`
`Grossman & Baim’s
`Cardiac Catheterization,
`Angiography,
`and Intervention
`
`EIGHTH EDITION
`
`EDITOR
`
`MAURO MOSCUCCI, MD, MBA
`Professor of Medicine
`
`Chairman, Department of Medicine (Acting)
`Chief, Cardiovascular Division
`University of Miami Miller School of Medicine
`Miami. Florida
`
`o.Wolters Kluwer Lippincott Williams & Wilkins
`Health
`Philadelphia - Baltimore - New York - London
`Buenos Alres . Hong Kong - Sydney - Tokyo
`
`
`Page 1
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`Acquisitions Editor: Julie Goolsby
`Product Manager: Leanne Vandetty
`Production Project Manager; David Orzcchnwshi
`Senior Mottttfnctu ring Manager: Beth Welsh
`Design Coordinator-flash Wendt
`Production Servicc lntcgra Software Services Pvt. Ltd
`
`E! 2014- hy TJPPINCOTI‘ W'lLLlAMS tS‘t' WILKINS. a WOLTERS KLUW'ER business
`Two Commerce Square
`2001 Market Street
`Philadelphia. PA 19103 USA
`LWWcom
`
`71h edition in 2006 by LlPPlNCOTT WILLIAMS 6: W'lLKlNS
`6th edition © 2000 by LIPPINCOTT W'lLLlAMS 5i: WiLKlNS
`51h edition © 1996 by WILLIAMS 6: WILKJNS
`
`All rights reserved. This book is protected by copyright, No part of this book may bt: reproduced in any form by
`any means. including photocopying. or utilized by any information storage and retrieval system without written
`permission from the copyright owner. except for brief quotations embodied in critical articles and reviews. Matcriais
`appearing in this book prepared by individuals as part of their official duties as 1.1.5. governmenl employees are not
`covered by the above-mentioned copyright
`Printed in China
`
`
`Library of Congress Cataloging-in-Puhlication Daltt
`Cardiac. catheterizaiion. angiography. and intervention.
`Grossman 5r Batm‘is cardiac catheterizatlon. ongiography. and interventiOn I editor. Mauro Moscucci. MD, MBA.
`professor of medicine. chairman. Department of Medicine. University of Miami Miller School of Medicine. Miami,
`Florida. -—- Eighth edition.
`P8585 cm
`includes bibliographical references and index.
`iSBN grad—451147409 (hardback)
`I. Moscttcci. Mauro. editor of compilation. 11. Title. ill. Title: Grossroan
`1. Cardiac catheterization. 2. Angingraphy.
`and Baim's cardiac catheterization. angiog-raphy. and intervention
`RC633.5.C25C38 2013
`616.1'20754—«dc23
`2013025399
`
`Care has been taken to confirm the accuracy of the information presented and to dficflhe generally accepted
`Pramices- HOWEVET. the authors. editor-9. and publisher are not responsible for errors or omissions or for any conse‘
`quences from application of the information in this hook and make no wan-attty. expressed or implied. with respect
`to the currency, completeness, or accuracy of the contents of the publication. Application of the information in a
`particular situation remains the professional responsibility of the practitioner.
`The authors. editors. and publisher have exerted every effort to ensure that drugsclection and dosage set forth in
`this text are in accordance with current recommendations and practice at the time ofpublicatian, However, in view of
`ongoing research. changes in government regulations. and the constant flow ofirtformaiion relating to drug therapy
`and drug reactions, the reader is urged to checlt the package insert for each drug for any change in indications and
`dosage and for added warnings and precautions, This is particularly important when the recommended agent is a
`new or infrequently employed drug.
`Some drugs rind medical devices presented in the publication have Food and Drug Administration (FDA) clear-
`ance [or 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.
`To purchase additional copies of this book. call our customer service department at (800) 638-3030 or fax orders
`to (301) 223-2320. international customers should call (301) 123-2300.
`Visit Lippincott Williams :5: Wilkins on the internet at: LWWcom. Lippincott Williams is: Wilkins customer
`service representatives are available from 8:30 rim to E1200 pm, EST,
`
`10987654
`
`HRS1903
`
`
`Page 2
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`Contributors
`
`vii
`
`Preface to the Eighth Edition
`
`xi
`
`Preface to the Website to the Eighth Edition
`Acknowledgments xv
`
`xiii
`
`SECTION I GENERAL PRINCIPLES
`
`1
`
`1. Cardiac Catheterization History and Current Practice Standards
`Mauro Moscucci
`
`1
`
`2. Cineangiographic Imaging, Radiation Safety, and Contrast Agents
`Stephen Balter and Mauro Moscucci
`
`17
`
`-
`
`3.
`
`Integrated Imaging Modalities in the Cardiac Catheterization Laboratory 44
`RobertA. Quaife and John D. Carroll
`
`4. Complications
`Mauro Moscucci
`
`77
`
`5. Adjunctivs Pharmacology for Cardiac Catheterization
`Kevin Croce and Daniel l. Simon
`
`106
`
`Bless A. Carabsilo and William Grossman
`
`SECTION III HEMODYNAIVIIC PRINCIPLES
`10. Pressure Measurement
`223
`Mauro Moscucci and William Grossman
`11. Blood Flow Measurement: Cardiac Output and Vascular Resistance
`Mauro Moscuccr' and William Grossman
`12. Shunt Detection and Quantification 261
`William Grossman and Mauro Moscucci
`13. Calculation of Stenotic Valve Orifice Area
`
`SECTION II BASIC TECHNIQUES
`
`139
`
`i
`
`6. Percutaneous Approach, includingTransseptal and Apical Puncture
`Claudia A. Martinez and Mauro Moscucci
`
`139‘
`
`170
`7. Radial Artery Approach
`Mauricio G. Cohen and Sunil M Rec
`8. CUtdOWn Approach: Brachial, Femoral, Axillary, Aortic andTransapical
`Ronald P. Caputo, G. Randall Green, and William GrosSman
`9. Diagnostic Catheterization in Childhood and Adult Congenital Heart Disease
`Gabriele Egidy Aessnza, James E. Lock, and Michael J. Landzberg
`
`191
`
`208
`
`223
`
`245
`
`272
`
`xvii
`
`
`Page 3
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`14. Pitfalls in the Evaluation of Hemodynamic Data
`Zoitan G. Turf
`
`284
`
`SECTION IV ANGIOGRAPHIC TECHNIQUES 295
`
`15. CoronaryAngiography 295
`Mauro Moscucci
`
`335
`16. Coronary Artery Anomalies
`Paolo Angelini and Jorge Monge
`
`17. CardiacVentriculography 354
`Mauro Moscucci and Robert C. Handel
`
`18. Pulmonary Angiography 370
`Kyung Cho and Nils Kucher
`
`399
`19. Angiography of the Aorta and Peripheral Arteries
`Michael H. Jaff, John Hundback, and Kenneth Hosenfield
`
`SECTION V EVALUATION OF CARDIAC FUNCTION 431
`
`20. StressTesting During Cardiac Catheterization: Exercise, Pacing,
`and Dobutamine Challenge
`431
`William Grossman and Mauro Moseucci
`
`21. Measurement ofVentricularVolurnes, Ejection Fraction,
`Mass,Wall Stress, and RegionalWall Motion 456
`MichaelA. Fifer and William Grossman
`
`22. Evaluation of Systolic and Diastolic Function of theVentricles
`and Myocardium 467
`William Grossman and Mauro Moscuccl
`
`23. Evaluation ofTamponade, Constrictiva, and Restrictive Physiology 489
`Mauro Moscucci and Barri/A. Borlaug
`
`SECTION VI SPECIAL CATHETER TECHNIQUES 505
`
`24. Evaluation of Myocardial and Coronary Blood Flow
`and Metabolism 505
`Morton J. Kern and Michael J. Lim
`
`25.
`
`545
`Intravascular Imaging Techniques
`Yasuhiro Honda, Peter J. Fitzgerald, and Paul G. Yock
`
`576
`26. Endomyocardial Biopsy
`Sandra lr: Chaparral and Mauro Moscucci
`27. Percutaneous Circulatory Support: Intra-aortic Balloon Counterpulsation.
`lmpella,TandemHeart, and Extracorporeal Bypass
`601
`Daniel Burkhoff, Mauro Moscucci, and Jose FIS‘ Henriques
`
`SECTION VII
`
`INTERVENTIONAL TECHNIQUES 627
`
`2B. Percutaneous Balloon Angioplasty and General Coronary Intervention 627
`Abhirarn Prasad and David H. Holmes
`
`29. Atherectomy,Thrombectomy, and Distal Protection Devices
`Robert N. Plans and Jeffrey J. Popma
`
`665
`
`
`
`
`Page 4
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`30.
`
`intervention forAcute Myocardial Infarction
`William O’Neill
`
`697
`
`31. Coronary Stenting 710
`Ajay J. Kirtane and Gregg W. Stone
`32. General Overview of Interventions for Structural Heart Disease
`Mauro Moscucci, John D. Carroll, and John G. Webb
`
`760
`
`33. PercutaneousTherapies forVaIvular Heart Disease 772
`Ted Feldman and Mauro Moscucci
`
`805
`34. Peripheral Intervention
`Mahdi H. Shishahbor and Samir Fl. Kapadia
`
`35.
`
`Intervention for Pediatric and Adult Congenital Heart Disease
`Robert J. Sommer
`
`838
`
`36. Cardiac Cell-BasedTherapy: Methods of Application
`and Delivery Systems
`871
`Joshua M. Hare, Arnon Slum, and Alan W. Haidman
`
`37. Aortic Endovascular Grafting 891
`Arash Bornak, Gilbert Fl. Upchurch, and Omaida C. Velazquez
`38. Pericardial Interventions: Pericardiocentesis, Balloon Pericardiotomy,
`and Epicardial Approach to Cardiac Procedures
`904
`Mauro Mosouoci and Juan E Wes-Gonzalez
`
`3B.
`
`921
`Interventions for Cardiac Arrhythmias
`Haris M. Haqqani and Francis E. Marchlinski
`
`
`SECTION VIII CLINICAL PROFILES
`40. Profiles in Valvular Heart Disease 943
`Ted Feldman, William Grossman, and Mauro Moscueci
`
`943
`
`41. Profiles in Coronary Artery Disease
`Robert N. Plans and Aaron Kugelmass
`
`970
`
`42. Profiles in Pulmonary Hypertension and Pulmonary Embolism 991
`Scott H. Visovatti and Vallerie V1 Mclaughlina
`
`43. Profiles in Cardiomyopathy and Heart Failure
`James C. Fang and Barry A. Borlaug
`44. Profiles in Pericardial Disease
`1045
`
`1011
`
`John E Robb, Finger J. Laham, and Mauro Moscucci
`
`1060
`45. Profiles in Congenital Heart Disease
`Gabriele EgidyAssenza, Robert J. Somme-r, and Michael J. Landzberg
`46. Profiles in Peripheral Arterial Disease
`1078
`Christopher J. White and Stephen Fl. Flamee
`
`Index
`
`1113
`
`
`Page 5
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`Radial Artery Approach
`
`MAURICIO G. COHEN and SUNIL V. RAO
`
`INTRODUCTION
`
`in 1989, Lucien Campeau published his successful series of
`100 coronary angiographies performed via the left radial artery
`with minimal occurrence of complications.‘ Subsequently in
`1993, Kiemeneij performed percutaneous coronary interven~
`tioris (PCI) using 6F guiding catheters in a time when most
`interventional procedures were performed with larger BF
`catheters.‘ Since then, transradial access ('l'RA) has continued
`to gain popularity in some regions of Europe, Canada, South
`America, Japan, and other sites outside of the United States
`where TRA is used in more than 60% of the cases.3 The most
`compelling reason for adopting TRA is the increased patient
`safety that results from the virtual elimination of access
`site bleeding and vascular complications. In addition, TRA
`is associated with early sheath removal,
`improved patient
`comfort. faster recovery, and lower costs in comparison with
`transfemoral access.” However, a relatively steep learning
`curve,
`increased radiation exposure, incompatibility of the
`radial artery with sheaths larger than 6F required for large
`rotablator burrs and complex bifurcation stenting, and higher
`access failure rates have been cited as reasons for not system—
`atically adopting ”IRA.” An early analysis of the American
`College of Cardiology National Cardiovascular Data Reg-
`istry (ACC/NCDR) of procedures performed between 2004
`and 2007 demonstrated a minimal use of TRA in the United
`States, with almost 90% of centers performing less than 2% of
`cases using the radial artery approach.” However, interven-
`tional cardiologists have been more open to change and TRA
`has gained renewed momentum in the United States with the
`recognition of access site bleeding as a predictor of adverse
`outcomes post-PCI,” wider access to training opportuni—
`ties, and the inception of dedicated micropuncture needles.
`hydrophilic-coated sheaths, and radial hentostasis devices.
`A more recent analysis including 1,776,625 patients treated
`at more than 1,200 U.S. hospitals demonstrated a significant
`uptake in TRA use from 1.3% in 2007 to 12.7% in 2011.”
`
`The ACCIAHA/SCAI guidelines now include "IRA as a class
`[IA recommendation with a level of evidence A to decrease
`
`acoess site complications." A class IlA recommendation for
`TRA is also included in the most recent European guidelines
`for the management of acute ST segment elevation myocar-
`dial infarction in the setting of primary PC], if performed by
`an experienced radial operator.”
`
`ANATOMICAL CONSIDERATIONS
`
`The radial artery arises together with the ulnar artery from
`the bifurcation of the brachial artery just below the bend
`of the elbow, The radial artery passes along the lateral side
`of the forearm from the neck of the radius to the forepart ol
`the styloid process in the wrist and is smaller in caliber that
`the ulnar artery. it then winds backward, around the latcra.
`side of the carpus. The distal portion of the artery in the fore-
`arm is superficial, being covered by the integument and [lit
`superficial and deep fascia, lying between the tendons of tht
`brachioradialis and flexor carpi radialis over the prominenct
`of the radius. With an average diameter ol'2.8 mm in femalet
`and 3.1 mm in males, the radial artery is compatible with of
`sheaths. The artery is accompanied by a pair of vertae comii
`tantes throughout its whole course, which can be used to per
`form right heart catheterization (RiiC).”‘“’
`Several anatomic characteristics explain the marker
`safety advantage of the radial artery over the femoral arter}
`approach. The flat, bony prominence of the radius provide:
`ease of compression and hemostasis after sheath removal; thl
`vast collateralization of the radial artery through the palms
`arch prevents ischemia of the hand; because the puncture sin
`is not overlying a joint, motion of the hand or the wrist doe
`not increase the risk of bleeding; and because of the absenCI
`of major adjacent nerve structures1 there is no rislt of neuro
`logic sequclae.2° in contrast,
`the ulnar artery is deep lying
`mobile, adjacent to the ulnar nerve, and consequently no
`
`. 113'.
`
`“
`
`
`Page 6
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`"I VT
`
`ideal for first—line vascular access. Despite this, ulnar access
`has been used successfully for coronary procedures, without
`evidence of an increased rate of complications when com—
`pared with TEA.“ The ulnar artery should not be used after
`a failed ipsilateral radial attempt because of a possible small
`risk of complete obstruction ofcirculation to the hand.
`The interventional cardiologist should be aware of rela-
`tively uncommon anatomic anomalies that may impede the
`advrtncement of catheters to the aorta or increase the risk of
`failure or complications. Variations include tortuous radial
`configurations, stenoses. hypoplasia, radioulnar loops, aber-
`rant right subclavian artery (arteria iusoria), and abnormal
`origin of the radial artery.2m in a series of 1,540 transradial
`procedures, anatomic anomalies were found in about 15% of
`cases. A high radial artery origin at the level of the mid or
`upper humerus was found in 7% of cases and was associated
`with a failure rate of4.o%, a loop in the proximal radial artery
`was found in 13% of ca5es and associated with a high failure
`rate of 37.1%, severe iortuosity was found in 2 “lo, and other
`miscellaneous anomalies in 2.5% of cases. These anomalies
`are usually unilateral, therefore vascular access crossover to
`the left radial artery may be indicated in cases of extreme tor-
`tuosity or angulatcd radial loops.” Significant subclavian or
`brachiocephalic tortuosity is present in about l0% of cases
`and is usually asaociated with advanced age, short stature,
`and long-standing history of hypertension, However, subcla—
`vian tortuosity is rarely a cause of procedural failure because
`it can be easily negotiated by the use of deep inspiration or
`supportive guidewires.” in rare cases (<]%), the right sub—
`tlavian artery arises directly from the distal segment. of the
`posterior aspect of the aortic aich and has a retroesophageal
`course toward the right upper extremity. This anomaly is
`known as arteria lusoria and represents a formidable chal-
`lenge for advancing a catheter from the subclavian artery to
`the ascending aorta. This anomaly is mostly asymptomatic
`but can be associated with dysphagia.22
`
`Preprocedure Assessment—Testing
`for Dual Circulation to the Hand
`9"“ Patifints undergoing IRA procedures in the catheteriza-
`“on laboratory should be assessed and undergo preparation
`according to a standardized protocol. Depending on the oper-
`ator's Preference, the groins can be prepped along with the
`“1515' WHETHER! of intravenous lines in the vicinity of the
`“”151 should be avoided. Sedation is strongly recommended
`‘0' decrease catecholamine release that can potentially con—
`‘nbme to radial spasm.
`There is significant variability in the vascular anatomy
`of t
`he hand. The superficial palmar arch that connects the
`“In
`of cat and radial arteries is complete in approximately 80%
`uses and the predominant blood supply to the hand is
`
`thought to be from the ulnar artery in the majority oi'cases.“
`In 1929, Edgar Van Nuys Allen introduced a “compression
`test” to diagnose arterial occlusion resulting from thrombo-
`artgiitis obliterans or Buerger disease. The test consists of
`simultaneously compressing the ulnar and the radial arter—
`ies at the level ofthe wrist for approximately 1 o): 2 minutes,
`the patient closes the hand tightly to squeeze as much blood
`out as possible, then quickly opens the hand and extends the
`fingers; then the operator releases compression of the ulnar
`artery and waits for the hand to regain color. In individuals
`with integrity of the hand circulation and a patent palmar
`arch, the pallor of the hand is quickly replaced by blushing
`of higher intensity than normal in about 5 to 9 seconds.
`Because the Allen‘s test is largely subjective and yields more
`than 30% of falsely abnormal results, Barbeau and coworlo
`are modified the test by attaching a pulse oximeter to the
`thumb to record oxygen saturation and plethysmography,
`in a study including 1,010 patients, Bar-beau and colleagues
`described four reading patterns: no damping of the pulse
`waveform immediately after 2 minutes of radial compares:
`sion, positive oximetry (Type A, frequency 15%); damping
`of the pulse waveform and positive oximctry, followed by
`complete recovery within 2 minutes of compression, (Type
`B, frequency 75%); loss of pulse waveform, negative oxim-
`city, with partial progressive recovery of the pulse wave-
`form and oximetry within 2 minutes of compression (Type
`C, frequency 5%); loss of pulse waveform, negative oxim-
`etry, without recovery of either pulse waveform or oxim—
`etry after 2 minutes of compression (Type D, frequency 5%)
`(Figure 7.1). After analyzing these patterns in the right and
`left wrists of the study participants, only 1.5% showed a
`bilateral Type D pattern and these patients did not undergo
`TRA procedures.
`In summary,
`this study suggésts that
`almost all patients are eligible for TRA procedures without
`risk ofischemic complications to the hand.“ Some operators
`have challenged the utility of testing the collateral circula-
`tion of the radial artery, stating that the presence of a rich
`collateral system and the presence ofinterosseous branches
`that supply circulation to the hand could possibly allow to
`tolerate concomitant radial and ulnar artery occlusion.” In
`addition, there is no evidence indicating that the modified
`Allen’s test predicts hand ischemia after TRA procedures,
`However, as part of the catheterization laboratory routine
`in most sites, a modified Allen‘s test using pulse oximetry
`and plethysmography is usually performed and the results
`documented.
`
`Patient Positioning—Right versus
`Left Radial Access
`TRA can be performed through the left or the right radial
`artery Due to ergonomic considerations, most operators pre—
`fer using right TRA, Regardless of the side of choice, a com-
`fortable position for the patient and the operator is crucial
`for successfully performing IRA procedures. The patient is
`
`
`Page 7
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`172
`
`
`
` RadialCompression
`
`
`
`— Testing for dual circulation to the hand.The Barbeau Grading System for assessment of collateral circu-
`lation of the painter arch.The presence of an arterial waveform on plethysmography (even if delayed
`or with reduced amplitude) and an oxygen saturation above 90% (Grades A, B, and Cl confirm the
`presence of dual circulation to the hand.
`
`positioned supine on the angiographic table. With right-sided
`Tim, an arm hoard extension is attached to the right hand
`side of the table. linportantly, there should be a platform that
`extends from the distal portion of the patiean hand to the
`table controls so that equipment can be placed in this area.
`Arm boards are commercially available in different shapes
`and designs. Many laboratories have opted for
`trapezoid-
`shaped acrylic glass board, with the narrow end tucked under
`the. mattress at the shoulder level and the. broad area at the
`wrist level (Figure 7.2). The patient's right arm is placed
`on the board and abducted at a 30° angle. The right wrist is
`placed in a hyperextended position using commercially avail—
`able splints or a rolled towel behind the wrist with the fingers
`taped to the arm board. A pulse oximeter probe can be placed
`in the right thumb for continuous monitoring of the circula-
`tion to the hand throughout the procedure (Figure. 7.3). Both
`groins may be prepped as well, depending on the anticipated
`need for femoral access.
`
`For left 'l'RA, the setup is completely different and varies
`widely across catheterization laboratories. As with right TRA,
`the operator stands on the right side of the patient for left
`TRA to avoid disruption of the traditional laboratory setup.
`
`The patient is positioned supine on the table and a custom
`arm rest, made of foam or pillow material, is attached to the
`left side of the table to elevate and prenate the left arm and
`guide the forearm toward the midsection of the patient's body
`and place the wrist over the leg where it can strapped to a
`splint (Figure 7.2).
`It has been shown that the prevalence of subclavian
`ortuosity and radial
`loops is three times higher in the
`right upper extremity.27 With right TRA the catheter has
`0 pass through the right subclavian artery and the bra-
`Cl‘tiocephalic trunk before reaching the aortic root. These
`wo areas of bifurcation can increase technical difficulty,
`especially when these vessels are atherosclerotic, tortuous,
`and calcified. Since the left subclavian artery arises directly
`rom the aorta, the path followed by the catheter in the left
`radial route into the ascending aorta is more straightfor—
`ward. often resulting in less complex catheter manipula-
`ion.
`in addition, left TRA should be strongly considered
`in patients who have undergone coronary artery bypass
`grafting (CABG), because it provides direct access to the
`eft internal mammary artery (LIMA). Certainly, the LIMA
`can also be cannulated from the right radial route, but this
`
`
`
`
`
`
`Page 8
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`173
`
`
`
`
` Positioning of the arm for right or left radial access. A.The right arm is placed on the board abducted
`at a 30° angle. B.The left arm rest on a large pillow placed on a regular arm board that guides the fore—
`arm towards the midsection of the patient’s body, placing the left wrist on top ofthe left groin.
`
`is significantly more challenging from a technical stand—
`point with a potential risk of embolic stroke clue to catheter
`manipulation and exchanges in the aortic arch. Random—
`'lzed data comparing right versus left radial access sug-
`gested that using left TRA during the learning curve may
`be advantageous as it allows novice operators to acquire the
`skills and confidence required for transradial procedures
`more quickly than the right radial route. in the TALENT
`trial (Transradial Approach {Left versus. Right] and Pro—
`cedural Times during Percutaneous Coronary Procedures)
`1,500 patients were randomized to right or left TRA. The
`study found that among trainees, left TRA was associated
`with a significantly shorter learning curve, with progres—
`sive reductions in cannulation and fluoroscopy times as the
`operator volume increased, compared to right TRAN-29
`
`Radial Puncture
`
`There are anumber ofTRA kits available in the market. in gen—
`eral. these kits include a micropuncture needle, :5. short 0.018
`to 0.021 inch wire, and an arterial sheath with or without
`hydrophilic coating ofshorter (10 to 13 cm) or longer (23 cm)
`length. Some operators advocate the use of longer sheaths to
`avoid difficulties with catheter manipulation should spasm
`occur, but a randomized trial comparing sheath lengths on
`arterial spasm showed no effect of longer sheaths on reducing
`spasm.JD On the other hand, hydrophilic coating allows easier
`sheath removal and is clearly associated with less spasm and
`patient discomfort.“ However. in the past decade. Kozak and
`colleagues reported sterile abscesses in the wrist alter the use
`of a particular transradial sheath brand. These abscesses were
`
`
`
`
`[99!“ Positioning of the hand fortransradial access. A.The hand is hyperextended with use of a rolled towel
`behind the wrist and tape holding the fingers, B. or with use of a dedicated positioning splint.
`
`
`Page 9
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`— Transradiai access technique {Step 1). After sterile preparation and draping. the wrist area is locally
`anesthetized with Iidocaine using a 256 needle and a small 3 co syringe.
`
`later found to be a foreign-body reaction to the hydrophilic
`coating of the sheaths.31 Conservative management ruling out
`the presence of infection, local wound care with drainage in
`case of abscess formation, and reassurance are recommended
`for the management of this complication. Sterile abscesses are
`rarely found in contemporary practice as the hydrophilic coat-
`ing causing the problem has been modified, although a recent
`isolated case of sterile abscess has been reported with new
`sheaths.“ A recent study randomized 790 patients undergo—
`ing TRA P61 in a 2X2 factorial design to shorter (13 cm) or
`longer (23 cm) sheaths with or without hydrophilic coating.
`Hydrophilic-coated sheaths were associated with a significant
`reduction in radial spasm (19.0% versus 39.9%, P C 0.001)
`and patient discomfort (15.1% versus 28.5%, OR 2.27, P 4:
`0.001), whereas sheath length did not have any effect in the
`occurrence of spasm or patient discomfort.” In addition,
`the operator may consider using smaller diameter sheaths as
`5F sheaths are associated with lower incidence of. radial artery
`
`occlusion (RAD) than 6F sheaths.” Therefore in current prac—
`tice, shorter 5F hydrophilic—coated sheaths are preferred.
`It is important to administer sedation to avoid the release
`of catecholamines associated with the emotional stress and
`
`fear that patients usually experience before the procedure,
`which can contribute to radial artery spasm. The. site of access
`is approximately 2 cm proximal to the radial styloid process,
`not at the wrist. The radial artery is most superficial in this
`area. Once the patient is prepped in sterile fashion, this area
`is anesthetized with approximately 2 to 3 cc of 1% lidocaine
`injected with a small syringe and a 256 needle (Figure 7.4).
`Usually, the arterial puncture is performed with either a short
`2.5 cm, stainless steel, ZlG needle or a micropuncture 1V cath-
`eter that consists of a fine metal needle and a 226 Teflon cath-
`
`eter that allow the passage of a 0.013 to 0.021 inch guidewire.
`While feeling the pulse with one hand, the operator advances
`the needle into the radial artery at a 30° angle with the other
`hand (Figure 7.5). Most operators prefer one of two different
`
`
`
`m Transradial access technique—front wall technique (Step 2).With the front wall technique. a short 2.5 cm
`215 stainless—still needle is used to puncture the radial artery.
`
`
`
`
`Page 10
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`rm“ Transradial access technique-front wail technique (Step 3i.The needle is advanced into the radial
`attery.The blood return indicates the intraluminal needle position.The blood return is rarely pulsatile
`or brisk.
`
`access techniques (single-wall versus double-wall or back—wall
`technique). With the single-wall technique, a stainless steel
`needle is advanced through the front wall of the artery into
`the lumen; once blood is noticed in the needle hub the wire
`can be advanced (Figure 7.6). Using this technique, the blood
`return is rarely brisk or pulsatile and sometimes the wire does
`not advance freely because the bevel may be directing the wire
`toward the vessel well. if this happens, the operator should
`never force the wire because of the risk of arterial dissection,
`The needle should be carefully rotated clockwise or counter-
`clockwise until the wire can be easily advanced without resis-
`tance (Figure 7,7) With the dual-wall or back—wall technique,
`a tnicropuneture catheter is advanced through the front wall
`into the lumen of the artery until blood is noticed in the hub
`and then intentionally pushed through the back wall of the
`
`artery (Figure 7.8). The fine needle is removed and the small
`Teflon microcatheter is slowly withdrawn until the appearance
`of brisk pulsat'tle flow (Figures 7.9 and 7.10). Then, the wire
`can be freely advanced and the microcatheter exchanged for the
`arterial sheath (Figure 7.11). The orifice in the back wall of the
`radial artery is sealed once the sheath is in place (Figure 7.12).
`This technique has not been reported to be associated with a
`higher incidence of wrist hematomas. Proponents of the back:
`wall technique argue that this method is simpler, more repro—
`ducible, easier to teach, allows easier advancement of the wire,
`and that the arterial pulsatile blood return is easier to recognize.
`After several unsuccessful puncture attempts, there are
`instances in which the radial pulse disappears due to spasm.
`in this situation, the operator should reassess the sedation
`status of the patient. consider administering 200 to 400 mcg
`
`
`
`m Transradial access technique—front wall technique (Step 4). A 0.018 inch short guidewira is advanced
`without resistance through the needle into the proximal radial artery/Then the needle is exchanged for
`a hydrophilicmoated sheath.
`
`
`Page 11
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`fig: "'
`
`
`
`_ Transradial access technique—backwall technique (Step 2).The microcatheter and needle are advanced
`in a 30° angle through the skin into the radial artery. The presence of blood in the hub of the needle
`indicates that the artery has been punctured.The needle is advanced forward through the back wall
`of the radial artery.
`
`of subcutaneous nitroglycerin at the site of the lost radial
`pulse. and wait patiently for 5 to 10 minutes until the pulse
`reappears before attempting a new puncture.”
`Even though TRA procedures can be successfully com-
`pleted in more than 95% of cases, inability to puncture the
`radial artery has been one of the most frequent mechanisms
`associated with TRA failure.” Therefore a consistent and
`meticulous radial artery puncture technique could not be
`emphasized more. A steep learning curve for TRA proce-
`dures has been well described. Spauldirtg et al., documented
`an initial access failure rate greater than 10% that decreased
`dramatically to about 1% after the first 80 cases. in addition,
`the time required for access and sheath insertion decreased
`from 10.2 t 7.6 to 2.8 I 2.5 minutes and the procedure time
`also decreased from 25.7 i 12.9 to 17.4 i 4.7 minutes after
`the first 80 cases.’ More recently, in a group of 28 operators,
`Ball and colleagues documented a stepwise reduction of This
`PCl failure rates from 7% to 1% (P = 0.01), contrast volume
`use from 180 I 79 to 168 i 79 mL (P = 0.05), and fluo-
`roscopy times from 15 i 10 to 12 i 9 minutes (P = 0.02)
`
`with increasing procedural volumes. The odds of TRA proce—
`dural failure showed a steep decline up to 50 cases, and after
`100 Cases the learning curve flattened. Figure 7.13 shows that
`reasons for failure are different according to operator volume.
`It is clear that with experience, the operator can overcome
`most hurdles and the major reasons for failure remain radial
`artery spasm and extreme vascular tortuosity.9
`
`Prevention of Radial Artery Spasm
`The radial artery has a high propensity to develop spasm due
`to its smaller caliber, large muscular media. and higher recep-
`tor—mediated vasomotion in comparison with similar arter—
`ies."5 Radial artery spasm is perhaps the most common IRA
`complication and a frequent reason for failure and crossover
`to transfemoral access?“ In the catheterization laboratory,
`spasm should be routinely prevented using a hydrophiliCa
`coated sheath with the injection of a single vasodilator or a
`cocktail of vasodilators through the sidearm of the sheath
`immediately after obtaining access
`(Figure 7.14). Most
`
`
`Page 12
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`IPR2020-00135
`
`
`
`
`
`E“ Transradial access technique—back-wall teehnique (Step 3). Once the tip of microcatheter and needle
`are through the back wall of the radial artery, th