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190
LATIB ET AL.
7. Dual antiplatelet pretreatment, testing for clopidogrel hyporesponsiveness, and ensuring uninterrupted adherence to at least 12 months of dual antiplatelet therapy is essential.
8. Elective hemodynamic support is recommended in selected cases such as very complex anatomy, severe calcifications, or low ejection fraction.
9. Adequate lesion preparation is important in severely calcified lesions, or where the predi­lating balloon will not pass the lesion or fully expand.
10. IVUS-guided DES implantation and optimization should be performed in all cases.
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22. Galassi AR, Colombo A, BuchbinderM, et al. Long-term outcomes of bifurcation lesions after implan­tation ofdrug-eluting stentswith the“mini-crush technique.”Catheter CardiovascInterv 2007;69:976–
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27. Chevalier B, Glatt B, RoyerT, et al.Placement of coronary stents in bifurcation lesions by the “culotte” technique. Am J Cardiol 1998; 82:943–949.
28. Erglis A, Kumsars I, Niemela M, et al.; for the Nordic PCI Study Group. Randomized comparison of coronary bifurcation stenting with the crush versus the culotte technique using sirolimus eluting stents: The Nordic Stent Technique Study. Circ Cardiovasc Interv 2009; 2:27–34.
29. 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.
30. Burzotta F, Gwon HC, Hahn JY, et al. Modified T-stenting with intentional protrusion of the side­branch stent within the main vessel stent to ensure ostial coverage and facilitate final kissing balloon: the T-stenting and small protrusion technique (TAP-stenting). Report ofbench testing and first clinical Italian-Korean two-centre experience. Catheter Cardiovasc Interv 2007; 70:75–82.
31. 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.
32. Adriaenssens T, Byrne RA, Dibra A, et al. Culotte stenting technique in coronary bifurcation disease: angiographic follow-up using dedicated quantitative coronary angiographic analysis and 12-month clinical outcomes. Eur Heart J 2008; 29:2868–2876.
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9
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Bench Testing of Coronary Bifurcation Stenting Techniques: How Is It Done? Does It Help Technical Decision Making?
Yoshinobu Murasato
Department of Cardiovascular Medicine, Heart Center, New Yukuhashi Hospital, Yukuhashi, Japan
WHY IS BENCH TESTING OF CORONARY BIFURCATION STENTING TECHNIQUES IMPORTANT?
PCI for coronary bifurcation lesions has been associated with high restenosis rates in the bare metal stent (BMS) era (1); however, the introduction of drug-eluting stents (DES) have led to significant reduction in restenosis and target lesion revascularization in bifurcation lesions (2–7). However, the risk of acute compromise and/or delayed restenosis in the ostium of the side branch (SB) remains an issue particularly in the “at risk” bifurcations (i.e., true bifurcation lesions with severe ostial SB lesion and/or wide bifurcation angle, particularly when the SB supplies a large myocardial territory).
Although the in vivo imaging modalities [angiography, intravascular ultrasound (IVUS), optical coherence tomography] that are used to guide bifurcation stenting are valuable in optimizing acute results, they provide limited insight into the relationship between bifurca­tion anatomy, stenting technique, and the ensuing stent configuration at the bifurcation. This information is critical to individualizing technique selection and refining technique execution [provisional vs. elective, fate of jailed SB, and necessity of kissing balloon inflation (KBI)].
Bench testing allowsdirect anddetailed inspection of stent configuration atthe bifurcation and its relationship to the simulated bifurcation anatomy and stenting technique. Imaging is typically performed with high-quality cameras, microscopy, and microfocus X-ray computed tomography (MFCT) with resolution of 0.06 mm (8–11). An example of the difference in the quality of information attainable with IVUS versus MFCT is shown in Figure 1(A) and 1(B). As shown in Figure 1(A), the proximal segment of the SB stent was crushed due to incorrect guidewire recrossing, and subsequent dilation, outside of the SB stent using the modified crush stenting technique. The three-dimensional (3-D) images of MFCT demonstrate a large gap at the proximal segment of the SB. In the cross-sectional views, the absence of struts on the carina side and the evidence of two layers of crushed stent at the opposite site were clearly observed [Fig. 1(A)]. As shown in Figure 1(B), the IVUS images also show the crushed stent and non– strut-covered area, but the image resolution is inferior to that of MFCT. This may be because of the uneven pullback speed due to the slack of the catheter in the corner of the bifurcation, as well as due to oblique projection from the lateral side of the SB sweeping to the MV.
Using these high-quality imaging modalities, the previous bench testing studies have clearly demonstrated stent distortion,stent apposition,gap formation, metal overlapping, open­ing of jailed strut, and polymer damage in each bifurcation stenting technique (8–15). Many factors that can potentially affect the results of bifurcation stenting has been investigated by bench testing such as stent platform, bifurcation angle, 3-D structure, balloon size, inflation pressure, balloon overlapping, KBI, and guidewire position (8–15).
HOW IS BENCH TESTING DONE?
In previous reports, silicone tubes (8,9,11,12), polyvinyl acetate (PVA) tubes (13), and silicone blocks (10,14,15) have been used as phantom models. Although a silicon tube has elasticity that resembles the human coronary artery, it is not transparent enough to allow direct observation externally, and the removal of the implanted stent for observation without inadvertent damage is challenging. PVA tubes are soft and can be embedded in the vessel mold constructed by the silicon block. The implanted stent can then be removed easily because the PVA tube melts
194 MURASATO
(A) (B)
Figure 1 Comparison in the resolution for the analysis of complex stenting between MFCT and IVUS. The proximal site of the SB stent was crushed by the SB balloon and there was a large gap at the opposite site. (A) MFCT images. Each cross-sectional view corresponds to the line in the 3-D view. The absence of the struts (
arrows
) and the crushed stent at the opposite site ( view corresponds to the line in the 3-D view. Although the absence of the strut ( the opposite site ( were missed.
gray arrows
Source
) were observed, their resolutions were inferior to the MFCT views so the problems
: From Ref. 9.
gray arrows
) were clearly visualized. (B) IVUS images. Each
arrows
) and the crushed stent at
in hot water immersion. Most studies were performed in the two-dimensional (2-D) model (10,11,13–16). However, it has been demonstrated that the 3-D structure of the bifurcation has a great impact on stent deformational behavior because of the various configurations of balloon overlapping (8,9,12).
We useda 7.5-cm diametercolumn toreproduce the3-D structureof theLMCA bifurcation. A 4-mm-diameter silicon tube, corresponding to the LAD, was glued and oriented vertically, while a 3-mm-diameter tube, corresponding to the circumflex artery (LCX), was glued in a transverse direction, with a 90-degree angle between both tubes. A tube corresponding to the LMCA was glued and oriented at a 135-degree angle with respect to the other two branches [Fig. 2(A)]. The 3-D structure of the model was inspected by fluoroscopy and confirmed to be similar to that of a human LMCA bifurcation [2(B–F)] (12).
(A)
Figure 2 3-D model of left main coronary bifurcation. The LAD tube was attached along the longitudinal axis and the LCX tube was attached obliquely to create an angle between the LMCA and the LAD, which was equal to that between the LMCA and the LCX (A). Fluoroscopic inspection, in the right anterior oblique 30 anterior oblique 50◦(C), anterior–posterior caudal 30◦(D), and in the spider view (E), confirmed the similarity of the model to a human coronary angiogram.
Source
: From Ref. 12.
(B) (C)
(D) (E)
◦
(B), left
BENCH TESTING OF CORONARY BIFURCATION STENTING TECHNIQUES 195
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The stenting procedure was performed under fluoroscopy or direct visualization. The magnified image of Charge Coupled Device (CCD) camera was useful for procedure execution such as guidewire recrossing through thetarget strut. Theexperiments were performed under a variety offactors, whichwere thought toaffect stentconfiguration. Although inthe initialstudies fluoroscopy, CCD camera, and microscopy were used (12–16), MFCT has become the standard imaging technique inlater investigations(8–11). Thistechnique provideshigh-resolution images in the 3-D reconstruction model and any cross-sectional or longitudinal views can be obtained.
WHAT ARE THE OBSERVATIONS GAINED FROM BENCH TESTING?
Bench testing of bifurcation stenting techniques have revealed numerous observations and insights that can help in refining the technical execution of the various bifurcation stenting techniques.
Insights into the Provisional Stenting Technique
Provisional stenting can result in outcome similar to elective double stenting with lower use of resources in appropriately selected patients (2–6). However, there are several technical steps that need to be performed to produce optimal results (17).
The Ideal Site for Guidewire Recrossing into the SB
Bench testing have demonstrated that the site of guidewire recrossing into the SB affects the scaffolding of the SB ostium after KBI. As shown in Figure 3, the ideal site of recrossing into the SB is the distal segment of the stent covering the ostium because that leads to scaffolding the SB ostium after SB dilation (black star in A[4]), whereas recrossing into the SB through the proximal segment (white triangles in C[4]) produces MV stent deformity without scaffolding the SB ostium.
(A) (B) (C)
Figure 3 Relation between stent configuration and the position of recrossed guidewire in the procedure of cross­over stenting followed by kissing balloon inflation (KBI). As the dotted arrows indicate, the wires were recrossed at distal (A), middle (B), and proximal (C) portions of the SB ostium [1]. Although the deformations of the MV stents were promoted by the SB ballooning (A[2], B[2]; B[4];
white arrows
through the distal portion (A[4]; was recrossed through the proximal portion (C[4],
). Finally, the SB ostium was scaffold by the protruded MV stent when the wire was recrossed
black star
). However, distal MV stent was protruded into the MV when the wire
arrows
), the KBI [3] corrected these deformations (A[4],
white triangles
).
196 MURASATO
The Importance of KBI
Bench testing demonstrated the importance of KBI to correct the deformation of the MV stent. As shown in Figure 3 (arrows in A[2] and B[2]), the deformation of the MV stent opposite to the SB ostium after SB dilation was corrected after subsequent KBI (white arrows in A[4] and B[4]).
Insights into the Double Stenting Techniques
Elective double stenting is often necessary in true bifurcation lesions that involve a large SB with severe ostial stenosis. Final KBI is considered a critical step to optimize the results and some believe that it may reduce the need for repeat interventions (19).
The Effects of Bifurcation Angle on Balloon Overlapping Patterns and Proximal MV Expansion
In electivedouble stenting techniques, two stentsare deployed consecutively orsimultaneously and KBI is performed to optimize the results. Therefore, understanding the 3-D pattern of stents/balloons overlap is important because the pattern of balloon overlapping affects the configuration of the proximal segment of the MV stent. As shown in Figure 4, the effect of bifurcation angle on the pattern of balloon overlapping was investigated in the simultaneous kissing stenting (SKS) technique using Multilink stents (Abbott Vascular, Santa Clara, CA). In narrow angle bifurcations [Fig. 4(A)], the two stents are aligned lateral to each other, whereas in wide-angle bifurcations the two stents are increasingly overlapped longitudinally according to the degree of the bifurcation angle [Fig. 4(B) and 4(C)] and the overlap pattern becomes
(A) (B) (C)
(D)
(E)
(F)
Figure 4 (A–C) Relation between bifurcation angle and style of stent overlapping during simultaneous kissing stenting (SKS). ( narrow angledbifurcation (A;30 according to the degree of the bifurcation angle (B;70 (D) Long overlapping also led to the x-shape crossing of the two stents in the proximal MV. This overlapping style showed maximal dilation at the proximal end of the stents ( (
white arrows
style showed maximal dilation at the bifurcation point ( (
white arrows
is more effective for plaque compression compared to x-shape crossing, because it can provide maximal dilation at the lateral area where plaque burden is rich.
Upper panels
). (E) Minimal overlapping in the same bifurcation model as shown in panel (D). This overlapping
). (F)Plaque distributionin the bifurcation according to recent pathological study. Minimal overlapping
) position of the two stents before inflation. (
◦
), the two stents positioned laterally, whereas the stents overlapped longitudinally
◦
) and the style finally changed to the x-shape (C;80◦).
black arrows
black arrows
) and minimal at the proximal end of the stents
Lower panels
) and minimal at the bifurcation point
) During inflation. In the
BENCH TESTING OF CORONARY BIFURCATION STENTING TECHNIQUES 197
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x-shaped in the widest angle [Fig. 4(C)]. The proximal in-stent area for stents implanted in wide-angle bifurcations (x-shaped overlap pattern) is larger than stents implanted in narrow angle bifurcations. This finding suggests that when kissing stents are deployed in a wide-angle bifurcation, the x-shaped pattern of overlap mayincrease the risk of proximal overdilation after SKS and after KBI. Furthermore, the x-shaped pattern of overlap can lead to underdilation of the segment proximal to the carina in the transverse direction [Fig. 4(D), where most of the plaque is typically localized [Fig. 4(F)] (18). Onthe other hand, minimizingthe extentof balloon overlapping (not x-shaped overlapping) leads to better plaque compression proximal to the carina [Fig. 4(E)].
We have previously demonstrated in a 3-D model that the wide bifurcation angle in the LMCA influences balloon overlapping patterns during KBI (8,9,12,13,20). Furthermore, we have illustratedthat the variouspatterns of overlap(MV balloon locatedover SB balloon and SB balloon located over MV balloon) can be easily reversed by the manipulation of the guidewire (Fig. 5) (12).
Crush stenting
Although thistechnique securesimmediate patency ofboth branches of the bifurcation, it can be associated with various stent deformities ifused in improper anatomy and/orif not performed in an optimal fashion. Studies using IVUS (20) and animal experiments (21) have shown stent malapposition at the SB ostium, excessive metal overlapping, and incomplete crush at the proximal MV.
Bench testing hasdemonstrated thatthe bifurcationangle had a significantimpact onstent apposition to the SB ostium (8–10,12,14,15). Although final KBI improvesSB ostium stent appo­sition in narrow-angled bifurcations, it does not do so in wide-angled bifurcations (persistence
(A) (B)
Figure 5 ( located over the LCX ( inspections in the anterior–posterior caudal ( the guidewire advanced from the LMCA into the LCX. The wire is visible on the myocardial side of the distal LMCA when the LAD balloon is positioned over the LCX balloon (A, middle and lower panels), and on nonmyocardial side when the overlapping is reversed (B, middle and lower panels).
See color insert
blue
) Overlap of the balloons in the distal LMCA. Visual inspection of the LAD (
) balloon (A, upper panel), and the reverse relationship (B, upper panel). Fluoroscopic
middle panels
), and spider (
Source
lower panels
: From Ref. 12.
) views. The arrows indicate
red
) balloon
198 MURASATO
of an unstented area at the distal carina site of the SB) (8,9,12,14). In a 3-D left main bifurcation model (Figs. 6 and 7), the cross-sectional images at the distal bifurcation clearly demonstrate a wedge-shaped gap between the stents [Fig. 6(B)] and the absence of struts [Fig. 7(C)]. In this model, when the LAD stent was located above the LCX stent, the stent was crushed on the myocardial side and the unstented area was observed on the nonmyocardial side. When this overlap was reversed, theLCX stent was crushed on the nonmyocardial side, and theunstented segment was located on the myocardial side (12).
Although it has been suggested that the two-step balloon dilation technique (10), the minicrush technique (22), and the double kiss crush technique (DK crush) (23) lead to better SB ostium apposition and improved long-term outcome, bench testing of these techniques still reveals lack of complete apposition to the distal carina. There are several factors, which may be responsible for these observations:
1. The position at which the guidewire recrosses the MV stent into the stented SB has a major
influence on ostial SB stent deformity. The ideal position for guidewire recrossing into the SB is the middle of the SB ostium. Guidewire recrossing into the SB through the proximal portion of the SB ostium leadsto incomplete expansion ofthe balloon during postdilatation. On the other hand, guidewire recrossing into the SB through the distal portion of the SB ostium (from the outside of the SB stent) leads to partial crushing of the proximal part of the SB stent with the postdilatation balloon (Fig. 8). As shown in Figure 9(A), the 3-D MFCT images demonstratea large gap onthe carina sideof the proximalsegment of theLCX artery
Figure 6 MFCT images after crush stenting in the 3-D LMCA bifurcation model with the LAD stent positioned above the LCX stent. (A) The 3-D image shows the crushed proximal end of the LCX stent extending onto the lateral LMCA and the gap at the distal carina ( the carina. Each image was acquired at the level of the arrows in panel (A). In the proximal carina, the protruding strut of the MV stent into the LCX covered the ostium of LCX (b, gap between the two stents was observed along the nonmyocardial site (d,
(A)
dotted arrow
(B)
). (B) Proximal to distal (a–d) cross-sectional images of
dotted arrow
). However, in the distal carina, a
arrows).Source
: From Ref. 8.
(1)
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(2)
(A)
(B)
(C)
Figure 7 (A) 3-D view of classical crush stenting using Express II stents in the 3-D LMCA bifurcation model. (B) Magnified view of the bifurcation. A relatively large gap was observed at the nonmyocardial site of the LCX ostium (B2, indicate absence of the struts.
encircled area
). (C)Cross-sectional views at the correspondinglines indicated in part (B1). The arrows
Source
: From Ref. 9.
(A)
(B) (C)
Figure 8 (A) 3-D view of the worst case of crush stenting that the guidewire was recrossed through the distal portion of the LCX ostium. The LCX stent was crushed more distally after kissing balloon inflation ( (B) Cross-sectional view at the corresponding lines in part (A). White arrows indicate the absence of the strut and the crushed stent was observed at the opposite site of the carina. (C) Mechanism of this phenomenon. The guidewire and balloon were advanced outside the proximal segment of the crushed stent (1) and the balloon was inflated (2). Finally, the proximal part of the LCX stent was recrushed more distally (3).
Source
dotted arrows
: From Ref. 9.
).