Bifurcation Interventions in 2014: What you Need to Know Dr. H. Störger Kardiocenter Red Cross Hospital Frankfurt Jeopardized Sidebranches and Consecutive Occlusion after Balloon and Stent 53% 54% stent balloon 19% 5% jeopardized occluded (1) Meier B., Am J. Cardiol. 1984; (2) Aliabadi D., Am J Cardiol. 1997 A Short History of Bifurcation Treatment % Kissing Balloon 100 DES BMS Kissing stent 80 Directional Atherectomy Rotative Atherectomy 60 Crush Minicrush T stenting Prov. SB stenting DK crush Y stenting Dedicated Culotte stenting DES Dedicated BMS 40 Jailed wire technique 20 0 1977 1982 Angio success Courtesy T. Lefèvre 1987 1992 In-hospital MACE 1998 2002 12 month TVR 2005 7 Randomized Studies with DES Comparing One vs Two Stents Approach Study Stent Patients (n) PS CS BBC One PES 250 Nordic SES 207 250 206 True Bif. (%) 83 ND Cross-over (%) to CS to PS 2.8 1.6 4.3 4.9 CS Technique (n) Crush 169 Culotte 75 T stent 7 Other 4 Crush 103 Culotte 43 Other 69 Final kissing (%) PS CS Angio FU (n) PS CS 29 76 ND 31 74 151 156 90 92 150 152 CACTUS SES 173 177 94 31.2 ND Crush BBK SES 101 101 68 19 3 T stent 120 100 100 ND Pan SES 47 44 86 2.1 9.1 T stent 45 56 77 80 DK Crush 2 SES 185 185 ND DK Crush 185 79.5 100 Colombo SES 43 43 100 T stent 60 86 95 V stent 1 Y stent 2 28.6 51.2 4.7 185 185 ND Higher Stent Thrombosis after Double Stent in Bifurcation Metaanalysis 12 major studies (> 100 patients): n=6961 DES Thrombosis 2.31 (1.33-4.03) p=0.04 Myocardial Infarction 2.01 (0.77-5.23) 1.88 (1.35-2.62) 2.55 (1.13-5.78) 1.85 (1.03-3.32) 1.86 (1.34-2.60) p=0.04 Zimarino M, JACC Cardiovascular Interventions 2013; Vol 6, No 7:687-95 95% CI Contemporary Bifurcation Stenting M Main prox. first A Main Accross side first D Distal first S Side branch first 1st stent PM stenting Provisional SB SB ostial stenting stenting is now the Gold Standard MB stenting across SB DM Provisional stenting SKS After balloon Skirt MB stenting + SB balloon MB stenting + kissing SB SB crush minicrush 2 stents Skirt + DM Skirt + SB Elective T stenting Internal crush Culotte TAP V stenting 3 stents Extended V Y. Louvard, CCI 2008;71(2):175-83. Trouser legs and seat SKS Syst. T Stenting Minicrush Crush Meta-Analysis of Randomized and Non Randomized Stent Studies BMS & SB Stent BMS & No SB Stent DES &SB Stent DES & No SB Stent DES 2nd generation & SB stent DES 2nd generation & No SB stent Adapted from Zamani, CCI 2011 Provisional Side Branch Stenting in Bifurcations Medina 1-1-“0.5“ Double Wire and Crossover-Stent MB Post Promus 2.5 x 28 mm + 3.0 x 23 mm SB wire change and Kissing Balloon Result Plaque or Carina Shifting? Pre-intervention Koo et al. EBC 2008 MB stenting Kissing balloon Atherosclerotic Plaques Develop Mostly at Bifurcation-Area but Rarely at Carina EDUCATIONAL CONTENT ENDORSED BY EAPCI, A REGISTERED BRANCH OF THE EUROPEAN SOCIETY OF CARDIOLOGY The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicine Bifurcation lesions Yves Louvard, Thierry Lefèvre, Marie-Claude Morice Shimada Y, Am J Cardiol 2006;98:193-6 Nakazawa G, J Am Coll Cardiol 2010;20:87-1679 © 2012 Europa Édition. All rights reserved. Figure 2 Flow-Pattern and Plaque-Distribution in Bifurcations Morphometric analysis Flow diagram Plaque distribution Plaque thickness Yazdani SK, EuroInervention 2010, Vol. 6 (Suppl. J), J24-J30 Necrotic core thickness Carina Shift vs Plaque Shift n=49, IVUS in MV and SB before and after Crossover-Stent Carina Shift causes 75% of Side branch compromise ! Xu H, Gwon HC, Korean Society of Cardiology 2010 Bifurcation and Carina Shift after Stentig LAD Crossover D1 3D- Reconstruction FD-OCT * * * * * Farooq V, J Am Coll Cardiol Intv 2011;4:921-31 * * thrombus * * * Bifurcations Have Strict Fractal Relations in Vessel-Diameters and Flowrates before and after the Sidebranches Finet, Eurointervention2010; Vol6 (suppl):J10-15 The 3 Diameters in Vascular Bifurcations Finet’s law D1 D2 D1 = 0.678 (D2 + D3) D2 D1 D3 D3 D13 = D23 + D33 (Murray’s law) Adapted from Koo et al. EBC 2008 Due to this Fractal Law the Selection of MV-Stent-Diameter Has a EDUCATIONAL CONTENT ENDORSED BY EAPCI, A REGISTERED BRANCHImpact OF THE EUROPEAN SOCIETY OF CARDIOLOGY Major in Provisional Stenting Figure 12 Carina shift Dissection DMV? Wire exchange, balloon and stent passage difficult Underexpansion PMV Strut protrusion No Carina-shift No overexpansion DMV POT Easy SB access for FKB or stent if neccessary The PCR-EAPCI Textbook – Percutaneous interventional cardiovascular medicine After: The PCR—EAPCI Textbook Percutaneous Interventional Cardiovascular Medicine 2012, Bifurcation lesions figure 12 Bifurcation lesions Yves Louvard, Thierry Lefèvre, Marie-Claude Morice Contempory Provisional SB-Stenting +POT = Respecting the Anatomy Crossover MV-stent sized for distal MV ø POT = postdilatation prox. MV up to carina sized for prox. MV ø After Darremont Olivier, Bordeaux, France expanded MV struts + easy distal (!) wire exchange Stent scaffold at SB ostium after Kiss or SB balloon Proximal vs Distal Cell for SB Recrossing Distal cell Proximal cell Pre Post KB Guidance of cell recrossing location using 3D OCT might improve results of bifurcation stenting in term of strut apposition (Alegria, Foin, Di Mario, Eur J Cardopvasc Imag 2012) Crossover to a 2-Stent Technique Chevalier B, TCT 2013 Provisionel T-Stenting with Small Protrusion in Bifurcations MB-Stent, Jailing SB + Wire+ POT Rewiring SB + Kiss (SB first, then simultaneous ) Modified DK-TAP Technique SB-Stenting with small protrusion, MB-balloon uninflated Final Kiss After Naganuma T et al, JACC Cardiovascular Interventions 2013, Vol. 6, No. 6:554-61 Final Result Long-term Outcome of DES T-Stenting with Small Protrusion Technique in Bifurcations Retrospective analysis n=95 from 2360 patients (4 %) (79% true bifurcations) requiring bailout SB-Stenting during provisional stenting strategy TVR MACE 12.9% 9.7% No cases of follow-up MI , definite or probable stent thrombosis Naganuma T, JACC Card Interv 2013; Vol 6 no: 554-61 Bifurcations Requiring Elective Main + SB-Stenting Baseline T-Stenting with small protrusion + final kiss Elective T-Stenting with Small Protrusion in LAD-D1 Bifurcation Appropriate positioning after predilation Proximal marker of the side branch stent is in a position between side branch ostium and uninflated main vessel balloon. First Kiss + Crossover Stent Proximal LAD + 2nd Stent Mid LAD + Final Kiss Right after implantation of the diagonal stent, kissing balloon inflation Final Result MACE Differences between 2-Stent Strategies in Bifurcation? T stenting n=128 Survival Survival free from MI Palmerini T, Circ Cardiovasc Interv 2008;1:185-192 Crush n=121 V stenting n=60 Survival free from cardial death Survival free from TLR Crush vs Culotte (SES) in True Bifurcations (NORDIC II) n=424 randomized Final Kiss 84.3% vs 91.6%, p=0.02 True bifurcation 73% vs 82%, p=0.03 Endpoint after 3 years MACE-free survival during 36-month follow-up Crush (n=209) Culotte (n=215) % 14,0 all ns 12,0 12,0 9,8 10,0 7,9 8,0 16.7% 11,5 6,7 6,5 6,0 6,0 6,5 6,2 6,1 5,3 4,8 3,3 3,0 4,0 2,0 Days after PTCA Niemelä EBC 2013 London ST s TV R TL R I M Re st en os i Ca rd ia c To ta ld p=0.32 de at h 0,0 ea th 18.7% Final Kissing Inflations are Essentiell in 2-Stent Technique Ge L, J Am Coll Cardiol 2005 ;46(4):613-20 Colombo A, Circulation 2009; 119(1):71-8 Value of Kissing Inflations in Simple Stenting? NORDIC III n=477 randomized Primary end point MACE after 6 months (MACE: Cardiac death, index lesion MI,TLR, stent thrombosis) Secondary end point In-stent restenosis Conclusion Routine use of Final Kissing Balloon (FKB) did not improve clinical outcome, but there was not a penalty for undertaking FKB Niemela M, Circulation 2011;123(1):79-86 FKB in 1-Stent Technique COBIS-Registry 16 Korean centres, 736 pts. in Non-FKB group, 329 in FKB group Propensity score-matching analysis performed in 222 patient pairs 22-month follow-up Propensity score-matched population Non-Kissing Kissing p=0.002 years Gwon H-C, Heart 2012;98:225-231 Survival free from MACE Survival free from MACE Total population Non-Kissing Kissing p=0.01 years Final Kissing and Long-Time Outcome after 1-Stent Technique in Bifurcation COBIS-Registry n=1065 (n=666 adjusted) % 12 10 No FK (n=736) FK (n=329) 10 9,1 8,5 8 p<0,001 p=0,002 p=0,001 6 4,9 ns 4 ns 2 0,7 0,9 2 3,4 3,4 ns 2,1 1,5 0 0 Card. Death Card. Death or MI Gwon H, Heart doi:10.1136/heartjnl-2011-300322 TLR MV-TLR SB-TLR MACE Angiographically Significant SB-Stenosis is Mostly not Functionally Significant Among side branch lesions >75% stenosis after main vessel stenting, only 27% were functionally significant. Koo BK, J Am Coll Cardiol 2005 Optimal Strategy for Provisional SB-Intervention in Bifurcations Aggressive if SB > 50% Conservative Aggressive FKB or SB ballooning Song YB, JACC Interv 2012 Vol 5 No11: 1133-40 Conservative if SB < 75% and TIMI < 3 SB-Stenting How to Perform Optimal Final Kissing? Balloon size according to distal reference Short & non compliant balloons Side branch first, then simultaneous At least 20-30 seconds Alternatively sequentional 2-step SB + prox. MV dilatation ? G Stankovic TCT 2013 A Short History of Bifurcation Treatment % Kissing Balloon 100 DES 2nd DES BMS Kissing stent 80 Crush Minicrush T stenting Prov. SB stenting DK crush Y stenting Dedicated Culotte DES 60 40 Dedicated BMS Jailed wire technique 20 0 1977 1982 Angio success Courtesy T. Lefèvre 1987 1992 In-hospital MACE 1998 2002 12 month TVR POT Kiss with NC balloons 2005 Provisional SB-Stenting in Bifurcation: Evidence of Improving Procedural + Clinical Outcome with Contempory DES Techniques Procedural Characteristics % 100 97,9 99,6 83,0 2005 n=300 2009 n=300 80 58,0 60 p<0.0001 36,3 40 p<0.0001 p<0.0001 22,3 p=0.26 p<0.0001 20 9,0 0,0 0,0 0,0 4,3 2,3 0 Final Kiss NC Ballons Mylotte D, Cath Cardiovasc Interv 2013; 82:E437-445 POT "New" DES SB Stent (>70%, TIMI<III, Diss>B) ST (all) Provisional SB-Stenting in Bifurcations: Evidence of Improving Procedural + Clinical Outcome with Contempory DES Techniques MACE 11.3 2005 5.7 2009 Ishemic TLR Cardiac Death 5.0 5.0 2005 2005 2009 2.0 Mylotte D, Cath Cardiovasc Interv 2013; 82:E437-445 2009 3.0 SEAside (*) and CORpal (**) Bifurcation Trial – Cooperative Study n=443 bifurcations with provisional approach 1:1 randomized to SES vs EES LANDMARK analysis: Late (>12 months) MACE by DES type 3-year MACE by DES type EES EES 93.2% 89.4% 98.6% SES SES p=0.025 p=0.16 12 12 EES (n=222) 0.02 SES (n=217) SB-Stent (TAP or T) 5.0% vs 5.4% Burzotta EBC 2013/London p=0.30 94.6% p=0.03 TRYTON Bifurcation Trial n=704 true bifurcations randomized to provisional 1-stent (MV) vs TRYTON + MV-DES FKB 86% vs 85% SB-stent in Provisional 8% Leon M, TCT 2013 Are Bioabsorbable Scaffolds Appropriate to Bifurcations? •Higher strut thickness (x 2) •Higher rate of SB occlusion •Strut overlap → strut distorsion + delayed strut coverage •Overexpansion → strut distorsion •Tissue bridges over floating struts •Trials excluded lesions + SB ≥ 2mm BVS in Fractal Silicon Tube OCT Bifurcation Test Distal MV POT & Side Absorb® 3.5x28mm POT NC balloon 4.0mm Side Branch NC balloon 2.5mm After Darremont O, EBC 2013 London Bifurcation Proximal MV BVS in Fractal Silicon Tube OCT Bifurcation Test Distal MV POT & Kiss Absorb® 3.5x28mm POT NC balloon 4.0mm Kissing balloon NC balloon 3.0mm & 2.0mm After Darremont O, EBC 2013 London Bifurcation Proximal MV BVS in Fractal Silicon Tube OCT Bifurcation Test POT, Kiss & POT Absorb® 3.5x28mm + POT NC balloon 4.0mm + Kissing balloon NC balloon 3.0mm &2.5mm Better apposition Final POT NC balloon 4.0mm After Darremont O, EBC 2013 London BVS in Bifurcations – Milan Experience BVS implantation in diagonal following pre-dilatation Positioning of the side branch stent Latib A, EBC 2013 London Kissing balloon + 2 LADBVS BVS in Bifurcations – Milan Experience OCT showing ideal T-stenting with BVS Latib A, EBC 2013 London Bifurcation Treated with „Mini Crush“ Using Bioabsorbable Scaffolds Inadequate crush pox. MV Jailed D1 + Strut distorsion Tamborino EBC 2013 Result after High Pressure Postdilatation LAD + D1 + Final Kiss „free“ D1 ostium „approved“ crush Tamborino EBC 2013 ABSORB Stent in Bifurcations Conclusions from bench and first experiences Simple bifurcations with large diameters only Provisional MV-Stenting for the majority POT is possible respecting the geometric fractal low Kissing balloon may lead to stent deformation and strut fracture POT + Side Branche opening + Final POT may be enough ? (= sequential SB and proximal MV inflation ) Crossover to 2-stents - T or TAP with BMS preferable OCT or IVUS of MV is suggested EBC 2013 London Thank you!
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