LightLab is a multicenter, prospective, observational clinical initiative designed to evaluate the impact of using a routine OCT workflow, MLD MAX, on physician decision-making and procedural efficiency during PCI with the goal of improving cath lab workflow, safety and efficiency.
Percutaneous coronary intervention (PCI) is most commonly guided by angiography which offers a two-dimensional view of the three-dimensional structure.1 It can’t depict the arterial vessel wall, and thus evaluate vessel dimensions and plaque characteristics, nor directly assess the results of stent implantation.2 Recent LightLab data give further insights into the limitations of angiography in the cath lab and highlights the benefits of using OCT.
OCT changed angio-based
Pre-PCI OCT changed angio-based
diagnosis and treatment decisions 5
OCT changed angio-based
vessel prep strategy4
Achieved when following LL
OCT workflow, MLD MAX3
When physicians used the full range of information from OCT with the MLD MAX workflow they changed decisions in 88% of lesions over their angiographic assessment. The largest impact was observed prior to stenting, in decisions involving morphology assessment, vessel preparation and stent sizing, key decisions which may influence final stent expansion. Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.2
When physicians used OCT to assess lesion morphology and composition of the plaque, they changed their angiographic-guided assessment in about half of lesions or in 48% of lesions. Due to the high resolution images, OCT provides additional information on lesion morphology which is important to determine how to prepare and treat the vessel appropriately, especially when calcification is present. Extensive calcification may adversely impact PCI procedure and final stent expansion.2
Proper vessel evaluation, lesion preparation, and sizing are essential to achieve optimal stent expansion.
When physicians assessed lesion morphology and severity with OCT, they changed vessel prep strategy. When a change in vessel prep strategy occurred, calcification was the predominant morphology as seen with OCT. Angiography underestimates morphological lesion severity which impacts treatment strategy.
When physicians used OCT pre-PCI in ISR lesions, they changed their angiographic diagnosis and treatment strategy in 91% of lesions. OCT can diagnose ISR and accurately identify the mechanism of stent failure which impacts ISR treatment strategy. In LightLab, OCT changed angio assessment of ISR mechanism in 48% of lesions with a quarter of these lesions missed as ISR by angiography.
Identifying the mechanism of stent failure is paramount to planning treatment as treatment strategy differs for ISR due to stent underexpansion and due to neointimal hyperplasia.2 Analysis of ISR by intravascular imaging is essential to understand the mechanism of failure and OCT is a preferred technique.2
Algorithm adapted from Ziad Ali, MD. CHIP guided by OCT, A Case Based Discussion, TCT 2017
Achieving optimal expansion is proven to reduce rates of major adverse cardiac events during PCI.2 Operators achieved 80% minimal stent expansion on average when following LightLab workflow, MLD MAX.
OCT makes it easy to detect underexpansion. Using Tapered Reference Mode, which is based on the natural tapering of vessels and factoring in side branches, OCT software automatically calculates expansion percentage % and highlights regions of underexpansion in red, well-expanded in white, see below.
Example 1: OCT software detected 67% stent expansion (A) meaning the stent is underexpanded based on the recommended expansion targets2 of MSA ≥ 80% or >90%. The software highlighted underexpansion in red, and well-expanded areas in white which can also be seen on the angio co-registration feature (B) and on the rendered stent feature (C).
Example 2: OCT software detected 86% stent expansion (A) and it is highlighted in white to indicate well-expanded stent based on the recommended expansion targets2 of MSA ≥ 80% or >90%. The software highlighted well-expanded stent in white on angio co-registration feature (B) and rendered stent feature (C).
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:
NOTE: The systems have no patient alarm functions. Do not use for cardiac monitoring.
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:
Warnings and Precautions:
Potential Adverse Events: The following complications may occur as a consequence of intravascular imaging: