CE/001001

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 !!!