Table Of ContentRESTENOSIS AFTER INTERVENTION WITH NEW
MECHANICAL DEVICES
Developments in
Cardiovascular Medicine
VOLUME 131
RESTENOSIS
after Intervention with New
Mechanical Devices
edited by
PATRICK W. SERRUYS
Professor of Interventional Cardiology,
Cardiac Catheterization Laborator)', Thorax Center,
Erasmus Unil'ersity, Rotterdam,
The Netherlands
BRADLEY H. STRAUSS
Cardiac Catheterization Laboratory, Thorax Center,
Erasmus University, ROllerdam,
The Netherlands
and
SPENCER B. KING III
Director, Andreas Gruentzig Cardiovascular Center
Emor)' University, Atlanta, Georgia, U.S.A.
With a foreword by
ERIC J. TOPOL
Springer Science+Business Media, B.V.
Library of Congress Cataloging-in-Publication Data
RestenoS1S after intervention with new mechanical devices / edited by
Patrlck W. Serruys, Bradley H. Strauss, and Spencer B. King III ;
wlth a foreword by Erik J. Topai.
p. cm. -- (Developments in cardiovascular medicine v. 131)
Inc 1u des index.
ISBN 978-94-010-5171-2 ISBN 978-94-011-2650-2 (eBook)
DOI 10.1007/978-94-011-2650-2
1. Coronary artery stenosis. 2. Transluminal angioplasty
-Comal icatlons and sequelae. 3. Endarterectomy--Compl ications and
sequelae. 4. Laser angioplasty--Complications and sequelae.
1. Serruys, P. W. II. Strauss, Bradley H., 1957- III. King,
Spencer B., 1937- IV. Series.
[DNLM: 1. Anglography--methods. 2. Angioplasty, Laser--methods.
3. Angloplasty, Transiumlnal, Percutaneous Coronary--methods.
4. Coronary Dlsease--diagnosis. 5. Coronary Dlsease--therapy.
6. Recurrence. 7. Ultrasonography--methods. ,,1 DE997VME v. 131
WG 300 R436J
RC685.C58R47 1992
DNLMlDLC
for Llbrary of Congress 91-35390
ISBN 978-94-010-5171-2
AII Rights Reserved
© 1992 by Springer Science+Business Media Dordrecht
Originally published by Kluwer Academic Publishers in 1992
No part of the material protected by this copyright notice may be reproduced or utilized in
any form or by any means, electronic or mechanical, including photocopying, recording or
by any information storage and retrieval system, without written permission from the copy
right owners.
Foreword
Many investigators in the field of interventional cardiology have passed
through at least two distinct phases in the new era of evaluating percutaneous
transcatheter technologies to treat coronary artery disease. The first phase
was sheer excitement. Who would have thought that by the end of the 1980's
we could physically remove atherosclerotic plaque or laser ablate it? Who
would have conceived of placing permanent prostheses inside such relatively
small, tortuous and diseased coronary arteries? With these completely differ
ent mechanistic approaches and radically altered goals, a strong hope was
that debulking the plaque or buttressing the arterial wall we would markedly
limit the chances for subsequent restenosis. Although preliminary data from
multiple observational studies of the new device technologies suggest that
this is not the case so far, it remains quite possible that properly directed or
applied use of any of the alternative technologies will ultimately have a place
in reducing the likelihood for recurrence. The true evaluation of the promise
will only be known after careful, prospective, randomized controlled trials
are complete.
The second phase that we are entering is one of some relative disil
lusionment. That is, with respect to the early high, pervasive restenosis rates
with new technologies, some investigators have voiced a sense of hope
lessness. This is particularly unfortunate because it may reflect premature
assessment and unrealistic demands of a novel front of technologies.
We have already learned a considerable amount about the underlying
process of restenosis directly from the new technologies. Although easily
overlooked, it is quite important to underscore some of these pivotal findings.
For example, prior to directional atherectomy, we had to rely on necropsy
specimen tissue to analyze the histologic process' of restenosis. Already it is
clear from literally thousands of specimens from live, symptomatic patients
what is found in the culprit atherosclerotic or restenotic lesion and adjacent
vessel wall. Sophisticated analysis of atherectomy-derived tissue specimens
have involved use of in situ hybridization and cell culture techniques. This
has revealed several important markers that "light up" with specific mes-
Foreword
VI
senger RNA probes including platelet derived growth factor, tissue factor,
plasminogen activator inhibitor, and fibroblast growth factor. The role of
platelets and the hemostatic system has long been emphasized in the process
of vessel wall repair. However, cell culture from atherectomy specimens
suggest that white cells, and in particular macrophages and monocytes, may
have a critical role.
Beyond these scientific advances from "live" atherectomy specimens, we
have taken home many lessons from the stents with respect to restenosis.
Precise quantitative coronary angiography of stented patients with 6 month
follow-up has revealed a near ubiquitous presence of re-narrowed target
vessel lumens. Only a few years ago, we had no concept that intimal hyper
plasia could occur inside the stent. Furthermore, the theory that "hyper
expansion" of the vessel lumen with a stent may compensate for some degree
of underlying hyperplasia or recoil deserves careful study.
These are only a few examples of vital lessons occurring as an outgrowth
of the new device era. In this monograph, Drs. Serruys, Strauss and King
have orchestrated a comprehensive assessment of restenosis from the per
spective of new technologies. In the first sections, a critical chapter addresses
the issues of angiography in restenosis research, which is a remarkably con
troversial topic. As clinical trials are designed to date, some of the most
frequently asked questions are: (1) What should be the angiographic end
point?; (2) Is an angiographic endpoint meaningful?; (3) Can or should
continuous measurements of absolute minimal diameter be used? The section
following angiographic assessment that precedes the actual technique dis
course is devoted to intravascular imaging. This is especially appropriate and
important. Just as we have garnished vital insights from working in the
coronary arteries with new tools, so are we gaining critical perspective from
"looking" inside the artery rather than simply relying on angiographic
shadows. For example, with on-line two-dimensional intravascular echocardi
ography, the actual extent of vessel recoil can be observed and quantitated.
Three-dimensional reconstructed panarterial imaging will undoubtedly play
a key role in the future, with its unique capacity to delineate all three layers
of the coronary artery. The longstanding debate of what really constitutes
restenosis: regrowth, recoil, or "pseudorestenosis" simply due to inadequate
primary dilatation will likely be fully resolved by intravascular imaging.
In the subsequent sections of this beautifully integrated text, fully de
veloped discussions of the various new technologies including stenting,
atherectomy, rotational angioplasty, and lasers are provided. Of particular
note, great care has been taken to provide a full menu, with inclusion of
all of the more widely tested techniques and lucid summaries provided by
internationally revered investigators. Whenever possible or appropriate, the
editors have included chapters from both sides of the Atlantic which is
particularly valuable given the diverse experience to date.
As a whole, this monograph is exceptionally worthwhile owing to its
complete, up-to-date, balanced, and visionary elements. There is no question
Foreword Vll
that the new coronary device era has ushered in some excitement, and some
despair. This book serves a pivotal purpose by weaving so many new concepts
together, establishing the groundwork for further development of mechanical
approaches to limit restenosis. I heartily recommend this text to all interven
tional cardiologists interested in practical and research aspects of restenosis.
It certainly appears that we are all "junior" students in a very complex field
and educational efforts such as the accompanying text can help us take a
giant step beyond elementary school.
Eric J. Topol
Cleveland, August 1991
Contents
Foreword by Eric J. Topol v
List of contributors xiii
PART ONE: ASSESSMENT OF STENOSIS/RESTENOSIS -
PRESENT AND FUTURE
Introduction by J. Richard Spears 3
1. Methodologic aspects of quantitative coronary angiography
(QCA) in interventional cardiology 11
by Bradley H. Strauss, Marie-Angele M. Morel, Eline J.
Montauban van Swijndregt, Walter R. M. Hermans, Victor
A. W. Umans, Benno J. W. M. Rensing, Peter de Jaegere,
Pim J. de Feyter and Patrick W. Serruys
PART TWO: INTRAVASCULAR IMAGING
Introduction by Klaas Born, C. T. Lancee, Wilma J. Gussenhoven
and Jos R. T. C. Roelandt 53
Historical aspects of intravascular imaging
2. Potential of intravascular ultrasound imaging in the evaluation
of morphology, elastic properties and vasomotor function of
coronary arteries 63
by Natesa G. Pandian, Tsui-Lieh Hsu and Andrew Weintrauh
3. Intravascular ultrasound imaging following mechanical coronary
interventions: theoretic advantages and initial clinical experience 73
by Steven E. Nissen and John C. Gurley
4. Ultrasound guidance for catheter-based plaque removal and
ablation techniques: potentionai impact on restenosis 97
x Contents
by Paul G. Y ock, Peter J. Fitzgerald, Krishnankutty Sudhir,
Victor K. Hargrave and Thomas A. Ports
5. Intravascular ultrasound: potential for optimizing mechanical
solutions to restenosis 111
by Jeffrey M. Isner, Kenneth Rosenfield, Douglas W. Losordo
and Ann Pieczek
6. Evaluation of restenosis following new coronary interventions 149
by Richard E. Kuntz and Donald S. Bairn
PART THREE: STENTS RESTENOSIS AND NEW TECHNIQUES
Introduction by Ulrich Sigwart
Stenting for restenosis? 163
7. The Wallstent experience: 1986-1990 167
by Patrick W. Serruys and Bradley H. Strauss
8. Restenosis after Palmaz-Schatz stent implantation 191
by David L. Fischman, Michael P. Savage, Stephen G. Ellis,
Richard A. Schatz, Martin B. Leon, Donald Bairn and
Sheldon Goldberg
9. Restenosis after Gianturco-Roubin stent. Placement for acute
closure 207
by James A. Hearn, Spencer B. King III, John S. Douglas
and Gary S. Roubin
10. Immediate and long-term morphologic changes in stenosis
geometry after Wiktor™ stent implantation in native coronary
arteries for recurrent stenosis following balloon angioplasty.
Report on the first fifty consecutive patients 215
by Peter De Jaegere, Patrick W. Serruys, Wim van der Giessen
and Pim de Feyter
PARTFOUR:ATHERECTOMY
Introduction by John B. Simpson 237
11. Restenosis: directional coronary atherectomy 241
by Tomoaki Hinohara, John B. Simpson, Gregory C. Robertson
and Matthew R. Selmon
12. Transluminal extraction endarterectomy 259
by Roger S. Gammon, Michael H. Sketch Jr. and Richard
S. Stack
Contents Xl
PART FIVE: ROTATIONAL ABLATION
Introduction by David Auth 275
Angioplasty with high speed rotary ablation
13. Percutaneous transluminal coronary rotary ablation with
Rotablator: European experience 289
by Michel E. Bertrand, Jean M. Lablanche, Fabrice Leroy,
Christophe Bauters, Peter De Jaegere, Patrick W. Serruys,
Jurgen Meyer, Ulrich Dietz and Raimund Erbel
14. Percutaneous coronary rotational atherectomy: the William
Beaumont Hospital experience 297
by Mark S. Freed, Khusrow Niazi and William W. O'Neill
15. Percutaneous transluminal coronary rotational ablation: serial
follow-up by quantitative angiography 313
by Kirk L. Peterson, Isabel Rivera, Martin McDaniel, John
Long, Allan Bond, Mikki Bhargava and the clinical
investigators of the multicenter trial of the Rotablator
PART SIX: LASERS
Introduction by Warren Grundfest, Frank Litvack, James Margolis,
J ames Laudenslager and Tsvi Goldenberg 331
16. Improved luminal dimensions and local pharmacological therapy
with laser balloon angioplasty for potential mitigation of
angioplasty restenosis 347
by J. Richard Spears
17. Laser balloon angioplasty: European experience 359
by H. W. Thijs Plokker and E. Gijs Mast
18. Coronary laser angioplasty 373
by Timothy A. Sanborn
19. Restenosis following laser angioplasty 385
by J. Michael Koch, Stephan Friedl, James M. Seeger,
Gerald Barbeau and George S. Abela
20. Sapphire-probe laser angioplasty - European experience 415
by Johannes Lammer
21. Excimer laser assisted angioplasty of peripheral vessels 427
by Giancarlo Biamino, P. Skarabis, H. Bottcher, G. Kampmann,
C. Ragg, U. Flesch and H. Witt
22. Clinical results of percutaneous coronary excimer laser
angioplasty trials 475
