Infusion Group Research Articles

Renal safety of zoledronic acid in patients with osteoporosis: a retrospective study.

This study aimed to investigate the renal safety of Zoledronic Acid (ZOL) in patients with osteoporosis (OP). A total of 1379 patients (baseline estimated glomerular filtration rate, eGFR ≥ 60 mL/min/1.73 m2) with primary OP who received ZOL from January 2008 to October 2020 at our hospital were retrospectively analyzed. Baseline and the changes in renal function within 1 year following infusions were collected, the incidence of renal impairment (eGFR < 60 mL/min/1.73 m2 or a > 25% reduction in the eGFR from baseline) was noted and the risk factors were analyzed. Furthermore, the changes in renal function between a 3-year consecutive infusion and a single infusion of ZOL were compared. Renal impairment occurred in 8.05% of patients, who with a significantly higher age, Charlson Comorbidity Index (CCI), smoking history, combination of hypertension or diabetes mellitus and worse renal function indicators (all P < 0.05). Binary logistic regression analysis showed that higher CCI (≥5) or smoking history or the baseline eGFR <90 mL/min/1.73 m2 were the risk factors for renal impairment (all P < 0.05). Patients of 3-year continuous infusion group had a significantly greater drop in the eGFR levels than the single infusion group after 1 year of infusion(s) (P < 0.05). Attention should be given to possible potential renal impairment following ZOL infusion in clinical practice for the management of OP, particularly in patients with higher CCI (≥5) or smoking history or the baseline eGFR <90 mL/min/1.73 m2. Continuous infusion of ZOL exerts a significant impact on renal function when compared to single infusion and intensive monitoring of renal function is necessary.

A retrospective study on the efficacy and safety of Endostar with chemotherapy in EGFR-TKI-resistant NSCLC

BackgroundEndostar is a strong angiogenesis inhibitor that is effective in treating non-small cell lung cancer (NSCLC), but the effect of Endostar in the treatment of patients with EGFR-TKI-resistant NSCLC remains unclear. We evaluated the clinical efficacy and safety of Endostar in EGFR-mutant NSCLC patients resistant to EGFR inhibition treatment.MethodsFrom January 1, 2016 to June 30, 2018, 68 patients were selected from the 4 institutions for the study. Patients with NSCLC received Endostar plus chemotherapy every 21-day cycle. Chemotherapy types included platinum-containing dual drugs and platinum-free single drugs. Endostar was administered by intermittent intravenous infusion or continuous microinfusion pump infusion. The overall response rate (ORR), disease control rate (DCR) and adverse events were analyzed. Survival of patients was also evaluated.ResultsFor all patients, the median progression-free survival (PFS) was 2.8 months, and the median overall survival (OS) was 14.2 months. PFS and OS in the Endostar pump continuous group were better than those in the Endostar intravenous infusion group. The disease control rate (DCR) was 79.4%. A total of 28 (41.2%) patients experienced varying grades of adverse events during treatment. No treatment-associated deaths were observed. The grade 3 treatment-emergent adverse events (TEAEs) were myelosuppression, weakness, and nausea/vomiting.ConclusionsEndostar was effective and well tolerated in advanced NSCLC patients. Endostar treatment showed promising survival results in EGFR-mutant NSCLC patients.

Donor T Cell Infusions Limit Novel Immune Checkpoint Therapy in Pancreatic Cancer: Implications for Adoptive T Cell Therapy

Background: We have previously published that pancreatic cancers over-express an immunosuppressive peptide, vasoactive intestinal polypeptide (VIP), and that a novel combination of antin-PD1 antibodies and small molecule antagonists to the VIP receptor can induce complete remission of pancreatic ductal adenocarcinoma (PDAC) in multiple mouse models (Ravibndranathan, Nat. Comm. 2022). To enhance the efficacy of this novel immunotherapy approach, we hypothesized that infusions of additional donor T cells to PDAC-bearing mice receiving the combination of anti-PD1/VIP receptor antagonists would lead to more intra-tumoral effector T cells and increased tumor regression rates. To investigate the potential impact of adoptive splenocyte infusion on checkpoint immunotherapy, we established sub-cutaneous KPC PDAC tumors in C57Bl/6 mice. As previously described, we treated them with a combination of ANT308 (VIP-receptor antagonists) and anti-PD1. We tested whether adding splenocyte infusions from donor mice that were immunologically naïve or donor mice previously engrafted with PDAC with regressed (positive control) or progressed tumors (negative control) would enhance the efficacy of the immune checkpoint blockade therapy. Methods: C57BL/6 B6 CD45.1 recipient mice were inoculated subcutaneously with 1 x 10 6 KPC-luc PDAC cell line cells on day -5. Recipient mice received anti-PD1 (200mg) every three days (totaling four doses) and 21 daily s.c. injections of 20 ug ANT308. Splenocytes from three groups of CD45.2+ C57BL/6 donor mice were injected into tumor-bearing recipients: naive mice, mice with a history of KPC regression post-ANT308/anti-PD1 treatment, and mice with progressed KPC tumors without any treatment. Anti-PD1 and ANT308 treatments were initiated simultaneously with adoptive splenocyte infusion (25 x 10 6 cells) on day 0. Tumor size was measured biweekly, and IVIS imaging was performed weekly. Blood was drawn weekly from recipient mice for flow cytometric analysis of immune cell subsets. A fraction of tumor-bearing recipient mice was euthanized ten days after donor splenocyte infusion and initiation of immune checkpoint therapy or at IAUCAC-defined endpoints. When tumor-bearing mice were euthanized, the spleen, lymph nodes, and tumors were harvested for further flow cytometric analysis. The remaining mice were monitored for tumor growth and survival kinetics. Results: Contrary to our original hypothesis, we observed substantially lower survival rates and faster tumor growth in the group that received splenocytes from immunologically naive donor mice versus the group treated with splenocytes from tumor-bearing mice (Figures 1A and 1B). Splenocytes from immunologically naive donors contained fewer Treg cells, whereas myeloid-derived suppressor cells (CD11b+Ly-6G+ Gr-1+) were increased in donor splenocytes from tumor-bearing mice. We next repeated the experiment utilizing the adoptive transfer of splenocytes from immunologically naïve donors separated into 8 x 10 6 MACS-purified T cell or 17 x 10 6 non-T cell fractions. Remarkably, the transfer of 8 x 10 6 immunologically naïve T cells abrogated the efficacy of immune checkpoint therapy leading to rapid tumor growth compared to tumor regression in mice treated with immune checkpoint therapy without added donor splenocytes or mice that received immune checkpoint therapy with 17 x 10 6 T-cell-depleted donor splenocytes. Flow cytometric and gene expression analyses of splenocytes from the recipient mice, and those not receiving donor T cell infusions, revealed that the tetramer population in the infusion group was significantly higher than in the group treated only with immune checkpoint inhibitors. Conclusion: Our findings indicated that natural suppressor/ Treg in immunologically naïve splenocytes could exert a profound negative regulatory effect on immune checkpoint therapy's efficacy in a murine PDAC model. Despite having fewer Treg than splenocytes from tumor-bearing donors, immunologically naïve natural Treg had increased potency in suppressing anti-cancer immunity. These findings suggest the importance of the depletion of natural Treg in adoptive cell therapy strategies to treat solid tumor malignancies. This research underscores the critical role of immune contexture in shaping therapeutic outcomes and proposes a novel biomarker for patient stratification in PDAC immunotherapy.

Responses of Saccharomyces cerevisiae Cells Grown in Cultures Prepared from Different Tea Infusions to Oxidative Stress

Tea is one of the most consumed beverages. Saccharomyces cerevisiae, a model organism in studies on oxidative stress and toxicology, was used to investigate the effects of tea on oxidative stress induced by H2O2. S. cerevisiae cultures were prepared from black, green and white tea infusions and incubated at 30°C for 72 hours. Glutathione-S-transferase enzyme activity and total protein spectrophotometric, malondialdehyde, glutathione and alpha-tocopherol and ergosterol analyses from cell pellets obtained from cultures were performed by HPLC, and fatty acids were performed by GC device. Although protein level in tea infusion groups was higher (p

BINAHONG [Anredera cordifolia (Tenore) Steenis] LEAF INFUSA FOR SUTURE WOUND INFECTION CONVALESCENCE

Background: Postpartum infections are the top 4 main causes of the high maternal mortality rate in Indonesia at 2022 of 183 per 100,000 live births. Efforts to prevent complications due to infection of puerperal suture wounds with pharmacological therapy using antibiotics and antiseptics, as well as non-pharmacological ones using plant extracts. Binahong is believed to contain flavonoids, terpenoids, saponins, tannins, essential oils, and alkaloids, which are especially useful in healing wound infections. The aim of the study was to determine the effectiveness of infusion of binahong leaves (Anredera cordifolia (Tenore) Steenis) on the healing of suture wound infections in rats (Rattus norvegicus) experimental animals. Method: The research method was a true-experimental posttest only control group design, the study was conducted from June to August 2023 at the Microbiology and Pharmacology Laboratory of Muhammadiyah Sidoarjo University, the research variables were binahong leaf infusion and healing of suture infection, assessment and data collection using the REEDA scale instrument, statistical analysis with the one-way ANOVA, and post-hoc follow-up tests. Result: The results showed p &lt;0.05, so there was a significant effect of giving binahong leaf infusion on the healing of suture wound infections. In terms of the difference in the mean value and the results of the post-hoc significant difference test, it appears that the 5% binahong leaf infusion group showed the most effective results in healing suture wound infections and was significantly different from the negative control group with less effective healing of suture infections. Conclusion : This is in line with research that states that the group given a 5% concentration of binahong extract was more effective than the group with a higher concentration. Thus, administration of a 5% concentration of binahong leaf infusion can be an alternative for healing suture wound infections due to the important content in it in the form of flavonoids, terpenoids, saponins, tannins, essential oils, and alkaloids. Further research is needed with lower concentrations of binahong leaf infusion to find out the minimum concentration that can have a good effect on the convalescence of suture wound infections.

Clinical parameters of laminoplasty and laminectomy with fusion in the treatment of cervical spondylosis and analysis of postoperative sagittal balance.

Cervical spondylosis is a progressive disease that causes degenerative changes affecting the spine, intervertebral discs, facets, and ligaments. With anterior and posterior surgical interventions, effective treatments can be applied in cervical spondylotic myelopathy (CSM). The relationship between regional and global spinal alignment and functional and pain outcomes was examined and it was revealed that these parameters play a significant role in obtaining good results. The aim of this study was to compare the perioperative and follow-up results of patients with CSM who underwent laminoplasty or laminectomy with fusion. CSM patients who were operated on between 2015 and 2020 and had at least 2 years of clinical and radiological follow-up were analyzed retrospectively. The patients were divided into 2 groups as the laminoplasty group and the laminectomy with fusion group, according to a simple random method. Demographic, clinical, radiological, and perioperative parameters were examined. Measurements were made by an independent observer using Surgimap and 2 years was considered to be sufficient time for the spine to take its final shape. A total of 112 patients, including 68 males and 44 females, were included. Of these patients, 69 were in the laminectomy with fusion group, and 43 were in the laminoplasty group. Patient ages ranged from 39 to 85 years. The mean follow-up period was 36.28 months. In both groups, at the 3-month follow-up, a statistically significant improvement in the clinical parameters (neck disability index, visual analogue scale, modified Japanese Orthopaedic Association scores) was observed. When the preoperative cervical radiological parameters were evaluated, no statistically significant difference was found between the groups. The C2-C7 lordotic angles and the cervical SVA values were increased in the postoperative period, for both groups (p < 0.001). Although it is noteworthy that the increases were higher in the laminectomy with fusion group, no statistically significant difference was found between the groups. Deformity in a spinal segment may indirectly affect another segment. Being aware of the compensatory mechanisms and radiological parameters will help in determining the effective treatment plan.

A comparative analysis of tranexamic acid dosing strategies in traumatic major hemorrhage.

Tranexamic acid (TXA) is a life-saving treatment for traumatic hemorrhage, but the optimal dosing regimen remains unknown. Different doses and treatment strategies have been proposed, including single bolus, repeated bolus, or bolus plus infusion. The aim of this study was to determine the effect of different TXA dosing strategies on clinical outcomes in bleeding trauma patients. Secondary analysis of a perpetual cohort study from a UK Level I trauma center. Adult patients who activated the local major hemorrhage protocol and received TXA were included. The primary outcome was 28-day mortality. Secondary outcomes were 24-hour mortality, multiple organ dysfunction syndrome, venous thromboembolism, and rotational thromboelastometry fibrinolysis. Over an 11-year period, 525 patients were included. Three dosing groups were identified: 1 g bolus only (n = 317), 1 g bolus +1 g infusion over 8 hours (n = 80), and 2 g bolus (n = 128). Demographics and admission physiology were similar, but there were differences in injury severity (median Injury Severity Score, 25, 29, and 25); and admission systolic blood pressure (median Systolic Blood Pressure, 99, 108, 99 mm Hg) across the 1-g, 1 g + 1 g, and 2-g groups. 28-day mortality was 21% in each treatment group. The incidence of multiple organ dysfunction syndrome was significantly higher in the bolus plus infusion group (84%) vs. 1 g bolus (64%) and 2 g bolus (62%) group, p = 0.002, but on multivariable analysis was nonsignificant. Venous thromboembolism rates were similar in the 1-g bolus (4%), 2 g bolus (8%) and bolus plus infusion groups (7%). There was no difference in rotational thromboelastometry maximum lysis at 24 hours: 5% in both the 1-g and 2-g bolus groups vs. 4% in bolus plus infusion group. Clinical outcomes and 24-hour fibrinolysis state were equivalent across three different dosing strategies of TXA. Single bolus administration is likely preferable to a bolus plus infusion regimen. Therapeutic/Care Management; Level III.

Growing rods in meningomyelocele lead to increased risk for complications in comparison with fusion; a retrospective study of 30 patients treated for at the University Hospital of Uppsala

PurposeTo compare the complication rates of two different types of posterior instrumentation in patients with MMC, namely, definitive fusion and fusionless surgery (growing rods).MethodsSingle-center retrospective study of 30 MMC patients that underwent posterior instrumentation for deformity (scoliosis and/or kyphosis) treatment from 2008 until 2020. The patients were grouped based on whether they received definitive fusion or a growth-accommodating system, whether they had a complication that led to early surgery, osteotomy or non-osteotomy. Number of major operations, Cobb angle correction and perioperative blood loss were the outcomes.Results18 patients received a growing system and 12 were fused at index surgery. The growing system group underwent a mean of 2.38 (± 1.03) surgeries versus 1.91 (± 2.27) in the fusion group, p = 0.01. If an early revision was necessitated due to a complication, then the number of major surgeries per patient was 3.37 (± 2.44) versus 1.77 (± 0.97) in the group that did not undergo an early revision, p = 0.01. Four patients developed a superficial and six a deep wound infection, while loosening/breakage occurred in 10 patients. The Cobb angle was improved from a mean of 69 to 22 degrees postoperatively. Osteotomy did not lead to an increase in perioperative blood loss or number of major operations.ConclusionGrowing systems had more major operations in comparison with fusion surgery and early revision surgery led to higher numbers of major operations per patient; these differences were statistically significant. Definitive fusion at index surgery might be the better option in some MMC patients with a high-risk profile.

Furosemide continuous infusion versus repeated injection in the management of acute decompensated heart failure in infants with left to right shunt: a randomized trial

BackgroundFurosemide is the foremost drug used in the management of acute decompensated heart failure (ADHF). By tradition, it was administered as repeated intravenous boluses but fluctuations in intravascular volume and blood pressure were noticed in addition to the possibility of toxicity. Hence, continuous intravenous infusion was thought of as an alternative route of administration. In searching the literature, all previously published data concerning the pediatric age group was for infants and children following cardiac surgery. This study aims to compare the efficacy and safety of furosemide repeated injection versus continuous infusion during the management of ADHF in infants with left to right shunt.MethodsA prospective parallel-design randomized study was conducted on 54 infants with ADHF, Ross class IV, secondary to left to right shunt. Twenty-seven infants received repeated injections of furosemide and 27 infants had furosemide continuous infusion. Patients were followed clinically for weight, urine output, hours required for resolution of failure symptoms, serum creatinine, sodium and potassium, and length of hospital stay.ResultsNon-significant differences were observed between both groups regarding preadmission oral furosemide dose and serum creatinine level. A lower daily dose of furosemide was observed in the continuous infusion arm (3.5 ± 0.6 vs 4.7 ± 1.0, p = 0.001) with less fluctuation in urine output and significantly fewer hours required for resolution of failure symptoms (42.1 ± 9 vs 56 ± 18.5, p = 0.001). At the end of furosemide infusion, serum creatinine was significantly higher in the continuous infusion group (0.39 ± 0.06 vs 0.34 ± 0.1, p = 0.030). However, before hospital discharge, non-significant differences were noticed (0.32 ± 0.05 vs 0.33 ± 0.06, p = 0.584). Non-significant differences between both groups regarding serum sodium and potassium levels at the end of furosemide injection were detected (p = 0.289, 0.890, respectively).ConclusionContinuous infusion of furosemide can be safely administered to infants with ADHF, Ross class IV, secondary to left to right shunt with clinical gradual alleviation of fluid overload symptoms and less hemodynamic instability than repeated injections.Trial registrationThe study was approved by the Mansoura Faculty of Medicine institutional research board (MS/16.02.41) on August 3rd, 2016.

Effect of sodium bicarbonate infusion on hospital mortality in acute kidney injury patients with metabolic acidosis.

Physicians usually consider that sodium bicarbonate (SB) infusion can be used for metabolic acidosis; however, there is little evidence available to assess its effect on hospital mortality in large AKI cohorts. Here, we investigated the effect of SB infusion in patients with AKI complicated by metabolic acidosis. Patients with AKI complicated by metabolic acidosis were screened from the MIMIC-IV database. A propensity score analysis (PSA) was used to decrease baseline differences in the probability of receiving SB. The marginal structural Cox model (MSCM) was employed to adjust for both baseline and time-varying confounding factors. A total of 1853 patients with AKI complicated with metabolic acidosis were included in our study. A total of 390 pairs of patients were divided into an SB infusion group and a non-SB infusion group. The SB infusion group had more serious and worse laboratory indicators, including lower pH [7.19 (0.11) vs. 7.26 (0.07)] and bicarbonate concentration (BC) [12.36 (4.26) vs. 15.96 (3.25) mmol/l]. While there was no significant effect on overall hospital mortality in AKI patients complicated with metabolic acidosis (p = 0.056), SB infusion was observed to have beneficial correlation on hospital mortality in patients with high AG acidosis (AG > 18 mmol/L) (p = 0.012). Similar results were replicated with the MSCM. We found that SB infusion in AKI patients with metabolic acidosis is not beneficial for hospital mortality. However, SB infusion for AKI patients and high AG metabolic acidosis significantly improved hospital mortality. Further larger randomized controlled trials are needed to confirm these results.

Adverse Events and Compliance Among Inflammatory Bowel Disease Patients Treated With Home- vs Office-Based Biologic Infusions.

Biologic medications are a common therapy for those with inflammatory bowel disease (IBD). There are limited data on the outcomes of home-based biologic infusions for patients with IBD. The aim of this study was to compare the safety and efficacy of biologic infusions for IBD patients who receive either home- or office-based administration. Patients receiving infliximab or vedolizumab were analyzed retrospectively over a period of 152 weeks. Survival free of major adverse events including delayed infusion reaction, steroid initiation, drug discontinuation, or IBD-related emergency department visits, admission, and surgery were compared using a Kaplan-Meier curve. Individual adverse events, infusion-.related quality measures, and markers of patient adherence were analyzed. Adverse event-free survival was greater among those receiving home-based infusion (n = 154) compared with office-based infusion (n = 133). The office infusion cohort had higher rates of delayed infusion reactions (4 vs 0), IBD-related surgery (6 vs 0), and drug discontinuation (44 vs 35); this was a sicker cohort of patients compared with those in the home infusion group. Home infusion patients were less likely to receive correct weight-based dosing for infliximab (71.7% vs 89.3%), obtain labs for drug monitoring (53.2% vs 71.4%), and adhere to routine clinic visits (37.9% vs 58.1%). The home-based infusion of biologics for IBD appears safe with lower rates of major adverse events compared with office-based infusions. However, those receiving home infusion were less likely to receive correct weight-based dosing for infliximab and were poorly adherent to routine follow-up.

Continuous vs intermittent induction of labor with oxytocin in nulliparous patients: a randomized controlled trial

Oxytocin is considered the drug of choice for the induction of labor, although the optimal protocol and infusion duration remain to be determined. This study aimed to assess whether the duration of oxytocin infusion increases 24-hour delivery rates and affects the length of time-to-delivery and patient's experience. A randomized controlled trial was performed at a single tertiary medical center, between January 1, 2020 and June 30, 2022. Nulliparous patients with a singleton pregnancy at a vertex presentation and a Bishop score ≥6 were randomly assigned to receive either continuous (16 hours, with a 4 hours pause in between infusions) or intermittent (8 hours, with a 4 hours pause in between infusions) oxytocin infusion, until delivery. In both groups, infusion was halted when signs of maternal or fetal compromise were observed. Randomization was conducted with a computer randomization sequence generation program. The primary outcome was delivery within 24 hours from the first oxytocin infusion and the secondary outcome included time-to-delivery, mode of delivery, and additional maternal and neonatal outcomes. Seventy-two patients per group were randomized to reach 80% statistical power with a 20% difference in the primary outcome according to previous studies. A total of 153 patients were randomized, 72 to the continuous oxytocin infusion group and 81 to the intermittent infusion group. The total oxytocin infusion time was similar between the groups. Patients in the continuous arm were more likely to deliver within 24 hours from oxytocin initiation (79.73% vs 62.96%, P<.05), and had a shorter oxytocin-to-delivery time interval, compared with patients receiving intermittent treatment (9.3±3.7 hours vs 21±11.7 hours, P<.001). Furthermore, time from ruptured membranes to delivery was shorter (9.3±3.7 hours vs 21±11.7 hours; P<.0001) and chorioamnionitis was less frequent (9.46% vs 21%; P<.05) in the continuous compared with the intermittent arm. Cesarean delivery rate was 20% in both groups (P=.226). There was no difference in postpartum hemorrhage, or adverse neonatal outcomes between the groups. Patients receiving continuous oxytocin infusion were more satisfied with the birthing experience. Continuous infusion of oxytocin for labor induction in nulliparous patients with a favorable cervix may be superior to intermittent oxytocin infusion, because it shortens time-to-delivery, decreases chorioamnionitis rate, and improves maternal satisfaction, without affecting adverse maternal or neonatal outcomes.

FRI642 The Effect Of Early Basal Insulin Administration On Diabetic Ketoacidosis (DKA) Management

Abstract Disclosure: H. Al-Marsumi: None. S.Z. Pollack: None. N. Simon: None. Background: DKA and HHS are considered serious acute complications of diabetes and constitute endocrine emergencies. Management of DKA and HHS consists of fluid, potassium replacement and weight-based adjusted rate intravenous insulin infusion, with close monitoring of capillary glucose, serum electrolytes, venous PH, and Beta-hydroxybutyrate. Current Standard DKA management protocols introduce and overlap subcutaneous insulin with intravenous insulin infusion after anion gap closure. In United states, few studies looked at different outcomes after early administration of basal insulin (i.e. before anion gap closure) during DKA management. Objective: The purpose of this research is to study the effect of early administration of basal long-acting insulin in addition to intravenous insulin on the time to anion gap closure, incidence of rebound hyperglycemia, hypoglycemia, transitional failure, length of ICU stays and length of Hospital stays, compared to intravenous insulin infusion only. Methods: This was a single-center, retrospective chart review study of adults 21 years or older admitted to the hospital with DKA diagnosis between September 2020 and May 2022. The patients were divided into two groups (Study group which includes those with early administration of basal long-acting insulin in addition to intravenous insulin infusion and Standard group which includes patients who received intravenous insulin infusion only). The primary outcome was the time to anion gap closure. The other outcomes included incidence of rebound hyperglycemia, hypoglycemia, transitional failure, length of ICU stay, as well as the length of hospital stay. Results: A total of 231 admissions were included for analysis; 29 patients were included in the (Study group) and 202 in the (Standard group). The mean time ± standard deviation for hours till anion gap closure in the study group and standard group were (21.3938 ± 25.2603 and 12.7679 ± 9.3512) respectively showing no statistical difference between the two groups with a P value of 0.0789. The incidence of hypoglycemia was 21% in the study group and 24% in the standard group with P value of 0.8173. There was no statistical difference in length of ICU stays, length of hospital stays, incidence of rebound hyperglycemia, transitional failure between the study and control groups with a p value of (0.3867, 0.7207, 0.7758 and 0.1387) respectively. Conclusion: There was no statistical difference in time to anion gap closure, length of ICU stays, length of hospital stays, incidence of rebound hyperglycemia, hypoglycemia, transitional failure between the study and Standard groups. Further Studies are needed to evaluate the effect of early basal insulin administration on DKA management. Presentation: Friday, June 16, 2023

Design and Biomechanical Evaluation of a Bidirectional Expandable Cage for Oblique Lateral Interbody Fusion

Oblique lateral interbody fusion (OLIF) surgery is a minimally invasive spinal surgery technique that has become increasingly popular in recent years. The primary objective of the current study was to design a minimally invasive expandable fusion device that can reduce iatrogenic nerve damage and minimize endplate damage during OLIF surgery, while restoring intervertebral height and alignment. The second objective was to use finite element analysis to evaluate the biomechanical stability of the newly designed expandable fusion device after implantation into the intervertebral space. A new bidirectional expandable cage was designed in this study. A finite element model (FEM) of L3-L5 lumbar segment was modified to simulate decompression and fusion. The modified FEMs were constructed in the following cases: intact model, bidirectional expandable cage (alone, with unilateral pedicle screws [UPSs], and with bilateral pedicle screws [BPSs]) model, conventional OLIF cage (alone, with UPSs, and with BPSs) model. To simulate physiological loadings, the models were subjected to a follower compressive pre-load of 400 N, in addition to 8.0 Nm of flexion, extension, lateral bending, and axial rotation moments. All modified FEMs exhibited a significant reduction in motion at L3-L5 compared to the intact model. Among the fusion models, the bidirectional expandable cage (BEC) with BPS model displayed the highest stiffness and demonstrated a reduced range of motion (48.5%-75.7%). Additionally, the peak stress on the endplate in the conventional OLIF cage (Conv-OLIF) model was generally lower than that in the BEC models. The cage in the BEC ALONE model exhibited the highest stress (93.87-176.3 MPa) on the endplate in most motion modes, while the cage in the Conv-OLIF+BPS model had the lowest stress (16.67-30.58 MPa) on the endplate in most motion modes. The maximum stress on the fixation in the BEC fusion models was generally lower than that in the Conv-OLIF fusion group under the same loading conditions. The OLIF ALONE model had the lowest stress on the adjacent disc, while the stress level in the BEC ALONE model was very close to it. The BEC implanted models had higher stiffness, and more proper stress distribution on the posterior fixation was comparable to that of the Conv-OLIF models. However, the endplate stress peaks and cage stress peaks of the BEC models were slightly higher than those of the Conv-OLIF models, though still within a clinically acceptable range. Taking into account both biomechanical and clinical perspectives, BEC-assisted unilateral pedicle screw fixation meet clinical demand and may serve as a viable alternative to Conv-OLIF fusion.

Negative Effects of Diffuse Idiopathic Skeletal Hyperostosis on Bone Fusion after Transforaminal Lumbar Interbody Fusion.

This study adopted a retrospective cohort study design. This study aimed to clarify the influence of diffuse idiopathic skeletal hyperostosis (DISH) on bone fusion after transforaminal lumbar interbody fusion (TLIF). The negative effects of DISH on lumbar degenerative diseases have been reported, and DISH may be involved in the onset and severity of lumbar spinal canal stenosis. Patients with DISH have significantly more reoperations after posterior lumbar fusion, including TLIF. However, the effects of DISH on bone fusion after TLIF have not been reported. The medical records of patients with intervertebral TLIF from 2012 to 2018 were retrospectively examined. The patients were divided into those with fusion and those with pseudoarthrosis, and the following data were compared: age, sex, DISH, diabetes mellitus, smoking, drinking, albumin levels, body mass index ≥30 kg/m2, and L5/S fixation. Statistical analyses were performed using regression models. In this study, 180 patients (78.6%) had fusion and 49 patients (21.4%) had pseudoarthrosis. The number of patients with DISH was significantly higher in the pseudoarthrosis group than in the fusion group (36.7% and 21.7%, respectively; univariate p=0.031, multivariate p =0.019). No significant differences in age, sex, diabetes mellitus, smoking, drinking, albumin levels, body mass index ≥30 kg/m2, and L5/S fixation were observed between the two groups. The risk factors for bone fusion were statistically analyzed in 57 patients with DISH. DISH with a caudal end below Th11 was an independent risk factor for pseudoarthrosis (univariate p=0.011, multivariate p=0.033). DISH is an independent risk factor for pseudoarthrosis after one intervertebral TLIF, and DISH with a caudal end below Th11 is associated with a higher risk of pseudoarthrosis than DISH without a caudal end below Th11.

Comparison of two surgical interventions for lumbar brucella spondylitis in adults: a retrospective analysis

This retrospective study aimed to compare the clinical efficacy of the posterior procedure with the combined anterior and posterior procedure in the surgical management of lumbar Brucella spondylitis. From January 2015 to June 2020, a total of 62 patients presenting with lumbar Brucella spondylitis underwent either one-stage posterior pedicle fixation, debridement, and interbody fusion (Group A, n = 33) or anterior debridement, bone grafting, and posterior instrumentation (Group B, n = 29). All patients were followed up for an average of 25.4 ± 1.5 months and achieved complete resolution of lumbar Brucella spondylitis. No significant differences between the groups were observed in terms of age or pre-operative, three-month postoperative and final follow-up indices of the VAS, ESR, CRP, lordosis angle, ODI scores, fusion time, and time of serum agglutination test conversion to negative (P > 0.05). Each patient exhibited notable improvements in neurological function, as assessed by the JOA score rating system. Group A demonstrated significantly shorter operative duration, intraoperative blood loss, and hospital stay compared to Group B (P < 0.05). Superficial wound infection was observed in one case in Group A, whereas Group B experienced one case each of intraoperative peritoneal rupture, postoperative ileus, iliac vein injury, and superficial wound infection. This study supports the efficacy of both surgical interventions in the treatment of lumbar Brucella spondylitis, with satisfactory outcomes. However, the posterior approach demonstrated advantages, including reduced surgical time, diminished blood loss, shorter hospital stays, and fewer perioperative complications. Consequently, the one-stage posterior pedicle fixation, debridement, and interbody fusion represent a superior treatment option.

Fusion imaging for pulmonary artery embolization: impact on fluoroscopy duration and contrast agent exposure.

To assess the impact of fusion imaging guidance on fluoroscopy duration and volume of contrast agent used for pulmonary artery embolization. Thirty-four consecutive patients who underwent pulmonary artery embolization for pulmonary arterio-venous malformation (n = 28) or hemoptysis (n = 6) were retrospectively included. In the experimental group (n = 15), patients were treated using fusion imaging with 2D/3D registration. In the control group (n = 19), no fusion imaging has been used. Fluoroscopy duration and amount of contrast used were measured and intergroup comparison was performed. The average volume of contrast agent used for embolization in the fusion group (118.3 ml) was significantly lower than in the control group (285.3 ml) (p < 0.002). The mean fluoroscopy duration was not significantly different between both groups (19.5 min in the fusion group vs 31.4 min in the control group (p = 0.10)). No significant difference was observed regarding the average X-ray exposure (Air Kerma) (p = 0.68 in the univariate analysis). Technical success rate was 100% for both groups. Fusion imaging significantly reduces contrast medium volumes needed to perform pulmonary artery embolization. The fluoroscopy duration and the X-ray exposure did not vary significantly. CTA-based fusion imaging using 2D-3D registration is a valuable tool for performing pulmonary artery embolization, helpful for planning and guiding catheterization.Compared to the traditional imaging guidance, fusion imaging reduces the volume of contrast agent used.

Serum antioxidant enzymes in spinal stenosis patients with lumbar disc herniation: correlation with degeneration severity and spinal fusion rate

ObjectiveTo determine whether superoxide dismutase (SOD) and glutathione reductase (GR) correlated with the intervertebral disc degeneration (IDD) severity and the postoperative spinal fusion rate in lumbar spinal stenosis patients accompanied with lumbar disc herniation.MethodsThis retrospective study investigated 310 cases of posterior lumbar decompression and fusion. The cumulative grade was calculated by adding the pfirrmann grades of all the lumbar discs. Subjects were grouped based on the median cumulative grade. Logistic regression was used to determine the associations among the demographical, clinical, and laboratory indexes and severe degeneration and fusion. The receiver operating characteristic (ROC) curve was performed to measure model discrimination, and Hosmer-Lemeshow (H-L) test was used to measure calibration.ResultsSOD and GR levels were significantly lower in the severe degeneration group (cumulative grade > 18) than in the mild to moderate degeneration group (cumulative grade ≤ 18). Furthermore, the SOD and GR concentrations of the fusion group were significantly higher than that of the non-fusion group (p < 0.001 and p = 0.006). The multivariate binary logistic models revealed that SOD and GR were independently influencing factors of the severe degeneration (OR: 0.966, 95%CI: 0.950–0.982, and OR: 0.946, 95%CI: 0.915–0.978, respectively) and non-fusion (OR: 0.962; 95% CI: 0.947–0.978; OR: 0.963; 95% CI: 0.933–0.994). The models showed excellent discrimination and calibration. Trend analysis indicated that the levels of SOD and GR tended to decrease with increasing severity (p for trend < 0.001 and 0.003). In addition, it also revealed that SOD provided protection from non-fusion in a concentration-dependent manner (p for trend < 0.001). However, GR concentration-dependent effects were not apparent (p for trend = 0.301).ConclusionHigh serum SOD and GR levels are associated with a better fusion prognosis and a relief in degeneration severity.

ASSOCIATION BETWEEN PLASMA TRANSFUSION AND IN-HOSPITAL MORTALITY IN CRITICALLY ILL PATIENTS WITH SEPSIS-INDUCED COAGULOPATHY.

Background: Plasma is commonly used in patients with coagulopathy; however, its role in patients with sepsis-induced coagulopathy (SIC) is unclear. This study aimed to evaluate the effect of plasma transfusion on the prognosis of patients with SIC. Methods: Data were collected from the Medical Information Mart for Intensive Care IV database. Multivariable logistic regression analysis was used to determine the association between plasma transfusion and the incidence of in-hospital mortality, pulmonary embolism, and lower extremity deep vein thrombosis in critically ill patients with SIC. Propensity score matching (PSM) and propensity score-based inverse probability of treatment weighting (IPTW) models were used to ensure the robustness of our findings. Furthermore, the nonparametric relationship between in-hospital mortality and plasma transfusion volume was analyzed using restricted cubic spline. Subgroups analyses were performed for age, sex, Charlson score, Sequential Organ Failure Assessment score, SIC score, and with hemorrhage. Results: A total of 8,747 patients with SIC were enrolled: of them, 1874 were in the plasma infusion group, and 6,873 were in the no plasma infusion group. Compared with the no plasma infusion group, the plasma infusion group had higher in-hospital mortality (odds ratio [OR], 1.4411; 95% confidence interval [CI], 1.2280-1.6897, P < 0.05), and the results were robust after PSM (OR, 1.3227; 95% CI, 1.1152-1.5697; P < 0.05) and IPTW (OR, 1.1541; 95% CI, 1.0738-1.2404; P < 0.05). Similar results were also observed in different subgroups. However, because of conflicting results after PSM and IPTW, we were unable to definitively link plasma transfusion with pulmonary embolism and deep vein thrombosis. Compared with the no early plasma transfusion group (≥12 h), the in-hospital mortality rate was lower in the early plasma transfusion group (<12 h) (OR, 0.5426; 95% CI, 0.4398-0.6844; P < 0.05). The restricted cubic spline analysis indicated that increased plasma transfusion was associated with increased in-hospital mortality in patients with SIC. Conclusion: Plasma transfusion increases in-hospital mortality in patients with SIC, and the mortality rate increases with the amount of plasma transfusion. Patients with SIC who received early plasma infusion had lower in-hospital mortality than those who received no early plasma transfusion.

Should patient eligibility criteria for cervical disc arthroplasty (CDA) be expanded? A retrospective cohort analysis of relatively contraindicated patients undergoing CDA

Background ContextCervical disc arthroplasty (CDA) is a safe and effective alternative to anterior cervical discectomy and fusion (ACDF) in the treatment of various degenerative pathologies with advantages of motion preservation and lower rates of adjacent segment degeneration (ASD). Absolute contraindications for CDA have been well outlined in order to prevent adverse outcomes in patients. However, in cases of patients with relative contraindications (kyphotic deformity, prior cervical surgery, etc.), there remains controversy. There is minimal literature evaluating long-term outcomes in this patient population. PurposeTo compare long-term clinical and functional outcomes of CDA in typical patients versus those with relative contraindications. DesignRetrospective cohort review. Patient SampleEighty-nine patients were included in the study: 55 (no contraindications) in Group 1 and 34 (relatively contraindicated) in Group 2 and 26 (preoperative segmental kyphosis) in Group 3. Outcome Measures(1) Patient demographics; (2) perioperative data; (3) rates of complications and revisions; (5) visual analogue scale (VAS), and neck disability index (NDI) scores. MethodsPatients were placed in the relatively contraindicated cohort if they possessed at least one of the following: (1) segmental kyphosis of 5° to 10°, (2) significant loss of disc height (between 50% and 75% of initial measurements or 1.5–3mm), (3) bridging osteophytes, and (4) prior cervical spine surgery based on preoperative cervical radiographs. The other cohort included patients without any relative contraindication who underwent CDA over the same time frame. Additionally, a subgroup analysis was used to compare those without any contraindications to those with only preoperative segmental kyphosis. Patients were included in this study if they met the following criteria: over 18 years of age, minimum follow-up of 24 months, and availability of complete medical records. Patient demographics, levels operated on, and perioperative outcomes were assessed between the two groups. Revision and complication rates were recorded. Functional outcomes scores were compared using VAS and NDI scores at 6-months, 12-months and final follow-up. ResultsMean follow-up was 40.8 months in Group 1 and 38.3 months in Group 2 (p=.569). Complication rates were 21.8% in Group 1 and 26.4% in Group 2 (p=.615). Complication rates in a comparison between Groups 1 and 3 were statistically insignificant (p=.383). The most common complication was transient approach-related postoperative dysphagia (Group 1: 20% vs Group 2: 23.5%, p=.693). No significant differences were observed in the rates of transient dysphonia (Group 1: 0.0% vs Group 2: 2.9%, p=.201), adjacent segment degeneration (ASD) (Group 1: 1.8% vs Group 2: 0.0%, p=.429), infection (Group 1: 1.8% vs Group 2: 2.9%, p=.712), heterotopic ossification (Group 1: 49.1% vs Group 2: 50.0%, p=.934) or spontaneous fusion (Group 1: 1.8% vs Group 2: 2.9%, p=.728). No revision surgeries were observed in either cohort. All three groups demonstrated significant improvements in their VAS and NDI scores compared with preoperative measurements (p<.001), but no significant differences were found in the degree of improvement between groups at any point in time. ConclusionsOur study found no significant differences in clinical and functional outcomes between patients undergoing 1- and 2-level CDA with relative contraindications versus typical patients. These findings suggest that patient eligibility criteria for CDA may warrant expansion. However, future prospective studies over a longer period of follow-up are necessary to corroborate our results.