Catheterization and Cardiovascular Diagnosis
`
`Volume23 • Number 2
`
`June 1991
`
`ORIGINALSTUDIES
`Inaccuracies in Patients
`Simplified Formula for the Calculation of Mitral Valve Area: Potential
`With Tachycardia, Walter C. Brogan III, Richard A. Lange, and L. David Hillis
`Angioplasty of Long or Tandem Coronary Artery Lesions Using a New Longer Balloon Dilatation
`Catheter: A Comparative StUdy, James F. Brymer. Fareed Khaja, and Phillip L. Krall
`Rapid Thrombus Dissolution by Continuous
`Infusion of UrOkinase Through an Intracoronary
`Perfusion Wire Prior to and Following PTCA: Results In Native Coronaries and Patent Saphenous
`Vein Grafts, Anthony T. Chapekis, Barry S. George, and Richard J. Candela
`Coronary Angloplasty Using New 6 French Guiding Catheters, Robert Feldman, Eric Glemser,
`Judy Kaizer, and Mary Standley
`Reduction in Injection Pain Using Buffered Lidocaine as a Local Anesthetic Before Cardiac
`Catheterization, Peter Sapin, Regina Petrozzi, and Gregory J. Dehmer
`Coronary Arteriography
`in Patients With Dextrocardia, James C. Blankenship
`and Jose Antonio F. Ramires
`CASE REPORTS
`In Tortuous Right Coronary Arteries During Percutaneous Transluminal Coronary
`Accordion Effect
`Angioplasty, R. Andrew Rauh, Robert W. Ninneman, David Joseph, Vinod K. Gupta, Dale G. Senior,
`and William P. Miller
`Accordion Right Coronary Artery: An Unusual Complication of PTCA Guidewire Entrapment,
`Ubeydullah Deligonul, Salyanarayana Tatineni, Randy Johnson, and Morton J. Kern
`Subacute Bilateral Coronary Ostial Stenoses Following Cardiac Catheterization and PTCA,
`Vance E. Wilson and Eric R. Bates
`in the
`Lack of Evidence for Small Vessel Disease in a Patient With "Slow Dye Progression"
`Coronary Arteries, Johan Van Lierde, Matty Vrolix, Dlmitris Sionis, Hilaire De Geest, and Jan Piessens ..
`Coronary Artery Narrowing Due to Extrinsic Compression by Myocardial Abscess, Cindy L. Wickline,
`Vasu D. Goli, and James C. Buell
`Coronary Focal Ectasia Formation Following Percutaneous Translumlnal Angioplasty,
`Herbert J. Semler ........................................................•...
`Successful Angioplasty of a Chronically Occluded Saphenous Vein Graft Using a Prolonged
`Urokinase Infusion From the Brachial Route, Andrew J. Doorey, Mark A. Rosenbloom, and
`Mark R. Zoinick
`Case Report of a Coronary Anomaly: Crossing Obtuse Marginal Arteries, Seth D. Bilazarian,
`Alice K. Jacobs, James D. Fonger, and David P. Faxon
`Multiple Coronary Artery-Left Ventricular Fistulae: Clinical, Angiographlc, and Pathologic Findings,
`Ian W. Black, Christine K.C. Loo, and Roger M. Allan
`Congestive Heart Failure Secondary to an Arteriovenous Fistula From Cardiac Catheterization and
`Angioplasty, Alexander O. Sy and Stephen Plantholt
`"End-Hole" Pigtail Catheter: An Unusual Complication of Left Ventriculography, Thomas C. Hilton,
`Ubeydullah Deligonul, Frank Aguirre, and Morton J. Kern
`In Vivo Thrombus Formation on a Guldewire During Intravascular Ultrasound Imaging: Evidence for
`Inadequate Heparinization, Paul A. Grayburn, John E. Willard, M. Elizabeth Brickner, and
`Eric J. Eichhorn
`BASIC INVESTIGATION
`of Contrast Media on Coronary Hemodynamics In a Canine
`Effects of Intracoronary Administration
`Post Ischemic Reperfusion Model, Sheng H. Sheu, Ming H. Hwang, Zhen E. Piao, Robert J. Hariman,
`Henry S. Loeb, and Patrick J. Scanlon
`LEITERS TO THE EDITOR
`Pseudoaneurysm Following Balloon Angioplasty? P. Syamasundar Rao
`Pseudoaneurysm Formation Following Balloon Angioplasty for Recurrent Coarctation of the
`Aorta: Reply, Douglas H. Joyce and Lynn B. McGrath
`A Simplified Approach to Cineangiogram Labeling, Abraham A. Embi, Lisa Anseeuw, and
`Dean H. Roller
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`Page 1
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`Medtronic Exhibit 1471
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`

`

`Catheterization and Cardiovascular Diagnosis 23:93-99 (1991)
`
`Coronary Angioplasty Using New 6
`French GUiding Catheters
`
`Robert Feldman MD, Eric Glemser BSN, Judy Kaizer RN, and Mary Standley BS
`
`6-French guiding
`constructed
`(PTCA) was performed with specially
`a~giopl~sty
`Coronary
`~Ith an mternallum~n
`of 0.051 inches.
`In 154 patients
`these guiding
`catheters
`catheters
`of configurations
`w.ere ~sed In a variety
`in conjunction
`with miniature
`balloon-on-a-wlre
`in 1.5 to 3.5 mm sizes to perform PTCA .
`dilatation
`catheters
`arteries
`. Overall patient
`success was 94%. PTCA was attempted
`in 24 totally occluded
`rate of 83% and 174 stenoses with a success
`with a success
`rate of 97%. 6 French guiding
`catheters
`can be used to successfully
`perform PTCA.
`
`artery
`coronary
`Key words:
`ease, coronary
`angioplasty
`
`disease,
`
`coronary
`
`revascularization,
`
`ischemic
`
`heart dis-
`
`INTRODUCTION
`One avenue in which percutaneous transluminal cor-
`onary angioplasty (PTCA) technology is rapidly advanc-
`ing is in the miniaturization of equipment, particularly
`balloon-on-a-wire
`dilatation system catheters. These
`miniature PTCA balloons are currently available from 3
`manufacturers
`(Cordis ORION™, Cordis Corp., Miami,
`FL; Sci-Med ACE™, Sci-Med Life Systems, Inc., Min-
`neapolis, MN; and USCI PROBE™, C.R. Bard, Inc.,
`USCI Division, Billerica, MA) in balloon sizes from 1.5
`through 3.5 mm and have balloon profiles in the 0.020-
`0.036 inch range (Table I). The shaft size of these bal-
`loon-on-a-wire
`dilatation catheters
`is 1.7-2.4 French
`(approximately 0.6-0.8 mm or 0.023-0.032 inches). In
`addition,
`a 1.5 mm Dilating Guidewire
`(.018 inches,
`Sci-Med) which can be used alone or placed through
`some over-the-wire balloons is also available.
`Because of their small catheter size these PTCA bal-
`loon dilatation systems can be used with smaller-sized
`guiding catheters than the larger conventional over-the-
`wire PTCA balloons. In fact, anecdotal and several case
`reports have documented use of the USCI PROBE bal-
`loon catheter with diagnostic catheters
`as small as 5
`French
`[1-6]. The 2.0 mm balloon sizes (ACE or
`PROBE)
`can work reasonably well
`through uncoated,
`tapered diagnostic catheters if considerable catheter ma-
`nipulation is not necessary in the target vessel. However,
`in our experience, balloons larger than the 2.0 mm size
`move poorly if at all through a diagnostic catheter. This
`poor movement becomes particularly apparent as the bal-
`loon exits or returns to the preformed curve of the diag-
`nostic catheter
`turned "guide." Any winging of the
`PTCA balloon after it has been inflated either during
`
`© 1991 Wiley-Liss, Inc.
`
`preparation or during dilatation adds to the difficulty in
`movement
`through a diagnostic catheter [4]. This paper
`describes our present experience using 6 French custom-
`made guiding catheters and miniature PTCA balloons in
`a range of clinical circumstances.
`
`MATERIALS AND METHODS
`The guiding catheters were constructed in conjunction
`with Cordis Corporation. The catheters are similar to the
`6 French Super Torque"
`diagnostic catheter, but differ
`in several important features. First, they are untapered in
`both their outer and internal diameter (.051 inches) from
`the hub to the tip. Second, attached to the distal end is a
`soft,
`radiopaque 2 mm extension, which is the Brite
`TipTM Third, unlike conventional guiding catheters
`where to facilitate balloon movement Teflon" comprises
`the inner layer,
`the internal
`lumen of this catheter
`is
`coated with silicone. An illustration showing relative
`guiding catheter-to-balloon shaft ratios, comparing an 8
`French guiding catheter with an over-the-wire balloon
`and a 6 French guiding catheter with a balloon-on-a-wire
`is shown in Figure I.
`PTCA was otherwise performed in a standard fashion.
`A successful PTCA was defined as a residual stenosis
`
`From the Munroe Regional Medical Center, Ocala Heart
`Ocala, Florida.
`
`Institute,
`
`Received October 2, 1990; revision accepted January 6, 1991.
`
`Address reprint requests to Munroe Regional Medical Center, 131
`S.W. 15th Street, Ocala, FL 32671.
`
`Page 2
`
`Medtronic Exhibit 1471
`
`

`

`TABLE I. Balloon-on-a-wlre Dilatation Catheters: Summary of
`Currently Available Profiles (In Inches)
`2.5 mm
`.030
`
`3.0 mm
`.032
`
`3.5 rom
`.036
`
`ACE™
`DGW™
`.030
`.028
`.028
`ORION™
`PROBeM~
`.030
`.020
`.025
`"Not currently available but when released will be available
`as well.
`
`94
`
`Feldman et al.
`
`1.5mm
`.020
`.018
`
`2.0mm
`.022
`
`.032
`
`in 114 sizings
`
`SF System
`0.074"--7""- .....
`
`0.046"--+
`
`6F System
`
`~0.051"
`
`~0.024"
`
`Fig. 1. Proportional comparison of a conventional 8 French
`gUiding catheter with 8 3.5 French over~the-wlre balloon and the
`described 6 French guiding catheter with a 1.8 French shall
`balloon-on-a-wlre.
`
`and no in-hospital angina, myocardial
`«50%)
`tion, bypass surgery, or death.
`
`infarc-
`
`RESULTS
`PTCA was performed using a 6 French guiding cath-
`eter in 154 patients.
`In 152 patients a 6 French guiding
`catheter was the initial guiding catheter chosen.
`In 2
`patients an 8 French guiding catheter was tried first. In
`one of these patients, no conventional 8 French guiding
`catheter would seat
`in' a small right ostium, but a 6
`French JR 4 fit well.
`In the other patient, both an 8
`French JL 4 and an 8 French AL 2, both without side
`holes, functionally occluded the left main artery; how-
`ever, a 6 French AL 2 fit without pressure dampening. A
`femoral approach was used in 144 patients and a percu-
`taneous right or left brachial approach in 10.
`-
`Patient diagnosis varied as expected,
`including silent
`ischemia in 3 patients, stable angina in 10, unstable an-
`gina in 95, evolving acute myocardial
`infarction in 16,
`and myocardial infarction within the past 2 weeks in 30.
`Patient weight averaged 76 kg (range 46 to 133 kg) and
`body surface area averaged 1.85 m2 (range 1.45 to 2.45
`m2). The average age was 66 years (range 38 to 85
`years), 81 of the patients were male, 73 female.
`Complications occurred in 5 patients, in hospital death
`occurred in 2 patients, myocardial
`infarction in 2, and
`coronary bypass surgery before discharge in 4 patients.
`I) An 85-year-old woman with refractory unstable an-
`gina and severe peripheral vascular disease agreed to
`PTCA, but declined surgery under any circumstances.
`PTCA of a subtotal anterior descending using a 6F AL 1
`
`TABLE II. Guiding Catheter Shspes selected
`
`Shape
`JL 5
`JL 4.5
`JL 4
`JL 3.5
`JL 5
`JR 4
`JR 3.5
`AL 2
`AL I
`AR 2
`LSVBG
`RSVBG
`IMA
`Sones
`
`LAD
`
`LM
`I
`
`34
`9
`
`8
`
`LeX
`2
`5
`20
`
`3
`II
`
`2'
`
`RCA
`
`DlAG
`
`GRAFT
`
`2
`I
`
`I
`36
`2
`
`4
`4
`19
`I
`2
`I
`
`2
`5
`4
`2
`
`'Congenitally
`
`aberrant arising from right Sinus of Valsalva.
`
`TABLE III. Balloon-on-a-Wlre Catheters Used
`2.5 rom
`1.5 rom
`I
`2
`I
`NIA
`N/A
`6
`N/A
`33
`
`2.0mm
`3
`
`17
`35
`
`ACE™
`ACS Gold™'
`PROBE™
`ORION™
`
`3.0mm
`3
`I
`12
`46
`
`3.5 rom
`I
`NIA
`NIA
`5
`
`devices.
`"Investigational
`- = Not used.
`N/A = Not available.
`
`and a 2.5 mm Cordis Orion by the percutaneous left
`brachial approach was initially technically successful
`(>90% to 30%). One hour later angina recurred and the
`anterior descending had occluded. Repeat PTCA was
`'complicated by repeated reocclusion. She died I day
`later having sustained an anterior infarction. 2) A 64-
`year-old woman presented in cardiogenic shock second-
`ary to an evolving inferior
`infarction. PTCA using a
`6-French JR 4 and a 3.0 mm Cordis Orion was successful
`in opening the occluded right coronary artery (100% to
`10%) and the patient stabilized. Because her left main
`was narrowed 90%, she underwent coronary bypass sur-
`gery 8 days later. Postoperatively she developed adult
`respiratory distress syndrome and died II days after
`PTCA. 3) A 65-year-old diabetic woman had multivessel
`PTCA. Her anterior descending (99% to 20%) occluded
`24 hours after PTCA and was heralded by recurrent an-
`gina, new nonspecific ST-T wave changes; and minimal
`CPK elevation. Rather than repeat PTCA, she chose by-
`pass surgery which was done 3 days after PTCA. 4) A
`63-year-old woman with silent ischemia and restenosis
`(90%) of a right coronary required emergent bypass. Ini-
`tial dilatation' was through a 6-French left saphenous vein
`bypass graft guide and a 3.0 mm Orion was used. Be-
`cause of residual stenosis of 40%, balloon size was in-
`creased to 3.5 mm (Orion). The final angiographic result
`
`Page 3
`
`Medtronic Exhibit 1471
`
`

`

`PlCA Using6 FrenchGuides
`
`95
`
`c
`
`Fig. 2. Patient example from a 47-yea,·old male (BSA 1.99m2,
`weight 86 kg) who presented with new onset unstable sngins.
`At dlagnosllc esthsterlz8tlon tha mid-anterior descending wss
`found to be totslly occluded (A, srrow). For PTCA, the 6 French
`diagnostic
`catheter was exchanged
`for 8 6 French JL 4 gUiding
`estheter
`(8). Tha 3.0 mm Orlon TM esthater easily crossed the
`occluded anterior descending.
`Lesion, vessel, and balloon vi-
`sualization during PTCA was axcellent
`(8). Tha mid-marker of
`tha belloon slthe area of prior occlusion and the wire tip (ar-
`rowheads)
`are clearly seen. Results 01 dilatation were easy to
`asse ..
`; after PTCA (C) the anterior descending was wldaly
`pslent.
`
`(10%) without dissection; but 2 hours later
`was excellent
`chest pain with transient ST changes occurred. Repeat
`angiography showed a new extensive partially occlusive
`dissection. Repeat dilatation with a larger guiding cath-
`eter (7-French, Cordis) and use of an ACS Stack Perfu-
`sion balloon (ACS, Advanced Cardiovascular Systems
`lnc., Temecula, California)
`failed to yield an optimal
`result and emergency bypass surgery was done. 5) A
`66-year-old woman with post-infarction
`angina was
`found to have 3-vessel disease including occlusion of the
`right. PTCA with a 6 French JR 4 guiding catheter and a
`3.0 mm Orion resulted in an excellent angiographic re-
`
`suit «
`30%). However repeated, symptomatic reocclu-
`sion led to urgent bypass surgery. None of the compli-
`cations seemed related to choice of initial equipment.
`Although in each case the stenosis was initially techni-
`cally successful crossed and dilated, none of these pa-
`tients or these lesions were counted as successful. No
`peripheral vascular complications requiring surgery oc-
`curred. Two patients had hematomas at the femoral cath-
`eterization site which were managed conservatively.
`PTCA was successful
`in 143 of the 152 patients in
`whom a 6 French guiding catheter was used initially and
`in both of those in whom an 8 French guiding catheter
`
`Page 4
`
`Medtronic Exhibit 1471
`
`

`

`96
`
`Feldman et al.
`
`A
`
`c
`
`Fig. 3. Pallent example from a 62-year-old mala (BSA 1.93 m',
`weight 76 kg) who preaanted with recent onset unstable angina.
`The circumflex arises at 8 sharp angle and hal 8 severe, com-
`plex stenosis (A, arrow). Oil_Ion
`was performed with a 6
`
`French JL 4.5 guiding catheter and a 3.5-mm Orton estheter.
`The Brite T1pTM (0), the balloon marker (arrow), wire tip (arrow-
`head), and stenosis (arrow) were easily visualized during PTCA
`(B and C). After PTCA (0) the circumflex was widely patent.
`
`had failed first. In order to achieve a successful dilatation
`a 6 French guiding catheter was changed to a 7 French
`guiding catheter in 4 patients. In each of these cases the
`initial 6 French shape chosen fit
`imperfectly or gave
`inadequate support. A 7 French guiding catheter of a
`different shape not available in 6 French was always
`used; and PTCA was uneventful. We suspect if the same
`
`shape had been available in the 6 French guiding cathe-
`ter, PTCA would have been successful as well. In 2
`patients PTCA was unsuccessful because of inability to
`cross a recent (2-month-old) total occlusion and a long
`tortuous subtotal occlusion, both in the right coronary
`artery. Despite attempts with 8 French guides and a va-
`riety of fixed and over-the-wire balloon systems, neither
`
`Page 5
`
`Medtronic Exhibit 1471
`
`

`

`PleA Using 6 French Guides
`
`97
`
`B
`
`c
`
`Patient example from 8 38-year-old male (BSA 2.23 m2,
`Fig. 4.
`weight 107 kg) who resented with 8 posterior
`Infarction compli-
`cated by postinfaretlon
`angina. The circumflex was occluded
`(arrow) in ita mid-portion (A). Dilatation waa accomplished with
`a 6 French JL 4 guiding catheter and a 2.5-mm Orion catheter.
`To obtain extra support
`the gUiding catheter was advanced over
`
`relatively far into the left main stem (8 and
`the balloon-on-a-wlre
`C). The catheter
`tip marker
`(0) was easily seen. Visualization of
`the balloon (arrowhead), wire tip (arrows),
`and lesion during
`PTCA (B and C) was excellent. Alter PTCA (0) the result was
`accaptable.
`
`the occlusion or the stenosis was crossed. Overall !'TCA
`was successful
`in 145 of 154 patients,
`in 178 of 186
`vessels, and in 189 of 198 lesions.
`!'TCA was attempted in 24 total occlusions and was
`successful
`in 21 (83%). These occlusions were usually in
`patients with a recent or evolving acute myocardial
`in-
`
`farction. !'TCA was attempted in 174 stenoses, <100%
`blocked, and was successful in 169 (97%). Visualization
`of the coronary anatomy when the balloon was in the
`guiding catheter or in the coronary arteries was adequate
`for diagnostic and technical purposes in each patient.
`When the balloon was in the guiding catheter or coronary
`
`Page 6
`
`Medtronic Exhibit 1471
`
`

`

`98
`Feldmanel al.
`artery, 50:50 or higher mixtures (70:30) of contrast me-
`dium (Omnipaque 350, Winthrop Pharmaceuticals, New
`York, NY; or Optiray 320, Mallinckrodt Medical, Inc.,
`St. Louis, MO) and heparinized normal saline were
`used.
`The selected 6-French guiding catheters had routine
`diagnostic curves and were used successfully in a variety
`of circumstances including vein and internal mammary
`artery bypass grafts and coronary arteries with anoma-
`lous origins (Table II). The sizes and frequency of the
`balloons used are listed in Table III. Angiographic ex-
`amples of lesion visualization before, during and after
`PTCA are shown in Figures 2-4.
`
`DISCUSSION
`Our experience documents that 6 French guiding cath-
`eters can be routinely and successfully used in a variety
`of PTCA patients. The success rate was excellent and no
`major problems attributed to the use of a small guiding
`catheter were identified. Specifically, no patient compli-
`cation occurred by using these smaller guiding catheters
`instead of larger conventional guiding catheters.
`Although there was no apparent learning curve or ma-
`jor difficulty encountered,
`these 6 French guiding cath-
`eter/balloon-on-a-wire dilatation systems have different
`handling characteristics when compared to conventional
`PTCA equipment. As discussed elsewhere, balloon-on-
`a-wire dilatation devices handle differently than standard
`shaft over-the-wire or larger fixed or partially moveable
`wire balloons [6]. The feel, control, stability, and ability
`to opacify the distal vessels differed with these 6 French
`guiding catheters as compared to larger guiding cathe-
`ters. Distal vessel opacification was adequate for diag-
`nostic images, but was obviously less than when these
`small balloons are used with 7 or 8 French guides. Al-
`though vessel opacification was not "quantified,"
`in our
`opinion vessel opacification was comparable to that ob-
`tained using of larger shaft 3.5 French over-the-wire di-
`latation balloons with standard 8 French guiding cathe-
`ters. Opacification 'as expected was better in the right
`than the left coronary system. Suboptimal visualization
`was uncom.mon and did not necessitate changing to a
`larger guide. Although conceptually backup' was ex-
`pected to be only fair at best, the 6-French guiding cath-
`eters offered good backup, Once the balloon-on-a-wire
`was into the coronary artery, the guiding catheter could
`usually,
`if desired, be advanced easily over the balloon
`shaft and provided considerable support (Fig. 4). When
`this maneuver was used,
`the guiding catheter did not
`seem to obstruct the coronary artery as significant pres-
`sure dampening was uncommon and chest pain or elec-
`trocardiographic changes did not occur. Clinical experi-
`
`ence remains limited, but no coronary dissections with
`these small guiding catheters occurred.
`Certain limitations of small guiding catheters are ob-
`vious. These include the inability to use standard bal-
`loon-over-a-wire systems. Specially angled baIloons and
`perfusion baIloons (ACS) are useful in certain circum-
`stances and cannot be used with 6 French guiding cath-
`eters. The ability to maintain access to the distal vessel is
`felt important by some Cardiologists. Control of the di-
`stal vessel can be maintained while using some baIloon-
`on-a-wire dilatation systems if a Probing Catheter™
`(USCI) is also used. However, this 4 French sheath can-
`not fit through a 6-French guiding catheter. Although in
`our opinion this is not a major limitation, others would
`disagree. Obviously capability of distal pressure mea-
`surement or distal dye injection is lost when baIloon-
`on-a-wire systems are used. This is true regardless of
`guiding catheter size.
`AdditionaIly,
`some cardiologists may on occasion
`choose to use distal perfusion with oxygenated blood or
`Fluosol"
`(Alpha Therapeutic Corporation, Los Ange-
`les, CAl which can only be done when using baIloon
`dilatation catheters with a large central lumen. Finally, it
`is not presently possible to simultaneously place multiple
`baIloons through one 6-French guiding catheter.
`In our initial endeavors (unreported cases) to develop
`a useable, smaIl guiding catheter, a 6-French untapered,
`uncoated catheter was first tried. Although most cases
`could be successfuIly completed, considerable resistance
`in baIloon catheter movements above the 2.0-mm size
`was encountered. Resistance was noted particularly in
`the preformed curves in the guiding catheter, as the bal-
`loon exited or after the dilatation as it was withdrawn and
`reentered the guiding catheter. A second generation
`which included an alternate lubricious coating was not
`helpful. The third generation, which this report ad-
`dresses, is promising, but ease of balloon movement re-
`mains less facile than with larger lumen guiding cathe-
`ters. Future developments
`in smaIl French guiding
`catheters are in progress [unpublished data, Feldman et
`al.]. Larger lumen 6 French guiding catheters will soon
`It wiIl soon be
`be available from several companies.
`possible to use over-the-wire balloons such as the new
`ACS Ten™
`and monorail-type standard and perfusion
`baIloons with smaIl French shaft size in 6-French guiding
`catheters.
`In our opinion, 6 and 7 French guiding catheters are
`particularly advantageous in patients with smaIl proximal
`right or left coronary arteries. A smaIl guiding catheter
`may obstruct the proximal coronary less or not at all as
`compared to 8 or 9 French guiding catheters. Addition-
`ally,
`in small vessels, as compared to larger guiding
`catheters, 6 French guiding catheters fit better, generaIly
`allow adequate perfusion, and are more stable. Although
`
`Page 7
`
`Medtronic Exhibit 1471
`
`

`

`8 French gniding catheters with side holes allow some
`perfusion,
`the 6 French guiding catheters may also be
`less traumatic by virtue of their smaller diameter and less
`tight fit. If necessary, 6 French guiding catheters could
`certainly have side holes as well. Several of our patients
`had ostial narrowing of the right coronary artery and a 6
`French guiding catheter always fit, but at times did oc-
`clude.
`Other reasons to develop a 6 French guiding catheter
`includes patients with severe peripheral vascular disease.
`In these patients PTCA has usually been performed by a
`brachial cutdown or percutaneously via the axillary or
`brachial approach. For years we had utilized a percuta-
`neous brachial approach with 7 French guiding catheters,
`but were concerned, especially in smaller women, about
`catheter size. Our initial experience with 6-French guid-
`ing catheters placed percutaneously from the right or left
`brachial artery using Amplatz or Judkins shapes has been
`satisfying and no local complications have occurred. In
`addition to patients with occlusive bi-femoral disease,
`we have also used the brachial route with 6 French guid-
`ing catheters for patients with massive obesity. Addition-
`ally, there is a trend toward shorter post-PTCA hospital-
`ization, earlier ambulation and patient discharge [7-8].
`The use of smaller French guiding catheters for PTCA in
`this setting would be similar to the rationale for the use
`of small French diagnostic catheters, especially in pa-
`tients undergoing outpatient diagnostic studies.
`
`PTCAUsing6 FrenchGuides
`
`99
`
`REFERENCES
`1. Kern MJ, Salinger MH: First use of a 5-french diagnostic catheter
`as a guiding catheter for percutaneous transluminal coronary an-
`gioplasty. Cathet Cardiovasc Diagn 18:276-278, 1989.
`2. Panayiotou H, Norris JW, Forman MB: Coronary angioplasty at
`the time of initial catheterization using small diagnostic catheters.
`Am Het J 119:204-205,
`January 1990.
`3. Martinez A, Pichard A, Little T, Lindsay]: Probe "Balloon on a
`Wire" ultra-low-profile coronary catheter: Results ofPTCA in 107
`patients. Cathet Cardiovas Diagn 18:222-226, 1989.
`4. Kern MJ, Talley JD, Deligonul D, SerotaH, Aguire F, Gudipati C,
`Ring M, Joseph A, Yussman ZA: Preliminary experience with 5F
`angiographic catheter as a guiding catheter for coronary angio-
`plasty. Cathet Dardiov Dlagn 19:295-296, 1990.
`5. Shani J, Mylavarapu S, Maddipoti R, Leeman D, Rivera M, Char-
`lap S, Greengart A, Hollander G, Lichstein E: Coronary angio-
`plasty through diagnostic catheters. Clinical Research (AFCR Car-
`diovascular) 37:295A, 1989.
`6. Avcdissian MG, Killeavy ES, Garcia JM, Dear ED: Percutaneous
`transluminal
`coronary angioplasty: A review of current balloon
`dilatation systems. Cathet Cardiovasc Diagn 18:263-275, 1989.
`7. Cragg DR, Friedman HZ, Almany SL, Gangaharan V, Ramos RG,
`Levine AB, LeBeau TA, O'Neil WW: Early hospital discharge
`after percutaneous transluminal coronary angioplasty. Am J Car-
`dial 64:1270-t274,
`1989.
`8. Feldman RL: Is short-stay angiopiasty safe? Clinical Cardiology,
`in press.
`
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`Medtronic Exhibit 1471
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