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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
Disclosure Statement of Financial Interest
I, (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.
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.
Dedicated Bifurcation Stent Technology: Implications for Everyday Practice
Dedicated Bifurcation Stent Technology: Implications for Everyday Practice
Treating coronary bifurcations
Why is it difficult?
• True versus non-true bifurcations
• Small and Large SB
• Diameter difference between MB and SB
• MB tapering
• Angels between MB and SB
• 4-D movements
• Extension of disease in SB
EuroIntervention 2014;10:545-560
Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10
years of the European Bifurcation Club meetings
©2015EuroIntervention.Allrightsreserved.
EuroIntervention 2015;11:V106-V110
Differences between the left main and other bifurcations
4-D movements
EuroIntervention 2014;10:545-560
Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10
years of the European Bifurcation Club meetings
Treating Bifurcation Lesions
Why is it difficult?
• Anatomic Variation
– Side Branch : Main Branch Diameter
– Angle of Bifurcation
• Disease Burden: Wide Variation Difficult to Assess
Workhorse DES: Optimized for Straight Lesions
Poorly Suited to of Bifurcation Lesions
• Wide Variety of Techniques Required
Poorly 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 branch
• Safety wire
• P.O.T.
• Kiss/No Kiss
• Post Dilate
– Non vs Semi Compliant
– Sizing
Many Techniques: Many Questions
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EuroIntervention2015;11:V96-V98
Patient level meta analysis of BBC1 &
NORDIC 1
Circ Cardiovasc interv. 2011;4:57-64
EuroIntervention 2014;10:545-560
Percutaneous 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.“
Søren 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.
Bifurcation Lesions: Defining The Need
• Coverage
• Radial Strength
• Addresses All
– Angulation
– SB-MB Diameter Differences
– Disease Burden
 Ease-of-Use
 Tracking (Single Wire)
 Equipment (Operator’s Choice)
– Guide Catheters (5 or 6 Fr)
– Guidewires
 Compatibility:
Workhorse stent (DES or BMS)
USER ISSUES CLINICAL REQUIREMENTS
Dedicated Bifurcation Stents:
Difficult Design Problem: Many Failures
Historical Dedicated Devices
Failed Clinically
Not ‘easy to use’
• Larger profile than workhorse stents
• Rotational orientation required
• Two wire tracking
Poor Clinical Outcomes
• Lower Procedural Success than standard stenting
• Higher Event Rates than standard stenting
The Ideal Dedicated Device
• Easy to use and safe
• Simplify the procedure
- Shorten procedural time, reduce X-ray exposure
- reduce contrast media
• Allow continuously SB access (wire)
• Predictable successful ostial SB-stenting
• High rate of procedural success
• Optimal long terms results (restenosis & ST-rates, low)
• Abel to treat all kinds of bifurcations.
• Abel to be flexible during cardiac cycles
Dedicated Bifurcation Stent Technology: Implications for Everyday Practice
Tryton
Tryton Pivotal Trials (RCT and Confirmatory):
• Landmark studies
• Improvement in clinical outcomes in large branches.
Long-term results required.
• Simplified 2-stent technique
• New guidelines include incorporation of dedicated
stents (Tryton).
Complex (1.1.1) Bifurcation Lesion
Involving a Large Side Branch (LAD-D1)
Baseline Tryton
- Dedicated devices should focus on:
1) Easy, safe and quick, treatment of the Left Main
2) Protection of a side branch the operator don´t want to loose
ESC & EBC 2014 (15) Consensus
Conclusion – the way forward
• Evaluate dedicated devices in “significant” SB
• Dedicated devices already challenge 2-stent techniques
– Ease of use (simplified technique)
– Designed, tested, and approved for bifurcation
• Indications for dedicated devices
– Large Side branches
– Complex Disease
– Left Main
• Dedicated 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.“
Søren Kirkegaard
(1813-1855 Danish philosopher)

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Dedicated Bifurcation Stent Technology: Implications for Everyday Practice

  • 1. Dedicated Bifurcation Stent Technology: Implications for Everyday Practice Jens Flensted Lassen MD, PH.D., FESC The Heart Centre, Rigshospitalet University of Copenhagen Denmark
  • 2. Disclosure Statement of Financial Interest I, (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.
  • 3. 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.
  • 6. Treating coronary bifurcations Why is it difficult? • True versus non-true bifurcations • Small and Large SB • Diameter difference between MB and SB • MB tapering • Angels between MB and SB • 4-D movements • Extension of disease in SB
  • 7. EuroIntervention 2014;10:545-560 Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings
  • 10. EuroIntervention 2014;10:545-560 Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings
  • 11. Treating Bifurcation Lesions Why is it difficult? • Anatomic Variation – Side Branch : Main Branch Diameter – Angle of Bifurcation • Disease Burden: Wide Variation Difficult to Assess
  • 12. Workhorse DES: Optimized for Straight Lesions Poorly Suited to of Bifurcation Lesions • Wide Variety of Techniques Required Poorly 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
  • 13. • Predilate – side branch and/or main branch • Safety wire • P.O.T. • Kiss/No Kiss • Post Dilate – Non vs Semi Compliant – Sizing Many Techniques: Many Questions ? ? ? ? ?? ? ? ? ? ? ?? ?? ? ? ? ?? ? ? ? ? ? ?? ? ? ? ?? ? ? ? ? ? ?? ? ? ? ? ? ? ? ? ? ? ?? ?
  • 15. Patient level meta analysis of BBC1 & NORDIC 1 Circ Cardiovasc interv. 2011;4:57-64
  • 16. EuroIntervention 2014;10:545-560 Percutaneous coronary intervention for coronary bifurcation disease: consensus from the first 10 years of the European Bifurcation Club meetings
  • 17. "Life can only be understood backwards; but it must be lived forwards.“ Søren Kirkegaard (1813-1855 Danish philosopher) The dilemma in the provisional side branch stenting in Bifurcation lesions
  • 18. 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.
  • 19. Bifurcation Lesions: Defining The Need • Coverage • Radial Strength • Addresses All – Angulation – SB-MB Diameter Differences – Disease Burden  Ease-of-Use  Tracking (Single Wire)  Equipment (Operator’s Choice) – Guide Catheters (5 or 6 Fr) – Guidewires  Compatibility: Workhorse stent (DES or BMS) USER ISSUES CLINICAL REQUIREMENTS
  • 20. Dedicated Bifurcation Stents: Difficult Design Problem: Many Failures
  • 21. Historical Dedicated Devices Failed Clinically Not ‘easy to use’ • Larger profile than workhorse stents • Rotational orientation required • Two wire tracking Poor Clinical Outcomes • Lower Procedural Success than standard stenting • Higher Event Rates than standard stenting
  • 22. The Ideal Dedicated Device • Easy to use and safe • Simplify the procedure - Shorten procedural time, reduce X-ray exposure - reduce contrast media • Allow continuously SB access (wire) • Predictable successful ostial SB-stenting • High rate of procedural success • Optimal long terms results (restenosis & ST-rates, low) • Abel to treat all kinds of bifurcations. • Abel to be flexible during cardiac cycles
  • 24. Tryton Tryton Pivotal Trials (RCT and Confirmatory): • Landmark studies • Improvement in clinical outcomes in large branches. Long-term results required. • Simplified 2-stent technique • New guidelines include incorporation of dedicated stents (Tryton).
  • 25. Complex (1.1.1) Bifurcation Lesion Involving a Large Side Branch (LAD-D1) Baseline Tryton
  • 26. - Dedicated devices should focus on: 1) Easy, safe and quick, treatment of the Left Main 2) Protection of a side branch the operator don´t want to loose ESC & EBC 2014 (15) Consensus
  • 27. Conclusion – the way forward • Evaluate dedicated devices in “significant” SB • Dedicated devices already challenge 2-stent techniques – Ease of use (simplified technique) – Designed, tested, and approved for bifurcation • Indications for dedicated devices – Large Side branches – Complex Disease – Left Main • Dedicated devices may challenge provisional stenting - Ease of use (simplified technique)
  • 28. Thank you for your attention "Life can only be understood backwards; but it must be lived forwards.“ Søren Kirkegaard (1813-1855 Danish philosopher)