INTERVENTION IN OSTIAL CORONARY LESIONS:

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1 INTERVENTION IN OSTIAL CORONARY LESIONS: Antony (92), le 18 septembre 2013 JEAN MARC PERNES Hopital Privé Antony FRANCE Perfection of Precise Ostial Stent Placement Ostial lesions, including aorta ostial lesions and Medina bifurcation lesions: known to create difficulty in precise stent placement. Unique challenges : associated with higher procedural and medium term complication rates linked to geographic miss of the Stent placement 1

2 Percutaneous coronary intervention of ostial lesions Ostial disease :a lesion arising within 3 mm of the vessel origin,classified by location as aorto ostial, non aorto ostial, or branch ostial Female sex: independant risk(or:2.3)for aorto ostial lesions GUIDE CATHETER: For aorto ostial lesions this is particularly important and less aggressive catheters (e.g., Judkins shape for native coronary vessels) are recommended to avoid deep engagement and wedging of the catheter within the lesion and to facilitate disengagement during stent placement 6 Fr guides are suitable for the majority of cases Equipment selection Exclusion of coronary spasm engagement of catheters at aorto ostial sites may provoke spasm and give a false impression of severe ostial disease. 2

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4 Equipment selection GUIDEWIRE In most cases a standard workhorse wire is appropriate, providing a satisfactory distal position within the vessel can be obtained.this is particularly important for aorto ostial lesions to aid stability during guide catheter disengagement A more supportive wire (eg Balance Heavyweight, ChoICE PT Extra Support, Asahi Grand Slam ) may be preferable, especially if the disengaged guide catheter s position in the ascending aorta is precarious. A buddy wire may also be used to provide additional stability,or as a marker in the ascending aorta or side branch to aid stent positioning. For intervention on severe aorto ostial disease, it is advisable to pre load the wire in the guide before vessel intubation to facilitate rapid wiring and catheter disengagement if necessary. STENT SELECTION Equipment selection DES vs. BMS: At ostial sites, DES appear to have equivalent safety to BMS but with lower MACE due to lower restenosis Specific stents although high radial strength is desirable at ostial locations, no comparison data exists for efficacy between stents from different manufacturers. 82 aorto ostial lesions using the SES (32 patients) or BMS (50 patients) RESULTS:. At 10 month follow up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE: less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow up : lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/ 0.31 mm vs / 1.37 mm, p < ) in the SES group. Iakovou Iet al. Clinical and angiographic outcome after sirolimus eluting stent implantation in aorto ostial lesions. J Am Coll Cardiol 2004;44:

5 STENT SELECTION FOR ULMD The ISAR LEFT MAIN randomized 607 patients to (PES) versus (SES) for the treatment of ULMCA disease. 1 year incidence MACE: 13.6% in the PES group and 15.8% in the SES group Angiographic restenosis :16.0% in the PES group and 19.4% in the SES group (P=.30). ISAR LEFT MAIN 2,:second generation DESs in treating left main disease, i 650 patients randomized to (ZES) or (EES). primary endpoint of MACE :17.5% in the ZES group and 14.3% in the EES group (P=.25). Angiographic restenosis :21% in the ZES group and 16% in the EES group. use of second generation DESs is feasible, with similar outcomes to those noted with the use of first generation DESs in ISAR LEFT MAIN. Additionally, both stent types appear to provide similar results at 1 year follow up 5

6 Procedural considerations LESION ASSESSMENT: Fractional flow reserve (FFR) Aorto ostial disease: FFRmay be valuable, but requires: (a) initial pressure equalisation in the ascending aorta prior to vessel engagement (b) guide catheter disengagement during FFR measurement so as not to occlude flow; (c) ideally, an intravenous infusion of adenosine rather than an intracoronary bolus, as the latter requires catheter engagement to allow selective injection and flush followed by rapid disengagement to allow FFR measurement. Procedural considerations LESION ASSESSMENT: Intravascular ultrasound (IVUS): IVUS has some limitations in assessment of the severity of ostial disease in that it is a non physiological test and the requirement for guide catheter disengagement during pullback risks non coaxial imaging of the ostium and overestimation of the luminal area. Ability to confirm or refute the presence of significant aorto ostial disease. Assessment of vessel size to guide stent selection Assessment of adequacy of stent expansion (We consider this mandatory for the LMS.) 6

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9 Procedural considerations LESION PREPARATION ± DEBULKING: Greater calcification and lesion rigidity at ostial sites plus the risk of significant plaque shift may dictate a plaque modification or debulking strategy. Predilatation with an (undersized) compliant or semi compliant balloon is recommended in all cases. If a compliant balloon fails to expand fully), an undersized non compliant balloon may be used at higher pressure. In markedly fibrotic or moderately calcified ostial lesions, a cutting balloon is a useful adjunct Rotational atherectomy should be considered at the outset for heavily calcified lesions to allow plaque modification or debulking. 9

10 Procedural considerations STENT POSITIONING Ostial PCI requires very precise stent positioning to obtain full lesion coverage, yet avoid unnecessary proximal extension which may result in obstruction of major vessels or excessive overhang into the aorta in some cases even with correct stent positioning there will be a degree of proximal stent protrusion:the more acute the angle is, the greater the risk of suboptimal stent positioning(some authors have suggested an ideal angle of >75 ) 10

11 Difficulties with accurate positioning include: Failure or inability to use appropriate angiographic views to properly demonstrate the ostium and minimise foreshortening or overlap Suboptimal visualisation in aorto ostial lesions due to guide catheter disengagement and resultant poor contrast opacification Excessive stent movement with cardiac contraction Angiographic views Use multiple angiographic views to minimise foreshortening or overlap. limitations of angiographically guided stent placement are clearly demonstrated Retrospectively reviewed the angiograms and clinical outcomes in 100 consecutive patients treated with stent implantation of native coronary aorto ostial or bypass graft aorto ostial (> 50%) lesions. Direct stenting was utilized in 63% A majority of the cases underwent postdilatation in an effort to flare or trumpet the stent struts against the aortic wall and maximize luminal diameter (86%). RCA = 60), LM(n = 10), SVG(n = 26), The aorto ostial stents placed included 80 (DES) and 20 (BMS). 11

12 Stent implantation was categorized as: 1) too distal (> 1 mm distal to the angiographically determined ostium with > 30% residual stenosis) or requiring a second proximal stent 2) 2) too proximal (> 1 mm proximal to the angiographically determined ostium, particularly if the ostium could not be re engagedwitha guiding or diagnostic catheter; 3) accurate (< 1 mm from the true ostium, with the ability to re engage the ostium and with good reflux of the contrast on angiography Forty five of the patients underwent angiographic restudy for recurrent symptoms from restenosis, or for other indications,. clinical follow up was obtained in 98/100 patients (98%). STENT placement missed the true ostium: 54%. RCA(32/60; 53%), LMCA(3/10; 30%),.IN 28/54 missed cases (52%), the stent was placed too proximally,. With an inability to adequately and coaxially re engage the treated vessel in 26/28 (93%) of deployed too distally in 48% of the missed cases, resulting in further intervention with at least one additional stent placed proximal to the first stent in 10/26 of these cases (38%) 12

13 Geographic miss occurs when the lesion is not fully covered or additional stents are required, which undoubtedly will contribute to edge restenosis and stent thrombosis These findings suggest that there is a need for tools or techniques to improve the accuracy of positioning of stents to treat aorto ostial disease Procedural considerations MEDINA 010: ostial LAD(or CX) stenosis.ostial LAD stenoses a decision must be made at the outset as to whether precise positioning of the stent at the ostium should be attempted, or whether stenting across the Cx back into the LMS is preferable. 13

14 The presence or absence of an ostial nub or stump to facilitate proximal positioning. The angle of the bifurcation with the Cx : angles <75 are associated with greater difficulty in stent positioning and increased risk of plaque shift. The presence of significant plaque in the distal LMS or Cx ostium may dictate an alternative PCI strategy or referral for coronary artery bypass surgery. The presence of heavy calcification which may impair visualisation and stent positioning, limit stent expansion and increase the risk of stent edge dissection or restenosis. 2 dominant strategies One consists of stent implantation to simultaneously cover the ostial LAD lesion, origin of the circumflex artery (Cx) and, to a greater or lesser extent, distal LMCA (elective T provisionnal stenting) This entails a further planned intervention to adapt the proximal portion of the stent to the bifurcation and the LMCA, usually by the simultaneous inflation of POT +two balloons (the kissing balloon technique). 14

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18 Cubeddu RJ, Wood FO, Saylors EK, Mann T. Isolated disease of the ostium left anterior descending or circumflex artery: management using a left main stenting technique. Clinical outcome at 2 years. J Invasive Cardiol. 2007;19: Second strategy :implanting a stent to cover the LAD ostium with minimal protrusion in the area of the carina Pretreatment intravascular ultrasound (IVUS) is considered extremely useful because it facilitates identification of significant disease in the distal LAD and who therefore require a different percutaneous treatment. SES stents in 68 consecutive patients with ostial LAD stenoses compared with 77 BMS patients during the preceding two years. In the SES group, for complete lesion coverage, stent positioning was intentionally extended into the distal left main coronary artery (LMCA) in 23 patients (34%) with intermediate LMCA narrowing. Seung KB, Kim YH, Park DW, Lee BK, Lee CW, Hong MK, et al. Effectiveness of sirolimus eluting stent implantation for the treatment of ostial left anterior descending artery stenosis with intravascular ultrasound guidance. J Am Coll Cardiol. 2005;46:

19 . RESULTS: The procedural success rate was 100% in both groups. The six month angiographic restenosis rate was significantly lower in the SES group than in the BMS group (5.1% vs. 32.3%, p<0.001). TLR was less frequent in the SES group than in the BMS group (0% vs. 17%, p<0.001). In the SES group, there were no restenoses in cases with LMCA coverage, compared with three restenoses (7.9%) in cases with precise stent positioning 65 patients with ostial disease of LAD or LC(x) underwent PCI using DES. In 56 patients the stent was placed perfectly at the ostium & in 9 patients the LMCA was covered as per protocol. Angiographically 48 patients had a bifurcation angle > 70 degrees whereas in 17 patients the angle was < 70 degrees. Indian Heart J Sep Oct;63(5): Impact of angiographic & procedural factors on the treatment of ostial LAD or LC(x) disease. Ray S, Chattopadhyay BP, Bandyopadhyay S, Kundu S, Deb A, Deb PK, Bannerjee AK, 19

20 LAD was treated in 88% 74% had bifurcation angle > 70 degrees. 26% presented with an angle < 70 degrees ; LMCA was covered during stent implantation in 12% of cases Overall MACE was 12%. Bifurcation angle > 70 degrees & use of Cypher stent remained significant in reduction of MACE (P < 0.05). Using Univariate analysis with angle of separation > 70 degrees (n = 48) & with angle less than < 70 degrees (n = 17), it was found that covering LMCA was beneficial in cases with angle of separation < 70 degres CONCLUSION: Angiographic factors like bifurcation angle is important to formulate the strategy of stenting procedure in the ostial disease of LAD or LC(x) even with DES. Indian Heart J Sep Oct;63(5): Impact of angiographic & procedural factors on the treatment of ostial LAD or LC(x) disease. Ray S, Chattopadhyay BP, Bandyopadhyay S, Kundu S, Deb A, Deb PK, Bannerjee AK,. 162 patients : 95 underwent focal ostial LAD stenting 67 stenting from the distal LM into the LAD ostium. The 2 year Kaplan Meier estimates of cardiac death, nonfatal myocardial infarction, overall TLR, and TLR LM were 2.6%, 2.1%, 8.3%, and 4.7%, respectively. Overall TLR and TLR LM rates were higher in the focal ostial LAD stenting group. There was a trend toward an independent increased risk of TLR associated with focal ostial stenting. CONCLUSION: DES for isolated ostial LAD lesions is a feasible, safe, and effective treatment strategy. this study suggested the hypothesis that a default distal LM LAD stenting, rather than focal ostial stenting, might provide more favorable outcomes. Am Heart J Nov;160(5): Long term outcomes after drug eluting stent for the treatment of ostial left anterior descending coronary artery lesions.capranzano P, Sanfilippo A, Tagliareni F 20

21 A THIRD option:the floating stent technique It consists of implanting a DES in the proximal LAD to partially cover the origin of the Cx without further planned interventions 71 patients with native LAD ostial lesions (Medina s LMCA classification {0,1,0}) Immediate procedure success at the level of the LAD was 100% In no patient did the stent protrude in the LMCA beyond the Cx ostium so post dilatation was not required at this level. We found focal angiographic disease in the Cx ostium in 19 (27%) patients. This was mild in most cases and significant (residual stenosis >50%) in only 7 (10%). In these patients, the decision to intervene at this level was at the discretion of the operator 21

22 Important points for successful positioning in ostial lesions: Specialised stent positioning techniques Stent draw back technique: This technique for non aorto ostial lesions requires placement of a second wire in the nontarget vessel beyond the bifurcation with the ostial stenosis. The stent is advanced distally into the sidebranch. Using a separate system, a balloon is inflated as a fulcrum in the main vessel within the segment straddling the sidebranch. The sidebranch stent is withdrawn undeployed until it contacts the inflated main vessel balloon and is then deployed This technique is more ideally suited to a bifurcation with angle >75, although acceptable results can be achieved with more acute angles as shown. It is preferable to perform this through a 7 Fr guide catheter to minimise friction and aid visualisation. This technique was attempted in 14 cases and successful in 13, with excellent stent deployment and lesion resolution attained in 12 cases. Schwartz L, Morsi A. The draw back stent deployment technique: a strategy for the treatment of coronary branch ostial lesions. J Invasive Cardiol 2002;14:

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25 Specialised stent-positioning technique Szabo or tail wire technique:szabo and colleagues have described a technique for precise positioning of an aorto ostial stent by using a second angioplasty wire positioned in the aorta to anchor the stent at the ostial location Stepwise illustration of Szabo technique for PCI of ostial LAD. (a) proximal end of the anchor wire in the Cx is threaded through the most proximal strut of the crimped LAD stent; (b) stent advanced into lesion until the anchor wire prevents further onward motion. Stent balloon is then inflated at 6 8 atm to allow easy removal of anchor wire; (c) after high pressure inflation showing satisfactory position. Szabo S, Abramowitz B, Vaitkus PT. New Technique of Aorto Ostial Stent Placement. Am J Cardiol 2005;96:212H. Proximal flaring of stent at 4 atm to facilitate threading of anchor wire. The end of the stent is then manually crimped back onto the balloon by gentle squeezing. Wong P. Two years experience of a simple technique of precise ostial coronary stenting. Catheter Cardiovasc Interv 2008;72:

26 .Gutierrez Chico et al : 78 patients with Medina (010 or 001) or aorta ostial lesions. angiographic success rate of 100%. Acute procedural success was 86%, and 30 day procedural success was 78%. Vaquerizo B et al : 26 patients who underwent the Szabo technique for ostial stent placement(80% LAD OSTIAL). Angiographic success :88.5% (23/26) with a cumulative major adverse cardiac event (MACE) rate of 13% at 1 year. However, despite a seemingly excellent immediate angiographic result, intravascular ultrasound (IVUS) examination revealed significant stent protrusion. Gutiérrez Chico JL, Villanueva Benito I, Villanueva Montoto L, et al. Szabo technique versus conventional angiographic placement in bifurcations of Medina and in aorto ostial stenting: angiographic and procedural results. EuroIntervention. 2010;5(7): Vaquerizo B, Serra A, Ormiston J, et al. Bench top evaluation and clinical experience with the Szabo technique: new questions for a complex lesion. Catheter Cardiovasc Interv. 2012;79(3): Specialised stent-positioning technique Aorta free floating wire technique (for aorta ostial lesion only) Or SEPAL technique The guide catheter is inserted into the vessel and the first guidewire is passed down the vessel distal to the lesion. The second wire is inserted into the guide and advanced to the tip of the guide. The guide catheter is backed out of the ostium and the second wire is advanced into the aorta. This second wire acts as a marker for the ostium and prevents the guide from deeply engaging the vessel Floating Wire Technique for Treatment of Aorto Ostial Lesions Jack P. Chen, MD, Northside Cardiology, P.C., Atlanta, Georgia 26

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29 Specialised ostial stenting devices THE OSTIAL PRO STENT SYSTEM (Ostial Solutions, Kalamazoo, MI, USA): simple nitinol device that is used in conjunction with standard stenting techniques to assist in the precise placement of aorto ostial stents. It is positioned within the guide catheter, and has distal selfexpanding legs that are advanced just distal to the catheter tip after the lesion has been crossed with the coronary guide wire and stent. The expanded nitinol legs prevent the entry of the guiding catheter into the target vessel, mark the plane of the aortic wall, and align the tip of the guide with the aorto ostial plane. It is FDA approved and commercially available. 29

30 Specialised stent-positioning technique Ostial Pro Stent Placement System (for aorta ostial lesion only). Fischell :30 patients using the Ostial Pro stent placement system in ostial right coronary artery, ostial left main artery, and ostial saphenous vein graft lesions.. Specialised stent-positioning technique New dedicated ostial stent For ostial side branch lesions (Medina 001), the Cappella Sideguard stent (Cappella Inc.) The Sideguard stent is made from nitinolis trumpet shaped and self expanding, so that it conforms completely to the shape of the bifurcation. Its dynamic design ensures continuous wall apposition and positive remodelling. 30

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32 Doi H, Maehara A, Mintz GS, Dani L, Leon MB, Grube E. Serial intravascular ultrasound analysis of bifurcation lesions treated using the novel self expanding sideguard side branch stent. Am J Cardiol. 2009;104(9): Specialised ostial stenting devices BULLSEYE RENAL OSTIAL STENT SYSTEM Animal studies have confirmed its efficacy and ease of use and the stent is currently being evaluated in humans in the BOSS 1 study. No coronary version is currently offered although this may become available in the future. 32

33 conclusions Technical considerations Establish whether ostial PCI is appropriate (vs. PCI with coverage of SB, or CABG) Guide catheter selection is crucial for aorto ostial lesions Use optimal, non overlapped, non foreshortened angiographic imaging IVUS to assess for proximal or SB disease, degree of calcification, reference diameter and stent expansion Adequate lesion preparation (± adjunctive device use) DES vs. BMS Position proximal stent marker proximal to lesion Use of marker wire in aorta or SB Stent draw back or Szabo techniques when conventional positioning isdifficult Mandatory high pressure post dilatation 33