Issues
Sameh K. Morcos. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139
Appendix. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143
21 ESUR Guidelines on Contrast Media prepared by the Contrast Media
Safety Committee of the European Society of Urogenital Radiology . . . . . . . . . . . . . 145
Subject Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161
List of Contributors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 169
Classifi cation and Terminology 1
1 Classification and Terminology
Peter Aspelin, Marie-France Bellin, Jarl Å. Jakobsen, and Judith A. W. Webb
CONTENTS several powers higher than audible sound which are
reflected back from tissue interfaces in the body to
1.1 Introduction 1 generate the image.
1.2 Radiographic Contrast Media 1
Contrast media may be used with all of these
1.2.1 Iodine Agents 1
1.2.2 Barium Contrast Media 2 imaging techniques to enhance the differences seen
1.3 MR Contrast Media 2 between the body tissues on the images. Contrast
1.3.1 Paramagnetic Contrast Agents 2 media alter the response of the tissues to the applied
1.3.2 Superparamagnetic Contrast Agents 3 electromagnetic or ultrasound energy by a variety
1.4 Ultrasound Contrast Media 3
of mechanisms. The ideal contrast medium would
1.4.1 Classification 4
achieve a very high concentration in the tissues with-
out producing any adverse effects. Unfortunately, so
far this has not been possible and all contrast media
1.1 have adverse effects.
Introduction This chapter deals with the classification of con-
trast agents and the terminology used to describe
Current radiological imaging uses either electro- them.
magnetic radiation (X-rays or radiowaves) or ultra-
sound. X-rays have a frequency and photon energy
several powers higher than visible light and can pen-
etrate the body. The radiation which emerges from 1.2
the body is detected either by analogue radiological Radiographic Contrast Media
film or by a variety of digital media. The radio-
waves used in magnetic resonance imaging have a Radiographic contrast media are divided into posi-
frequency and photon energy several powers lower tive and negative contrast agents. The positive con-
than visible light. The radiowaves cause deflec- trast media attenuate X-rays more than do the body
tion of protons in the body which have aligned in soft tissues and can be divided into water soluble
the magnetic field in the scanner and as the pro- iodine agents and non water soluble barium agents.
tons relax back to their resting position, they emit Negative contrast media attenuate X-rays less than
radiowaves which are used to generate the image. do the body soft tissues. No negative contrast media
Ultrasound imaging uses sound (pressure) waves are commercially available.
P. Aspelin, MD
Department of Radiology, Karolinska University Hospital, 1.2.1
14186 Stockholm, Sweden
Iodine Agents
M.-F. Bellin, MD
Department of Radiology, University Paris-Sud 11, Paul
Brousse Hospital, AP-HP, 12–14 avenue. Paul Vaillant C outurier, Water soluble iodinated contrast agents which dif-
94804 Villejuif Cedex, France fuse throughout the extracellular space are prin-
J. Å. Jakobsen, MD cipally used for angiography, during computed
Department of Diagnostic Radiology, Rikshospitalet, 0017
tomography (CT) and conventional radiography.
Oslo, Norway
They can also be administered directly into the body
J. A. W. Webb, MD
Department of Diagnostic Imaging, St. Bartholomew’s Hospi- cavities, for example the gastrointestinal tract and
tal, West Smithfi eld, London EC1A 7BE, UK urinary tract.