1. BRS Sizing and Vessel Preparation
BRS Technologies: Technology & Innovation
BRS for Clinical Use, Implantation Technique and Patient Selection
BRS Sizing and Vessel Preparation
Ricardo A. Costa, MD, PhD
Institute Dante Pazzanese, Sao Paulo, Brazil
Sunday, Feb. 19th 2017 – 11:08 to 11:15 am (7 minutes)
Room Congressional AB – The Omni Shoreham Hotel
Washington, DC, USA

2. Conflict of Interest Statement
Ricardo A. Costa, MD, PhD
I have no relevant financial relationships to disclose

3. BRS Issues Associated with Vessel Sizing
Thick struts (~150 microns)
Limited size range
Rectangular/square shape
Limited overexpansion capability
Impact on flow dynamics
Suboptimal expansion
Need to full embedment and apposition

4. Lipinski et al. JACC Cardiovasc Interv 2016;9(1):12-24
Increased Risk of ST with 1st Generation BVS compared to 2nd Generation EES
Lipinski et al. JACC Cardiovasc Interv 2016;9(1):12-24

5. Increased Risk of Very Late ST in ABSORB II
Serruys et al. Lancet 2016;

6. Meta-Analysis: 16,830 pts in 59 Studies
Variable
Coefficient
95% CI
P value
Univariate Model
Dyslipidemia to
0.03
Diabetes mellitus to
Vessel size (RVD) to
0.02
Residual % DS
0.0673 to
<0.0001
Residual stenosis (%)
0.001
Multivariate Model
0.091 to
0.052
Collet et al. Minerva Cardioangiol 2016:published online

7. Inaccuracy of Visual Estimation of Vessel Size
NC 3.5 x 12
(20 atm)
3.25 x 18 mm Scaffold
(After pre-dil w/ 3.0x15 NC Balloon)
Pre-PCI Angio
Control Angio
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Courtesy: Daniel Chamié, MD, Brazil 7

8. Inaccuracy of Visual Estimation of Vessel Size
Control Angio After 3.25x18 mm PLLA-based scaffold post-dilated to > 3.5 mm
3.25x18 mm
scaffold
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9. Inaccuracy of Visual Estimation of Vessel SizeB 3 2 1 A A 1 2 3 B
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Lumen Area: mm2
Max. Diam.: 4.13 mm
Lumen Area: 7.42 mm2
Max. Diam.: 3.23 mm 9

10. Farooq V, et al. Cathet Cardiovasc Interv. 2012;79:880-888

11. Inaccuracy of Visual Estimation of Vessel Size
Quantification by QCA of vessels treated with 3.0-mm scaffolds in ABSORB Cohort B (n=102) (visual estimation of vessel size)
56.9%
47.1%
40.2%
39.2%
16.7%
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2.9%
Inadequately
sized scaffolds
Adequate reference size range for a 3.0 Absorb
Inadequately
sized scaffolds
Farooq V, et al. Cathet Cardiovasc Interv. 2012;79: 11

12. QCA: Interpolated Diameter vs. Max. Diameter
Quantification by QCA of vessels treated with 3.0-mm scaffolds in ABSORB Cohort B (visual estimation of vessel size) and in ABSORB EXTEND (QCA mandated - DMAX)
P=0.001
69.4%
P=0.057
56.9%
57.0%
47.1%
P=0.002
40.2%
41.1%
39.2%
26.9%
16.7%
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2.9%
3.7%
1.9%
ABSORB Cohort B
(n=102)
ABSORB EXTEND
(n=108)a (n=107)b
a n=108 for Dmax assessment
b n=107 for interp. diam. assessment
Farooq V, et al. Cathet Cardiovasc Interv. 2012;79: 12

13. QCA vs. IVUS vs. OCT
100 CAD patients from 5 centers were studied with Angio, IVUS and FD-OCT
5 Phantom models, with known luminal dimensions were examined with FD-OCT and IVUS
Differences in MLD among Angio, IVUS and FD-OCT
Differences in Lumen Area between IVUS and FD-OCT
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Kubo T, et al. JACC Cardiovasc Imaging 2013;6: 13

14. Intravascular Imaging: Vessel Diameter Sizing
Maximum diameter of the smaller reference.
Average of the maximum diameters of the prox. and distal references.
Maximum diameter of the largest reference.
Mid-wall to mid-wall diameters (between lumen and media)
Media-to-media diameter 2
Increasingly Aggressive 1 2 1 2 1
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Max. LD: 4.01 mm
Mean Mid-wall diam.: 4.18 mm
Mean EEM diam: 4.28 mm
Max. LD: 3.09 mm
Mean Mid-wall diam.: 3.14 mm
Mean EEM diam: 3.26 mm
Max. LD: 3.96 mm
Mean Mid-wall diam.: 4.02 mm
Mean EEM diam: 4.19 mm
Max. LD: 3.00 mm
Mean Mid-wall diam.: 3.09 mm
Mean EEM diam: 3.19 mm 14

15. Integrating Concepts This is the Bulleted List slide.
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16. Intended landing zones
Integrating Concepts
6F guide
3.5 x 20 mm NC balloon
Intended landing zones
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17. Step back and rethink your strategy
Integrating Concepts A B C C B A
LA: 8.68 mm2
Max. LD: 3.56 mm
Mean EEM: 4.00
LA: 7.25 mm2
Max. LD: 3.04 mm
LA: mm2
Max. LD: 4.18 mm
Mean EEM: 4.46 mm
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Step back and rethink your strategy 17

18. Post-dil w/ 4.5/15 NC balloon
Integrating Concepts
4.0x30 mm DES
Post-dil w/ 4.5/15 NC balloon
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19. Take Advantage of the Inflated Balloon
Acquire a proper angiogram after IC nitro administration; Pre-dilate the lesion with a NC balloon sized 1:1 to the target vessel size at the intended landing zones
NC Balloon
3.0 x 15 mm
NC Balloon
3.0 x 15 mm
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20. Puricel et al. J Am Coll Cardiol 2016;67(8):921-31
Impact of Optimal Implantation Technique on the Reduction of the Risk of ST
1) pre-dilatation with NC balloon – same size as RVD (1:1)
2) BVS implant only if optimal result achieved
3) BVS same size as RVD implanted at atm
4) Systematic postdilatation with NC balloon up to 0.5 mm larger with atm
Puricel et al. J Am Coll Cardiol 2016;67(8):921-31

21. Tanaka et al. EuroIntervention 2016;published online
Milan Series: 264 pts Treated with BVS with Optimal Technique – 2 Yrs
400 complex lesions (B2/C >70%)
Bifurcation 47%, Heavy calcium 23%, CTO 6%, ISR 5%
Mean scaffold length: 53.2 mm
44% received scaffold sized 2.5 mm
IVUS/OCT in 86% (AVIO criteria)
Additional treatment in 25% due to:
Underexpansion in 82
Malapposition in 11
Edge dissection in 4
Incomplete lesion coverage in 1
ST: 3 cases (1.2%) up to 2 years (no very late ST)
Tanaka et al. EuroIntervention 2016;published online

22. Impact of OCT-Guided PCI

23. Baseline Lesion Characteristics
Variable
BVS (n=50)
DES (n=50)
P value
LAD
68%
50%
0.11
Type C lesion (ACC/AHA)
64%
74%
0.38
Significant calcium
62%
0.28
Ostial location
14%
10%
0.76
Bifurcation
34%
46%
0.30
ISR
12% 6%
0.48
QCA
Lesion length, mm
24.7
25.1
0.86
RD, mm
2.7
MLD, mm
0.8
0.7
0.16
AS, %
83.7
86.9
0.25
Mattesini et al. JACC Cardiovasc Interv 2014;7(7):741-50

24. Mattesini et al. JACC Cardiovasc Interv 2014;7(7):741-50
Procedure
Variable
BVS (n=50)
DES (n=50)
P value
Balloon predilatation
- Maximal diameter, mm
3.0
2.5
<0.01
- Maximal pressure, atm
18.7
15.1
- Balloon/artery ratio
1.1
0.9
- Balloon type: NC
100%
87%
Scaffolds/Stents 63 61 -
- Nominal diameter, mm
0.94
- Nominal length, mm
28.0
0.42
- Devices per lesion
1.3
1.2
0.28
Balloon postdilatation
3.5
0.60
21.3
17.1
Mattesini et al. JACC Cardiovasc Interv 2014;7(7):741-50

26. Mattesini et al. JACC Cardiovasc Interv 2014;7(7):741-50
OCT Findings
Variable
BVS (n=50)
DES (n=50)
P value
Mean device area, mm2
7.3
7.5
0.51
Minimal stent area, mm2
5.9
5.5
0.67
Mean lumen area, mm2
7.2
7.4
0.40
Minimal lumen area, mm2
5.8
0.97
Minimal device diameter, mm
2.7
2.8
0.46
Residual area stenosis, %
20.2
21.7
0.32
- >20%
39.7
42.6
0.85
Eccentricity index
0.86
0.45
ISA (per struts), %
1.7
1.9
0.62
Prolapse area, mm2
1.5
0.8
0.08
Fracture, %
3.2
0.49
Edge dissection, %
7.9
11.5
0.55
Mattesini et al. JACC Cardiovasc Interv 2014;7(7):741-50

27. Chamie et al. Catheter Cardiovasc Interv. 2016;88(S1):38-53
How to Size the Vessel?
Chamie et al. Catheter Cardiovasc Interv. 2016;88(S1):38-53

28. Proposed Algorithm

32. Considerations
Visual estimation is the standard method of vessel sizing, but it is subject to high variability and inaccuracy.
QCA (DMAX) helps standardize measurements, but it underestimates lumen diameters in comparison to intravascular imaging methods.
NC compliant balloon fully expanded at 1:1 ratio to the target landing zones is extremely helpful.
Intravascular imaging (IVUS/OCT) is not mandatory, but lower threshold for use is highly recommended.
OCT provides more accurate lumen quantification than IVUS.
Specific protocol for sizing with IVUS/OCT for BRS still needs validation.
Careful lesion predilatation under the PSP guidance may significantly improve outcomes.
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33. Thanks for your attention!