Association of Malnutrition with Surgical and Hospital Outcomes after Spine Surgery for Spinal Metastases: A National Surgical Quality Improvement Program Study of 1613 Patients.

Background: Malnutrition is a common condition that may exacerbate many medical and surgical pathologies. However, few have studied the impact of malnutrition on surgical outcomes for patients undergoing surgery for metastatic disease of the spine. This study aims to evaluate the impact of malnutrition on perioperative complications and healthcare resource utilization following surgical treatment of spinal metastases. Methods: We conducted a retrospective cohort study using the 2011-2019 American College of Surgeons National Surgical Quality Improvement Program database. Adult patients with spinal metastases who underwent laminectomy, corpectomy, or posterior fusion for extradural spinal metastases were identified using the CPT, ICD-9-CM, and ICD-10-CM codes. The study population was divided into two cohorts: Nourished (preoperative serum albumin values ≥ 3.5 g/dL) and Malnourished (preoperative serum albumin values < 3.5 g/dL). We assessed patient demographics, comorbidities, intraoperative variables, postoperative adverse events (AEs), hospital LOS, discharge disposition, readmission, and reoperation. Multivariate logistic regression analyses were performed to identify the factors associated with a prolonged length of stay (LOS), AEs, non-routine discharge (NRD), and unplanned readmission. Results: Of the 1613 patients identified, 26.0% were Malnourished. Compared to Nourished patients, Malnourished patients were significantly more likely to be African American and have a lower BMI, but the age and sex were similar between the cohorts. The baseline comorbidity burden was significantly higher in the Malnourished cohort compared to the Nourished cohort. Compared to Nourished patients, Malnourished patients experienced significantly higher rates of one or more AEs (Nourished: 19.8% vs. Malnourished: 27.6%, p = 0.004) and serious AEs (Nourished: 15.2% vs. Malnourished: 22.6%, p < 0.001). Upon multivariate regression analysis, malnutrition was found to be an independent and associated with an extended LOS [aRR: 3.49, CI (1.97, 5.02), p < 0.001], NRD [saturated aOR: 1.76, CI (1.34, 2.32), p < 0.001], and unplanned readmission [saturated aOR: 1.42, CI (1.04, 1.95), p = 0.028]. Conclusions: Our study suggests that malnutrition increases the risk of postoperative complication, prolonged hospitalizations, non-routine discharges, and unplanned hospital readmissions. Further studies are necessary to identify the protocols that pre- and postoperatively optimize malnourished patients undergoing spinal surgery for metastatic spinal disease.

Curcumin Encapsulation in Geranium Oil Microemulsion Elevates Its Antibacterial, Antioxidant, Anti-Inflammatory, and Anticancer Activities.

One of the major challenges with curcumin is its poor solubility in water, which limits its absorption and bioavailability in the body. This study aimed to develop and characterize stable microemulsions (MEs) as MEs increase the dispersibility of curcumin in water and aid its absorption in the body. Curcumin-loaded MEs were developed with the goal of enhancing topical delivery and its pharmacological activity (antioxidant, antibacterial, anticancer activity, and anti-inflammatory). The pseudoternary phase diagram was constructed to find out the desired microemulsion region. The prepared MEs (ME1-ME5) were evaluated for pH, viscosity, size of the particle, electrical conductivity, zeta potential, and ex vivo permeation of the drug. The optimized ME formulation was selected based on particle size and was further evaluated for biological activity (in vitro/vivo). In vitro cytotoxic effects of formulations were checked on the human liver cancer cell line, HEPG2 (a cell line exhibiting epithelial-like morphology that was isolated from a hepatocellular carcinoma). Geranium oil, Tween 80 (as a surfactant), and propylene glycol (as a cosurfactant) were screened out based on solubility to formulate MEs. The optimized ME formulation (ME5), with a composition of 20:50:30 (geranium oil:Tween 80:propylene glycol), exhibited pH 4.36 ± 0.057, conductivity of 40.06 ± 0.05 µS/cm, viscosity of 165 ± 0.37 mPa·s, and droplet diameter of 199.39 ± 0.017 nm. The ex vivo permeation study demonstrated a significant cumulative amount of curcumin permeated in 24 h and had a flux of 130.91 ± 0.02 µg/cm2/h. Antioxidant activity demonstrated that curcumin-loaded microemulsion (ME5) exhibited higher scavenging activity (99.27 ± 0.021%) than blank microemulsion (94.67 ± 0.001%). Optimized curcumin-loaded microemulsion (ME5) exhibited zones of inhibition of 25.18 and 28.37 mm against Escherichia coli and Staphylococcus aureus, respectively. Among the cell lines tested, a higher concentration of ME5 showed the greatest cytotoxicity with a % viability of 8.22 ± 1.09%. Evidently, it also revealed significant in vivo anti-inflammatory effects with 93.29 ± 0.030% inhibition by the carrageenan-induced paw edema model (6 h study) and 88.39 ± 0.002% inhibition by the formalin-induced paw edema model (14 day study). In conclusion, microemulsion was safe and effective for effective delivery of curcumin with the potential for antioxidant, antibacterial, cytotoxic, and in vivo anti-inflammatory activities.

The Impact of Preoperative Spinal Injection Timing on Postoperative Complications of Lumbar Decompression Surgery.

BACKGROUND AND OBJECTIVES: Epidural steroid injections (ESIs) are commonly used for lower back pain management. The effect of these injections on lumbar decompression surgery outcomes is hitherto underexplored. The study objective was to determine the impact of ESIs on postoperative rates of medical and surgical complications and to define the appropriate interval before lumbar decompression surgery. METHODS: This retrospective all-payer database analysis identified 587 651 adult patients undergoing one- to three-level laminectomies from January 2010 to October 2021. A 2:1 propensity score match accounting for comorbidities, levels of surgery, and demographics was performed to create two cohorts: (1) 43 674 patients who had received an ESI in the 90 days before laminectomy and (2) 87 348 patients who had not received an ESI. The primary outcome was the rates of medical and surgical complications between groups at 30 days postoperatively. Patients were divided into five cohorts based on injection time before surgery: 1 to 30 days, 31 to 45 days, 46 to 60 days, 61 to 75 days, and 76 to 90 days. Logistic regression was performed between groups to identify temporal associations of complication rates. Confidence intervals of 95% are provided when appropriate. P values < .01 were considered significant. RESULTS: Rates of medical complications within 30 days of surgery were significantly higher in those with ESI compared with control (4.83% vs 3.9%, P < .001). Cerebrospinal fluid (CSF) leak rates were increased in the ESI group at 0.28% vs 0.1% (P < .001), but surgical site infection rates were not significantly different between groups (1.31% vs 1.42% P = .11). ESI performed within 30 days was associated with increased odds of CSF leak (OR: 5.32, 95% CI: 3.96-7.15). CONCLUSION: Preoperative ESI increases the risk of CSF leak and medical complications after lumbar decompression. Because these complications were significantly associated with ESIs given 1 to 30 days before surgery, avoiding ESIs at least 30 days before surgery may be advisable.

In Vitro and Biological Evaluation of Oral Fast-Disintegrating Films Containing Ranitidine HCl and Syloid® 244FP-Based Ternary Solid Dispersion of Flurbiprofen.

Flurbiprofen (FBP), a nonsteroidal anti-inflammatory drug (NSAID), is commonly used to treat the pain of rheumatoid arthritis, but in prolonged use it causes gastric irritation and ulcer. To avoid these adverse events of NSAIDs, the simultaneous administration of H2 receptor antagonists such as ranitidine hydrochloride (RHCl) is obligatory. Here, we developed composite oral fast-disintegrating films (ODFs) containing FBP along with RHCl to provide a gastroprotective effect as well as to enhance the solubility and bioavailability of FBP. The ternary solid dispersion (TSD) of FBP was fabricated with Syloid® 244FP and poloxamer® 188 using the solvent evaporation technique. The synthesized FBP-TSD (coded as TSD) was loaded alone (S1) and in combination with plain RHCl (S2) in the composite ODFs based on hydroxypropyl methyl cellulose E5 (HPMC E5). The synthesized composite ODFs were evaluated by in vitro (thickness, folding endurance, tensile strength, disintegration, SEM, FTIR, XRD and release study) and in vivo (analgesic, anti-inflammatory activity, pro-inflammatory cytokines and gastroprotective assay) studies. The in vitro characterization revealed that TSD preserved its integrity and was effectively loaded in S1 and S2 with optimal compatibility. The films were durable and flexible with a disintegration time ≈15 s. The release profile at pH 6.8 showed that the solid dispersion of FBP improved the drug solubility and release when compared with pure FBP. After in vitro studies, it was observed that the analgesic and anti-inflammatory activity of S2 was higher than that of pure FBP and other synthesized formulations (TSD and S1). Similarly, the level of cytokines (TNF-α and IL-6) was also markedly reduced by S2. Furthermore, a gastroprotective assay confirmed that S2 has a higher safety profile in comparison to pure FBP and other synthesized formulations (TSD and S1). Thus, composite ODF (S2) can effectively enhance the FBP solubility and its therapeutic efficacy, along with its gastroprotective effect.

Assessing the efficacy of VerifyNow platelet-function testing in predicting postoperative hemorrhagic complications of neuroendovascular surgery: A systematic review and meta-analysis (part 2).

BACKGROUND: Dual antiplatelet therapy is used to reduce the risk of thromboembolic complications in neuroendovascular surgery. However, the predictive utility of preoperative platelet-sensitivity testing for decreasing bleed risk in patients undergoing endovascular neurointervention remains unclear. OBJECTIVE: We conducted a systematic review and meta-analysis to illustrate the association between platelet response and risk of hemorrhagic complications from neuroendovascular surgery, examine the efficacy of the VerifyNow platelet reactivity unit (PRU) assay in predicting hemorrhagic outcomes, and assess whether a clinically useful threshold for platelet response can be defined to standardize guidelines. METHODS: PubMed, Embase, and Scopus were searched. Articles were screened for relevance by title and abstract, followed by full text. RESULTS: Of 735 resultant articles, 17 studies of 2084 patients undergoing neuroendovascular intervention were included. Diagnoses included both intracranial and extracranial pathologies, of which 37.8% were treated with flow diversion, 22.4% with stent-assisted coil embolization, 14.3% with intracranial stenting, 12.8% with simple coil embolization, 5.8% with balloon-assisted coil embolization, 2.0% with extracranial stenting, and 4.8% with an alternate method. Precisely, 52.9% (9 out of 17) of studies determined platelet hyperresponse to be an independent predictor of postoperative hemorrhagic complications, with 11.8% (2 out of 17) of studies reporting a similar but non-statistically significant trend. 35.3% (6 out of 17) of studies found no relationship between platelet response and postoperative hemorrhagic complications. The estimated clinical threshold for PRU to prevent hemorrhagic complications varied considerably across studies (range: <46-118 PRU). Meta-analysis found platelet hyperresponse to have more than a 3-fold increased risk of hemorrhagic complications compared to normoresponders (relative risk = 3.2, p = 0.001). CONCLUSION: Although this meta-analysis shows the predictive utility of the P2Y12 assay for postoperative hemorrhagic complications in neuroendovascular surgery, the optimal therapeutic threshold for minimizing bleeding risk is still uncertain. To better understand the utility of the P2Y12 assay in the perioperative period, further prospective research is needed.

Assessing the efficacy of VerifyNow platelet-function testing in predicting postoperative thromboembolic complications of neuroendovascular surgery: A systematic review and meta-analysis (part 1).

BACKGROUND: Despite the heavily debated use of routine platelet-function testing, the VerifyNow Platelet Reactivity Unit (PRU) assay has been increasingly adopted as standard of care for assessing risk of postoperative thromboembolic complications of neuroendovascular surgery. OBJECTIVE: We conducted a systematic review and meta-analysis to examine the relationship between platelet response and risk of ischemic events from neuroendovascular surgery, assess the efficacy of point-of-care platelet-function testing in predicting thromboembolic outcomes, and assess whether a clinically useful threshold for platelet response can be defined in order to standardize guidelines. METHODS: PubMed, Embase, and Scopus were searched. Following deduplication, articles were first screened for relevance by title and abstract, followed by full text. RESULTS: Of 735 resultant articles, 22 studies consisting of 3266 patients undergoing neuroendovascular intervention were included. Diagnoses included both intracranial and extracranial pathologies, of which 45.8% were treated with flow diversion, 16.4% with stent-assisted coil embolization, 15.8% with intracranial stenting, 12.0% with simple coil embolization, 3.4% with balloon-assisted coil embolization, 3.6% with extracranial stenting, and 3.0% with an alternate method. 54.5% (12/22) of studies determined platelet hyporesponse to be an independent predictor of postoperative thromboembolic complications, with 27.3% (6/22) of studies reporting a similar, but non-statistically significant trend. 18.2% (4/22) of studies found no relationship between platelet response and postoperative thromboembolic complications. The estimated clinical threshold for PRU to prevent thromboembolic complications varied greatly across studies (Range: > 144-295 PRU). Meta-analysis found platelet hyporesponse to have a 2.23-fold increased risk of thromboembolic complications compared to normoresponders (RR = 2.23, P = 0.03). CONCLUSION: While PRU demonstrates a significant predictive value for postoperative thromboembolic complications of neuroendovascular surgery, the target therapeutic threshold for minimizing ischemic events remains unclear. Further studies, such as large multicenter cohorts of the existing data, are needed to standardize guidelines.

Synthetic Interbody Devices and Traditional Bone Graft Are Associated With a Similar Rate of Surgical Complications After 1-2 Level Anterior Cervical Discectomy and Fusions.

STUDY DESIGN: Retrospective cohort. OBJECTIVE: To compare the rates of all-cause surgical complications of synthetic interbody devices versus allograft or autograft in patients undergoing 1-2 levels anterior cervical discectomy and fusion (ACDF) procedures. SUMMARY OF BACKGROUND DATA: Cervical degenerative disorders affect up to 60% of older adults in the United States. Both traditional allograft or autograft and synthetic interbody devices (polyetheretherketone or titanium) are used for decompression and arthrodesis, with increasing utilization of the latter. However, the differences in their postsurgical complication profiles are not well-characterized. PATIENTS AND METHODS: Patients who underwent 1-2 level ACDFs for cervical radiculopathy or myelopathy between 2010 and 2022 were identified using the PearlDiver Mariner all-claims insurance database. Patients undergoing surgery for nondegenerative pathologies, such as tumors, trauma, or infection, were excluded. 1:1 exact matching was performed based on factors that were significant predictors of all-cause surgical complications in a linear regression model. The primary outcome measure was the development of all-cause surgical complications after 1-2 level ACDFs. The secondary outcome was all-cause medical complications. RESULTS: 1:1 exact matching resulted in two equal groups of 11,430 patients who received treatment with synthetic interbody devices or allograft/autograft. No statistically significant difference in all-cause surgical complications was found between the synthetic cohort and the allograft or autograft cohort after 1-2 level ACDFs (Relative Risk: 0.86, 95% confidence interval: 0.730-1.014, P = 0.079). No significant differences were observed regarding any specific surgical complications except for pseudoarthrosis (Relative Risk: 0.73, 95% confidence interval: 0.554-0.974, P = 0.037), which was higher in the allograft/autograft cohort. CONCLUSION: After 1:1 exact matching to control for confounding variables, the findings of this study suggest that all-cause surgical complications are similar in patients undergoing ACDFs with synthetic interbody devices or allograft/autographs. However, the rate of pseudarthrosis appears to be higher in patients with allograft/autographs. Future prospective studies are needed to corroborate these findings.

Cannabis Use is Associated With Higher Rates of Pseudarthrosis Following TLIF: A Multi-Institutional Matched-Cohort Study.

STUDY DESIGN: This was a retrospective cohort study. OBJECTIVE: To compare the rates of pseudarthrosis in patients undergoing 1 to 3 level transforaminal lumbar interbody fusion (TLIF) procedures between cannabis users and noncannabis users. SUMMARY OF BACKGROUND DATA: Recreational use of cannabis is common, though it remains poorly studied and legally ambiguous in the United States. Patients with back pain may turn to adjunctive use of cannabis to manage their pain. However, the implications of cannabis use on the achievement of bony fusion are not well-characterized. METHODS: Patients who underwent 1 to 3 level TLIF for degenerative disc disease or degenerative spondylolisthesis between 2010 and 2022 were identified using the PearlDiver Mariner all-claims insurance database. Cannabis users were identified with ICD 10 code F12.90. Patients undergoing surgery for nondegenerative pathologies such as tumors, trauma, or infection were excluded. 1:1 exact matching was performed using demographic factors, medical comorbidities, and surgical factors which were significantly associated with pseudarthrosis in a linear regression model. The primary outcome measure was development of pseudarthrosis within 24 months after 1 to 3 level TLIF. The secondary outcomes were the development of all-cause surgical complications as well as all-cause medical complications. RESULTS: A 1:1 exact matching resulted in two equal groups of 1593 patients who did or did not use cannabis and underwent 1 to 3 level TLIF. Patients who used cannabis were 80% more likely to experience pseudarthrosis compared with patients who do not [relative risk (RR): 1.816, 95% CI: 1.291-2.556, P <0.001]. Similarly, cannabis use was associated with significantly higher rates of all-cause surgical complications (RR: 2.350, 95% CI: 1.399-3.947, P =0.001) and all-cause medical complications (RR: 1.934, 95% CI: 1.516-2.467, P <0.001). CONCLUSION: After 1:1 exact matching to control for confounding variables, the findings of this study suggest that cannabis use is associated with higher rates of pseudarthrosis, as well as higher rates of all-cause surgical and all-cause medical complications. Further studies are needed to corroborate our findings.

5-year stroke rates in nonvalvular atrial fibrillation after watchman compared to direct oral anticoagulants.

BACKGROUND: The WATCHMAN device (Boston Scientific; Marlborough, MA, USA) is noninferior to warfarin in preventing ischemic strokes while reducing bleeding risks associated with long term anticoagulation in nonvalvular atrial fibrillation (AFib). The device's performance compared to direct oral anticoagulants (DOAC) is less well known. OBJECTIVE: To compare 5-year major bleeding and ischemic stroke rates in patients with nonvalvular AFib who received a WATCHMAN device or DOAC therapy after a major bleeding event. METHODS: This retrospective, multicenter, 1:1 matched cohort study was derived from the PearlDiver Mariner database from 2010 to 2020. Patients with nonvalvular AFib on oral anticoagulation who had a major bleeding event were identified. Those who received either WATCHMAN or DOAC after resolution of the bleeding event were selected. The two groups were exactly matched 1:1 based on various comorbidities. Rates of ischemic stroke, transient ischemic attack (TIA), major bleeding, and hemorrhagic stroke were compared over 5 years. RESULTS: Each cohort consisted of 2248 patients after 1:1 matching. The mean CHADS2-VASC score was 4.81 ±â€¯1.25. At 5 years, the WATCHMAN cohort had significantly lower rates of major bleeding events [OR 0.24 (0.21, 0.27)], TIAs [OR 0.75 (0.58, 0.95)], and ischemic strokes [OR 0.72 (0.61, 0.86)]. There was no significant difference in hemorrhagic strokes [OR 1.14 (0.83, 1.58)]. CONCLUSION: Even in a high-risk population, the WATCHMAN is comparable to DOAC therapy in the primary prevention of hemorrhagic strokes and may provide benefit in the rates of bleeding events, TIAs, and ischemic strokes.

Machine learning-based detection of sarcopenic obesity and association with adverse outcomes in patients undergoing surgical treatment for spinal metastases.

OBJECTIVE: The distributions and proportions of lean and fat tissues may help better assess the prognosis and outcomes of patients with spinal metastases. Specifically, in obese patients, sarcopenia may be easily overlooked as a poor prognostic indicator. The role of this body phenotype, sarcopenic obesity (SO), has not been adequately studied among patients undergoing surgical treatment for spinal metastases. To this end, here the authors investigated the role of SO as a potential prognostic factor in patients undergoing surgical treatment for spinal metastases. METHODS: The authors identified patients who underwent surgical treatment for spinal metastases between 2010 and 2020. A validated deep learning approach evaluated sarcopenia and adiposity on routine preoperative CT images. Based on composition analyses, patients were classified with SO or nonsarcopenic obesity. After nearest-neighbor propensity matching that accounted for confounders, the authors compared the rates and odds of postoperative complications, length of stay, 30-day readmission, and all-cause mortality at 90 days and 1 year between the SO and nonsarcopenic obesity groups. RESULTS: A total of 62 patients with obesity underwent surgical treatment for spinal metastases during the study period. Of these, 37 patients had nonsarcopenic obesity and 25 had SO. After propensity matching, 50 records were evaluated that were equally composed of patients with nonsarcopenic obesity and SO (25 patients each). Patients with SO were noted to have increased odds of nonhome discharge (OR 6.0, 95% CI 1.69-21.26), 30-day readmission (OR 3.27, 95% CI 1.01-10.62), and 90-day (OR 4.85, 95% CI 1.29-18.26) and 1-year (OR 3.78, 95% CI 1.17-12.19) mortality, as well as increased time to mortality after surgery (12.60 ± 19.84 months vs 37.16 ± 35.19 months, p = 0.002; standardized mean difference 0.86). No significant differences were noted in terms of length of stay or postoperative complications when comparing the two groups (p > 0.05). CONCLUSIONS: The SO phenotype was associated with increased odds of nonhome discharge, readmission, and postoperative mortality. This study suggests that SO may be an important prognostic factor to consider when developing care plans for patients with spinal metastases.

Ehlers-Danlos Syndrome is Associated with Increased Rates of Adjacent Segment Disease Following TLIF: A Propensity Matched Study.

BACKGROUND: Ehlers-Danlos syndrome (EDS) is a collection of connective tissue disorders which are often associated with tissue laxity and disc degeneration. However, the implications of EDS on the risk of adjacent segment disease (ASD) after transforaminal lumbar interbody fusion (TLIF) are not well described. The objective of this study is to compare the rates of ASD among patients with EDS and those without EDS. METHODS: Patients who underwent 1-3 level TLIF for degenerative disc disease between 2010-2022 were identified using the PearlDiver Mariner all-claims insurance database. Patients with all types of EDS were included. Patients undergoing surgery for tumors, trauma, or infection were excluded. 1:1 propensity matching was performed using demographic factors, medical comorbidities, and surgical factors which were significantly associated with ASD in a linear regression model. The primary outcome measure was the development of ASD. The secondary outcomes were the development of pseudoarthrosis, medical complications, and surgical complications. RESULTS: Propensity matching resulted in 2 equal groups of 85 patients who did or did not have EDS and underwent 1-3 level TLIF. Patients without EDS were less likely to experience ASD (RR 0.18, 95% CI 0.09-0.35, P < 0.001). There was no significant difference between the 2 patient groups with regards to a diagnosis of pseudoarthrosis, and there was no significant difference for all-cause medical and surgical complications between the 2 patient groups. CONCLUSIONS: After propensity matching to control for confounding variables, the findings of this study suggest that EDS may be associated with an increased risk of ASD following TLIF. Future studies are needed to corroborate these findings.

The Impact of Preoperative Antithrombotic Therapy on the Risks for Thrombo-ischemic Events and Bleeding among Patients Undergoing Elective Spine Surgery.

STUDY DESIGN: Retrospective matched analysis. PURPOSE: To evaluate the effect of antithrombotic drug therapy on the rates of thrombo-ischemic or bleeding events 90 days following elective spine surgery. OVERVIEW OF LITERATURE: Thrombo-ischemic and bleeding complications in patients undergoing spine surgery are major causes of morbidity. Many patients who pursue elective spine surgery are concurrently receiving antithrombotic therapy for unrelated conditions; however, at this time, the effects of preoperative antithrombotic use on postoperative bleeding and thrombosis are unclear. METHODS: Using an all-payer claims database, patients who underwent elective cervical and lumbar spine interventions between January 1, 2010, and June 30, 2018, were identified. Individuals were categorized into groups taking and not taking antithrombotics. A 1:1 analysis was constructed based on comorbidities found to be independently associated with bleeding or ischemic complications using logistic regression models. The primary outcomes were the rates of thrombo-ischemic events and bleeding complications. RESULTS: A total of 660,866 patients were eligible for inclusion. Following the matching procedure, 56,476 patient records were analyzed, with 28,238 in each group. The antithrombotic agent group had significantly greater odds of developing any 90-day thromboischemic event after surgery: deep vein thrombosis (odds ratio [OR], 3.61; 95% confidence interval [CI], 3.06-4.25), pulmonary embolism (OR, 3.93; 95% CI, 3.34-4.62), myocardial infarction (OR, 6.20; 95% CI, 5.69-6.76), and ischemic stroke (OR, 3.76; 95% CI, 3.31-4.27). In addition, the antithrombotic agent group had an increased likelihood of experiencing hematoma (OR, 1.54; 95% CI, 1.35-1.76) and need for transfusion (OR, 2.61; 95% CI, 2.29-2.96). CONCLUSIONS: Patients taking antithrombotic medications before elective surgery of the cervical and lumbar spine had increased risks of both ischemic and bleeding events. Spine surgeons should carefully consider these implications when appraising patients for surgery, given the lack of guidelines on perioperative management of antithrombotic agents.

Enhancing operative documentation of emergency laparotomy: a systematic review and development of a synoptic reporting template.

INTRODUCTION: Currently, operative reports are narrative and often handwritten, making interpretation difficult and potentially omitting key steps of the procedure. This study undertook a systematic review to determine the current availability of synoptic operative reporting and develop a synoptic operative record template for emergency laparotomy (EL). METHODS: A PROSPERO registered study from January 1st, 2012, to December 31st, 2022, was conducted using PubMed, Scopus, and Web of Science databases in February 2023. KEYWORDS: emergency laparotomy AND operation notes OR operative notes OR documentation OR report OR pro forma OR narrative OR synoptic OR digital OR audio-visual. Studies on paediatric or pregnant patients, systematic reviews, meta-analyses, case reports, editorial comments, and letters were excluded. A synoptic operative record was designed to include key standards in the documentation, as suggested by the Colleges of Surgeons. RESULTS: The literature search yielded 4687 articles, and no relevant published articles were found. A detailed synoptic template was developed, which included 111 fields related to patient demographics, operative findings, interventions, and documentation of key variables associated with patient outcomes. 11 were text boxes, two were related to digital audio-visual uploads, and three facilitated the digital scoring/grading of findings. CONCLUSION: This systematic review identified a limited number of publications reporting synoptic operative reporting, and none related to emergency laparotomy. This novel operative template provides a platform for clear documentation of the surgery performed during emergency laparotomy, potentially facilitating data analysis, resident training, and research, in turn leading to a better understanding of patient outcomes.

Nanosizing of Lavender, Basil, and Clove Essential Oils into Microemulsions for Enhanced Antioxidant Potential and Antibacterial and Antibiofilm Activities.

Plant essential oils (EOs) possess significant bioactivities (antibacterial and antioxidant) and can be substituted for potentially harmful synthetic preservatives in the food industry. However, limited water solubility, bioavailability, volatility, and stability limit their use. Therefore, the goal of this research was nanosizing lavender essential oil (LEO), basil essential oil (BEO), and clove essential oil (CEO) in a microemulsion (ME) to improve their physicochemical attributes and bioefficacy. Tween 80 and Transcutol P were utilized for construction of pseudoternary phase diagrams. It was observed that the concentration of EOs had a great impact on the physicochemical and biological properties of MEs. A spherical droplet of MEs with a diameter of less than 20 nm with a narrower size distribution (polydispersity index (PDI) = 0.10-0.27) and a ζ potential of -0.27 to -9.03 was observed. ME formulations were also evaluated for viscosity, conductivity, and the refractive index. Moreover, the impact of delivery systems on the antibacterial property of EOs was assessed by determining the zone of inhibition and minimum inhibitory concentration against two distinct pathogen classes (S. aureus and E. coli). Crystal violet assay was used to measure the growth and development of biofilms. According to bioefficacy assays, ME demonstrated more efficient antibacterial activity against microorganisms at concentrations lower than pure EOs. CEO ME had superior activity againstS. aureus and E. coli. Similarly, dose-dependent antioxidant capacity was noted for MEs. Consequently, nanosized EO formulations with improved physicochemical properties and enhanced bioactivities can be employed in the food processing sector as a preservation agent.

The Diagnostic Accuracy of Hyperbilirubinemia in Predicting Appendicitis and Appendiceal Perforation.

Background Every diagnostic tool that may assist in the identification of appendicitis is of great importance to emergency general surgeons. While recent research has indicated that hyperbilirubinemia can serve as a valuable predictor of appendiceal perforation, these studies have not specifically examined the role of bilirubin as an indicator for acute appendicitis. This study aimed to assess the role of hyperbilirubinemia as a diagnostic factor in detecting appendicitis and appendiceal perforation. Methodology This single-center retrospective study involved 333 patients with acute appendicitis who underwent an emergency appendectomy at a model three hospital between January 2021 and December 2022. Statistical analysis was performed using STATA/SE 18.0 for Windows (StataCorp., College Station, TX, USA) to compare bilirubin levels, white blood cell count (WCC), and C-reactive protein (CRP) among normal appendices, non-perforated appendicitis, and perforated appendicitis. Results Among 333 patients, 60.66% were male, and 39.34% were female, with a male-to-female ratio of 1.54:1. The average hospital stay was 3.27 ± 3.02 days. Hyperbilirubinemia was observed in 25.53% (85 individuals). Among the 51 cases of perforated appendicitis, 70.59% had elevated bilirubin levels of above 20 µmol/L. Significantly more patients with appendiceal perforation had hyperbilirubinemia than non-perforated appendicitis (70.59% vs. 19.03%, p < 0.001). Bilirubin had higher specificity (94.29%) for detecting non-perforated appendicitis than normal appendices (odds ratio = 3.88), while WCC and CRP showed higher sensitivities. WCC had a sensitivity of 73.28% and a specificity of 42.86%, and CRP had a sensitivity of 76.53% and a specificity of 60.00%. When comparing perforated appendicitis with non-perforated appendicitis, bilirubin showed a specificity of 80.97% and an odds ratio of 10.21. The likelihood of a patient with hyperbilirubinemia having perforated appendicitis was more than 10 times higher than those without appendiceal perforation, suggesting it to be a potential indicator for appendiceal perforation. WCC showed a specificity of 26.72% and an odds ratio of 4.28, while CRP had a specificity of 23.48% and an odds ratio of 4.91. Conclusions The significant association between bilirubin levels and appendicitis highlights its potential as a valuable marker for predicting appendicitis and appendiceal perforation. The simplicity, cost-effectiveness, and diagnostic value of bilirubin assessment support its routine use in suspected cases of acute appendicitis.

Efficacy and Safety Profile of Ticagrelor Versus Clopidogrel in Percutaneous Coronary Intervention (PCI) for Acute Coronary Syndrome (ACS): A Systematic Review and Meta-Analysis.

The utilization of individualized anti-platelet therapy is of paramount significance in this era of cardiovascular advancement. This meta-analysis is also aiming to get more information relating to the effectiveness of ticagrelor versus clopidogrel among patients undergoing percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS). A comprehensive literature search was done through various databases like PubMed, Google Scholar, EMBASE, Web of Science, and the Cochrane Database Library from January 15, 2023, to February 23, 2023. After careful screening, eight articles with highly significant variables were involved in the synthesis of this meta-analysis. Data analysis was done through Review Manager (RevMan, Version 5.4; The Cochrane Collaboration, Copenhagen, Denmark). In our study, ticagrelor and clopidogrel were evaluated in 10614 and 14662 patients, respectively. Ticagrelor was significantly superior to Clopidogrel in terms of all-cause mortality (RR 0.79, 95% CI 0.69-0.91, p = 0.001), risk of MI (RR 0.74, 95% CI 0.61-0.89, p = 0.001), and stroke (RR 0.64, 95% CI 0.42-0.98, p = 0.04), but a higher risk of bleeding events was observed with Ticagrelor (RR 1.36, 95% CI 1.04-1.79, p = 0.03). The two regimens were comparable in terms of stent thrombosis. Ticagrelor was found to be best in terms of reducing post-PCI myocardial infarction, stroke, stent thrombosis, and all other mortality events in comparison to Clopidogrel. However, the bleeding events were of significant concern for the utilization of ticagrelor and required further investigations.

Effect of hydrophilic polymers on the solubility and dissolution enhancement of rivaroxaban/beta-cyclodextrin inclusion complexes.

BCS class II drugs exhibit low aqueous solubility and high permeability. Such drugs often have an incomplete or erratic absorption profile. This study aimed to predict the effects of ß-cyclodextrin (ßCD) and different hydrophilic polymers (poloxamer 188 (PXM-188), polyvinyl pyrrolidone (PVP) and soluplus (SOLO)) on the saturated solubility and dissolution profile of hydrophobic model drug rivaroxaban (RIV). Binary inclusion complex with ßCD were prepared by kneading and solvent evaporation method, at drug to cyclodextrin weight molar ratios of 1:1, 1:2, and 1:4. Saturated solubility of the hydrophobic model moiety was evaluated with ßCD to explore the increment in saturated solubility. Dissolution test was carried out to assess the drug release from the produced binary inclusion complex in the aqueous medium. Solid state analysis was performed using Fourier transform infrared spectroscopy (FTIR), Differential scanning calorimetry (DSC), X-ray diffraction (XRD), and Scanning electron microscopy (SEM) techniques. When compared to pure drug, the binary complex (Drug: ßCD at molar ratio of 1:2 w/w) demonstrated the best performance in terms of enhanced solubility and drug release. Furthermore, ternary inclusion complex was prepared with hydrophilic polymers SOLO, PVP K-30 and PXM-188 at 0.5%,1%,2.5%,5% and 10% w/w to optimized binary formulation RIV:ßCD (1:2) prepared by kneading (KN) and solvent evaporation (S.E) method. The findings demonstrated that among ternary formulations (1:2 Drug: ßCD: SOLO 10% S.E) manifested greatest improvement in saturated solubility and dissolution rate. Results of solubility enhancement and improvement in dissolution profile of model drug by ternary inclusion complexation were also supported by FTIR, DSC, XRD, and SEM analysis. So, it can be concluded that the ternary inclusion systems were more effective compared to the binary combinations in improving solubility as well as dissolution of hydrophobic model drug rivaroxaban.

Outcomes Following 2-Level Cervical Interventions with Cage-and-Plate, Zero-Profile, or Arthroplasty Constructs.

BACKGROUND: Though cage-and-plate constructs are widely used for disk height restoration in surgery for cervical disc disease, concerns over range of motion limitations and adjacent disc space violations have fueled the development of artificial disc and zero-profile constructs. This study investigated the outcomes of patients undergoing two-level cervical interventions via arthroplasty, cage-and-plate, or zero-profile constructs. METHODS: Patients undergoing two-level anterior cervical procedures between 2010 and 2020 were identified using an all-payer claims database. Logistic regression models were utilized to develop criteria for a 1:1:1-exact match procedure. The primary outcome was the need for additional surgery within 30 months, and the secondary outcomes included medical and surgical complications observed within 30 days of index intervention. P values < 0.05 were considered statistically significant. RESULTS: 133,831 patients were identified as undergoing two-level anterior cervical interventions. Seven thousand three hundred seventy-one records were analyzed through a 1:1:1 match. Patients who received zero-profile versus cage-and-plate constructs had significantly decreased odds of requiring additional surgery within 30 months (Odds Ratio [OR] 0.64; 95% Confidence Interval [CI] 0.51-0.81). However, postoperative medical complications were increased among patients who received zero-profile constructs compared to cage-and-plate (OR 1.59; 95%CI 1.07-2.37). Patients who underwent arthroplasty also had decreased odds for additional surgery versus cage-and-plate (OR 0.75; 95%CI 0.60-0.93). There was no significant difference between arthroplasty and cage-and-plate constructs in developing postoperative surgical or medical complications. CONCLUSIONS: Among patients undergoing two-level interventions, cage-and-plate constructs were associated with increased odds of additional surgery within 30 months following index procedures when compared to zero-profile constructs or arthroplasty.

Development, stabilization, and characterization of nanoemulsion of vitamin D3-enriched canola oil.

In this study, the oil-in-water nanoemulsion (NE) was prepared and loaded with vitamin D3 in food-grade (edible) canola oil and stabilized by Tween 80 and Span 80 by using a water titration technique with droplet sizes of 20 to 200 nm. A phase diagram was established for the influence of water, oil, and S-Mix concentration. The outcomes revealed that the particle size of blank canola oil nanoemulsion (NE) ranged from 60.12 to 62.27 (d.nm) and vitamin D3 NE ranged from 93.92 to 185.5 (d.nm). Droplet size and polydispersity index (PDI) of both blank and vitamin D3-loaded NE results were less than 1, and zeta potential results for blank and vitamin D3 loaded NE ranged from -9.71 to -15.32 mV and -7.29 to -13.56 mV, respectively. Furthermore, the pH and electrical conductivity of blank NE were 6.0 to 6.2 and 20 to 100 (µs/cm), respectively, whereas vitamin D3-loaded NE results were 6.0 to 6.2 and 30 to 100 (µs/cm), respectively. The viscosity results of blank NE ranged from 0.544 to 0.789 (mPa.s), while that of vitamin D3-loaded NE ranged from 0.613 to 0.793 (mPa.s). In this study, the long-term stability (3 months) of canola oil NE containing vitamin D3 at room temperature (25 C) and high temperature (40 C) was observed.

Pharmacological and toxicological evaluation of methyl 4-hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxoide against haloperidol induced Parkinson like symptoms in animal model: In-vitro and in-vivo studies.

In Parkinson's disease (PD), degradation of dopaminergic neurons in substantia nigra causes striatal deficiency of dopamine, which results in tremors, bradykinesia with instability in posture, rigidity and shuffled gait. Prevalence of PD increases with age as from 65 to 85 years. In an attempt to devise targeted safe therapy, nanoparticles of methyl 4-hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide (MBD) (MBDN), were prepared and their acute toxicity and safety was evaluated. Thirty-six healthy albino mice were randomly divided into six groups (n = 6): normal control, diseased control, standard (levodopa/carbidopa (100/25 mg/kg) and the remaining three groups were administered 1.25, 2.5 and 5 mg/kg MBDN during 21 days study. Except control, all mice, were injected haloperidol (1 mg/ kg i.p.) 1-h prior to treatment to induce PD. Acute toxicity test showed, no effect of MBDN on lipid profile, brain, renal and liver function and histoarchitecture of kidney, liver and heart, except decreased (p < 0.05) platelet count. Behavioral studies showed significant improvement (p < 0.001) in motor function and reduction of oxidation status in a MBDN in a dose dependent manner. Thus, the study findings revealed significance of MBDN as a selective MAO-B inhibitor for the improvement of Parkinson's symptoms in animal model.