Transradial access for IVUS guided left main PCI, R Gil

1. Robert J. Gil, MD, PhD, FESC
Transradial access for IVUS guided
left main PCI.
5th Advanced International Masterclass AIM-RADIAL 2016, Budapest 22-23.09.2016

2. Disclosure Statement of Financial Interest
• Grant/Research Support
• Consulting Fees/Honoraria
• Major Stock Shareholder/Equity
• Royalty Income
• Ownership/Founder
• Intellectual Property Rights
• Other Financial Benefit
• NA
• Astra-Zeneca, Abbott Vascular, Balton, Boston Scientific,
Medtronic, Servier, St Jude, Volcano
• NA
• NA
• NA
• NA
• NA
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or
affiliation with the organization(s) listed below.
Affiliation/Financial Relationship Company

3. Coronary bifurcations - challenges
• Bifurcated lesions are common (15-30%)
• Increased risk of MACE (ISR, IST)
• Lesion subtype heterogeneous:
-Variable size of vessel
-Variable angulations
-Variable plaque distribution
-Extent of SB involvement
-SB access
Dynamic changes in anatomy during treatment:
- Plaque shift
- Carina shift
- Dissection
- SB complication (deterioration, occlussion, snow-plough effect)
- Stent distortion
No two bifurcation are identical!!!!

5. RADAR Study
Valgimigli M, et. al. JACC 2014

6. Large Associated Benefit
Katib et al. JACC Intv 2015

7. Park et al. Circ Cardiovasc Intervent 2009;2:167-77

8. Clinical value
of intracoronary
diagnostic techniques

10. My faith that:
… is great, but !
LEFT RADIAL IS DEFAULT APPROACH

11. Study N Radial access Femoral access
BiOSS Expert Registry 63 73% 27%
BiOSS Expert in LM Registry 54 63% 37%
BiOSS LIM Registry 60 61.7% 38.3%
BiOSS LIM in LM Registry 74 60.8% 39.2%
POLBOS I
BiOSS N = 120 80.8% 19.2%
rDES N = 123 82.1% 17.9%
POLBOS II
BiOSS N = 102 63.7% 36.3%
rDES N = 100 81% 19%
BiOSS® Clinical Program
(IVUS guided cases incidentally)

12. Study Stent Radial access
[ml]
Femoral access
[ml]
POLBOS I
BiOSS 180±49 185±58
rDES 170±50 177±62
POLBOS II
BiOSS 129±44 135±55
rDES 122±55 139±46
Study Stent LM
[ml]
Non-LM
[ml]
POLBOS I
BiOSS 190±55 174±68
rDES 181±34 167±42
POLBOS II
BiOSS 140±24 121±44*
rDES 145±49 119±32*
Contrast volume
(IVUS guided cases incidentally)
* p <0.05
IVUS reduces the volume of the contrast
media by the about 20 ml !!!

13. Fluoroscopy time
Study Stent LM
[min]
Non-LM
[min]
POLBOS I
BiOSS 17.4±7.2 12.1±4.7*
rDES 18.3±6.1 13.1±6.4*
POLBOS II
BiOSS 14.9±11.3 9.9±3.4*
rDES 15.3±8.7 10.4±6.5*
Study Stent Radial access
[min]
Femoral access
[min]
POLBOS I
BiOSS 12.9±5.4 15.5±6.2*
rDES 13.7±5.4 16.5±3.1*
POLBOS II
BiOSS 11.6±6.3 13.7±10.5
rDES 11.8±8.3 13.1±6.7
(IVUS guided cases incidentally)
* p <0.05
IVUS shortens the fluoroscopy time on
average about 3 minutes !!!

14. Access technique - 1 cm above styloid process

15. Radial access: anterior puncture
Stick through back wall.
• use a shallower angle for a
thin person, when you are
hitting bone.
• Pullback slowly
• Tension-releasing
technique.
• Don’t be too eager to wire
• Spin the wire and
advance, stop with any
resistance
Radial Artery Access
• TR vs. TF access
smaller needle (20” or
16”)
bare-needle vs. teflon-
sheathed needle 0.018”
or 0.021” guidewire

18. Anticoagulants:
• Unfractionated heparin at least 50 U/Kg
• Nitrates (200 mcg IA)
Radial Cocktail:
• Vasodilators(prevent spasm)
• Nitrates (200 mcg IA)
• Calcium channel blockers
• Diltiazem 5 mg, Verapamil 2.5 mg IA

19. Anticoagulate, Vasodilator
• Ask pt to take deep breaths if having difficulty getting into ascending aorta
• use LAO projection
• Can use traditional JL and JR or radial-specific catheters (e.g. Jacky, Ikari...) but
in my Institution: 97% : 3%
Getting Catheters to Coronaries
Successfully and Efficiently Completing Interventions
• Don’t choose a weak guide
Weak guides
• Left: XB3, EBU3, CLS 3, XBLAD
• Right: JR, Ikari right
Intermediate guides
• Left:3.5guides,Ikari3.5
• Right: Ikari left, Hockey stick
Strong guides
• Left: XB4, EBU4 Voda4
• Right: AL 0.75 and greater
Use techniques to give you more support:
• Exchange for supportive wires
• Guideextension
• Anchoring
• Use a bigger guide if needed, but in my Institution: 97% : 3%

20. Preprocedural Coronary angiography
RCA RCA

21. Preprocedural Coronary angiography
LCA LCA

22. LCx ostium
LCx reference
Distal LMS
LAD ostium
LAD reference
LMS reference
MLA 3.63mm2 MLA 3.14mm2
MLA 2.31mm2
Preprocedural
IVUS assessment
LA 9,72 mm2 (3.4x3.59mm)
VA 18.91 mm2 (4.71x5.10mm)
LA 7.19 mm2 (2.79x3.29mm),
VA 11.7 mm2 (3.8x3.96mm)
LA 8.05 mm2 (3.12x3.62mm),
VA 12.97 mm2 (3.61x4.7mm)

23. Operator`s choice
BiOSS® Lim (Balton, PL): 3.75x3.0x23 mm
The BiOSS® LIM is a coronary, dedicated balloon-expandable bifurcation stent. The platform is made of 316L stainless
steel (strut thickness 120 μm) and is coated with a biodegradable polymer that elutes sirolimus (drug concentration: 1.4
µg/mm2).

24. 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).
How BiOSS® works?

25. BiOSS® Expert First-In-Men (n=63)
EuroIntervention. 2012 Jul 20;8(3):316-24.
POLBOS I: BiOSS® Expert vs regular DES
randomized trial (120/123)
Can J Cardiol. 2015 May;31(5):671-8
BiOSS® Expert Left Main
Registry (n=54)
J Interven Cardiol 2014;9999:1-10
BiOSS® Lim First-In-Men
n=60
J Interv Cardiol. 2015 Feb;28(1):51-60. doi:
10.1111/joic.12180.
BiOSS® Expert vs regular DES for mechanisms of lumen enlargement assessed with IVUS (n=32) Int J
Cardiovasc Imaging (2013) 29:1667–1676
POLBOS II: BiOSS® Lim vs regular DES randomized
trial (n=102/100)
EuroIntervention 2015;11-online publish-ahead-of-print November 2015
BiOSS® Lim Left Main
Registry n=75
EuroIntervention. 2015 Oct 15;11(6). pii:
20150313-02
BiOSS® stent Clinical Programme
12-month intravascular ultrasound observations from BiOSS® First-
In-Man studies (n=32)
Int J Cardiovasc Imaging (2016) accepted June

26. BiOSS® Lim in LMS
Gil RJ et al.:EuroIntervention 2015, published

27. BiOSS®: Expert + Lim in LMS
Bil J et al.: J Interven Cardiol 2014;27:242-252
Gil RJ et al.: EuroIntervention 2015, accepted

28. Initial dilatation in kissing balloon technique
BA: 3.0x15mm & 2.5x15mm View after KB

29. BiOSS® LIM stent implantation
Stent positioning
(BiOSS LIM 3.75x3.0x23mm, 12 atm)
Stent deployment

30. Result after BiOSS LIM implantation

31. Optimization of the Result (1)
Proximal Optimization Technique (POT)
NC balloon: 4.0x9mm (16 atm)
View after POT

32. Ostium/proximal LCx dilatation
Balloon NC 2.5x15mm (12 atm)
Final Kossing Balloons (FKB) (3.0x15mm,
2.5x15mm, 14atm)
Optimization of the Result (2)

33. LAD prox
Carina
LCx prox
LMS mid
MLA 12.08mm2
MLA 10.1mm2
MLA 4.36mm2
MLA 9.15mm2
Final IVUS
assessment
LMS prox
(LD 3.5x4.33mm)
LA 11.62 mm2(3.45x4.25mm)
VA 20.95 mm2 (4.5x5.82mm)

34. Final result

35. BIOSS® Lim CrCo (Balton Co, PL)
L605 alloy
Closed cell
Strut thickness 0.07mm
Polymer: biodegradable PLGA
Drug: Sirolimus 1.4 µg/mm2
Polymer with drug layer thickness: 5 µm

36. Left coronary system

37. Right coronary system

38. IVUS in LCX prox
IVUS in LMdist
IVUS in LMdist
IVUS in LAD prox
IVUS in LM prox
Preprocedural
IVUS
assessment

39. LAD mid: Balloon 2.5x20 /16atm

40. LAD mid: Stent Alex® 2.75x29 /14atm

41. LMS predilatation: Balloon 3.0x15 /14atm

42. Stent BiOSS® LimCrCo 4.25x3.5x19 /14 atm
“Partial” inflation during positioning

43. After stent Alex® implantation

44. LCX prox: NC ballon 3.25x15 /12 atm

45. „Kissing” with balloons: 3.0x15 /8 atm in Cx
and 3.25x15 /8 atm in LAD

46. „TAP” technique:
Stent Alex® 3.0x12 /14 atm in LCX and
balloon 3.25x15 /12 atm in LAD

48. Balloon 3.25x15 /8 atm (in Cx) & 3.0x12 /10 atm (in LAD)

49. FINAL RESULT

50. Postprocedural
OCT
assessment
MLA 13.22mm2
MLA 10.63mm2
MLA 4.95mm2
MLA 9.63mm2MLA 7.92mm2
MLA 13.34mm2
MLA 12.3mm2

53. Conclusions
The IVUS application in the course of PCI treatments on
the left main stem besides the improvement of the
patient`s late outcome is taking effects:
- shortening the duration of the treatment,
- supporting the reduction in the used contrast media
- and the time of the fluoroscopy.