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Guide catheter selection for transradial Pci

Authors:
JULY/AUGUST 2013 CARDIAC INTERVENTIONS TODAY 1
cover story
The transradial approach (TRA) has gone through
significant changes and improvements since it
was first described by Dr. Campeau in the late
1980s. TRA has also been proven to be a very
suitable method for performing coronary catheterization
and percutaneous coronary intervention (PCI) as it pro-
vides a decrease in access site bleeding1,2 and mortality.3,4
Nonetheless, it is still underutilized in the cardiac interven-
tional community because of some perceived drawbacks
that make it unappealing to femorally trained operators.
The major drawback is centered around the learning
curve for many interventionists. The higher incidence of ana-
tomical variations seen in the upper limbs and the innomi-
nate-arch junction could render coronary angiography and
PCI difficult and trickier to perform. Furthermore, the use of
smaller-sized equipment (ie, sheaths, catheters) makes TRA
unattractive because of a false perception that certain tech-
niques are not feasible. However, these apparent drawbacks
can easily be overcome by a trained TRA operator. It is the
purpose of this article to review and discuss guiding catheter
sizes and shapes to be used for transradial PCI.
CHOOSING THE APPROPRIATE SIZE
Radial artery diameter is of a smaller caliber than the
femoral artery (normal diameter of the radial artery lumen
is 2.4 mm [range, 1.8–3 mm]), making tool selection and
manipulation for TRA entirely different compared to the
femoral approach. PCI cases have been previously described
using guides as small as 4 F5 and as big as 8 F.6 However,
the majority of TRA interventions performed today can
be successfully accomplished with 5- or 6-F guiding cath-
eters,7 as all of our current stents can be delivered through
these guides for the treatment of simple or even the most
complex lesions (ie, bifurcation or chronic total occlusion).
Furthermore, bulky equipment, such as rotational atherec-
tomy or intravascular ultrasound, can be performed safely
and adequately with these guides. Nonetheless, certain dis-
advantages can present with smaller-sized guides (Table 1)
but usually do not hinder the ability to successfully perform
coronary interventions.
CHOOSING THE APPROPRIATE GUIDE
For optimal stent delivery, good guide support (also
known as backup support) is necessary. Good guide sup-
port revolves around the ability of the guide catheter to
remain in position and to provide appropriate stability for
the advancement of interventional equipment. Two types
of backup support exist: passive and active backup. Passive
backup usually relies on the property of the shaft and tip
to maintain position at the ostium. Support is provided by
either the aortic root or valve or by the catheter shape.8
These catheters usually require minimal manipulation and
rarely deep-seats the coronary ostium. On the other hand,
active backup catheters use the aortic root to accomplish a
desired shape and to provide support, which requires a fair
amount of active manipulation by the operator to obtain
Choosing the proper guide catheter size and shape can help ease
the transition to radial adoption.
By JImmy mACHAAlANy, mD; ElTIGANI ABDElAAl, mD;
AND OlIvIER F. BERTRAND, mD, PhD
Guide Catheter
Selection for
Transradial PCI
2 CARDIAC INTERVENTIONS TODAY JULY/AUGUST 2013
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a stable position coaxially. With the transradial approach,
active support of the guiding catheter plays a more impor-
tant role than with the standard femoral approach.
Both active and passive backup support can be achieved
with 6-F catheters. With 5-F guiding catheters, active sup-
port is required in a number of cases. Catheters 7 F will
provide better passive support at the expense of minimal
active support and the inability of deep coronary engage-
ment. Conversely, 5-F catheters provide good active sup-
port and are able to be deep-seat into the coronary artery,
therefore providing guide “extension” and accordingly pro-
vide better support and coaxial alignment during coronary
interventions. Furthermore, long Brite Tip catheters (Cordis
Corporation, Bridgewater, NJ), are primarily those with
longer and softer tips, can also be employed and provide
greater safety during deep-seating maneuvers.
A “mother-child” hybrid system has also been proposed
as a way to enhance the backup support of 6-F catheters
and at the same time permit the use of smaller guide cath-
eters to perform deep intubation maneuvers. Takahashi
et al9 first described the five-in-six system in which a 5-F,
120-cm-long guide catheter was inserted into a 6-F, 100-cm-
long guide catheter. Subsequently, a four-in-six system was
attempted10; this technique revealed superior trackability
because of the 4-F child catheter and higher backup sup-
port, which ultimately resulted in a higher stenting success
rate (> 90%) for lesions in which conventional techniques
had been unsuccessful. Another option is the use of the
GuideLiner device (Vascular Solutions, Inc., Minneapolis,
MN), which also provides additional support with 6-F guid-
ing catheters and is particularly helpful in complex PCIs,
such as heavily calcified vessels and distal lesions, tortuous
vessels, or chronic total occlusions.11-13
THE TRANSRADIAl APPROACH
Accessing the Ascending Aorta
In most cases, accessing the ascending aorta via the
right or left radial artery is easily done and does not pose
any major challenges. In certain cases, this important step
could be hampered and is usually a result of an anatomic
difficulty. From the left radial approach, the regular 0.035-
inch J-wire could preferentially enter the descending aorta;
however, this nuisance could be easily corrected with a deep
inspiration, with or without a counterclockwise catheter
rotation, to re-orient the wire. On the other hand, the right
radial approach might provide more difficulty because of
the higher incidence of right subclavian artery tortuosity
and innominate arch junction distortion. Once again, a
deep inspiration could partially help in the unfolding of the
tortuosity. Other options include the use of a hydrophilic
Table 1. Devices anD Techniques available for TransraDial Pci
Catheter Size Devices Technique
5 F • Balloon5mm
• Stent4.5mm
• Intravenousultrasound(EagleEyecatheter,VolcanoCorporation,SanDiego,
CA)
• Cuttingballoon2.5mm
• Rotablator1.25mm(BostonScientificCorporation,Natick,MA)
Twowiresallowed
forbifurcationbut
nokissingballoons
(onlyforslender
techniquesinJapana)
6 F • Allballoonsizes
• Allstentsizes
• Intravenousultrasound(EagleEyeandRevolutioncatheters,Volcano
Corporation)
• Opticalcoherencetomography
• Cuttingballoon>2.5mm
• Rotablator1.5mm
• Thrombectomydevices
• Saphenousveingraftprotectiondevices
• Mother-child
• GuideLiner
Kissingballoon
7 FbRotablator>1.75mm Kissingstents
aNote, the “slender technique” is an approach used in Japan to minimize the diameter of guide catheters, guidewires, and puncture
sites.
bAn alternative to 7–8 F outside the United States is to use Asahi sheathless 6.5- or 7.5-F devices (Asahi Intecc USA, Inc., Santa Ana,
CA).
JULY/AUGUST 2013 CARDIAC INTERVENTIONS TODAY 3
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guidewire (HydroSteer, St. Jude Medical, Inc., St. Paul, MN),
as it may slip itself more easily into the ascending aorta.
Guide catheter kinking while maneuvering into the
coronary ostia may also occur. Deep inspiration or leav-
ing the J-wire within the catheter to enhance torqueability
is usually sufficient to correct this matter. This maneuver,
albeit simple, is probably the single most critical one in TRA
because it may help in both cannulating the coronary ostia
and improving guide catheter
support.
Guide Selection for Different
Clinical Situations
Guide selection is important
because the operator must
select a guide that provides
good backup support, coaxiality,
and stability once the ostium
of the artery is intubated. It
should be emphasized that most
curves designed for the femoral
approach are perfectly suited for
transradial PCI. In fact, an inter-
national survey among radialists
revealed that for the left coro-
nary system, extra backup (EBU,
Medtronic, Inc., Minneapolis,
MN; or XB, Cordis Corporation)
guiding catheters were the most
popular, and the JR 4 remained
the standard shape for the right
coronary artery. Furthermore,
for left-sided vein grafts, radial
operators prefer Amplatz-type
guiding catheters and JR 4 or
multipurpose guiding catheters
for the right-sided vein grafts. It
remains controversial whether
left TRA better suits these cath-
eters compared to the right
radial approach. Overall, radial
operators use the right radial
approach in 90% of cases, except
for post-CABG involving the
left internal mammary artery
(LIMA) (Figure 1).14 In these
cases, cannulation of the LIMA
is much easier from the left side,
although it remains possible to
cannulate the LIMA from the
right radial approach.15
Left coronary system. PCI
of the left coronary system is usually accomplished with
extra-backup catheters (XB or EBU); however, catheter
size is usually 0.5 F smaller than what would be used in
femoral procedures (3 or 3.5 F vs 3.5 or 4 F, respectively).
Engagement into the left main artery is also different from
the femoral approach as the guide is usually cannulated
from below the ostium with a counterclockwise movement
compared to the more direct and superior cannulation if
Figure 1. A breakdown of the different PCI guiding catheters used with TRA. Right coro-
nary artery (A). Left coronary artery (B).
B
A
4 CARDIAC INTERVENTIONS TODAY JULY/AUGUST 2013
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the femoral route is selected. These catheters provide all of
the active support backup from the contralateral aortic wall
and offer appropriate deep-seating capability. The Amplatz
left catheters (AL 1 or 2 F) provide great passive backup
support and is usually the catheter of choice for complex
coronary interventions (ie, calcified lesions, chronic total
occlusion). Finally, the Judkins left catheters do not usually
provide good backup support in TRA and therefore are less
frequently utilized; however, they can be useful in the set-
ting of ostial left main stenosis where guide support is not a
major concern.
Right coronary system. For noncomplex or ostial lesions,
a Judkins right 4-F catheter is adequate for PCI. Nonetheless,
this guide catheter is usually inadequate in the presence of a
dilated aortic root because we loose the contralateral aortic
wall active support or in the setting of a complex procedure.
Furthermore, when the right coronary artery (RCA) arises
from an anterior or posterior position, coaxial position is
limited, and PCI is usually cumbersome. An Amplatz right (1
or 2) or Amplatz left (0.75 or 1) would be a better selection
and would provide better support. However, a judicious
ostial approach is always recommended with these cath-
eters to avoid traumatic dissections. It should be noted that
the respiration of the patient might induce larger back and
forth displacements of the guid-
ing catheter seated at the ostium
of the RCA, and thus, caution
should be exercised during PCI,
especially with Amplatz guiding
catheters.
A range of radially dedicated
guide catheters has been pro-
duced (Barbeau, Kimney, Fadajet),
and they are effective for RCA
PCI. The Barbeau is a modified
multipurpose catheter with an
additional 135º curve at the tip to
assist in cannulation. Cannulation
of the RCA is usually performed
with a clockwise “corkscrew”
maneuver while coming from
above the ostium. In certain
instances, an inferior approach
is appropriate and is done by
pushing down on the catheter,
forcing the tip to bend up toward
the RCA. The Barbeau also has
excellent malleability and permits
guide “Amplatzing” (ie, when
you modify the form of a cath-
eter into one that resembles an
Amplatz catheter) and very deep
coronary intubation (Figure 2).
The Kimney catheter has a 45º primary curve with a sec-
ondary curve of 90º that allows it to support itself on the
contralateral aortic wall. It is common to cannulate the left
coronary artery from below with this catheter while com-
ing from a horizontal or superior position to cannulate the
right. Both of these catheters provide good backup support
and enable coronary intubation during PCI, especially in
very tortuous arteries (ie, shepherd’s hook RCA). It should
be noted that these shapes designed by radial pioneers
remain less frequently used than traditionally shaped
guiding catheters. An exception to this statement is the
left and right Ikari curve, specifically designed by Terumo
Interventional Systems, Inc. (Somerset, NJ) for transradial
PCI. Compared to Judkins-type guiding catheters, the Ikari
curves provide more support.8 Unfortunately, they have not
yet been compared to EBU- or XB-type curves.
LIMA grafts. LIMAs are best approached via left TRA
with a modified or nonmodified mammary catheter.
Conversely, cannulation of the right internal mammary
arteries is usually attempted via the right TRA and is usually
harder to achieve because the ostium takeoff is at 90º to
the catheter plane. Reshaping of the mammary catheter tip
in the subclavian or innominate artery, by bending and col-
Figure 2. Different guide catheter use in TRA. A 5-F Barbeau catheter with deep-seating
of the vein graft to the RCA (A, B). Simultaneous bilateral ostia intubation during a chron-
ic total occlusion procedure with the 6-F AL 1 from the left TRA into the RCA and a 6-F XB
3.5 from the right TRA into the left main artery (C). Use of the 6-F AL 2 catheter for a left
vein graft PCI (D).
A
C
B
D
JULY/AUGUST 2013 CARDIAC INTERVENTIONS TODAY 5
cover story
lapsing the tip on itself, might provide some aid. The other
possibility is to use a percutaneous guidewire (ie, balanced
middle-weight [BMW], Abbott Vascular, Santa Clara, CA) to
cannulate the right internal mammary artery and, thereaf-
ter, track the catheter over it.
CONClUSION
The majority of PCIs can be performed using 6-F guid-
ing catheters, and 5-F guiding catheters remain particu-
larly attractive because catheter-radial artery mismatch
increases the risks of postcatheterization radial artery
occlusion. Although some dedicated radial shapes have
been developed, most radial operators use standard-
shaped guide catheters. Apart from operator preferences,
further studies will be required to determine whether
universal radial catheters may offer some benefits com-
pared to standard shapes in terms of duration of proce-
dures, radiation exposure, and contrast volume. n
Jimmy MacHaalany, MD, is with the Quebec Heart and
Lung Institute in Quebec City, Quebec, Canada. He stated
that he has no financial interests related to this article.
Eltigani Abdelaal, MD, is with the Quebec Heart and
Lung Institute in Quebec City, Quebec, Canada. He stated
that he has no financial interests related to this article.
Olivier F. Bertrand, MD, PhD, is with the Quebec Heart
and Lung Institute in Quebec City, Quebec, Canada. He
stated that he has no financial interests related to this
article. Dr. Bertrand may be reached at (418) 656-8711;
olivier.bertrand@criucpq.ulaval.ca.
1. Bertrand OF, Belisle P, Joyal D, et al. Comparison of transradial and femoral approaches for percutaneous coro-
nary interventions: a systematic review and hierarchical Bayesian meta-analysis. Am Heart J. 2012;163:632-648.
2. Joyal D, Bertrand OF, Rinfret S, et al. Meta-analysis of ten trials on the effectiveness of the radial versus the
femoral approach in primary percutaneous coronary intervention. Am J Cardiol. 2012;109:813-818.
3. Jolly SS, Yusuf S, Cairns J, et al. Radial versus femoral access for coronary angiography and intervention
in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet.
2011;377:1409-1420.
4. Romagnoli E, Biondi-Zoccai G, Sciahbasi A, et al. Radial versus femoral randomized investigation in ST-segment
elevation acute coronary syndrome: the RIFLE-STEACS (Radial Versus Femoral Randomized Investigation in ST-
Elevation Acute Coronary Syndrome) study. J Am Coll Cardiol. 2012;60:2481-2489.
5. Takeshita S, Shiono T, Takagi A, et al. Percutaneous coronary intervention using a novel 4-French coronary acces-
sor. Catheter Cardiovasc Interv. 2008;72:222-227.
6. Cheng CI, Wu CJ, Fang CY, et al. Feasibility and safety of transradial stenting for unprotected left main coronary
artery stenoses. Circulation. 2007;71:855-861.
7. Metz D, Meyer P, Touati C, et al. Comparison of 6F with 7F and 8F guiding catheters for elective coronary
angioplasty: results of a prospective, multicenter, randomized trial. Am Heart J. 1997;134:131-137.
8. Ikari Y, Nagaoka M, Kim JY, et al. The physics of guiding catheters for the left coronary artery in transfemoral and
transradial interventions. J Invasive Cardiol. 2005;17:636-641.
9. Takahashi S, Saito S, Tanaka S, et al. New method to increase a backup support of a 6 French guiding coronary
catheter. Catheter Cardiovasc Interv. 2004;63:452-456.
10. Takeshita S, Shishido K, Sugitatsu K, et al. In vitro and human studies of a 4F double-coaxial technique (“mother-child”
configuration) to facilitate stent implantation in resistant coronary vessels. Circulation. 2011;4:155-161.
11. Serajian A. Novel use of a GuideLiner catheter to visualize distal LAD after LIMA anastomosis in selective coronary
angiography. J Invas Cardiol. 2012;24:E30-31.
12. Moynagh A, Garot P, Lefevre T, Louvard Y. Angiographic success and successful stent delivery for complex lesions using
the GuideLiner five-in-six system—a case report. Am Heart Hosp J. 2011;9:E44-47.
13. Farooq V, Mamas MA, Fath-Ordoubadi F, Fraser DG. The use of a guide catheter extension system as an aid during tran-
sradial percutaneous coronary intervention of coronary artery bypass grafts. Catheter Cardiovasc Interv. 2011;78:847-863.
14. Bertrand OF, Rao SV, Pancholy S, et al. Transradial approach for coronary angiography and interventions: results of the
first international transradial practice survey. JACC: Cardiovasc Interv. 2010;3:1022-1031.
15. Patel T, Shah S, Patel T. Cannulating LIMA graft using right transradial approach: two simple and innovative techniques.
Catheter Cardiovasc Interv. 2012;80:316-320.
... If the ostium is higher than normal, an Amplatz left (AL)3, Voda left, or Champ catheter is preferred. 6,7 Right coronary artery A Judkins right (JR) is the first choice catheter for most RCA interventions but has no contact with the opposite wall of the aorta. This limits the support provided in complicated cases and in such situations catheters are generally switched over to an AR or AL. 7 In some patients, a shepherd's crook in the proximal course of the RCA poses problems when engaging the guide because of the upwards pointing RCA ostium. ...
... The smaller inner 5 F tube penetrates deeply and provides greater backup support with less risk of complications such as dissections. 6 Takahashi et al first described the five-in-six mother-child system in which a 5 F, 120 cm long smaller sized catheter was inserted into a 6 F, 100 cm long guide catheter. 14 It was later realized that a four-in-six system was better than a five-in-six system because it provided superior track-ability and stent delivery 15 In vitro experimental models have demonstrated that the 5 F mother-child system can generate strong backup support exceeding that of an 8 F guiding catheter whereas backup support generated by a 4 F catheter does not exceed that of a 7 F catheter. ...
... 19 As a result of the above Other dedicated radial catheters include the Barbeau and Kimney catheters. 6 The Barbeau is basically a modified multipurpose catheter with an additional 135° curve at the tip to assist cannulation. The Barbeau has a softer terminal portion, and with manipulation allows the guide to take the shape of an Amplatz catheter and enables deeper coronary intubation. ...
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