VOLUME2
`
`Second Edition
`
`TEXTBOOK
`
`INTERVENTIONAL
`
`CARDIOLOGY
`
`
`
`ERIC J. TOPOL, M.D.
`
`Chairman, Department of Cardiology
`Director, Center for Thrombosis and Vascular Biology
`Cleveland Clinic Foundation
`Professor of Medicine
`Cleveland Clinic Health Sciences Center
`Ohio State University
`Cleveland, Ohio
`
`W.B. SAUNDERS COMPANY
`
`A Division of Harcourt Brace & Company
`
`Philadelphia, London, Toronto, Montreal, Sydney, Tokyo
`
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` wy
`
`Trak
`
`W. B. SAUNDERS COMPANY
`A Division of Harcourt Brace & Company
`The Curtis Center
`Independence Square West
`Philadelphia, PA 19106
`
`
`
`Library of Congress Cataloging-in-Publication Data
`
`
`
`Textbook of interventional cardiology / [edited by] Eric J. Topol —
`2nd ed.
`.
`om.
`Includes bibliographical references and index.
`ISBN 0-7216-6749-X (V. 1).—ISBN 0-7216-6750-3 (V. 2).—
`ISBN 0-7216-6722-8 (Set)
`1. Angioplasty.
`2. Cardiovascular system—Diseases—Treatment.
`|. Topol, Erie J.
`[DNLM:
`1. Cardiovascular Diseases—surgery.
`168 T355 1994]
`RD598.5.T49
`1994
`617.4'12059—dc20
`DNLM/DLC
`
`2. Angioplasty. WG
`
`93-15130
`
`Textbook of INTERVENTIONAL CARDIOLOGY
`
`Volume 1 0-7216-6749-X
`Volume 2 0-7216-6750-3
`Set ISBN 0-7216-6722-8
`
`Copyright © 1994, 1990 by W. B. Saunders Company.
`All rights reserved. Nopartof this publication may be reproduced or transmitted in any form or by
`anymeans, electronic or mechanical, including photocopy, recording, or any information storage and
`retrieval system, without permission in writing from the publisher.
`Printed in the United States of America.
`
`Last digit is the print number:
`
`9
`
`8
`
`7
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`6
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`5
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`4
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`3
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`2
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`
`
`CONTENTS
`
`
`
`VOLUME1
`
`1 Pharmacologic Intervention
`1.
`
`ROLE OF PLATELET-INHIBITOR AGENTS IN CORONARY ARTERY DISEASE.
`Valentin Fuster and Ik-Kyung Jang
`
`2.
`
`ANTICOAGULANTS AND THEIR USE IN ACUTE ISCHEMIC SYNDROMES. ...
`Pierre Théroux and Rosa-Maria Lidén
`
`3
`
`EFFECTS OF BETA-BLOCKERS, CALCIUM CHANNEL BLOCKERS, NITRATES,
`AND MAGNESIUM IN ACUTE MYOCARDIAL INFARCTION AND UNSTABLE
`ANGINA PECTORIS.
`ooccccceccccccccecccscueecenescencrscceseasenscensceuecneeeeseeseaasegesaseseeengeeees
`Peter H. Held, Koon K. Teo, and Salim Yusuf
`
`4
`
`3
`
`23
`
`46
`
`ANGIOTENSIN-CONVERTING ENZYMEINHIBITION.
`Marc A. Pfeffer
`
`........::c:ccccsssssssseesessesees
`
`60
`
`5
`
`THROMBOLYTIC INTERVENTION. .....ccc0sseecesseessserssessseeeseteeeeeesersnetseeeeensnstearees
`Eric J. Topol
`
`6
`
`OMEGA-3 FATTY ACIDS. cocicccccee ret rrre eerie eeeerenenmereenenneeerens
`Gregory J. Dehmer
`
`7
`
`68
`
`112
`
`FREE RADICAL SCAVENGERS AND LEUKOCYTE INHIBITORS.
`Steven W. Werns
`
` ..........:000:00000
`
`137
`
`8.
`
`HYPOLIPIDEMIC INTERVENTION AND PROSPECTS FOR REGRESSION. ........
`Robert A. Vogel
`
`161
`
`If Coronary and Peripheral Angioplasty
`9
`
`CORONARY AND PERIPHERAL ANGIOPLASTY: HISTORICAL PERSPECTIVE.
`Richard K. Myler and Simon H. Stertzer
`
`171
`
`10.
`
`ELECTIVE CORONARY ANGIOPLASTY: TECHNIQUE AND
`COMPLICATIONS,
`ssssssassansenascsttasncesscuthesssniisessvssetarenuilbaietecdin ataammaeiennensecces
`Stephen G.Ellis
`
`186
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`
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`; f;
`
`:
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`4
`
`XX
`
`CONTENTS
`
`11.
`
`..... cses:ssvsrevsenenesenesenenesisensaannnceniuverenvousteneuseesensos
`ABRUPT VESSEL CLOSURE. _
`A. Michael Lincoff and Eric J. Topol
`
`207
`
`12.
`
`COMPLEX AND MULTIVESSEL DILATION.
`David R. Holmes, Jr. and Peter B. Berger
`
`oo. cccccccsssssseesseerseeseveeseeersnneeeneres sees
`
`231
`
`13.
`
`EFFICACY OF PERCUTANEOUS TRANSLUMINAL CORONARY
`ANGIOPLASTY (PTCA) IN CORONARY ARTERY DISEASE: WHY WE NEED
`RANDOMIZED TRIALS.
`voc. cccccceeceseesteessuuteeeeeeaueseeneuscssesccauuesessaeeceapectenseeestesenness
`Bernard J. Gersh
`
`14.
`
`PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY FOR
`UNSTABLE ANGINA. 00... cccccccccccccscscceescsneeeeecneaasaeasaeneeeeteeenceseseeeesaueenenerereseauna
`Pim J. de Feyter and Patrick W. Serruys
`
`15.
`
`MECHANICAL INTERVENTIONS FOR ACUTE MYOCARDIAL INFARCTION.
`Eric J. Topol
`
`251
`
`274
`
`292
`
`16.
`
`CHRONIC TOTAL OCCLUSION.
`Bernhard Meier
`
`17.
`
`......ccccccceceveseecueceuccecseceucssucaessnesaessseeeensececuecenees
`
`318
`
`PERCUTANEOUS INTERVENTION IN PATIENTS WITH PRIOR CORONARY
`BYPASS SURGERY.
`oo... oc eeeccceceenceseeneeessenaneeeeetaeeeesseseeecnseeseesseeeessesseseseeraeeeen
`John S. Douglas, fr.
`
`339
`
`18.
`
`RESTENOSIS: INVOLVEMENT OF GROWTH FACTORS AND CYTOKINES......
`Peter Libby
`
`355
`
`19,
`
`ANIMAL MODELS OF HUMAN CORONARY RESTENOSIS.
`Robert S. Schwartz
`
`........:::ceseseeceeecesenes
`
`365
`
`20.
`
`RESTENOSIS: PATHOPHYSIOLOGIC CONSIDERATIONS.
`Christian C. Haudenschild
`
`socccccsesessescesessesveresvens
`
`382
`
`21.
`NONPHARMACOLOGIC DEVICE PREVENTION OF CORONARY
`RESTENOSIS. oe. seccccsccsccccseesesessesessvecsessesseeassecsesessessesssscsssseeecsacaveavesaseeseaseaes
`Neal Eigler and James S. Forrester
`
`22.
`
`...c.cscsesscssssssssesesssscscscsseucavevavecrisscareceenees
`RESTENOSIS: THE CLINICAL ISSUES.
`William B. Hillegass, E. Magnus Ohman, and Robert M. Califf
`
`400
`
`415
`
`23.
`SITE-SPECIFIC THERAPY FOR THE PREVENTION OF RESTENOSIS.
`David W. M. Muller
`
`....-..-.e00e0:
`
`436
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`

`CONTENTS
`
`24.
`
`THE PATHOLOGY OF INTERVENTIONAL CORONARY ARTERY
`TECHNIQUES AND DEVICES.
`o.....eceeececcceeerseeeneeseeeeeeee sete eea seca sesnneeuu enna enna erage
`Bruce F. Waller and Cass A. Pinkerton
`
`25.
`
`......c..cccecceeeeeenueeeeereeeeeenseaueeanauseaaeeesaepenteareeanerteeeneee
`PERFUSION ANGIOPLASTY.
`Dean J. Kereiakes, Michael H. Sketch, Jr., and Richard S. Stack
`
`449
`
`477
`
`26,
`
`SUPPORTED ANGIOPLASTY.
`Robert A. Vogel
`
`27.
`
`.......cccsseseeseecceoneeansesevesaneepeudnauraveesesqeasneateerentesereass
`
`495
`
`PHARMACOLOGICALLY PROTECTED PERCUTANEOUS TRANSLUMINAL
`CORONARY ANGIOPLASTY.
`oo... .c.ccccceccct ene cne eee en ee erence ener eee ener eee et bere rene taeeeeen
`Michael W. Cleman and John M. Lasala
`
`28.
`
`HIGH-RISK ANGIOPLASTY: IDENTIFICATION AND MANAGEMENT...........-.
`Alice K. Jacobs and David P. Faxon
`
`502
`
`520
`
`29.
`
`PERCUTANEOUS LEFT VENTRICULAR ASSIST.
`Richard W. Smalling
`
`voccccccccccccccccsesereeeeeeereeeeeereenensees
`
`539
`
`30.
`
`BRACHIAL TECHNIQUE TO INTERVENTION.
`Barry S. George
`
`...ccccccccccccseecseereeeeetereteeeeeeeeeneaas
`
`549
`
`31.
`
`SURGICAL STANDBY FOR PTCA. wi.ccccccccecascnesesecueceenesseeueaeeusesaeenseetereeseesesisertes
`Bernhard Meier
`
`32.
`
`CORONARY ARTERY PERFORATION: RISK FACTORS AND MANAGEMENT.
`Joseph M. Sutton, Russell E. Raymond, and Stephen G.Ellis
`
`33.
`
`ANGIOPLASTY AND INTERVENTIONAL VASCULAR PROCEDURES IN THE
`PERIPHERAL, RENAL, VISCERAL, AND EXTRACRANIAL CIRCULATION......
`Mark H. Wholey and Arthur J. Nussbaum
`
`34.
`
`PERCUTANEOUS VASCULAR HEMOSTASIS DEVICES FOR ARTERIAL
`SEALING AFTER INTERVENTIONAL PROCEDURES. 0.0... eeecceeseseeeseneernteeeeens
`Harry H. Gibbs and Timothy A. Sanborn
`
`565
`
`576
`
`600
`
`629
`
`lll Coronary Atherectomy
`35.
`
`.....cseeecesssetteeeeeeteseeteeeneeeereasesenes
`DIRECTIONAL CORONARY ATHERECTOMY.,
`Tomoaki Hinohara, Gregory C. Robertson, John B. Simpson
`
`36.
`
`PERCUTANEOUS CORONARY ROTATIONAL ANGIOPLASTY WITH THE
`ROTOBLATOR. oo... cceceeeeee reece etn ene teen ener eeedteeee eed eee eea eas ea sa eeeeeeeeeneaennenaegs
`Michel E. Bertrand, Christophe Bauters, Jean-Marc Lablanche
`
`659
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`
`
`xxi
`
`CONTENTS
`
`37.
`
`EXTRACTION ATHERECTOMY. o....sssssssssssscsssssssessssssssssssasanastesssstnteeeeccscccc,
`Michael H. Sketch, Jr., Marino Labinaz, and Richard S. Stack
`38.
`
`OVERVIEW OF CORONARY ATHERECTOMY.
`David W. M. Muller and Eric J. Topol
`INDEX wrserccsscensenstatisstsstnstnetsstsenstrstnstsinstistiitiiuneeeeeecc.
`
`...cscccsessesssseesstssssvessseeseeseeoccccc...
`
`668
`
`678
`
`i
`
`VOLUME2
`COLOR PLATES 1-8
`
`IV Coronary Stenting
`39.
`
`..cscsssssusnsntstsnstastinnatiiuiieesecc.
`THE CORONARY WALLSTENT.
`Bradley H. Strauss and Patrick W. Serruys
`40.
`
`687
`
`THE PALMAZ-SCHATZ STENT: CLINICAL APPLICATIONS.
`
`Stephen G.Ellis
`
`oceesccccccesseseosscs....
`
`702
`
`41.
`
`THE GIANTURCO-ROUBIN STENT,
`Adam D. Cannon and Gary S. Roubin
`42.
`
`ssssssssssossstssssssssssasstdbsiivosenseesengneonsnesssensevess
`
`712
`
`THE WIKTOR STENT. o..s..sestestestscessnsntstsatststtnptatiatssiitiontegeesc.
`Patrick L. Whitlow, Peter P. de Jaegere, and Patrick W. Serruys
`
`727
`
`43.
`
`THE STRECKER STENT.
`
`Christian W. Hamm
`
`ssesssssssssossseeeeesenssonetsesnnsssssssssstessssststansaresasennseseccccce,
`
`742
`
`A4
`
`COATING OF ENDOVASCULARSTENTS.
`Steven R. Bailey
`
`....scssscssesssesssssssssissetvsatieeeeeeccc..
`
`754
`
`45
`
`sssssessssssesseesessssssssssstsecunnssotetistatessssstssannsescusecccsce,
`TEMPORARY STENTS.
`Neal Eigler, Frank Litvack, and Patrick L. Whitlow
`46.
`
`PHARMACEUTIC STENTS AND REGIONAL THERAPY FOR RESTENOSIS.
`RobertJ. Levy
`
`.....
`
`47.
`
`oa..sesoSscseeeeeessisrsss330630SSeemeaneneerennsseuseoenee
`BIODEGRADABLE STENTS.
`James P, Zidar, A. Michael Lincoff, and Richard S. Stack
`48
`
`766
`
`776
`
`787
`
`AN OVERVIEW OF INTRAVASCULARSTENTS: OLD AND NEW.
`
`Ulrich Sigwart
`
`..o.occccccccees,
`
`803
`
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`

`CONTENTS
`
`xxilt
`
`V_ Laser and Other Ablative, New Forms of Angioplasty
`49.
`
`“HOT” BALLOON ANGIOPLASTY: RADIOFREQUENCY, NEODYMIUM:YAG
`AND MICROWAVE.
`ou. cccccccccesccesecsscessseessesssatesteessevssscassessevareussssasessssesseesecseees
`Daniel B. Fram and Raymond G. McKay
`
`819
`
`50.
`
`EXCIMER LASER CORONARY ANGIOPLASTY.
`Frank Litvack
`
`o...ccccccccccccsccsscsesesscesesveseecesecesees
`
`840
`
`Sl.
`
`HOLMIUM: YAG LASER CORONARY ANGIOPLASTY: EARLY EXPERIENCE.
`Christopher J. White and Stephen R. Ramee
`
`.
`
`859
`
`52.
`
`HOLMIUM: YAG CORONARY ANGIOPLASTY: THE MULTICENTER
`REGISTRY. o...cccecccseessscscsseesecesecsaeeeseseeesesaeesecenesesecasssssseescassusascausecusevauseasnaee
`On Topaz
`
`867
`
`53.
`
`LASER THROMBOLYSIS.
`Kenton W. Gregory
`
`54.
`
`......::ccccsscerereesteeeeesesssesesenecenseeceasteeeeasceceaaeeeeeseseetseaners
`
`892
`
`RECENT TRENDS AND FUTURE DIRECTIONS IN LASER ANGIOPLASTY.
`Martin B. Leon and Robert F. Bonner
`
`.....
`
`903
`
`55.
`
`:
`
`
`
`LIMITATIONS..cescvesnenssvecaseracasauwaseusvennaseswanevaveuvedsevarsccunsucrevesiausescetesas\ieeawhelis 917
`
`LASER ANGIOPLASTY: POTENTIAL EFFECTS AND CURRENT
`
`John A. Bittl, Gerard Barbeau, and George S. Abela
`
`56.
`
`......cccecceceessseeeeeesssersseseseesseessesesseseessareeeeeserstens
`ULTRASOUND ANGIOPLASTY.
`Robert J. Siegel, Wolfgang Steffen, and David C. Cumberland
`
`931
`
`57.
`
`PHYSIOLOGICALLY CONTROLLED LOW-STRESS ANGIOPLASTY.
`Ezra Deutsch
`
` ..ccccseccseseeee
`
`947
`
`58.
`
`LASER ANGIOPLASTY: CURRENT AND FUTURE PROSPECTS.
`James S. Forrester
`
`.......cccceeceseeeeers
`
`959
`
`Sg.
`
`DEVELOPING AN INTEGRATED APPROACH TO THE USE OF NEW DEVICES
`FOR CORONARYINTERVENTION.
`......cccccccecscccesscesssesscecsecessseceseseecacecensceseees
`Donald S. Baim
`
`966
`
`60
`
`A LESION-SPECIFIC APPROACH TO NEW-DEVICE ANGIOPLASTY.
`Jeffrey J. Popma and Martin B. Leon
`
`....sccses0000.
`
`973
`
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`
`
`xxiv
`
`CONTENTS
`
`VI Gene Transfer and Therapy
`61.
`INTERVENTIONAL APPROACHES TO THE INTRODUCTION OF GENETIC
`MATERIAL INTO THE VASCULATURE.
`oscsscsscssscsesstessesssussstessssssissssceseecesecseecg
`David A, Dichek
`
`62.
`MOLECULAR GENETIC INTERVENTIONS FOR CARDIOVASCULAR
`DISEASES.
`ssssssssssssessssssssssscssssserssnsvenssnissssseseeccessssssssssansssstestnsstusssosteseesececcccc
`Eizabeth G. Nabel and Gary J. Nabel
`
`63.
`
`PERCUTANEOUS GENE THERAPY FOR CARDIOVASCULARDISEASE...........
`Guy Leclerc and Jeffrey M. Isner
`Vil Evaluation of Coronary Interventional Techniques
`
`64.
`DIGITAL CORONARY ANGIOGRAPHY IN THE EVALUATION OF
`INTERVENTIONAL TECHNIQUES,
`oo..eseeesccsssssssssesssssssssusssnsisensessssteseeseecescccce..
`
`G. B. John Mancini
`
`989
`
`1006
`
`1019
`
`1033
`
`65.
`
`QUALITATIVE AND QUANTITATIVE ANGIOGRAPHY.
`Jeffrey J. Popma and Thomas M. Bashore
`
`ooccccscsceccessssecesecesecees..
`
`1052
`
`66.
`
`..sscssssssssssssssssssesssstsssttinsttiasisesuneeeseseecccc
`INTRACORONARY DOPPLER.
`Patrick W. Serruys, Carlo Di Mario, and Morton J. Kern
`67.
`;
`
`PERCUTANEOUS CORONARY ANGIOSCOPY. oo...seccsccsssssestessavssecresveseeseesesss.
`Stephen R. Ramee and Christopher J. White
`68.
`
`INTRAVASCULAR ULTRASOUND. wossssscccssessscssccsscsscecssssssnnsenssessassssnensansssssssess
`Paul G. Yock, PeterJ. Fitzgerald, and Krishnankutty Sudhir
`69.
`.
`-
`
`1069
`
`1122
`
`1136
`
`INTRAVASCULAR ULTRASOUNDIN PATIENTS UNDERGOING CORONARY
`AND PERIPHERAL ARTERIAL REVASCULARIZATION.
`oo.cescececcssccsssecseeseessse.
`KennethRosenfield and Jeffrey M. Isner
`
`1153
`
`VI Valvuloplasty, Congenital and Pericardial Heart Disease
`
`70.
`AORTIC AND MITRAL BALLOON
`vy
`:
`EXPERIENCE, |...PALLOOneEeUNTIEDSTATE og
`Peter C. Block and Igor F. Palacios
`71.
`
`MITRAL VALVULOPLASTY. THE FRENCH EXPERIENCE,
`Alec Vahanian and Jean Acay
`
`ooeccscccecsessscseescecceceees
`
`1206
`
`
`
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`
`
`a
`
`CONTENTS
`
`72.
`
`PERCUTANEOUS TRANSVENOUS MITRAL COMMISSUROTOMY: THE FAR
`EAST EXPERIENCES:
`isssvissiasacrscnnanaannneccnecisnurnacacevanccinansirersmunensuutaenmen bhawanas
`Kanji Inoue and Jui-Sung Hung
`
`73.
`
`PERCUTANEOUS BALLOON AORTIC VALVULOPLASTY.
`Alain Cribier and Brice Letac
`
` ..........:ccccccseseneeeueeees
`
`TA.
`
`RETROGRADE NONTRANSSEPTAL MITRAL VALVULOPLASTY.
`Christodoulos Stefanadis and Pavlos Toutouzas
`
`.......:::cceeeree
`
`75.
`
`PERCUTANEOUS EXPANDABLE PROSTHETIC VALVES.
`Steven R. Bailey
`
`.....cc:csccscseeetesreeeennnees
`
`76.
`
`BALLOON VALVULOPLASTY AND STENTING FOR CONGENITAL HEART
`DISEASE.
`ascsscississioussata teas caterers enacnricr ain miciciceenna sc aeee Reese iseieaN OVER
`Robert H. Beekman and Thomas R. Lloyd
`
`77.
`
`TRANSCATHETER CLOSURE OF ATRIAL SEPTAL DEFECT AND PATENT
`DUCTUS ARTERIOSUS,
`oo.ccccccccceeeecccccec cece ee cece reer eee eee anne ee DE EEE EEE RE EERE EE UE EA OEE OH EE SEES
`Thomas R. Lloyd and Robert H. Beekman
`
`78.
`
`PERCUTANEOUS BALLOON PERICARDIOTOMY FOR PATIENTS WITH
`PERICARDIAL EFFUSION AND TAMPONADE.
`.......ccccceceeesscetteeetenneeserspineeetenns
`Andrew A. Ziskind and Igor F. Palacios
`
`IX Outcome Effectiveness of Interventional Cardiology
`
`79.
`
`MEDICAL ECONOMICS AND HEALTH POLICY ISSUES FOR
`INTERVENTIONAL CARDIOLOGY.
`oo...cccccccccccccccecseceeeeeeseecetseneesseneseeebeeseneeneeas
`Daniel B. Mark
`
`80.
`
`QUALITY OF CARE IN INTERVENTIONAL CARDIOLOGY.
`Eric J. Topol
`
`........ccceseereseeeeeeees
`
`1354
`
`81.
`
`TRAINING AND CREDENTIALING, .....-.c:esssereeesceterenseeeceeeseeeeeeseseeeeseenenneesanens
`Thomas J. Ryan
`
`82.
`
`MEDICOLEGAL ISSUES. wo.ccceccceccescnsseseeeeeeseerereeeeeeeeeeecaeeeeeeeseenenteneeeeseanennneeeeesenen
`M.Lee Cheney and Daniel B. Mark
`
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`

`tO
`Percutaneous Expandable
`Prosthetic Valves
`
`Steven R. Bailey
`
`The introduction of percutaneous techniques for vascular
`intervention has resulted in the rapid development of new
`devices and techniques for the treatmentof coronary and vas-
`cular diseases. One important area of potential interest is the
`application of percutaneous techniques for the treatment of
`valvular heart disease. The exponential growth of percuta-
`neous endovascular proceduresis similar to that experienced
`in cardiovascular surgery after the introduction of cardiopul-
`monary bypass. The design of implantable prosthetic heart
`valves to be delivered using a percutaneous approach has
`become an important area for investigation.
`Theinitial implantation of a prosthetic heart valve was per-
`formed in 1952 and published in 1953 by Hufnagel and Har-
`vey,’ with a follow-up report in 1954.? The Hufnagel valve is
`composed of a chamber with a central ball valve as seen in
`Figure 75-1. This bulky device was surgically placed in the
`descending aorta distal to the left subclavian artery. Patients
`did surprisingly well clinically despite the fact that only 75
`percent of the regurgitant volume was diminished using this
`valve in the descending aorta. Subcoronary placement of
`prosthetic valves became possible only after the introduction
`of cardiopulmonary bypass in 1960.’ The past three decades
`have seen significant improvements in the performance of
`mechanical, tissue, and homograft prosthetic valves, with nu-
`merousalterations occurring in the designs of these prosthe-
`ses.’ These changes have improvedthe functionalorifice area
`as well as decreased the complications associated with valve
`replacement such as thrombus formation, embolism, andlate
`valve dysfunction.
`Unfortunately, placement of prosthetic heart valves re-
`mains a relatively difficult and often dangerous procedure.
`The surgical risks rise rapidly in patients with serious prob-
`lems such as acute valvular regurgitation and in patients
`whose valvular disease is
`associated with myocardial
`ischemia.”
`The development of percutaneous catheter-based systems
`for stabilization and treatment of unstable patients with val-
`vular disease, which could be performed at a lower risk to
`the patient, is therefore an important area for research. De-
`veloping a chronically implanted catheter-based valve pros-
`thesis is an exciting new frontierin interventional cardiology.
`1268
`
`HISTORY OF CATHETER-BASED VALVES
`
`The demonstrated success of the Hufnagel valvein treating
`aortic insufficiency precipitated the initial
`investigation in
`1965 by Hywel Davies’of a catheter-mounted valve for tem-
`porary relief of aortic insufficiency. This device, although
`crude by today’s standards, was very interesting in design.
`As seen in Figure 75-2 this cone-shaped device was essen-
`tially an inverted parachute. The valve closed during systole
`due to the forward flow of blood out of the ventricle, and
`opened during diastole as the regurgitant flow returned to
`the ventricle. It was anchored onto a 5-Fr. catheter with thin
`guy wires. No information was provided regarding the type
`of material from which this valve was constructed.Initial an-
`imal experiments were promising, although no human inves-
`tigations were ever reported. Onesignificant problem dis-
`played by this valve was the rapid development of thrombi
`at the base of the cone, a theme commonto all prosthetic
`valves. This predisposition was probably enhanced by pro-
`longed stasis of blood in the base of the conical valve.
`Moulopoulos et
`al.* reported their
`investigations into
`catheter-mounted aortic valves in 1971. Utilizing the investi-
`gators’ experience in developing electrocardiographically
`(ECG) triggered intra-aortic balloon pumps,
`they designed
`and evaluated three separate systems (Fig. 75-3). One was a
`spherical balloon triggered by the ECG to inflate during di-
`astole. The second was a spherical balloon that was pressure
`responsive and deflated when systolic pressure exceeded a
`predetermined value. It inflated whenpressure fell below 4
`specified diastolic value, resulting in diastasis. Their third
`system was an umbrella-shaped balloon similar to that used
`by Davies et al, They concluded that the relatively simple
`umbrella system wasbest, significantly reducing the severity
`of
`acute
`aortic
`insufficiency without major
`acute
`complications.
`There were several disadvantages ofa catheter-based valve
`found by these investigators in the chronic animal model, I~
`cluding the developmentofsignificant thrombi in the base of
`the umbrella in all animals followed chronically. Most um
`portantly, variable decreases in coronary flow also occurre
`in these animals. The decreased coronary flow was attributed
`
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`
`i
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`

`75—PERCUTANEOUS EXPANDABLE PROSTHETIC VALVES
`
`1269
`
`to stabilize the valve.
`
`FIGURE 75-1, The Hufnagel valve, when
`assembled, consisted of a hollow plastic
`tube, the fixation rings on each end, and
`the polypropylene central ball.
`
`FIGURE 75-2. The Davis valve was an in-
`verted plastic cone anchored to the shaft
`of a 5-Fr, catheter. Note the guy wires used
`
`A
`
`A
`
`SYSTOLE
`
`DIASTOLE
`
`SYSTOLE
`
`DIASTOLE
`
`
`
`FIGURE 75-3. The top section demonstrates the valve motion during systole and diastole. The bottom left
`is a photographof the umbrella valve and the middle is the balloon valve. The bottom rightis a picture of
`the glass cast used to manufacture the umbrella valve.
`
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`

`

`1270
`
`VITI—VALVULOPLASTY, CONGENITAL AND PERICARDIAL HEART DISEASE
`
`to prevent inversion of the valve.
`
`
`FIGURE 75-4. A, The catheter with the bal-
`loon mounted atthe tip is shown.B, A close-
`up view of the balloon, Note the small strip
`of plastic that fixes the valve to the catheter
`
`FIGURE 75~5. This complicated valve
`consists of a 7-Fr. catheter with a distal
`balloon. The catheter has (a) a distal lu-
`men,(b) latex balloon, (c) side hole distal
`to the balloon,
`(d) side hole proximal to
`balloon,(e) the latex valve, (f) 8-Fr. sheath,
`(g) 7-Fr. catheter shaft, (h) a stopcock con-
`nected to distal lumen, and (i) a lumento
`inflate the balloon valve.
`
`:
`'
`
`|
`|
`t
`
`|}
`
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`

`

`75—PERCUTANEOUS EXPANDABLE PROSTHETIC VALVES
`
`1271
`
`eettes,
`
`TABLE 75-1. HIGH-RISK PATIENTS WHO MIGHT BENEFIT
`FROM PERCUTANEOUS VALVE PLACEMENT
`Mitral regurgitation due to
`Acute myocardial infarction
`Bacterial endocarditis
`Flail mitral leaflet
`Decompensated chronic mitral regurgitation
`Aortic regurgitation due to
`Bacterial endocarditis
`Decompensated chronic aortic regurgitation
`Tricuspid regurgitation due to
`Bacterial endocarditis
`Pulmonary hypertension
`Right ventricular dysfunction
`ee
`
`to the valve leaflets covering the coronary ostia during
`diastole.
`Phillips et al.’ reported a modification of the balloon-
`mounted valve conceptin 1976. Figure 75-4 displays the seg-
`mented polyurethane cusp mounted 1 cm from the distal end
`of the catheter that was used in their study. The distal end of
`the catheter contained side holes for monitoring pressure dur-
`ing the procedure. In their dog model they demonstrated a
`significant reduction in aortic diastolic pressure, pulse pres-
`sure, andleft ventricular end-diastolic pressure. Coronary ar-
`tery blood flow did notfall and in fact increased slightly with
`their balloon system.
`The most
`recent
`investigation of a balloon catheter—
`mounted valve was that of Matsubara etal. in 1992." They
`used the valve shown in Figure 75-5. This somewhat com-
`plicated valve system consists of an 8-Fr. catheter with a latex
`balloon mounted on the catheter. Using hemodynamic eval-
`uation without angiography they demonstrated significant
`decreases in pulse pressure and left ventricular end-diastolic
`pressure as wellas increasesinaortic diastolic pressure. After
`placement of the device, however, the experimental animals
`still had a significant tachycardia and a larger pulse pressure
`than at baseline, suggesting continued aortic regurgitation.
`Unfortunately, the severity of the persistent aortic regurgita-
`tion was notquantitated by the authors.
`Although catheter-based balloon valve technology mayof-
`fer some acute relief from valvular aortic regurgitation,it is
`nota technology that could feasibly be used over an extended
`period of time as an indwelling device,
`
`Ive
`stal
`lu-
`stal
`| to
`ath,
`‘on-
`ito
`
`BALLOON-EXPANDABLE VALVES
`
`The success of balloon-expandable endovascularstents has
`inspired some investigators to try to develop implantable,
`
`TABLE 75-2. LIMITATIONS OF CURRENT VALVE
`PROTHESES
`—_—eee
`Mechanical
`Reduction in valve orifice
`Hemolysis
`Pannus formation
`Thrombotic
`Systemic emboli
`Stroke
`Complications of anticoagulation
`Hemorrhagic stroke
`Gastrointestinal bleeding
`Infective endocarditis
`ee
`
`TABLE 75-3. DESIGN PROBLEMS OF PERCUTANEOUS
`VALVES
`Ln
`Delivery sheath
`Size of sheath
`Material required to avoid ferchon
`Stiffness of sheath
`Delivery system
`Self-expanding
`Balloon expandable
`Mechanical expansion
`Type of valve
`Bioprosthetic
`Mechanical
`Polymer
`ee
`
`a
`balloon-expandable valvular prostheses, Conceptually,
`“stent” should provide a rigid frame, allowing the valve
`struts sufficient strength to remainstable during systole while
`anchoring the valve to the surroundingtissue, Following this
`premise, one should beable to develop a delivery system and
`valve that can be delivered percutaneously from a large ar-
`tery or even trans-septally from the femoral vein, This
`method of delivery might answer the immediate needs of
`acutelyill patients or those patients at very high surgical risk
`from valvular regurgitation for valve placement(Table 75-1).
`
`DESIGN PROBLEMS OF
`PERCUTANEOUS VALVES
`
`Current mechanical and prosthetic valves suffer from a
`numberof problems (Table 75-2) including the predisposi-
`tion to thrombus formation and embolization, perivalvular
`leak,
`infection, difficulty sizing valve to annulus, valve de-
`generation, and pannusformation. The designerof any per-
`cutaneously placed valve will need to consider these issues
`duringits design and developmentin order to minimize these
`problems. A high probability exists that percutaneous valves
`will be used, at leastinitially, as a temporizing measure in
`patients whoare not acceptable candidates for surgical valve
`replacement. The long-term problemsof valve degeneration
`and calcification will therefore not be as importantin the sub-
`set of patients undergoing percutaneous valve insertion as a
`stabilizing procedure.
`The design of a new percutaneous valve is frought with a
`large number of problems as detailed in Table 75-3. The
`problems can be subdivided into three major categories: (1)
`the problem of a delivery sheath that will allow safe and ef-
`fective delivery of a bulky balloon and valve; (2) a balloon
`system thatis capableof precisely implanting the valve must
`be manufactured; and (3) modifications of current valves or
`developmentof new valvular prostheses must occur.
`
`TABLE 75-4. BALLOON-EXPANDABLE VALVE
`Advantages
`Percutaneous arteriotomy
`Large expansionratio of stent
`Approach to multiple valves with same system
`Ability to easily increase size of valve
`Disadvantages
`Closure of arteriotomy
`Technically demanding
`Possible dislodgment
`Myocardial ischemia
`———————
`
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`

`1272
`
`VITI—VALVULOPLASTY, CONGENITAL AND PERICARDIAL HEART DISEASE
`
`
`
`
`<A, The stent ring is constructed of stainless-steel
`FIGURE 75-6.
`wires folded in loops. B, A porcine valve was mounted inside the
`rings and attached by meansof suture. C, A view from above valve
`illustrating the intact valve with three cusps.
`
`a
`
`Percutaneous Delivery System
`
`Large lumen sheaths and catheters (up to 22-Fr.) are cur-
`rently used for vascular access for such procedures as cuta-
`neous perfusion devices. Such a large arterial puncture is a
`major concern with any delivery system, due to the potential
`for injury to the artery, bleeding, or pseudoaneurysm for-
`mation. New technologies are emerging for the local repair
`and sealing of large arteriotomies that should aid the percu-
`taneous placementof valves. In the past, up to 25 per cent of
`arteriotomies performed for balloon valvuloplasty or cuta-
`neous perfusion devices required direct surgical closure. This
`repair if necessary, however, could be performed underlocal
`anesthesia andis a relatively minor surgical procedure com-
`pared to valve replacement.
`Ideally, a successful percutaneous delivery system must be
`no larger than 20 Fr. (6.6 mm) in order to be used in a large
`numberof patients. In addition, a removable trochar with a
`soft distal tip will be necessary to successfully deliver this
`guide sheath to the valve with the smallest amountofarterial
`trauma. Once the delivery sheath is appropriately positioned,
`the trochar can be removed.
`A protective sleeve covering the balloon and valve will
`
`be required in order to minimize the friction between the
`balloon-valve and the guide catheter. This sleeve might also
`serve the purposes of constraining the valve and preventing
`slippage or embolization of the valve. Alternatively, the bal-
`loon catheteritself might have a sleeve coveringjust the stent
`to provide similar protection. After expansion of the valve
`the balloon could be retracted into the sheath to avoid arterial
`injury associated with removalof the balloon.
`
`TABLE 75-5. BALLOON DEPLOYABLE VALVE:
`THE OPTIMAL SYSTEM
`
`Requirements for valve
`Minimal vascular trauma
`Mustnot be dislodged
`During delivery
`During balloon withdrawal
`Valve must be matched to annulus
`Valve must remain competent
`Local tissue injury avoided
`Avoid myocardial ischemia
`Nosignificant thrombosis
`
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`

`75—PERCUTANEOUS EXPANDABLE PROSTHETIC VALVES
`
`1273
`
`FIGURE 75-7. A, The compressed valve and stent are shown from
`the top view. B, The stent and valve have been mounted on the
`delivery balloon. Note the plastic wedges oneither side of the stent
`to anchorit in place.
`
`aaaes8eee,
`
`
`
`
`DELIVERY BALLOON CHARACTERISTICS
`
`TABLE 75-6. VALVE CONSTRUCTION DESIGN
`
` REQUIREMENTS
`An important issue central to the success of percutaneous
`Orifice
`valve placementwill be the device or system used to implant
`Primary
`the valve. The valve could be self-expanding, expandable
`Central blood flow
`by some mechanical device as yet undefined, or balloon ex-
`Secondary
`pandable. In order to be practical, some form of a balloon-
`Area between primary orifice and occluder
`expandable system will probably be required in order for
`Tertiary
`Area between occluder andaortic wall
`such a system to be widely employed. A balloon-expandable
`Seating patterns
`system offers the advantages and disadvantages listed in
`Table 75-4. The advantages include the ability to use a rela-
`Peeping
`tively small arterial puncture or arteriotomy in the placement
`Valve types
`of an introducer sheath. Additionally, the use of a balloon
`Mechanical
`system will allow expansion of the device from a much
`Homograft
`smaller compressed state to the larger fully deployedstate.
`Xenograft
`Materials used
`This could result in an expansion ratio between three and ten
`Metals used.
`times the compressed diameter. Such an expansion ratio
`Stainless-steel
`might even allow percutaneous placementoflarge mitral and
`3
`:
`f
`:
`E
`Titanium
`tricuspid valves. Such expansion ratios need not require an
`Alloys
`expandable metal mesh, but might occur in the form of a
`Stellite 21
`single ring designed muchlike a hose clamp that opens; even
`Elgiloy
`self-expanding alloys might be utilized if correctly designed.
`Pyrollite
`Placement techniques must be devised to assuresite-specific
`Polymers
`localization and stabilization of such a device as well as an
`oe
`orientation that is coaxial to blood flow. In mostcases these
`ee
`Ive
`ld be placed for
`severe valvular regurgitation, as-
`arabian
`
`
`Polypropylene : valves wou placed for gurgi
`
`
`
`suring a large-volume, high-velocity jet at the site of intended
`
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`

`1274
`
`VHI-—VALVULOPLASTY, CONGENITAL AND PERICARDIAL HEART DISEASE
`
`iy
`
`
`
`
`10mm
`
`FIGURE 75-8. A, The expanded balloon with the stent still in
`place. The arrowsindicate the elastic blocks used to keep the valve
`in place. B, The fully expanded valve is seen from thetop.
`
`placement. Such a large blood volume may well require a
`secondary balloon or a novel stabilization methodin orderto
`assure exact valve placement. In addition, this delivery sys-
`tem will need to be capable of angiographic injections to de-
`termine exact location of the valve and to assure that coro-
`nary ostia are not compromised. Several options are possible
`for such a delivery catheter, including a short segmentof
`catheter distal to the valve prosthesis for sampling pressures
`and performing the angiographicinjections.
`In order to successfully deploy a percutaneous valve, the
`delivery system will need to meet several criteria (Table 75-
`5). The first will be that the valve is not displaced from the
`balloon during delivery. Second, the balloon must expand to
`a large enough diameter to securely anchor the valvein place,
`Third, retraction of the balloon must notdislodge the valve.
`Andfourth, the delivery balloon must not damage surround-
`ing tissue.
`The delivery balloon could be constructed of multiple bal-
`loons placed ona single catheter, although hourglass con-
`struction of the variety currently employed by the Inouebal-
`loon may be preferable. Multilobed balloons do allow a
`smaller diameter of the deflated balloon but are unstable in
`
`high-flow fields such as one would find in mitral or aortic
`regurgitation.
`The hourglass balloon might have twoinflation lumens—
`one for the distal balloon and a second for the proximal bal-
`loon and valve. This technique will allow the valve to be im-
`planted only after the distal balloon has first been anchored
`in place at the site of the valve annulus.This type of balloon
`would also result in less damage to surrounding tissue, since
`the largest diameter of such a balloon wouldbeatits center,
`where the valve wassituated. Additionally, this single bal-
`loon would beless likely to become entangled in the valve
`and dislodgeit. Finally, the hourglass shape is more adapt-
`able to lar