40th Annual International Congress of the Egyptian Society of Cardiology. Cairo 25-28.02.2013
Symposium: Dedicated Bifurcation Stent Workshop. Part 1. Technique Part 2. Types of stents Part 3. Tips and Tricks
Robert J. Gil1,2, Dobrin Vassiliev3 1- Mossakowski Medical Research Centre, Polish Academy of Sciences 2- Invasive Cardiology Dept., Central Hospital of the Internal Affairs Ministry, Warsaw, Poland, 3- National Heart Institute, Sofia, Bulgaria
Definition „A bifurcation stenosis is a coronary artery narrowing occuring adjacent to, and/or involving, the origin of a significant side branch. A significant SB is a branch that you don’t want to lose in the global context of a particular patient.�
Catheter Cardiovasc. Interv. 2000 Mar;49(3):274-83.
Bifurcation stenting problems • Real clinical problem: occurrence 15-20% • Huge variation in anatomy – vessel sizes differences, between vessels angulations, plaques distribution • Conventional stent is not intended for bifurcations – stent deformation, drug coverage disruption • High restenosis rates • Higher rates of stent thrombosis
Medina classification
MADS classification
Louvard et al. Classification of Coronary Artery Bifurcation Lesions and Treatments
Bifurcation lesion treatment Simple approach: - provisional T stenting (PTS)
Complex approach: -double stent techniques: Crush and Mini-Crush Simultaneous Kissing Stent (SKS) TAP Culotte
Only DES!!!!
Provisional SB Stenting The Concept Wiring of both branches
Preserve patency of SB Secure side branch
MB
marker of SB origin can be used to open the SB
Modify the A angle SB
DMB
facilitating the access
Provisional SB Stenting Main Branch Stenting Stent selection expansion ability size of struts
MB
Stent diameter according to the D of the main distal branch SB
DMB
Provisional SB Stenting Proximal Optimization Technique (POT)
Inflating a short, bigger balloon just proximal to the carina
Provisional SB Stenting Proximal Optimization Technique (POT) Good proximal stent apposition Restoring the normal carina configuration. Restores SB orientation
MB
facilitates wire/balloon entrance
SB ostium is covered by stent’s stuts SB
DMB
THE CONCEPT OF CARINA DISPLACEMENT
Îą
Vassilev & Gil, Polish Heart Jour. 2008, April Vassilev & Gil Jour. Geriatric. Card. 2008 June Vassilev & Gil Jour. Geriatric Card. 2008 March
Anatomic considerations
M. Russel TCT 2009
No carina displacement
50% Carina displacement
100% Vassilev & Gil J. Interv. Card. 2010
Not every SB is compromised significantly !
Bon-Kwon Koo JACC 2005; 46: 633-7
Difference between MLD (% Diameter Stenosis) and MLA (% Area Stenosis) MLD
MLA - CIRCLE
MLA – OVAL (ELLIPSE)
MLA ELLIPSE >>> MLA CIRCLE !!!!! Vassilev D, Gil RJ: J Geriatr Cardiol 2008; 5(1):43-49
Myonecrosis after PCI (in the area perfused by the side branch) Pre PCI
Post PCI
Michalek et al. presented on TCT 2009
New LGE after PCI – 11 pts out from 21 (52%)
No new areas of hypokinesis on cine CMR Michalek et al. presented on TCT 2009
Importance of carina length for extent of SB compromise
Extension distance
ED
Theoretical considerations IDEAL SITUATION
MB
SB
REAL SITUATION
MB
SB
The role of the CL on deviation of observed SB compromise from expected according to cosine formula (84 pts, 92 bif’s) 0,40
Carina deformation Predicted SB %DS minus observed SB %DS
0,30
Less SB compromise than expected
46% 0,20
0,10
0,00
8% intraobserver variability
-0,10
13%
-0,20
-0,30
30%
Carina deformation + plaque shift? -3,00
-2,00
-1,00
More SB compromise than expected
Plaque shift 0,00
1,00
2,00
3,00
4,00
CLE.D
CL excess
CL deficit Vassilev & Gil, Intern J Cardiol 2010
Factors governing SB compromise (significant, anatomical and functional, stenosis at SB ostium after MV stenting)
• Plaque shift • Ostial spasm • Ostial dissection • Local thrombosis • Stent strut obstruction • Carina displacement
When should we stent SB?
Severe (>75DS%) and long lesion (>5mm) in a big SB (>2,5mm) disease extends beyond SB ostium – systematic SB stenting Poor result in the SB after stent implantation in the MV and final kissing (TIMI <2, FFR < 0.75) Flow-limiting dissection
Bifurcation lesion treatment Simple approach:
Complex approach:
- provisional T stenting (PTS)
-double stent techniques: Crush and Mini-Crush TAP Culotte Simultaneous Kissing Stent (SKS)
Provisional SB Stenting – „intention to treat” failure
A
B
A
B
<70o
>70o
The importance of angles T-stenting – technically difficult
T-stenting – technique of choice
The Crush Technique
After Kissing Balloon Inflation
Double Kissing Crush Stenting
Choice of stenting strategy in true coronary artery bifurcation lesions. Lin QF et al.: Coron Artery Dis 2010, Sep; 21 (6): 345-51
108 pts with true BL treated with SES+PES; Population:
Group 1 – routine 2 vessels stenting Group 2 – provisional T stenting
Follow-up – 8 months; MACE (MI, cardiac death, stent thrombosis, TVR)
Conclusion: Routine stenting significantly improved the MACE outcome of PCI in true coronary bifurcation and bifurcation angle of 60 or less as compared with provisional stenting.
Steps of culotte stenting
NORDIC study Eight Months Angiographic Follow-up in Patients Randomized to Crush or Culotte Stenting of Coronary Artery Bifurcation Lesions
The Nordic Bifurcation Stent Technique Study TCT 2007
Steps of SKS wire both branches and predilate
Position two parallel stents covering both branches and extending into the main branch
Steps of SKS Inflate the first â&#x20AC;Ś.
And then the second stent
Steps of SKS Kissing at medium pressure
Final result
NORDIC I + BBC I composed metaanalysis (simple vs complex)
No benefits from complex Behan et al. Circ Cardiovasc Interv. 2011;4:57-64
Consequences of regular DES optimization in bifurcation stenting
3,0мм DES
After POT (NC 3,5 мм BA)
After KBI (3,5x2,75 мм NC BA)
Risk of: carina displacement and SB compromise difficulties with proper stent apposition → increased probability of thrombosis and restenosi stent`s structure and „curative surface” disorganisation
Foin N. , EuroPCR 2012
Finite Element Analysis of Sidebranch Expansion
Mortier P et al, Medical Enginnering & Physics 2009
Stent cell size requirements (with ideal positioning against SB/MB opening) SB OPENING DISTANCE (SBOD)
MB OPENING DISTANCE (MBOD)
SBOD = SB RVD/sin α MBOD = MB RVD/sin α
Stent`s design and geometrical implications 3.5 mm stents
Maximum cell diameter (mm)
BioDyvisio (Abbott)
2.9
Bx Velocity (Cordis)
3.0
Carbostent (Sorin)
3.0
Express (Boston)
3.7
Liberte
4.5
Flexstent (Jomed)
2.9â&#x20AC;&#x201C;3.6
Penta (Abbott)
4.0
Driver
6.5
R stent (Orbus)
4.5
Chopin2 (Balton)
3.97
Modified from Louvard et al. Heart 2004
White points show possible places for wire recrossing and accordingly â&#x20AC;&#x201C; SB balloon positioning during KBI
Even extremely high SB ostial postdilatation could not achieve complete strut apposition
ML Vision
Liberte
Cypher
What is best solution? Provisional T-stenting with dedicated bifurcation stent
Bifurcation Optimization System Stent (BiOSS速)
1st stent recreating anatomy of coronary bifurcation
Stent is delivered by 6F compatible monorail system, which allows fast, precise and one man handling!!!
BiOSS® (Balton, PL) 1. Delivery system is based on dedicated balloon (Bottle®, Balton, PL) which restore MV – MB sizes without need of additional dilatation (kissing like effect) 2. It`s profile is quite low (1.08mm), which makes possible to implant stent even through 5 Fr guiding catheter 3. Two parts of stent (dedicated for MV and MB) made of 316L stainless steel are connected with two struts at the step-up mid zone – it keeps SB ostial diameter 4. Balloon mid-marker allows exact stent positioning
BiOSS® (Balton, PL) 4. The stent construction prevents carina displacement, as a basic mechanism of side branch compromise 5. The stent strut/vessel area ratio varies between 15 – 18%. Nominal foreshortening of the stent is less than 0.5%. 6. Stent belongs to DES class – biodegradable polimer with paclitaxel (BiOSS® Expert Bis) or syrolimus (BiOSS® Lim) 6.
速 BiOSS速 Family available sizes Stent length [mm]
15.00
18.00
23.00
Proximal diameter [mm] 4.50 4.25 3.75 3.50 3.25 4,50 4.25 3.75 3.75 3.50 4.50 4.25 3.75 3.50 3.25
Distal diameter [mm] 3,75 3.50 3.00 3.00 2.50 3,75 3.50 3.00 3.00 2.50 3,75 3.50 3.00 3.00 2.50
Dedicated bifurcation optimization balloon
Balloon diameters
Balloon length Guide compatible Compatible guidewires
Distal 2.50 2.50 2.75 3.00 3.00 3.50 2.50
Proximal 2.75 3.25 3.00 3.50 3.75 4.25 2.75 10 , 15 mm 5F .014â&#x20AC;?
Pressure nominal / maximal
8 atm / 16 atm
Delivery system type
Rapid Exchange
BiOSS® – CREATED ON THE BASE OF LUC-CHOPIN2 STENT WITH BIODEGRADABLE POLIMER PLGA CO-POLYMER Physical Properties
Mechanical integrity
Combination of polilactide and polyglicolyc polymers -Inert -flexible, ductable -thin, with high drug loading capacity
Strong adhesion to stent
Biocompatibility Manufacturability High stability of the manufacture process
Luc-Chopin2: PLGA Co-polymer
Low thrombogenicity and inflamation (Polylactide and poliglicolyde is physiologically present in human body)
Controlled degradation time = controlled drug release PLGA degradates in 8 weeks releasing CO2 and H2O only
BiOSS in angiogram
Comparative analysis of lumen enlargement mechanisms achieved with bifurcation dedicated stent BiOSS® and provisional T stenting strategy – IVUS study.
Aim of the study was to analyze mechanisms of lumen enlargement after coronary bifurcation dedicated stent BiOSS® (Balton, PL) and classical stent implantation according to provisional T stenting (PTS) strategy based on intravascular ultrasound (IVUS) measurements.
Gil RJ et coll.: BiOSS vs DES – mechanisms of lumen enlargement (under revision )
Sites for quantitative IVUS measurements
Bifurcation after BiOSS速 implantation
BiOSS vs regular DES – Intravascular Ultrasound Study DES
BiOSS
p
pre
post
pre
post
pre
post
MLA target [mm2]
2.87±0.78
6.08±2.01
2.99±0.82
6.49±2.2
0.68
0.68
Lumen Area PL [mm2]
4.78±1.49
7.86±2.08
3.89±0.98
7.84±1.99
0.06
0.97
Lumen Area DL [mm2]
5.21±3.18
7.46±2.2
4.78±2.18
6.44±1.85
0.66
0.17
LA window [mm2]
4.86±2.44
7.63±2.03
3.99±1.19
6.52±1.64
0.21
0.1
Window length (mm)
2.31±0.38
1.76±0.52
2.09±0.50
2.21±0.37
0.79
0.01
Gil RJ.: BiOSS vs DES – mechanisms of lumen enlargement (under revision)
Analysis component`s of lumen enlargement
Gil RJ.: BiOSS vs DES â&#x20AC;&#x201C; mechanisms of lumen enlargement (under revision)
How BiOSS® works?
BiOSS® after balloon deflation, copies the bifurcation configuration matching proximal – distal main vessel size requirements. It fits all parts of bifurcation (parent vessel – daughter branches) according to principles of optimality of energy distribution in coronary artery branching region (Murray law).
BiOSS vs regular DES – procedural comparison Affected vessel – lesions
BiOSS
DES
p
MV predilatation (n/%) SB predilatation (n/%) MV + SB predilatation (n/%) MV stent diameter (mm)
54 (83) 19 (29) 15 (23) 3.62 ± .22 2.87 ± .22 16 ±1.44 8 (13) 17 (27) 33 (52) 6 (5 LM) 55 ± 13 138 ± 39 9.4 ± 3.4
13(81) 9(56) 7(44) 3.41 ± 0.36 18.94 ± 6.14 10(62) 0 12(75) 1(6) 64±18 154±42 14.8,2
NS 0,06 0,09 NS 0,2 0,05 0,09 0,05 0.1 0,09 0,2
27%/73%
12.5%/87.5%
-
87%/13%
100%
-
MB stent diameter (mm) Stent length, mm Final kissing balloon (n/%) Bottle balloon postdilatation SB balloon postdilatation Additional stent in SB Procedural time (min) Contrast volume (ml) Fluoroscopic time (min) Vascular access (n/%) femoral/ radial Guide catheter size (n/%) 6F/7F
Gil RJ et al.: BiOSS Expert –FIM. EuroIntervention 2012 Gil RJ.: BiOSS vs DES – mechanisms of lumen enlargement (under revision)
速
BIOSS® Expert/Lim Bifurcation Optimization Stent System (Balton, PL) GOOD ACCESS TO SIDE BRANCH
Truly bifurcation dedicated stent – one balloon with two diameters providing efect of POT Available in very wide range of diameters also in LM versions: 4,5x3,75mm and 4,25x3,5mm (15 and 18mm long)
17th Warsaw Course on Cardiovascular Interventions
April 17th â&#x20AC;&#x201C; 19th 2013, Warsaw Radisson Blue Hotel SAS Centrum, 24 Grzybowska St, Warsaw
www.wcci.pl
You are cordially welcome !!!