American Heart Journal
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`Congestive H, "... Failure
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`DIG trial: Stimulus fj~Jurther
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`of cardiopulmonary
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`Amlodipine
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`Reproducibility
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`activity in heart
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`failure
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`parameters
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`Warfarin and coagulation markers
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`Effects of enalapril during exercise
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`Epoprostenol
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`in CHF: The FIRSTtrial
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`Outcomes, Health Policy, and Managed Care
`NY surgeons view their outcomes
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`Acute Ischemic Heart Disease
`Usefulness of TIMI system
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`Age as mojor
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`risk foctor
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`for hemorrhagic
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`Imaging/Diagnostic Testing
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`Clinical-based algorithm before noncardiac surgery
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`Eledrophysiology
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`AUG11 1997
`
`iEPLTH SCIENCES LIBRARIES i
`Interventional Cardiology .
`~
`Recycling catheters
`)
`
`,.
`
`I
`
`PTCA guiding catheter size
`
`;tth;M~eii~g~;page'138.
`-..
`
`.-.' ....,:
`
`.-'"
`
`-',
`
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`American Heart journal
`Copyright © 1997 by Mosby- Yeor Book, Inc.
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`Robert M Coliff, MD, arid Daniel B. Mark, MD, MPH, Durham, N.C
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`Congestive Heart Failu.e
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`trial: A stimulus for further
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`Effect of amlodipine on norepinephrine kinetics and
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`Steven R. Goldsmith, MD, Minneapolis, Minn.
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`American Heart Journal 3A
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`Medtronic Exhibit 1470
`
`

`

`Comparison of 6F with 7Fand SFguiding catheters
`for elective coronary angioplasty: Results of a
`prospective, multicenter, randomized trial
`
`Danlien Metz, MD,a Pierre Meyer, MD,b Claude Touati, MD,b Pierre Coste, MD,e Pierre Yves Petiteau, MD,d
`Philippe Durand, MD,b Rene Faivre, MD,d Thierry Lefevre, MD,e and Jacques Elaerts, MDa Reims, St Laurent du
`Vur, Bordeaux Pessac, Besancon, and NeuiUy, France
`
`study of assessment of the efficiency and safety of 6F (infernal
`A group of 460 patients was considered
`in our prospective
`by the femoral approach
`to perform elective percutaneous
`coronary
`angioplasty
`diameter
`0.062
`inches) guiding catheters
`by using conventional balloon systems. The patients were randomly assigned either a 6F guiding catheter (first group, n =
`231; 247 coronary
`lesions), or a 7F or 8F guiding catheter
`[second group, n ~ 229; 252 coronary
`lesions). The exclusion
`criteria were the ongoing myocardial
`infarction,
`the marked reduction of left ventricular function, and the decision to treat
`the lesion with a device not fitting the 6F guiding catheter. The angioplasty successrates (87% in the 6F group vs 88% in the
`7F or 8F group) and the stent implantation rates (21% vs 25%) were similar in both groups. The ischemic complication rates
`in the 6F group
`(death, 2 vs 1) were also similar. The incidence of the femoral complications was significantly less importonf
`time (36 ±
`p < 0.01). Significant
`than in the 7/8F group (13.8% vs 23.5%;
`differences
`also were noted for the procedural
`22 vs 41 ± 28 min; p < O.OJl,
`time (11 ± 10 vs 14 ± 4 min; p < 0.051,
`the fluoroscopy
`the volume of contrast
`injected (136
`± 68 ml vs 168 ± 95 ml; p < 0.0001),
`sheath removal 111.7 ± 9 vs
`and the time of femoral compression
`after the introducer
`14.1 ± 12 min; p < 0.01). Our data suggest that 6F guiding catheters for elective coronary angioplasty are more effective
`than are the larger diameter catheters. Besides a significant decrease of vascular complications, angioplasty with a 6F quid-
`ing catheter
`reduces
`the procedural
`time and the amount of contrast.
`[Am HeortJ
`1997; 134: 131.137.)
`
`factor in
`choice is an important
`The guiding-catheter
`coronary angioplasty success. It must offer a compro-
`mise between its back-up support allowing balloon
`catheters
`to reach and cross severe narrowing,
`its corn-
`patibility with' bailout
`techniques
`in failed angioplasty,
`and its coronary ostia tolerance. Large guiding catheters
`are usually considered to fulfill these requirements, but
`they are associated with an increased risk of bleeding
`complications
`at the vascular access site, especially
`when a severe anticoagulation regimen is necessary
`(e.g.,
`after stenting)."
`2
`
`From the Sections of In/erventional Cardiology, °Hospilal Robert Debre, blnstilul
`AmoutJ Tzanck,
`"Hospital Sud, dClinique 51. Vincent, and eClinique Horfrncno. A com-
`plete list of principal
`investigators and sfudy coordinators
`is provided
`in the appendix.
`in part by Cordis Corporafion.
`Supported
`have no commercial or financial interest in Cordis and had full control of
`The authors
`the study protocol design, data analysis, and manuscript preparation.
`Received
`for publicarion Aug. 7, 1996; accepted March 31, 1997
`Reprint
`reqoesfs: Domien Metz, Service de Cordi%gie Hopitol Robert Debre,
`51092 Re;ms, France.
`Copyright © 1997 by Mosby-
`Year Book,
`0002-8703/$5.00 + 0 4/1/82315
`
`Inc.
`
`Recent reports show successful coronary angioplasty
`with 7F,36F4~7guiding catheters, and even with 6F and
`4F diagnostic cathetcrs.v!" The theoretic advantages of
`smaller catheters include reduced local vascular compli-
`cations,
`less bleeding during percutaneous
`transluminal
`coronary
`angioplasty
`(PTGA), decreased
`coronary pres-
`sure damping, and therefore earlier hospital discharge and
`cost savings. On the other hand, in spite of an improved
`maneuverability, its potential disadvantages include an
`inadequate back-up support and a potential increased
`procedure failure. Furthermore,
`the lack of an angiograph-
`ic quality control, in comparison with that obtained with
`larger guiding catheters, remains a controversial problem.
`However, preliminary studies suggest that 6F guiding
`catheters are not prejudicial to the success and safety of
`the procedure- 7 because of their ability to accommodate
`intracoronary unsheathed Pahnaz-Schatz stents.!! 12
`The aim of this prospective
`randomized multicenter
`trial was therefore
`the assessment of the technical
`performance
`and the possible clinical advantages
`PTCA by using a 6F guiding catheter
`in comparison
`with usual PTCA with a 7F or SF guiding catheter.
`
`of
`
`Page 3
`
`Medtronic Exhibit 1470
`
`

`

`132 Melz el 01
`
`t
`
`Methods
`Patient population and selection criteria
`A multicenter
`cohort of 460 patients was prospectively
`randomized
`over a 7-month period between May 1994 and
`December
`1994. The investigators were selected on the basis
`of their previous experience with 6F
`7F, or 8F guiding
`catheters (GCs). Only physicians having a prior personal
`experience
`of ;::100 6F PTCA procedures were considered
`for the trial.
`Only patients with demonstrated ischemic heart disease
`with angiographic
`coronary artery disease or coronary artery
`bypass grafts deemed suitable for balloon angioplasty were
`considered
`for the trial. Candidates
`eligible for the study
`included successive patients, except
`those with the following
`criteria: ongoing acute myocardial
`infarction, 6F device not
`fitting the coronary anatomy (atherectomy), marked reduc-
`tion of left ventricular
`last remaining
`ejection fraction «300!o),
`coronary vessel,
`the need for radial approach,
`and patients
`enrolled in another
`study. Previous coronary angioplasty was
`not a criterion of exclusion.
`PICA procedure
`femoral
`by the percutaneous
`Angioplasry was performed
`approach
`according to current clinical practice and after the
`informed consent of the patient had been obtained. All
`patients
`received either
`long-term oral aspirin, 100 to 250
`mg/day, or intravenous
`aspirin, 250 to 500 mg, before the
`P'TCA procedure. Full heparinization was performed
`after
`arterial access by using an intravenous
`bolus of 10,000 to
`15,000 U, with repeated bolus if needed.
`'The GC was insert-
`ed through a catheter-sheath
`introducer of the same size as
`the GC used during the PTCA.
`W11en the randomization
`assigned a 6F GC size for the
`PTCA procedure,
`a Cordis Petite Brite tip 61"guiding catheter
`(Cordis Corp., Miami, Fla.) was used with all the available
`configurations
`including Judkins
`left and right, Amplarz left
`and right, Extra backup.U multipurpose, EI Gamal, Bypass
`left and right, and internal mammal)'. This GC has an inner
`diameter of 0.062 inches, allowing balloon shafts :S:3.5Fand
`the use of most standard "rapid exchange"
`and "over the
`wire" balloon catheters
`commercially
`available. When 7F or
`SF GCs were used,
`the size was decided by the operator's
`judgment
`about
`[he coronary anatomy and the approach
`condition
`of the lesion. Guide wires and balloon catheters
`.were chosen without
`restriction by the operator
`in the two
`groups. Contrast
`injections were manually performed with a
`standard coronary injection syringe by using either
`ionic or
`nonicnic
`contrast dye.
`If a stenting procedure was decided on, additional heparin
`was given if needed. When 6F GCs were used, only uncoat-
`ed Palmaz-Schatz balloon expandable
`stents were available,
`generally manually crimped onto the previously used
`Monorail balloon.U:
`stent was used
`12 The Gianturco-Roubin
`
`only in the SF group or after a crossing over. In these stented
`patients, adjunctive oral ticlopldlne
`(250 or 500 mg/day) was
`administrated
`the day of stent
`implantation
`and given over a
`6-week period without coumadin.l''
`-1 hours after the
`Femoral sheaths were removed either
`angioplasty or me day after, following the operator's
`deci-
`sion. Heparin infusion was maintained
`in patients with
`unstable
`angina or in whom sheaths were left in place. Local
`hemostasis
`after sheath removal was achieved by either
`manual or mechanical
`(Pemostop, Radi Medical System,
`Uppsala, Sweden) compression.
`
`End points and data collection
`toler-
`The study purpose was to assess PTCA efficiency,
`ance of the procedure,
`and the peripheral vascular complica-
`tion rate with 6F GCs.
`The PTCA efficiency was judged by the PTCA success rate,
`the time required for fluoroscopy,
`the procedure
`time begin-
`ning with the introduction
`of the first GC through the aorta,
`the number of devices and amount of contrast used, and
`final PTCA results after stenting,
`if needed. The technical suc-
`cess of angioplasty,
`clinical or electrocardiographic
`evidence
`of ischemia after the procedure,
`and events like abrupt clo-
`sure, myocardial
`infarction, need for emergency coronary
`surgery, and death were assessed.
`evaluation of GC ability
`An additional subjective operator
`satisfactory; 2, acceptable; 3, mod-
`was noted from 1 to 4 0,
`erate; and 4, unacceptable).
`the back-up sup-
`It concerned
`port,
`the coronary ostia tolerance
`(either coronary artery
`"damping" and spasm, dissection,
`and coronary slow flow),
`the GC stability, the coronary dye injection,
`the balloon slid-
`ing, and the quality of the angiogram. The procedure
`toler-
`ance was further estimated by the femoral bleeding (assessed
`subjectively by the operator during the procedure
`and deter-
`mined by the decrease
`in hemoglobin
`concentration
`before
`and after the PTCA procedure),
`the renal function (serum
`creatinine levels), and the creatine kinase increase the day
`after the angioplasry.
`like groin
`The peripheral vascular complications
`hematoma,
`false aneurysm, or ecchymosis were judged by a
`physician examination,
`other
`than the primary operator.
`Moreover,
`the lime between PTCA and the sheath removal,
`the time necessary to achieve local hemostasis
`after sheath
`removal, duration of supine bed rest, and duration of hospi-
`talization also were assessed.
`data were
`Clinical, procedural,
`and postprocedural
`database
`file.
`prospectively collected in a computerized
`Qualitative analysis was performed with cineangiograms
`two independent
`invasive cardiologists who were not
`informed about
`the clinical outcome,
`the GC size, or the
`stent used. Lesions before angloplasry and after PTCA dissec-
`tion were classified by visual assessment
`by using [WO
`orthogonal
`projections.
`IS. J6 Thrombolysis
`in myocardial
`infarction (TI.MI) flow grade after angioplasty was evaluated.
`
`by
`
`American Heart Journal
`july 1997
`
`Page 4
`
`Medtronic Exhibit 1470
`
`

`

`Metz et 01.
`
`133
`
`Number
`Age (yr)
`Sex (% female)
`Stable angina
`Unstable angina
`Prior MI
`Prior PTCA
`Prior CABG
`
`229
`61.± 11
`6
`77(33%)
`100 (44%)
`52 (23%)
`19 (8.3%}
`15 (6.6%1
`
`231
`62 ± 11
`4.8
`83 (36%1
`86 (37%)
`62 (27%1
`23 (10%)
`14(6.1%)
`
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`
`CABG, Comncry
`
`artery bypass graft; /'1\:, n'yocard,ol,nlo:dion.
`
`An additional subjective semiquantitative analysis was per-
`formed in the selected view, where the final result was
`judged the most pejorative. A residual stenosis of <50%and a
`normal anterograde flow defined angiographic success, and a
`residual stenosis of <30%without dissection grade more than
`type B defined a "perfect" result.
`A further quantitative coronary angiographic analysis was
`performed by a trained technician on previous selected end-
`diastolic cine frames from views showing the lesion clearly
`without overlap or foreshortening. Pre- and post-PTCAper-
`centage stenosis at the lesion site was determined in the
`most suggestive frame and measured with digital electronic
`calipers and computer-assisted edge detection. Each narrow-
`ing of a Iesioned coronary artery was compared with the
`normal adjacent arterial regions and eJ~pressedin percentiles.
`
`Statistical analysis
`All data are presented as mean ± SD. Differences in cate-
`goric variables were analyzed by chi-square tests, and differ-
`ences in continuous variables were analyzed by unpaired
`Student's t tests. Tests of differences were two-sided and the
`limit of significance was set at p = 0.05.
`
`Results
`Clinical and angiographic characteristics of the 460
`randomized
`patients are summarized in Tables I and II.
`Coronary angioplasty was attempted in 247 lesions of
`231 patients by using a 6F GC and in 252 lesions of 229
`patients by using a 7F (85%) or an 8F 05%) Gc. There
`were no differences
`in gender, mean age, unstable
`exertional angina,
`location, or American Heart
`Association! American College of Cardiology class coro-
`nary lesions, Of the angioplasty procedures, 75% were
`performed immediately after the coronary angiography
`with the same rate in both groups (72% in the 6F group
`vs 77% in the 7F/8F group; p ~ NS). Overall angiopiasty
`success rate was similar in both groups (87% in the 6F
`group vs 88% in the 7F/8F group; p ~ NS), with coro-
`nary stenting if needed (21% vs 25%; P ~ NS). The
`
`American HeartJournal
`Volume 134, Number 1
`
`No. of lesions
`Lesionsper patient
`Ejection fraction
`Multivessel disease
`Lesion location
`Left main
`Leftanterior
`descending artery
`Right coronory artery
`Leftcircumflex artery
`Saphenous CABG
`Type of lesion
`TypeAand Bl
`Type B2
`Type C
`Mean stenosis(%)
`Restenosis
`
`252
`1.1
`0.65 ± 0.13
`62(27%)
`
`247
`1.07
`0.64±0.14
`64 (27%)
`
`0
`105
`
`66
`80
`1
`
`1
`103
`
`81
`60
`3
`
`133 (53%)
`102 (40%1
`17 (7%)
`85.4 ± 11
`13 (5.7%1
`
`141 (57%)
`93 (38%1
`13(5%)
`83.5 ± 12
`17(7:4%)
`
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`
`mean residual stenosis in the successfully dilated lesions
`was 34.4% ± 21% in the 6F group and 34.5% ± 21% in
`the 7F/8F group (p ~ NS). In-hospital outcome was sim-
`ilar in the two groups, with no significant difference in
`ischemic complication rates (non-Q wave myocardial
`infarctions, coronary bypass grafting, and deaths), and
`in duration of hospitalization (Table un The amount of
`contrast agents (136 ± 75 vs 167 ± 90 ml; p < 0.0001),
`the procedure time (36 ± 22 minutes vs 41 ± 28 min-
`utes; p < 0.01), and the fluoroscopy time 01 ± 9 min-
`utes vs 14 ± 14 minutes; p < 0.05) were significantly less
`in the 6F group. Subjective assessment of GC efficacy
`is shown in Table N.
`by the PTCA primary operator
`Vessel opacification at the lesion site after balloon infla-
`tion with the guide wire across the lesion and the bal-
`loon withdrawn was subjectively better appreciated in
`tl,e 7F/8F group. Conversely,
`the hack-up support,
`the
`maneuverability,
`the ostia tolerance, and the reduced
`procedural bleeding were significantly superior in the
`6F GC group, with an overall reduction in procedure
`duration. In this group, a significant decrease of bleed-
`ing complications at the vascular access site was noted
`03.8% vs 23.5%;P < 0.01) with a significant difference
`for the compression time after sheath removal (11.7 ± 9
`minutes vs 14.1 ± 12 minutes; p < 0.01) and supine bed-
`rest duration (34 ± 12 hours vs 37 ± 13 hours; p < 0.05;
`in the 6F group required a
`Table \I). One patient
`delayed surgical repair at the vascular access site after
`the ticlopidine regimen was stopped. Nevertheless, no
`significant differences appeared between both groups
`concerning changes in creatinine level, but there was a
`significant decrease in hemoglobin level in the 7F/8F
`
`Page 5
`
`Medtronic Exhibit 1470
`
`

`

`134 Melz e: 01.
`
`. Table m, T~chni~al, ang,iogr~phi~:~~,~d
`Size of the GC
`
`used
`used
`
`Technical considerations
`PTCA ad hac
`Heparin dose bolus (lUj
`Procedure
`time {min)
`Fluoroscopy lime
`(min)
`Amount of contrast (mil
`Number of balloon catheters
`Number of guiding catheters
`Crossover exchange
`Angiographic
`results
`Procedural
`success
`Residual stenosis after PICA (%)
`Perfect
`result
`Coronary slenting
`Bailout
`Suboptimal
`Elective
`Stent failure
`Clinical complications
`Non-O wave M I
`CABG
`Death
`
`result
`
`CABG, Coronary ortery byposs 9,oft; MI, myocardiol
`
`Infarction,
`
`176(77%)
`.l1,400 ± 3,200
`41 ± 2B
`14± 14
`168 ± 95
`270 IU8/paNenl}
`260IU3/paNent)
`4
`
`88%
`34.5 ± 21
`66%
`57(24.9%1
`31 (54%)
`19 (34%}
`7(12%)
`1
`
`8 (3.5%}
`2 (0.8%1
`1 (0.4%1
`
`6F
`
`166 {72%1
`10,600 ± 3,500
`36±22
`11 ± 9
`136 ± 68
`253 [l.Ov/pottenf
`265 (U5/paNenf)
`1
`
`87%
`34.4 ± 21
`66%
`48 (20.7%}
`25 (52%)
`18 (3B%)
`5 (10%1
`o
`
`4 (1.7%1
`1(0.4%)
`2108%)
`
`pValue
`
`NS
`NS
`<0.01
`<0.05
`<0.0001NS
`NS
`
`NS
`NS
`NS
`NS
`NS
`NS
`NS
`
`NS
`NS
`NS
`
`: Tabl'; IV. Evaluation scor~ of GC efficacy by PICA'pri'~-;;ry::]
`,~~,:·.;::'1{
`P Value
`
`_'_"
`
`i~.
`
`physician
`-. investigator
`Size ofthe GC
`
`7F/8F
`
`6F
`
`Backup support
`Maneuverability
`Ostia tolerance
`Vessel opacification
`Balloon catheter
`sliding
`Device exchange
`Procedural blood loss
`
`1.6 ± 0.9
`1.4 ± 0.7
`1.9 ± 0.8
`1.2 ± 0.5
`1.1 ± 0.3
`1.08 ± 0.3
`1.7 ± 0.6
`
`1.2 ± O.S
`1.1 ± 0.3
`1.3 ± 0.7
`1.4 ± 0.5
`1.1 ±0.3
`1.06 ± 0.2
`1.05 ± 0.3
`
`<0.005
`<0.001
`<0.0001
`<0.05NS
`NS
`<0.0001
`
`group (fable V).
`Discussion
`Since the introduction of PTCA for treatment of coro-
`nary artery disease, angioplasty equipment has been
`miniaturized. Until then,
`the combination of low-profile
`balloon catheters with large inner-lumen 6F GCs was,
`however,
`judged a controversial compromise between
`the procedure
`effectiveness and the prevention of post-
`procedural vascular complications,
`especially when
`stenting was necessary. The vascular access site may
`indeed be a site for bleeding complications,
`because
`the sheath must be retrieved without
`interruption of the
`anticoagulation regimen. These bleeding complications
`can partially be prevented by the use of mechanical
`external compression.
`In spite of various bailout devices
`
`safety,
`compatible with 6F GCs that enhance procedur..l
`especially the Palmaz-Schatz stentl!' 12 and pertu sion
`balloon carheters.F: 18its capacity to perform elective
`PTCA and to have proper angiographic
`control before
`the removal of the guide wire is still under discussion.
`Many of the procedures
`that use GCs with small inner
`diameters have been compromised
`by poor angie-
`graphic visualization of the coronary arteries with the
`balloon catheter placed in the GC and are the result of
`the bad secondary profile of the bigger balloons (vwing-
`ing" effect). Our study reports the summarized data of a
`prospective
`randomized trial comparing the 6F GCs
`with larger catheters in elective PTCA. An important and
`positive conclusion of this study is that the majority of
`coronary angioplasty procedures may be currently per-
`formed through a 6F O.062-inch inner diameter GC, as
`well as with a larger Gc.
`that the use of a 6F GC
`Thus our data demonstrate
`does not decrease the procedural
`success rate of elec-
`tive PTCA. Procedural
`failures in this 6F study group
`were not
`in relation with the size of GC, but they were
`the result of the incapacity of the balloon catheter
`to
`reach, cross, or dilate the culprit
`lesion with a satisfacto-
`if the operator
`result. At any moment,
`ry angiographic
`judged the GC size not optimal, he or she could
`exchange it with a larger one to complete the proce-
`dure. Four procedures with a 7F/8F GC that failed
`
`American Heart Journal
`,
`july 1997
`
`Page 6
`
`Medtronic Exhibit 1470
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`

`Metz et ol.
`
`135
`
`<0.01NS
`NS
`NS
`
`NS
`<0.01
`<0.05NS
`NS
`
`NS
`NS
`NS
`<0.05NS
`
`32(13.8%)
`14(6%)
`6(2.6%)
`12(5.2%)
`
`11
`
`12.3 ± 10
`11.7±9
`34± 12
`3±2
`199(86.1%)
`
`96.9 ± 22
`99.4± 23
`
`9.3± 1
`9.1 ± 1.3
`1.06 ± 0.2
`
`54 (23.5%1
`25 (10.1%)
`7(3%)
`22 (9.5%)
`
`o 2
`
`12.5± 9
`14.1 ± 12
`37± 13
`3.45 ± 2.8
`201 (87.7%)
`
`100.8 ± 34
`106.5±27
`
`9.2 ± 1.7
`8.7 ± 1.4
`1.05 ± 0.2
`
`(hr)
`
`complications
`Femoral
`Groin hematoma
`Folse aneurysms
`Bruises
`repairs
`Surgical
`Blood fransfusions
`Duration
`Time to sheath removal
`Compression
`time {min)
`Duration of supine bed rest (hr}
`(days)
`Time 10 hospital dischorge
`success without
`Procedural
`in-hospital events
`Biologic data
`levels {lUJ
`Creatinine
`Before PICA
`After PTCA
`levels (IU)
`Hemoglobin
`Before PICA
`After PICA
`Patient satisfaction
`
`because of pressure clamping or impossibility of selec-
`tively cannulating the right coronary ostia were success-
`fully completed
`after crossover exchange with a 6F Gc.
`During the procedure, manipulation of the devices
`inside the GC was judged easy without severe friction
`of the balloon catheter and resulted in a shorter proce-
`dure time. The balloon could always be retracted -in the
`GG Nevertheless,
`the operator's evaluation of the quali-
`ty of the angiographic
`control was better appreciated
`with the larger GC size. This explained the predominant
`routine use of monorail
`rapid-exchange balloon
`catheters with the 6F GC size. Apart from the facility to
`perform a rapid stent implantation with the previously
`used balloon catheter and consequent
`cost savings in a
`bailout situation,
`the monorail design allows easier con-
`trast injection and optimizes the coronary angiogram
`with the distal tip maintained in the coronary artery and
`out of the guiding catheter. For precise positioning of
`the stent before deployment by adequate angiographic
`control, stronger contrast dye injection was required
`with 6F GCs. Our series shows that 6F GCs provided
`good back-up support. This parameter
`is caused most
`by the rigidity of the material
`tlian the GC size. In diffi-
`culties in reaching or crossing the culprit lesion with a
`low-profile balloon catlieter, 6F GCs could be carefully
`engaged deeper over the balloon catheter shaft and
`thus provide safe additional back-up support. Coronary
`ostia tolerance with 6F GCs was always judged ade-
`
`quare in this trial, without pressure damping or coro-
`nary ostia dissection.
`No significant difference in ischemic complications
`after coronary angioplasty by using 6F GCs during the
`hospitalization was demonstrated in our study, and the
`6F GCs were considered as safe as 7F or SF GCs. Mostly
`only non-Q wave myocardial
`infarction with an increase
`in CK levels of <500 IV occurred in this series. This was
`caused by the compatibility of the 6F GCs with some
`bailout devices. Nevertheless, bailout device choice
`remains limited to the naked Palmaz-Schatz stentll,
`12
`and perfusion balloon cathetersl7-18 during this study
`period. Thus the possibility of performing a PTCA pro-
`cedure with a 6F GC and achieving a perfect anglo-
`graphic result is limited by the prosthesis quality and its
`cross ability. The Palmaz-Schatz stent is not considered
`able to offer satisfactory results in a bend or in coronary
`lesions located after severe tortuous coronary segments,
`unlike the incompatible 6F Wiktor or Gianturco-Roubin
`stents. A crossover exchange with an SF GC in the 6F
`group was required for a Gianturco-Roubin stent
`implantation. This incompatibility could be partially cir-
`cumvented in poorly tolerated prolonged balloon infla-
`tion by the possibility of restoring satisfactory coronary
`perfusion by using a low-profile autoperfusion balloon
`catheter. The stent delivery system (a protective sheath
`that covers the balloon and the premounted stent) of
`the Palmaz-Schatz device does not fit a O.062'inch 6F
`GC (compatible with a ;'SF size) and does not allow the
`
`American Heart Journal
`Volume 134, Number 1
`
`Page 7
`
`Medtronic Exhibit 1470
`
`

`

`136 Melzet01.
`
`advantage of lack of embolization risk of this device,
`in
`spite of its entirely nonoptimal profile to cross coronary
`lesions. Conversely and independent
`of the GC size, it
`is important, when the lesion cannot be crossed with
`the unsheathed
`stent,
`to retrieve the GC and the bal-
`loon stent entirely, preferably over the guide wire,
`which remains in position. Thus the return of the bal-
`loon-mounted
`stent in the GC can safely be attempted
`in the descending aorta.
`issue of this trial is the clinical advan-
`An important
`tage of the 6F GC in preventing complications
`in vascu-
`lar site access. This point was not previously demon-
`strated in a randomized trial comparing 7F and SF
`GCS.19However,
`to consider
`the overall
`it is important
`bleeding complication rate of the whole sample. These
`were less in comparison to those previously pub-
`lished'9,
`20 In spite of a stenting rate of >21%, we
`observed durIng the in-hospital period a groin
`hematoma or bruises in 16% of the procedures. One
`(0,2%) patient
`required surgical repair, and three (0,6%) ,
`patients required blood transfusions, Probably such vas-
`cular complications depend more on the procedural
`arterial puncture quality and meticulous monitoring of
`the puncture site by the medical and nurse staff after
`return to the ward than on the GC size. A further gain is
`obtained by reducing the time of compression after
`removal of the 6F-size femoral sheath and allowing
`early ambulation, Another potential advantage of the 6F
`size in preventing vascular complications
`is that it
`allows performance of PTCA through the radial
`approach." This option had been initially excluded
`from the study design because of incompatibility with
`the randomized design with larger GCs, In addition to a
`smaller femoral artery puncture site, one of the poten-
`tial advantages of the use of 6F GCs was reduced bleed-
`ing with diminished backbleeding during balloon
`catheter
`introduction and exchange.
`In this setting, our
`data show a better subjective amount of procedural
`bleeding, demonsrrated by the significantly reduced
`hemoglobin level decreases,
`Miniaturization of PTCA devices suggested the need
`for cost reduction including the facilitation of early
`ambulation and earlier hospital discharge.
`In our series,
`we' noticed an average of 30 mlless contrast medium
`used for the patients in the 6F group, No difference
`appears in the creatinine level. This benefits represent
`potential cost savings, especially when nonionic con-
`trast agents are used. Thus in a detailed economic
`analysis, Talley et al.22 demonstrated
`a cost-saving effect
`of PTCA performed with 6F GCs because of a smaller
`
`sheath insertiC?nand a
`arteriotomy accompanying
`reduced rate of clinical coronary and peripheral vascu-
`lar complications. Reduction in cost is further amplified
`if PTCA is immediately performed at the time of the
`diagnostic catheterizanon/f
`requiring a larger
`24 without
`French system and through the same femoral sheath,
`The most
`important potential
`limitation of this study
`is probabiy the intentional comparison of the 6F GC
`size with either 7F or SF GC size, In only 15% of the
`patients
`in the Iarger-Gc group were SF GCs used.
`Indeed it was not possible to consider only the SF size
`because 7F and 6F sizes were used routinely before the
`onset of the trial in all participating catheterization lab-
`oratories. Only the SF size has a sufficient
`inner diame-
`ter for crossing devices such as Wiktor or Gianturco-
`Roubin stents during the study period. Thus it was not
`judged ethical
`to rule out these specific bailout means.
`However, a significant difference appeared
`in our study
`by using a majority of 7F GCs in the 7F1SF group in the
`prevention
`of vascular complications
`and in the
`amount of contrast used. These differences will be
`probably emphasized in a trial comparing 6F and
`exclusively SF GCs,
`of the GC
`evaluation
`In addition,
`the subjective
`efficiency could not be blindly assessed by the PTCA
`operator. Thus operator bias may be present
`in the
`technical-characteristics
`analysis of the Gc. Because
`the operators
`routinely used 6F GCs,
`this probably
`artificially enhanced
`some of the subjective parame-
`ter outcomes.
`In conclusion. our data show that the 6F GC is rather
`efficient and safe for performing elective PTCA when
`compared with larger-diameter GCs. There are signifi-
`cant advantages of the 6F GCs in decreasing procedural
`time and in preventing vascular complications. The
`main limitation of the 6F GC is the use of stents com-
`patible with this size, Thus further progress is required
`in this setting to extend 6F-compatible devices and par-
`ticularly flexible stents able to cross tortuous coronary
`segments and to be implanted at curved lesion sites.
`We thank A. Aimonetti, CV7;for excellent logistic sup-
`pan, and thank all the participating catheterization labo-
`ratory teams.
`
`References
`1. Serruys PW, De [oeqere P, Ktemenef F,Macaya C, RutschW,
`Heyndrlckx G, et 01.for the Benestent Study Group. A comparison of
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`patients with coronary artery disease. N Engl J Med 1994;331 :489-95.
`
`American Heart Journal
`July 1997
`
`Page 8
`
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`

`

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`
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`P, Schmitt, Durand P,Guarino L,lena P,Gomez-Moreno J
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