Catheter Device Research Articles

Mechanical Aspiration of a Heavy Thrombus in the Left Anterior Descending Artery using Penumbra Aspiration Catheter

Left anterior descending artery thrombosis is a medical emergency that requires prompt intervention to achieve the best possible clinical outcomes [1]. Early recanalization of obstructed vessels and thrombectomy with subsequent stenting effectively restore blood flow and improve procedural outcomes [2]. However, Manual Aspiration Thrombectomy (MAT) using a flexible aspiration catheter is also an alternative method that can be used to open blocked vessels [3]. Recent advancements in aspiration catheters have improved their trackability and size, making them comparable in efficacy to SBT [4]. As a result, Stent-Based Thrombectomy (SBT) and mechanical aspiration thrombectomy have become the primary treatment options for endovascular therapy in particular cases of coronary artery disease. The concurrent utilization of SBT and MAT as first-line and fallback interventions has been demonstrated to be effective in restoring vascular recanalization [5]. Besides SBT and MAT, a new aspiration catheter device has emerged. It is a relatively new technique for treating a thrombus in LAD that involves using a specialized catheter to remove the blood clot from the culprit artery [6]. This minimally invasive procedure is faster and more effective than traditional treatments such as thrombolytic therapy or Percutaneous Coronary Intervention (PCI) [7]. Penumbra medical technology company (Penumbra Inc, Alameda, CA, USA) introduced the Aspiration System in 2014 [8]. This system is specifically designed to remove blood clots from veins and arteries in the "peripheral vasculature" as well as for the treatment of "pulmonary embolism" [9]. The CAT family of catheters, developed by Penumbra, is known for its robustness, trackability, and atraumatic design, making it well-suited for peripheral anatomy where a thrombus forms [10]. The system comes equipped with the "Penumbra ENGINE aspiration source," which can administer almost untainted and consistent vacuum to catheters. This proficiency enables the extraction of thrombus in vessels of assorted dimensions. Recently, a penumbra aspiration catheter was used in a case report to remove thrombosis in acute coronary syndrome. According to the findings presented in this case report, it can be deduced that the Penumbra CAT RX catheter represents a secure and remarkably efficient alternative for eliminating blood clots in urgent scenarios. Notably, this method mitigates the heightened vulnerability to stroke often associated with the conventional approach of manual aspiration thrombectomy [11]. Previously, penumbra reperfusion catheter and MAT have been used as a "first-line therapy," and SBT with a "Solitaire stent" as a rescue therapy since 2012. This approach showed promising results regarding vessel recanalization and clinical outcomes [12].

The potential role of through the needle PIVC insertion in reducing early catheter contamination.

Over-the-needle (OTN) PIVC devices are at inherent risk of insertion related skin contamination. Through-the-needle (TTN) catheter deployment resulted in no measurable contamination in this study. OTN catheters were 1.67 times more likely to be contaminated than TTN in this study. To compare a traditional over-the-needle peripheral intravenous catheter device to a through-the-needle (TTN) peripheral intravenous catheter device for early bacterial contamination during insertion. Five TTN test devices (OspreyIV 20 g SkyDance Vascular, Inc) and 5 OTN comparative devices (Insyte Autoguard 20 g Becton Dickinson) were aseptically inserted through targeted zones inoculated with 1 mL aliquot suspension of approximately 1 × 10 CFU of Staphylococcus aureus among 3 healthy sheep. Immediately after insertion, each study catheter was surgically removed from the surrounding tissue and cultured for the presence of Staphylococcus aureus inoculum that may have been transferred to the catheter during insertion. Final culture results of the 5 test articles found no bacterial colonies. Final culture results of the 5 comparative articles revealed 2 of 5 were contaminated with bacterial colonies. The absolute risk reduction is 40%, or a 40% rate of contamination drops to a 0% rate of contamination when the TTN catheter deployment was used. The risk ratio achieved was 1.67, indicating catheters placed using the OTN deployment were 1.67 times more like to be contaminated than the TTN deployed catheters. In this present ovine study, the data revealed that use of a novel TTN approach resulted in less contamination than the more traditional OTN approach. Traditional OTN devices, developed over 70 years ago, are at inherent risk of insertion-related contact contamination. The results of this research, as well as previously published studies, point toward considering physical catheter protection strategies such as TTN devices as a potential alternative to OTN devices.

An international prospective study of INICC analyzing the incidence and risk factors for catheter-associated urinary tract infections in 235 ICUs across 8 Asian Countries

Identify urinary catheter (UC)-associated urinary tract infections (CAUTI) incidence and risk factors (RF) in 235 ICUs in 8 Asian countries: India, Malaysia, Mongolia, Nepal, Pakistan, the Philippines, Thailand, and Vietnam. From January 1, 2014, to February 12, 2022, we conducted a prospective cohort study. To estimate CAUTI incidence, the number of UC days was the denominator, and CAUTI was the numerator. To estimate CAUTI RFs, we analyzed 11 variables using multiple logistic regression. 84,920 patients hospitalized for 499,272 patient days acquired 869 CAUTIs. The pooled CAUTI rate per 1,000 UC-days was 3.08; for those using suprapubic-catheters (4.11); indwelling-catheters (2.65); trauma-ICU (10.55), neurologic-ICU (7.17), neurosurgical-ICU (5.28); in lower-middle-income countries (3.05); in upper-middle-income countries (1.71); at public-hospitals (5.98), at private-hospitals (3.09), at teaching-hospitals (2.04). The following variables were identified as CAUTI RFs: Age (adjusted odds ratio [aOR]=1.01; 95% CI=1.01-1.02; P<.0001); female sex (aOR=1.39; 95% CI=1.21-1.59; P<.0001); using suprapubic-catheter (aOR=4.72; 95% CI=1.69-13.21; P<.0001); length of stay before CAUTI acquisition (aOR=1.04; 95% CI=1.04-1.05; P<.0001); UC and device utilization-ratio (aOR=1.07; 95% CI=1.01-1.13; P=.02); hospitalized at trauma-ICU (aOR=14.12; 95% CI=4.68-42.67; P<.0001), neurologic-ICU (aOR=14.13; 95% CI=6.63-30.11; P<.0001), neurosurgical-ICU (aOR=13.79; 95% CI=6.88-27.64; P<.0001); public-facilities (aOR=3.23; 95% CI=2.34-4.46; P<.0001). CAUTI rate and risk are higher for older patients, women, hospitalized at trauma-ICU, neurologic-ICU, neurosurgical-ICU, and public facilities. All of them are unlikely to change. It is suggested to focus on reducing the length of stay and the Urinary catheter device utilization ratio, avoiding suprapubic catheters, and implementing evidence-based CAUTI prevention recommendations.

Predictors of Angiographic Outcome After Failed Thrombectomy for Large Vessel Occlusion: Insights from the Stroke Thrombectomy and Aneurysm Registry.

Mechanical thrombectomy failure (MTF) occurs in approximately 15% of cases. To investigate factors that predict MTF. This was a retrospective review of prospectively collected data from the Stroke Thrombectomy and Aneurysm Registry. Patients who underwent mechanical thrombectomy (MT) for large vessel occlusion (LVO) were included. Patients were categorized by mechanical thrombectomy success (MTS) (≥mTICI 2b) or MTF (<mTICI 2b). Demographics, pretreatment, and treatment information were included in a univariate (UVA) and multivariate (MVA) analysis for prediction of MTF. A total of 6780 patients were included, and 1001 experienced anterior circulation MTF. Patients in the MTF group were older (73 vs 72, P = .044) and had higher poor premorbid modified Rankin Scale (mRS) (10.8% vs 8.4%, P = .017). Onset to puncture time was greater in the MTF group (273 vs 260 min, P = .08). No significant differences were found between the access site, use of balloon guide catheter, frontline technique, or first-pass devices between the MTF and MTS groups. More complications occurred in the MTF group (14% vs 5.8%), including symptomatic intracerebral hemorrhage (9.4% vs 6.1%) and craniectomies (10% vs 2.8%) ( P < .001). On UVA, age, poor pretreatment mRS, increased number of passes, and increased procedure time were associated with MTF. Internal carotid artery, M1, and M2 occlusions had decreased odds of MTF. Poor preprocedure mRS, number of passes, and procedure time remained significant on MVA. A subgroup analysis of posterior circulation LVO revealed that number of passes and total procedure time correlated with increased odds of MTF ( P < .001) while rescue stenting was associated with less odds of MTF (odds ratio 0.20, 95% CI 0.06-0.63). Number of passes remained significant on MVA of posterior circulation occlusion subgroup analysis. Anterior circulation MTF is associated with more complications and worse outcomes. No differences were found between techniques or devises used for the first pass during MT. Rescue intracranial stenting may decrease the likelihood of MTF for posterior circulation MT.

Difficult-to-Treat Pathogens: A Review on the Management of Multidrug-Resistant Staphylococcus epidermidis.

Multidrug-resistant Staphylococcus epidermidis (MDRSE) is responsible for difficult-to-treat infections in humans and hospital-acquired-infections. This review discusses the epidemiology, microbiology, diagnosis, and treatment of MDRSE infection and identifies knowledge gaps. By using the search term "pan resistant Staphylococcus epidermidis" OR "multi-drug resistant Staphylococcus epidermidis" OR "multidrug-resistant lineages of Staphylococcus epidermidis", a total of 64 records have been identified from various previously published studies. The proportion of methicillin resistance in S. epidermidis has been reported to be as high as 92%. Several studies across the world have aimed to detect the main phylogenetic lineages and antibiotically resistant genes through culture, mass spectrometry, and genomic analysis. Molecular biology tools are now available for the identification of S. epidermidis and its drug resistance mechanisms, especially in blood cultures. However, understanding the distinction between a simple colonization and a bloodstream infection (BSI) caused by S. epidermidis is still a challenge for clinicians. Some important parameters to keep in mind are the number of positive samples, the symptoms and signs of the patient, the comorbidities of the patient, the presence of central venous catheter (CVC) or other medical device, and the resistance phenotype of the organism. The agent of choice for empiric parenteral therapy is vancomycin. Other treatment options, depending on different clinical settings, may include teicoplanin, daptomycin, oxazolidinones, long-acting lipoglycopeptides, and ceftaroline. For patients with S. epidermidis infections associated with the presence of an indwelling device, assessment regarding whether the device warrants removal is an important component of management. This study provides an overview of the MDRSE infection. Further studies are needed to explore and establish the most correct form of management of this infection.

Printable piezoresistive polymer composites for self-sensing medical catheter device applications

There is a constant demand for new and/or improved health treatments that require flexible sensor devices. This is particularly relevant in relation to neurogenic bladder dysfunction.In this context, polymer composites have been developed based on three different matrices, carboxymethyl cellulose (CMC), styrene-ethylene/butylene-styrene (SEBS) and polyvinyl alcohol (PVA), with different concentrations of multiwalled carbon-nanotubes (CNT) filler contents for catheter medical device application.The mechanical properties of the nanocomposites are critically dependent on the polymeric matrix and also depend on CNT content with maximum strain is about 4%, 100% and 700% for CMC, PVA and SEBS materials, respectively. Electrical conductivity increases near 10 orders of magnitude up to 0.11 S/m for PVA with 5 wt percentage (wt.%) of CNT, one magnitude order than the most filled PVA and CMC composites. The percolation threshold (fc) of the composites are fc = 3 wt% for CMC, fc = 2 wt% for SEBS, and fc = 1 wt% for PVA as polymer matrices. Furthermore, the functional performance of the composites is characterized by the piezoresistive response, with a gauge factor (GF) ranging between 1 and 6 for the different composites. Finally, a self-sending catheter device was developed as a proof-of-concept, based on a PVA composite with a GF∼1.5. demonstrating proper adhesion and excellent sensing behavior at bending up to 7 mm.Thus, it is demonstrated that screen-printable piezoresistive sustainable composites can be developed for medical application with excellent electrical and mechanical properties.

Early Mobility in Patients With Femoral Catheters

Early Mobility in Patients With Femoral Catheters

The Potential Role of through the Needle PIVC Insertion in Reducing Early Catheter Contamination

HighlightsAbstractAim:To compare a traditional over-the-needle peripheral intravenous catheter device to a through-the-needle (TTN) peripheral intravenous catheter device for early bacterial contamination during insertion.Methods:Five TTN test devices (OspreyIV 20g SkyDance Vascular, Inc) and 5 OTN comparative devices (Insyte Autoguard 20g Becton Dickinson) were aseptically inserted through targeted zones inoculated with 1 mL aliquot suspension of approximately 1 × 10 CFU of Staphylococcus aureus among 3 healthy sheep. Immediately after insertion, each study catheter was surgically removed from the surrounding tissue and cultured for the presence of Staphylococcus aureus inoculum that may have been transferred to the catheter during insertion.Results:Final culture results of the 5 test articles found no bacterial colonies. Final culture results of the 5 comparative articles revealed 2 of 5 were contaminated with bacterial colonies. The absolute risk reduction is 40%, or a 40% rate of contamination drops to a 0% rate of contamination when the TTN catheter deployment was used. The risk ratio achieved was 1.67, indicating catheters placed using the OTN deployment were 1.67 times more like to be contaminated than the TTN deployed catheters.Conclusion:In this present ovine study, the data revealed that use of a novel TTN approach resulted in less contamination than the more traditional OTN approach. Traditional OTN devices, developed over 70 years ago, are at inherent risk of insertion-related contact contamination. The results of this research, as well as previously published studies, point toward considering physical catheter protection strategies such as TTN devices as a potential alternative to OTN devices.

Abstract P1-10-11: Optical stimulated luminescence dosimeters for skin dose measurements during accelerated partial breast brachytherapy: In vivo dosimetric validation and clinical outcomes

Abstract BACKGROUND: The role of multi-lumen catheter devices in the delivery of high dose rate (HDR) brachytherapy for adjuvant accelerated partial breast irradiation (APBI) for women with DCIS or early-stage breast cancer has been well established. In vivo dosimetry (IVD) using optically stimulating luminescence dosimeters (OSLD) is a feasible way to detect applicator instability that may cause translational and rotational inaccuracies during HDR brachytherapy delivery. Herein, we evaluate the accuracy and effectiveness of IVD to improve patient outcomes following APBI brachytherapy using the Strut Adjusted Volume Irradiation (SAVI) device. METHODS: Single-institution cohort study piloting the use of OSLD on the patient’s skin during HDR brachytherapy APBI to assess the estimated maximum skin dose (skin Dmax) and the achievable accuracy of OSLD for skin Dmax measurements. Women treated with SAVI-based APBI between November 1, 2018 and October 1, 2021 were eligible to enroll in our study. All patients met the American Society for Radiation Oncology “suitable” or “cautionary” criteria and were treated according to the American Brachytherapy Society consensus treatment planning guidelines. A SAVI preplan was created to estimate the probable point of skin Dmax. During CT simulation, a radiopaque marker was placed on the skin for visualization during treatment planning. Correction factors were applied to account for the OSLD tissue-air interface that is not present in the TG-43 expected dose calculations. Measured and calculated IVD doses were analyzed to assess agreement and cause for discrepancies found. Breast phantom IVD measurements repeated seven times with two independent dose points were analyzed to assess the best accuracy achievable under ideal conditions. RESULTS: We enrolled 41 patients with an average age of 68 years. Table 1 details the brachytherapy treatment delivery and dosimetry data. Higher skin Dmax as a percentage of the radiation prescription was associated with the occurrence of breast volume loss noted on subsequent clinical breast exams (OR 1.84 per each 5% increase in skin Dmax; 95% CI 1.21 – 3.32; p=0.016). The graphically estimated skin Dmax threshold was 80% with all cases of noted breast volume loss occurring above this threshold. The overall level of achievable IVD accuracy was ±3.32% based on breast phantom measurements. Under ideal conditions, all measurements were in the ±7% range. Three of 14 phantom measurement exceeded the 6% discrepancy range. Clinical IVD measurements detected 5 true positive cases (12.2% of cohort) that required intervention due to rotations in the SAVI applicator. For a ±7% tolerance criteria, 90.2% of the patients tested passed IVD. Of the eight patients that failed at the 7% level, IVD detected 3 OSLD placement errors, 2 rotational discrepancy cases, and 1 large air-gap at the point of measurement. CONCLUSIONS: Accuracy and reproducibility are imperative tenets of HDR brachytherapy APBI. IVD utilizing OSLD is an effective method for detecting treatment set-up and delivery errors for patients receiving SAVI-based APBI with dose accuracy within ±3.32%. Errors requiring intervention due to SAVI device rotation were detected in 12.2% of our cohort, and these errors would have likely gone undetected without IVD. Using OSLD as IVD to measure skin Dmax doses that may increase the risk of breast cosmetic defects should be investigated further. Table 1. Brachytherapy treatment delivery and dosimetry data. *PTV-Eval is a uniform 10 mm expansion on the CTV with exclusion of PTV within 5 mm of skin or chest wall. +Percent dose discrepancy refers to difference in dose between APBI plan calculations and IVD measurements. Citation Format: Tyler Gutschenritter, Afua Yorke, Nayak Polissar, Nirnaya Miljacic, Janice Kim, Lori Young. Optical stimulated luminescence dosimeters for skin dose measurements during accelerated partial breast brachytherapy: In vivo dosimetric validation and clinical outcomes [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-10-11.

Incidence, Predictors, and Clinical Impact of the Impeded-By-Stent Phenomenon After Placing Two-Linked Design New Generation Drug-Eluting Stents

BackgroundWhen a catheter device is delivered during percutaneous coronary intervention, its passage can be disrupted by a deployed in a coronary artery. However, the condition and details of this phenomenon, that is impeded-by-stent phenomenon (ISP), remain unclear. MethodsWe designed a prospective, open-label, single-center, observational study to clarify the incidence, predictors, and clinical impact of ISP in drug-eluting stents (DESs). Two independent operators observed and judged the occurrence of ISP, which was defined as all disturbances to a device delivery by deployed DESs. We consecutively used the Ultimaster™ (Terumo, Tokyo, Japan) DES for one month (109 patients, October 2018), followed by the Synergy™ (Boston Scientific Corporation, Marlborough, MA, USA) DES the next month (119 patients, November 2018). ResultsDESs (2.5–4.0 mm in diameter) were implanted in 230 de novo coronary vessels. ISPs were observed in 17 of 239 stented segments (7.1 %). Multivariate analysis showed that bifurcation lesions (adjusted odds ratio [OR], 4.2; 95 % confidence interval [CI], 1.5–12.6; p = 0.008), predilatation balloon diameter (mm) (OR, 0.2; 95 % CI, 0.1–0.9; p = 0.03), and Ultimaster™ use (OR, 6.0; 95 % CI, 1.9–27.2; p = 0.002) were independent predictors of ISPs. During the 1.5-year follow-up period, no repeat revascularization or stent thrombosis occurred in patients with ISP. ConclusionsISP itself does not trigger notable clinical outcomes, including repeat revascularization and stent thrombosis. However, caution should be considered regarding the latent risk of procedural complications.

Numerical Methodology to Evaluate Trackability and Pushability of PTCA Balloon Catheter.

During percutaneous coronary intervention (PCI), the ability to navigate a catheter without causing injury to the vessel and damage to the device is crucial outcome of the procedure. This study aimed to develop a numerical model to analyse the percutaneous transluminal coronary angioplasty (PTCA) catheter navigation in coronary vessels. Trackability and pushability are two major parameters used to characterize the navigation of PTCA balloon catheters, and they are influenced by vessel tortuosity, contact interactions and catheter design. In the current study, finite element analysis model is presented to evaluate trackability and pushability considering two different vessel geometries. Impact of contact interactions among catheter, guidewire, and vessel were studied to validate the numerical model with in vitro test data. Further, a parametric study was conducted to understand the influence of distal shaft, and proximal shaft outer diameter. Obtained results suggest that contact interaction and co-efficient of friction between guidewire and catheter are critical parameters to obtain numerical results comparable to experimental data. Results from the parametric study predicted strong positive correlation of distal shaft diameter on pushability, and weak correlation on trackability force. Furthermore, parametric variation in proximal shaft diameter has strong positive correlation on trackability force and strong negative correlation on pushability. Numerical methodology presented in this study is a preliminary attempt to simulate the behavior of PTCA balloon catheter navigation. This methodology will be helpful in the design and optimization of PTCA balloon catheter and similar devices with improved deliverability.

Petromyzontidae‐Biomimetic Multimodal Microneedles‐Integrated Bioelectronic Catheters for Theranostic Endoscopic Surgery

AbstractCurrent catheter devices in minimally invasive surgery still possess limited functional options, lacking multimodal integration of both sensing and therapy. Catheter devices usually operate outside the tissue, incapable to detect intra‐tissue biochemical information for accurate localization and assessment of lesions during surgery. Inspired by the feature and functions of Petromyzontidae, here a multimodal core‐shell microneedles‐integrated bioelectronic catheter (MNIBC) for tissue‐penetrating theranostics in endoscopic surgery is developed. The microneedle (MN) device possesses individually addressable functionality at single‐MN tip resolution, enabling multiplex functions (a total of 11 functions distributed in three types of catheters) including biochemical sensing, myoelectric modulation, electroporation, and drug delivery in a submucosal environment. The MNIBC is prepared through hybrid fabrication and dimensionality reduction strategies, where the MN electrodes are functionalized with an MXene‐carbon nanotube (MXene‐CNT)‐based electron mediator, addressing the challenge of reduced electrode sensitivity on ultra‐small MN tip. The functionalities of MNIBC are demonstrated both ex vivo and in vivo on anesthetized rabbits via laparoscopy, simulated cystoscopy, and laparotomy. The MNIBC can effectively detect intra‐tissue biochemical signals in the bladder, and offers localized electroporation and intra‐tissue drug delivery for precise treatments of lesions. The versatile features of the MNIBC present a highly advanced platform for precise surgeries.

Comparing Patency Rates of Arteriovenous Dialysis Access following Percutaneous Thrombectomy Using Various Catheter Directed Therapies

Arteriovenous fistulas often require frequent interventions to maintain patency for hemodialysis. Interventions may include open or percutaneous thrombectomy with additional targeted interventions as indicated. We evaluated the primary and cumulative functional patency rates following three unique approaches to percutaneous thrombectomy of thrombosed dialysis access. A retrospective review of 236 unique patients who presented with thrombosed hemodialysis access was analyzed over a period of 4 years from 2016-2020. We analyzed a total of 413 procedures that utilized 3 separate percutaneous thrombectomy devices to assist with restoring patency. The Indigo System CAT-D Aspiration Thrombectomy Catheter (Penumbra; Alameda, CA), the Arrow-Trerotola Rotational Thrombectomy System (Teleflex; Wayne, PA) and the Angiojet Rheolytic Thrombectomy Catheter (Boston Scientific, Marlborough, MA) devices were compared for primary and cumulative functional patency. Primary Patency was defined as time from percutaneous thrombectomy to next intervention (Angioplasty, stenting, repeat thrombectomy). Cumulative functional patency was defined as time from percutaneous thrombectomy to time of access abandonment. Medical record chart review was utilized to determine patency rates. A total of 413 percutaneous thrombectomy procedures were performed. Of the procedures performed, 98 utilized Angiojet, 103 utilized Trerotola, and 212 used Penumbra. Mean primary patency rates in (days) for the devices was as follows: Angiojet (194), Trerotola (204), and Penumbra (107). Mean cumulative functional patency rates (in days) for the devices was as follows: rheolytic thrombectomy (450 days), aspiration thrombectomy (292 days), rotational thrombectomy (475 days). Angiojet vs Penumbra and Trerotola vs Penumbra both showed diminished patency rates when using the Penumbra Catheter that were statistically significant (P<.05) CONCLUSION: All percutaneous thrombectomy approaches do not result in the same primary or cumulative functional patency rates. Approaches with Trerotola and Angiojet resulted in improved primary and cumulative functional patency rates compared to those using Penumbra.

Abstract P058: Rapid, noninvasive, office-based, esophageal cell collection for early detection of esophageal precancer and cancer

Abstract Purpose: Esophageal Adenocarcinoma (EAC) is the second most lethal (&amp;lt;20% five-year survival) and fastest growing (&amp;gt;500% increase in incidence over 40 years) cancer in the U.S. All EAC is believed to arise from a metaplastic esophageal precancer, Barrett’s Esophagus (BE), in at-risk patients with gastroesophageal reflux disease (GERD). Non-dysplastic BE can be monitored for progression to dysplastic BE, which can be ablated endoscopically, reliably halting progression to EAC. Since mortality is high even in early stage EAC (&amp;lt;50% five-year survival), clinical practice guidelines recommend BE screening in GERD patients with multiple risk factors. Since, endoscopic BE screening has failed (&amp;lt;10% compliance with guidelines), recently updated guidelines from both the American College of Gastroenterology and American Gastroenterological Association now support non-endoscopic biomarker screening as an acceptable alternative to endoscopy. EsoCheck®, a noninvasive swallowable balloon capsule catheter device, is the only FDA 510(k)-cleared esophageal cell collection device which permits anatomically targeted and protected sampling of distal esophageal mucosal cells. The sample is collected in a less than five-minute office procedure, without sedation or anesthesia, and sent to a central laboratory for molecular biomarker testing. We report our initial clinical experience using EsoCheck® for collection of esophageal cells in outpatient test centers. Experimental Design: 687 patients underwent EsoCheck® distal esophageal cell sampling by a trained nurse practitioner (average sampled length 5 cm). Patient tolerance was rated on a five-point scale for gag reflex (GR) severity: 1 = no GR; 2 = minimal GR; 3 = mild GR; 4 = severe GR; and 5 = worst GR therefore collection could not be completed. DNA was extracted using the QIAamp DNA Mini kit and quantitated using Qubit™ dsDNA Assay kit. Cytologic assessment using H&amp;E staining was performed on 15 samples. Results: 98% of patients successfully completed the procedure. 88% tolerated it well (rating ≤ 3); 10% experienced severe gagging (rating 4); and only 2% were unable to complete the procedure (rating 5). Average procedure time was 3.5 min (range: 1 min to 15 min). Average DNA yield was 868 ng (range: 0 ng to 19 µg) and 92% yielded at least 100 ng. The samples undergoing cytologic assessment averaged 500,000 cells (range: 100,000 to 2.5 million). Conclusion: Rapid, noninvasive, office-based, anatomically-targeted, and protected sampling of distal esophageal mucosal cells using EsoCheck® can be successfully performed in nearly all patients and is broadly well-tolerated. Cellular and DNA yields were very good and are expected to improve with clinical experience and assay optimization. When combined with a highly sensitive molecular biomarker test, the EsoCheck® device has the potential to significantly improve BE screening compliance and prevent EAC deaths. Citation Format: Suman M. Verma, Ivy T. Le, Abhisek B. Ghosal, Marci L. Hageman, Victoria T. Lee, Brian J. deGuzman, Lishan Aklog. Rapid, noninvasive, office-based, esophageal cell collection for early detection of esophageal precancer and cancer. [abstract]. In: Proceedings of the AACR Special Conference: Precision Prevention, Early Detection, and Interception of Cancer; 2022 Nov 17-19; Austin, TX. Philadelphia (PA): AACR; Can Prev Res 2023;16(1 Suppl): Abstract nr P058.

Summary a case of endovascular treatment of a patient with tandem occlusions of cerebral arteries caused by a mine-explosive injury

One case of successful endovascular treatment of a patient with a mine blast injury is presented, which due to the action of the blast wave led to traumatic dissection of the internal carotid artery and the right anterior cerebral artery, which in turn led to the development of a secondary ischemic stroke.The patient is a combatant, a 59-year-old man. During the artillery shelling of the position, he was thrown back by the explosive wave and briefly lost consciousness. Upon regaining consciousness, within two hours there was weakness and decreased sensation in the left limbs, which completely regressed, but cognitive impairment and communication problems were observed. Computed tomography of the brain performed in the hospital closest to the hostilities did not reveal any pathological changes. Two days later, the patient was taken to the Dnipropetrovsk Regional Hospital named after I.I. Mechnikov. Repeated computed tomography revealed a small infarct in the basin of Heubner's right artery. Cerebral angiography (CT angiography and subtraction selective cerebral angiography) revealed a short occlusion of the right internal carotid artery from its ostium to the upper border of its bulb, and lack of contrast of the A1-segment of the right anterior cerebral artery. Changes on the CT perfusion maps indicated critical oligemia in the entire basin area of the right middle cerebral artery. The patient at hospitalization is conscious, with preserved movements and sensitivity. However, the patient has significant cognitive decline (MoCA (Montreal Cognitive Assessment Scale) 17). After double antiplatelet preparation, endovascular recanalization and stenting of the occluded right internal carotid artery was performed via transfemoral access using combined proximal and distal antiembolic protection (Cello 9F balloon guide catheter and SpiderFX distal antiembolic protection device) and with implantation of a carotid stent Protégé. Blood flow in the right internal carotid artery has been restored, there are no carotid artery stenoses on the right, the basin of the middle cerebral artery on the right is completely contrasted. In two days, there is normalization on the CT perfusion maps and recovery of the patient's cognitive functions to the MoCA 24.

Chemical Characterization of Leachables in Catheter Device.

Extractables or leachables of biomaterials or residues of additives used in the manufacturing process that are potentially released from a medical device may have an adverse effect on a patient. Chemical characterization of leachable chemicals and degradation products in a medical device is an important aspect of its overall biocompatibility assessment process, which helps to ensure that the therapeutical benefits exceed the potential biological risks associated with the use of the device or its components or materials. By evaluating the types and amounts of chemicals that may migrate from a device to a patient during clinical use, potential toxicological risks can be assessed. A semipolar solvent, 40% ethanol in water (v/v), an appropriate surrogate for blood and blood related substances, was used as an extraction medium to mimic the body fluid in contact with a medical device. The extraction was conducted at 37 °C for 24 h for limited exposure medical devices per ISO 10993-12:2021. From gas chromatography-mass spectrometry (GC-MS) and liquid chromatography-mass spectrometry (LC-MS) analysis, leachable chemicals of polylactams, linear polyamides, cyclic polytetramethylene ether (PTME), poly(tetramethylene ether) glycol (PTMEG), cyclic and linear poly(tetramethylene ether) glycol adipate (PTMEGA), cyclic and linear poly(tetramethylene ether) glycol adipamide (PTMEGAA) were structurally elucidated. The workflow presented in this study was proven to be a successful approach for rapid extractable and leachable profiling and identification with confidence.

HPB V09 Pringles manoeuvre- How we do it!

Abstract Background Minimally invasive liver resection (MILR) is a complex surgical procedure requiring extensive training and expertise. One of the critical challenges in MILR is the control of bleeding from the transection plane. Intraoperative blood loss and blood transfusion requirements are associated with increased operating time, postoperative morbidity, mortality, and reduced disease-free survival. Pringles manoeuvre is an established strategy to facilitate liver resection whilst maintaining haemostasis from the transection plane. Several techniques for performing the Pringle manoeuvre in MILR have been described. However, an optimal method has not been identified yet. Methods In our video presentation, we describe a novel technique for Pringle's manoeuvre in MILR using a deceptively simple Foley catheter device. Results A Foley catheter can provide uniform constriction of the hilar structures owing to its silastic properties. Its atraumatic tip allows its safe passage behind hilar structures without other instrument use. It does not require additional ports, is less traumatic, and is easy to apply. A foley catheter is also relatively inexpensive and readily available in operation theatres. Conclusions Pringle's manoeuvre using a Foley catheter is a simple, safe, easily reproducible, and cost-effective technique. We encourage this method of hepatic inflow occlusion in modern minimally invasive liver surgery.

A novel cell-based transplantation method using a Rho kinase inhibitor and a specific catheter device for the treatment of salivary gland damage after head and neck radiotherapy

Radiotherapy (RT) for head and neck cancer results in irreversible damage to salivary glands (SGs) and decreases saliva production, leading to a dry mouth. To date, there are no satisfactory therapies to solve this problem. We recently established a novel culturing method using a Rho kinase inhibitor (RI), Y-27632, that maintained cellular morphology and function for a prolonged period of time. In the present study, we investigated whether cell-based transplantation using our culturing method ameliorated the dysfunction of irradiated SGs. First, rat SG cells were cultured in a medium with RI. Cells were characterized by morphological findings and mRNA expression analysis. We also assessed features of SG cells in three-dimensional (3-D) culture by scanning electron microscopy and immunohistochemistry (IHC). The RI-containing medium led to higher cell proliferation of rat SG cells with preservation of cell morphology and higher alpha-amylase (AMY) expression in both 2-D and 3-D culture systems. To establish the atrophic-SG models, external RT at a dose of 15 Gy was delivered to the head and neck fields of nude rats. The SG cells derived from GFP-rats were cultured in medium with RI, after which they were transplanted into the submandibular glands of atrophic-SG rats using a catheter placed into Wharton's duct. IHC and salivary flow rate (SFR) analyses were measured 12 weeks after the transplantation. Following transplantation, donor cells (GFP-SG cells) were primarily located in the ductal region of the SG, and AMY expression in SGs and the SFR were increased in the SG cell transplantation group compared with the control. Those data indicated that cell-based therapy using RI-treated SG cells could restore salivary hypofunction of irradiated SGs by direct integration of the donor cells in the duct of SGs. We propose that these data support future clinical plans in which SG cells would be excised from the labial minor SGs of the patients with head and neck cancers prior to RT, cultured during RT, and auto-transplanted into SGs using a catheter into the Wharton's duct. We believe that our culturing and transplantation methods can be applied to SG cells, constituting a therapeutic approach for the treatment of patients with dry mouth after not only RT but also aging and Sjögren's syndrome.

The ABBA project (Assess Better Before Access): A retrospective cohort study of neonatal intravascular device outcomes.

Venous access devices (VADs) play a vital role within the neonatal intensive care unit. However, there are significant risks associated with the use of VADs, with complications such as infection, thrombosis, device occlusion, and infiltration/extravasation frequently contributing to device-related failures and increasing the risk of significant patient harm or injury. This study aimed to explore the relationships between risk factors and different venous access device complications in the neonatal setting, and then use that evidence to develop an algorithm based on observational data. This is a retrospective, single-center cohort study that was conducted in a large 112-bed neonatal intensive care unit in Qatar. We examined venous access device data from January 2016 to December 2018 for all term and preterm neonates. Descriptive statistics were used to summarize the outcomes, which included a mean and its standard deviation or median and an interquartile range for continuous variables regarding normal distribution, and absolute numbers with percentages for discrete variables. The authors recorded a total of 23,858 VADs inserted during the study period. Of these, 21,313 (89%) were peripheral intravenous catheters, 689 (3%) were extended dwell-peripheral intravenous catheters, 1,335 (6%) were epicutaneo-caval catheters, and 521 (2%) were umbilical venous catheters. In total, 51,179 catheter days were registered, with 2.17 catheter days reported per patient. Peripheral device dwell times were significantly shorter when compared with central venous catheter devices (P < 0.001), with mean dwell times of 22 days ± 23 h and 236 days ± 183 h, respectively. After insertion, a complication occurred in 11,177 (51%) of peripheral VADs and 221 (12%) of central VADs. The type of device inserted [P < 0.001, hazard ratio (HR) = 0.52, 95% confidence interval (CI): 0.50-0.54], reason/indication for intravenous therapy (P < 0.001, HR = 0.85, 95% CI: 0.82-0.87), and the side of insertion of the device (P < 0.001, HR = 1.25, 95% CI: 1.24-1.27) had a significant relationship with outcomes. Four subgroups of VADs were identified (peripheral intravenous catheters, extended dwell-peripheral intravenous devices, epicutaneo-caval catheters, and umbilical venous catheters) with outcome-related differences. Central venous access devices (epicutaneo-caval catheters and umbilical venous catheters) had lower complications compared with peripheral VADs. Proper venous access device selection, early insertion, and early removal approaches remain crucial to preventing venous access device complications. Peripheral intravenous devices should be used carefully and closely watched for early detection of complications.

8148 Comparison of Surface Area Covered by Intrauterine Foley Catheter vs. T-Shaped Intrauterine Device Following Hysteroscopic Adhesiolysis

Study Objective To visualize the surface area covered by a T-shaped IUD versus that of a pediatric-sized foley catheter following hysteroscopic adhesiolysis for Asherman's Syndrome. Design Visual demonstration of hysteroscopic adhesiolysis with scissors, followed by the insertion of either a copper-T IUD or a size 8 Foley catheter. Setting N/A. Patients or Participants Case series (2 patients). Interventions Hysteroscopic adhesiolysis was performed with 5F hysteroscopic scissors, starting from the most distal adhesions and progressively moving towards the uterine fundus. In Case 1, a copper-T IUD was inserted with the copper coil removed to prevent unwanted inflammatory effects. In Case 2, a size 8 Foley catheter was inserted, and the balloon progressively inflated with 1ml, 2ml, and finally 3mL of sterile water. Measurements and Main Results The copper-T IUD covered a much smaller proportion of the endometrial cavity compared to that covered by the inflated foley catheter. Conclusion This video visually demonstrates the relatively small surface area occupied by the T-shaped IUD compared to the area covered by a pediatric-sized Foley catheter. A Foley catheter with the balloon inflated with at least 3mL of sterile water occupies more space and therefore can separate the endometrial walls much more effectively than a T-shaped device, potentially contributing to less IUA formation. Further research comparing these two alternatives in the prevention of IUA reformation are necessary. To visualize the surface area covered by a T-shaped IUD versus that of a pediatric-sized foley catheter following hysteroscopic adhesiolysis for Asherman's Syndrome. Visual demonstration of hysteroscopic adhesiolysis with scissors, followed by the insertion of either a copper-T IUD or a size 8 Foley catheter. N/A. Case series (2 patients). Hysteroscopic adhesiolysis was performed with 5F hysteroscopic scissors, starting from the most distal adhesions and progressively moving towards the uterine fundus. In Case 1, a copper-T IUD was inserted with the copper coil removed to prevent unwanted inflammatory effects. In Case 2, a size 8 Foley catheter was inserted, and the balloon progressively inflated with 1ml, 2ml, and finally 3mL of sterile water. The copper-T IUD covered a much smaller proportion of the endometrial cavity compared to that covered by the inflated foley catheter. This video visually demonstrates the relatively small surface area occupied by the T-shaped IUD compared to the area covered by a pediatric-sized Foley catheter. A Foley catheter with the balloon inflated with at least 3mL of sterile water occupies more space and therefore can separate the endometrial walls much more effectively than a T-shaped device, potentially contributing to less IUA formation. Further research comparing these two alternatives in the prevention of IUA reformation are necessary.