Baxter Healthcare Research Articles

Comparison of side-hole and step-tip catheters for patients requiring continuous renal replacement therapy in intensive care units: study protocol for a randomised controlled trial

IntroductionIn addition to various techniques involved in catheter insertion, catheter placement location, lumen diameter and operation and management during continuous renal replacement therapy (CRRT), the design of the tip and...

P082 Nephrolithiasis associated with uricosuric therapies for the treatment of gout: a systematic review

Abstract Background/Aims Uric acid nephrolithiasis is a recognised side-effect of uricosuric therapies and a contraindication to their use. The objective of this systematic review was to assess the incidence and risk of nephrolithiasis in people with gout receiving uricosuric therapy. Methods A systematic review was undertaken using MEDLINE, Embase, Cochrane Library, Web of Science and Clinical Trials electronic databases from inception to 16th May 2023. Pre-specified search terms relating to ‘gout’, ‘uricosuric drugs’ and ‘nephrolithiasis’ and their synonyms were used. Title/abstract and full-text screening and data extraction were undertaken independently by two reviewers. Randomised controlled trials (RCTs) and observational cohort studies assessing the incidence and risk of nephrolithiasis in adults with gout treated with uricosuric therapies were included (with or without a non-uricosuric urate-lowering therapy (ULT) comparator group). The Cochrane Risk of Bias (RoB)-2 for randomised trials and the Risk Of Bias In Non-randomised Studies of Interventions (ROBINS-I) tools were used to assess the quality of included RCTs and cohort studies respectively. Results 507 articles were identified, of which 22 studies (8 RCTs, 14 cohort studies) were eligible for inclusion. The mean age of participants ranged from 51.2 years (standard deviation (SD) 10.9) to 66.8 years (SD 9.1). Participants were predominantly male (range 69-100%). Length of follow-up ranged from three months to 10 years. Eleven studies included participants with a prior history of nephrolithiasis. Ten studies assessed Benzbromarone monotherapy, five Lesinurad plus xanthine oxidase inhibitor (XOI), four Probenecid, three Sulfinpyrazone and one Lesinurad monotherapy (total 3091 participants). Ten studies included a non-uricosuric comparator group(s) (five placebo plus XOI, four XOI only, and one placebo only (total 1386 participants)), whereas 12 had no comparator group. Most studies assessed nephrolithiasis through clinical adverse event reporting rather than systematic assessment. The incidence of nephrolithiasis ranged from 0.0% to 11.8% in people receiving uricosuric therapy (four studies reported no stone events; incidence 0.1%-5% in seven studies, 5.1-10% in 9, and >10% in two). The incidence of nephrolithiasis ranged from 0.0% to 4.2% in those not receiving uricosurics. No studies calculated the risk of nephrolithiasis between uricosuric-treated and untreated groups. Few studies documented renal stone composition or reported the severity of clinical presentation of nephrolithiasis events. Conclusion Nephrolithiasis is a common side-effect of uricosuric therapy for gout. Future studies should provide risk estimates between uricosuric-treated and untreated groups, describe clinical presentation of stone events and, where possible, assess stone composition. Disclosure C. Dahanayake: None. R. Bajpai: Other; Dr Bajpai is a member of the Versus Arthritis College of Experts. K.M. Jordan: Other; Dr Jordan is a Trustee of the UK Gout Society. M. Lambie: Honoraria; Dr Lambie has received speakers honoraria from Baxter Healthcare and Fresenius Medical Care. Grants/research support; Dr Lambie has received an unrestricted research grant from Baxter Healthcare. E. Roddy: None.

A Comparative Review of Two Major Topical Hemostasis Agents in Spine Surgery

Achieving adequate hemostasis in spine surgery is critical for both the patient and surgeon. Currently, there are two major topical hemostatic matrix agents used in spine surgery—Floseal (Baxter Healthcare, Deerfield, Illinois, USA) and Surgiflo (Ethicon Inc., Raritan, New Jersey, USA). While both products have been shown to be effective at achieving hemostasis, there is no consensus supporting the use of one agent over another in spine surgery. There are studies comparing outcomes and cost between Floseal and Surgiflo, but a significant portion of the studies have industry affiliations. Generally, existing literature reports low to moderate cost savings in favor of one agent or the other, with no clinically significant differences in other patient-based outcomes such as postoperative hematomas. Animal model studies also suggest unique complications, including epidural fibrosis and associated nerve root compression with use of a flowable topical hemostatic agent. Further non-industry-affiliated studies are warranted to compare efficacy, patient outcomes, cost analyses, and possible unique complications associated with the two hemostatic agents.

FLOSEAL Versus SURGIFLO in Lumbar Surgery: Similar Outcomes, Different Costs in a Matched Cohort Analysis

Flowable gelatin-based matrices with thrombin for hemostatic control are commercially available as Floseal (Baxter International Inc.) and Surgiflo (Ethicon Inc.). The objective of this study is to compare the rate of blood transfusions following the use of Floseal and Surgiflo in lumbar spine surgery. Elective lumbar spine surgery patients between September 2019 and March 2021 were identified via CPT codes. Floseal 10 mL (N=102) and Surgiflo matrix 8 mL (N=108) cohorts excluded those younger than 18 years or those who underwent surgeries for infection, trauma, or tumor. The primary outcome was blood transfusion. Surgical complexity was controlled using the Surgical Invasiveness Index and Adult Spinal Deformity Invasiveness Score. The 1:1 propensity score matching was performed using demographic information, Surgical Invasiveness Index, Adult Spinal Deformity Invasiveness Score, and tranexamic acid use. A total of 77 Floseal patients were propensity score matched with 77 Surgiflo patients. There was no difference in the rate of blood transfusion (p=0.441). There was also no difference in operative time, estimated blood loss, or postoperative hemoglobin levels. The Surgiflo cohort used more units per surgery (p=0.004) and cost $102.45 more per surgery. Switching to Floseal saves $102,450 per year per 1000 surgeries. There was no difference in transfusion rates between using Floseal or Surgiflo for lumbar spine surgery. Surgiflo had higher usage per surgery and costs than Floseal.

158-LB: The Effect of Electronic Nudges on Influenza Vaccination Uptake in Older Adults with Diabetes—A Prespecified Analysis of the NUDGE-FLU Trial

Background: Influenza vaccination is associated with reduced risk of all-cause mortality in patients with diabetes mellitus (DM). However, vaccination rates remain suboptimal. Methods: NUDGE-FLU was a nationwide, pragmatic implementation trial among Danish citizens ≥65 years during the 2022/23 influenza season. Households were randomized in a 9:1:1:1:1:1:1:1:1:1 ratio to usual care or 9 different electronic nudge letters. Baseline and outcome data were obtained via nationwide registries. The endpoint was receipt of a seasonal influenza vaccine before Jan. 1, 2023. In this pre-specified sub-study, effect modification by DM status was assessed in a pooled analysis of all intervention arms vs. usual care, and for individual letters. Results: Of 964,870 participants from 691,820 households, 123,974 had DM. During follow-up, 84.2% with DM vs. 81.5% without DM received a vaccine (p<0.001). In the pooled analysis, DM status modified the effect of any electronic letter compared with usual care on vaccine uptake (p=0.030) such that the effect of any letter was attenuated in participants with DM (82.7% vs. 83.0%; difference, -0.23 percentage points; 99.55%CI: -0.94-0.48; p=0.37) vs. without DM (80.0% vs. 79.7%; difference, +0.36 percentage points; (0.07-0.66); p<0.001). In NUDGE-FLU, 2 of the 9 letters (one emphasizing potential cardiovascular benefits of vaccination and a repeated letter) significantly increased vaccine uptake vs. usual care. Point estimates suggested benefits were more pronounced in participants without DM, but no significant interactions were observed in either case (p>0.10). Conclusion: In a pooled analysis, the effect of any electronic nudge was moderately albeit significantly greater in participants without DM. These findings further suggest that the beneficial effects of specific nudges, including repeated messaging and emphasizing cardiovascular benefits, may be more pronounced in participants without DM. Disclosure M. C. H. Lassen: None. J. S. Jensen: None. C. Martel: None. P. Valentiner-branth: None. T. Biering-sørensen: Advisory Panel; Sanofi, Amgen Inc., GlaxoSmithKline plc., Research Support; Sanofi, Amgen Inc., Boston Scientific Corporation, Novo Nordisk, AstraZeneca, Speaker's Bureau; Sanofi, GlaxoSmithKline plc. N. Johansen: None. M. Vaduganathan: Advisory Panel; American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Chiesi, Cytokinetics, Lexicon Pharmaceuticals, Novartis, Novo Nordisk, Pharmacosmos, Relypsa, Roche Diagnostics,, Research Support; American Regent, Amgen, AstraZeneca, Boehringer Ingelheim, Bayer AG, Galmed, Novartis, Bayer AG, Occlutech, Impulse Dynamics, and Roche Diagnostics, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim, Cytokinetics, Novartis, Roche Diagnostics. A. Bhatt: None. D. Midin: None. B. Claggett: Consultant; Corvia, Cardurion, Cytokinetics Inc., Novartis, Intellia. S. I. Samson: Employee; Sanofi. M. Loiacono: Employee; Sanofi. P. Sivapalan: None. Funding Sanofi

#3482 IN VIVO EVALUATIONS OF THE PROTECTIVE EFFECTS OF NEW FORMULATIONS FOR PERITONEAL DIALYSIS ADOPTING A POWERFUL MULTI-PHOTON MICROSCOPY BASED APPROACH

Abstract Background and Aims Peritoneal dialysis (PD) is a renal replacement therapy that enables metabolic waste products and excess fluids to be eliminated through the peritoneal membrane. Exposure to conventional dialysates at high glucose concentrations is considered critical for the pathogenesis of peritoneal fibrosis, angiogenesis, and epithelial-mesenchymal transition (EMT). These events largely contribute to peritoneal membrane aging, resulting in ultrafiltration and clearance failure. Pre-clinical research in this field suffers from the lack of valid and reproducible in vivo systems and so far has been limited to in vitro systems of mesothelial or endothelial cell lines. In vitro studies on mesothelial cell monolayers have validated the significant protective effects of dialysates with alternative osmo-metabolic agents. With their better biocompatibility these novel formulations could provide a valid substitute for conventional solutions (1,2). The method proposed, based on multi-photon microscopy, aims to study the physiology of the peritoneal membrane during dialysis exchange and to validate the effects of biocompatible dialysates in animal models of fibrosis as observed in the course of dialysis treatment. Method We have implemented a surgical procedure to optimize the stability of a flap of parietal peritoneum to allow direct microscope observation. The innovative technology of multi-photon microscopy enables one to observe the vessels of microcirculation in vivo and provides a 3D rendering of the peritoneal membrane, giving an overview of all the single layers without the use of specific markers (Figure 1). One may also assess specific phenomena induced by the fibrotic process, such as the thickening of the sub-mesothelial interstitium, exploiting the autofluorescence signal from excited collagen fibers caused by the physical phenomenon of Second Harmonic generation. In vivo microscopy evaluation of peritoneal membrane senescence parameters was conducted in rats subjected to one daily intraperitoneal injection (10 mL/day) for 15 days with one of the following PD solutions: a commercially available glucose-based neutral-pH, low-GDP, PD solution (Physioneal 3.86%, Baxter Healthcare, Italy), and a new single-chamber low glucose PD solution containing osmo-metabolic agents such as L-carnitine and xylitol (XyloCore HS, Galenica Senese, Italy). XyloCore HS is a lactate-buffered PD solution with glucose (1.5%), L-carnitine (0.02%) and xylitol (2.0%). The osmotic strength of the two PD solutions tested was comparable. Results Treatment with XyloCore HS was associated with a significant reduction in thickness of the sub-mesothelial interstitium (p = 0.013), the density of collagen fibers (p = 0.012) and the vascular composition (p = 0.006), as well as the number of branch points (p = 0.0335), when compared to rats treated with a commercial glucose-based PD solution, Physioneal. Figure 2 shows the different thicknesses of sub-mesothelial stroma upon treatment with the PD solutions under investigation. Conclusion Previous in vitro studies have shown that XyloCore (1,2), a novel glucose-sparing PD solution currently in Phase III clinical development (ELIXIR - NCT03994471), is able to counteract the glucotoxic effects on the peritoneal membrane induced by conventional dialysates. Our pre-clinical in vivo methodology not only confirms our previous in vitro findings, but also suggests that long-term protective effects may be achieved with XyloCore. Further studies are in progress in a diabetic animal model to extend the favorable peritoneal in vivo findings of XyloCore treatment to a systemic level, possibly by improving glycemic control.

Nephrologists’ Perspectives on Home Dialysis Utilization: A National Survey From Israel

Nephrologists’ Perspectives on Home Dialysis Utilization: A National Survey From Israel

Aspirin and Statins Reduce the Risk of Stroke in Women with Endometriosis (S3.002)

<h3>Objective:</h3> To determine (1) the risk of stroke in women with endometriosis and (2) the effect of aspirin and statins on that risk. <h3>Background:</h3> Endometriosis is an inflammatory chronic gynecologic condition that affects approximately 10% of reproductive aged women. Previous research suggests that endometriosis increases stroke risk, but the role of medications known to prevent stroke in modifying this risk is uncertain. <h3>Design/Methods:</h3> We retrospectively analyzed data from the California Teachers Study, a large prospective cohort of female teachers followed continuously since 1995, excluding those with prior stroke or heart attack. This analyses’ exposure was self-reported history of endometriosis, and the outcome was hospitalization for any stroke (ischemic stroke, intracerebral and subarachnoid hemorrhage). Study covariates were self-reported use of aspirin and statin, race-ethnicity, hysterectomy, and vascular risk factors: hypertension, diabetes mellitus, obesity, migraine, current or prior tobacco use, malignancy, and oral contraceptive use. We used Cox proportional hazards models to calculate hazard ratios (HR) and 95% confidence intervals (CI) for stroke by age among women with and without history of endometriosis after adjustment for demographics and vascular risk factors. We examined association of aspirin and statin use with stroke among women with endometriosis. <h3>Results:</h3> Of 121,993 women, 13,938 (11.4%) reported a history of endometriosis. Women with endometriosis had slightly higher rates of vascular risk factors than women without endometriosis. Adjusted risk of stroke in the endometriosis group was higher than in the non-endometriosis group (HR 1.20, CI 1.09–1.28). Stroke occurred at a younger age among women with endometriosis (77.9 vs 80.2, p&lt;0.01). Within the endometriosis group, stroke risk in users of aspirin (HR 0.80, CI 0.69–0.92) or statins (HR 0.74, CI 0.62–0.88) was lower than that of non-users. <h3>Conclusions:</h3> In a large cohort study, history of endometriosis was associated with increased stroke risk and, among women with endometriosis, aspirin and statin use decreased this risk. <b>Disclosure:</b> Dr. Seitz has stock in Baxter International Inc. (&lt;0.0003% ownership), Bristol-Myers Squibb Company (&lt;0.0001%), Colgate-Palmolive Company (&lt;0.0002%), CVS Health Corporation (&lt;0.0002%), Johnson &amp; Johnson (&lt;0.00004%), Eli Lilly and Company (&lt;0.00005%), Proctor &amp; Gamble Company (&lt;0.00005%), UnitedHealth Group Incorporated (&lt;0.00002%), Walgreen Boots Alliance, Inc. (&lt;0.0002%), White Mountains Insurance (&lt;0.002%). Ms. Bull has stock in United Bank. Ms. Bull has received research support from Weill Cornell Medical College. Dr. Parikh has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for cases of neurological illness. The institution of Dr. Parikh has received research support from Leon Levy Foundation. The institution of Dr. Parikh has received research support from Florence Gould Foundation. The institution of Dr. Parikh has received research support from NY State Empire Clinical Research Investigator Program. The institution of Dr. Parikh has received research support from NIA. The institution of Dr. Parikh has received research support from Medtronic. Dr. Navi has nothing to disclose. Dr. Merkler has received personal compensation in the range of $0-$499 for serving as a Consultant for GLG. Dr. Merkler has received personal compensation in the range of $0-$499 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for The Neurohospitalist. Dr. Merkler has received personal compensation in the range of $10,000-$49,999 for serving as an Expert Witness for n/a. The institution of Dr. Merkler has received research support from AHA. The institution of Dr. Merkler has received research support from Weill Cornell Medical College. Dr. Kamel has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for JAMA Neurology. Dr. Kamel has received personal compensation in the range of $50,000-$99,999 for serving as a Endpoint adjudication committee with Boehringer-Ingelheim. The institution of Dr. Liberman has received research support from NIH.

Impact of intravenous fluid administration on cardiac output and oxygenation during cardiopulmonary resuscitation

BackgroundThe effect of intravenous fluid (IVF) administration during cardiopulmonary resuscitation (CPR) is an unexplored factor that may improve cardiac output (CO) during CPR. The aim of this study was to determine the effect of IVF administration on CO and oxygenation during CPR.MethodsThis experimental animal study was performed in a critical care animal laboratory. Twenty-two Landrace-Yorkshire female piglets weighing 27–37 kg were anesthetized, intubated, and placed on positive pressure ventilation. Irreversible cardiac arrest was induced with bupivacaine. CPR was performed with a LUCAS 3 mechanical compression device. Pigs were randomized into IVF or no-IVF groups. Pigs in the IVF group were given 20 mL/kg of Plasma-Lyte (Baxter International, Deerfield, IL USA), infused from 15 to 35 min of CPR. CPR was maintained for 50 min with serial measurements of CO obtained using ultrasound dilution technology and partial pressure of oxygen (PaO2).ResultsA mixed-effects repeated measures analysis of variance was used to compare within-group, and between-group mean changes in CO and PaO2 over time. CO and PaO2 for the piglets were measured at 10-min intervals during the 50 min of CPR. CO was greater in the IVF compared with the control group at all time points during and after the infusion of the IVF. Mean PaO2 decreased with time; however, at no time was there a significant difference in PaO2 between the IVF and control groups.ConclusionsAdministration of IVF during CPR resulted in a significant increase in CO during CPR both during and after the IVF infusion. There was no statistically significant decrease in PaO2 between the IVF and control groups.

Inhalation anesthesia in laser surgery of retinopathy of prematurity

Purpose: to assess the efficacy of inhalation anesthesia with laryngeal mask in extremely premature infants with low or extremely low birthweight and somatic comorbidities during the surgery of retinopathy of prematurity (ROP) in the active phase of the disease. Materials and methods. 477 infants of 25 to 32 weeks’ gestational age were treated by delimiting retinal laser photocoagulation. Inductive anesthesia with Sevoflurane (BAXTER HEALTHCARE Corp, USA) was followed by placing a laryngeal mask. The delimiting retinal laser photocoagulation was performed using laser devices with an adapter on a binocular forehead ophthalmoscope Supra (Quantel Medical, France) and LachtaMylon (Lasermedservis, Russia,). After the surgery, the recovery from sedation and return of consciousness took 7 to 10 minutes. Results. An inhalation of Sevoflurane with the adoption of a laryngeal mask airway significantly decreases complications of anesthesia in premature infants with comorbidities and reduces the length of hospital stay. The quick clearance of Sevoflurane makes it possible to begin feeding the infant one hour after the surgery. Conclusion. Inhalation anesthesia with Sevoflurane is a method ensuring that preterm infants receive adequate anesthesia in the treatment of retinopathy of prematurity in its active phase.

Henri J. R. Maget

Henri J. R. Maget, 93, died Nov. 24, 2022, in La Jolla, California. “Henri was tenacious and had a masterful sense of humor. He started his industrial career in 1960, joining General Electric’s Direct Energy Conversion operation, participating in the pioneering development of the first proton-exchange membrane fuel cell to operate in space (Project Gemini). He became manager of engineering and manager of a GE Center of Excellence. His interest in energy conversion led him to direct the development of a photovoltaic solar energy business for Varian Associates. Eventually he started his own company, Electrochemical Drug Delivery, which he sold to Baxter International. He has over 100 worldwide patents in applied electrochemistry.”—Elizabeth Maget, wife Most recent title: Founder and president, Med-e-Cell Education: BS, chemistry, University of Strasbourg, 1950; MS, petroleum engineering, École National Supérieure du Pétrole et des Moteurs, 1953; MSChE, chemical engineering, University of Michigan, 1957 Survivors: Wife, Elizabeth;

Artificial Intelligence in Continuous Kidney Replacement Therapy.

Artificial Intelligence in Continuous Kidney Replacement Therapy.

Modified Periosteal Inhibition (MPI) Technique for Extraction Sockets: A Case Series Report

Several Alveolar Ridge Preservation (ARP) procedures have been proposed over the years. The purpose of this study was to describe the new Modified Periosteal Inhibition (MPI) technique for ARP. Seven patients were enrolled (age range: 28–72 years old; 5 males, 2 females). In total, nine hopeless teeth were treated. Following the elevation of a full-thickness flap, atraumatic tooth extraction was conducted, preserving the buccal bone of the alveolar socket. OsteoBiol® Lamina Soft (Tecnoss®, Giaveno, Italy), 0.5 mm thick, was suitably shaped (8–10 mm in height, extending from the mesial and to the distal corners of the socket). The lamina was gently positioned between the buccal periosteum and the buccal bone plate. Tisseel® (Baxter Healthcare Corporation, Deerfield, IL, USA) was applied to seal the cortical membrane. The flaps were sutured with PTFE 4-0 (Omnia, Fidenza, Italy). Postoperative instructions were provided. Patients were strictly monitored during the follow-up. No early or late biological complications were experienced. Cone Beam Computed Tomography (CBCT) exams were performed at baseline and 4 months later. The thickness of the buccal cortical bone at baseline was 1.18 ± 0.57 mm. The pre-operative and post-operative ridge widths were 10.74 ± 1.54 mm and 11.16 ± 1.57 mm, respectively. A horizontal ridge increase of 0.41 ± 0.21 mm was observed during the healing period. At 4 months of healing, the bone volume was adequate for implant placement and no additional bone regeneration procedures were required. MPI technique was effective in preventing the horizontal contraction of the post-extraction socket. Further studies will be needed in the future to confirm our positive results.

Community Houses to Increase Access to Home Dialysis.

Community Houses to Increase Access to Home Dialysis.

Autologous versus allogeneic: the future of manufacturing and standardization in cell therapies

Rupa Pike, PhD is the Senior Director of Technical Affairs for Advanced Therapies, Pharma Services Group at Thermo Fisher Scientific. The Office of Technical Affairs comprises scientific experts that serve as a strategic, innovational and educational leaders in the area of cell-based therapies, plasmids and mRNA therapeutics. In her prior role as the Director of Enterprise Science and Innovation Partnerships, she developed and managed strategic partnerships with global BioPharma, Biotech and Healthcare customers in the area of Cell and Gene Therapy. Prior to this, she was the Head of Technical Operations (Patheon/Thermo Fisher Scientific) where she worked closely with customers to conduct technology transfer and process optimization activities related to GMP manufacturing of cell-based therapies. She has over 15 years of expertise in GMP manufacturing and has successfully led GMP operations, Process Development and MSAT activities, infrastructure buildout, customer relations and business development.Delara Motlagh, PhD the General Manager of Cell Therapy Technologies at Terumo Blood and Cell Technologies, headquartered in Lakewood, Colorado. She is passionate about the cell &amp; gene therapy market and the potential these innovative therapies hold to improve the lives of patients.She brings more than 18 years of experience in biotechnology and healthcare in various therapeutic areas including oncology, cardiology, orthopedics, hematology, and nephrology. Prior to joining Terumo Blood and Cell Therapies in 2017, Delara served in diverse leadership roles at Baxter Healthcare in marketing, research &amp; development, and operations. Her cross-functional background provides a unique perspective and deep understanding of development, cell manufacturing, and commercialization elements in the industry. Delara received a PhD in Physiology and Biophysics from the University of Illinois, fellowship in Vascular Tissue Engineering at Northwestern University, and Executive MBA from Kellogg School of Management.Patrick Hanley, PhD is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, quality, and testing of novel cellular therapies and is responsible for seeking partnerships and commercialization of promising cell and gene therapies. Trained as an Immunologist, Dr Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 15 years he has helped to translate more than 300 products on over 25 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic.

A comparative study of conventional intermarginal split lamella with labial mucous membrane graft versus sutureless procedure using fibrin sealant to manage major trichiasis.

In the intermarginal split lamella with labial mucous membrane graft procedure to manage major trichiasis, the graft is usually sutured in the receptor bed using 6-0 polyglactin sutures. We aimed to compare the use of fibrin sealant to seal the graft to the receptor bed versus the conventional technique using sutures. This is a retrospective comparative study of patients who underwent conventional intermarginal split lamella with labial mucous membrane graft or sutureless procedure using fibrin sealant (Tisseel, Baxter Healthcare Corp) between 2016 and 2021. Etiology of the trichiasis, procedure duration, postoperative discomfort and edema, complications, and follow-up period were extracted from these patients' charts. Twenty-seven eyelids from 19 patients underwent the procedure: twelve patients underwent the sutureless procedure, while seven underwent the conventional procedure. Mean follow-up was 8.4 ± 2.9months and 13.7 ± 6.5months for the sutureless and conventional groups, respectively. Patients who underwent the sutureless procedure reported no postoperative foreign body sensation, while 71.4% of patients who underwent the conventional procedure reported some degree of ocular discomfort. In the sutureless group, operating time and postoperative edema were significantly reduced. Labial mucous membrane graft dehiscence was observed in one eyelid (8.3%) on the first postoperative day in the sutureless group. No dehiscence was observed in the conventional technique group. The use of fibrin sealant showed to be a good alternative to conventional absorbable sutures. Advantages include expedited operating time, decreased postoperative discomfort, and expedite postoperative recovery.

COVID-19 Infection and Risk for Neuropsychiatric Symptoms

COVID-19 Infection and Risk for Neuropsychiatric Symptoms

Prescribing Nirmatrelvir/Ritonavir for COVID-19 in Advanced CKD.

Prescribing Nirmatrelvir/Ritonavir for COVID-19 in Advanced CKD.

1090-P: Prevalence of Diabetic Cardiomyopathy in an Electronic Health Record–Based Cohort

Introduction: Diabetic cardiomyopathy (DbCM) is characterized by abnormal cardiac structure/function, associated with incident HF, and has a 67% prevalence in the community. However, the prevalence of DbCM in a real-world, electronic health record (EHR) system is not known. Methods: Adult patients with DM in a single center EHR free of CVD with available data on HF risk factors were included. The presence of DbCM was defined using different definitions (Figure) . DbCM prevalence was compared across subgroups with differences assessed using the chi-squared test. Adjusted logistic regression models were constructed to evaluate significant predictors of DbCM. Results: Among 1,921 individuals with DM, prevalence of DbCM in the overall cohort was 8.7% and 64.4% in the most and least restrictive definitions, respectively. Across all definitions, increasing age and Hispanic ethnicity was associated with higher proportion of DbCM (Figure A,D) . No consistent differences in DbCM prevalence were observed across sex and race-based subgroups across definitions (Figure B-C) . In multivariable-adjusted logistic regression, higher creatinine and longer QRS duration were associated with higher risk of DbCM across all definitions. Conclusions: In a single-center, EHR cohort, the prevalence of DbCM was up to 64.4%. Increasing age and Hispanic ethnicity had a higher prevalence of DbCM. Disclosure M.W.Segar: None. K.Patel: None. M.Vaduganathan: Advisory Panel; American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Pharmacosmos, Relypsa, Roche Diagnostics, and Sanofi, Other Relationship; Novartis and Galmed , Research Support; Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, Roche Diagnostics, and Sanofi, Speaker's Bureau; Novartis and Roche Diagnostics. A.Chandra: None. D.L.Willett: None. A.Pandey: Advisory Panel; Lilly, Consultant; Tricog, Research Support; Applied Therapeutics, Gilead Sciences, Inc.

355-OR: WATCH-DM Identifies Diabetic Cardiomyopathy: A Multicohort Analysis

Introduction: Diabetic cardiomyopathy (DbCM) , a transitional phenotype that may precede overt heart failure (HF) onset, is characterized by abnormalities in cardiac structure or function in DM in the absence of cardiovascular disease (CVD) or major risk factors. Whether WATCH-DM, a validated risk score to identify incident heart failure (HF) among individuals with DM, can identify DbCM is unknown. Methods: Adults without known prevalent CAD or overt HF were pooled from 2 community-based cohort studies (ARIC and CHS) . Presence of DbCM in patients with DM was defined using different definitions (Figure) . Adjusted logistic regression and restricted spline models were used to evaluate the association of WATCH-DM and the individual components of DbCM. Results: Among 2,241 individuals with DM, the prevalence of DbCM was 9.8% and 62.8% applying the most and least restrictive definitions, respectively. For every 1-unit increase, the WATCH-DM score was associated with higher risk of LV hypertrophy and diastolic dysfunction (odds ratio [95% CI] = 1.20 [1.15-1.27] and 1.[1.05-1.13], respectively) , but not LA enlargement (Figure A) . Across definitions, higher WATCH-DM scores were associated with a higher risk of DbCM (Figure B) . Conclusions: The WATCH-DM risk score is associated with higher prevalence of DbCM and may be a useful tool in screening for DbCM. Disclosure M.W.Segar: None. K.Patel: None. M.Vaduganathan: Advisory Panel; American Regent, Amgen, AstraZeneca, Bayer AG, Baxter Healthcare, Boehringer Ingelheim, Cytokinetics, Lexicon Pharmaceuticals, Pharmacosmos, Relypsa, Roche Diagnostics, and Sanofi, Other Relationship; Novartis and Galmed , Research Support; Amgen, AstraZeneca, Boehringer Ingelheim, Novartis, Roche Diagnostics, and Sanofi, Speaker's Bureau; Novartis and Roche Diagnostics. A.Chandra: None. D.L.Willett: None. A.Pandey: Advisory Panel; Lilly, Consultant; Tricog, Research Support; Applied Therapeutics, Gilead Sciences, Inc.