bvs: history & current limitations · do not dilate the scaffold beyond the maximum dilatation...
TRANSCRIPT
BVS: History & Current Limitations
Richard J Rapoza, PhD Divisional Vice President, R&D
Product and Therapy Innovation Abbott Vascular
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 2
Balloon
Angioplasty
(PTCA)
Bare
Metal Stents
(BMS)
Coronary Drug
Eluting Stents
(DES)
XIENCE
Durable
Polymer
DES
Absorb
Fully
Bioresorbable
Vascular
Scaffold (BVS)
Advancements in PCI
With Every Evolution There is a Learning Curve
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 3
The Absorb Bioresorbable Vascular Scaffold
Note: the struts are not visible under fluoroscopy. Photos taken and data on file at Abbott Vascular.
Markers on
back side
of scaffold
0.7 mm
There are two pairs of platinum marker beads – one pair at each end of the scaffold
Each end of the scaffold is aligned with markers on the delivery catheter
– Scaffold markers lie
near the inner edge of
each marker on the
delivery catheter
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 4
Expansion Limits Must be Respected
When expanding the scaffold, be sure to stay within the expansion limits of the device:
Nominal
Scaffold Diameter
CAUTION
Do not dilate the scaffold beyond the maximum dilatation limit.
Expansion beyond the dilatation limits listed above, may result in scaffold damage.
2.5 mm
3.0 mm
3.5 mm
3.00 mm
3.50 mm
4.00 mm
Maximum
Dilatation Limit
This is consistent with the Absorb IFU, Section 10.7
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 5
3.0 mm 3.1 mm 3.0 mm 2.8 mm
Actual OCT IVUS QCA
Visual
Estimate
2.7 – 3.3 mm
over-estimates under-estimates inter/intra-observer
variability
Margin of Error*
Use pre-dilatation to help guide and confirm vessel size
Proper Vessel Sizing
Limitations of Various Vessel Sizing Techniques
*Margin of error estimates based on resolution for each imaging modality: Resolution of OCT and IVUS:
Bezerra, H.G., J Am Coll Cardiol.: Cardiovasc Interv. 2009; 2: 1035. Resolution of QCA: Dahm, J. and van
Buuren, F. Int J Vasc Med. 2012. Offset and variability of visual estimate: data on file at Abbott Vascular.
Recognize risk of underestimating vessel size by visual estimation
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 6
X-Ray Considerations on Polymeric Scaffolds
• Radiopaque metallic stents may enhance the
contrast density at the lumen edges
X-ray
Path
The treated segment may appear slightly smaller than it actually is, simply due to non-radiopaque struts reducing contrast density
Images are artistic renderings and not to be considered engineering drawings.
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 7
Do’s and Don’ts
• Properly and carefully size
the vessel
• Prep the lesion thoroughly
• Pay attention to expansion
limits
• Leave scaffolds under-
expanded
• Re-insert the device after
it has been removed from
the body
• Push against resistance during
delivery, or when passing
other catheters through a
deployed scaffold
DO DON’T
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Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 8
Resorption M
n (
kD
a)
Months
Ma
ss
Lo
ss
(%
)
Months
Molecular Weight (Mn) and Mass Loss: Resorption by 36 Months
Images and data on file with Abbott Vascular. Histology images are porcine arteries.
1 month 12 months 18 months 24 months 30 months 36 months 42 months
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 9
1 month 12 months 18 months 24 months 30 months 36 months 42 months 6 months 3 months
Remodeling R
efe
ren
ce V
ess
el L
um
en
Are
a (
mm
2)
Model Inherent Arterial Growth
Lu
me
n A
rea
(m
m2)
Lumen Gain with Absorb BVS
Results obtained by IVUS. Data presented as Mean ± SD. Data and images on file with Abbott Vascular.
Benign Lumen Gain via Arterial Growth
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 10
Post-Dilatation Kissing Balloon
• Simultaneous balloon inflations will cause mechanical disruption of
proximal scaffold rings, if kissing balloons are over-sized
• Mechanical Disruption of Ring = impact radial strength
• Mechanical Disruption of Link = no impact on radial strength
Example:
D1 = 3.32 mm
D2 = 2.81 mm
R = 4.36 mm
Main Branch Balloon
Side Branch Balloon
Kissing Balloons
SEVERE OVER-EXPANSION
Morino, Y., et al. Circ J. 2008; 72: 886-892.
DO NOT PERFORM THIS TECHNIQUE!
*Kissing balloon technique is considered off-label and techniques referenced must be indicated by physician only.
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 11
Various Approaches to Estimate Diameters
Perimeter Limits ( p*D)
3.5 = 11 mm
Example:
D1 = 3.32 mm
D2 = 2.81 mm
Finet Dm = 4.156 mm
Perimeter = 13 mm
From Stankovic, G, Treatment of Bifurcation Lesions: General Perspective, EBC 2011, Paris, FR
The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter.
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 12
Protecting a Side Branch
• Protecting a side branch with a wire while deploying a scaffold in
the main branch
• Side Branch Protection
– HI-TORQUE BALANCE MIDDLEWEIGHT wires in main branch and side branch
– 3.0 x 18 mm BVS in main branch deployed at 16 atm for 30 seconds
Impressions on the coating denoting the location of the wire
but no structural or signifcant coating integrity defects.
Photos taken by and on file with Abbott Vascular.
The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter.
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 13
Side Branch Dilatation ONLY
Malapposition
2.5 mm balloon in side branch taken to nominal pressure
Photos taken by and on file with Abbott Vascular.
The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter..
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 14
SB Dilatation with Sequential MB Post-Dilatation
No Malapposition
2.5 mm balloon in side branch taken to nominal pressure, deflated, then 3.0 x 18 mm delivery system balloon taken to 16 atm for post-dilatation
Photos taken by and on file with Abbott Vascular.
The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter..
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 15
Side Branch Dilatation ONLY
= Mechanical Disruption of Link
Photos taken by and on file with Abbott Vascular.
The Absorb IFU precautions the operator against scaffolding across side branches ≥ 2.0 mm in diameter.
Absorb is authorized for sale in CE Mark and certain independently regulated countries outside the United States.
Please check the regulatory status of the device in your geographic location prior to distribution.
Not to be reproduced, distributed or excerpted. ©2013 Abbott. All rights reserved AP2939100-OUS Rev. A 10/13 16
Summary – the Do’s and Don’ts
• Properly and carefully size
the vessel
• Prep the lesion thoroughly
• Pay attention to expansion
limits
• Never use the kissing
balloon technique*
• Leave scaffolds under-
expanded
• Re-insert the device after
it has been removed from
the body
• Push against resistance
during delivery, or when
passing other catheters
through a deployed scaffold
*Kissing balloon technique is considered off-label and techniques referenced must be indicated by physician only.
DO DON’T
Abbott Vascular International BVBA, Park Lane, Culliganlaan 2B, B-1831 Diegem, Belgium, Tel:
+32 2 714 14 11.
Absorb and HI-TORQUE BALANCE MIDDLEWEIGHT are trademarks of the Abbott Group of
Companies. Absorb is authorized for sale in CE Mark and certain independently regulated
countries outside of the U.S.. Please check
the regulatory status of the device in your geographic location prior to distribution. Not to be
reproduced, distributed or excerpted.
For more information, visit our web site at www.abbottvascular.com.
©2013 Abbott. All rights reserved.
AP2939100-OUS Rev A 10/13