Catheterization and cardiovascular interv(IM)
`v. 53, no. 3 (July 2001)
`General Collection
`W1 CA967
`2001-07-162:59:68
`
`
`
`' VOLUME 53, NUMBER8, JULY 2001
`
`Catheterization
`and
`
`Cardiovascular
`Interventions
`
`OFFICIAL JOURNAL OF THE SOCIETY FOR
`
`CARDIAC ANGIOGRAPHY & INTERVENTIONS
`
`
`PROPERTYOFTHENATIONALLIBRARYOFMEDICINE
`
`
`Subject US Copyright Laws
`
`Page 1
`
`Medtronic Exhibit 1031
`
`Page 1
`
`Medtronic Exhibit 1031
`
`

`

`All articles published, including but notlimited to original research,clinical notes, editorials, reviews, reports, letters, and book reviews, represent the opinions
`and views of the authors and donotreflect any official policy or medical opinion of the institutions with which the authorsare affiliated or of the Publisher unless
`this is clearly specified. Articles published herein are intended to further generalscientific research, understanding, and discussion only and are not intended
`and should not be relied upon as recommending or promoting a specific method, diagnosis, or treatment by physicians for any particular patient.
`
`While the Editor and Publisher believe that drug selections and dosagesand the specifications and usage of equipmentand devices assetforth herein are in
`accord with current recommendations and practice at the time of publication, they accept nolegal responsibility for any errors or omissions, and make no
`warranty, express or implied, with respect to material contained herein.
`Publication of an advertisement or other discussions of products in the Journal should not be construed as an endorsement of the products or the
`manufacturers’ claims. Readers are encouraged to contact the manufacturers with any questions about the featuresorlimitations of the products mentioned.
`
`publication may be reproducedin any form or by any means, except as permitted under section
`| No part of this
`Altri
`© 2001 Wiley-Li
`107 or 108ctweoa rigitsreserved’ Copyright Act, without either the prior written permission of the publisher, or authorization through
`the Copyright Clearance Center, 222 Rosewood Drive, Danvers, MA 01923,(978) 750-8400, fax (978) 750-4470. Requests to the publisher for permission
`should be addressed to
`the
`Permissions
`Department. Such permission requests and other permission inquiries should be addressedto the Permissions
`
`Department, John Wiley &Sons,Inc.,605 Third Avenue, New York, NY 10158-0012; (212) 850-6011, fax (212) 850-6008, e-mail: permreq@wiley.com.
`
`Catheterization and Cardiovascular Interventions (Print ISSN 1522-1946, Online ISSN 1522-726X at Wiley Interscience, www.interscience.wiley.
`com) is published monthly by Wiley-Liss, Inc., a division of John Wiley & Sons, inc., 605 Third Avenue, New York, NY 10158-0012. Send subscription inquiries
`to: John Wiley & Sons,Inc., Subscription Department, 9th floor, 605 Third Avenue, New York, NY 10158.
`Advertising inquiries should be addressed to: M.J. Mevica and Associates,Inc., 2 West Taunton Avenue, Berlin, NJ 08009; (609) 768-9360. For advertising
`inquiries outside the United States, contact Caroline Melling, Non-Subscription Sales Manager, John Wiley & Sons,Ltd., Baffins Lane, Chichester, West Sussex,
`PO19 1 UD, United Kingdom; 44 (0) 1234 770351, fax 44 (0) 1234 770429.
`Subscription price: Volumes 52-54, 2001, twelve issues, $1,760in the U.S., $1,880 in Canada and Mexico, $1,982 outside North America. Special Personal
`Rate: Volumes 52-54, 2001, within North America $295, $367 outside North America. NOTE: Subscriptions at the personal rate MUST be paid by personal
`check,credit card, bank draft or moneyorder. Special “Physicians in Training”Rate: $99 for 2000 within North America. ALL orders at the Special Physicians
`in Training rate MUST be accompanied by a signature certifying participation in the program (Director of Program). All subscriptions outside North America will
`be sent by air. Payment must be made in U.S. dollars drawn on a U.S, bank, Members of the Society for Cardiac Angiography and Interventions receive
`the journal as part of their dues. Offprint sales and inquiries should be directed to the ReprintBilling Department, John Wiley & Sons,Inc., 605 Third Avenue,
`New York, NY 10158-0012, (212) 850-8776;all other inquiries should be directed to the Customer Service Department (212) 850-6645. Change of Address:
`Please forward to the subscriptions addresslisted above 6 weeksprior to move; enclose present mailing label with changeof address. Claims for undelivered
`copies will be accepted only after the following issue has been received. Please enclose a copy of the mailing label or cite your subscriber reference number
`in order to expedite handling. Missing copieswill be supplied whenlosses have been sustainedin transit and where reserve stock permits. Send claims to John
`Wiley & Sons, Inc., Customer Service, 605 Third Avenue, New York, NY 10158.
`If claims are not resolved satisfactorily, please write to Caroline Rothaug,
`Subscription Fulfiliment and Sales, John Wiley & Sons,Inc., 605 Third Avenue, New York, NY 10158. Cancellations: Subscription cancellations will not be
`accepted after thefirst issue has been mailed. Periodicals postage paid at N.Y., N.Y., andat an additional mailing office. POSTMASTER: Send change of
`address to Catheterization and Cardiovascular Interventions, Subscription Systems andDistribution, John Wiley & Sans, Inc., 605 Third Avenue, New York, NY
`58.
`
`Indexed by: BIOSIS Data Base ¢ Biomedical Engineering Citation Index * Cardiology Digest * Chemical Abstracts * Current Contents/Clinical Medicine »
`Sciencecitation Index * SCISEARCH Database ® Current Opinion in Cardiolagy « Current Opinionin Radiology * Excerpta Medica ¢ Index Medicus. Printed
`in the United States of America.
`Copyright © 2001 Wiley-Liss, Inc.
`
`This journal is printed on acid-free paper.
`
`Page 2
`
`Medtronic Exhibit 1031
`
`Page 2
`
`Medtronic Exhibit 1031
`
`

`

`Catheterization and Cardiovascular Interventions
`
`
`
`
`July 2001
`
`Use of ICHOR-Platelet Works to Assess
`Platelet Function in Patients Treated With
`GP Ilb/illa Inhibitors, Nasser M. Lakkis,
`Sima George, Elson Thomas, Mohamad Ali,
`Kirk Guyer, and David Carville... ....... 346
`
`Noninvasive Detection of Coronary Lesions by
`Multislice Computed Tomography: Results
`of the New AgePilot Trial,
`Stephen Schroeder, Andreas F. Kopp,
`Andreas Baumbach, Axel Kuettner,
`Christian Herdeg, Albert Rosenberger,
`Hans-K. Selbmann, Claus D. Claussen,
`Martin Oberhoff, and Karl R. Karsch. ...... 352
`
`Angiographic Analysis of Immediate and
`Long-Term Results of PTCR vs. PTCAin
`Complex Lesions (COBRA Study),
`Ulrich Dietz, Hans-Juergen Rupprecht,
`Okan Ekinci, Thorsten Dill, Raimund Erbel,
`Karl-Heinz Kuck, Reza Abdollahnia,
`Gerd Rippin, Juergen Meyer,
`and Christian Hamm. ............... 359
`
`313
`
`EDITORIAL COMMENT: Timing and Long-Term
`Benefit, Raoul Bonan...............,
`
`Volume 53-Number 3
`ORIGINAL STUDIES
`Common Femoral Artery AnatomyIs
`Influenced by Demographics and
`Comorbidity: Implications for Cardiac and
`Peripheral Invasive Studies, Guido Schnyder,
`Neil Sawhney, Brian Whisenant,
`Sotirios Tsimikas, and Zoltan G. Turi... -- 289
`Impact of Abciximab Versus Eptifibatide on
`Length of Hospital Stay for PCI Patients,
`Maureen J. Lage, Beth L. Barber,
`Patrick L. McCollam, Mohan Bala,
`and Joel Scherer... 0.6 eee rs 296
`EDITORIAL COMMENT:GlycoproteinIb/lila
`Inhibitors: More Different Than Alike?,
`Gregg W. Stone... ee 304
`Percutaneous Coronary Interventions Using a
`New 5 French Guiding Catheter: Results of
`a Prospective Study, Wolfgang A. Schobel,
`|. Spyridopoulos, H.M. Hoffmeister,
`and. Seipel. .. 0.6 ees 308
`EDITORIAL COMMENT:Bigger Might Not
`Always Be Better, Eulogio Garcia......-+
`Acute and Long-Term Outcomes ofStenting in
`Coronary Vessel > 3.0 mm, 3.0-2.5 mm,
`and < 2.5 mm, !-Chang Hsieh,
`Chu-Chun Chien, Hern-Jia Chang,
`Ming-Shyan Chem, Kuo-Ghun Hung,
`Fun-Chung Lin, and Delon Wu... --- +++:
`Characterization of Ultrasound-Detected
`Cerebral Microemboli in Patients
`Undergoing Cardiac Catheterization Using
`an In Vitro Middle Cerebral Artery Model,
`Yi Yang, Donald G. Grosset, Tao Yang,
`and Kennedy R. Lees... - et
`Significance of Balloon Imprint During
`Coronary Angioplasty, Reubenllia,
`Carlos Cafri, Jean Marc Weinstein,
`Akram Abu-Ful, Miri Merkin,
`Sergei Yaroslavisev, Harel Gilutz,
`and Azai Appelbaum. ...-- ee ete 331
`Three-Year Follow-Up After Rotational
`Atherectomyfor the Treatmentof Diffuse
`In-Stent Restenosis: Predictors of Major
`Adverse Cardiac Events, Peter W. Radke,
`Juergen vom Dahl, Rainer Hoffmann,
`Heinrich G. Klues, Massud Hosseini,
`Uwe Janssens, and Peter Hanrath......---
`Use of Fenoldopam to Prevent Radiocontrast
`Nephropathy in High-Risk Patients,
`Hooman Madyoon, Linda Croushore,
`341
`Douglas Weaver, and Vandana Mathur... --
`This materia] was copied
`atthe NLM and maybe
`Subject US Copyright Laws
`
`314
`
`323
`
`334
`
`Page 3
`
`The Puncture Technique: A New Methodfor
`Transcatheter Closure of Patent Foramen
`Ovale, Carlos E. Ruiz, Ernerio T. Alboliras,
`and Stephen G. Pophal... 2... 2.0.2.0.
`Transcatheter Closure of Atrial Septal Defect
`Using Amplatzer Septal Occluderin
`Chinese Adults, Chi-hang Lee, On-hing Kwok,
`Katherine Fan, Elaine Chau, Alex Yip,
`and Wing-hing Chow ........ 0.2200.
`
`EDITORIAL COMMENT:Transcatheter Closure
`of the Atrial Septum: It’s Been a Long
`Strange Trip, Morton R. Rinder
`and John M. Lasala..............02.
`
`368
`
`369
`
`373
`
`378
`
`PRELIMINARY REPORTS
`Combined Right Transradial Coronary
`Angiography and Selective Carotid
`Angiography: Safety and Feasibility in
`Unselected Patients, Kwang Soo Cha,
`Moo Hyun Kim, Young Dae Kim,
`and Jong Seong Kim ............... 380
`
`PEDIATRIC INTERVENTIONS
`Morphological Variations of Secundum-Type
`Atrial Septal Defects: Feasibility for
`Percutaneous Closure Using Amplatzer
`Septal Occluders, Tomaz Podnar,
`Peter Martanovié, Pavol Gavora,
`and Jozef Masura . 6. 0. ee ee 386
`
`(continued)
`
`Medtronic Exhibit 1031
`
`Page 3
`
`Medtronic Exhibit 1031
`
`

`

`392
`
`(continued from previous page)
`Inferior Vena Cava Occlusion Catheter for
`Pediatric Patients With Heart Disease: For
`More Detailed Cardiovascular Assessments,
`Hideaki Senzaki, Katuya Miyagawa,
`Yoshikazu Kishigami, Nozomu Sasaki,
`Satoshi Masutani, Mio Taketazu,
`Jun Kobayashi, Toshiki Kobyashi,
`Haruhiko Asano, Shunei Kyo, and Yuji Yokote.
`EDITORIAL COMMENT:IVC Occlusion
`Catheter: Works Well, But Will It Be Widely
`Applied?, Neil Wilson... ............ 397
`CASE REPORTS
`.
`Transcatheter Closure of Large Persistent Left
`Superior Vena Cava Causing Cyanosis in
`Two Patients Post-Fontan Operation
`Utilizing the Gianturco Grifka Vascular
`Occlusion Device, Michael R. Recto,
`Francisco Elbl, and Erle Austin. ......... 398
`Amplatzing a 6 Fr Judkins Right Guiding
`Catheter for Increased Success in Complex
`Right Coronary Artery Anatomy,
`Rajpal K. Abhaichand,Thierry Lefévre,
`Yves Louvard, and Marie-Claude Morice... .
`Percutaneous Ulnar Artery Approach for
`Coronary Angiography: A Preliminary
`Report in Nine Patients,
`Masayoshi Terashima, Taiichiro Meguro,
`Hisanao Takeda, Norio Endoh, YukoIto,
`Mikio Mitsuoka, Tatsushi Ohtomo,
`Osamu Murai, Satomi Fujiwara,
`Hidehiko Honda, Yasusuke Miyazaki,
`Ryoji Kuhara, Osamu Kawashima,
`and Shogen Isoyama ...........004.4 410
`
`405
`
`Inadvertent Stent Extraction Six Months After
`Implantation by an Entrapped Cutting
`Balloon, Tareq S. Harb and Frederick S. Ling .
`
`415
`
`,
`
`BASIC INVESTIGATIONS
`A Comparison of Four Stent Designs on
`Arterial Injury, Cellular Proliferation,
`Neointima Formation, and Arterial
`Dimensions in an Experimental Porcine
`Model, Allen J. Taylor, Patrick D. Gorman,
`Bruce Kenwood, Craig Hudak, Gerti Tashko
`,
`,
`,
`and Renu Virmani.............,....
`EDITORIAL COMMENT:“Metaling” With New
`Stent Designs, Andrew J. Carter,
`David P. Lee, and AlanC. Yeung ........ 426
`
`420
`
`Intramyocardial Delivery of FGF2 in
`Combination With Radio Frequency
`Transmyocardial Revascularization,
`Jialin Bao, Wendy Naimark, Maria Palasis,
`Roger Laham, Michael Simons,
`and Mark J. Post... 2.2... ee 429
`
`PRESIDENT’S PAGE
`Intravascular Radiation: Let’s Not Let a
`Promising Therapy Go Unfulfilled,
`CarlL. Tommaso..................
`
`435
`
`Volume 53, Issue 3 was mailed the week of June 25, 2001.
`
`WILEY-LISS
`
`SWILEY
`
`InterS@ience’
`
`This journal is online
`
`A JOHNWILEY & SONS, INC., PUBLICATION
`WwW
`e
`i
`rote
`shane
`ee”
`sings
`¥
`.
`.
`.
`
`New York¢Chichester * Brisbane * Toronto ¢ Singapore This material was copied
`atthe NLAb and may be
`Subject US Copyright Laws
`
`Page 4
`
`www.interscience.wiley.com
`
`Medtronic Exhibit 1031
`
`Page 4
`
`Medtronic Exhibit 1031
`
`

`

`Catheterization and Cardiovascular Interventions 53:308-312 (2001)
`
`Percutaneous Coronary Interventions Using a New 5
`French Guiding Catheter: Results of a Prospective Study
`
`Wolfgang A. Schobel,” mp, 1. Spyridopoulos, mp, H.M. Hoffmeister, mp, and L. Seipel, mo
`
`The aim of this prospective study wasto analyze the technical feasibility, the success rate,
`and the special complications of percutaneous coronary interventions (PCls) using a newly
`released 5 Fr guiding catheter with an inner diameter of 0.058”. The study was performedin
`150 consecutive patients subjected to coronary angioplasty. In 89% of the patients, the
`intervention wasstarted with a 5 Fr catheter (JR4 or JL4); in 16 patients a 6 or 7 Fr catheter
`was used becauseofunstable clinical conditions according to the decision of the interven-
`tional cardiologist. In 12 out of 134 patients, the guiding catheter had to be changed during
`the intervention from 5 Fr to a6 or 7 Fr catheter due to poor backup support.In 112 out of 118
`patients, the intervention was successfully performed using a 5 Fr catheter (95%); in 12 out
`of 16 patients, after changing the guiding catheter, the overall success rate was 93%. In
`patients with type A and B lesions who wereinitially treated using a 5 Fr catheter, the
`procedural successrate was 100% (81 out of 81), whereasin patients with type C lesions the
`procedural success rate was 83%(43 out of 53; P = 0.000053, Fisher’s exacttest). Further-
`more,in patients with a diameter stenosis < 90%, the procedural success rate was 100%(57
`out of 57), whereas in patients with a diameter stenosis of 90%-100%, the procedural
`success rate was 87%(67 out of 77; P = 0.0050). Stent implantation was performed suc-
`cessfully in 24 patients (18%) using the 5 Fr guiding catheter. This study confirms that PCI
`wastechnically feasible using a 5 Fr guiding catheterin the majority of consecutive patients
`with a successrate of 95%. There were significant differences in the success rate depending
`on the lesion type and the diameter stenosis. Complications were very rare and were not
`related to the guiding catheter. Limitations of the 5 Fr guiding catheters arose mainly from a
`poor backup support in long lesions and severe stenosis. Cathet Cardiovasc Intervent 2001;
`§3:308-312.
`© 2001 Wiley-Liss, Inc.
`
`Key words: guiding catheter; 5 French; percutaneous coronary intervention
`
`INTRODUCTION
`
`Using 6 Fr guiding catheters for elective percutaneous
`coronaryinterventions (PCIs) has been shownto be more
`effective than using larger-diametercatheters, leading to
`a decrease in vascular complications and reduction of the
`procedural time as well as the amount of contrast me-
`dium in a prospective, randomized, multicentertrial [1].
`The area of the peripheral puncture site is decreased
`using 5 Fr sheaths (2.2 mm?) in comparison with 6 Fr
`(3.1 mm?) by 31%, in comparison with 7 Fr (4.3 mm”) by
`49%, and in comparison with 8 Fr (5.6 mm”) by 61%.
`Using 5 Fr sheaths performing a femoral approach, an
`easier hemostasis at the puncture site could be expected,
`as well as a shorter bed rest in supine position, an earlier
`discharge, and a decreased number of vascular compli-
`cations. Previously used small guiding catheters (6 Fr
`and smaller) did not allow stent insertion because of an
`inner lumen of less than 0.058” [2-6].
`Now, anew 5 Fr guiding catheter with an inner diam-
`eter of 0.058” (Z2, Medtronic AVE) is on the market.
`This guiding catheter allows the use of standard balloon
`
`catheters and the insertion of recently commercially
`available stents with a diameter of up to 4.0 mmand a
`length of up to 28 mm. However, no prospective data
`about the technical feasibility of PCI using 5 Fr guiding
`catheters exists. Thus, the aim ofthis prospective single-
`user study was to analyze the technical feasibility, the
`success rate, and the special problems of PCI using the
`recently available new 5 Fr guiding catheter.
`
`MATERIALS AND METHODS
`Patients
`
`This study was performed in 150 consecutive patients
`subjected to PCI primarily by the same interventional
`
`Department of Cardiology, University of Tiibingen, Tubingen,
`Germany
`
`*Correspondence to: Dr. Wolfgang A. Schébel, Department of Cardi-
`ology, University of Tiibingen, Otfried-Miiller-Strasse 10, 72076 Tii-
`bingen, Germany. E-mail: wgschoeb @ med.uni-tuebingen.de
`
`Received 20 October 2000; Revision accepted 30 January 2001
`
`© 2001 Wiley-Liss, Inc.
`Page 5
`
`TE ae td eB
`
`i a ma
`
`Medtronic Exhibit 1031
`
`Page 5
`
`Medtronic Exhibit 1031
`
`

`

`TABLE |. Demographic Data of the Patients (n = 150)
`Initially 6 or 7 Fr
`(n=
`16)
`
`Initially 5 Fr
`(Qu = 134)
`
`Percutaneous Coronary Interventions
`
`309
`
`Meanage (years + SD)
`Male gender
`One-vessel disease
`Two-vessel disease
`Three-vessel disease
`Stable angina
`Unstable angina
`Acute myocardial infarction
`Cardiogenic shock
`Prior myocardial infarction
`PCI ad hoe
`Transbrachial approach
`Situs inversus
`
`SCoORMEUNUBREBD
`
`Hn
`%
`n
`Ge
`
`range, 47-75
`63 + 10
`range, 37-85
`59 +8
`75
`90
`67
`50
`80
`60
`25
`39
`29
`25
`15
`11
`31
`84
`63
`44
`38
`28
`19
`11
`8
`6
`1
`1
`19
`32
`24
`25
`54
`40
`4
`3
`1
`I
`
`TABLEII. Baseline Angiographic Characteristics of the Patients (n = 150)
`Initially 6 or 7 Fr (n =
`16)
`Initially 5 Fr Qi = 134)
`n
`%
`n
`%
`
`
`7
`4
`5
`
`44
`25
`31
`
`Target vessel
`Right coronary artery
`Left anterior descending artery
`Left circumflex artery
`Type oflesion
`4
`5
`0
`A
`16
`22
`0
`Bl
`40
`54
`19
`3
`B2
`40
`53
`81
`13
`Cc
`range, 70-100
`87 + 10
`range, 80-100
`95+ 8
`Meanstenosis (% + SD)
`58
`78
`81
`13
`Stenosis 90-100%
`42
`56
`19
`3
`Stenosis <90%
`
`
`44
`69
`21
`
`33
`51
`16
`
`cardiologist at our center between May and August 2000.
`The demographic data of the patients are provided in
`Table I. The data of all patients subjected to PCI were
`collected without any exclusioncriteria forthis study. All
`patients gave their informed consent to the PCI proce-
`dure.
`
`PCI Procedure
`
`The baseline angiographic characteristics of all pa-
`tients are provided in Table HI. The PCI was performed
`according to currentclinical practice by the percutaneous
`femoral approach in 146 patients (97%) and by percuta-
`ncous transbrachial approach in 4 patients (3%) due to
`clinically significant peripheral vascular discase. All pa-
`ticnts received either long-term oral therapy with aspirin
`(100 mg/day) or intravenous 250 mg before the proce-
`dure and long-term oral
`therapy. Heparinization was
`performed after arterial access with a bolus of 10,000 U.
`The guiding catheter was inserted through a catheter
`sheath introducerofthe same size as the guiding catheter
`to be used during the procedure.
`
`The PCI was intended to be performed by using a nor-
`mal-shaped 5 Fr guiding catheter Judkin right 4 orleft 4).
`In stentedpatients, adjunctive therapy with oral clopidogrel
`(300 mg) was administered on the day of stent insertion and
`given over a 4-week period (75 mg/day).
`A 6 or 7 Fr guiding catheter was used depending on the
`judgment ofthe interventional cardiologist about clinical
`condition of the patient,
`the coronary anatomy, and the
`approaching condition of the lesion. Guidewires and bal-
`loon catheters were chosen withoutrestriction by the inter-
`ventional cardiologist. The sheaths were removed either 2
`hrafter the PCT orthe day after, following the interventional
`cardiologist’s decision. Local hemostasis after sheath re-
`moval was achieved by manual compression.
`
`Data Analysis
`Technical feasibility of the PCI using the 5 Fr guiding
`catheter was judged by the procedural success rate,
`the
`guiding catheter used,
`the need for guiding catheter ex-
`change, mean numberof guiding catheters used, and mean
`number of balloon catheters used. Additional subjective
`
`Page 6
`
`Medtronic Exhibit 1031
`
`Page 6
`
`Medtronic Exhibit 1031
`
`

`

`310
`
`Schobel et al.
`
`evaluation from the interventional cardiologist of the guid-
`ing catheter attributes was noted concerning the backup
`support, the coronary ostia tolerance (unintended deep in-
`tubation, guiding-related dissection, pressure damping),
`ease of balloon or stent movement, and vesselvisualization.
`Peripheral vascular conditions such as hematoma or
`false aneurysm were judged by examination from a phy-
`sician other than the primary interventional cardiologist.
`Lesions before and after PCI were classified by visual
`assessment using two orthogonal projections [7]. A re-
`sidual stenosis of < 30% and a normal anterograde flow
`defined angiographic success. All clinical and angio-
`graphic variables,
`including complications, were pro-
`spectively entered into a computerized databasefile.
`
`Statistical Analysis
`The results are expressed as mean value * standard
`deviation (SD). Categorical variables were compared
`with Fisher’s exact test. A P value < 0.05 was consid-
`ercd statistically significant.
`
`RESULTS
`
`Overall, 16 of the 150 consecutive patients had to be
`treated with a 6 or 7 Fr guiding catheter. The decision
`was made in patients with poor clinical condition (n =
`11; unstable angina, acute myocardial infarction, or car-
`diogenic shock; sce Table I) and in patients in whom the
`angiography has shown that standard 5 Fr catheters were
`not suitable (n = 5).
`Technical results of the 134 patients in whom the PCI
`wasstarted using a 5 Fr guiding catheter are summarized
`in Table ILL. In 118 out of 134 patients (88%), the PCI
`was performed with 5 Fr guiding catheter. In 16 patients
`(12%), the guiding catheter had to be upgraded to 6 or 7
`Fr due to the coronary anatomyin 3 patients, the jet of a
`mechanical aortic replacement
`in | patient, and poor
`backup support
`in 12 patients. The mean number of
`guiding catheters used per patient was 1.1 + 0.4 (range,
`1-3). A change in the balloon catheter was required in 12
`patients. In these patients, the selected balloon catheter
`(3.0-4.0 mm nominal diameter) could not be inserted in
`the target lesion due to severe stenosis and poor backup
`support. After predilatation using a 1.5 mm balloon cath-
`eter in all patients, the selected balloon catheter could be
`placed in the target lesion. The mean numberof balloon
`catheters used per patient was 1.1 + 0.3 (range, 1-2).
`Coronary stenting was performed in 24 (18%) patients
`without any complication. In two patients, an unintended
`deep intubation of the guiding catheter in the coronary
`ostia occurred and was corrected. Vessel visualization
`was reduced by the angioplasty device in the guiding
`catheter, but normalized after the pullback of the device
`halfway out of the guiding catheter.
`
`TABLEIII. Technical Results: 134 Patients in Whom Initially a
`5 Fr Guiding Catheter Was Used*
`
`Initially 5 Fr Ga = 134)
`nN
`%oF range
`
`Guiding catheter used
`IR4 (5 Fr)
`JL4 (5 Fr)
`JR4 (6 Fr)
`JL4 (6 Fr)
`ALI (6 Fr)
`AL2 (6 Fr)
`JR4 (7 Fr)
`Guiding catheter exchange
`Mean numberofguiding cathcters used
`Guidewires used
`Floppy wire 0.014"
`Floppy wire 0.014" with distal 0.010"
`Recanalization wire 0.014”
`Balloon catheter used
`Balloon catheter exchange
`Numberof balloon catheters used
`Meanballoon diameter (mm)
`Coronary stenting
`Meanstent diameter (mm)
`Meanstent length (mm)
`Glycoprotein I[b/IHa receptor blocker
`Fluoroscopic time (min)
`Procedure time (min)
`Amount of contrast dye used (ml)
`
`44
`90
`5
`4
`5
`3
`I
`16
`11 +04
`
`86
`43
`5
`
`12
`11 +03
`3.1 +06
`24
`34 +04
`16.8 + 4.8
`9
`10.1469
`44.8 + 20
`156+ 61
`
`*JR, Judgkin right, JL, Judgkin left; AL, Amplatz left.
`
`33
`67
`4
`3
`4
`2
`I
`12
`1-3
`
`64
`32
`4
`
`9
`1-2
`1.54.0
`18
`3,0-4.0
`8-24
`7
`2.4-38.9
`14-122
`50-370
`
`Overall PCI success rate was 93%in the 134 patients
`initially using 5 Fr guiding catheters (Fig. 1). In 4 out of
`the 16 patients requiring a change to larger guiding
`catheters, the recanalization of a chronic vessel occlusion
`could not be achieved. In 6 out of 118 patients treated
`with 5 Fr guiding catheters, the PCI was not successful,
`irrespective of the guiding catheter.
`In four out of six
`patients, the recanalization of a chronic vessel closure
`was not achieved; in two out of six patients the passage
`ofthe target lesion with the guidewire was not achieved
`due to the vessel anatomy.
`Predictors of procedural failure with the 5 Fr guiding
`catheter were type C Jesion morphology (P = 0.000053,
`Fisher’s exact test) and a diameter stenosis of 90%and
`more (P < 0.0050, Fisher’s exact test; Tables IV and V).
`Procedural complications occurred in 3 out of 134 pa-
`tients (2%). One patient was diagnosed with a non-Q-
`wave myocardial infarction following the occlusion of a
`side branch; another patient suffered from a catheter-
`related proximal dissection, requiring stent insertion. In
`one patient, ventricular fibrillation occurred after recan-
`alization and angioplasty of an occluded LAD in acute
`myocardial infarction. There was no need for coronary
`artery bypass grafting and no death occurred.
`Peripheral complications occurred in five patients
`(4%) who had hematoma of diameter = 2 cmafter the
`
`Page 7
`
`Medtronic Exhibit 1031
`
`Page 7
`
`Medtronic Exhibit 1031
`
`

`

`
`
`9
`95%
`
`93%
`
`
`
`75%
`
`112
`
`124
`
`
`
`
`Hino success
`
`
`
`
`
`procedural
`success
`
`100%
`90% +
`80%
`70%
`60%
`50%
`40%
`30%
`20%
`10%
`0% +
`
`Percutaneous Coronary Interventions
`
`311
`
`backup support (75%). Procedural failures did not corre-
`late with the size of the guiding catheters, but they were
`in significant relation to the type of the lesion (type C)
`and the severity of the stenosis (90%—-100% diameter
`stenosis). Furthermore, the data demonstrate that about
`80% of all consecutive patients were eligible for PCI
`using a standard 5 Fr guiding catheter, since 16 out of
`150 patients (10.5%) were selected for PCI using 6 or 7
`Fr guiding and in 16 out of 150 patients (10.5%) a change
`in catheter size to 6 or 7 Fr was required. Up to now,
`comparable data about the use of 5 Fr guiding catheters
`have not yet been reported.
`
`Feasibility
`
`Our data demonstrate that the main problem using a 5
`Fr guiding catheter was poor backup support. Particu-
`larly, difficulties in reaching or crossing the target lesion
`with the guidewire in long and severe lesions required an
`exchange of the guiding catheter to 6 or 7 Fr in 12
`patients (9%). Furthermore, difficulties in crossing the
`target lesion with a low-profile balloon catheter required
`a predilatation using a 1.5 mm balloon catheter in 12
`other patients (9%).
`In some other patients,
`the 5 Fr
`guiding catheter could be carefully inserted deeper over
`the guidewire and the ballooncatheter shaft in the prox-
`imal vessel
`to improve the backup support. This was
`previously described as the technique of deep seating
`[1,8,9]. Coronary stent insertion was performed without
`any complicationafter predilatation with a balloon cath-
`eter. Unintended deep intubation of the proximal vessel
`was very rare and easy to correct. One case of obvious
`catheter-induced dissection of the right coronary ostia
`could be successfully treated by stent implantation. Pres-
`sure damping of the coronary artery occurred in 15% of
`patients treated with 7 or 8 Fr guiding catheters due to
`intubation ofthe coronary artery [10]. Using 5 Fr guiding
`catheters, pressure damping did not occurin the coronary
`artery, but damping ofthe recorded pressure was caused
`by the balloon catheter or the stenting device within the
`guiding catheter. Other catheter-related problems did not
`occur, while there was a particularly good kink resis-
`tance, a good torque response, and a goodtip visibility.
`The best vesscl visualization could be achieved after
`retrieval of the balloon catheter out ofthe guiding cath-
`eter. For precise positioning of a stent before deployment
`by adequate angiographic control, a strong injection of
`contrast dye was required, but
`this is similar for 6 Fr
`guiding catheters with an inner diameter of 0.062"[1].
`The mean procedure time of 44.8 + 20 min did not
`differ from studies with patients treated with a 6, 7, or 8
`Fr guiding catheter [1] (41 + 28 min and 36 +22 min,
`respectively). The procedural time was shorter than in an
`older study [10] (about 64 + 35 min). Furthermore, the
`mean fluoroscopy time of our study (10 + 6.9 min) was
`
`1
`
`T
`
`1
`
`initially 5F,
`exchange to 6F
`or 7F (n=16)
`
`SF (n=118)
`
`total (n=134)
`
`Fig. 1. Dependence of procedural success on the use of the
`guiding catheter in patients in whom initially a 5 Fr guiding
`catheter was used (n = 134).
`
`TABLEIV. Relation Between Lesion Type and Procedural
`Success in Patients in Whom Initially a 5 Fr Guiding Catheter
`Was Used (n = 134)*
` Type A/B Type C Total
`
`
`Nosuccess
`0
`10
`10
`Procedural success
`81
`43
`124
`Total 134 81 53
`
`
`
`
`*P = 0.000053 (Fisher's exact test).
`
`TABLEV. Relation Between Stenosis Rate and Procedural
`Successin Patients in Whom Initially a 5 Fr Guiding Catheter
`Was Used (n = 134)*
`
`Rate ofstenosis
`
`
` <90% 90-100% Total
`
`0
`10
`10
`Nosuccess
`57
`67
`124
`Procedural success
`Total 134Oe57 V7
`
`
`
`
`*P < 0.0050 (Fisher’s exact test).
`
`In one patient, a false
`removal of the vascular sheath.
`aneurysm occurred and was treated by ultrasound-guided
`manual compression. There was no need for surgical
`interventions or blood transfusions, The mean procedural
`time was 44.8 = 20 min (range, 14-122 min; Table ITI)
`and the mean fluoroscopic time was 10.1 + 6.9 min
`(range, 2.4-38 min). The amount of contrast dye used
`was 156 + 61 ml (range, 50-370 ml).
`
`DISCUSSION
`
`Ourdata demonstrate that PC] wastechnicallyfeasible
`using a standard 5 Fr guiding catheterin 88% fromatotal
`of 134 consecutive patients with a success rate of 95%.
`Upgrade in catheter size to 6 or 7 Fr was required in 16
`out of 134 patients (12%) and was mainly related to poor
`
`Page 8
`
`Medtronic Exhibit 1031
`
`Page 8
`
`Medtronic Exhibit 1031
`
`

`

`312
`
`SchGébel etal.
`
`very short in comparisonto other studies [1,10] (14 + 14
`min,
`|] + 9 min, and about 17 + 15 min,respectively).
`The mean amountofcontrast dye used in our population
`was comparable to other studies [1,10].
`
`Success Rate
`
`In a study from 1994 comparing 7 Fr and 8 Fr guiding
`catheters in elective PCI, the procedural success rate was
`83% [LO}. Another study from 1997 comparing 6 Fr with
`7 and 8 Fr guiding catheters in elective PCI reported a
`procedural success rate of 88% in both groups, with a
`comparable stenting rate to our study of about 20% [1].
`At present, the success rate of PCI is noted at about 75%
`in chronic total occlusions [11] and about 98% in acute
`myocardial
`infarction [12]. A recent preliminary study
`about 40 patients reported the same procedural success
`rate of 95% as our study using 5 Fr guiding catheters [9].
`However, this study did not indicate the selection criteria
`of the patients and stents were used in 96% ofthe patients
`[9]. Moreover, patients were selected for elective PCI,
`without acute myocardial infarction and chronic vessel
`closure.
`In contrast, our series represents consecutive
`patients. Thus, our data demonstrate that the use of a5 Fr
`guiding catheter doesnotdecreasethe procedural success
`rate of PCI in both elective and unstable patients.
`
`Peripheral Vascular Complications
`In our study, no major vascular complications occurred
`and there was no need for surgical
`intervention. Minor
`peripheral vascular complications such as small hematoma
`occurred in 49% of the patients. Only a few data of system-
`atic studies exist concerning peripheral vascular complica-
`tions. In a review of 5,042 PCIs using 6 to 11 Fr sheaths, no
`correlation was found between sheath size and groin com-
`plications [13];
`in another registry,
`the rate of bleeding
`increased with the size using 6 to 8 Fr and greater sheaths
`[14]. Our experience supports the latter study, namely, that
`a good peripheral vascular result is much easier to achieve
`if a small sheath was used.
`In summary,
`it
`is unclear
`whether there is a definitive advantage of 5 Fr guiding
`catheters over larger guiding catheters concerning periph-
`eral vascular complications.
`This study confirms that PCIs were technically feasi-
`ble using a 5 Fr guiding catheter in the majority of
`consecutive patients with a success rate of 95%. Com-
`plications were very rare and were not related to the
`guiding catheter. Limitations of the 5 Fr guiding cathe-
`
`ters arose mainly from poor backup support
`lesions and severe stenosis.
`
`in long
`
`REFERENCES
`
`Ne
`
`1. Metz D, Meyer P, Touati C, ct al. Comparison of 6F with 7F and
`8F guiding catheters for elective coronary angioplasty: results of
`a prospective, multicenter, randomized trial. Am Heart J 1997;
`134:131-137.
`. Chatelain P, Urban P, Camenzind E, et al. Evaluation of the
`systemalic use of a new type of diagnostic/interventional 6F
`catheters for co