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`Volume 30 0 Number 1 0 September 1993
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`
`
`Catheterization
`
`and
`Cardiovascular
`
`
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`Page 1
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`Medtronic Exhibit 1420
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`Batheterization and Gardiovascuiar Diagnosis
`Editor 0 Frank J. Hildner, MD 0 Editorial Office, Ocala, Florida
`Associate Editors
`David A. Clark, MD
`Morton J. Kern
`Stanford University
`St. Louis University
`Stanford, California
`St. Louis, Missouri
`
`Robert A. Chahine, MD
`University of Miami
`Miami, Florida
`
`George W. Vetrovec, MD
`Medical College of Virginia
`Richmond. Virginia
`
`Donald S. Baim, MD
`Beth Israel Hospital
`Boston, Massachusetts
`Thomas M. Bashore, MD
`Duke University
`Durham, North Carolina
`Michel E. Bertrand, MD
`H6pital Cardiologique
`Lille, France
`Peter C. Block, MD
`St. Vincent Heart Institute
`Portland, Oregon
`Alfred A. Bove, MD
`Temple University
`Philadelphia, Pennsylvania
`Tsung 0. Cheng, MD
`George Washington University
`Washington, DC
`David C. Cumberland, MD
`Northern General Hospital
`Sheffield, England
`Gerald Dorros, MD
`St. Luke’s Health Sciences Offices
`Milwaukee, Wisconsin
`Ted E. Feldman, MD
`University of Chicago
`Chicago, Illinois
`Barry S. George, MD
`Riverside Methodist Hospital
`Columbus, Ohio
`Julius H. Grollman, Jr., MD
`Little Company of Mary Hospital
`Torrance, California
`Geoffrey 0. Hartzler, MD
`Mid America Heart Institute
`Kansas City, Missouri
`Richard R. Heuser, MD
`Arizona Heart Institute & Foundation
`Phoenix, Arizona
`
`Editorial Board
`John W. Hirshfeld, Jr., MD
`Hospital of the University of
`Pennsylvania
`Philadelphia, Pennsylvania
`David R. Holmes, Jr., MD
`Mayo Clinic
`Rochester, Minnesota
`Abdulmassih S. lskandrian, MD
`Philadelphia Heart Institute
`Philadelphia, Pennsylvania
`Jeffrey M. lsner, MD
`St. Elisabeth Hospital
`Boston, Massachusetts
`Joel K. Kahn, MD
`William Beaumont Hospital
`Royal Oak, Michigan
`Spencer 8. King III, MD
`Emory University Clinic
`Atlanta, Georgia
`Warren K. Laskey, MD
`University of Pennsylvania
`Philadelphia, Pennsylvania
`Francis Y.K. Lau, MD
`Loma Linda University
`Loma Linda, California
`Thomas J. Linnemeier, MD
`Northside Cardiology, PC
`Indianapolis, Indiana
`Ben D. McCallister, MD
`Cardiovascular Consultants, Inc.
`Kansas City, Missouri
`Bernhard Meier, MD
`Medizinische Universitatsklinik
`Insepspital
`Bern, Switzerland
`Charles E. Mullins, MD
`Texas Children‘s Hospital
`Houston, Texas
`Richard K. Myler, MD
`San Francisco Heart Institute
`Daly City, California
`
`Masakiyo Nobuyoshi, MD
`Kokura Memorial Hospital
`Kokurakita-Ku, Kitakyusyu, Japan
`Martin P. O'Laughin
`Duke Childrens‘ Hospital
`Durham, North Carolina
`William W. O'Neill, MD
`William Beaumont Hospital
`Royal Oak, Michigan
`Igor F. Palacios, MD
`Massachusetts General Hospital
`Boston, Massachusetts
`John 0. Parker, MD
`Kingston General Hospital
`Kingston, Ontario, Canada
`Carl J. Pepine, MD
`University of Florida
`Gainesville, Florida
`Johan H.C. Reiber, PhD
`University Hospital
`Lieden, The Netherlands
`Gary S. Roubin, MD, PhD
`University of Alabama
`Birmingham, Alabama
`Carlos E. Ruiz, MD
`Loma Linda University
`Lorna Linda, California
`Richard W. Smalling, MD, PhD
`University of Texas
`Health Science Center
`Houston, Texas
`Jonathan Tobis, MD
`University of California at Irvine
`Orange, California
`Zoltan Turi, MD
`Wayne State University
`Detroit, Michigan
`William H. Willis, Jr., MD
`Florida Hospital
`Orlando, Florida
`
`
`
`© 1993 Wiley-Liss, Inc. All rights reserved. No part of this publication may be reproduced in any form or by any means, except as
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`Indexed by: BIOSIS Data Base ' Biomedical Engineering Citation Index ' Cardiology Digest - Current Contents/Clinical Medicine ' Science
`Citation Index ' Scisearch ' Current Opinion in Cardiology ' Current Opinion in Radiology - Excerpta Medica - Index Medicus.
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`Medtronic Exhibit 1420
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`Gatheterization and Cardiovascular Diagnosis
`
`September 1993
`
`Volume 30 c Number 1
`
`ORIGINAL STUDIES
`Guidelines for Training, Credentialing, and Maintenance of Competence for the Performance of
`Coronary Angioplasty: A Report From the interventional Cardiology Committee and the Training
`Program Standards Committee of the Society for Cardiac Angiography and Interventions,
`axon, and David R. Holmes, Jr ..............................
`Michael J. Cowley, David P. F
`on and Management of Ostial Saphenous Vein
`Application of Intracoronary Flow Velocity for Detecti
`Graft Lesions, Morton J. Kern, Michael S. Flynn, Frank V. Aguirre, Thomas J. Donohue, Richard G. Bach
`......................................
`and Eugene A. Caracciolo ................
`Radiation Exposure: Comparison of Rapid Exchange and Conventional Over-the-Wire Coronary
`Angioplasty Systems, Thomas J. Linnemeier, Scott H. McCallister, Daniel L. Lips, Melissa A. Klette,
`Donald A. Rothbaum, Michael W. Ball, Ronald J. Landin, Zachary I. Hodes. and Robert V. Ridden ,,,,,,
`Simplified Method tor Calculating Aortic Valve Resistance: Correlation With Valve Area and Standard
`Formula, Jeffrey G. Kegel, Bennett D. Schalet, William J. Corin, and Abdulmassih S. Iskandrian ,,,,,,,
`Coronary Angioplasty Through 4 French Diagnostic Catheters, Vivek K. Mehan, Bernhard Meier,
`Philip Urban, Vitali Verine, Emmanuel Haine, and Pierre-Andre Dorsaz .........................
`CASE REPORTS
`Fragmentation and Embolization of a Plastic-Coated Guidewire, Kerry C. Prewitt, Jon R. Resar, and
`Jeffrey A. Brinker ............................................................
`Catheter Atherectomy of Intimal Fibroplasia of the Common Iliac Artery, Jyotsna V. Mandke,
`M. Phatak, Vasundhara P. Sanzgiri, Yunus S. Loya, and
`Satyavan Sharma, Anuradha
`Dhruman M. Desai ...........................................................
`Bail-Out Coronary Stenting in an Extremely Tortuous Right Coronary Artery With the Palmaz-Schatz
`Stent and Teleguide Sheath, J.P.M. Foran, J.E. Nordrehaug, G. Xynopoulos. and R.J. Wainwright,,,,,,
`Percutaneous Transluminal Coronary Angioplasty of a Right Coronary Artery Arising From the Left
`Main Coronary Artery, Harry H. Gibbs, Artur M. Spokojny, Thomas J. Molloy, Mazen O. Kamen, and
`.............................
`Timothy A. Sanborn .......................
`Percutaneous Transvenous Mitral
`'
`‘
`atients With Severe KyphoscoliosiS,
`hari, Morgan Fu, Kou-Ho Yeh, and Jul-Sung Hung ..............
`Dewi Ramasamy, Robaayah Zamba
`inating From the Left and Right Coronary Artery: A Rare
`Double LeIt Anterior Descending Artery Orig
`Coronary Artery Anomaly, Vasiiis Voudris, Anastasios Salachas. Maria Saounotsou, Dimitris Sionis,
`George Ifantis, Nikolaos Margaris, and Gabriel Koroxenidis.................................
`Pseudocoarctation ot the Aorta: A Magnetic Resonance Imaging Correlation, Dipen C. Shah,
`I. Sathyamurthy, Millind Raje, and Iqbal Ahmed ........................................
`TECHNICAL NOTE
`Evaluation of Two Oximeters for Use in Cardiac Catheterization Laboratories, Gregory L Freeman and
`.....................................
`John M. Steinke ........................
`BASIC INVESTIGATION
`operiusion Balloon Catheters, Ebo D. de Muinck,
`In Vitro Evaluation of BIOod Flow Through Aut
`Bart J. Verkerke, Gerhard Rakhorst, Rene B. van Dijk, and
`Paolo Angelini, Kathy Dougherty,
`Kong I. Lie ................................................................
`PRELIMINARY REPORTS
`Retrieval Techniques tor Managing Flexible Intracoronary Stent Misplacement, Karl W. Foster-Smith,
`Kirk N. Garratt, Stuart T. Higano, and David R. Holmes, Jr .................................
`Brachial Approach Directional Coronary Atherectomy of a Left Coronary Artery saphenous Vein
`Bypass Graft, Robert L. Feldman and Paul L, Urban ....................................
`Facilitated Drainage of Pericardial Effusion With a Fenestrated Pigtail Catheter and Sheath System,
`Michael S. Flynn, Morton J. Kern, Frank V. Aguirre, Eugene A. Caracoolo. Thomas J. Donohue, and
`..........................................
`
`Richard G. Bach ...................
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`5
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`11
`15
`22
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`27
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`30
`33
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`37
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`4o
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`45
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`51
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`53
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`53
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`73
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`Page 3
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`Catheterization and Cardiovascular Diagnosis 30:22-26 (1 993)
`
`Coronary Angioplasty Through 4 French
`Diagnostic Catheters
`
`Vivek K. Mehan, MD, Bernhard Meier, MD, Philip Urban, MD, Vitali Verine, MD,
`Emmanuel Haine, MD, and Pierre-Andre Dorsaz, PhD
`
`In 50 consecutive patients subjected to coronary angioplasty immediately following a 4
`French (F) diagnostic study, the technical feasibility and economical aspects of angio-
`plasty through 4F catheters of 54 lesions were assessed. The patients were selected, but
`multiple, eccentric, and long lesions were not a prior1 excluded. 4F diagnostic catheters
`(Cordis), and fixed-wire dilatation catheters (Ace, Scimed) were used in all cases. The
`procedure was successful in 43 lesions (80%) using 4F catheters. For 11 stenoses (20%),
`a change over to a larger French size was required. Two of these lesions could not be
`crossed with the balloon despite the larger sized guiding catheter. The final overall suc-
`cess rate was 96%, and there were no major complications. The use of diagnostic 4F
`catheters for angioplasty in these 50 patients resulted in the saving of 39 guiding cath-
`eters and 19 introducer sheaths. For 12 lesions (22%), an additional 4F catheter became
`necessary since the shape used for the diagnostic study was inadequate for angioplasty.
`In 7 cases, more than 1 balloon was used, but 5 of these balloon exchanges were inde-
`pendent of the use of 4F catheters. Three exchanges were performed through the 4F
`catheter (1 for need of a larger balloon to improve on an unsatisfactory angiographic
`result and 2 for a crimped guide wire tip of the Ace balloon). In the remaining 4, a larger
`catheter was used; in 2 of them, angioplasty eventually failed (failure to cross lesion) and
`in the remainlng 2, a Monorail system solved the problem, which is incompatible with 4F
`catheters. In these 4 cases, a balloon could have been saved if the procedure had been
`started with a larger catheter and a movable wire system. We conclude that angioplasty
`through diagnostic 4F catheters completing a 4F coronary angiography is technically
`feasible and represents an economically viable alternative in selected patients.
`Q 1993 Wiiey-Liss, Inc.
`
`Key words: interventional cardiology, coronary disease, PTCA
`
`INTRODUCTION
`In an era where cost constraints dictate short hospital
`stays, the use of outpatient cardiac catheterization for the
`diagnosis of coronary artery disease is growing. Several
`reports have described the use of 6 French (F) [ 1],5F [2],
`and 4F [3,4] catheters for coronary angiography. When
`combining coronary angioplasty with the diagnostic
`study, (as in ad hoc coronary angioplasty, or “PTCA at
`first sight” [5]) it is intriguing to use the same small
`catheter for both procedures [6-81. This has become
`possible due to thinner-walled catheters with good torque
`control and ultralow profile fixed-wire dilatation cathe-
`ters with low friction coating. This report describes our
`initial experience of coronary angioplasty through 4F di-
`agnostic catheters.
`
`diagnostic catheters. This series started in December
`1990.
`
`Patients
`The population was predominantly male (Table I). The
`majority of patients had single vessel disease and good
`left ventricular function. Single vessel angioplasty ac-
`counted for 92% of the cases. A total of 54 lesions were
`attempted in the 50 patients. Most patients had mid seg-
`ment lesions. The patients were selected, but multiple,
`eccentric, and long lesions were not a priori excluded.
`There was 1 case of chronic total occlusion. The hard-
`
`From the Cardiology Center, University Hospital, 121 1 Geneva 14.
`Switzerland.
`
`METHODS
`The study population comprises the first 50 consecu-
`tive patients to undergo coronary angioplasty through 4F
`
`Received January 23, 1993; revision accepted March 10, 1993.
`
`Address reprint requests to Dr. Bernhard Meier, Department of Car-
`diology, University Hospital, 30 10 Bern, Switzerland.
`
`0 1993 Wiley-Liss, Inc.
`
`Page 4
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`Medtronic Exhibit 1420
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`
`
`-
`
`N
`
`%
`
`57 2 10 (36-77)
`43
`86
`42
`84
`17
`34
`4
`8
`16
`32
`20
`10
`20
`10
`22
`44
`16
`32
`2
`4
`
`67 ? 10 (43-86)
`
`TABLE 1. Baseline Characteristics: 50 Patientsl54 Lesions
`Characteristics
`Clinical
`Mean age (years)
`Male sex
`Smoking
`Hypertension
`Diabetes
`Asymptomatic, objective signs of ischemia
`Angina class 111 or iV*
`Unstable angina
`Previous infarction
`Previous angioplasty
`Previous bypass surgery
`Angiographic
`Ejection fraction (%)
`Number of sites attempted
`I -.
`L
`Coronary artery attempted
`Right
`Left anterior descending
`Left circumflex
`Site of lesion
`Proximal
`26
`14
`Mid
`68
`37
`Distal
`6
`3
`Mean initial stenosis (%)
`91 f 8 (70-100)
`21 * 18 (0-95)
`Mean residual stenosis (%)
`*According to the classification of the Canadian Cardiovascular Society.
`
`46
`4
`
`15
`19
`20
`
`92
`8
`
`28
`35
`37
`
`ware utilized is depicted in Table 11. In most cases
`(87%), a single balloon was used.
`
`Technique
`The diagnostic study was performed by the femoral
`route, with 4F catheters using previously described tech-
`niques [3]. The use of a 4F introducer sheath was up to
`the discretion of the operator. In the majority of cases, it
`was not used (Table 11). In 4 cases (8%), an Amplatz
`catheter in addition to the Judkins catheter was required
`for the diagnostic study. The 4F catheter (Cordis) (Fig.
`1) has an external diameter of 1.3 mm (0.054”), and a
`lumen of 1 .O mm (0.040”). Its novel shaft technology is
`based on Pellethane, braided with stainless steel wire,
`and provides excellent torque control [3]. All angioplasty
`procedures (except for 1 done during a demonstration
`course) were performed immediately following a diag-
`nostic study with 4F catheters. Patients for whom it was
`anticipated that several balloons, stents, or perfusion
`catheters might be required, were not considered for 4F
`angioplasty . Standard angioplasty techniques were used
`[8,9]. The patients received intravenous aspirin unless
`they were on oral aspirin, and 20,000 units of heparin
`intravenously before
`the procedure, Ace balloons
`(Scimed), ranging in sizes from 2.0 mm to 3.5 mm, were
`
`N
`
`38
`16
`
`4 French Coronary Angioplasty
`TABLE II. Hardware: 50 Patients/54 Lesions
`Hardware
`4F diagnostic catheter for angioplasty
`Judkins shape
`Amplatz shape
`Introducer sheath
`None
`4F
`Larger, for crossover
`Changeover to larger guiding catheter
`Right coronary artery
`Left anterior descending coronary artery
`Left circumflex coronary artery
`Size of largest balloon
`2.0 mm
`2.5 mm
`3.0 nun
`3.5 mm
`Use of additional balloons
`With 4F catheter:
`Crimped wire while negotiating lesion
`Inadequate results with first balloon
`With larger guiding catheter:
`Failed angioplasty
`Need for a Monorail system
`
`19
`20
`1 1
`1 1
`2
`3
`6
`
`I
`26
`26
`I
`7
`3
`2
`1
`4
`2
`2
`
`23
`
`%
`
`70
`30
`
`38
`40
`22
`20
`4
`6
`1 1
`
`2
`48
`48
`2
`13
`6
`4
`2
`8
`4
`4
`
`utilized in all patients (Fig. 1). In 10 lesions (18%), the
`residual pressure gradient across the dilated stenosis was
`assessed by advancing the 4F catheter beyond the lesion
`over the distally placed balloon and performing a pull-
`back pressure recording (Fig. 2).
`Continuous variables are expressed as mean ? SD.
`
`RESULTS
`Primary success through the 4F catheter was obtained
`for 43 lesions (80%) (Table 111). All 4 double vessel
`angioplasties were successful. For 11 lesions (20%), a
`change over to a larger catheter became necessary; in 2
`due to the need for a movable wire system, with its
`greater maneuverability (Monorail system in both, which
`are incompatible with 4F catheters), in 1 since the bal-
`loon could not be negotiated into an acute take off of the
`left anterior descending coronary artery using the 4F sys-
`tem (poor torque control of the balloon straddling the tip
`of the 4F catheter), and in 8 patients, including 1 with a
`chronic occlusion of the first marginal branch of the left
`circumflex coronary artery, due to problems with the 4F
`catheter (e.g., unstable position in the ostium, inade-
`quate support). In 2 of these 8 patients, it remained im-
`possible to negotiate the lesions using 7F guiding cath-
`eters and a variety of guide wires and balloons. In no
`case was wedging of the 4F catheter in the coronary
`ostium observed, and deep intubation of the catheter for
`
`Page 5
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`Medtronic Exhibit 1420
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`24
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`Mehan et al.
`
`descending coronary artery stenosis with a good angio-
`graphic result (Table 111).
`
`DISCUSSION
`It is obvious that 4F coronary angioplasty makes sense
`only if it is completing a 4F diagnostic study, which has
`become routine at some centers [3,4].
`Advantages of 4F Angioplasty
`The advantages of a smaller arterial access are appar-
`ent. In addition, there is no ostial wedging of catheters,
`allowing adequate perfusion of the coronary arteries
`proximal to the lesion at all times. Moreover, 4F cathe-
`ters can more easily be deeply intubated for increased
`backup support than larger catheters. This technique can
`also be used for assessing the translesional pressure gra-
`dient, by advancing the catheter over the balloon across
`the stenosis (Fig. 2). Finally, to use the diagnostic cath-
`eter for angioplasty, saves the cost for a special guiding
`catheter. In the 50 patients, a total of 39 guiding catheters
`were saved, from which the cost of 12 diagnostic 4F
`Amplatz catheters may be deducted. They were substi-
`tuted for angioplasty because the 4F Judkins catheters
`used for the diagnostic study provided inadequate sup-
`port. However, a diagnostic catheter costs only a fourth
`of a guiding catheter. Moreover, since 4F catheters can
`be easily advanced over a 0.035” guide wire without the
`need for a skin incision or an introducer sheath, there
`was an additional saving of 19 sheaths. A 4F sheath was
`used in 20 patients (electively, or for the final angiogram
`in case of impossibility to remove the balloon through
`the diagnostic catheter, as described below), and a larger
`sheath was required for cross-over to a large French size
`in 11 cases (Table 11).
`Disadvantages of 4F Angioplasty
`4F angioplasty should be restricted to fairly straight-
`forward cases and experienced operators. First, there is
`the problem of limited intrinsic backup support of the 4F
`catheter. This was the cause for the change to a larger
`French size in 8 cases (15%), of which 2 lesions could
`not be crossed using larger guiding catheters either. In 1
`case, the balloon could not negotiate an acute take off of
`a left anterior descending coronary artery using the 4F
`catheter because of poor torque control while the balloon
`was straddling the catheter tip. A 6F catheter solved the
`problem. However, such a change to a larger sized cath-
`eter does neither impair the result, nor increase cost com-
`pared to an angioplasty commenced with a larger cathe-
`ter following a 4F coronary angiography. Second, the
`small lumen of the 4F catheter, which is further reduced
`by the balloon, interferes with dye injection for coronary
`visualization. This problem can be partially overcome by
`
`Fig. 1. Ace balloon (3.0 mm, Scimed) passed through a 4F
`right Judklns diagnostic catheter (Cordis). A: Balloon inflated.
`8: Balloon deflated and partially withdrawn. A 7F guiding cath-
`eter (arrow) is shown for comparison.
`
`additional support was easily possible whenever re-
`quired, with the exceptions mentioned above.
`In 12 cases (22%), an Amplatz 4F catheter was em-
`ployed for angioplasty since the Judkins catheter used for
`the diagnostic study was inadequate. In 7 cases, more
`than 1 balloon was used (Table 11). In 3 of them, the
`balloon exchange was done through the 4F catheter (1 for
`need of a larger balloon to improve on an unsatisfactory
`angiographic result and 2 for a crimped guide wire tip of
`the Ace balloon). In the remaining 4, a larger catheter
`was used; in 2 of them, angioplasty eventually failed
`(failure to cross lesion) and in the remaining 2 a Mono-
`rail system (which is incompatible with 4F catheters)
`solved the problem. In these 4 cases, a balloon could
`have been saved if the procedure had been started with a
`larger catheter and a movable wire system.
`There was no mortality or need for emergency coro-
`nary surgery. One patient experienced an acute (non-Q
`wave) myocardial infarction related to an occlusion of a
`diagonal branch following dilatation of a left anterior
`
`Page 6
`
`Medtronic Exhibit 1420
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`
`
`4 French Coronary Angioplasty
`
`25
`
`1
`
`IC
`
`1
`
`1
`
`r
`
`.I
`
`100 -"]I
`
`c 0 1
`
`Distal
`
`Proximal
`
`Fig. 2. A: Right coronary angiogram: before (top) and after
`(bottom) 4F angioplasty, revealing a satisfactory angiographic
`result. B: lntracoronary pressure measurement with the 4F
`"guiding" catheter distal (top) and proximal (bottom) to the le-
`sion revealing a mean residual transiesionai pressure gradient
`
`of 12 mmHg (C). Note the change in the intracoronary (IC) ECG
`[lo] (accentuation of p wave and attenuation of QRS amplitude),
`related to a small change in the location of the guidewire tip
`bringing it closer to the atrioventricular groove.
`
`Page 7
`
`Medtronic Exhibit 1420
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`
`
`26
`
`Mehan et al.
`
`TABLE 111. Outcome and Complications:
`50 Patients154 Lesions
`
`N
`
`Success
`Primary success with 4F system
`43
`Overall primary success
`52
`Failure of 4F system (success with a larger guiding catheter)
`Inadequate backup support
`6
`Need for movable wire system
`2
`Balloon unable to cross lesion
`1
`Failed angioplasty (failure. to cross lesion)
`2
`In-hospital complications
`Myocardial infarction
`Q-wave infarction
`Need for emergency bypass surgery
`Death
`
`1
`0
`0
`0
`
`%
`
`80
`96
`
`11
`4
`2
`4
`
`2
`
`inadequate result. Lastly, there remains the problem of a
`limited lumen of the 4F catheter, which does not allow
`for the use of stents or perfusion balloons, necessitating
`change over to a larger system if these are required in the
`event of threatened or acute closure of an important ves-
`sel. This complication did not occur in our series, but
`awareness of such a possibility and discretion in patient
`selection is warranted.
`In conclusion, angioplasty through 4F diagnostic cath-
`eters is technically feasible. It is a rational and econom-
`ically interesting alternative only if carried out in the
`same session following a 4F diagnostic study. At
`present, it should be limited to selected, low risk cases.
`However, its application may increase with new catheter
`and balloon technology and the development of outpa-
`tient coronary angioplasty. It is also of interest for access
`through the arm.
`
`using a small (2-ml) glass syringe, and forceful injec-
`tions. The quality of such injections can be judged from
`Figure 2B. Third, only fixed-wire balloons can be used
`with 4F catheters. This imposes the well-known disad-
`vantages of fixed-wire balloons (limited steerability , re-
`negotiation of the lesion in case of balloon exchange).
`Additionally, the balloon size has to be limited to 3.5 or
`even 3.0 mm and “winging” of the balloon often ham-
`pers retrieval of the balloon after deflation. The 3.5-mm
`balloon used could not be retrieved without removing the
`4F catheter. Likewise, 3 .O-mm balloons, which were
`inflated to 1 8 bar, 2.5-mm balloons inflated to 2 1 2 bar,
`and ruptured balloons were often difficult to retrieve
`through the 4F catheter. In most cases, retrieval of the
`balloon and the 4F catheter as a unit was necessary, with
`sacrifice of the balloon before reintroduction of the cath-
`eter for the final angiogram. If the catheter had been used
`without an introducer sheath, arterial access was main-
`tained by breaking off the hub of the balloon and remov-
`ing the 4F catheter leaving the balloon within the iliac
`artery. The balloon shaft served as a guidewire, over
`which a 4F arterial sheath was introduced through which
`the 4F catheter was reinserted for the final angiogram. In
`case an insufficient result becomes apparent at this time,
`a new balloon is required. However, this is not a com-
`mon problem, as it did not occur in this series. More-
`over, a new, larger balloon is the common answer to an
`
`2.
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`3.
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`4.
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`5 .
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`6.
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`7.
`
`8.
`
`REFERENCES
`I.
`Clements SD Jr, Gatlin S: Outpatient cardiac catheterization: A
`report of 3,000 cases. Clin Cardiol 14:477-80, 1991.
`Kern MI, Cohen M, Talley JD, et al: Early ambulation after 5
`French diagnostic cardiac catheterization: Results of a multicenter
`trial. J Am Coll Cardiol 15:1475-1483, 1990.
`Pande AK, Meier B, Urban P, Venn V, Moles VP, Chappuis F.
`Mehan V: Coronary angiography with 4 French catheters. Am J
`Cardiol 70: 1085-1086, 1992.
`Talley JD, Smith SM, Walton-Shirley M, et al: A prospective
`randomized study of 4.1 French catheters utilizing the percutane-
`ous right brachial approach for diagnosis of coronary artery dis-
`ease. Cathet Cardiovasc Diagn 2655-60, 1992.
`Moles, VP, Meier B, Pande AK, Mehan VK, Urban P, Dorsaz P:
`PTCA at first sight: Angioplasty based on video only. J lnvasive
`Cardiol 4:344-348, 1992.
`Villavicencio R, Urban P, Muller T. Favre J, Meier B: Coronary
`balloon angioplasty through diagnostic 6 French catheters. Cathet
`Cardiovasc Diagn 2256-59, 1991.
`Kern MJ, Talley D, Deligonul U, et al: Preliminary experience
`with 5 and 6 French diagnostic catheters as guiding catheters for
`coronary angioplasty. Cathet Cardiovasc Diagn 2250-63, 1991.
`Moles VP, Meier B, Urban P, de la Serna F, Pande A: Percuta-
`neous transluminal angioplasty through 4 French diagnostic cath-
`eters. Cathet Cardiovasc Diagn 25:98-100, 1992.
`Meier B: Technique of coronary angioplasty. In Meier B (ed):
`Interventional Cardiology. Toronto: Hogrefe & Huber, 1990, pp
`45 -70.
`Pande AK, Meier B, Urban P, Moles V, Dorsaz PA, Favre J:
`Intracoronary electrocardiogram during coronary angioplasty.
`Am Heart J 124:337-341, 1992.
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