Problems associated with the production of recombinant protein.pdf
Aeha muller 2
2. Clinical Identification of
Vulnerable Patients and Plaques
Screen the
General
Population
By
Conventional
Risk Factors
(Age,
Gender,
FH,
etc)
Vulnerable
Patients
by
blood
test
Vulnerable
Patients
and
?Vulnerable
Plaques by
Non-
invasive
assessment
Plaque
Vulnerability
Index
by
Invasive
Assessment
ACS and Stable Angina
Patients
4. Non-invasive CT and MR for VP
…. although there is much discussed
on soft versus hard plaque – the
characterization of any “soft” plaque
as one that is potentially
“vulnerable” remains moot.
Dr. John Rumberger
10. Image Interpretation
The Volcano IVUS Program
• In-vivo characterization of plaque composition via advanced
spectral analysis
Pending 510(K) review – not available in the United States
11. Volcano IVUS – Program Goals
Re-Thinking IVUS…
• Speeding the IVUS procedure
• Improving ease of image
interpretation
• Improving consistency of image
interpretation
• Understanding benefit of more
information on plaque
composition
– during PCI
– for risk stratifying lesions and
patients
Pending 510(K) review – not available in the United States
12. Volcano IVUS – Confirming Feasibility
in a Clinical Setting
Repeatability / Reproducibility (J. Margolis, Miami)
Miami_AA_ROI1_RCA1
0
0.5
1
1.5
2
2.5
3
3.5
4
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57
Frame NumberCSA(mm^2)
Lipid Core Cross-Sectional Area
Fibro-Lipidic Cross-Sectional Area
Fibrous Cross-Sectional Area
Calcified Cross-Sectional Area
Distal Proximal
Miami_AA_ROI1_RCA2
0
0.5
1
1.5
2
2.5
3
3.5
4
4.5
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39 41 43 45 47 49 51 53 55 57
Frame Number
CSA(mm^2)
Lipid Core Cross-Sectional Area
Fibro-Lipidic Cross-Sectional Area
Fibrous Cross-Sectional Area
Calcified Cross-Sectional Area
Distal Proximal
1st Pull-Back
Same Catheter, 2nd Pull-Back
One catheter, two runs
Pending 510(K) review – not available in the United States
14. Temperature heterogeneity over the surface of
an endartherectomized carotid plaque
Casscells W et al. Lancet. 1996;347:1447-51
15. OCT of Disrupted CoronaryPlaque
in a Living Patient MI
Rupture Site, In Vivo
C
L
L
L
Jang, Bouma, Tearney et al, CIMIT
16. Intravascular MRI CatheterIntravascular MRI Catheter
NC
NCMagnet
Coil
Luminal Zone
Mural Zone
Catheter based real-time MRI - No external magnets
High sensitivity & specificity for differentiating:
Fibrous tissue
Lipid rich necrotic core
Calcium
Thrombus (next generation) Virmani et al, JACC 2004 (Submitted)
Presented by RL Wilensky @ TCT 2004
Over 18 patients studied by
Dr. Hennen – No AE
17. NIR Spectroscopy for VP Detection
• NIR spectroscopy is a well-validated method
frequently used to assess chemical composition.
• Laser, fiber-optic, and chemometric technologies
make intra-coronary use feasible.
• 3.2Fr IVUS-like rapid-exchange coronary catheter
• Can scan artery through blood
• 20 msec spectra acquisition
• Identifies chemical composition of vessel wall
– TCFA sensitivity and specificity > 85% ex vivo
– TCFA surrogates detected in phantom
18. Natural History Study of Detection Vulnerable Plaque
1000 patients
with ACS
undergoing
PTCA/
Stenting
Vulnerability Detector
100
Patients
with
suspected
VP
900
Patients
without
suspectedV
P
1 yr F.U.
MI
SCD
19. Prospect StudyProspect Study
PI, Dr. Gregg StonePI, Dr. Gregg Stone
Guidant, VolcanoGuidant, Volcano
3-vessel imaging post PCI3-vessel imaging post PCI
Angiography (QCA of entire coronary tree)Angiography (QCA of entire coronary tree)
IVUSIVUS
Virtual histologyVirtual histology
PalpographyPalpography
± Thermography (EU only)± Thermography (EU only)
F/U: 1 mo, 6 mo, 1 yrF/U: 1 mo, 6 mo, 1 yr
2 yr,2 yr, ±±3-5 yr3-5 yr
(event driven)(event driven) Repeat imagingRepeat imaging
in pts with eventsin pts with events
Meds recMeds rec
AspirinAspirin
Plavix 1yrPlavix 1yr
StatinStatin
20. 1-year MACE (adjudicated to non-culprit lsn)1-year MACE (adjudicated to non-culprit lsn)
-- Cardiac deathCardiac death
-- Cardiac arrestCardiac arrest
-- Rehospitalization for ACSRehospitalization for ACS
-- Myocardial infarctionMyocardial infarction
-- Clinically driven revascularizationClinically driven revascularization
Procedural Success and Imaging SafetyProcedural Success and Imaging Safety
Ability to complete the protocol-specifiedAbility to complete the protocol-specified
imaging procedures w/o imaging deviceimaging procedures w/o imaging device
related complicationsrelated complications
PROSPECT:PROSPECT: Primary endpointsPrimary endpoints
21. 1 year Follow-up for
Cardiac Events: MI, SCD, UA
Vulnerability Map
of the Human Coronary Artery
Editor's Notes
Volcano is also developing advanced tissue characterization software, to ease image interpretation and give more information about the composition of atherosclerotic plaques. This technology, licensed from The Cleveland Clinic Foundation, is based on over 8 years of intensive development. This sophisticated software algorithm uses spectral analysis of the ultrasound frequency (rather than just the amplitude – or power, as is used for grayscale IVUS) of the returning sound wave to predict composition of plaques. Thus, instead of the physician being asked to interpret highly subjective images based on 256 shades of gray, interpretation is simplified with presentation of the most commonly found tissue types in just 4 colors on screen.
Volcano’s next generation of IVUS reflects our mission to “Re-Think” IVUS – making it faster, easier to interpret, with more information from the images and data.
Repeatability studies have been run in Miami to assess variability, from one catheter run to the next in the same patient…
Volcano recently secured a world-wide exclusive license to technology out of Rotterdam, The Netherlands, called palpography. This technology, which uses the very same raw RF data that we use to do VH, essentially allows for an estimation of the stiffness of the inside of an artery. This really clever technology, which has been built around the Avanar / Eagle Eye catheters, uses the native changes in blood pressure during coronary cycle to essentially “palpate” the inner lumen of the vessel. It then highlights the interface between “stiff” and “squishy” segments of the vessel wall. It is hypothesized that it is at this interface between stiff and squishy that you have the fibrous caps vulnerable to rupture.
Again, the unique aspect of this technology is that we believe we can collect this data and display the findings real time, all from the same catheter and on the same pull-back.