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OCT -INTERPRETATION.pptx

1) The document describes an OCT catheter and its modes for high resolution and survey imaging of coronary arteries. It also details the pullback types and user interface. 2) OCT can be used to assess lesion morphology, length, and diameter to guide percutaneous coronary intervention planning and stent optimization. Morphology is assessed to determine lesion preparation needs while length and diameter measurements inform stent and balloon sizing. 3) Pre-PCI OCT imaging helps determine lesion characteristics to strategize the optimal PCI approach, while post-PCI OCT allows optimization and assessment of stent apposition and expansion.

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MLD MAX PHYSICIAN PRESENTATION: MLD MAX OCT Algorithm Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 1 of 53
OCT Catheter and Modes OCT Modes • High res: 54 mm- 10 frames per mm • • Survey: 75 mm- 5 frames per mm Stationary 2.7F ™ Catheter Monorail tip Lens Proximal marker High res: 54 mm Survey Mode: 75 mm 27 mm monorail Refer to Instructions For Use (IFU) for additional information. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 2 of 53
Pullback Type Survey-mode acquisition: 75 mm, 5 frames/mm - 2.1 Sec High-resolution acquisition: 54 mm, 10 frames/mm - 3.0 Sec Useful for: • Bifurcation re- crossing Stent fracture assessment • Refer to Instructions For Use (IFU) for additional information. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 3 of 53
User Interface Refer to Instructions For Use (IFU) for additional information. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 4 of 53
Modern OCT Guided PCI Workflow | MLD MAX Each OCT run serves a separate purpose. The pre-PCI run helps determine the PCI strategy, and the post-PCI run allows for optimization of the stent as needed. Pre-PCI OCT | Strategize MORPHOLOGY LENGTH Post-PCI OCT | Optimize Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 5 of 53 MEDIAL DISSECTION APPOSITION DIAMETER EXPANSION
Pre-PCI OCT-Guidance Pre-PCI OCT | Strategize MORPHOLOGY LENGTH DIAMETER Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 6 of 53
SECTION 1 Morphology Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 10 of 53
Normal Artery Morphology on OCT • Intima = hard sponge • IEL = rubber band • Media = soft rope • EEL = rubber band • Adventitia = mesh Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 8 of 53
OCT Image Interpretation Can the EEL (rope) and Adventitia (mesh) be visualized? Normal Artery Fibrous Plaque Is the signal change in the lumen or the wall? Wall Lumen Could you draw a line NO YES Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent around the signal change? Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 13 of 53 Low Attenuation Calcium High Attenuation Lipid Low Attenuation (light refracted) White Thrombus High Attenuation (light absorbed) Red Thrombus
OCT Signal Attenuation HIGH ATTENUATION Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 10 of 53 LOW ATTENUATION Light Blocked Light refracted (bent)
OCT Image Interpretation Normal Can the EEL and Adventitia be visualized? Yes Normal Artery Fibrous Plaque Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 11 of 53
OCT Image Interpretation Can the EEL and Adventitia be visualized? Yes Normal Artery Fibrous Plaque Fibrous Plaque Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 12 of 53
OCT Image Interpretation Is the signal change in the lumen or the wall? Fibro-fatty Plaque Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 13 of 53 Wall High Attenuation Lipid
OCT Image Interpretation Is the signal change in the lumen or the wall? Calcium Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 14 of 53 Wall Low Attenuation Calcium
OCT Image Interpretation Is the signal change in the lumen or the wall? Red Thrombus Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 15 of 53 Lumen High Attenuation Red Thrombus
OCT Image Interpretation Is the signal change in the lumen or the wall? White Thrombus Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 20 of 53 Lumen Low Attenuation White Thrombus
Morphology Guided Lesion Preparation Lipidic DIRECT STENTING1 Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 17 of 53 Fibrotic Mild/Moderate Ca2+ Severe Ca2+ COMPLIANT BALLOON2 NON-COMPLIANT BALLOON3 ATHERECTOMY OR IVL4 1. Taylor, A., et al. Efficacy and Safety of Direct Stenting in Coronary Angioplasty, J. Invasive Cardiology, 2000; 12(11); 2. Romagnoli, E., et al. Drug Eluting Stenting, JACC Cardiovascular Interventions, 2008; 1(1): 21-31; 3. Seyithanoglu, B., Compliant vs Non-compliant balloons. A Prospective Randomised Study, 1998; 39(1): 45-54; 4. Tomey, M., Current Status of Rotational Atherectomy, JACC Cardiovascular Interventions, 2014; 7(4): 345-354.
Influence of Ca2+ on Stent Expansion by OCT Rule of 5’s • 0.5 mm thickness • 5.0 mm long • 50% vessel arc >50% Length >5 mm 1. Fujino, A. et al. A new optical coherence tomography-based calcium scoring system to predict stent under expansion. EuroIntervention, April 2018; 13(18):e2182-e2189. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 18 of 53 OCT-Based Calcium Volume Index Score1 1. Maximum Calcium Angle (o) ≤ 90o 90o < Angle ≤ 180o > 180o ► 0 point ► 1 point ► 2 points 2. Maximum Calcium Thickness (mm) ≤ 0.5 mm > 0.5 mm ► 0 point ► 1 point 3. Calcium Length (mm) ≤ 5.0 mm > 5.0 mm ► 0 point ► 1 point Total score 0 to 4 points
Ca2+-Dependent Lesion Preparation Area 2.06 mm2 Area 2.93 mm2 Area 5.08 mm2 Area 9.38 mm2 Pre-OCT Atherectomy reduces thickness Ca2+ fracture at point of thinning Expansion >100% Ali, Ziad A. Shining Light on Calcified Lesions, Plaque Stabilization and Physiologic Significance: New Insights from Intracoronary OCT. EuroIntervention, vol. 13, no. 18, 2018, pp. 2105–2108. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 23 of 53
OCT-Guided Morphology Assessment Identify: • Normal or fibrous edges • Severe Ca2+ Case courtesy of Dr. Ziad A. Ali Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 20 of 53
SECTION 2 Length Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 21 of 53
Identify Landing Zones Traditional 2-D Angiogram OCT 3-D Lumenogram Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 22 of 53
Identify Landing Zones “normal” OCT lumenogram “normal” OCT lumenogram 5) Adjust the length to an available DES size at the “more normal” reference 4) Is this a safe place to land the proximal stent edge? The more visible the EEL the safer your landing zone Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 23 of 53 Lesion length 33 mm The more visible the EEL the safer your landing zone 1) Scroll reference vessel 2) Is this a safe place to land 3) Scroll reference vessel markers to distal the distal stent edge? markers to proximal
SECTION 3 Diameter Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 24 of 53
OCT Stent Sizing Algorithm Can the EEL be identified at the distal reference segment to allow vessel diameter measurement? PRE-PCI OCT Stent diameter decided by OCT measurement of mean EEL to EEL diameter rounded down to nearest stent size1 Stent diameter decided by OCT measurement of mean lumen diameter rounded up to nearest stent size2 NO YES 1. Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016; 1-11. 2. Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 25 of 53
OCT Post-Dilatation Balloon Sizing Algorithm Can the EEL be identified at the proximal and distal reference segment to allow vessel diameter measurement? YES NO PRE-PCI OCT Balloon diameter decided by OCT measurement of mean EEL to EEL diameter rounded down to nearest balloon size1 Balloon diameter decided by OCT measurement of mean lumen diameter rounded up 0.25-0.50 mm2 1. Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016; 1-11. 2. Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 26 of 53
OCT Guided Stent / Balloon Sizing – Distal Reference • At the LAD distal reference the vessel wall can be measured • Mean EEL = 3.04 mm • Round down to nearest stent size = 3.0 mm Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 27 of 53
OCT Guided Post-Dilatation Balloon Sizing - Proximal • At the LAD proximal reference the vessel wall can be measured. EEL = 4.36 mm • Round down to nearest balloon size for post-dilation (if necessary) = 4.00 mm • At the LAD proximal reference if the vessel wall can not be measured. MLD = 3.02 mm • Round up to nearest balloon size for post-dilation (if necessary) = 3.50 mm Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 28 of 53
Modern OCT Guided PCI Workflow | MLD MAX Each OCT run serves a separate purpose. The pre-PCI run helps determine the PCI strategy, and the post-PCI run allows for optimization of the stent as needed. Pre-PCI OCT | Strategize MORPHOLOGY LENGTH Post-PCI OCT | Optimize Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 29 of 53 MEDIAL DISSECTION APPOSITION DIAMETER EXPANSION
SECTION 4 Medial Dissection Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 30 of 53
Dissections 1. Kubo, T. et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083; 2. Ali, Z. et al. ILUMIEN III: Optimize PCI. Lancet 2016, 388:2618-2628. Address Significant Dissection1 Dissection penetrates medial layer, and is greater than 1 quadrant arc Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 31 of 53 Intimal Medial Intramural Hematoma Common Practice1,2 Place additional stent (particularly for distal dissections)
SECTION 5 Apposition Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 40 of 53
Apposition If the stent struts are in contact with the artery wall, the stent is apposed Address Gross Malapposition • Longer than 3 mm,1 and ≥0.3 mm from wall2 Common Practice3 • Dilate with semi-compliant balloon at low pressure Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 33 of 53 MALAPPOSTION 1. Ali, Z. et al. ILUMIEN III: Optimize PCI. Lancet 2016, 388:2618-2628. 2. Souteyrand, G. et al. PESTO French Registry. European Heart Journal, 2016:37:1208-1216. 3. Kubo, T. et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083.
Apposition Indicator OCT AUTOMATICALLY DETECTS MALAPPOSITION Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 34 of 53
SECTION 6 eXpansion Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 35 of 53
eXpansion If the stent is expanding the lumen, holding the lesion close to, or greater than, the normal reference segment, the stent is expanded. GOAL Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 36 of 53 ACCEPTABLE = MSA ≥ 80% OF MEAN REFERENCE LUMEN AREA1 OPTIMAL = MSA ≥ 90% OF MEAN REFERENCE LUMEN AREA1 1. Kubo, T. et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083; Meneveau, N. et al. DOCTORS Study. Circulation, September 2016, 134:906-917.; Zhang, J. et al. The ULTIMATE Trial. Journal of the American College of Cardiology, Dec 2018: Vol 72, No 24:3126- 37.; Russo, R. et al. The AVID Trial. Circ Cardiovasc Intervent, April 2009; 2:113-123.; De Jaegere, P. et al. MUSICStudy. European Heart Journal, February 1998:19,1214-1223.
Determine Expansion / MSA - Dual Fully automated expansion display • ROI automatically detected • Expansion automatically displayed Proximal Half Distal Half Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 37 of 53
OCT Guided Optimization of Underexpansion Measure: • EEL-EEL, if possible • Mean lumen diameter, if no EEL-EEL Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 38 of 53
OCT Guided Optimization of Underexpansion The post-PCI OCT is used to choose the balloon size for post-dilation in the segment of stent with underexpansion Mean EEL = 3.27, therefore a 3.25 mm balloon should be used for post-dilation Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 39 of 53
Optimized Expansion The MSA is 6.17 mm2 and the distal reference 5.60 mm2, therefore the stent is fully expanded distally >100%. Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 40 of 53
OCT -INTERPRETATION.pptx

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OCT -INTERPRETATION.pptx

  • 1.
    MLD MAX PHYSICIANPRESENTATION: MLD MAX OCT Algorithm Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 1 of 53
  • 2.
    OCT Catheter andModes OCT Modes • High res: 54 mm- 10 frames per mm • • Survey: 75 mm- 5 frames per mm Stationary 2.7F ™ Catheter Monorail tip Lens Proximal marker High res: 54 mm Survey Mode: 75 mm 27 mm monorail Refer to Instructions For Use (IFU) for additional information. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 2 of 53
  • 3.
    Pullback Type Survey-mode acquisition:75 mm, 5 frames/mm - 2.1 Sec High-resolution acquisition: 54 mm, 10 frames/mm - 3.0 Sec Useful for: • Bifurcation re- crossing Stent fracture assessment • Refer to Instructions For Use (IFU) for additional information. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 3 of 53
  • 4.
    User Interface Refer toInstructions For Use (IFU) for additional information. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 4 of 53
  • 5.
    Modern OCT GuidedPCI Workflow | MLD MAX Each OCT run serves a separate purpose. The pre-PCI run helps determine the PCI strategy, and the post-PCI run allows for optimization of the stent as needed. Pre-PCI OCT | Strategize MORPHOLOGY LENGTH Post-PCI OCT | Optimize Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 5 of 53 MEDIAL DISSECTION APPOSITION DIAMETER EXPANSION
  • 6.
    Pre-PCI OCT-Guidance Pre-PCI OCT| Strategize MORPHOLOGY LENGTH DIAMETER Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 6 of 53
  • 7.
    SECTION 1 Morphology Information containedherein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 10 of 53
  • 8.
    Normal Artery Morphologyon OCT • Intima = hard sponge • IEL = rubber band • Media = soft rope • EEL = rubber band • Adventitia = mesh Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 8 of 53
  • 9.
    OCT Image Interpretation Canthe EEL (rope) and Adventitia (mesh) be visualized? Normal Artery Fibrous Plaque Is the signal change in the lumen or the wall? Wall Lumen Could you draw a line NO YES Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent around the signal change? Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 13 of 53 Low Attenuation Calcium High Attenuation Lipid Low Attenuation (light refracted) White Thrombus High Attenuation (light absorbed) Red Thrombus
  • 10.
    OCT Signal Attenuation HIGHATTENUATION Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 10 of 53 LOW ATTENUATION Light Blocked Light refracted (bent)
  • 11.
    OCT Image Interpretation Normal Canthe EEL and Adventitia be visualized? Yes Normal Artery Fibrous Plaque Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 11 of 53
  • 12.
    OCT Image Interpretation Canthe EEL and Adventitia be visualized? Yes Normal Artery Fibrous Plaque Fibrous Plaque Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 12 of 53
  • 13.
    OCT Image Interpretation Isthe signal change in the lumen or the wall? Fibro-fatty Plaque Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 13 of 53 Wall High Attenuation Lipid
  • 14.
    OCT Image Interpretation Isthe signal change in the lumen or the wall? Calcium Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 14 of 53 Wall Low Attenuation Calcium
  • 15.
    OCT Image Interpretation Isthe signal change in the lumen or the wall? Red Thrombus Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 15 of 53 Lumen High Attenuation Red Thrombus
  • 16.
    OCT Image Interpretation Isthe signal change in the lumen or the wall? White Thrombus Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 20 of 53 Lumen Low Attenuation White Thrombus
  • 17.
    Morphology Guided LesionPreparation Lipidic DIRECT STENTING1 Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 17 of 53 Fibrotic Mild/Moderate Ca2+ Severe Ca2+ COMPLIANT BALLOON2 NON-COMPLIANT BALLOON3 ATHERECTOMY OR IVL4 1. Taylor, A., et al. Efficacy and Safety of Direct Stenting in Coronary Angioplasty, J. Invasive Cardiology, 2000; 12(11); 2. Romagnoli, E., et al. Drug Eluting Stenting, JACC Cardiovascular Interventions, 2008; 1(1): 21-31; 3. Seyithanoglu, B., Compliant vs Non-compliant balloons. A Prospective Randomised Study, 1998; 39(1): 45-54; 4. Tomey, M., Current Status of Rotational Atherectomy, JACC Cardiovascular Interventions, 2014; 7(4): 345-354.
  • 18.
    Influence of Ca2+on Stent Expansion by OCT Rule of 5’s • 0.5 mm thickness • 5.0 mm long • 50% vessel arc >50% Length >5 mm 1. Fujino, A. et al. A new optical coherence tomography-based calcium scoring system to predict stent under expansion. EuroIntervention, April 2018; 13(18):e2182-e2189. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 18 of 53 OCT-Based Calcium Volume Index Score1 1. Maximum Calcium Angle (o) ≤ 90o 90o < Angle ≤ 180o > 180o ► 0 point ► 1 point ► 2 points 2. Maximum Calcium Thickness (mm) ≤ 0.5 mm > 0.5 mm ► 0 point ► 1 point 3. Calcium Length (mm) ≤ 5.0 mm > 5.0 mm ► 0 point ► 1 point Total score 0 to 4 points
  • 19.
    Ca2+-Dependent Lesion Preparation Area2.06 mm2 Area 2.93 mm2 Area 5.08 mm2 Area 9.38 mm2 Pre-OCT Atherectomy reduces thickness Ca2+ fracture at point of thinning Expansion >100% Ali, Ziad A. Shining Light on Calcified Lesions, Plaque Stabilization and Physiologic Significance: New Insights from Intracoronary OCT. EuroIntervention, vol. 13, no. 18, 2018, pp. 2105–2108. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 23 of 53
  • 20.
    OCT-Guided Morphology Assessment Identify: •Normal or fibrous edges • Severe Ca2+ Case courtesy of Dr. Ziad A. Ali Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 20 of 53
  • 21.
    SECTION 2 Length Courtesy ofDr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 21 of 53
  • 22.
    Identify Landing Zones Traditional2-D Angiogram OCT 3-D Lumenogram Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 22 of 53
  • 23.
    Identify Landing Zones “normal”OCT lumenogram “normal” OCT lumenogram 5) Adjust the length to an available DES size at the “more normal” reference 4) Is this a safe place to land the proximal stent edge? The more visible the EEL the safer your landing zone Courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 23 of 53 Lesion length 33 mm The more visible the EEL the safer your landing zone 1) Scroll reference vessel 2) Is this a safe place to land 3) Scroll reference vessel markers to distal the distal stent edge? markers to proximal
  • 24.
    SECTION 3 Diameter Information containedherein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 24 of 53
  • 25.
    OCT Stent SizingAlgorithm Can the EEL be identified at the distal reference segment to allow vessel diameter measurement? PRE-PCI OCT Stent diameter decided by OCT measurement of mean EEL to EEL diameter rounded down to nearest stent size1 Stent diameter decided by OCT measurement of mean lumen diameter rounded up to nearest stent size2 NO YES 1. Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016; 1-11. 2. Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 25 of 53
  • 26.
    OCT Post-Dilatation BalloonSizing Algorithm Can the EEL be identified at the proximal and distal reference segment to allow vessel diameter measurement? YES NO PRE-PCI OCT Balloon diameter decided by OCT measurement of mean EEL to EEL diameter rounded down to nearest balloon size1 Balloon diameter decided by OCT measurement of mean lumen diameter rounded up 0.25-0.50 mm2 1. Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016; 1-11. 2. Shlofmitz, E. et al. Algorithmic Approach for OCT Guided Stent Implantation During PCI. Intervent Cardiol Clin 7 (2018) 329-344. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 26 of 53
  • 27.
    OCT Guided Stent/ Balloon Sizing – Distal Reference • At the LAD distal reference the vessel wall can be measured • Mean EEL = 3.04 mm • Round down to nearest stent size = 3.0 mm Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 27 of 53
  • 28.
    OCT Guided Post-DilatationBalloon Sizing - Proximal • At the LAD proximal reference the vessel wall can be measured. EEL = 4.36 mm • Round down to nearest balloon size for post-dilation (if necessary) = 4.00 mm • At the LAD proximal reference if the vessel wall can not be measured. MLD = 3.02 mm • Round up to nearest balloon size for post-dilation (if necessary) = 3.50 mm Ali, Z., et al., ILUMIEN III Study, Lancet Journal, 2016. Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 28 of 53
  • 29.
    Modern OCT GuidedPCI Workflow | MLD MAX Each OCT run serves a separate purpose. The pre-PCI run helps determine the PCI strategy, and the post-PCI run allows for optimization of the stent as needed. Pre-PCI OCT | Strategize MORPHOLOGY LENGTH Post-PCI OCT | Optimize Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 29 of 53 MEDIAL DISSECTION APPOSITION DIAMETER EXPANSION
  • 30.
    SECTION 4 Medial Dissection Informationcontained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 30 of 53
  • 31.
    Dissections 1. Kubo, T.et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083; 2. Ali, Z. et al. ILUMIEN III: Optimize PCI. Lancet 2016, 388:2618-2628. Address Significant Dissection1 Dissection penetrates medial layer, and is greater than 1 quadrant arc Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 31 of 53 Intimal Medial Intramural Hematoma Common Practice1,2 Place additional stent (particularly for distal dissections)
  • 32.
    SECTION 5 Apposition Information containedherein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 40 of 53
  • 33.
    Apposition If the stentstruts are in contact with the artery wall, the stent is apposed Address Gross Malapposition • Longer than 3 mm,1 and ≥0.3 mm from wall2 Common Practice3 • Dilate with semi-compliant balloon at low pressure Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 33 of 53 MALAPPOSTION 1. Ali, Z. et al. ILUMIEN III: Optimize PCI. Lancet 2016, 388:2618-2628. 2. Souteyrand, G. et al. PESTO French Registry. European Heart Journal, 2016:37:1208-1216. 3. Kubo, T. et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083.
  • 34.
    Apposition Indicator OCT AUTOMATICALLYDETECTS MALAPPOSITION Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 34 of 53
  • 35.
    SECTION 6 eXpansion Information containedherein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 35 of 53
  • 36.
    eXpansion If the stentis expanding the lumen, holding the lesion close to, or greater than, the normal reference segment, the stent is expanded. GOAL Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 36 of 53 ACCEPTABLE = MSA ≥ 80% OF MEAN REFERENCE LUMEN AREA1 OPTIMAL = MSA ≥ 90% OF MEAN REFERENCE LUMEN AREA1 1. Kubo, T. et al. Application of Optical Coherence Tomography in Percutaneous Coronary Intervention. Circulation Journal, September 2012: Vol. 76, 2076-2083; Meneveau, N. et al. DOCTORS Study. Circulation, September 2016, 134:906-917.; Zhang, J. et al. The ULTIMATE Trial. Journal of the American College of Cardiology, Dec 2018: Vol 72, No 24:3126- 37.; Russo, R. et al. The AVID Trial. Circ Cardiovasc Intervent, April 2009; 2:113-123.; De Jaegere, P. et al. MUSICStudy. European Heart Journal, February 1998:19,1214-1223.
  • 37.
    Determine Expansion /MSA - Dual Fully automated expansion display • ROI automatically detected • Expansion automatically displayed Proximal Half Distal Half Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 37 of 53
  • 38.
    OCT Guided Optimizationof Underexpansion Measure: • EEL-EEL, if possible • Mean lumen diameter, if no EEL-EEL Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 38 of 53
  • 39.
    OCT Guided Optimizationof Underexpansion The post-PCI OCT is used to choose the balloon size for post-dilation in the segment of stent with underexpansion Mean EEL = 3.27, therefore a 3.25 mm balloon should be used for post-dilation Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 39 of 53
  • 40.
    Optimized Expansion The MSAis 6.17 mm2 and the distal reference 5.60 mm2, therefore the stent is fully expanded distally >100%. Case courtesy of Dr. Ziad A. Ali Information contained herein for DISTRIBUTION outside of the U.S. only. Check the regulatory status of the device in areas where CE marking is not the regulation in force. ©2020 Abbott. All rights reserved. IN CP0045-EN 06/20 Rev. A. Page 40 of 53