throbber

`
`Grossman & Baim’s
`Cardiac Catheterization,
`Angiography,
`and Intervention
`
`EIGHTH EDITION
`
`EDITOR
`
`MAURO MOSCUCCI, MD, MBA
`Professor of Medicine
`
`Chairman, Department of Medicine (Acting)
`Chief, Cardiovaecular Division
`
`University of Miami Miller School of Medicine
`Miami. Florida
`
`a. Wolters Kluwer Lippincott Williams & Wilkins
`Health
`Philadelphia - Baltimore - New York - London
`Buenos Aires - Hong Kong - Sydney ‘ Tokyo
`
`
`Page 1
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`Acquisitions Editor: julie Gooish)r
`Product Manager: Leanne Vanderty
`Production Project Manager: David Ot'zechowslti
`Senior Manufacturing Manager: Beth Welsh
`Design Coordinatorrjoan Wendt
`Production Service: inlegra Software Services Pvt. Ltd
`
`E! 2014 by LIPPINCOTI' W'ILLIAMS iS‘t' WiLKiNS. a WOLTERS KLUW'ER business
`Two Commerce Square
`2001 Market Street
`Philadelphia. PA 19103 USA
`LWWcom
`
`Tih edition [0 2006 by LiPPINCOTT WILLIAMS 5! WTLiilNS
`filh edition © 2000 by LiPPINCOTT WILLIAMS iSt: WILKINE
`5th editltm © 1996 by WILLIAMS 5! WlLiflNS
`
`All rights reserved. This book is protected by copyright. No part of this book may be 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 brieiquotations embodied in critical articles and reviews. Materials
`appearing in this book prepared by individuals as part of their official duties as us. government employees are not
`covered by the above-mentioned copyright.
`Printed in China
`
`Library of Congress Cataloging-in-Publicatiun Data
`Cardiac eatheterization. angiography, and intervention
`Gross-man Sr Bairnls cardiac catheterization. angiography. and intervention] editor. Mauro Moscueet. MD, MBA,
`omit-55m of medicine. chairman. Department of Medicine. University of Miami Miller School of Medicine. Miami.
`Florida. -—- Elghth edition.
`P53” cm
`includes bibliographical references. and index.
`iSEN 973—1-451142740—9 (hardback)
`
`i. Moscucci. Mauro. editor or compilation. it. Title. ili. Title: Grossrnan
`1. Cardiac catheteriza lion. 2‘ Angtography.
`and Eaim's cardiac catheterization. angiography. and intervention.
`RCEB35iC25C3Ei 2013
`616.]‘20734—dc23
`
`2013025399
`—-—————_.—_______—__________
`
`Care has been taken to confirm the accuracy of the information presented and to dacrihe generally accepted
`practices. However. the authors. editors. and publisher an: not responsible for errors or omissions or for any eonsea
`quences from application oi the information in this hook and make no warranty. expressed or implied. with respect
`to the currency. completeness, or accuracy of the contents of the publication Application or 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 drugsciection and dosage set forth in
`this text are in accordance with current recommendations and practice at the time oipublication, However. in view of
`ongoing research. changes in government regulations. and the constant flow of information relating to drug therapy
`and drug TCECUDHS. Iht I‘tadfir is Uffieii to Check the package insert [or each tirug for any change in indications and
`dosage and for added warnings and pretautions, This is particularly important when the recommended agent is a
`new or infrequently employed drug.
`Some drugs and medical devices presented in the publication have Food and Drug Administration (FDA) clear-
`ance [or lintited 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 (300) 638-3030 or fax orders
`to (301) 223-2320. international customers should call (301.) 123-2300.
`Visit Lippiitcott Williams t5: Wilkins on the Internet at: LWWicom. Lippiocott Williams o": Wilkins customer
`service representatives are available from 8:30 am to 6:00 pm. EST.
`
`1098765~1
`
`HRS15I13
`
`
`Page 2
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`
`
`Contributors
`
`vii
`
`Preface to the Eighth Edition
`
`xi
`
`Preface to the Website to the Eighth Edition
`Acknowledgments xv
`
`xiii
`
`1. Cardiac Catheterization History and Current Practice Standards
`Mauro Moscucci
`
`1
`
`1
`
`2. Cineangiographic imaging, Radiation Safety, and Contrast Agents
`Stephen Halter and li/lauro Moscucci
`Integrated Imaging Modalities in the Cardiac Catheterization Laboratory 44
`Robert/fl. Ouaife and John D. Carroll
`
`17
`
`3.
`
` SECTION I GENERAL PRINCIPLES
`
`SECTION III HEMODYNAMIC PRINCIPLES
`10. Pressure Measurement 223
`Mauro Moscucci and William Grossman
`11. Blood Flow Measurement: Cardiac Output and Vascular Resistance
`Mauro Moscuccl and William Grossman
`12. Shunt Detection and Quantification 261
`William Grossman and Mauro Moscucci
`13. Calculation of Stenotic Valve Orifice Area
`BlaseA. Carabello and William Grossman
`
`4. Complications
`Mauro Moscucci
`
`77
`
`5. Adjunctive Pharmacology for Cardiac Catheterization
`Kevin Croce and Daniel l. Simon
`
`106
`
`SECTION II BASIC TECHNIQUES
`
`139
`
`.
`
`B. Percutaneous Approach, includingTransseptal and Apical Puncture
`Claudia A. Martinez and Mauro Moscucci
`
`139‘
`
`170
`7. Radial Artery Approach
`Mauricio G. Cohen and Sunll M Rao
`8. CutdOWn Approach: Brachial, Femoral, Axillary, Aortic andTransapical
`Ronald F.’ Caputo, G. Randall Green, and William Grossman
`9. Diagnostic Catheterization in Childhood and Adult Congenital Heart Disease 208
`Gabriele EgidyAssanza, James E. Lock, and Michael J. Landzbarg
`
`191
`
`223
`
`245
`
`272
`
`xvii
`
`
`Page 3
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`
`
`14. Pitfalls in the Evaluation of Hemodynamic Data
`Zoltan G. Turf
`
`234
`
`SECTION IV ANGIOGRAPHIC TECHNIQUES 295
`
`15. CoronaryAngiography 295
`Mauro Moscucci
`
`335
`16. Coronary Artery Anomalies
`Paolo Angelini and Jorge Mange
`
`17. CardiacVentriculography 354
`Mauro Moscuccl and Robert C. Handel
`
`18. Pulmonary Angiography 370
`Kyung Cho and Nils Kucher
`
`399
`19. Angiography of the Aorta and Peripheral Arteries
`Michael H. Jafl} John Rundbaclr, and Kenneth Rosenfielcl
`
`SECTION V EVALUATION OF CARDIAC FUNCTION 431
`
`20. StressTesting During Cardiac Catheterization: Exercise, Pacing,
`and Dobutamine Challenge
`431
`William Grossman and Mauro Moscucci
`
`21. Measurement ofVentricularVolurnes, Ejection Fraction,
`Mass,Wall Stress, and RegionalWail Motion 456
`MichaalA. Fifar and William Grossman
`
`22. Evaluation of Systolic and Diastolic Function of the Ventricles
`and Myocardium 467
`William Grossman and Mauro Moscucci
`
`23. Evaluation ofTamponade, Constrictive, and Restrictive Physiology 489
`Mauro Moscucci and Barry 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
`lntravascular ImagingTechniques
`Yasuhiro Honda, Peter J. Fitzgerald, and Paul G. Yook
`
`576
`26. Endomvocardial BiOpsy
`Sandra Ir! Chaparro and Mauro Moscucci
`
`27. Percutaneous Circulatory Support: Intra-aortic Balloon Counterpulsation,
`impella,TandemHeart, and Extracorporeal Bypass
`601
`Daniel Burkhoff, Mauro Moscucci, and Jose RS. Henriques
`
`SECTION VII
`
`INTERVENTIONAL TECHNIQUES 627
`
`28. Percutaneous Balloon Angioplasty and General Coronary Intervention 627
`Abhiram Prasad and David R. Holmes
`
`29. Atherectomy,Thrombectomy, and Distal Protection Devices
`Hobart N. Flame and Jeffrey J. Popma
`
`665
`
`
`Page 4
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`
`
`xix
`
`so.
`
`Intervention forAcute Myocardial Infarction
`William O'Neill
`
`697
`
`31. Coronary Stenting 710
`Ajay J. Kirfane 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. Shishehbor and Sarnir Fl. Kapadia
`
`35.
`
`Intervention for Pediatric and Adult Congenital Heart Disease
`Robert J. Sommer
`
`839
`
`36. Cardiac Cell-BasedTherapy: Methods of Application
`and Delivery Systems
`871
`Joshua M. Hare, Arnon Bium, and Alan W. Heldman
`
`31. 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 [files-Gonzalez
`
`39.
`
`921
`Interventions for Cardiac Arrhythmias
`Haris M. Ha qqani and Francis E. Marohiinski
`
`
`SECTION VIII CLINICAL PROFILES
`
`943
`
`40. Profiles in Valvular Heart Disease
`
`943
`
`Ted Feidman, William Grossman, and Mauro Moscucci
`
`41. Profiles in Coronary Artery Disease
`Robert N. Piana and Aaron Kugelmass
`
`970
`
`42. Profiles in Pulmonary Hypertension and Pulmonary Embolism 991
`Scott H. Visovatti and Valierie V. Mciaughiina
`
`43. Profiles in Cardiomyopathy and Heart Failure
`James C. Fang and BarryA. Boriaug
`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. Summer, and Michael J. Landzberg
`
`1078
`46. Profiles in Peripheral Alterial Disease
`Christopher J. White and Stephen H. Flames
`
`Index
`
`1113
`
`
`Page 5
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`
`
`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.1 Subsequently in
`1993, Kiemeneij performed percutaneous coronary interven—
`tiotts (PCI) using 6F guiding catheters in a time when most
`interventional procedures were performed with larger EIF
`catheters.z 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 ”IRA 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
`transfernoral access"6 However, a relatively steep learning
`curve, increased radiation exposure, incompatibility of the
`radial artery with sheaths larger than 6F required for large
`rorablator 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 (ACCINCDR) of procedures performed between 2004
`and 2007 demonstrated a minimal use of Tim 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.
`hydrophilicvcoatcd sheaths, and radial hemostasis devices.
`A more recent analysis including 1.776.625 patients treated
`at more than 1,200 U.5. hospitals demonstrated a significant
`uptake in IRA use from 1.3% in 2007 to 12.7% in 2011_“
`
`The ACCIAHA/SCAI guidelines now include TRA as a class
`[IA recommendation with a level of evidence A to decrease;
`
`access site complications." A class llA 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.“5
`
`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 lateral
`side of the carpus. The distal portion of the artery in the fore-
`arm is superficial. being covered by the integument and tht
`superficial and deep fascia, lying between the tendons of tht
`brachioradialis and flexor carpi radialis over the prominencr
`of the radius. With an average diameter of 2.8 mm in female.I
`and 3,1 mm in males, the radial artery is compatible with 61"
`sheaths. The artery is accompanied by a pair of venae comi-
`tantcs throughout its whole course, which can be used to per-
`form right heart catheterization (RHC).”"°
`Several anatomic characteristics explain the marltct
`safety advantage of the radial artery over the femoral artcr';
`approach. The flat, bony prominence of the radius provide:
`ease of compression and hemostasis after sheath removal; tl‘tl
`vast collateralization of the radial artery through the palma
`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 absenct
`of major adjacent nerve structures. there is no rislt of neuro
`logic sequelae,20 in contrast, the ulnar artery is deep lying
`mobile, adjacent to the ulnar nerve, and consequently no
`
`. 17m.
`
`
`Page 6
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`* "WT
`
`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 TRA.21 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 interventions] cardiologist should be aware of rela—
`tively uncommon anatomic anomalies that. may impede the
`advancement of catheters to the aorta or increase the rislt of
`failure or complications. Variations include tortuous radial
`configurations, stenoses, hypoplasia. radioulnar loops, aber-
`rant right subclavian artery Carter-ta lusoria), and abnormal
`origin of the radial artery.“-” 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 of 4.6%, a loop in the proximal radial artery
`was found in- 2.3% of cases and associated with a high failure
`rate of37.l%, severe iortuosity was found in 2 %, 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 angulated radial loops.” Significant subclavian or
`brachlocephalic toriuosiiy is present in about 10% of cases
`and is usually associated with advanced age, short stature,
`and longstanding 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 ((1%), the right sub—
`clavian artery arises directly from the distal segment. of the
`posterior aspect of the aortic arch 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
`""11 Patients undergoing TRA procedures in the catheteriza-
`11011 laboratory should be assessed and undergo preparation
`according to a standardized protocol. Depending on the oper-
`ator's Preference, the gtoins can be prepped along with the
`W515. Placement of intravenous lines in the vicinity of the
`Wrist should be avoided. Sedation is strongly recommended
`to. decrease catecholamine release that can potentially con—
`mbutfl to radial spasm.
`There is significant variability in the vascular anatomy
`:{nlhe hand. The superficial paimar arch that connects the
`of c“ and radial arteries is complete in approximately 80%
`fists and the predominant blood supply to the band 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—
`angiitis obliterans or Energer disease. The test consists of
`simultaneously compressing the ulnar and the radial arter—
`ies at the level ofthe wrist for approximately 1 or 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 cowork-
`ers modified the test by attaching a pulse oximeter to the
`thumb to record oxygen saturation and plethysmography.
`in a study including 1,010 patients, Barbeau and colleagues
`described faur reading patterns: no damping of the pulse
`waveform immediately after 2 minutes of radial compres-
`sion, positive ortimetry (Type A, frequency 15%); damping
`of the pulse waveform and positive oxinictry, followed by
`complete recovery within 2 minutes of compression, (Type
`B, frequency 75%); loss of pulse waveform, negative oxim-
`etry, 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 sugge'sts 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}6 It‘i
`addition, there is no evidence indicating that the modified
`Allen’s tcsi predicts hand ischerttia after TRA procedures,
`HUWever. 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 TRA procedures. The patient is
`
`
`Page 7
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`172
`
`
`
`
`
`RadialCompression
`
`F: e
`
`
`_ Testing for dual Circulation to the hendThe Barbeau Grading System for assessment of collateral circu-
`lation of the palmar arch.The presence of an arterial waveform on plethysmography (even if delayed
`or with reduced amplitudel 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. lntportantly, 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 hypcrextended 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).1‘50th
`groins may be prepped as well, depending on the anticipated
`need for femoral access.
`
`For left "IRA, 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
`tortuosity and radial loops is three times higher in the
`right upper extremity." With right "IRA the catheter has
`to pass through the right suhclavian artery and the bra-
`chiocephalic trunk before reaching the aortic root. These
`two areas of bifurcation can increase technical. difficulty,
`especially when these vessels are atherosclerotic, tortuous,
`and calcified. Since the left subclavian artery arises directly
`from 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-
`tion. 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
`left internal mammary artery (LIMA). Certainly, the LIMA
`can also be cannuiated from the right radial route. but this
`
`
`
`
`Page 8
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`
`
`
`
`.‘Figm 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 of the left groin.
`
`is significantly more challenging from a technical stand-
`point with a potential risk of anabolic stroke due to catheter
`manipulation and exchanges in the aortic arch. Random”
`izetl 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
`SILIClY found that among trainees, left TRA was associated
`with a significantly shorter learning curve, with progres—
`Sive reductions in cannulation and fluoroscopy tithes as the
`Operator volume increased, compared to right TRA.19-29
`
`Radial Puncture
`
`There are a number of TRA kits available in the market. in gen—
`eral, these kits include a rnicropurtcture needle, a short 0,018
`to 0.021 inch wire, and an arterial sheath with or without
`
`hydrophilic coating of shorter (10 to 13 cm) or longer (23 cm)
`length. Sorne operators advocate the use of longer sheaths to
`avoid difficulties with catheter manipulation should spasm-1
`occur, but a randomized trial comparing sheath lengths on
`arterial spasm showed no effect of longer sheaths on reducing
`spasm.” On the other hand, hydrophilic coating allows easier
`Sheath removal and is clearly associated with less spasm and
`patient discomfort.Jl 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
`
`
`
`
`
`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
`
`

`

`
`
`— Transradiai access technique (Step 1). After sterile preparation and draping. the wrist area is locally
`anesthetized with lidocaine using a 256 needle and a small 3 cc syringe.
`
`later found to be a foreign-body reaction to the hydrophilic
`coating of the sheaths."1 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.
`Hydrophiiie-eoated sheaths were associated with a significant
`reduction in radial spasm (19.0% versus 39.9%, P <’. 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.JD 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 25G needle (Figure 7.4).
`Usually, the arterial puncture is performed with either a short
`2.5 cm, stainless steel. llG needle or a micropuncturc [V cath-
`eter that consists of a fine metal needle and a 22G Teflon cath—
`
`eter that allow the passage of a 0.018 to 0.021 inch guidewit‘e.
`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
`21 G stainless-still needle is used to puncture the radial artery.
`
`
`
`
`Page 10
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`
`
`IN“ Transradial access technique-front wall technique {Step 3i.The needle is advanced into the radial
`artery.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 wall. 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 micropuncture catheter is advanced through the front wall
`into the lumen of the artery until blood is noticed in the hull
`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 brislt pulsatile flow (Figures 7.9 and 7.10). Then, the wire
`can be freely advanced and the microcatheter exchanged for the
`arterial sheath (Figure 7.1 l). 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 hematornas. Proponents of the backs
`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 tech
`nique [Step 4). A 0.018 inch short guidewira is advanced
`he proximal radial artery.Then the needle is exchanged for
`without resistance through the needle intot
`a hydrophilic~coeted sheath.
`
`
`Page 11
`
`Teleflex Ex. 2167
`Medtronic v. Teleflex
`
`

`

`1%: '*
`
`
`
`_ Transradial access tschnique—back~wall 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. Spaulding et al., documented
`an initial access failure rate greater than 10% that decreased
`dramatically to about 2% 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.7 More recently, in a group of 28 operators,
`Ball and colleagues documented a stepwise reducticm ofTRA-
`PCI failure rates from 7% to 2% (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 TM 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.“ Radial artery spasm is perhaps the most common TRA
`complication and a frequent reason for failure and crossover
`to transfemoral access?“ in the catheterization laboratory,
`spasm should be routinely prevented using a hydrophilic-
`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
`
`

`

`
`
`
`
` Transradial access techni
`que—back-Wall technique (
`Step 3). Once the tip of microcatheter and needle
`are through the back wall of the radial arteryr the needle is removed and the microcatheter left in place
`across the radial artery.
`
`commonly use

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket