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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3840_Библиотеки_им_академика_М_И_Перельмана
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230
Side branch lumen
(SBL)
SBL
Marker bands
Main branch marker bands
(A)
Side (petal) balloon
Petal
Main branch
stent
LATIB ET AL.
Main branch
balloon
(B)
Figure 9 (A) A graphical representation of the Taxus PetalTMdelivery catheter and balloon. Markers on the
catheter are used to aid stent placement. The Petal
system with an elliptical SB balloon that deploys the SB struts when both balloons are inflated by a single
indeflator. (B)ThePetal
ostium (inset demonstrates petal elements before deployment). Baseline angiography (C) showing a bifurcation
lesion at the crux of the right coronary artery. (D) Advancement of the Taxus Petal stent over the MB guidewire,
with the SB wire protruding from the tip of the SB component to avoid wire wrap (twisting). Placement of the
SB wire without “wrap,” and the Petal
(E). (F) Separation of the proximal and distal catheter markers confirm rotational alignment of the stent within
the bifurcation (separation denoted by arrows). Balloon inflation to 12 atm deploying the stent (arrow denotes
elliptical petal balloon inflation), followed by kissing balloon postdilatation with noncompliant balloons (G). Final
angiography (H) confirms an excellent result that was maintained at six months (I). Final angiographic assessment
of the Taxus Petal stent (J) (arrow indicates the level of IVUS image), IVUS image from the MB at the level of
the bifurcation, demonstrating the SB ostium within the petal elements (K). Six-month follow-up angiography (L)
demonstrates a minor neointimal response within the proximal end of the stent and widely patent SB ostium. (M)
Six-month IVUS assessment from the MB at the level of the bifurcation.
TM
stent; the stent name alludes to the “petal” elements that are expanded into the SB
TM
was then advanced to the bifurcation with separation of the markers
TM
is mounted on a dual lumen, double balloon stent delivery
Source
: Adapted from Ref. 39.
(
Continued on pages 231 and 232
)
(C)
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(D) (E)
(F)
Figure 9 (
Continued
)
SB
balloon
Post dilatation
proximally
(G)
Kissing
post-dilatation
(H) (I)
(J) (M)
SB
SB
Petals
Figure 9 (
Index
Continued
MB
(K)
)
Petals
MB
6 months
(L)
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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233
in one patient (3.7%) due to a non–Q-wave MI. At six months after implantation, two further
events had occurred: one target vessel and one target lesion revascularization but no additional
MI or deaths. Angiographic outcomes at six months demonstrated a restenosis rate of 5% in the
proximal MB, 10% in distal MB, and 10% in the SB. The late lumen loss was 0.42 ± 0.58 mm in
the MB and 0.18 ± 0.40 mm in the SB.
Antares SAS
The Antares Stent System
TM
(Trireme Medical Inc)
TM
with automaticSB support deployment(Fig. 10) consists of asingle
balloon expandable 316 L stainless steel stent. It has an ostial preservation (OP) structure in the
center of the stent provided with radiopaque tantalum markers for positioning and orienting
at the bifurcation site. The original Antares
TM
system had four radiopaque tantalum markers,
but the current generation system has only two markers. Stent deployment is achieved using
a single rapid-exchange balloon catheter and a preloaded SB stabilizing wire encased in a peel
away lumen to minimize wire crossing. As the stent approaches the targeted bifurcation, the
catheter is torqued to align the stent centralopening withthe SBostium. The SB wire is advanced
into the ostium, thus assisting with accurate placement and facilitating access after MB stent
deployment. Upon expansionof themain stent body, the OP structure isautomatically deployed
with elements protruding approximately2 mminto the SB to scaffold theostium. The Antares
is very similar to the PetalTMstent but has the advantage of tracking over a single wire, and
unlike the Petal
with this stent. Furthermore, in comparison to the Petal that relies on passive rotation (selfpositioning) for placement, the Antares
TM
that uses a balloon to expand the SB elements, they expand automatically
TM
SDS is torqueable, thus allowing active alignment
TM
and rotation of the device that facilitates accurate positioning of the OP structure, particularly
in challenging lesions. There is also a DES version currently under development.
Ostial preservation
structure
Side branch wire lumen
•Allows placement of wire to
maintain SB access at all times
• Peel away prevents wire wrap
Torqueable shaft
• Allows proper alignment of OPS to SB
Low profile tip
Figure 10 A graphical representation of the design features of the AntaresTMdelivery system and stent (A). A
Medina 1.1.0 bifurcation lesion at the crux of the right coronary artery that underwent provisional stenting with
the Antares
(C), which resulted in plaque shift toward the ostium of the posterolateral branch (D), and thus the SB was also
dilated (E). (F)TheAntares
system is actively rotated until correctly positioned. Accurate positioning is confirmed when both the MB and SB
wires are visible parallel to each other and only a single ostial (central) radiopaque marker is visible. The SB
access wire is then advanced into the SB. Inflation of the balloon at nominal pressure to deploy the MB stent also
results in automatic expansion of the SB elements. (G), followed by postdilatation of the Antares
angiographic result (I).
TM
(B). Both branches of the bifurcation were wired; the posterior descending artery was predilated
TM
is advanced on the MB wire to the bifurcation, and using the hub, the delivery
Source
: Photos courtesy of Dr. Riccardo Costa.
Small crossing profile
(A)
•
• Provides excellent ostial
coverage
• Asymmetric “wings” allow
treatment of all SB angles
• Radiopaque markers facilitate
precise SB stent placement if
needed
Single balloon
• Allows low crossing profile
TM
stent (H). Final
(
Continued on pages 234 and 235
)
(B) (C)
(D) (E)
Figure 10 (
Continued
(F)
)
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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(G)
235
Figure 10 (
Continued
(H) (I)
)
The 30-day results of the first 11 patients/lesions treated with the AntaresTMstent were
presented at the 2008 SCAI-ACCi2 summit (27). Device success in this small cohort was 100%
and there were no adverse events in-hospital or at 30-day follow-up. Subsequently, results from
the TOP (TMI Ostial Preservation) multicenter single arm FIM study have become available
(28). The TOP Study will enroll up to 100 patients with de novo bifurcation lesions to undergo
Antares
Liberte
success with 100% deliverability of the Antares
TM
implantation on the MB, and if SB stenting is required the protocol mandates Taxus
TM
implantation. Preliminary results on the first 39 patients showed an excellent device
TM
. At 30 days, the MACE rate was 5.9% (2/34)
due to a periprocedural non–Q-wave MI in one patient and another patient suffering from a
subacute stent thrombosis, which resulted in a MI and TLR (28).
Sideguard
The Cappella Sideguard
TM
(Cappella Inc)
TM
coronary side branch stent (Fig. 11) is a self-expanding trumpet-
shaped nitinol stentwith a three-segment design (cup, transition zone, anchor) that is deployed
236
LATIB ET AL.
using a special balloon release sheath system. It is currently a bare-metal stent, but there may
be a next-generation drug-eluting version with a biodegradable polymer. The Sideguard’s
TM
trumpet-shaped design helps the stent conform to the anatomy of the ostium allowing for
complete stent-to-wall apposition, optimizing scaffolding and potential drug delivery. Its short
length, self-expandable nitinol system, and low-profile (3.1 Fr) delivery system allow greater
navigability even in very tortuous anatomy. Radiopaque markers located at the distal and
proximal ends of the Sideguard
ostium. Sideguard
TM
will be indicated for bifurcation angles from 45 degrees to 135 degrees
before wiring. The stent is deployed using a nominal pressure balloon, which helps tear a
protective sheath that keeps the Sideguard
Sideguard
TM
self-expands into place. The delivery system and the guidewire are then removed
TM
delivery system facilitate positioning of the stent at the SB
TM
in place until deployment. Once released, the
from the SB.A conventional stentis then placedin the MB,the SB isreaccessed with aguidewire
and the procedure is completed with a standard final kissing inflation. The six-month results of
the first 20 patients enrolled in the Sideguard
TM
FIM trial (SG-1) were presented at TCT 2007.
Technical success was achieved in 16 (80%) patients. At six months, the TLR rate was 12.5%
(2/16) and there were no cases of stent thrombosis (29)
Spacer
Cup
Gimbal
Anchor
Cup Gimbal Anchor
• Flared end with three
markers, conforms to
ostium of side branch
• Excellent ostial coverage
and protection
• Lowest radial force (easy
to cross)
Figure 11 (A) The design characteristics of the self-expanding SideguardTMcoronary side branch stent. The
delivery system has the lowest profile of any of the self-expanding stents and unlike other self-expanding stents
has a unique balloon actuated splittable sheath that allows for accurate placement (B). Baseline angiography showing a true bifurcation lesion of the left anterior descending artery and large second diagonal branch
(C and D). Both branches of the bifurcation were wired and predilated (E and F). The Sideguard
was then advanced into the SB (G) and a semicompliant balloon into the MB to the level of the bifurcation.
The Sideguard
Sideguard
for the Sideguard
balloon is then inflated to ensure that are no struts into the MB lumen (K). (L) The angiographic result after
Sideguard
SB is recrossed with a guidewire; and final kissing inflation is performed (N). (O) The final result graphically and
angiographically.
TM
is then positioned (H) with the proximal ostial marker on the ostium border line (OBL). The
TM
catheter is then inflated to split the sheath and deploy the stent (I). After waiting a few seconds
TM
to fully expand, the delivery system and guidewire are removed from the SB (J). The MB
TM
implantation. A drug-eluting stent is then implanted on the MB across the ostium of the SB (M); the
• Cylindrical portion with
higher radial force (550
mm Hg) to dilate ostial
lesions
• Provides expanding force to
open the side branch
• Transition zone between
cup and anchor
A
• Cylindrical portion with
lower radial force (225
mm Hg); two markers
• “Spacer” improves
anchoring, keeping stent
from migrating
• Enhances crossing flexibility
TM
stent
(
Continued on pages 237–240
)
Low-profile balloon delivery catheter Split sheath technology
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(B)
(C) (D)
(E)
(F) (G)
Figure 11 (
Continued
)
238
LATIB ET AL.
(H)
(I)
Figure 11 (
Continued
)
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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(J) (K)
239
(L)
(M) (N)
Figure 11 (
Continued
)
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