».‘ um} mtewUM)
`
`Catheterlzahon and can»
`v 5ij no I} (.ILIIy 7001)
`GeneraI C(JIIL‘LIII'HI
`W1 CAEIB/
`ZUOIJIY 'I'th'fyeévéB
`
`
`
`' VOLUME 53, NUMBER 3, JULY 2001
`
`Catheterization
`and
`
`Cardiovaspular
`Interventions
`
`CARDIAC ANGIOGRAPHY & INTERVENTIONS
`
` OFFICIAL JOURNAL OF THE SOCIETY FOR
`PROPERTYOFTHENATIONALLIBRARYOFMEDICINE
`
`Page 1
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`Medtronic Exhibit 1031
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`

`

`Catheterization and Cardiovascular Interventions
`
`
`
`
`July 2001
`
`Use of lCHOR-Platelet Works to Assess
`Platelet Function in Patients Treated With
`GP lib/Illa Inhibitors, Nasser M. Lakkis,
`Sima George, Elson Thomas, Mohamad Ali,
`Kirk Guyer, and David Carville ..........
`
`Noninvasive Detection of Coronary Lesions by
`Muitislice Computed Tomography: Results
`of the New Age Pilot 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 .......
`
`346
`
`352
`
`Volume 53. Number 3
`ORIGINAL STUDIES
`
`Common Femoral Artery Anatomy ls
`Influenced by Demographics and
`Comorbidity: implications for Cardiac and
`Peripheral invasive Studies, Guido Schnyder,
`Neil Sawhney, Brian Whisenant,
`Sotirios Tsimikas, and Zoltan G. Turi ......
`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 ..................
`
`EDITORIAL COMMENT: Glycoprotein lib/Illa
`Inhibitors: More Different Than Alike?,
`Gregg W. Stone ..................
`
`Percutaneous Coronary Interventions Using a
`New 5 French Guiding Catheter: Results of
`a Prospective Study, Wolfgang A. Schébel,
`'- Spyridopoulos, H.M. Hoffmeister,
`and L. Seipel ....................
`
`EDITORIAL COMMENT: Bigger Might Not
`A'Ways Be Better, Eulogio Garcia ........
`
`ACute and Long-Term Outcomes of Stenting in
`Coronary Vessel > 3.0 mm, 3.0—2.5 mm,
`and < 2.5 mm, I—Chang Hsieh,
`Chu-Chun Chien, Hern-Jia Chang,
`Ming-Shyan Chem, Kuo-Chun Hung,
`Fun-Chung Lin, and Delon Wu ..........
`Characterization of Ultrasound—Detected
`Cerebrai Microemboli in Patients
`under90ing Cardiac Catheterization Using
`an In Vitro Middle Cerebral Artery Model,
`Yi Yang, Donald G. Grosset, Tao Yang,
`and Kennedy R. Lees ...............
`Significance of Balloon Imprint During
`Coronary Angioplasty, Reuben Ilia,
`Carlos Cafri, Jean Marc Weinstein,
`Akram Abu-Ful. Miri Merkin,
`Sergei Yaroslavtsev, Harel Gilutz,
`and Azai Appelbaum ................
`
`Thre9-Year Follow-Up After Rotational
`A'therectomy for the Treatment of Diffuse
`ln-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 ........
`
`289
`
`296
`
`304
`
`308
`
`313
`
`314
`
`323
`
`331
`
`334
`
`Angiographic Analysis of Immediate and
`Long-Term Results of PTCR vs. PTCA in
`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 ................
`
`EDITORIAL COMMENT: Timing and Long-Term
`Benefit, Raoul Bonan ...............
`
`The Puncture Technique: A New Method for
`Transcatheter Closure of Patent Foramen
`Ovale, Carlos E. Ruiz, Ernerio T. Alboliras,
`and Stephen G. Pophal ..............
`Transcatheter Closure of Atrial Septal Defect
`Using Ampiatzer Septal Occluder in
`Chinese Adults, Chi-hang Lee, On-hing Kwok,
`Katherine Fan, Elaine Chau, Alex Yip,
`and Wing—hing Chow ...............
`
`EDITORIAL COMMENT: Transcatheter Closure
`of the Atrial Septum: It’s Been a Long
`Strange Trip, Morton R. Rinder
`and John M. Lasala ................
`
`PRELIMINARY REPORTS
`
`Combined Right Transradial Coronary
`Angiography and Selective Carotid
`Angiography: Safety and Feasibility in
`Unselected Patients, Kwang Soc Cha,
`Moo Hyun Kim, Young Dae Kim,
`and Jong Seong Kim ...............
`
`PEDIATRIC INTERVENTIONS
`
`Morphological Variations of Secundum-Type
`Atrial Septal Defects: Feasibility for
`Percutaneous Closure Using AmpIatzer
`Septal Occluders, Tomai Podnar,
`Peter Martanovié, Pavol Gavora,
`and Jozef Masura .................
`
`359
`
`368
`
`369
`
`373
`
`378
`
`380
`
`386
`
`Use of Fenoldopam to Prevent Radiocontrast
`Nephropathy In High-Risk Patients,
`Hooman Madyoon, Linda Croushore,
`DOUglas Weaver, and Vandana Mathur .....
`Th is material was copied
`at the NLM and may Isa
`S‘u bjact. US Copyright. Laws
`
`341
`
`Page 3
`
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`(continued)
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`

`

`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 Alan C. Yeung ........
`
`398
`
`405
`
`.
`
`Intramyocardial Delivery of FGF2 in
`Combination With Radio Frequency
`Transmyocardial Revascularization,
`Jialin Bao, Wendy Naimark, Marla Palasis,
`Roger Laham, Michael Simons,
`and Mark J. Post ..................
`
`420
`
`426
`
`429
`
`(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, Shunel Kyo, and Yuji Yokote .
`EDITORIAL COMMENT: IVC Occlusion
`
`Catheter: Works Well, But Will It Be Widely
`Applied?, Neil Wilson ...............
`CASE REPORTS
`
`397
`
`Inadvertent Stent Extraction Six Months After
`Implantation by an Entrapped Cutting
`Balloon, Tareq S. Harb and Frederick S. Ling .
`
`415
`
`392
`
`BASIC INVESTIGATIONS
`
`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 Erie Austin ..........
`
`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 Terashirna, Taiichiro Meguro,
`Hisanao Takeda, Norio Endoh, Yuko lto,
`Mikio Mitsuoka, Tatsushi Ohtomo,
`Osamu Mural, Satomi Fujiwara,
`Hidehiko Honda, Yasusuke Miyazaki,
`Ryoji Kuhara, Osamu Kawashima,
`and Shogen Isoyama ...............
`
`PRESIDENT’S PAGE
`
`Intravascular Radiation: Let’s Not Let a
`Promising Therapy Go Unfulfilled,
`Carl L. Tommaso ..................
`
`435
`
`410
`
`Volume 53, issue 3 was mailed the week of June 25, 2001.
`
`.WILEY-LISS
`
`A JOHN WILEY & SONS, INC. , PUBLICATION
`New York ‘ Chichcstcr - Brisbane - Toronto ' Singapore
`
`This mate-rial was flooded
`at the FILM and may be
`Subject US Copyright; Laws
`
`"leLEY
`
`This journal is online
`Intersieience‘
`www.interscience.wileg.com‘
`
`Page 4
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`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. Schébelj“ MD, I. Spyridopoulos, MD, H.M. Hoffmeister, MD, and L. Seipel, MD
`
`The aim of this prospective study was to 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 performed in
`150 consecutive patients subjected to coronary angioplasty. In 89% of the patients, the
`intervention was started with a 5 Fr catheter (JR4 or JL4); in 16 patients a 6 or 7 Fr catheter
`was used because of unstable 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 a 6 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 were initially treated using a 5 Fr catheter, the
`procedural success rate was 100% (81 out of 81), whereas in patients with type C lesions the
`procedural success rate was 83% (43 out of 53; P = 0.000053, Fisher's exact test). 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
`was technically feasible using a 5 Fr guiding catheter in the majority of consecutive patients
`with a success rate 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 Inten/ent 2001;
`53:308—312.
`0 2001 Wiley-Liss, Inc.
`
`Key words: guiding catheter; 5 French; percutaneous coronary intervention
`
`INTRODUCTION
`
`Using 6 Fr guiding catheters for elective percutaneous
`coronary interventions (PCIs) has been shown to be more
`effective than using larger—diameter catheters, 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, multicenter trial [I].
`The area of the peripheral puncture site is decreased
`using 5 Fr sheaths (2.2 mmz) in comparison with 6 Fr
`(3.1 mmz) by 31%, in comparison with 7 Fr (4.3 mmz) 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” (22, Medtronic AVE) is on the market.
`
`catheters and the insertion of recently commercially
`available stents with a diameter of up to 4.0 mm and 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 of this 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 Tubingen, TUbingen,
`Germany
`
`*Correspondence to: Dr. Wolfgang A. Schiibcl. Department of Cardi-
`ology, University of Tiibingen, Otl‘ried-Miillcr-Strasse 10, 72076 Tii-
`bingen, Germany. E-mail: wgschoeb@med.uni-tucbingen.dc
`
`This guiding catheter allows the use of standard balloon
`
`Received 20 October 2000; Revision accepted 30 January 2001
`
`© 2001 Wiley-Liss, Inc.
`
`I'L:_ "_.__:_i....
`
`__ ___:_4
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`Percutaneous Coronary Interventions
`
`309
`
`TABLE I. Demographic Data of the Patients (n = 150)
`
`Initially 6 or 7 Fr
`(” = 1(3)
`
`Initially 5 Fr
`(n = 134)
`
`n
`%
`”
`(7"
`
`59 f: 8
`range, 47—75
`63 1' I0
`range, 37—85
`12
`75
`90
`67
`8
`50
`80
`()0
`4
`25
`39
`29
`4
`25
`15
`l
`1
`S
`31
`84
`63
`7
`44
`38
`28
`3
`19
`l
`l
`8
`I
`6
`I
`I
`3
`l9
`3?.
`24
`4
`25
`54
`40
`0
`4
`3
`v
`1
`I
`
`Mean age (years ”1 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 hoc
`Transbrachial approach
`Situs in vet'sus
`
`TABLE II. Baseline Angiographic Characteristics of the Patients (n = 150)
`Initially 6 or 7 Fr (II =
`16)
`Initially 5 Fr (n = 134)
`n
`%
`n
`%
`
`
`7
`4
`5
`
`44
`25
`31
`
`Target vessel
`Right coronary artery
`Left anterior descending artery
`Left circumflex artery
`Type of lesion
`4
`5
`0
`A
`16
`22
`()
`Bl
`.10
`54
`I9
`3
`B2
`40
`53
`SI
`13
`C
`range, 70—100
`87 t 10
`range, 80-100
`95 I 8
`Mean stenosis (% : SD)
`58
`7X
`81
`13
`Stenosis 90-100%
`42
`56
`I9
`3
`Stcnosis <90%
`
`
`44
`69
`2l
`
`33
`51
`16
`
`cardiologist at our center between May and August 2000.
`The demographic data of the patients are provided in
`Table 1. The data of all patients subjected to PCI were
`collected without any exclusion criteria for this 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 II. The PCI was performed
`according to current clinical practice by the percutaneous
`femoral approach in 146 patients (97%) and by percuta-
`neous transbrachial approach in 4 patients (3%) due to
`clinically significant peripheral vascular disease. All pa-
`tients 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 introducer of the same size as the guiding catheter
`to be used during the procedure.
`
`The PC] was intended to be performed by using a nor-
`mal—shaped 5 Fr guiding catheter (Judkin right 4 or left 4).
`In stented patients, 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 of the intewentional cardiologist about clinical
`condition of the patient,
`the coronary anatomy, and the
`approaching condition of the lesion. Guidewires and bal-
`loon catheters were chosen without restriction by the inter-
`ventional cardiologist. The sheaths were removed either 2
`hr after the PC] or the 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 PC] 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 number of guiding catheters used, and mean
`number of balloon catheters used. Additional subjective
`
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`

`TABLE III. Technical Results: 134 Patients in Whom Initially a
`5 Fr Guiding Catheter Was Used*
`
`Initially 5 Fr (n = 134)
`n
`‘70 or range
`
`33
`67
`4
`3
`4
`2
`l
`12
`1—3
`
`64
`32
`4
`
`44
`90
`5
`4
`5
`"t
`1
`16
`1.1 t 0.4
`
`86
`43
`5
`
`Guiding catheter used
`1R4 (5 Fr)
`IL4 (5 Fr)
`JR4 (6 Fr)
`JL4 (,6 Fr)
`ALI (6 Fr)
`AL2 (6 Fr)
`JR4 (7 Fr)
`Guiding catheter exchange
`Mean number of guiding catheters used
`Guidewires used
`Floppy wire 0.014”
`Floppy wire 0.014” with distal 0.010"
`Recanalization wire 0.014"
`Balloon catheter used
`9
`12
`Balloon catheter exchange
`1—2
`1 t 0.3
`1
`Number of balloon catheters used
`1.54.0
`3.1 t 0.6
`Mean balloon diameter (mm)
`18
`24
`Coronary stcnting
`3.0—4.0
`3.4 i 0.4
`Mean stent dialnetcr (into)
`8424
`16.8 t 4.8
`Mean stent length (mm)
`7
`9
`Glycoprotein IIb/IIIa receptor blocker
`24—389
`10.1 t (3.9
`Fluoroscopic time (min)
`14—122
`44.8 I 20
`Procedure time (min)
`
`
`156 i 61Amount of contrast dye used (ml) 504370
`*JR. Judgkin right; JL, Iudgkin left; AL, Amplatz left,
`
`310
`
`SchtSbel 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 vessel visualization.
`
`Peripheral vascular conditions such as hematoma or
`false aneurysm werejudged 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 database file.
`
`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-
`
`ered 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; see 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 PC]
`was started using a 5 Fr guiding catheter are summarized
`in Table III. In 118 out of 134 patients (88%), the PC]
`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 anatomy in 3 patients, thejet of a
`mechanical aortic replacement
`in 1 patient, and poor
`backup support
`in 12 patients. The mean number of
`guiding catheters used per patient was 1.1 i 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 number of balloon
`catheters used per patient was 1.1 i 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.
`
`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
`of the 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 lesion 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 2 cm after the
`
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`t)
`95 /o
`
`93 %
`
`75%
`
`112
`
`124
`
`
`
`I no success
`
`
`
`
`procedural
`success
`
`
`
`
`
`
`100% i
`90% —
`80%
`70%
`60%
`50%
`40%
`30%
`20%
`10%
`0% i
`
`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 reachng 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 balloon catheter 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 complication after 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 of the coronary artery [10]. Using 5 Fr guiding
`catheters, pressure damping did not occur in the coronary
`artery, but damping of the 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 good tip visibility.
`The best vessel visualization could be achieved after
`
`retrieval of the balloon catheter out of the 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 i 28 min and 36 :22 min,
`respectively). The procedural time was shorter than in an
`older study [10] (about 64 i 35 min). Furthermore. the
`mean lluoroscopy time of our study (10 i 6.9 min) was
`
`i
`
`i
`
`.
`
`initially 5F,
`exchange to SF
`or 7F (n=16)
`
`5F (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).
`
`TABLE IV. Relation Between Lesion Type and Procedural
`Success in Patients in Whom Initially a 5 Fr Guiding Catheter
`Was Used (n = 134)*
` Type /\/B Type C Total
`
`
`No success
`()
`It)
`10
`Procedural success
`81
`43
`124
`Total 134 81 53
`
`
`
`
`*l’ = 0.000053 (Fisher's exact test).
`
`TABLE V. Relation Between Stenosis Rate and Procedural
`Success in Patients in Whom Initially a 5 Fr Guiding Catheter
`Was Used (n = 134)‘
`
`Rate of stenosis
`
`
` <90‘7n 90-10070 Total
`
`(1
`10
`10
`No success
`57
`67
`124
`Procedural success
`——__________
`Total
`57
`77
`I 34
`
`*l’ < 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 i 20 min (range, 14—122 min; Table 111)
`and the mean fluoroscopic time was 10.1 i 6.9 min
`(range, 24—38 min). The amount of contrast dye used
`was 156 i 61 ml (range, 50—370 ml).
`
`DISCUSSION
`
`Our data demonstrate that PCI was technically feasible
`using a standard 5 Fr guiding catheter in 88% from a total
`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
`
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`312
`
`Sch6be| et al.
`
`very short in comparison to other studies [1, IO] (14 i 14
`min,
`I
`1 i 9 min, and about 17 i 15 min, respectively).
`The mean amount of contrast 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% [10]. 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 [l 1] 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
`ofthe 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 a 5 Fr
`guiding catheter does not decrease the 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 4% of the patients. Only a few data of system-
`atic studies exist concerning peripheral vascular complica-
`tions. In a review of 5,042 PCls using 6 to 1 1 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
`
`F)
`
`1. Metz D, Meyer P, Touati C. et al. Comparison of 6