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Stress Testing the Cardiac Catheterization Laboratory: A Novel Use of In Situ Simulation to Identify and Mitigate Latent Safety Threats During Acute Airway Management

Jafri, Farrukh Nadeem; Santana Felipes, Rachel C; Bliagos, Dimitrios; Torres, Rafael E; Bellido, Simon; Arif, Amber; Elwell, Diana; Mirante, Doreen; Ellsworth, Kelly; Cardasis, John; Anastasian, George; Pinto, Hazel; Kochar, Ajar
INTRODUCTION/BACKGROUND:Although uncommon, cardiac arrests in the cardiac catheterization laboratory (CCL) are often catastrophic and likely to increase with rising case complexity. In situ simulation (ISS) has been used to identify latent safety threats (LSTs) in inpatient units but has not yet been studied in the CCL. METHODS:Three Plan-Do-Study-Act (PDSA) cycles leveraging ISS were conducted focused on acute airway management. Data collected through debriefs focused on (1) airway management, (2) equipment availability, and (3) interdepartmental communication. The LSTs were subcategorized and plotted on the Survey Analysis for Evaluating Risk (SAFER)-Matrix. A SAFER score was calculated based on quantifying the likelihood of harm, scope, and the number of times a threat was identified during simulation. Time to definitive airway was collected as a secondary measure. Interventions were developed using cause and effect and driver diagrams between PDSA cycles. RESULTS:Eleven total simulations through 3 PDSA cycles were conducted between January and December 2021 (5 in PDSA 1, 4 in PDSA 2, and 2 in PDSA 3). One hundred one LSTs were identified with 14 total subcategories. The mean SAFER score decreased from 5.37 in PDSA 1, to 2.96 in PDSA 2, and to 1.00 in PDSA 3. Bivariate regression analysis showed a decrease in SAFER score of 2.19 for every PDSA cycle ( P = 0.011). Ordinary least squares regression had a decrease of 1.65 in airway-related threats every PDSA cycle ( P < 0.01) as well as an increase in intubation time of 35.0 seconds for every 1-unit increase in communication threat identified ( P = 0.037). CONCLUSIONS:This study successfully leveraged ISS and existing quality improvement initiatives in the CCL, resulting in a decrease in airway-related threats as measured through simulation.
PMID: 37094366
ISSN: 1559-713x
CID: 5650522

A technology evaluation of the Onyx Frontier drug-eluting stent

Leone, Pier Pasquale; Assafin, Manaf; Scotti, Andrea; Gonzalez, Maday; Mignatti, Andrea; Dawson, Kathryn; Rauch, Judah; Khaliq, Asma; Bliagos, Dimitrios; Latib, Azeem
INTRODUCTION:represents the latest iteration within the family of zotarolimus-eluting stents (ZES), designed for the treatment of coronary artery disease. Approval by the Food and Drug Administration was granted in May 2022, and Conformité Européenne marking followed in August 2022. AREAS COVERED:We hereby review the principal design features of Onyx Frontier, highlighting differences and similarities with other currently available drug-eluting stents. In addition, we focus on the refinements of this newest platform as compared with previous ZES versions, including the attributes yielding its exceptional crossing profile and deliverability. The clinical implications related to both its newest and inherited characteristics will be discussed. EXPERT OPINION:The nuances of the latest Onyx Frontier, together with the continuous refinement previously witnessed throughout the development of ZES, lead to a latest generation device ideal for a diverse spectrum of clinical and anatomical scenarios. In particular, its peculiarities will be of benefit in the settings often offered by a progressively aging population, such as high bleeding risk patients and complex coronary lesions.
PMID: 37203200
ISSN: 1744-7593
CID: 5650532

Preclinical research performed on reanimated/perfused swine kidneys: The Visible Kidney™ methodologies

Valenzuela, Thomas F; Schinstock, Emma; Kohnle, Samantha; Latib, Azeem; Bliagos, Dimitrios; Tunev, Stefan; Iaizzo, Paul A
Preclinical research remains the essential platform in the development and optimization of medical therapies and advancements in translational medicines. However, specifically to animal research, federal laws, and institutional policies require investigators to apply the principles of the 3R's (replacement, reduction, and refinement). The concept of benchtop models utilizing isolated organs, in which multiple variables can be controlled to recreate human function, has been innovative advancements in preclinical research models that adhere to these principles. More specifically, isolated perfused kidney (IPK) models have been invaluable preclinical tools that have led to numerous advancements over the decades, including understanding renal physiology, pharmacologic therapies, and improvements in renal transplantation. However, pre-existing IPK models are not without their own limitations, leaving areas for improvement. An isolated perfused kidney apparatus was designed to best recreate human use conditions as a preclinical tool. Porcine renal blocks were chosen over the more commonly used rodent models, due to their greater similarities to human anatomies. Sixteen porcine kidney pairs obtained en bloc were extracted and placed onto an apparatus where aortic flows, pressures, and overall systemic temperatures were controlled. Organ viability was assessed in 10 renal blocks (n = 8 fresh and n = 2 previously frozen specimens) via both urinary flows and compositions at timepoints up to 180 min. Multimodality imaging, which included fluoroscopy, ultrasound, optical coherence tomography (OCT), and video scopes, was also employed to capture internal and external images to determine renal artery orientations and dimensions. Anatomical measurements and viability assessments of porcine renal blocks were successfully achieved in our perfusion model. Renal main artery diameters averaged smaller in our sample size than in human anatomy while also having more superior takeoff angles. Yet, the average lengths of each main segment were comparable to human anatomy: 32.09 ± 7.97 mm and 42.23 ± 7.33 mm in the left and right renal main artery, respectively. Urine production and urine composition of the fresh renal blocks, when compared to the frozen blocks and baseline perfusate, showed kidney viabilities of up to 3 h via excretion and retention of various metabolites. In this paper, we described a protocol for an isolated perfused kidney apparatus using large mammalian renal blocks. We believe this protocol to be an improvement from similar pre-existing models in better representing human physiologic function while allowing for multimodal imaging. The resulting Visible Kidney™ preclinical model, which has shown viability after isolation and reperfusion, can be a fast and reliable tool for the development of medical devices while also reducing the unnecessary use of animals for research.
PMID: 36878878
ISSN: 2051-817x
CID: 5650512

Complementary Utility of Intravascular Lithotripsy With Atherectomy for Severely Calcified Coronary Stenoses in Contemporary Practice

Takahashi, Tatsunori; Menegus, Mark; Choi, Hansol; Bliagos, Dimitrios; Assafin, Manaf; Rauch, Judah; Johnson, Michael; Greenberg, Mark; Khaliq, Asma; Scotti, Andrea; Latib, Azeem
BACKGROUND:The effectiveness and safety of a contemporary combined approach that incorporates the novel intravascular lithotripsy (IVL) technology into conventional tools including atherectomy have yet to be studied. METHODS:We retrospectively included consecutive patients who underwent percutaneous coronary intervention (PCI) with IVL from March 2021 to February 2022. Effectiveness (residual stenosis of <30%) and safety outcomes (procedural complications and major adverse cardiovascular event [MACE] defined as a composite of all-cause death, myocardial infarction, or target vessel revascularization) were compared between patients undergoing IVL with and without atherectomy. RESULTS:A total of 109 patients underwent IVL, of whom 33 patients (30.3%) were treated with both IVL and atherectomy and had higher risk features including reduced cardiac function and more frequent use of mechanical circulatory support. Angiographic success for calcified de novo lesions was achieved in 85.7% and 90.6% of the combined and non-atherectomy groups, respectively (P=.49). Each group had one case of coronary perforation (P=.52) while major dissection occurred in 2 cases of calcific stent underexpansion in the combined group (6.1% vs 0%; P=.09). Thirty-day MACE occurred in 4.8% of patients including 3 deaths in the atherectomy group and 1 cardiac death and 1 myocardial infarction in the non-atherectomy group (P=.16). CONCLUSION:Procedural success and complications were similar in patients undergoing IVL with and without atherectomy when treating calcified de novo lesions. Those who required a combined approach represented a high-risk population with high mortality, suggesting that a multidisciplinary approach is needed to optimize case selection and care beyond PCI.
PMID: 36495542
ISSN: 1557-2501
CID: 5650502

Contemporary technologies to modify calcified plaque in coronary artery disease

Rozenbaum, Zach; Takahashi, Tatsunori; Kobayashi, Yuhei; Bliagos, Dimitrios; Menegus, Mark; Colombo, Antonio; Latib, Azeem
With aging society, one of the more challenging obstacles in percutaneous coronary interventions are calcified coronary lesions. Calcified lesions may impede stent delivery, limit balloon and stent expansion, cause uneven drug distribution, and hinder wire advancement. Even in the setting of acceptable procedural success, vessel calcification is independently associated with increased target lesion revascularization rates at follow-up and lower survival rates. In order to effectively manage such lesions, dedicated technologies have been developed. Atherectomy aims at excising tissue and debulking plaques, as well as compressing and reshaping the atheroma, generally referred to as lesion preparation that enables further balloon and/or stent expansion in contemporary clinical practice. In the current review, we will discuss the available methods for atherectomy, including rotational, orbital, and excimer laser coronary atherectomy, as well as intravascular lithotripsy. In addition, we will review the role of imaging in calcified lesions.
PMID: 34252411
ISSN: 1873-1740
CID: 5650492

Redo thoracic endovascular aortic repair due to endoleak with celiac artery snorkeling [Case Report]

Planer, David; Bliagos, Dimitrios; Gray, William A
Reintervention due to endoleak of aortic endograft repair is often challenging. Herein, we report endovascular endoleak repair in a patient with previous thoracic and abdominal endovascular grafts with extensive coverage of the aorta. The present technique included snorkeling of the celiac trunk to preserve antegrade flow in the celiac artery and to maintain future options for reintervention.
PMID: 21835581
ISSN: 1615-5947
CID: 5650482