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210 MURASATO
10. Ormiston JA, Webster MWI, Webber B, et al. The “crush” technique for coronary artery bifurcation
stenting: insights from micro-computedtomographic imagingof benchdeployment. JACCCardiovasc
Interv 2008; 1:351–357.
11. Hikichi Y, Inoue T, Node K. Benefits and limitations of Cypher sent-based bifurcation approaches: in
vitro evaluation using micro-focus CT scan. J Interv Cardiol 2009; 22:128–134.
12. Murasato Y. Impact of three-dimensional characteristics of the left main coronary artery bifurcation
on outcome of crush stenting. Catheter Cardiovasc Interv 2007; 69:248–256.
13. Murasato Y, Suzuka H, Suzuki Y. Incomplete stent apposition in a left main bifurcated lesion after
kissing stent implantation. J Invasive Cardiol 2006; 18:E279–E284.
14. Ormiston JA, Currie E, Webster MW, et al. Drug-eluting stents for coronary bifurcations: insights into
the crush technique. Catheter Cardiovasc Interv 2004; 63:332–336.
15. Ormiston JA, Webster MW, El Jack S, et al. Drug-elutingstents for coronary bifurcations: bench testing
of provisional side-branch strategies. Catheter Cardiovasc Interv 2006; 67:49–55.
16. Louvard Y,Lef`evreT,Morice MC.Percutaneouscoronary interventionforbifurcation coronarydisease.
Heart 2004; 90:713–722.
17. Louvard Y, Thomas M, Dzavik V, et al. Classification of coronary artery bifurcation lesions and
treatments: time for a consensus! Catheter Cardiovasc Interv 2008; 71:175–183.
18. Nakazawa G, Joner M, Ladich E, et al. Pathologic findings of coronary bifurcation stenting: drugeluting stent vs. bare metal stent. American College of Cardiology & i2 Summit 2007.
19. Hoye A, Iakovou I, Ge L, et al. Long-term outcomes after stenting of bifurcation lesions with the
“crush” technique: predictors of an adverse outcome. J Am Coll Cardiol 2006; 47:1949–1958.
20. Costa RA, Mintz GS, Carlier SG, et al. Bifurcation coronary lesions treated with the “crush”technique:
an intravascular ultrasound analysis. J Am Coll Cardiol 2005; 46:599–605.
21. Murasato Y, Suzuka H, Kamezaki F. Vascular endoscopic and macroscopic observations after crush
stenting of coronary artery bifurcations in pigs. Catheter Cardiovasc Interv 2005; 66:237–243.
22. Galassi AR, Tomasello SD, Capodanno D, et al. Mini-crush versus t-provisional techniques in bifurcation lesions: clinical and angiographic long-term outcome after implantation of drug-eluting stents.
JACC Cardiovasc Interv 2009; 2:185–194.
23. Chen SL,YeF,Zhang JJ,et al.DK crushtechnique: modifiedtreatment of bifurcationlesions incoronary
artery. Chin Med J 2005; 118:1746–1750.
24. Colombo A, Moses JW, Morice MC, et al. Randomized study to evaluate sirolimus-eluting stents
implanted at coronary bifurcation lesions. Circulation 2004; 109:1244–1249.
25. Russel ME, KonstantinE, BinyaminG. Main vessel to sidebranch transition zone in humancoronaries;
Unique geometric insights missed by QCA. 3rd European Bifurcation Club, 2007.
26. Meliga E, Garcia-Garcia HM, Valgimigli M, etal.; DELFT (Drug Eluting stent for LeFT main) Registry.
Longest available clinical outcomes after drug-eluting stent implantation for unprotected left main
coronary artery disease: the DELFT (Drug Eluting stent for LeFT main) Registry. J Am Coll Cardiol
2008; 51:2212–2219.
27. Vaquerizo B,Lef`evre T, Darremont O,et al. Unprotected left main stenting in the real world. Two-year
outcomes of the French left main Taxus registry. Circulation. 2009.
28. Carri´e D, Eltchaninoff H, Lef`evre T, et al.; FRIEND. Twelve month clinical and angiographic outcome
after stenting of unprotected left main coronary artery stenosis with paclitaxel-eluting stents—results
of the multicentre FRIEND registry. EuroIntervention 2009; 4:449–456.
29. Collins N, Seidelin PH, Daly P, et al. Long-term outcomes after percutaneous coronary intervention
of bifurcation narrowings. Am J Cardiol 2008; 102:404–410.
10
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Current Status and Future of Dedicated
Bifurcation Stent Systems
Azeem Latib, Giuseppe M. Sangiorgi, and Antonio Colombo
Interventional Cardiology Unit, San Raffaele Scientific Institute, and Interventional Cardiology Unit,
EMO-GVM Centro Cuore Columbus, Milan, Italy
IS THERE A NEED FOR DEDICATED BIFURCATION STENT SYSTEMS?
Defining the clinical need for dedicated bifurcation stent systems is not a straightforward
exercise. If one were to adopt the results of the randomized controlled trials (RCTs) (1–5) that
evaluated provisional versus elective double stenting in bifurcation lesions as reflective of
real world clinical practice, there would hardly be a compelling reason to develop expensive
dedicated bifurcation stent systems! In these trials, provisional stenting appeared simple to
use, carried minimal procedural risks, was associated with good long-term outcome, and was
inexpensive! Considering all these attributes of a “simple” stenting technique, why would any
operator need a dedicated bifurcation stent system? The simple answer to this question is that
patients recruited into theRCTs had low-risk coronary bifurcation anatomywhere investigators
thought that a provisional approach would have high chances of success. Therefore, it would
be inappropriate to generalize the results of these trials to patients with complex bifurcation
coronary disease (Chaps. 1 and 2).
In reality, PCI for coronary bifurcation disease remains technically challenging and is
associated withlower proceduralsuccess rates andworse clinical outcomes than nonbifurcation
lesions. A need does exist for coronary bifurcation stent systems in patients with “complex”
coronary bifurcation lesions irrespective of the technique that will be utilized (provisional or
elective double stenting) for the following reasons:
r
Although provisional stenting has been conveyed as a simple and safe procedure, this
may not be the case in complex bifurcations where several problems may arise. With this
approach the most critical issue is to maintain adequate patency of the SB throughout the
procedure. SB patency can be threatened after predilatation, after MB stent placement that
may cause plaque or carina shift, and after attempts to rewire the SB. SB rewiring can be
difficult in lesions with unfavorable angles and in cases where the SB flow is compromised.
Furthermore, the SB ostium is often not fully covered and scaffolded. In fact, acceptance of
a suboptimal result in the SB is almost inherent to the provisional strategy (6).
r
Similarly, patients with complex bifurcation lesions who need double stenting (elective or
provisional) have to undergo a complex procedure that is more time and resource intensive
and end up with stent deformity at the carina irrespective of the technique used.
Therefore, novel devices that can enhance the safety of provisional stenting in complex
lesions as well as reduce the complexity of two-stent approaches are certainly desirable.
WHAT SHOULD AN IDEAL DEDICATED BIFURCATED STENT SYSTEM ACHIEVE?
The ideal dedicated bifurcation stent system should make PCI of complex coronary bifurcation
lesions simpler and should improve short- and long-term outcomes. To achieve this task, the
device should have a low profile and be highly deliverable even in challenging anatomy. It
should allow for an optimal coverage of the bifurcation carina while maintaining a versatile
platform forvarious bifurcationanatomies andprocedural scenarios (e.g.,provisional vs.double
stenting techniques). The device should be actively torqueable when alignment of the SB access
is needed to accurately place the device. The dedicated bifurcation device should ensure and
facilitate rapid SB access and protection during the procedure (7).
The first generation ofdedicated bifurcation stent systems were difficult todeploy,as they
were stiff and accurate positioning ofthe stent at the SB ostium was tricky. Many also hadlarger
212
LATIB ET AL.
crossing profiles and less flexibility compared with conventional stents, so they were difficult
to deliver in tortuous or calcified arteries. Nonetheless, these devices have undergone rapid
evolution from design and bench top testing a few years ago to clinical testing in First-In-Man
(FIM) studies. One of the most important steps is the shift from bare metal to drug-elution
platforms. There are now at least six devices that have CE mark and are commercially available
in Europe, whereas in the United States none of these devices are FDA approved and are thus
under investigational use only. The development of more drug-eluting platforms and larger
studies with control groups demonstrating their clinical applicability, efficacy, and safety are
required before they are widely incorporated into daily practice.
CATEGORIES OF DEDICATED BIFUCRATION STENTS
The currently available (or under investigation) dedicated bifurcation stents can be broadly
divided into:
1. Stents that are implanted in both the MB and the SB at the same time; that is, complete
bifurcation “Y” stents such as the Medtronic Bifurcation Stent
TM
(Medtronic, Santa Rosa,
CA).
2. Stents forprovisional SBstenting that facilitate ormaintain access to the SBafter MB stenting
and do not require recrossing of MB stent struts [e.g., Petal
entific, Natick, MA); Invatec Twin-Rail
Medical Inc, CA); Y-med Sidekick
vasys, Genevilliers, France); Multi-linkFrontier
TM
(Invatec S.r.l., Brescia, Italy); AntaresTM(Trireme
TM
(Y-med Inc, San Diego, CA); Nile CroCoTM(Min-
TM
(Abbott Vascular Devices,Redwood City,
TM
, former AST stent (Boston Sci-
CA/Guidant Corporation,Santa Clara, CA)]. These stentsallow placement ofa second stent
in the SB if needed.
3. Stents that usually require another stent implanted in the bifurcation—for example,
Sideguard
Ltd., Beijing, China); Axxess Plus
and Biguard
stenting for final kissing inflation. The Axxess
TM
(Cappella Inc,MA); TrytonTM(Tryton Medical, MA); BiguardTM(Lepu Medical
TM
are designed to treat the SB first and require recrossing into the SB after MB
TM
(Devax Inc, Irvine, CA). The TrytonTM, SideguardTM,
TM
is the exception, as it is implanted in the
proximal MB at the level of the carina and does not require recrossing into the SB but may
require the additional implantation of two further stents to completely treat some types of
bifurcation lesions.
TECHNICAL CHALLENGES FACING DEDICATED BIFURCATION STENT SYSTEMS
The stent delivery systems (SDS) of these dedicated bifurcation systems have a number of
design features in common, which explain both their strengths and weaknesses:
(a) Double balloon SDS has to be tracked over two wires, and thus wire wrap (twisting) is
a common problem. However, the stent is implanted by simultaneous kissing inflation
possibly resulting in shorter procedure times. In addition, these devices still tend to be
bulkier than single balloon SDS requiring guide catheters larger than the standard 6F and
limiting their use in calcified lesions and tortuous vessels.
(b) Devices that track over two wires may be limited by wire wrap, wire bias, and atheroma
(Fig. 1) that prevent device advancement and rotation to align with the SB (8).
r
Wire wrap ortwisting is the most frequent problem and isrecognized as resistance when
advancing the device and is often visible on fluoroscopy. Wire wrap can be avoided by
wiring the most difficult branch first, then wiring the second branch with minimal
rotation, and avoiding wire wrap on the catheterization table. If wire wrap prevents
advancement of the device, then the following can be tried to resolve the problem: pull
back one wire up to the tip of the balloon or catheter and rewire with limited rotation;
or place the SB wire into the MB, push the device up to the bifurcation, pull back the
device slightly, and rewire the SB.
r
Wire bias results in the SB wire directing the SB component away from the SB and
prevents rotational alignment with the SB. It is less of a problem in distal lesions and
with shallower SB angles.
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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Wrap (twisting)
Wire bias (wire directs stent away from the
SB)
Atheroma/calcium prevents rotation and
alignment
213
Figure 1 Delivery challenges for SB access dedicated bifurcation stents, particularly those that are delivered
over two wires include wire wrap, wire bias, and atheroma that may prevent device advancement and rotation to
align with the SB.
r
Atheroma and/or calcium prevent rotation and alignment of the device. Adequate
Source
: Photo courtesy of Dr. John Ormiston.
predilatation and lesion preparation of both branches is mandatory with all of these
devices.
(c) Stents with a preformed SB aperture maintain access to the SB during MB stenting but
successful implantation is dependent on accurate positioning with very little tolerance
for incorrect placement. Also, an optimal view of the bifurcation is crucial for axial and
longitudinal alignment and SB positioning.
(d) An SDS with a side hole needs to have axial and rotational self-positioning properties, that
is,
r
Axial: SDS has a “stopper” to position the side cell at the SB level, closest to the carina.
r
Rotational: SDS automatically turns the side hole exactly towards SB. Rotation to align
the device with the SB ostium may be passive (Nile
TM
, PetalTM, Medtronic Y-stentTM) or active and torquable rotation may be possible
Rail
(Antares
(e) The Nile
TM
and SidekickTM).
TM
, FrontierTM, Twin-RailTM, SidekickTM, and StentysTMSDS have struts that only
partially cover the ostium, and thus leave the potential for a gap and ostial restenosis.
(f) Stents that have struts that can be expanded into SB ostium (Petal
TM
, Frontier/PathfinderTM, Twin-
TM
, AntaresTM)maybe
clinically advantageous, as they provide complete coverage of the SB orifice and offer the
possibility of delivering drug to the SB ostium.
(f) SB specific stents commit the operator to stenting both branches.
(g) Unfortunately, most are still BMS but with DES currently under development in the
majority.
214
LATIB ET AL.
DEDICATED BIFURCATION STENT SYSTEMS: TECHNICAL DESCRIPTION
AND STAGE OF DEVELOPMENT
This section describes each of these devices in detail, including their unique design features
and implantation technique, and where possible we have provided a case example. The main
technical characteristics have been summarized in Table 1, and the available clinical results
regarding their implantation in humans in Table 2.
Medtronic Bifurcation Y-StentTM(Medtronic)
The Medtronicbifurcated Y-stent is based on the Medtronic Driverstent cobalt alloy designand
is essentially 3 Driver/MicroDriver stents fused into a trouser leg bifurcation design (Fig. 2)
(9,10). This balloon expandable bifurcated stent is premounted on a dual monorail SDS, with a
single inflation lumen, has a crossing profile of 0.062 inches, and an ostial marker band, which
facilitates device placement. After adequate predilatation of both branches, the stent is tracked
over two wires and advanced to the carina. The stent is deployed by simultaneous inflation
of both balloons using a single indeflator, which also provides the final kissing inflation and
potentially decreases the number of procedural steps. No recrossing of the SB is required with
this device as access to both branches is maintained throughout the procedure.
The first generationof thisdual-branch stentshould accommodate bifurcationangles from
0 to 70 degrees. This device is currently undergoing investigation in a 60-patient multicenter
nonrandomized FIM BRANCH (Bare metal bifuRcAtion steNt Clinical trial in Humans) study.
The primaryendpoint ofthe study isa compositeof cardiacdeath, target-vesselMI, andclinically
driven TVRat 30 days. Preliminary data on the60 patients enrolled showed acute devicesuccess
in 83% with some ofthe failures being dueto underrotation of the device (10). If the final results
of the BRANCH study appear promising, Medtronic is expected to invest in a DES platform
that will utilize the Endeavor Resolute technology, that is, the Biolinx biocompatible polymer
and Zotarolimus.
Y-med Sidekick
The Sidekick
TM
(Y-med Inc)
TM
(Fig. 3) is a low profile 6F guide compatible SDS that integrates a MB fixedwire platform with a rapid exchange steerable SB guidewire designed to preserve SB access
during bifurcation stenting. There are three models with different exit ports (proximal, mid,
and distal) that are selected depending on the location of the disease in the bifurcation; for
example, proximal exit port for a lesion distal to the bifurcation or an ostial lesion. When the
device is close to the carina, a guidewire is passed through the SB exit port and MB stent struts
into the SB, thus avoiding recrossing into the SB. This steerable SB wire enables torquability
for optimal stent orientation axially and longitudinally without wire twist. The fixed MB wire
becomes movable poststent deployment to preserve MB access. Various BMS designs and even
a DES platform are currently under investigation.
The only clinical data available for the Sidekick
TM
is unpublished data from a First-InMan (FIM) study performed in 17 patients with 20 lesions presented at the 2007 Cardiovascular
Revascularization Therapies (CRT) conference (11). The device success rate was 80% and an
additional stent was required in 40% of cases. During the short follow-up period (68 ±32 days),
there was one major adverse cardiac event (MACE) due to a subacute stent thrombosis.
Multilink Frontier
The Multilink Frontier
TM
and PathfinderTM(Abbott Vascular Devices/Guidant Corporation)
TM
coronary stent system (Fig. 4) is a balloon-expandable 316 L stainless
steel stent premounted on a dedicated delivery system with two balloons (monorail for MB and
over-the-wire innerlumen for SB) and two guidewire lumens.To assist tracking and avoid wire
wrap, the Multilink Frontier
MB balloon tip includes a pocket on the distal sleeve for joining the MB and SB balloon tips
with a mandrel. The Multilink Frontier
TM
has an integrated tip design that allows single tip delivery—the
TM
is advanced into the MB over a conventional wire.
The joining mandrel is retracted, releasing the over-the-wire SB tip and a 300-cm exchange wire
is inserted into the SB balloon lumen and into the SB. The system is advanced to the carina and
simultaneous kissing inflation of the two balloons is performed, using a single indeflator, to
expand the stent on the MB and SB.
ostium; potential SB
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gap when placing
second stent
ostium; Potential SB
gap when placing
second stent
partial coverage of SB
ostium; potential SB
gap when placing
second stent; no DES
under development
partial coverage of SB
ostium; potential SB
gap when placing
second stent that can
)
Continued
(
be overcome by
placing Nile Delta SB
stent
+±
– +±
– ++Tracks over 2 wires
– +±Partial coverage of SB
– +±Partial coverage of SB
+±
– +±Tracks over 2 wires;
– +±Tracks over 2 wires;
paclitaxel
Everolimus-
rapid exchange
Cobalt alloy Double balloon, dual
system
Single rapid exchange
Cobalt
system
chromium
wire tracking, dual
lumen tip, MB rapid
Double balloon, single
steel
Stainless
exchange & SB
over-the-wire
Cobalt
Fluoropolymer
rapid exchange
system
Double balloon, dual
chromium
steel
Stainless
rapid exchange
system, 2
Double balloon, dual
steel
Stainless
independent
catheters
chromium
Cobalt
Polymer-free
chromium
Cobalt
Mechanism Ostial
expandable
expandable
expandable
expandable
expandable
Tab le 1 Summary of the Main Characteristics of Current Dedicated Bifurcation Stents
Stent of stent Stent Drug- SB SB
Manufacturer type GC expansion material SDS eluted protection coverage Comments
Medtronic Y-stent 7Fr Balloon-
5F Balloon-
TM
Y-Med SideKick
7F Balloon-
TM
Guidant/Abbott Frontier
TM
Pathfinder
6F Balloon-
TM
Twin-Rail
Invatec Invatec
TM
6F Balloon-
Minvasys Nile
TM
Nile CroCo
TM
Nile Pax
ostium; potential SB
gap when placing
second stent; no DES
under development
ostium; potential SB
gap when placing
second stent
required to fully treat
rotation possible
both branches
mandatory
both branches
mandatory; No DES
under development
bifurcation
complete coverage of
true bifurcation lesion
– + – No coverage of SB
over-the-wire system
Single balloon, dual
steel
Stainless
– ± Partial coverage of SB
polymer
Paclitaxel-PESU
exchange system
++Tracks over 2 wires
polymer
Translute
Paclitaxel-
wire rapid exchange
system
Double balloon, dual
Chromium
Platinum
– ++Torqueable and active
wire rapid exchange
system
Single balloon, single
steel
Stainless
–N/A++ SB stent; Stenting of
wire rapid exchange
–N/A++ SB stent; Stenting of
system
Single balloon, single
Cobalt
wire rapid exchange
system
chromium
Sirolimus N/A ++ SB stent; MB stenting
wire rapid exchange
system
Single balloon, single
steel
Stainless
+ – Requires 3 stents for
polymer
BiolimusA9-PLA
exchange system
Mechanism Ostial
expandable
expandable
expandable
expandable
expandable
)
Continued
Tab le 1 (
Stent of stent Stent Drug- SB SB
Manufacturer type GC expansion material SDS eluted protection coverage Comments
8F Balloon-
TM
SLK view
Stent
Advanced
Technology
7F Self-expandable Nitinol Single wire rapid
TM
Stentys Stentys
7F Balloon-
TM
Petal
Scientific
Boston
6F Balloon-
TM
Antares
Medical Inc
Tr i re m e
6F Self-expandable Nitinol Single balloon, single
TM
Cappella Sideguard
5F Balloon-
TM
Tryton Medical Tryton
Biguard 6F Balloon-
Ltd.
Lepu Medical
7F Self-expandable Nitinol Single wire rapid
TM
Devax Axxess
: GC, guiding catheter size (French); SB; side branch; MB; main branch; SDS, stent delivery system; DES, drug-eluting stent.
: Adapted from Ref. 7.
Abbreviations
Source
Restenosis
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MB SB
(%) (%)
c
N/A N/A N/A
2.7 6.7
2 9.4 N/A N/A N/A
N/A N/A
e
2.9
e
2.9
e
5.9
b
d
e
5.8 5.8 0 5.8 N/A N/A
a
of Follow- Device stent in
Number Additional
patients/ up success MB/SB MACE MI TLR ST
Multicenter Registry 93 180 96 0/13 11.8
FIM Study 13 120 92.3 54/38 33.3 33.3 16.7 N/A 45.5 54.5
FIM Study ongoing 28 180 89.3 36/25 11.5 3.8 3.8 0 15 10
139 180 93.5 71/52 11.2 6.0 7.5 2.2 4.8 9.2
(AXXESS PLUS)
FIM-Study 30 180 96.7 N/A 9.9 6.6 6.6 0 4.3 0
33 180 N/A N/A 12.1 9.1 9.1 0 6.9 16.1
302 210 98.3 82/68 7.7 4.3 4.3 1.0 3.6 4.3
(DIVERGE)
Multicenter Registry
(AXXENT)
Ormiston
TM
Verheye et al. (23,24) FIM Study (OPEN I) 40 180 95.5 23/33 25 1 22.5 0 25 14
AST Petal
TM
Stentys
Petal
et al. (25)
PI: J. Ormiston
TM
Taxus Petal
Grube et al. (26)
TM
Di Mario et al. (28) FIM Study (TOP) 39 30 100 0/18 5.9
Grube et al. (29) FIM Study (SG-1) 20 180 80 N/A 12.5 6.3 12.5 0 N/A N/A
TM
Sideguard
Antares
PI: E. Grube Combined SG-1 & SG-2 83 180 86 – 10.8 3.6 6 3.2 2.5 14.5
Kaplan et al. (31) and Onuma
TM
Tr y to n
et al. (32)
Grube et al. (34) Multicenter Registry
TM
Axxess
Tab le 2 Summary of the Available Data and Trials of Current Dedicated Bifurcation Stents
Device Study Study type lesions (days) (%) (%) (%) (%) (%) (%)
PI: I. Meredith (10) FIM Study (BRANCH) 60 30 83 N/A 3.3 3.3 0 0 N/A N/A
TM
Medtronic Y-stent
TM
Solar et al. (11) FIM Study 17/20 68 ± 32 80 40
SideKick
Lefevre et al. (12) Multicenter Registry 105 180 91 40/43 17.1 3.8 13.3 0 29.9 29.1
TM
Frontier
Lefevre et al. (14) FIM Study (DESIRE) 15 210 75 17/23 14.3 0 14.3 0 N/A N/A
Hoffman et al. (16) Single-center Registry 41 180 88 0/29 19.4 0 17 0 N/A N/A
TM
Invatec Twin-Rail
Cervinka et al. (17) RCT 30 360 97 0/0 13 0 14 0 14 N/A
Lefevre et al. (18) Multicenter Registry 75 210 90.7 28/15 10.7
TM
Nile
TM
Minvasys Nile
Del Blanco
TM
et al. (19)
Nile CroCo
PI: J. Fadajet FIM Study ongoing (BIPAX) 100 – – – ––––– –
TM
Nile Pax
Ikeno et al. (21) Multicenter Registry 81/84 180 97.6 14/25 31 2.5 21.3 1.3 28.3 37.7
TM
SLK view
TM
Hasegawa
TM
Verheye et al. (35) Multicenter Registry
et al. (36,37)
Axxess-LM
a
Not specified whether MB or SB.bFollow-up data available only on 45 patients.
Study reports results for target vessel revascularization only and not TLR.
c
d
Follow-up data available only on 85 patients.eFollow-up data available only on 34 patients.
: PI, principal investigator; FIM, First-In-Man study; MACE, major adverse cardiac event; MI, myocardial infarction; TLR, target lesion revascularization; ST, stent thrombosis; MB, main
Abbreviations
branch; SB, side branch; N/A, not available.
: Adapted from Ref. 7.
Source
218
Figure 2 The Medtronic bifurcation Y-stent is mounted on a dual-wire double balloon SDS and is the only true
complete bifurcation stent that has both a MB and SB components.
LATIB ET AL.
The safety and performance of the Multilink FrontierTMstent has been evaluated in a 105patient multicenter registry (12). Device success was 91% and procedural success 93%. Reasons
for failure to deliver the device were vessel calcification in eight cases and wire wrap in one
case. Two patients suffered an in-hospital myocardial infarction secondary to SB occlusion.
The late loss for the Multilink Frontier
TM
was 0.84 ± 0.55 mm and the overall bifurcation
restenosis rate (44.8%) was high (MB: 29.9%, SB: 29.1%). At six-month follow-up, the target
lesion revascularization (TLR) and MACE rates were 13.3% and 17.1%, respectively. There
were no cases of subacute or late stent thrombosis during the follow-up period. The acute
device success but high restenosis rates of the Multilink Frontier
the development of Abbott’s next generation bifurcation DES, called the Abbott Pathfinder
The Pathfinder
TM
utilizes thesame unique SDS ofthe FrontierTM, butthe stent is nowchromium
TM
formed the platform for
TM
.
(B)
(A)
Figure 3 The Y-med SidekickTM(
is afixed-wire main branch stent delivery system
with different exit ports for the side branch protection wire located either proximally (A), mid
(B), or distally. The torqueable shaft actively
rotates the stent to allow alignment with the SB
(
lower panel
).
upper panel
)
CURRENT STATUS AND FUTURE OF DEDICATED BIFURCATION STENT SYSTEMS
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(A)
(B)
219
Figure 4 The Multilink FrontierTM–
(C)
(D)
cobalt with the Xience VTMDES platform (i.e., Everolimus on a nonerodable acrylic and fluoro
Pathfinder
stent delivery system with the two balloons
joined by a mandrel (A), thus allowing tracking
of the device into the MB over a single wire
to prevent wire wrapping (B); when the device
is close to the carina, the joining mandrel is
retracted releasing the over-the-wire SB balloon, a guidewire is then placed via this balloon
into the SB, and the entire system is advanced
to the carina (C); the stent is expanded into the
MB and SB with simultaneous kissing inflation
of the two balloons using a single indeflator (D).
polymer) (13). There are no clinical data currently available for the Pathfinder
The Invatec Twin-Rail
The Invatec Twin-Rail
TM
(Invatec S.r.l.)
TM
(Fig. 5) is a slotted tube, 316 L stainless steel stent premounted on
TM
is a dual lumen, double balloon
TM
.
double balloons in its proximal portion, and only on the MB balloon in its distal portion. The
stent has a closed cell-type design with variable stent geometry. This 6F-compatible system
consists of a single dual lumen catheter splitting into two distal balloons, with a central stopper
that prevents further advancement of the SDS when the carina is reached. The stent is deployed
by simultaneous kissing inflation with a single indeflator. The Twin-Rail
Multilink Frontier
tapered balloon while in the Twin-Rail there is a full dilatation balloon.
The Twin-Rail
TM
double-balloon system except that in the latter the SB balloon is a short
TM
double balloon SDS was evaluated in the unpublished DESIRE (DoublE
TM
is similar to the
vs. Single balloon stent delivery systems for bifurcation lesions) trial. This trial presented at the
Transcatheter Cardiovascular Therapeutics(TCT) 2005meeting comparedthe safetyand efficacy
of the Twin-Rail
Although angiographic success was high, device success was only 75% with the Twin-Rail
TM
double balloon SDS (15 patients) to a single balloon SDS (24 patients) (14).
TM
,
Соседние файлы в папке Библиотека им академика М.И. Перельмана