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OCT Intravascular Imaging

OPTIS™ Imaging Systems
Calcified Lesions
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OCT removes ambiguities in calcified lesions enabling proper stent expansion to achieve optimal results

Calcium is associated with decreased procedural success and stent expansion, resulting in worse clinical outcomes.1

Presence and severity of coronary artery calcification is growing; up to 25% of patients, or 1 in 4, have mild to severe calcium.2 If left undiagnosed and untreated, coronary artery calcification adversely impacts PCI outcomes.3

  • Calcified lesions limit stent expansion, which is a major predictor of stent failure, such as stent thrombosis and restenosis.1
  • Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.4
  • Proper expansion confirmed by intravascular imaging results in safety and efficacy benefits.4

From left to right: Superficial almost 360 degree calcium; Calcific nodule from 12-3 o’clock and from 8-10 o’clock; Superficial 360 degree concentric calcium that’s fractured at 3, 6 and 9 o’clock.

OCT imaging can effectively characterize the degree of calcification and inform optimal device selection and assess treatment result.1

The most important aspect of addressing the calcium problem is to recognize and classify calcium with OCT imaging. By addressing the degree of calcific burden, you can select the right lesion preparation strategy which impacts treatment strategy.

OCT workflow, MLD MAX guides a user through treatment decisions for pre- and post- PCI. The first step of the workflow is to assess Morphology (M) to understand what type of plaque you are dealing with and how to best prepare the vessel before stenting. In calcified lesions, this assessment helps to determine the type of calcific plaque and its severity.

In LightLab Clinical Initiative,5 physicians changed lesion prep strategy in nearly 1/3 of lesions after they assessed lesion morphology and severity with OCT. When a change in vessel prep strategy occurred, calcification was the predominant morphology as seen with OCT.

In the LightLab case, pre-PCI angio assessment and planned treatment approach (left image) was changed after performing pre-PCI OCT (right image).

The impactful changes include:

  1. angiographic underestimation of lesion calcification (identified calcific nodule)
  2. change in vessel prep (changed from compliant balloon to NC balloon, added rotational atherectomy)
  3. change in stent size: +6 mm

Morphology:

Calcified Mid LAD lesion (Type B)
Hemodynamically significant (iFR = 0.85)

Length:

30 mm

Diameter:

3.0 mm Distal, 3.5 mm Proximal

Vessel Prep Planned: Compliant Balloon
Treatment planned: 3.0 mm x 32 mm stent

Morphology:

Calcified Mid LAD lesion (Type B)

Length:

38 mm

Diameter:

2.82 mm Distal EEL, 3.75 mm Proximal EEL

Minimum Lumen Area: 2.3 mm²
OCT Vessel Prep Planned: Non-Compliant Balloon, Rotational Atherectomy
Treatment planned: 3.0 mm x 38 mm stent

OCT classification of calcium

The use of intravascular imaging allows for more specific characterization and quantification of calcification compared to angiographic calcium classification as mild, moderate, or severe.

OCT classifies calcium into deep, superficial and nodular, as well as eccentric or concentric calcium. Morphology and calcium assessment which are performed in the first step of MLD MAX workflow, M -Morphology, are important factors in determining the optimal treatment approach because different types of calcium requires a different treatment technique.1

OCT calcium score: Rule of 5s

Measuring calcium depth w/ an OCT-based calcium score algorithm can help identify calcific lesions that would benefit from plaque modification before stent implantation.6 This algorithm looks at calcium thickness, calcium angle and calcium length which are among the most important parameters used to predict the need and success of calcium modification devices.

  • Thickness >0.5 mm
  • Angle >50% vessel arc
  • Length >5 mm

Lesions at risk of stent under-expansion have a calcium score of 4:6

OCT-Based Calcium Volume Index Score1

  1   Maximum Calcium Angle (°)

≤ 90° 0 point 

90° < Angle ≤ 180° 1 point  

> 180° 2 points

  2   Maximum Calcium Thickness (mm)

≤ 0.5 mm 0 point 

> 0.5 mm 1 point  

  3   Calcium Length (mm)

≤ 5.0 mm 0 point 

> 5.0 mm 1 point  

Total Score = 0-4 Points

Rule of 5s

  1   0.5 mm thickness

  2   50% vessel arc

    

  3   5.0 mm long

Evaluation of calcium thickness is key in predicting stent expansion.7 With IVUS, the sound waves bounce off calcium and create a dark shadow. With OCT, the light can penetrate calcium thus evaluating its thickness.7

How to diagnose and treat calcified lesions with OCT

  1. Start PCI with the MLD MAX workflow
  2. Assess Morphology (M) to determine the type of plaque
  3. For calcific plaque, apply OCT-guided treatment of Calcified lesions algorithm.1 The algorithm guides physicians from assessment of calcific burden to lesion preparation and through treatment.
    Such approach relies on OCT’s ability to accurately recognize and access calcific burden to inform vessel preparation (device selection, stent sizing) to ensure adequate stent expansion.
OCT-guided algorithm to treat calcified lesions

Watch Video: OCT-Guided Treatment of Calcified Lesions.

In this video, Dr. Tej Sheth discussed how to apply MLD MAX algorithm to identify and treat calcified lesions.

How does OCT imaging compare to other modalities used for calcified lesions?

OCT is the best imaging modality to detect, localize and quantify coronary calcium.8

Coronary angiography, coronary computed tomography (CT), intravascular ultrasound (IVUS), radiofrequency (RF), intravascular ultrasound-virtual histology (IVUS-VH), and optical coherence tomography (OCT) can all detect and attempt to localize and quantify calcium, albeit with very different diagnostic accuracies, as concluded by Gary Mintz after 20 years of intravascular imaging studies of the relationship between calcium and coronary atherosclerosis.8

 Coronary AngiographyCTIVUSRF-IVUS (IVUS-VH)OCT
IMAGING
MODALITIES
Detection of coronary artery calcium++++++++++++++
Localization of coronary artery calcium++++++++++++++
Quantification of coronary artery calcium+++++++++++++
 

Successful PCI and reduction in future revascularizations are closely tied to final stent expansion.1 Coronary artery calcification is often underappreciated by angiography because angiography underestimates morphological lesion severity which impacts treatment strategy.5

Using OCT imaging with MLD MAX workflow to guide PCI helps to determine the right treatment approach and achieve optimal stent expansion. In LightLab, operators achieved 80% minimal stent expansion on average when following MLD MAX workflow.

References

  1. Shlofmitz, E., Sosa, F. A., Ali, Z. A., Waksman, R., Jeremias, A., & Shlofmitz, R. (2019). OCT-Guided Treatment of Calcified Coronary Artery Disease: Breaking the Barrier to Stent Expansion. Current Cardiovascular Imaging Reports, 12(8), 32.
  2. Dean Kereiakes, Disrupt CAD III: Lithotripsy for Vessel Preparation in Calcified Coronary Arteries Prior to Stenting, CLD. Dec 29, 2020.
  3. Madhavan MV, Tarigopula M, Mintz GS, Maehara A, Stone GW, Généreux P. Coronary artery calcification: pathogenesis and prognostic implications. J Am Coll Cardiol. 2014 May 06;63(17):1703-14.
  4. Räber L, et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018;39(35):3281-3300.
  5. Croce, K. et al: Optical Coherence Tomography Influences Procedure and Vessel Preparation Decisions During Percutaneous Coronary Intervention– Insights from the LightLab Initiative. TCTConnect2020 Presentation.
  6. Fujino, A et al. A new optical coherence tomography-based calcium scoring system to predict stent underexpansion. EuroIntervention. 2018 Apr 6;13(18):e2182-e2189. doi: 10.4244/EIJ-D-17-00962.
  7. Wang, X et al. In vivo calcium detection by comparing optical coherence tomography, intravascular ultrasound, and angiography. JACC Cardiovasc Imaging. 2017 Aug;10(8):869-879. doi: 10.1016/j.jcmg.2017.05.014.
  8. Mintz,G. Intravascular Imaging of Coronary Calcification and its Clinical Implications. JACC Cardiovascular Imaging, 2015. https://dx.doi.org/10.1016/j.jcmg.2015.02.003

MAT-2113912 v1.0

IMPORTANT SAFETY INFORMATION

OPTIS™ Imaging Systems and Software

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Indications The OPTIS™ Software and AptiVue™ E Series Software are intended to be used only with compatible OPTIS™ Imaging Systems.

The OPTIS™ Imaging System with a compatible Dragonfly™ Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The compatible Dragonfly™ Imaging Catheters are intended for use in vessels 2.0 to 3.5 mm in diameter. The compatible Dragonfly™ Imaging Catheters are not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

The OPTIS™ Imaging System is intended for use in the catheterization and related cardiovascular specialty laboratories and will further compute and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices. The physician may use the acquired physiological parameters, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.

Contraindications: The OPTIS™ Integrated System and Mobile System with Software are contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients diagnosed with coronary artery spasm
  • Patients disqualified for CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Total occlusion
  • Large thrombus
  • Acute renal failure

NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
 

Warnings:

  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage.
  • Leave the guidewire engaged with the catheter at all times during use. Do not withdraw or advance the guidewire prior to withdrawing the catheter.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter and guidewire together.
  • The Dragonfly™ Imaging Catheter should never be forced into lumens that are narrower than the catheter body or forced through a tight or heavily calcified lesion.
  • The Dragonfly™ Imaging Catheter should not be advanced through abnormally tortuous anatomy.
  • When advancing or retracting a catheter with a monorail tip through a stented vessel, the catheter may engage the stent between the junction of the Dragonfly™ Imaging Catheter and guidewire, resulting in entrapment of catheter/guidewire, catheter tip separation, and/or stent dislocation.
  • Refer to the contrast media’s instructions-for-use for general warnings and precautions relating to use of the contrast media.
  • To protect the privacy and security of sensitive information, including electronic protected health information (EPHI), and to protect the integrity of the system itself, the system should be located in a physically secure, access controlled environment.
  • Do not use the OPTIS™ Imaging System if there is reason to believe the system's security has been compromised or if the system was unaccounted for a period of time (i.e. misappropriated, modified or tampered with).


Precautions:

  • Safety and effectiveness have been established for the following patient population: adult patients undergoing non-emergent percutaneous coronary interventions in lesions with reference vessel diameters between 2.0 to 3.5 mm, which were not located in the left main coronary artery or in a target vessel which has undergone previous bypass procedures.
  • For optimal imaging, only use 100% contrast media.
  • Store the Dragonfly™ Imaging Catheter at ambient temperature in a dry location out of direct sunlight.
  • Never attempt to attach or detach a Dragonfly™ Imaging Catheter to the DOC while the “lock” LED is lit.
  • Do not kink, sharply bend, pinch, or crush the Dragonfly™ Imaging Catheter at any time.
  • The Dragonfly™ Imaging Catheter is for single use only. Do not reuse, re-sterilize, or reprocess.
  • The Dragonfly™ Imaging Catheter is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged.
  • After use, the Dragonfly™ Imaging Catheter may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The Dragonfly™ Imaging Catheter has no user serviceable parts. Do not attempt to repair or alter any part of the catheter assembly as provided.

MAT-2115909 v2.0

Dragonfly™ OPTIS™ Imaging Catheter

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Indications: The Dragonfly™ OPTIS™ Imaging Catheter with the OCT Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly™ OPTIS™ Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly™ OPTIS™ Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

Contraindications: Use of the Dragonfly™ OPTIS™ Imaging Catheter is contraindicated where introduction of any catheter would constitute a threat to patient safety. Contraindications include:

  • Bacteremia or sepsis
  • Major coagulation system abnormalities
  • Patients disqualified for CABG surgery
  • Patients disqualified for PTCA
  • Severe hemodynamic instability or shock
  • Patients diagnosed with coronary artery spasm
  • Total occlusion
  • Large thrombus
  • Acute renal failure


Warnings and Precautions:

  • Store at ambient temperature in a dry location out of direct sunlight.
  • Ensure the catheter is at room temperature (10°C to 32°C) before use.
  • This device is sterilized by ethylene oxide and is intended for one time use only. Non-pyrogenic. Do not use if the package is opened or damaged. Do not reuse or re-sterilize.
  • Appropriate anticoagulant and vasodilator therapy must be used during the procedure as needed.
  • Observe all advancement and movement of the Dragonfly™ OPTIS™ Imaging Catheter under fluoroscopy. Always advance and withdraw the catheter slowly. Failure to observe device movement fluoroscopically may result in vessel injury or device damage. To assure proper placement do not move the guide wire after the Dragonfly™ OPTIS™ Imaging Catheter is in place.
  • If resistance is encountered during advancement or withdrawal of the Dragonfly™ OPTIS™ Imaging Catheter, stop manipulation and evaluate under fluoroscopy. If the cause of resistance cannot be determined or mitigated, carefully remove the catheter from the patient.
  • Use the minimum flush rate and volume required to image the desired anatomy.
  • After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
  • The instructions for use are recyclable. Dispose of all packaging materials appropriately.
  • Refer to contrast media Instructions for Use for general warnings and precautions relating to contrast media.
  • This package contains a Sterile Single Use Only Device. Any attempt to re-use or re-sterilize may compromise the structural integrity of this device.
  • Do not remove the Dragonfly™ OPTIS™ Imaging Catheter from the DOC until the procedure is complete to avoid a potential sterility breach.
  • Always verify that the catheter has been properly prepared prior to inserting into vasculature.


Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging:

  • Coronary artery spasm
  • Unstable angina
  • Allergic reaction to the contrast media
  • Arterial dissection, injury or perforation
  • Thrombus formation, abrupt closure, or total occlusion
  • Abnormal heart arrhythmias
  • Embolism
  • Acute myocardial infarction
  • Death

MAT-2115908 v2.0

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HEALTHCARE PROFESSIONALS
PATIENTS & CAREGIVERS
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CAUTION: These products are intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or online for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

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MAT-1900882 v12.0