dedicated bifurcation stent technology: implications for everyday practice

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Dedicated Bifurcation Stent Technology: Implications for Everyday Practice Jens Flensted Lassen MD, PH.D., FESC The Heart Centre, Rigshospitalet University of Copenhagen Denmark

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Dedicated Bifurcation Stent Technology:Implications for Everyday PracticeJens Flensted Lassen MD, PH.D., FESCThe Heart Centre, Rigshospitalet University of Copenhagen Denmark

Disclosure Statement of Financial InterestI, (Jens Flensted Lassen) DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

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Disclosure Statement of Financial Interest. BUT !!!I, (Jens Flensted Lassen) am a Board member and one of the Directors of the European Bifurcation Club (EBC) and my view on bifurcation stenting is heavily influenced by the thoughts and consensus statements of EBC.

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Treating coronary bifurcationsWhy is it difficult?True versus non-true bifurcationsSmall and Large SB Diameter difference between MB and SBMB taperingAngels between MB and SB4-D movementsExtension of disease in SB

EuroIntervention 2014;10:545-560Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings

2015 EuroIntervention. All rights reserved.EuroIntervention 2015;11:V106-V110Differences between the left main and other bifurcations

4-D movements

EuroIntervention 2014;10:545-560Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings

Treating Bifurcation LesionsWhy is it difficult?Anatomic VariationSide Branch : Main Branch DiameterAngle of BifurcationDisease Burden: Wide Variation Difficult to Assess

Workhorse DES: Optimized for Straight LesionsPoorly Suited to of Bifurcation Lesions

Wide Variety of Techniques RequiredPoorly Characterized/Inconsistently Performed:crush, culotte, reverse culotte, internal crush, reverse crush, T, provisional T, Y, extended Y, V, SKS, shotgun, Helqvist, sleeve, modified crush, Buchbinder, minicrush, mini crush, short back and sides, DK crush, flower

Predilate side branch and/or main branchSafety wireP.O.T.Kiss/No KissPost DilateNon vs Semi CompliantSizing

Many Techniques: Many Questions????????????????????????????????????????????????????

EuroIntervention 2015;11:V96-V98

Patient level meta analysis of BBC1 & NORDIC 1

Circ Cardiovasc interv. 2011;4:57-64

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EuroIntervention 2014;10:545-560Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings

"Life can only be understood backwards;but it must be lived forwards.

Sren Kirkegaard(1813-1855 Danish philosopher)

The dilemma in the provisional side branch stenting in Bifurcation lesions

EBC Consensus:Side branch diameter and length can both be used visually as surrogates for volume of muscle at risk.Large side branches with ostial disease extending >5mm from the carina are likely to require two stents.Side branches whose access is particularly challenging should be secured by stenting once accessed.

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Bifurcation Lesions: Defining The Need

CoverageRadial StrengthAddresses AllAngulationSB-MB Diameter DifferencesDisease BurdenEase-of-UseTracking (Single Wire) Equipment (Operators Choice)Guide Catheters (5 or 6 Fr)GuidewiresCompatibility: Workhorse stent (DES or BMS)USER ISSUESCLINICAL REQUIREMENTS

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Dedicated Bifurcation Stents:Difficult Design Problem: Many Failures

Historical Dedicated Devices Failed ClinicallyNot easy to useLarger profile than workhorse stentsRotational orientation requiredTwo wire tracking

Poor Clinical OutcomesLower Procedural Success than standard stentingHigher Event Rates than standard stenting

The Ideal Dedicated DeviceEasy to use and safeSimplify the procedure- Shorten procedural time, reduce X-ray exposure- reduce contrast mediaAllow continuously SB access (wire)Predictable successful ostial SB-stenting High rate of procedural successOptimal long terms results (restenosis & ST-rates, low)Abel to treat all kinds of bifurcations.Abel to be flexible during cardiac cycles

TrytonTryton Pivotal Trials (RCT and Confirmatory): Landmark studiesImprovement in clinical outcomes in large branches. Long-term results required.Simplified 2-stent techniqueNew guidelines include incorporation of dedicated stents (Tryton).

Complex (1.1.1) Bifurcation Lesion Involving a Large Side Branch (LAD-D1)

BaselineTryton

- Dedicated devices should focus on:Easy, safe and quick, treatment of the Left MainProtection of a side branch the operator dont want to loose

ESC & EBC 2014 (15) Consensus

Conclusion the way forwardEvaluate dedicated devices in significant SBDedicated devices already challenge 2-stent techniquesEase of use (simplified technique)Designed, tested, and approved for bifurcationIndications for dedicated devices Large Side branchesComplex DiseaseLeft MainDedicated devices may challenge provisional stenting- Ease of use (simplified technique)

Thank you for your attention

"Life can only be understood backwards;but it must be lived forwards.

Sren Kirkegaard(1813-1855 Danish philosopher)