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`catheterization and Gardiovascular Diagnosis
`Editor . Frank J. Hildner, MD . Editorial Office, Ocala, Florida
`Associate Editors
`Morton J. Kern
`David A. Clark, MD
`St. Louis University
`Stanford University
`Stanford, California
`St. Louis, Missouri
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`D
`_
`Geor e W. Vetrovec, M .
`Megticai College of Virginia
`Richmond, Virginia
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`University of Miami
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`Hopital Cardiologique
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`Catheterization and Cardiovascular Diagnosis
`
`
`
`
`March 1993
`
`Volume 28 ~ Number 3
`
`ORIGINAL STUDIES
`
`
`
`Accuracy and Precision of Quantitative Digital Coronary Arteriography: Observer-, Short-, and
`Medium-Term Variabilities, Johan H.C. Reiber, Pieter M.J. van der Zwet, Gerhard Koning,
`Craig D. von Land, Bert van Meurs, Jan J. Gerbrands, Beert Buis, and Ad E. van Voorthuisen .......... 187
`Effect of Balloon Size and Stepwise Inflation Technique on the Acute Results of lnoue Mitral
`Commissurotomy, Ted Feldman, John D. Carroll, Howard C. Herrmann. David R. Holmes,
`Thomas M. Bashore, Jeitrey M. lsner, Gerald Dorros, and Jonathan M. Tobis ....................... 199
`Coronary Venous Fletropertusion oI Arterial Blood for the Treatment of Acute Myocardial Ischemia,
`J. Craig Barnett, Robert J. Freedman, Robert C. Touchon, and Mark R. Mesner ...................... 206
`Urokinase Infusion Alter Unsuccessful Angioplasty in Patients With Chronic Total Occlusion of Native
`Coronary Arteries, Felipe A. Cecefia ....................................................... 214
`Cardiac Catheterization 1991: A Report of the Registry of the Society for Cardiac Angiography and
`Interventions (SCAM), Lewis W. Johnson, Ronald Krone, and the Registry Committee of the Society for
`Cardiac Angiography and Interventions ...................................................... 219
`CASE REPORTS
`
`Coronary Artery Spasm Culminating in Thrombosis Following Ergonovine Stimulation, John T. Hays,
`R. Dennis Hamill, Clement A. DeFelice, and Albert E. Raizner .................................... 221
`Radiation-Induced Stenosis of the Left Main Coronary Artery, Sun King Wan and Joseph D. Babb ...... 225
`Patent Ductus Arteriosus Presenting in Old Age, Chi-Ling Hang and J. Thompson Sullebarger .......... 228
`Partial Congenital Detect of the Left Pericardium: Angiographic Diagnosis and Treatment by
`Thoracoscopic Pericardiectomy: Case Report, Andrew P. Rees, William Risher, P. Michael McFadden,
`Stephen R. Ramee, and Christopher J. White ................................................. 231
`Angiographic Recognition of a Proximal Balloon Tear During lnoue Balloon Mitral Valvotomy,
`Wing-Hing Chow, Tsun—Cheung Chow, and King-Loong Cheung .................................. 235
`Repeat Balloon Occlusion of a Pulmonary Arteriovenous Fistula Following Cavopulmonary
`Anastomosis in Tetralogy of Fallot, Henry J. Chen, Thomas J. Wargovich, J. Parker Mickie, and
`James A. Hill ........................................................................... 238
`
`“Hugging Balloon" Dilatation: Modification and Limitation of the Technique in Oversized Vessels,
`N.S. Chan, J. Berland, A. Cribier, and B. Letac ................................................ 241
`HEMODYNAMIC FIOUNDS
`Interpretation of Cardiac Pathophysiology From Pressure Wavelorm Analysis: Acute Aortic lnsufliciency,
`K.J. Godiewski, J. David Talley, and Glenn T. Morris ........................................... 244
`COMMENTARY Morton J. Kern ............................................................
`248
`PEARLS
`Tracker Tricks: Applications of a Novel Infusion Catheter in Coronary Intervention, A.G. Violaris and
`D. Tsikaderis ........................................................................... 250
`TECHNICAL NOTE
`Balloon Catheter Systems lor PTCA: The Importance of the Catheter Length, Eliezer A. Rozenbaum,
`On Topaz, and Douglas G. Wysham ........................................................ 252
`PRELIMINARY REPORTS
`Rupture and Entrapment at a Balloon Catheter in the Lelt Anterior Descending Artery: Fluoroscopic
`Appearance of Impending Balloon Failure, William G. Kussmaul III, Kevin Marzo, John Tomaszewski, ..
`and Verdi J. DiSesa ...................................................................
`
`256
`
`New Technique for Right Heart Catheterization Using a Mullins' Sheath, J.C. Tascon Perez.
`J.F. Delgado Jimenez, C. Gomez Pajuelo, A. Albarran Gonzalez, A. Llovet Verdugo, Zuheir Kabbani, and
`J. Andreu Dussac ....................................................................... 260
`
`Coronary Stenting Through 6 French Guiding Catheters, Philip Urban, Bernhard Meier, Emmanuel Haine,
`VitaIi Verine, and Vivek Mehan ............................................................. 263
`Letters to the Editor ......................................................................... 267
`
`Society News ............................................................................... 270
`
`@WILEYeLlss
`
`A [OHN WILEY & SONS, INC. , PUBLICATION
`T is materialw seemed
`New York ' (:th1 HE‘FIUA gfiafiaggt‘bgaToronto 0 Singapore
`Subject UEzfiopyrigh: Laws
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`Catheterization and Cardiovascular Diagnosis 28:263-266 (1993)
`
`Coronary Stenting Through 6
`French Guiding Catheters
`Philip Urban, MD, Bernhard Meier, MD,
`Emmanuel Haine, MD, Vitali Verine, MD,
`and Vivek Mehan, MD
`
`Most stent implantation procedures currently require the use of
`large-diameter guiding catheters. We describe our preliminary
`successful experience with 6 French guiding catheters to de(cid:173)
`liver balloon-expandable Palmaz-Schatz stents to the coronary
`arteries.
`
`Key words: stent implantation, 6 French guiding catheter,
`coronary arteries
`
`INTRODUCTION
`
`Coronary stent implantation constitutes a rapidly de(cid:173)
`veloping adjunct to balloon angioplasty. It is an effective
`form of treatment for a majority of cases when abrupt
`closure occurs [1,2] and is currently being evaluated in
`several randomized trials for its potential benefit in pre(cid:173)
`venting late restenosis. The major drawback of all cur(cid:173)
`rently available devices, however, is the risk of throm(cid:173)
`botic stent occlusion and the ensuing need for aggressive
`antiplatelet and anticoagulant treatment. Vascular access
`site is a frequent localization for bleeding complications
`since the sheath must be retrieved without prolonged
`interruption of the anticoagulation regimen [3,4]. This
`problem can be partially overcome by the use of vascular
`sealing devices [5] and improved external compression,
`but it remains desirable to minimize local arterial trauma.
`Guiding catheters have been decreasing in outer diam(cid:173)
`eter over the years: from the early 9 French (9F) to cur(cid:173)
`rent high-flow 7F systems [6]. Recently, our group [7,8]
`and others [9] have reported the use of 6F and even 4F
`diagnostic catheters [10] for coronary angioplasty with
`excellent results for selected cases. During the past
`months, several manufacturers have produced 6F high(cid:173)
`flow guiding catheters that allow the use of Monorail
`type balloons. We report our early experience with cor(cid:173)
`onary stent implantation using a Monorail balloon
`through such catheters in 3 patients.
`
`From Cardiology Center, University Hospital, Geneva, Switzerland.
`
`Received August 20, 1992; revision accepted November 16, 1992.
`
`Address reprint requests to Philip Urban M.D., Cardiology Center,
`University Hospital, 1211 Geneva 4, Switzerland.
`
`© 1993 Wiley-Liss, Inc.
`
`MATERIALS AND METHODS
`
`Our current stent implantation protocol consists of
`manually crimping a naked articulated Palmaz-Schatz
`stent (or half a stent, [11]) onto the previously used
`Monorail balloon catheter, placing this across the target
`segment, and inflating the balloon to deliver the stent.
`When 2 stents are required, the distal one is implanted
`first. Heparin is given in all cases, either a 20,000-IU
`bolus, or titrated to reach an ACT of 300 sec. We no
`longer routinely give dextran or urokinase to all patients,
`the femoral sheath is pulled immediately after complet(cid:173)
`ing the procedure, and local hemostasis is achieved with
`a combination of a collagen sealing device (Vasoseal,
`Datascope) and an external compression system (Femo(cid:173)
`stop, Radi Medical Systems). Following this, oral anti(cid:173)
`coagulation is given for 3 to 6 months (INR > 2.3)
`together with aspirin (100 mg/day) and dipyridamole
`(225 mg/day).
`
`RESULTS
`Patient 1
`A 59-year-old man with recent onset of Canadian Car(cid:173)
`diovascular Society (CCS) class 3 angina pectoris and a
`positive stress test. Angiography showed normal left
`ventricular function with an ejection fraction of 72% and
`a single 95% stenosis of the midportion of the left ante(cid:173)
`rior descending coronary artery with good collaterals
`originating from the right coronary artery. Heparin
`(20,000 IU) was given and balloon angioplasty was car(cid:173)
`ried out during the same session using a 6F femoral
`sheath, a 6F number 4 Judkins guiding catheter with a
`0.060-inch inner lumen (Schneider) and a 3.0-mm
`Speedy-plus Monorail balloon catheter (Schneider) with
`a 0.014-inch wire. After 4 inflations to a maximum of 6
`bars, there was a significant, long dissection with re(cid:173)
`duced flow at the site of previous balloon inflations.
`There was no chest pain or resting ECG changes due to
`the well developed collaterals. Two Palmaz-Schatz
`stents (Johnson and Johnson) were successively hand(cid:173)
`crimped onto the Speedy balloon and delivered to the
`dissected site by balloon inflation to 6 bar with a good
`angiographic result. The femoral sheath was removed
`immediately after the procedure, a Vasoseal collagen
`sealing device was placed and external compression was
`achieved with a Femostop device. The patient's subse(cid:173)
`quent hospital course was uneventful, and he was dis(cid:173)
`charged home 6 days later with a regimen of phenpro(cid:173)
`coumone, aspirin 100 mg/day and dipyridamole 225 mgt
`day.
`
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`264
`
`Urban et al.
`
`Patient 2
`A 55-year-old man with CCS class 3 angina pectoris
`following a nontransmural anterior myocardial infarct.
`Angiography showed a tight stenosis of the middle third
`of the left anterior descending artery. During the same
`session, and after informed consent was obtained, the
`patient was included in an ongoing randomized multi(cid:173)
`center study of elective stent implantation for prevention
`of restenosis. Heparin 20,000 IU was given and balloon
`angioplasty was first carried out with a Schneider Speedy
`3.5-mm Monorail balloon catheter and a 0.014-inch
`floppy wire through a 6F number 4 Judkins guiding cath(cid:173)
`eter with a 0.060-inch inner lumen (Schneider) and a 6F
`femoral sheath. After this was completed, a Palmaz(cid:173)
`Schatz stent was hand-crimped onto the previously used
`balloon and implanted into the target lesion. Angio(cid:173)
`graphic appearance was excellent (Fig. 1). The femoral
`sheath was withdrawn immediately upon completing the
`procedure, and a combination of Vasoseal and Femostop
`devices was again used to insure local hemostasis. The
`patient developed a minor groin hematoma, but was am(cid:173)
`bulated normally after 48 hours and did not require trans(cid:173)
`fusions. He was discharged free of angina on day 6 with
`acenocoumarol, aspirin, dipyridamole and nifedipine.
`
`Patient 3
`A 68-year-old carpenter with stable CCS class 2 an(cid:173)
`gina pectoris and a positive stress test. Cardiac catheter(cid:173)
`ization in another hospital had shown the left ventricular
`function to be normal, and revealed single vessel disease
`with a 70% proximal stenosis in the left anterior descend(cid:173)
`ing artery. After heparin 20,000 IU was administered,
`balloon angioplasty was carried out using a 6F sheath, a
`6F number 4 left Judkins guiding catheter with a 0.062-
`inch inner lumen (Cordis) and a Speedy 3.0-mm mono(cid:173)
`rail balloon catheter over a 0.014-inch wire. A large
`dissection developed after 2 inflations to a maximum of
`6 bar and bail-out stenting was decided. A single Pal(cid:173)
`maz-Schatz stent was hand-crimped onto the previously
`used balloon and delivered to the dissected site with an
`excellent angiographic result (Fig. 2). The sheath was
`pulled immediately and hemostasis was achieved with a
`combination of Vasoseal and Femostop devices. The
`hospital course was uneventful, the patient remained
`asymptomatic and was discharged after 4 days on aceno(cid:173)
`coumarol, aspirin and dipyridamole.
`
`Fig. 1. A: Left lateral view of the left coronary artery showing a
`moderately severe stenosis of the mid left anterior descending
`coronary artery. B: Intermediate result, after dilatation with a
`3.S-mm balloon. The guide wire remains across the lesion. C:
`The 1S-mm Palmaz-Schatz stent is crimped onto the same bal(cid:173)
`loon and placed across the lesion. The central balloon marker is
`well visible, and dye injection allows for precise positioning
`prior to deployment. 0: After implantation, there is no visible
`residual stenosis.
`
`DISCUSSION
`
`Minimizing the size of the femoral puncture site is a
`desirable improvement for all angioplasty procedures,
`since it should bring about a decrease of local bleeding
`complications [7-10]. This is all the more true when
`
`uninterrupted anticoagulation is necessary after the pro(cid:173)
`cedure, as is the case after metallic coronary stent im(cid:173)
`plantation [3,4]. Using 6F diagnostic catheters for se(cid:173)
`lected patients undergoing coronary balloon angioplasty
`has shown itself to be a safe, rapid, and simple approach
`when the anatomy of the stenosis was favorable, but the
`
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`

`Stenting Through 6 French Catheters
`
`265
`
`main limitations remained those of being restricted to the
`use of fixed-wire systems with very low profiles, and
`having to change to a larger catheter in case bail-out
`stenting was thought necessary. During the past months
`several manufacturers have produced 6F guiding cathe(cid:173)
`ters with high-flow inner lumens varying between 0.057
`and 0.062 inches. These now make it possible to use
`other types of balloon catheters, such as Monorail sys(cid:173)
`terns, and therefore allow for balloon exchange and stent
`delivery when necessary.
`Although further experience with 6F guiding catheters
`is needed prior to definitive conclusions, their ability to
`allow balloon exchange and stent implantation may well
`make them become the first choice guiding system for a
`large proportion of PTCA procedures. Previous experi(cid:173)
`ence with inner diameters or 0.055" of less has shown
`that backup support, angiographic visualisation, and pro(cid:173)
`cedure success rates have become comparable with 7 or
`8 French catheters for routine PTCA [8]. However,
`large-diameter (7-8 French or more) guiding catheters
`still have certain advantages left that make them prefer(cid:173)
`able for selected cases: they allow the use of high-profile
`equipment such as the Magnum wire, perfusion bal(cid:173)
`loons, or premounted stent/balloon systems [2,13], and
`are still necessary for certain procedures such as kissing
`balloon techniques, intravascular ultrasound imaging,
`and atherectomy. However, the trauma to the femoral
`artery is greater, and wedging in the coronary ostia is
`more likely to occur.
`Technically, the method of manually crimping the na(cid:173)
`ked stent onto the previously used balloon has proved
`safe both in our hands [12] and in those of others [11],
`despite previously expressed concern [4,14] that stent
`embolization or misplacement might be a frequent oc(cid:173)
`currence. The use of this method together with 6F guid(cid:173)
`ing catheters proved to be of equal ease and safety: it is
`fast and simple and saves the added inconvenience and
`cost of exchanging for a pre-mounted system.
`
`REFERENCES
`1. Sigwart V, Vrban P, Golf S, Kaufmann V, Imbert C, Fischer A,
`Kappenberger L: Emergency stenting for acute occlusion follow(cid:173)
`ing coronary balloon angioplasty. Circulation 78:1121-1127,
`1988.
`2. Roubin GS, Cannon AD, Agrawal SK, Macander PJ, Dean LS,
`Baxley WA, Breland J: Intracoronary stenting for acute and
`threatened closure complicating percutaneous transluminal coro(cid:173)
`nary angioplasty. Circulation 85:916-927, 1992.
`3. Sigwart V, Puel J, Mirkovitch V, Joffre F, Kappenberger L:
`Intravascular stents to prevent occlusion and restenosis after trans(cid:173)
`luminal angioplasty. N Engl J Med 316:701-706, 1987.
`4. Schatz RA, Bairn OS, Leon M, Ellis SG, Goldberg S, Hirschfeld
`JW, Cleman MW, Cabin HS, Walker C, Stagg J, Buchbinder M,
`Teirstein PS, Topol EJ, Savage M, Perez JA, Curry RC, Whit(cid:173)
`worth H, Sousa E, Tio F, Almagor Y, Ponder R, Penn 1M,
`
`Fig. 2. A: Right anterior oblique view of the left coronary artery
`showing some nonsignificant irregularities of the left main
`stem, and a moderately severe proximal stenosis in the left
`anterior descending coronary artery. B: After balloon angio(cid:173)
`plasty with a 3.0-mm Monorail Speedy balloon at a maximal
`pressure of 6 bar, an important dissection flap is visible. C:
`After implantation of a single Palmaz-Schatz stent on the same
`balloon, the dissection is tacked-up against the vessel wall, and
`the luminal surface is free of residual irregularities.
`
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`266
`
`Urban et al.
`
`Leonard B, Levine SL, Fish D, Palmaz JC: Clinical experience
`with the Palmaz-Schatz coronary stent. Initial results of a multi(cid:173)
`center study. Circulation 83: 148 -161, 1991.
`5. Ernst J, Kloos R, Schrader R, Kaltenbach M, Sigwart U, Sanborn
`T: Immediate sealing of arterial puncture sites after catheteriza(cid:173)
`tion and PTCA using a vascular hemostasis device with collagen:
`an international registry. Circulation 84:11-68, 1991 (abst).
`6. Villavicencio R, Meier B, Pande AK, Urban P, Sztajzel J, de la
`Serna F: Coronary angioplasty with 7F guiding catheters. Am
`Heart J 122:1519-1521,1991.
`7. Villavicencio R, Urban P, Muller T, Favre J, Meier B. Coronary
`balloon angioplasty though diagnostic 6F catheters. Cathet Car(cid:173)
`diovasc Diagn 22:56-59, 1991.
`8. Urban P, Moles VP, Pande AK, Verine V, Haine E, Meier B:
`Percutaneous coronary angioplasty through six French catheters.
`J Invas Cardiol 4:335-338, 1992.
`9. Feldman R, Glemser E, Kaiser J, Standley M: Coronary angio(cid:173)
`plasty using new 6 French guiding catheters. Cathet Cardiovasc
`Diagn 23:93-99, 1991.
`10. Moles VP, Meier B, Urban P, de la Serna F, Pande AK: Percu(cid:173)
`taneous Transluminal coronary angioplasty through 4 French di(cid:173)
`agnostic catheters. Cathet Cardiovasc Diagn 25:98-100, 1992.
`
`II. Colombo A, Hall P, Thomas J, Almagor Y, Finei L: Initial ex(cid:173)
`perience with the disarticulated Palmaz-Schatz stent: A technical
`report. Cathet Cardiovasc Diagn 25:304-308, 1992.
`12. Haine E, Urban P, Pande AK, Verine V, Meier B: Implantation
`en urgence de stents intracoronaires apres echec d'une angioplas(cid:173)
`tie. Resultats immediats et It moyen terme (abstract) Schweiz Med
`Wochenschr 122(suppl 46):9, 1992.
`13. Herrmann HC, Buchbinder M, Clemen MW, Fischman D, Gold(cid:173)
`berg S, Leon MB, Schatz RA, Tierstein P, Walker CM, Hirshfeld
`JW: Emergent use of balloon-expandable coronary artery stenting
`for failed percutaneous transluminal coronary angioplasty. Circu(cid:173)
`lation 86:812-819, 1992.
`14. Bairn DS, Schatz R, Gleman M, Curry C: Predictors of unsuc(cid:173)
`cessful placement of the Schatz-Palmaz coronary stent. Circula(cid:173)
`tion 80(suppl II):II-174, 1989 (abst).
`
`Page 7
`
`Medtronic Exhibit 1439
`
`

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