Improving efficiency and operator proficiency during percutaneous coronary interventions utilizing a standardized optical coherence tomography workflow
This study was designed to compare efficiency and quality metrics between percutaneous coronary intervention (PCI) procedures using optical coherence tomography (OCT) guided by a variable workflow versus a standardized workflow in a real-world population.
The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption.
The LL Initiative was a multicenter, prospective, observational study. PCI efficiency data were collected from 1/21/19 to 1/8/21 from 45 physicians at 17 US centers. OCT-guided PCIs were compared between baseline phase (variable workflow; N = 383) and the LL workflow utilization phase (N = 447). The LL workflow uses OCT to assess lesion Morphology, Length and Diameter, and then optimize outcomes by correcting for Medial dissection, stent mal-Apposition, and under-eXpansion (MLD MAX). Matching based on propensity scores was used to control for differences betwe...
OCT utilization: Summary statistics from the LightLab clinical initiative
The study describes the evolution of optical coherence tomography (OCT) adoption and performance during percutaneous coronary intervention (PCI) following implementation of a standardized LightLab (LL) workflow.
The purpose of the LL Clinical Initiative was to evaluate the impact of a standardized workflow on physician efficiency, decision making, and image quality.
The LL Clinical Initiative is a multicenter, prospective, observational clinical program. Data were collected from 48 physicians at 17 U.S. centers from 01/21/19 to 06/08/21. The study included 401 OCT-guided PCIs during the baseline phase and 1898 during the LL workflow phases. The baseline phase consisted of physicians utilizing OCT at their discretion. After completing the baseline phase, the workflow progressed through multiple phases culminating in the expansion phase, which focused on addressing greater procedural complexity. The LL workflow utilized OCT to assess plaque Morpholog...
The MLD MAX OCT algorithm: An imaging-based workflow for percutaneous coronary intervention
Although extensive clinical data support the utility of intravascular imaging to guide and optimize outcomes following percutaneous coronary interventions (PCI), clinical adoption remains limited. One of the primary reasons for limited utilization may be a lack of standardization on how to best integrate the data provided by intravascular imaging practically. Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality with integrated software automation that allows for incorporation of OCT into the routine workflow of PCIs. We suggest use of an algorithm called MLD MAX to incorporate OCT for imaging-guided interventions: the baseline OCT imaging run is intended to facilitate procedural planning and strategizing, consisting of assessment for predominant lesion morphology (M), measurement for stent length (L) and determination of stent diameter (D); the post-PCI OCT imaging run is designated for assessment of need for further optimization of stent result...
Investigating real-world impact of optical coherence tomography workflow-guided coronary interventions: Design and rationale of the LightLab Clinical Initiative
The LightLab Clinical Initiative was designed to examine adoption of optical coherence tomography (OCT) imaging during routine percutaneous coronary intervention (PCI) practice, and enable identification and reduction of barriers to broader adoption of intracoronary imaging in real-world practice.
Intracoronary imaging guidance during PCI has been shown to improve clinical outcomes and features as a recommendation in societal guidelines, yet widespread routine adoption remains low. Perceived barriers to utilization include familiarity with, and ability to interpret imaging, concerns over added procedure time and contrast load, alongside a lack of actionable outcome data.
Methods and Results
LightLab was a multicenter prospective observational data-gathering project, conducted between January 2019, and June 2021, with 17 participating hospitals and physicians. Data were gathered in real-time, where OCT guidance was employed during PCI using a standardized OC...
Decision-Making During Percutaneous Coronary Intervention Guided by Optical Coherence Tomography: Insights From the LightLab Initiative
Background: Use of intracoronary imaging is associated with improved outcomes in patients undergoing percutaneous coronary intervention (PCI). Yet, the impact of intracoronary imaging on real-time physician decision-making during PCI is not fully known. Methods: The LightLab Initiative is a multicenter, prospective, observational study designed to characterize the use of a standardized optical coherence tomography (OCT) workflow during PCI. Participating physicians performed pre-PCI and post-PCI OCT in accordance with this workflow and operator assessments of lesion characteristics and treatment plan were recorded for each lesion based on angiography alone and following OCT. Physicians were categorized as having low (n=15), intermediate (n=13), or high (n=14) OCT use in the year preceding participation. Results: Among 925 patients with 1328 lesions undergoing PCI, the prescribed OCT workflow was followed in 773 (84%) of patients with 836 lesions. Operator lesion assessment and decis...
Safety and efficiency of percutaneous coronary intervention using a standardised optical coherence tomography workflow
Background: While intravascular imaging guidance during percutaneous coronary intervention (PCI) improves outcomes, routine intravascular imaging usage remains low, in part due to perceived inefficiency and safety concerns. Aims: The LightLab (LL) Initiative was designed to evaluate whether implementing a standardised optical coherence tomography (OCT) workflow impacts PCI safety metrics and procedural efficiency. Methods: In this multicentre, prospective, observational study, PCI procedural data were collected over 2 years from 45 physicians at 17 US centres. OCT-guided PCI incorporating the LL workflow (N=264), a structured algorithm using routine pre- and post-PCI OCT imaging, was compared with baseline angiography-only PCI (angio) (N=428). Propensity score analysis identified 207 matched procedures. Outcomes included procedure time, radiation exposure, contrast volume, device utilisation, and treatment strategy. Results: Compared with angiography alone, LL workflow OCT-guided PC...
Optical coherence tomography versus angiography and intravascular ultrasound to guide coronary stent implantation: A systematic review and meta-analysis
Background: Optical coherence tomography (OCT) is an adjunct to angiography-guided coronary stent placement. However, in the absence of dedicated, appropriately powered randomized controlled trials, the impact of OCT on clinical outcomes is unclear. Objective: To conduct a systematic review and meta-analysis of all available studies comparing OCT-guided versus angiography-guided and intravascular ultrasound (IVUS)-guided coronary stent implantation. Methods: MEDLINE and Cochrane Central were queried from their inception through July 2022 for all studies that sought to compare OCT-guided percutaneous coronary intervention (PCI) to angiography-guided and IVUS-guided PCI. The primary endpoint was minimal stent area (MSA) compared between modalities. Clinical endpoints of interest were all-cause and cardiovascular mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thro...
Interobserver variability between expert, experienced and novice operator affects interpretation of Optical Coherence Tomography & 20 MHz Intravascular Ultrasound imaging
Background: Vessel sizing and calcium detection by intracoronary imaging informs optimal strategy during coronary interventions, but image interpretation and analysis software vary considerably between platforms. We compared the interobserver variability of clinicians with a range of experience in assessing co-registered optical coherence tomography (OCT) and 20 MHz solid state intravascular ultrasound (IVUS) vessel/ lumen geometry and quantitative plaque data. Methods: Co-registered OCT and IVUS frames at the minimum lumen area (MLA) and 5 frames at 2 mm intervals upstream and downstream were read blinded by an expert, consultant, interventional fellow and registrar to define vessel and lumen sizes, plaque characteristics (arc of calcium and lipid) and presence of OCT-defined thin-capped fibroatheroma (TCFA). Results: Overall, 143 paired frames of OCT and IVUS were analysed. Excellent consistency was seen for all OCT measures of vessel/luminal geometry irrespective of experience (a...
Longitudinal display of coronary artery calcium burden
The present disclosure provides systems and methods to receiving OCT or IVUS image data frames to output one or more representations of a blood vessel segment. The image data frames may be stretched and/or aligned using various windows or bins or alignment features. Arterial features, such as the calcium burden, may be detected in each of the image data frames. The arterial features may be scored. The score may be a stent under-expansion risk.
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Visualizing Inside Conduits – Intraoperative Screening of Grafts by Optical Coherence Tomography
PURPOSE Saphenous vein graft (SVG) failure is a complex phenomenon, with technical, biological and local factors contributing to early-, medium- and long-term failure after coronary artery bypass graft (CABG). Both technical and conduit factors may have significant impact on the early SVG failure. DESCRIPTION We review the complex factors that play a pathogenic role in SVG failure followed by reviewing the existing literature on potential utility of high-definition optical coherence tomography (OCT) in comprehensive intraoperative assessment of SVGs. EVALUATION We describe a new technique for intraoperative acquisition of OCT images in the harvested SVGs, and introduce a classification system for pathologies that can be detected in the harvested SVG conduits by OCT. CONCLUSIONS The potential impact of the exclusion of segments of SVGs that are less optimal (i.e., containing fibroatheroma, retained thrombus, sclerotic valves or procurement injury) on early graft failure will be exami...
Procedure-Related Differences and Clinical Outcomes in Patients Treated with Percutaneous Coronary Intervention Assisted by Optical Coherence Tomography between New and Earlier Generation Software (Ultreon™ 1.0 Software vs. AptiVue™ Software)
(1) Introduction: Optical coherence tomography (OCT) intravascular imaging facilitates percutaneous coronary intervention (PCI). Software for OCT is being constantly improved, including the latest version Ultreon™ 1.0 Software (U) (Abbott Vascular, Santa Clara, CA, USA). In the current analysis, we aim to compare processing results, procedural indices as well as clinical outcomes in patients treated via PCI. This was conducted using earlier generation OCT imaging software versions (non-U) and the newest available one on the market (U). (2) Methods: The study comprised 95 subsequent and not selected patients (55 processed with U and 40 non-U). The non-U processings were transferred for evaluation by U software, while the comparison of OCT parameters, selected clinical and procedural indices was performed between groups. We further assessed clinical outcomes during the follow-up period, i.e., major adverse cardiovascular events (MACE) and predictors of stent expansion. (3) Resul...
Optical coherence tomography-guided percutaneous coronary intervention in a myocardial …
Optical coherence tomography (OCT) is a modern intravascular imaging technique that enables high - definition visualization of coronary plaque morphology and its length, as well as precise assessment of coronary artery diameter while planning a percutaneous coronary intervention (PCI). Moreover, OCT is highly effective in the evaluation of the PCI results  . As has been demonstrated in the multicenter CLI - OPCI registry, suboptimal stent deployment confirmed with OCT was associated with unfavorable clinical outcomes  . These findings contributed to the development of a multicenter, prospective, observational LightLab initiative. Its main goals are to evaluate the impact of a routine OCT clinical implementation on the physician decision - making process and improving the safety and efficiency of modern cath labs  . We present a 53 - year - old man, with hypercholesterolemia and a history of smoking, who was hospitalized for non - ST - segment elevation myocardial infarction...
Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band
Abbott has recalled its Dragonfly OpStar imaging catheter, used for imaging the coronary arteries with optical coherence tomography, due to the possibility that the marker band farthest from the tip of the catheter could become loose and harm the patient, the US Food and Drug Administration announced Thursday . The recall has been deemed Class I, the most serious type. The issue has been associated with five incidents and one injury, but no deaths. In two cases, the loose band separated completely from the catheter while it was in use. If that happens and the band remains behind in the patient, it could cause vascular injury or death, according to the FDA note. The recall, which Abbott initiated on April 11, applies to 4,800 devices distributed in the United States. Affected catheters, with lot numbers listed in the FDA’s recall database , should be returned to the company.
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