`Cardiac Catheterization,
`Angiography, and
`Intervention
`SIXTH EDITION
`
`DONALD S. BAIM
`WILLIAM GROSSMAN
`
`Page 1
`
`Medtronic Exhibit 1415
`
`
`
`-Ip
`
`Grossman
`
`Cardiac Catheterization
`
`Angiography
`
`and Intervention
`
`Sixth Edition
`
`Edited by
`
`Bairn M.D
`Donald
`Professor of Medicine
`Harvard Medical School
`Director Center for Innovative Minimally Invasive Therapy
`Brigham and Womens Hospital
`Boston Massachusetts
`
`William Grossman M.D
`Meyer Friedman Distingvished Professor of Medicine
`University of California San Francisco School of Medicine
`Chief Division of Cardiology
`University of California San Francisco Medical Center
`San Francisco California
`
`LIPPINCOTT WILLIAMS
`
`WILKINS
`
`Wolters Kiuwer Company
`
`Philadelphia
`BuenosAires
`
`Baltimore
`
`Hong Kong
`
`New York
`Sydney
`
`London
`
`Tokyo
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`Acquisitions Editor Ruth
`Weinberg
`Developmental Editor Leah Ann Kiehne Hayes
`Manufacturing Manager Cohn Warnock
`Cover Designer Christine Jenny
`Compositor Maryland Composition Inc
`Printer Courier Westford
`
`2000 by LIPPINCOTT WILLIAMS
`530 Walnut Street
`Philadelphia PA 19106 USA
`LWW.com
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`WILKINS
`
`by copyright No part of this book may be reproduced
`rights reserved This book is protected
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`any form or by any means including photocopying or utilized by any information storage and retrieval
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`in
`and reviews Materials appearing
`in this book prepared by individuals as part of their
`articles
`official duties as U.S government
`employees are not covered by the above mentioned
`copyright
`
`critical
`
`in
`
`Printed in the USA
`
`Library of Congress Cataloging-in-Publication
`
`Data
`
`references and index
`
`Grossmans cardiac catheterization angiography and intervention/
`Baim William Grossman.6 ed
`edited by Donald
`cm
`Includes bibliographical
`ISBN 683-30741-X
`Heart catheterization
`
`Angiography
`II Baim Donald
`angiography and intervention
`Cardiac catheterization angiography and intervention
`DNLM
`Heart Catheterization
`Angioardiography
`Heart Function Tests WG 141.5.C2.G878
`Balloon Dilatation
`RC683.5.C25
`C38 2000
`616.1 207572dc2l
`
`Title Cardiac catheterization
`III Grossman William 1940
`
`IV
`
`Angioplasty Laser
`2000
`
`00-027379
`
`Care has been taken to confirm the accuracy of the information presented
`and to describe generally
`accepted practices However
`the authors editors and publisher are not responsible for errors or omissions
`or for any consequences from application of the information in this book and make no warranty expressed
`to the currency completeness or accuracy of the contents of the publication
`or implied with respect
`particular situation remains
`Application of this information in
`the professional responsibility of the
`
`practitioner
`to ensure that drug selection and dosage
`The authors editors and publisher have exerted every effort
`set forth in this text are in accordance with current
`recommendations
`and practice at the time of publication
`in view of ongoing
`However
`flow of
`regulations and the constant
`changes in government
`research
`information relating to drug therapy and drug reactions the reader
`is urged to check the package insert
`and precautions This
`for each drug for any change in indications and dosage and for added warnings
`is particularly important when the recommended
`new or infrequently employed drug
`agent
`is
`Some drugs and medical
`in this publication have Food and Drug Administration
`devices presented
`FDA clearance for limited use in restricted research settings It
`is the responsibility of the health care
`provider to ascertain the FDA status of each drug or device planned for use in their clinical practice
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`10987654321
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`Page 3
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`Medtronic Exhibit 1415
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`Gi ossinans Cai diac Catheteriatioi Angiogi aphy and Intervention
`Grossman
`Sisth Edit ion edited by D.S Bairn and
`2000
`Lippincott Williams Wilkins Philadelphia
`
`Historical Perspective and Present Practice
`of Cardiac Catheterization
`
`William Grossman
`
`University of California San Francisco School of Medicine Division of Cardiology University of
`California San Francisco Medical Center San Francisco California 94143
`
`It
`
`to imagine what our concepts of
`is difficult
`heart disease might be like today if we had to
`them without
`the enormous reservoir
`construct
`of physiologic and anatomic knowledge derived
`from the past 60 years experience in the cardiac
`laboratory As Andre Cournand
`catheterization
`lecture of December 11
`remarked in his Nobel
`1956 the cardiac catheter was..
`the key in
`the lock
`By turning this key Cournand
`new era in the
`and his colleagues led us into
`understanding of normal and disordered cardiac
`function in humans
`According to Cournand
`cardiac catheteri
`zation was first performed and so named by
`Claude Bernard in 1844 The subject was
`
`horse and both the right and left ventricles were
`retrograde approach from the jugu
`entered by
`lar vein and carotid artery In an excellent review
`of the history of cardiac catheterization angiog
`raphy and interventional cardiology Mueller
`and Sanborn
`describe and cite references for
`experiments by Stephen Hales and others whose
`work antedates that of Claude Bernard and the
`interested reader is referred to their review for
`
`Although he may not have been the
`details
`to perform cardiac catheterization Claude
`first
`Bernards
`careful
`of
`scientific
`application
`method to the study of cardiac physiology using
`the cardiac catheter demonstrated the enormous
`innovation An era of in
`value of this technical
`vestigation of cardiovascular physiology in ani
`mals then followed resulting in the development
`and principles
`of many important
`
`techniques
`
`e.g pressure manometry the Fick cardiac out
`put method which awaited direct application to
`the patient with heart disease
`Werner Forssmann usually is credited with
`
`level
`
`to other concerns
`
`catheter
`into the
`being the first person to pass
`At age 25
`heart of
`living personhimself
`while receiving clinical
`instruction in surgery at
`Eberswalde near Berlin he passed
`catheter
`65 cm through one of his left antecubital veins
`guiding it by fluoroscopy until
`it entered his
`right atrium He then walked to the radiology
`department which was on
`different
`re
`quiring that he climb stairs where the catheter
`position was documented by
`chest roentgeno
`gram Fig 1.1 During the next
`years Forss
`mann continued to perform catheterization stud
`ies
`six additional
`to
`including
`attempts
`catheterize himself Bitter criticism based on an
`unsubstantiated belief in the danger of his exper
`iments caused Forssmann to turn his attention
`and he eventually
`pursued
`Nevertheless for his
`career as
`urologist
`contribution and foresight he shared the Nobel
`Prize in Medicine with Andre Cournand
`and
`Dickinson Richards in 1956
`Forssmanns primary goal
`tion studies was to develop
`nique for the direct delivery of drugs into the
`heart He wrote
`
`in his catheteriza
`tech
`
`therapeutic
`
`If cardiac action ceases suddenly as is seen
`in acute
`shock or in heart disease or during
`anesthesia or poisoning one is forced to deliver
`drugs locally In such cases the intracardiac
`in-
`
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`
`
`SECTION
`
`GENERAL PRINCiPLES
`
`FIG 1.1 The first documented cardiac catheterization At age 25 while receiving clinical
`instruction
`in surgery at Eberswalde Werner Forssmann passed
`catheter 65 cm through one of his left antecu
`its tip entered the right atrium He than walked to the radiology department where
`bital veins until
`des rechten Herzens K/in Wo
`this roentgenogram was taken Forssmann
`Die Sondierung
`
`chenschr 929 with permission of Springer-Verlag Berlin
`
`jection of drugs may be life saving However
`this may be
`dangerous procedure because of
`many incidents of laceration of coronary arter
`ies and their branches leading to cardiac tam
`and death .. Because of such inci
`ponade
`dents one often waits until
`the very
`last
`moment and valuable time is wasted Therefore
`new way to approach the
`started to look for
`heart and
`catheterized
`the right side of the
`heart through the yenous system
`
`diagnostic tool
`
`the potential of Forss
`Others appreciated
`manns technique as
`In 1930
`Klein reported 11 right-sided heart catheteriza
`tions including passage to the right ventricle and
`measurement of cardiac output using the Fick
`The cardiac outputs were 4.5 and
`
`principle
`
`heart catheterization
`
`for these
`
`5.6 L/min in two patients without heart disease
`In 1932 Padillo and coworkers
`reported right
`and measurement of car
`in two subjects
`diac output
`Except
`few studies application of cardiac catheteriza
`tion to study the circulation in normal and dis
`the work of
`ease states was fragmentary until
`Andre Cournand and Dickinson Richards who
`re
`separately and in collaboration produced
`markable series of investigations of right heart
`
`physiology in humans 79 In 1947 Dexter
`reported his studies on congenital heart disease
`10 He went
`further than his predecessors by
`to the distal pulmonary ar
`passing the catheter
`the oxygen
`and
`saturation
`
`tery observing
`
`Page 5
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`CHAPTER
`
`HISTORICAL PERSPECTIVE AND PRESENT PRACTICE
`
`source of pulmonary capillary blood obtained
`from the pulmonary artery wedge position
`10 Subsequent studies from Dexters labora
`tory 11 and by WerkO 12 elaborated on this
`pulmonary artery wedge position and pressure
`this position was reported to be
`measured at
`good estimate of pulmonary venous and left
`atrial pressure During this exciting early period
`catheterization was used to investigate problems
`physiology by McMichael
`in cardiovascular
`England 13 Lenègre in Paris 14 and Warren
`Stead Bing Dexter Cournand and others in the
`United States 15 23
`Further developments came rapidly and high
`lights include the following
`
`in
`
`first
`
`Retrograde left-sided heart catheterization was
`reported by Zimmerman 24 and by
`Liinon-Lason 25 in 1950
`technique developed by Sel
`The percutaneous
`dinger in 1953 was soon applied to cardiac
`nf both the left and right heart
`catheterization
`
`as
`
`chambers 26
`Transseptal catheterization was first developed
`in 1959 by Ross 27 and Cope 28 and
`standard tech
`quickly became accepted
`nique
`Selective coronary arteriography was reported
`re
`by Sones in 1959 and was perfected to
`markable excellence over
`the ensuing years
`2930 This technique was modified for
`and
`by Ricketts
`approach
`percutaneous
`Abrams 31 in 1962 and Judkins 32 in
`1967
`In 1970 Swan and Ganz introduced
`catheter
`
`flow-guided
`balloon-tipped
`nique that enabled the application of catheteri
`zation outside the laboratory 33
`
`tech
`
`practical
`
`INTERVENTIONAL CARDIOLOGY
`
`In the last 25 years investigators have focused
`once again on the therapeutic potential of
`the
`In 1977 Gruntzig introduced
`cardiac catheter
`the technique of percutaneous transluminal cor
`onary angioplasty PTCA 3435 In the ensu
`ing years catheter-based coronary revasculari
`zation has been applied widely With rapidly
`and expanding indications
`
`evolving technology
`
`PTCA and its offspring e.g stents atherec
`tomy first rivaled and have now surpassed coro
`nary bypass surgery as the dominant therapeutic
`modality for coronary artery disease The devel
`intervention
`opment of percutaneous
`coronary
`such as balloon val
`stimulated other innovations
`
`vuloplasty and devices
`to close intracardiac
`have made interven
`shunts which together
`new field in cardiovascular
`tional cardiology
`medicine The history of interventional cardiol
`ogy has been summarized by Spencer King in
`review 36 and the interested
`an excellent
`
`reader is referred there for further details In
`
`has returned to its
`sense cardiac catheterization
`as mentioned earlier Werner
`roots because
`Forssmanns original
`intention had been to use
`tool for therapy not diagnosis
`the catheter as
`At approximately the same time that Grtlntzig
`was developing
`balloon angioplasty in Zurich
`in Germany and Los Angeles were
`investigators
`administering the thrombolytic agent streptoki
`nase through catheters placed selectively
`in the
`coronary arteries of patients early in the acute
`infarction This
`phase of transmural myocardial
`new catheter-based therapy which was viewed
`the time produced angiographic
`as radical at
`findings that confirmed beyond any doubt
`the
`role of acute coronary thrombosis in the genesis
`infarction When investigators
`of myocardial
`found that similar therapeutic benefit could be
`achieved by intravenous administration of
`the
`the intracoronary direct-in
`thrombolytic agent
`fusion technique all but died out except
`indications However
`few special
`catheter-
`based therapy for acute coronary thrombosis has
`renaissance in the last 10 years with
`undergone
`the demonstration that PTCA/stenting in this set
`ting produces results that are comparable or su
`perior to those achieved with thrombolytic ther
`apy 3738
`is clear as we enter
`the 21st century that
`interventional cardiologyby virtue of its new
`drug therapies
`technologies potent adjunctive
`e.g blockers of the platelet Jib/lila receptor
`re
`and
`indications
`expanding
`improving
`sultshas blossomed In many ways interven
`than purely diagnostic
`tional cardiology rather
`has become the dominant discipline
`techniques
`within the broad field of cardiac catheterization
`
`for
`
`It
`
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`
`SECTION
`
`GENERAL PRINCIPLES
`
`Although the emphasis in the field and in this
`textbook is now appropriately on the dynamic
`field of catheter-based intervention
`the basic
`principles of catheter
`insertion hernodynamic
`measurement high-quality angiography and in
`tegration of catheterization
`findings with both
`the clinical scenario and the findings of noninva
`sive tests are not just historical curiosities they
`are the foundations
`on which all current
`inter
`techniques are bui1 and from which
`future evolution of cardiac catheterization will
`
`ventional
`
`proceed
`
`INDICATIONS FOR CARDIAC
`CATHETERIZATION
`
`is
`
`As performed today cardiac catheterization
`combined hemodynamic and angiographic
`procedure undertaken for diagnostic
`and often
`therapeutic purposes As with any invasive pro
`cedure the decision to perform cardiac catheteri
`zation must be based
`on
`careful balance of
`
`the anticipated
`
`the risk of the piocedure against
`summary of the indica
`benefit to the patient
`tions for cardiac catheterization is given in Table
`1.1 and discussed in the following paragraphs
`recom
`Cardiac
`catheterization
`usually is
`mended to confirm the presence of
`define its anatomic
`and
`suspected condition
`physiologic severity and determine the presence
`or absence of associated conditions when
`ther
`
`clinically
`
`apeutic intervention is planned in
`symptomatic
`patient The most common indication for cardiac
`today arises in the patient with
`catheterization
`an acute coronary ischernic syndrome in whom
`intervention PTCA
`an
`invasive
`therapeutic
`stent or coronary artery bypass graft surgery is
`contemplated The patient with an acute coro
`nary ischemic syndrome has most commonly ex
`rupture of an atherosclerotic
`perienced recent
`plaque within
`coronary artery Exposure of
`plaque contents to flowing blood leads to platelet
`and coronary thrombosis which in
`deposition
`the throrn
`turn leads to transmural ischernia if
`bus is completely obstructing or to unstable an
`it causes only partial or intermittent oc
`gina if
`clusion The goal of cardiac catheterization
`such patients is to identify the culprit artery and
`restore vessel patency by PTCA/stent
`
`place-
`
`in
`
`TABLE 1.1 Indications for cardiac
`catheterization
`
`Need to choose among therapeutic options
`Revascularization
`catheter-based
`or coronary
`artery bypass grafting versus continued medi
`therapyPerform coronary
`cal
`angiography
`and in selected patients left ventriculography
`in patients with
`Acute coronary syndrome
`Incapacitating or progressive angina
`Coronary artery disease with high-risk stress
`test
`
`Valve
`continued
`versus
`replacement/repair
`medical
`therapyAssess coronary anatomy
`and associated conditions e.g pulmonary hy
`pertension that may increase risk in patients
`with
`Aortic stenosis with angina syncope and/or
`heart
`failure
`
`Aortic mitral or tricuspid regurgitation with
`congestive heart
`failure or evi
`increasing
`dence of decreasing ventricular
`function
`Mitral pulmonic or tricuspid stenosis and
`progressive symptoms who are candidates
`for balloon valvuloplasty
`Anticoagulation
`thrombolytic
`therapy
`versus
`nonein patients with suspected acute pulmo
`nary embolism if
`lung scan is nondiagnostic or
`if there is acute congestive heart
`failure or hypo
`tension
`Repair of congenital heart or vascular defect
`Assess anatomy and physiology in preparation
`therapy e.g atrial
`for catheter-based
`septal
`plug balloon valvuloplasty or whenever uncer
`tainties remain despite thorough nonhuman re
`search
`II Obscure or confusing clinical picture even when
`there is no immediate therapeutic question
`in patients with chest
`Coronary
`angiography
`pain of uncertain origin
`biopsy in patients with idio
`Endomyocardial
`pathic cardiomyopathy
`Ill Research studiesCardiac catheterization
`for pure
`research purposes e.g follow up coronary angi
`to assess
`regression of atherosclerosis
`ography
`therapy or collateral develop
`after
`lipid-lowering
`ment after treatment with growth factor should be
`done only if the patient has given informed consent
`and there is
`that has been approved by
`protocol
`the institutions Committee on Human Research
`
`ment The diagnostic part of the catheterization
`procedure may reveal other features e.g mul
`tivessel or left main coronary artery disease se
`vere associated valvular disease that provide
`information for the decision to proceed
`with open-heart surgery
`Is cardiac catheterization
`
`necessary in all pa
`tients being considered for cardiac surgery Al-
`
`critical
`
`Page 7
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`
`CHAPTER
`
`HISTORICAL PERSPECTIVE AND PRESENT PRACTICE
`
`car
`
`the course
`
`care
`
`though few would disagree that consideration
`of heart surgery is an adequate reason for the
`performance of catheterization clinicians differ
`about whether all patients being considered for
`heart surgery should undergo preoperative
`diac catheterization In this regard it should be
`the risks of catheterization
`emphasized that
`are
`small compared with those of embarking upon
`for whom an incor
`cardiac surgery in
`patient
`rect clinical diagnosis or the presence of an un
`suspected additional condition greatly prolongs
`and complicates
`the planned surgical approach
`The operating room is not
`good place for sur
`prises by providing the surgical
`team with
`precise and complete road map of
`ahead cardiac catheterization
`can permit
`fully reasoned and maximally efficient operative
`procedure Furthermore information obtained
`by cardiac catheterization may be invaluable in
`the assessment of crucial determinants of prog
`nosis such as left ventricular function status of
`the pulmonary vasculature and patency of
`the
`coronary arteries For these reasons my col
`recommend cardiac catheterization
`leagues and
`for almost all patients for whom heart surgery
`is contemplated
`be
`Other major
`considerations
`therapeutic
`sides heart surgery may depend on the informa
`and an
`tion afforded by cardiac catheterization
`For example
`decision
`intervention with heparin and/or
`pharmacologic
`thrombolytic agent in suspected acute pulmo
`nary embolism or with high doses of
`blocker and/or calcium antagonists in suspected
`hypertrophic subaortic stenosis might well be
`to warrant
`considered of sufficient magnitude
`confirmation of the diagnoses by angiographic
`and hemodynamic investigation before the initi
`ation of therapy
`clinical diagnosis of primary
`pulmonary hypertension made by echocardio
`graphy usually requires cardiac catheterization
`and
`to confirm the diagnosis
`
`giography
`
`the
`
`for
`
`to assess
`
`to
`
`potential
`
`responsiveness
`pharmacologic
`agents such as epoprostenol 39
`second broad indication for performing car
`is diagnosis of obscure or
`diac catheterization
`confusing problems in heart disease even when
`imminent
`major therapeutic decision is not
`common instance of this indication iS prescnted
`
`by the patient with chest pain of uncertain cause
`about whom there is confusion
`regarding the
`presence of obstructive coronary artery disease
`Both management and prognosis of this difficult
`is known
`problem are greatly simplified when it
`for example
`that
`the
`coronary
`arteries are
`widely patent Another example within this cate
`gory might be the symptomatic patient with
`of cardiomyopathy Al
`suspected diagnosis
`though some may feel satisfied with
`clinical
`diagnosis of this condition the implications of
`such
`diagnosis in terms of prognosis and ther
`apy e.g long-term bed rest chronic anticoagu
`lant therapy are so important
`that
`believe it
`worthwhile to be aggressive in ruling out poten
`conditions e.g hemochro
`correctable
`tially
`matosis pericardial effusive-constrictive dis
`ease with certainty even though the likelihood
`their presence may appear to be remote on
`of
`clinical grounds
`
`is
`
`Research
`
`On occasion
`cardiac catheterization
`is per
`research procedure Al
`formed primarily as
`though research is conducted to some degree in
`many of the diagnostic and therapeutic
`studies
`performed at major medical centers this is quite
`from catheterization
`for the sole pur
`different
`research investigation Such studies
`pose of
`should be cairied out only under the direct super
`vision of an experienced investigator who is an
`proto
`in cardiac catheterization using
`expert
`that has been carefully scrutinized and ap
`col
`proved by the Committee on Human Research
`thor
`at the investigators institution and after
`ough explanation has been made to the patient
`detailing the risks of the procedure and the fact
`that the purpose of the investigation is to gather
`research information
`
`Contraindications
`
`If it
`
`contraindications
`
`is important to carefully consider the indi
`in each pa
`cations for cardiac catheterization
`is equally important to discover any con
`tient it
`traindications Over
`the years the concept of
`has been modified by the fact
`that patients with acute iriyocardial
`
`infarction
`
`Page 8
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`
`SECTION
`
`GENERAL PRINCIPLES
`
`TABLE 1.2 Relative contraindications
`and angiography
`cardiac catheterization
`
`to
`
`Uncontrolled ventricular
`
`irritability
`
`the risk of ventric
`
`ular tachycardia/fibrillation
`during catheterization
`increased if ventricular
`is uncontrolled
`Uncorrected hypokalemia or digitalis toxicity
`Uncorrected hypertension predisposes to myocar
`ischemia and/or heart
`failure during angiog
`dial
`
`irritability
`
`is
`
`raphy
`Intercurrent
`
`febrile illness
`Decompensated
`heart failure especially acute pul
`monary edema unless catheterization
`can be done
`with the patient sitting up
`state prothrombin time longer
`Anticoagulated
`18 seconds
`Severe allergy to radiographic contrast agent
`insufficiency and/or anuria unless di
`Sevpre renal
`alysis is planned to remove fluid and radiographic
`contrast
`load
`
`than
`
`cardiogenic shock intractable ventricular tachy
`cardia and other extreme conditions have toler
`and coronary angiography
`ated catheterization
`surprisingly well At present
`the only absolute
`contraindication to cardiac catheterization
`
`is the
`to con
`
`refusal of mentally competent patient
`
`sent to the procedure
`long list of relative contraindications must
`in mind however and these include all
`be kept
`intercurrent conditions that can be corrected and
`whose correction would improve the safeti of
`the procedure Table 1.2 lists these relative con
`traindications For example ventricular irritabil
`ity can increase the risk and difficulty of
`left
`and can greatly interfere
`see
`with interpretation of ventriculography
`Chapter 12 if possible ventricular
`irritability
`should be suppressed medically before or during
`catheterization Hypertension increases predis
`position to ischemia and/or pulmonary edema
`and should be controlled before and during cath
`that should be con
`eterization Other conditions
`trolled before elective catheterization include in
`
`heart catheterization
`
`left-
`
`tercurrent
`
`febrile illness decompensated
`sided heart failure correctable anemia digitalis
`toxicity and hypokalemia Allergy to
`radio
`relative contraindica
`graphic contrast agent is
`tion to cardiac angiography but proper premedi
`cation can substantially reduce the risks of
`major adverse reaction as discussed in Chapter
`
`as
`
`therapy is more controversial
`Anticoagulant
`contraindication As pointed out in Chapters
`and 11 heparin may lower the incidence of
`thromboembolic complications during coronary
`angiography 40 It
`is important to distinguish
`with oral anticoagulants e.g
`anticoagulation
`warfarin from that with heparin Heparin anti-
`coagulation can be reversed rapidly during cath
`eterization if necessary e.g in the case of perfo
`of
`ration
`the
`heart
`or
`vessels
`or
`great
`uncontrolled bleeding from femoral or brachial
`sites Reversal of
`the prolonged prothrombin
`before or during car
`time of oral anticoagulation
`represents more complex
`diac catheterization
`problem strongly oppose acute reversal of oral
`be
`vitamin
`with parenteral
`anticoagulation
`cause of the occasional
`induction of hypercoa
`gulable state which has been known to result
`in thrombosis of prosthetic
`valves or thrombus
`formation within cardiac chambers arteries or
`is re
`veins If
`reversal of oral anticoagulation
`quired we favor administration of fresh-frozen
`plasiria For patients chronically ariticoagulated
`with an oral agent we routinely recommend dis
`48 hours
`continuation of the oral anticoagulants
`catheterization with heparin
`before
`cardiac
`given during these 48 hours for patients who
`have
`strong indication for continuous anticoag
`ulation e.g mechanical
`valve pros
`cardiac
`prefer to have the international normal
`thesis
`ized ratio INR less than 2.0 or the prothrombin
`timeless than 18 seconds and no heparin admin
`hours before the catheterization
`istration for
`therapy cannot be interrupted at
`If anticoagulant
`all we prefer heparin for the reasons just men
`tioned
`
`FACTORS INFLUENCING CHOICE OF
`APPROACH
`
`Of the various approaches to cardiac catheter
`ization certain ones have only historical
`interest
`
`transtho
`approach
`transbronchial
`posterior
`racic left atrial puncture and suprasternal punc
`the left atrium In this book only the
`ture of
`catheteriza
`following are discussed in detail
`approach from various
`tion by percutaneous
`including femoral
`radial arteries
`sites
`transseptal catheterization and apical
`
`left yen
`
`or
`
`Page 9
`
`Medtronic Exhibit 1415
`
`
`
`CHAPTER
`
`HISTORICAL PERSPECTIVE AND PRESENT PRACTICE
`
`by di
`tricular puncture and
`catheterization
`rect surgical exposure of the brachial artery and
`vein
`The great vessels and all cardiac chambers
`can be entered in almost all cases by either the
`direct exposure or percutaneous approaches or
`combination of both Each method has its ad
`vantages and disadvantages
`its adherents and
`detractors In reality the methods are not mu
`tually exclusive but rather complementary ide
`ally the physician performing cardiac catheteri
`zation should be well versed in both methods
`
`Advantages of the Percutaneous Femoral
`Approach
`
`The percutaneous femoral approach is clearly
`the dominant
`technique in cardiac catheteriza
`broad set of advantages
`tion today presenting
`and indications The femoral approach does not
`require arteriotomy and arterial repair and can
`be performed repeatedly in the same patient
`intervals whereas the brachial arteriotomy ap
`proach can rarely be repeated safely more than
`two or three times infection and thrombophlebi
`
`at
`
`tis at
`
`the catheterization
`
`site are rare surgical
`suture closure of the skin is not necessary and
`variety of
`the approach is readily adaptable to
`other entry vessels e.g internal
`jugular vein
`axillary artery radial artery Larger-caliber de
`vices i.e valvuloplasty balloons or intraaortic
`catheters can be introduced
`counterpulsation
`into the femoral artery but not usually into the
`smaller brachial artery The femoral approach is
`clearly the method of choice in
`patient with
`absent or diminished radial and brachial pulsa
`tions or when the direct brachial approach has
`In the occasional patient with
`been unsuccessful
`tight aortic stenosis in whom retrograde cathe
`terization has proved impossible percutaneous
`transseptal catheterization of the left atrium and
`in the rare instance in which
`ventricle is helpful
`retrograde arterial and transseptal
`tion have not succeeded
`
`catheteriza
`
`in gaining entry into
`the left ventricle or are contraindicated
`by the
`presence of disc mitral and/or aortic prostheses
`thrombus percutaneous
`transtho
`or left atrial
`racic puncture of the left ventricle may be con
`sidered see Chapter
`
`Advantages of the Percutaneous Radial
`Approach
`
`In recent years percutaneous technique using
`
`transradial
`
`the radial brachial or ulnar arteries as entry sites
`4146 has been applied to retrograde left heart
`catheterization coronary angiography PTCA
`and even stent placement This approach is be
`coming increasingly popular and has been dem
`onstrated to have advantages of cost and patient
`study by Mann and colleagues 41
`comfort
`reported on the use of percutaneous
`in patients
`catheterization
`for stent placement
`total of 144
`with acute coronary syndromes
`syndromes were
`patients with acute
`coronary
`femoral or
`radial
`randomly assigned to either
`approach Stenting from the radial approach al
`lowed earlier hospital discharge and was associ
`ated with decreased hospital charges and fewer
`complications Not all patients as
`bleeding
`signed to the radial approach strategy were able
`to have radial artery catheterization Six of the
`negative Allen test or Doppler examina
`74 had
`tion or both suggesting an incomplete palmar
`arch so that radial catheterization was thought
`to be contraindicated accordingly they were in
`cluded in the femoral approach group In three
`additional patients the radial artery was not suc
`and these patients
`cessfully cannulated
`also
`crossed over to the femoral approach group
`
`Advantages of the Brachial Approach
`
`Much less common today the direct exposure
`approach usually utilizes cutdown on the bra
`chial artery and basilic vein at
`the elbow see
`In general
`the percutaneous radial
`Chapter
`the advantages of the direct bra
`approach has all
`chial approach and few of
`its disadvatitages
`Nevertheless the brachial cutdown approach is
`few centers and is worthy of some
`still used by
`comment The brachial approach may have ad
`patient with severe peripheral vas
`vantages in
`cular disease involving the abdominal aorta
`iliac or femoral arteries suspected femoral vein
`or inferior vena caval
`thrombosis or coarctation
`of the aorta The brachial or radial approach may
`also have advantages in the very obese patient
`in whom the percutaneous
`femoral
`technique
`
`Page 10
`
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`
`
`
`10
`
`SECTION
`
`GENERAL PRINCIPLES
`
`may be technically difficult and where hard to
`control breathing occurs after catheter removal
`cited for the di
`Another advantage occasionally
`rect brachial approach is use of
`catheter Sones catheter
`for left ventriculogra
`phy and coronary angiography
`
`single left heart
`
`reflects individual patient differences With re
`
`to keep in
`is important
`gard to angiography it
`mind Suttons law when asked why he robbed
`banks Willie Sutton is reported to have replied
`Because thats where the money is and order
`injections in relation to the most
`
`the contrast
`
`important diagnostic
`
`considerations
`
`in
`
`given
`
`DESIGN OF THE CATHETERIZATION
`PROTOCOL
`
`patient
`
`Every cardiac catheterization
`
`should have
`
`protocol
`
`carefully reasoned sequential plan
`
`designed specifically for the individual patient
`Although this protocol may exist only in the
`iiind of the operator it
`is often helpful to prepare
`written protocol and post it
`in the catheteriza
`in the laboratory
`tion suite so that all personnel
`is planned and can an
`understand exactly what
`ticipate the needs of the operator
`Certain general principles should be consid
`protocol First hemody
`ered in the design of
`namic measurements
`should
`precede angio
`studies whenever
`that
`possible
`graphic
`so
`crucial pressure and flow measurements may be
`made as close as possible to the basal state
`separate arterial monitor line which may be just
`the sidearm of the arterial sheath can be helpful
`when complications develop and they do no
`matter how skilled the operator
`this second
`transducer allows continuous monitoring of arte
`rial pressure Second pressures and selected oxy
`gen saturation values should be measured and
`recorded in each chamber on the way in that
`is immediately after the catheter enters and be
`is directed toward the next chamber
`fore it
`problems should develop during the later stages
`of
`catheterization
`fibrillation
`procedure atrial
`or other arrhythmia pyrogen reaction hypoten
`sion or reaction to contrast material the inves
`tigator will be glad to have measured pressures
`than waiting
`this way rather
`and saturations
`the time of catheter pullback Third mea
`surements of pressure and cardiac output should
`be made as simultaneously as possible
`simple
`routine for recording pressure during the cardiac
`output measurement can be l