:ae TerMANaSoatES (see : : as = =o
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`
`
`Zeitschrift fiir
`
`Kardiologie
`Vol. 76, Supplement 6 (1987)
`German Journal of Cardiology
`Organ of the German Society for Heart and Circulation
`Research
`
`Fditors
`
`Scientific Committee
`
`Prof. Dr. P.R. Lichtlen
`Abteilung flr Kardiologie
`Department flr Innere Medizin
`Konstanty-Gutschow-Strake 8
`3000 Hannover 61
`Prof. Dr. F. Loogen
`Medizinische Klinik (Kardiologie)
`Universitat Dusseldorf
`Moorenstrake 5
`4000 Dusseldorf 1
`
`W.E. Adam, Ulm
`E. Bassenge, Freiburg
`G. Breithardt, Dusseldorf
`J.C. Frolich, Hannover
`P. Heintzen, Kiel
`W. Hort, Dusseldorf
`M. Kaltenbach, Frankfurt/M.
`H. Krayenbuhl, Zurich
`W. Kubler, Heidelberg
`B, Luderitz, Bonn
`L. Seipel, Tubingen
`
`
`Advisory Board
`
`K. Bachmann, Erlangen
`F. Bender, Minster i. W.
`W.Bircks, Diisseldorf
`W.Bleifeld, Hamburg
`H. BlOmer, Munchen
`D. Burckhardt, Basel
`S. Effert. Aachen
`H. Gillmann, Ludwigshafen
`U. Gleichmann, Bad Oeynhausen
`
`H.P. Gurtner, Bern
`H.H. Hilger, Koln
`H, Hochrein, Berlin
`R. Jacob, Tubingen
`H. Just, Freiburg i. Br.
`F, Kaindl, Wien
`J. Keul, Freiburg
`K. Kochsiek, Wurzburg
`H. Kreuzer, Gdttingen
`
`H. Kuhn, Bielefeld
`K.H. Leitz, Bremen
`O. Pachinger, Wien
`H. Roskamm, Bad Krozingen
`W. Schaper, Bad Nauheim
`M. Schlepper, Bad Nauheim
`W. Schoop, Engelskirchen
`B.E. Strauer, Dusseldorf
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`

`Z. Kardiol. 76, Supplement 6 (1987)
`
`T. Bonzel, P.W. Serruys (Eds.)
`
`Intravascular
`and Intracardiac
`Interventional
`Catheter Therapy
`
`Techniques and Instrumentation
`
` @ Steinkopff Verlag Darmstadt
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`ISSN 0300-5860
`
`This work is subject to copyright. All rights are reserved, whether the whole or part of Aeailing,e
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`1965,
`in
`parts thereofis only permitted under the provisions of the German Copyright Law of
`Sep th vosecution
`its version of June 24, 1985, and a copyright fee must always be paid. Violations fall under
`the p
`act of the German Copyright Law.
`
`Darmstadt
`:
`ated
`+
`:
`«
`Ls
`Copyright © 1987 by Dr. Dietrich Steinkopff Verlag GmbH & Co. KG,
`fae"
`Medicaleditor: Juliane K. Weller - Copy editing: Deborah Marston - Production: Heinz J. Schafer
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`Printed in Germany
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`The use ofregistered names, trademarks, etc, in this publication does not imply, even inthe apseoe
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`Zeitschrift fir
`
`
` Ka rdiologie Z. Kardiol. 76: Suppl. 6, VI (1987)
`
`Contents
`
`Introduction 20.ee ee
`
`Vv
`
`PTCA - Clinical aspects
`King IH, SB... ee ee ee ee
`
`1
`
`Technology of current dilatation systems and methodological procedures
`Meier, BL
`22.ee 5
`
`Radiological prerequisites for spatial intracoronary orientation and quantitation in interventional
`cardiology
`Wollschlager, H., Bonzel, T., Zeiher, A.M., Just, H. 2.2... . eee ee 11
`
`Methodsfor the assessment of PTCA success
`Luijten, H.E., Serruys, PW...0 15
`
`Platelet-vessel wall interactions in the development of restenosis after coronary angioplasty
`Monsen, C.H., Adams, P.C., Badimon, L., Chesebro, J.H., Fuster, V. 2... 2... 2. we,
`
`23
`
`Coronary angioplasty guidewire technology
`(Powell) McDermott B.A. 200ee eee 29
`
`Dilatation balloons: polymer selection, balloon design and assembly
`Crittenden,JF.ee 33
`
`The use of pressure-volume curves to assess the mechanism and adequacy of stenosis dilatation by
`balloon angioplasty
`Demer, L.L., Biichi, M., Nishikawa, A., Smalling, R.W., Gould, K.L.
`
`2... .........00,
`
`37
`
`Technology and laboratory investigation of perfusion and transfusion techniques
`Busch, U. 2... kkk es 43
`
`Continuous coronary perfusion and prolonged balloon inflation during stenosis dilatation
`Erbel, R., Rupprecht, H.J., Busch, U., Darius, H., Pop, T., Blomer, H., Meyer,J.
`........
`
`49
`
`Long wire technique — experience with 1000 procedures
`Kaltenbach, M., Vallbracht, C., Kober, G. 2... 2.0.0.0... 000. ee eee eee 53
`
`Rotational approaches to atherectomy and thrombectomy
`Ritchie, J.L., Hansen, D.D., Intlekofer, M.J., Hall, M., Auth, D.C. 2... 2.2.0, 59
`
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`Vu
`
`Contents
`
`A
`Spark erosionof arteriosclerotic plaques
`Slager, C.J., Phaff, A.C., Essed, C.E., Schuurbiers, J.C.H., Bom, N., Vandenbroucke, V.A.,
`Serruys, P.W.
`Lee 67
`
`Balloon valvuloplasty in congenital and acquired heart disease: morphologic considerations
`Becker, A.E., Hoedemaker,G.ee
`Changing conceptsin the diagnosis and management of patients with valvular heart disease:
`a clinician’s view
`Alpert, JS., Dalen,NEee
`Transfemoral plug closure of patent ductus arteriosus
`Bussmann, W.-D., Sievert, H., Kohler, K.P., Hanke, H., Nieméller, E., Kaltenbach,M. .... -
`Ballondilatation kongenitaler Aortenstenosen
`Neuhaus, K.-L., Rupprath,Ge
`Percutaneous aortic valve dilatation: indications and results in adult acquired calcified aortic stenosis
`Cribier, A., Berland, J., Savin,T., Koning, R., Mechmeche,R., Letac, B22. es
`Mitral balloon valvuloplasty in adults
`Vahanian, A., Michel, P.L., Slama, M., Cormier, B., Trabelsi, S., Dermine, P., Acar, J.
`Transarterial balloon mitral valvuloplasty
`Babic, U.U., Pejcic, P., Djurisic, Z., Vucinic, M., Grujicic, SM. De ee
`The sliding rail system (monorail): description of a new technique for intravascular instrumentation
`119
`and its application to coronary angioplasty
`Bonzel, T., Wollschlager, H., Kasper, W., Meinertz, T., Just, Ho 22. ee
`SubjectIndex 123
`
`...--
`
`3
`
`81
`85
`91
`99
`105
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`
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`
`
`
`
`
`
`
`
`This material may be protected by copyright law (Title 17, U.S. Code)
`
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`
`Zeitschrift fur
`Kardiologie
`
`Z. Kardiol. 76: Suppl. 6, 119-122 (1987)
`
`The sliding rail system (monorail): description of a new
`technique for intravascular instrumentation and its application to
`coronary angioplasty
`
`T. Bonzel, H. Wollschlager, W. Kasper, T. Meinertz, H. Just
`
`University Medical Clinic, Dept. of Cardiology, Freiburg, West Germany
`
`Summary: Thesliding rail technique is a new
`technique for intravascular instrumentation, espe-
`cially coronary stenosis dilatation. The so-called
`monorail balloon catheter is the first device which
`can be used according to this technique. The
`monorail catheter has a single lumen shaft and
`only a short central tube within the distal balloon
`part. With the guidewire inserted into the tube,
`the balloon can be advanced or retracted on the
`guidewire as on a sliding rail. The most relevant
`improvements for coronary dilatation are steera-
`bility, contrast flow and rapid and easy exchan-
`geability of balloon catheters and other intracor-
`onary devices. These characteristics are felt to re-
`
`sult in a more simple and time- and fluorascopy-
`saving dilatation procedure. A special transfusion
`catheter may also improve procedural safety. The
`first clinical results in 69 patients with a success
`rate of 96%, an emergency bypass rate of two pa-
`tients (one infarction) and a stenosis improve-
`ment of 58% confirm the theoretically conceived
`advantages.
`
`technique: monorail
`Key words: sliding rail
`balloon catheter; coronary stenosis dilatation;
`contrast agent flow; exchangeability of cathe-
`ters.
`
`
`
`Introduction
`
`Two essential reasons can be cited for the suc-
`cess and spreadofthe clinical application of cor-
`onary stenosis balloon dilatation:
`firstly,
`the
`growth of personal experience and the accumula-
`tion of information from controlled studies, and
`secondly, the technological progress of radiologi-
`cal systems (1) and balloon catheter systems(2).
`Up to now the most important improvements of
`Griintzig’s original balloon catheter have been the
`steerable systems introduced by Simpson (3), cath-
`eters with improved trackability,
`introduced by
`Hartzler, and the long wire technique promoted
`by Kaltenbach (4). Nevertheless, some properties
`of dilatation systems still need to be improved,
`such as steerability, contrast flow and the rapid
`and safe exchangeability of intracoronary devices.
`To realise these demands, we have introduced the
`sliding rail technique for intravascular instrumen-
`tation and have applied the technique with the
`monorail catheter for coronary dilatation. The
`
`name “monorail” was coined by Meier and has
`been generally accepted.
`
`Materials
`
`The monorail catheter (Schneider-Shiley, Zu-
`rick) consists of a single lumen shaft with a distal
`balloon. A short central tube within the distal bal-
`loon with openings at the end and proximal to the
`balloon serves to take up the guidewire (Fig. 1).
`Thus the guidewire runs only over a short dis-
`tance within the distal catheter and runs outside
`and parallel to the catheter shaft over the rest of
`the distance. The single lumen catheter shaft with
`a low profile of 3 F serves for balloon inflation
`and deflation and to advance andretract the bal-
`loon over the guidewire, as on a sliding rail. The
`guidewire itself is of normal length with a diam-
`eter of 0.3 or 0.35 mm (Fig. 2).
`The procedure itself is modified as follows:
`first, the guidewire is advanced through a special
`
`
`
`
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`
`
`120 Z. Kardiol. 76: Suppl. 6 (1987)
`
`d
`
`
`ME
`
`
`
`Cee
`LPOEEE Leg
`ro
`
`ite
`VeeLEA,
`MEE
` SELESSASS ALTEISTPLIISES
`
`
`
`z,
`EEE
`
`LEEEE.
`SE
`
`
`
`
`\
`
`Fig. 1. Schematic representation of the monorail catheter
`based on the sliding rail principle. The catheter tip (balloon
`part) at the distal end of the guiding catheter and ‘the guide-
`wire are shown.(a) Guiding catheter, (b) gold markers,(c) bal-
`
`loon member, (d) single lumen catheter shaft, (e) indeflation
`tube, (f) guidewire, (g) contrast fluid, (h) central tube to take
`up the guidewire.
`
`y-connector (with a variable coaxial opening) into
`the guiding catheter and across the stenosis. Thus
`friction is reduced to a minimum within the wide
`tube of the guiding catheter, resulting in unhin-
`dered steerability. Next
`the balloon is pushed
`onto the guidewire and with the guidewire fixed
`at the outside is advanced through the y-connec-
`tor until crossing the stenosis. Correspondingly,
`the balloon may be retracted, readvanced or ex-
`changed in favor of other devices or different bal-
`loon sizes. Due to the low shaft profile, the re-
`maining space within the guiding catheter of 2
`mm’ cross sectional area permits a nearly normal
`contrast flow even with highly concentrated con-
`trast medium of 370 mg/ml iodine. In compari-
`son, this remaining space is 1.5 mm? with 3.6 F
`and 1.1 mm? with 4.3 F balloon catheter shafts
`(Fig. 3). Distal pressure measurementis not pro-
`vided in standard monorail dilatation catheters.
`A second device is a monorail transfusion cath-
`eter with a 4 F outer diameter and an especially
`wide lumen for autotransfusion of blood into the
`postocclusional coronary segment. This end open
`
`
`
`Fig. 2. Sliding rail dilatation system consisting of guiding
`catheter with y-connector (left) and monorail balloon catheter
`advanced along the guidewire and leaving the guiding cathe-
`ter.
`
`catheter has a soft distal tip and two side holes
`proximalto this tip as blood and guidewire exits.
`Flow rates between 40 and 60 ml/min or more of
`arterial blood may be transfused with a hand-op-
`erated syringe over a three-way stop cock at pres-
`
`a)
`
`#2,56mm £1,B3mm
`
`
`
`p1.42mmWL,
`#0,35mm
`
`
`
`
`DK=2.8 Fr
`
` FK=8 Fr
`
`Fig. 3. Cross section of an 8 F guiding catheter (FK,hatched)
`with dilatation catheters inside (DK, dense hatching). Outer
`diameter of the FK 2.66 mm,inner diameter 1.83 mm. (a) 43
`F, (b) 3.6 F dilatation catheter, each with two two luminue
`(white) to accommodatethe guidewire (hatched circle) and for
`inflation/deflation of the balloon.
`(c) Monorail dilatatron
`catheter according to the sliding rail principle: shaft with
`single lumen, guidewire beside it;
`large free cross-sectional
`area available for contrast medium (dotted, 2 mm°).
`
`
`
`
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` Bonzel et al., Description of a new technique for intravascular instrumentation and its application to coronary angioplasty
`
`Clinical results
`
`The sliding rail principle was studied with the
`application of monorail balloon catheters in 69
`consecutive patients (49 males and 16 females)
`aged 32 to 72 years with single vessel disease
`(> 50%, mean 78% diameter reduction). Angio-
`plasty was felt to be indicated with positive ECG
`or thallium exercise tests or with typical stable or
`unstable angina pectoris. Dilatation success was
`defined as diameter increase > 20% normal vessel
`diameter. Stenosis distribution was LAD 50,left
`circumflex 9, right coronary artery 4, others 6 ste-
`noses. Monorail catheters were always used ini-
`tially. Overall dilatation success rate was 96%. In
`five cases, special low profile catheters (Hartzler,
`Advanced Catheter Systems, Griintzig Pass Key,
`Schneider Shiley) had to be used for first stenosis
`passage because of primary failure of the mono-
`rail balloon. Stenosis passage with the monorail
`guidewire itselfwas possible in 99% of cases. A
`stenosis
`reduction to <30% was always at-
`tempted, necessitating the exchange of smaller in
`favourof larger balloons in 20 cases. The average
`final diameter improvement in successful dilata-
`tion was +58%, Mean guidewire and mean bal-
`loon passage times between y-connector and ste-
`nosis crossing were 98 s and 97 s, respectively.
`Mean balloon exchange time in 20 cases was 136
`s, including withdrawl of the first balloon from
`the distal guiding catheter, switch of indeflator
`“from first to second balloon, mounting of second
`balloon onto the guidewire and repassage of the
`.coronary stenosis. Contrast
`flow through the
`guiding catheter was not impaired at any time,
`yielding optimal stenosis morphology images be-
`fore, during and after the procedure.
`In two cases, emergency bypass surgery had to
`‘be performed becauseofirreversible acute steno-
`sis occlusion. In the second ofthese cases, a trans-
`fusion catheter (not available in the first case) was
`exchanged andarterial blood taken from the con-
`tralateral femoral artery was transfused by hand
`into the distal coronary segment. The procedure
`successfully reverted ischemia until surgery. Myo-
`cardial infarction, as documented by postsurgical
`ECG and LV-angiogram, could be avoided. De-
`tails of transfusion procedures will be published
`separately.
`
`121
`
`
`
`
`sures of 2-5 bar. The transfusion catheter is a
`among the most important features of coronary
`balloon catheters (5). In theory, the sliding rail
`bail- out device to control ischemia during trans-
`fer for emergency surgery in the case of acute cor-
`principle as described above provides these prop-
`onary occlusion.
`erties. The steerability of the monorail balloon
`catheter is principally that of the guidewire and is
`therefore related to the properties of the guide-
`wireitself. It is not reduced by friction within the
`long shaft of standard steerable systems or by me-
`chanical construction-related limitations of one-
`piece (“not over the wire”) balloon catheters.
`Rapid exchange or extraction, tip reshaping and
`reinsertion of guidewires can be easily performed.
`In addition, contrast can be freely injected to de-
`liniate the coronary passway. Clinical experience
`in our series showeda high stenosis crossing rate
`of nearly 100% and an average stenosis crossing
`time of 90 s.
`Also, with the balloon catheter in place, con-
`trast flow is not impaired because of the large re-
`maining space within a standard 8 F guiding
`catheter. Optimal contrast filling of the coronary
`stenosis with detailed morphology outlining was
`always obtained in our patients.
`On the other hand, transstenotic pressure gra-
`dients cannot be measured with standard mono-
`rail catheters, Pressure gradients are preferentially
`used by someinvestigators to assess dilatation re-
`sults. However, the disadvantages of pressure gra-
`dients for this purpose are: (1) they can only be
`measured with the balloon across the stenosis and
`not in the observation period after dilatation, (2)
`the reliability of pressure tracings is limited and
`(3) most ofall, pressure gradients depend on the
`relation between vessel size and deflated balloon
`profile. The latter would result in normal pressure
`gradients in large vessels even with residual ste-
`noses of 50% (6) and in high residual pressure gra-
`dients in small or distal vessels. On the other
`hand, angiographic stenosis morphology provides
`primary and repeated information on stenosis di-
`ameter and also on the cause of eventual acute
`restenoses, ¢.g., dissection, thrombosis, etc. Thus,
`optimal visualization by undisturbed contrast
`flow in most cases will result in a broader and
`more meaningful information. This is especially
`relevant when the result of dilatation is not satis-
`factory and further therapeutic steps have to be
`considered. High
`resolution multidirectional
`imaging systems are prerequisites for this infor-
`mation (1).
`Balloon exchange could be performed without
`technical difficulties in all cases within the very
`short time of little more than 2 min. The reason
`for exchange in favor of a larger balloon was
`usually an angiographically insufficient
`result,
`e.g., a residual stenosis of more than 30% or 40%,
`In some cases, when balloon passage of the ste-
`noses was not possible, a smaller balloon was
`It was claimed that the properties steerability,
`used for a first stenosis widening and was then
`reexchanged in favor of the first and larger bal-
`contrast agent
`flow and exchangeability are
`
`
`
`
`
`Discussion
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`
`
`122 Z. Kardiol. 76: Suppl. 6 (1987)
`
`
`
`loon. In addition, a transfusion catheter could be
`successfully used in one case. Transfusion or per-
`fusion catheters are primarily designed as bail-out
`devices for temporary use in acute emergencysit-
`uations. It is expected that the time to bypass sur-
`gery in this situation may be expanded with trans-
`fusion. Manually controlled extracorporeal auto-
`transfusion — as the procedure may be called with
`the use of the monorail transfusion catheter - may
`be superior to perfusion techniques using the
`physiological pressure gradient across the steno-
`sis. These techniques rely on stable aortic pres-
`sures and provide no information on distal coron-
`ary flow. In general, up to now theclinical relia-
`bility of bail-out systems has not been established
`and further investigation is needed.
`The advantages of the sliding rail system in
`steerability, contrast flow and exchangeability of
`balloon catheters have in our experience resulted
`in a simplification of the standard dilatation pro-
`cedure, an improvementin the assessmentofdila-
`tation results and an increase of safety in critical
`situations. This may be of special relevance in
`complicated stenoses of large vessels and in mul-
`tivessel disease. The reduction of investigation
`and fluoroscopy time may also be the result of a
`more simple procedure. Intended future develop-
`ments include different devices for intracoronary
`diagnostic and therapeutic interventions, such as
`low profile
`transstenotic pressure
`catheters,
`Doppler catheters and hot balloons for wall weld-
`
`ing. The sliding rail technique principally enables
`the sequential use of such devices over a stable
`transstenotic guidewire.
`
`References
`1, Wollschlager H, Bonzel T, Zeiher AM,Just H (1987) Radio.
`logical prerequisites for spatial intracoronary orientation
`and quantitation in interventional cardiology. This yo].
`ume.
`
`2. Meier B (1987) Technology of current dilatation systems
`and methodological procedures. This volume.
`3. Simpson J, Baim D, Robert E, Harrison D (1982) A new
`catheter system for coronary angioplasty. Am J Cardiol
`49:1216-1222
`4. Kaltenbach M (1984) The long wire technique - a new tech-
`nique for steerable balloon catheter dilatation of coronary
`artery stenoses. Eur Heart J 5:1004-1009
`5. Bonzel T, Woilschléger H, Just H (1986) Ein neues Kathe-
`tersystem zur mechanischen Dilatation von Koronarste-
`nosen mit austauschbaren intrakoronaren Kathetern, ho-
`herem KontrastmittelfluB und verbesserter Steuerbarkeit,
`Biomed Tech 31:195-200
`6. Bonzel T, Wollschlager H, Gick M, Léllgen H, Just H
`(1984) Die Bedeutung verbesserter Angiographiesysteme
`fiir die Quantifizierung proximaler Koronarstenosen. Ver-
`gleich angiographischer und hamodynamischer Messungen
`in vivo. Schw Med Wschr 114, Suppl 16:77-81
`Authors’ address:
`Priv. Doz. Dr. med. T. Bonzel
`Medizinische Universitatsklinik
`Abt. Innere Medizin III — Kardiologie
`Hugstetter Str. 55
`7800 Freiburg
`West Germany
`
`oo
`
`(ore
`
`
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