Aeha muller 2
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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
- 3. “Soft Plaque” on Contrast-enhanced EBCT Dr. John Rumberger
- 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
- 5. Presumably Vulnerable Plaques Discovered in 6 Autopsy Specimens
- 6. Disrupted Coronary Artery Plaques in 6 Autopsy Specimens
- 7. Prevalence of Thin-capped Fibroatheromas (TCFAs) and Disrupted Plaques in 50 Hearts Examined at Autopsy NUMBER OF HEARTS NUMBER OF TCFAs NUMBER OF DPs 32 0 0 4 1 0 2 1 1 3 2 0 1 2 3 1 3 0 1 3 1 1 4 0 1 5 3 4 1 0 From approximately 3000 slides, 0.5% showed DPs and 1 % TCFAs. Unpublished data, InfraRedx
- 8. TCFA & DP Frequency Frequency of TCFAs & DPs in Individual Patients (N=50 patients & 3599 spots examined) 0 5 10 15 20 0 1 2 3 4 5 6 7 8 # TCFAs & DPs #Patients
- 9. Thermography intravascular MR Optical Coherence Tomography Angioscopy Near IR Catheter-based Detection of Vulnerable Plaque IVUS, VH Elastog raphy JTS Nuclear
- 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
- 13. SOFT HARD IVUS-based Intravascular Palpography Investigational Use Only – Not Available for Sale 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
Notas del editor
- 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.