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Dedicated stents and delivery systems: advantages and drawbacks

Explore the benefits and limitations of dedicated bifurcation stents and delivery systems for treating bifurcation lesions in coronary arteries. Learn about the technical aspects and desired features of these devices. Institute of Cardiology Krakow.

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Dedicated stents and delivery systems: advantages and drawbacks

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  1. Dedicated stents and delivery systems: advantages and drawbacks Dariusz Dudek Institute of Cardiology Krakow, Poland

  2. Bifurcation lesions - PCI Standard stenting practice and dissection or plaque shift can induce the occlusion of significant side branch (>1 mm) in 3-9% of the attempted lesions Several modalities for stenting of the side branch and the main vessel have been raported, often with the trend for better outcome when using one compared to two stents DES do not solve the problem

  3. Outcome of Bifurcation Lesion PCIMACEs at 9 months Garot et al. JAAC Vol.46, No 4. 2005:606-12

  4. Coronary Bifurcations - Distribution LM 1st DIAG • Left Main Bif. (LAD - CX) • LAD - 1st DIAG • LAD - 2nd DIAG • CX - OM1 • CX - OM2 • Distal RCA Bif. (PDA - PLA) • ______________________ Most Risky! LAD CX OM1 Most Common (> 50%) Most Challenging R-PLA R-PDA

  5. Provisional T Stenting 1 2 3 4 • The “good” and the “bad” of stent deformation Side branch ostium scaffolding Best achieved when the cell closest to the carena is engaged Radial stent dislodgement

  6. Optimal stent expansion and vessel coverage

  7. Bifurcation lesions - BDS Bifurcation dedicated stents (BDS) allows for a stent to be implanted in the main branch and simultaneous preservation and access of the side branch for balloon dilatation or stenting when indicated

  8. The Frontier Stent Registry Lefevre et al. JAAC Vol.46, No 4. 2005:592-8

  9. Bifurcation lesions MULTI LINK FRONTIER Registry I * device success – 92% * aute patency of side branch – 98% with TIMI3 * MACE at 1 month – 2,9 % MULTI LINK FRONTIER REGISTRY II * ongoing registry * device assessment in a large, more general and less selective pts population

  10. Comparison of bifurcation studies Lefevre et al. JAAC Vol.46, No 4. 2005:592-8

  11. Dedicated Bif. Stent System - limitations • Limited number of sizes: 2.5 – 4.0 mm side branch > 2mm or > 2.5 mm • One length of stent for main branch and fixed length of proximal vs distal part of stent • Indicated for appriopriate lesion morphology, only moderately calcified lesions and moderately tortousity

  12. Twin-Rail: Stent length: 15mm Stent diameters: 3.0, 3.5 SB balloon diameter: 1.5 mm Frontier: Stent length 18 mm Stent diameters: 2.5, 3.0, 3.5, 4.0 SB balloon diameter: 2.0 (MV 2.5 and 3.0) 2.5 (MV 3.5 and 4.0) Dedicated bifurcation systemsDiffcult matching of size and length to the lesion 18 mm 10 mm 8 mm

  13. Complex PCI – LMCA ?PCI CX DES 3.5 x 32 mm

  14. Complex PCI LAD – 3.0 x 18 mm DES

  15. Dedicated Bif. Stent System - limitations • Difficult to deliver when target lesion distal to previously implanted stent • Diffcult to deliver when target lesion distal to > 50% stenosis that cannot be predilated (or no indications for dilatation) • 7F guiding catheter • No data for interventions for Acute Coronary Syndromes

  16. Dedicated Bif. Stent System- technical aspects • wire management : parallel wires with clear divergence at the carina indicate optimal positioning prior to deployment • positioning still a challenge (don`t torque the system) • don`t push the system forward without a second wire • supportive wire in the SB or MB might be helpful to get the system more in phase (when is out of phase)

  17. Dedicated Bif. Stent System- technical aspects • don`t pull back undeployed stent through guiding catheter (if needed so remove everything as single unit) • effective predilatation needed (full balloon expansion) • kissing balloon seems to be important if SB > 2.5 mm • sizing according to distal diameter ( „undersized” only for delivery, but postdilatation with bigger balloon possible)

  18. Dedicated Bif. Stent System • Dedicated Stent Platform and SDS • Stent Delivery System • double balloon design • undersized Side Branch balloon  1.5 mm • long flexible Side Branch balloon Tip • Double RX • 6F Guiding Catheter compatible • Stent Platform • Closed Cell design • Variable Stent Geometry

  19. Stent Delivery System SB SB MV MV • Long, Ultra Flexible SB balloon Tip • Easy access to SB • SB balloon Tip reaching target lesion earlier than MV Tip • Pushing force is entirely used to access SB first • Facilitated - in-phase - circumf. positioning • Easier and anticipated stent rotation into the right phase • Best driving the SB balloon to end up fully inside the SB + 3 mm

  20. Wish List for a Dedicated Bif. Stent SDS Stent Platform : 100% SB preservation • Full Time SB access (w/out GW and SB Jailing) : User Friendly Handling • Self Positioning (axial and circumferential) / precise positioning of SB stent • Double RX design, friendly single operator usage • 6 F Guiding Catheter compatibility : Right Scaffolding • Closed Cell design with optimal MV and SB ostium scaffolding by: • 100% guaranteed access / dilatation of the cell closest to the carina • MV cell, facing SB, able to withstand major dilatation • Highly adaptive cell ring at the level of the carina, able to withstand extra deformation • Safety • Easiness • Efficacy

  21. Bifurcation Dedicated Stents (BDS) We should consider difference between Bifurcation Dedicated Stent Vs Side Branch Access stent

  22. Dedicated Bif. Stent System • Mean features of this new generation are :- Chromium Cobalt stent - 73µ thickness(Nile CroCo) • Dedicated stent design developed to improve • carena's coverage without cells overstretching • Dedicated delivery system with specific balloon • shape for the side branch • - Dedicated side branch stent designed to be added • to the Nile Croco in case of plaque shifting .

  23. Bifurcation Dedicated Stents (BDS) 1. Proper treatment of bifurcation lesions requires a dedicated stent Platform 2. Specially tailored SDS is mandatory in order to: • make that dedicated stent platform work correctly • guarantee high safety level • provide easy and fast operation 3. A proper, synergic combination of Platform + SDS is the crucial key of lecture for the optimal bifurcation device 4. Experience shows that kissing balloon post dilatation remains mostly adopted in bif treatment, including BDS systems

  24. Bifurcation Dedicated Stents (BDS) BDS systems are bulky to implant and as yet, bare and subject to not insignificant rates of restenosis However, maintanance of side branch access is improved and the need for several stent layers is avoided Good future platform for loading with the appropriate drug, however with respect to anatomical variations The high prevalence of bifurcations lesions in cath labs calls for further development of bifurcation dedicated stents

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