Improving efficiency and operator proficiency during percutaneous coronary interventions utilizing a standardized optical coherence tomography workflow

January 20, 2023 | Cardiology | Abbott, Beth Israel Deaconess Medical Center, Harvard University, Loyola University

Amir Darki, Bassem M. Chehab, Bimal B. Padaliya, Eric A. Secemsky, Gregory Amis, Jana Buccola, Matheen A. Khuddus, Nick E. J. West, Richard J. Rapoza

Objectives 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. Background The LightLab (LL) Initiative was designed to evaluate the impact of a standardized OCT workflow during PCI to address barriers to adoption. Methods 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

January 20, 2023 | Cardiology | Abbott, Beth Israel Deaconess Medical Center, Columbia University, Harvard University

Aishwarya Raja, Brian A. Bergmark, Eric A. Osborn, Eric A. Secemsky, Hector Tamez, Jana Buccola, Jennifer Meinen, Kevin D. Croce, Marie-France Poulin, Nick West

Objectives 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. Background The purpose of the LL Clinical Initiative was to evaluate the impact of a standardized workflow on physician efficiency, decision making, and image quality. Methods 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

January 20, 2023 | Cardiology | Abbott, Brigham and Women’s Hospital, Cardiovascular Research Foundation, McMaster University

Bassem Chehab, Evan Shlofmitz, Hiram Bezerra, Kevin Croce, Nick E. J. West, Richard Shlofmitz, Tej Sheth, Ziad A. Ali

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

January 20, 2023 | Cardiology | Abbott

Jana Buccola, Jennifer Meinen, Joia Spinelli, Michael Hammerstone, Nick E. J. West, Richard Rapoza

Objective 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. Background 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

November 16, 2022 | Cardiology | Abbott, Brigham and Women’s Hospital, Harvard University

Brian Bergmark, Gabriel T. R. Pereira, Jana Buccola, Jason Wollmuth, Jennifer Meinen, John Lopez, Joia Spinelli, Julia F. Kuder, Kevin Croce, Luis A. P. Dallan, Nick E. J. West, Sabina A. Murphy

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

November 8, 2022 | Ophthalmology | Abbott, Beth Israel Deaconess Medical Center, Harvard University

Aziz Maksoud, Daniel Spoon, Eric A. Osborn, Ethan C. Korngold, Frank J. Zidar, Hector Garcia Cabrera, Jana Buccola, Judah Rauch, Michael Johnson, Nick E. J. West, Richard J. Rapoza

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...

Treatment of Functionally Non-significant Vulnerable Plaques in Patients With Multivessel ST-elevation Myocardial Infarction The VULNERABLE Randomized Trial

October 31, 2022 | Cardiology, Clinical Trials | Abbott

The study aims to compare a preventive percutaneous coronary intervention (PCI) plus optimal medical treatment (OMT) strategy vs. OMT for treatment of non-functionally significant non-culprit lesions presenting with optical coherence tomography (OCT) findings indicative of vulnerable plaque, in patients with ST-elevation myocardial infarction (STEMI) and multivessel disease. ( Read Full Article )

Optical coherence tomography versus angiography and intravascular ultrasound to guide coronary stent implantation: A systematic review and meta-analysis

October 19, 2022 | Cardiology | Abbott, Cardiovascular Research Foundation, Columbia University, Duke University

Allen Jeremias, Eric Wolff, Evan Shlofmitz, Jason Hochler, Jeffrey W. Moses, Karen Chau, Keyvan Karimi Galougahi, Muhammad Shahzeb Khan, Nick E. J. West, Omar Khalique, Richard A. Shlofmitz, Sunil Rao, Tariq Jamal Siddiqi, Ziad A. Ali

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

October 9, 2022 | Cardiology | Abbott

Edwina McNaughton, Nick E. J. West, Paul B. Bambrough, Stephen P. Hoole, William G. Martin

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

September 6, 2022 | Cardiology, Patents | Abbott

Ajay Gopinath, Gregory Patrick Amis, Mark Hoeveler

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. ( Read Full Article )

Visualizing Inside Conduits – Intraoperative Screening of Grafts by Optical Coherence Tomography

August 17, 2022 | Cardiology | Abbott, Cardiovascular Research Foundation

Akiko Maehara, Allen Jeremias, Craig R. Porter, David J. Cohen, Dylan Dominguez- Sulca, Edward F. Lundy, Elma Chowdhury, Evan S. Shlofmitz, Gary S. Mintz, Jeffrey W. Moses, Keyvan Karimi Galougahi, Mitsuaki Matsumura, Newell B. Robinson, Nick West, Richard A. Shlofmitz, Susan V. Thomas, Ziad A. Ali

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)

July 26, 2022 | Cardiology | Abbott

Andrzej Surdacki, Grzegorz Heba, Karol Sabatowski, Krzysztof Bartuś, Krzysztof Piotr Malinowski, Leszek Bryniarski, Łukasz Rzeszutko, Michał Chyrchel, Rafał Januszek, Sławomir Surowiec, Stanisław Bartuś, Wojciech Siłka

(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 …

June 13, 2022 | Cardiology | Abbott, Terumo, Terumo Corporation

Aleksandra Karcińska, Alicia del Carmen Yika, Anna Matrejek, Ewelina Lichota, Grażyna Nowak, Jadwiga Nessler, Jaroslaw Zalewski, Karol Nowak, Konrad Stępień, Michael Platschek, Patrycja Furczyńska

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 [1] . As has been demonstrated in the multicenter CLI - OPCI registry, suboptimal stent deployment confirmed with OCT was associated with unfavorable clinical outcomes [2] . 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 [3] . We present a 53 - year - old man, with hypercholesterolemia and a history of smoking, who was hospitalized for non - ST - segment elevation myocardial infarction...

Acute Myocardial Infarction Caused by Plaque Erosion After Recovery From COVID-19 Infection Assessed by Multimodality Intracoronary Imaging

June 2, 2022 | Cardiology | Abbott

Kazuki Matsuda, Masahiro Hoshino, Tomoyo Sugiyama, Tsunekazu Kakuta

We report a case of non-ST-elevation acute myocardial infarction after recovery from COVID-19 infection. An emergency coronary angiography revealed 50% stenosis with thrombotic occlusion in the middle left anterior descending artery. Optical coherence tomography and coronary angioscopy revealed plaque erosion with mixed thrombus on a lipid-rich plaque. This case report may help to understand the underlying mechanisms of cardiac complications following COVID-19 infection. ( Read Full Article )

Dragonfly OpStar OCT Catheter Recalled for Loose Marker Band

May 28, 2022 | Cardiology, Other Business News | Abbott, FDA

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. ( Read Full Article )